You have an authorized PCCP. When you retrain, will your modification survive FDA scrutiny?
Every FDA-cleared AI device with a PCCP has monitoring commitments baked into a binding regulatory document — and most vendors aren't producing the evidence those commitments require until an inspector asks or a hospital deal stalls in procurement. Sentir is the independent system of record for your model's performance: a continuous, tamper-evident record, kept separately from your own engineering dashboards, that produces audit-defensible evidence for your PCCP automatically.
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Now accepting design partners. Limited cohort. Design partners receive full onboarding, first conformance package generated, two strategy sessions, and design-partner pricing.
Writing your PCCP monitoring section now? We help you write it to be defensible and automatable — then deliver the infrastructure that satisfies it from day one of deployment.
Or request a product brief by email.
The next time you exercise your PCCP, you need this.
When you exercise your PCCP — retrain your model, add a scanner vendor, expand to a new population — you need to produce a conformance package demonstrating the change stayed within your cleared regulatory envelope under 515C. That package has two parts most teams miss.
Part one: your new model's performance against the acceptance criteria in your modification protocol. PPV, F1, accuracy, non-inferiority — whatever your PCCP specifies, run against your cleared baseline.
Part two: evidence that the deployed model was operating within spec during the entire prior deployment period. This is the part that requires monitoring data you cannot reconstruct retroactively on the day you exercise the modification. If you have not been collecting it, your conformance package has a gap. A sophisticated inspector will find it.
Only 9% of FDA-cleared AI devices have any post-market surveillance plan. If you have an authorized PCCP, you are in the 9% — and your conformance package needs to show it.
What a complete PCCP conformance package contains
Sentir generates all four sections automatically.
Section 1 — New model performance validation. Your modified device's results against the acceptance criteria in your modification protocol. PPV, F1, accuracy, non-inferiority — whatever your PCCP specifies, run against your cleared baseline, with statistical evidence and sample sizes.
Section 2 — Deployment-period field monitoring. Weekly distribution analysis from the entire deployment period of the prior version. Input distribution stability. Subpopulation monitoring across every dimension your PCCP specifies. Ground truth re-test results at the cadence your modification protocol requires. Evidence the prior version was operating within its cleared envelope before you exercised the modification. This is the section most manual conformance packages are missing.
Section 3 — Modification traceability. This change maps to PCCP modification category X. Here is the protocol it follows. Here is the impact assessment. Here is the evidence it stays within the cleared envelope.
Section 4 — Part 11 audit trail. Every data point, every computation, every report generation event. Timestamps. Model versions. Data versions. Regulatory lead approval signature. Tamper-evident. Producible on demand in response to an FDA inquiry or a hospital procurement request.
Without Section 2, your conformance package has a gap. Section 2 requires continuous deployment-period monitoring. Sentir runs that monitoring automatically from the day your device deploys — so when you exercise your PCCP, the evidence is already there.
Excerpt from a complete Sentir conformance package.
How it works
We read your PCCP
Upload your authorized PCCP. Sentir extracts every monitoring commitment your modification protocol requires — metrics, thresholds, subpopulations, cadence, ground truth protocol. We map it to your cleared sections. This becomes the structure your conformance package is built around — and the standard every downstream evidence item is measured against.
We run the monitoring
A lightweight SDK integrates into your inference pipeline in hours. Sentir captures prediction events asynchronously — no latency impact, no PHI in the pipeline. Weekly, we run distribution checks against your training baseline across every subpopulation your PCCP specifies. This is the deployment-period evidence your conformance package requires. It accumulates from day one of deployment, automatically.
We generate the report
At modification time and every quarter, Sentir generates your complete PCCP conformance package — Section 1 through Section 4, statistically evidenced, Part 11 audit-trailed. Your regulatory lead reviews and approves in the platform. The artifact is yours, in your regulatory file, ready to produce on demand.
Silent drift doesn't show up in dashboards.
Confidence dashboards and complaint logs only catch the problems a model admits to. A model can degrade while staying confident, and clinicians anchored on confident outputs override less, not more — so both signals stay quiet while performance slips. That's why Sentir runs a scheduled, stratified non-inferiority re-test against your cleared baseline, not just telemetry.
Built for FDA-cleared AI/SaMD vendors
Vendors with authorized PCCPs
You have a PCCP. Every time you exercise it, you need a conformance package. Sentir generates it automatically — including the deployment-period monitoring evidence that makes it complete. No scramble. No gaps. No manual reconstruction.
Vendors preparing PCCP submissions
Your monitoring section determines what you will be obligated to produce post-clearance. We help you write it to be both defensible and automatable — then deliver the infrastructure that satisfies it from day one of deployment. Start producing evidence before your first modification.
Radiology AI, diagnostic AI, intraoperative AI
Denoising models, arrhythmia classifiers, intraoperative neuromonitoring algorithms — each has a different monitoring surface, different ground truth protocol, different PCCP structure. Sentir handles all of them. The PCCP is the spec. We execute it.
Every authorized PCCP, mapped.
Sentir maintains a structured database of every FDA-authorized PCCP — device, manufacturer, modification scope, monitoring commitments, regulatory contact. If your device is in here, your conformance package structure is already partially mapped.
We have read every cleared PCCP. We know what your modification protocol requires. That is where your onboarding starts.
Not sure if your device has an authorized PCCP? Look it up here.
More than one cleared device?
One cleared device with a PCCP means one conformance package per modification cycle. Three devices, four modifications each per year — that is twelve conformance packages annually, each requiring deployment-period monitoring evidence, each needing a Part 11 audit trail, each mapping to different PCCP sections with different acceptance criteria. Building and maintaining that infrastructure in-house is a material engineering investment for a non-core capability. Sentir covers your entire portfolio from one system. Every device. Every PCCP. Every modification.
Engineering dashboards show you what is happening — but they're built and run by the same team being audited. Consultants produce reports when you ask, weeks later. Sentir is the independent system of record: a continuous, tamper-evident record of your model's performance that produces audit-defensible evidence for an FDA inspector or a hospital procurement team automatically, without a consultant in the loop and without a manual scramble. The difference is not what gets monitored. The difference is what gets produced.
The question your hospital procurement team is asking
Hospital IT security teams are asking AI device vendors: how do you know your model is still performing within its validated parameters in our environment? Most vendors answer with dashboards or verbal assurances. The vendors closing enterprise deals answer with documentation — a structured, audit-trailed evidence package that maps field performance to their specific cleared regulatory commitments. That documentation is the PCCP conformance package. Sentir is how you produce it.
If you have an authorized PCCP, this is the conversation.
Talk to us before your next retrain, your next hospital contract renewal, or your next FDA audit. We'll show you what your audit-defensible evidence looks like today — and what it needs to look like before your modification has to survive scrutiny.
Or request a product brief by email.