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510(k) Data Aggregation
(224 days)
The Fluoro-Tex™ Cardiovascular Patch is intended to be used for the repair of the cardiovascular system.
Fluoro-Tex Cardiovascular Patch consists of a sheet of porous expanded polytetrafluoroethylene (ePTFE) internally reinforced with fluorinated ethylene propylene (FEP).
Here's an analysis of the provided text regarding the Fluoro-Tex™ Cardiovascular Patch, structured according to your request:
In this case, the device is a cardiovascular patch, and the testing focuses on mechanical and biocompatibility properties rather than algorithm performance. Therefore, questions related to AI/algorithm performance (such as sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training data) are not applicable.
Acceptance Criteria and Device Performance for Fluoro-Tex™ Cardiovascular Patch
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" but rather presents a comparison of the Fluoro-Tex™ Cardiovascular Patch to predicate devices. The implicit acceptance criterion is that the Fluoro-Tex™ patch performs comparably or better than the predicate devices across the measured mechanical properties.
| Test / Performance Metric | Predicate Device 1 (Gore-Tex® Cardiovascular Patch) | Predicate Device 2 (IMPRA® Cardiovascular Patch) | Fluoro-Tex™ Cardiovascular Patch (Reported Performance) | Implicit Acceptance Criteria (Comparative) |
|---|---|---|---|---|
| Tensile Strength (kg/cm²) | 26.7 (n=4) | 20.5 (n=4) | 20.7 (n=6) | Comparable to or exceeding predicate devices |
| Suture Strength (kg/pin) | 2.1 (n=4) | 1.8 (n=4) | 2.0 (n=6) | Comparable to or exceeding predicate devices |
| Burst Strength (psi) | Na (Not applicable/not provided) | 294 (n=5) | 284 (n=5) | Comparable to or exceeding the IMPRA® patch (as Gore-Tex® data is not available) |
2. Sample size used for the test set and the data provenance:
- Tensile Strength:
- Gore-Tex®: n=4
- IMPRA®: n=4
- Fluoro-Tex™: n=6
- Suture Strength:
- Gore-Tex®: n=4
- IMPRA®: n=4
- Fluoro-Tex™: n=6
- Burst Strength:
- IMPRA®: n=5
- Fluoro-Tex™: n=5
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This appears to be laboratory-based mechanical testing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as this is laboratory mechanical testing data, not expert-derived ground truth.
4. Adjudication method for the test set:
Not applicable, as this is laboratory mechanical testing data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable, as this device is a physical medical patch, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this device is a physical medical patch, not an algorithm.
7. The type of ground truth used:
- Mechanical Tests: The "ground truth" implicitly refers to the measured physical properties of the materials and devices under controlled laboratory conditions, using established engineering test methods.
- Biocompatibility: Demonstrated through cytotox, FTIR, and in-house cleanliness testing, relying on the known safety profile of PTFE, the material used in the device and its predicates.
8. The sample size for the training set:
Not applicable, as this is a physical medical device, not an AI/machine learning model.
9. How the ground truth for the training set was established:
Not applicable, as this is a physical medical device.
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