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For reconstruction and repair of the pericardium

Biocompatible, expanded polytetrafluoroethylene (ePTFE). The ePTFE material has a nominal pore size of < 1 µm. The device is in sheet configuration with a variety of width and length dimensions.

The provided document is a 510(k) Premarket Notification for the PRECLUDE® Pericardial Membrane. It details a modification to the labeling only of an already marketed device. Therefore, the information provided does not contain a study proving the device meets acceptance criteria as this submission is not introducing a new device or a change in technological characteristics. Instead, it relies on the substantial equivalence to its predicate device.

Here's an analysis based on the understanding that this is a labeling modification submission:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this submission is a modification to labeling only, there are no new acceptance criteria or reported device performance metrics established for this specific submission. The device's performance relies on the previous clearance of the predicate device.

2. Sample Size Used for the Test Set and the Data Provenance:

No new test set was used for this submission. The efficacy and safety of the ePTFE material were previously established and are referenced as: "Reports of data from animal studies and from clinical experiences documented in the literature demonstrate that ePTFE material with a nominal pore size of < 1 µm limits tissue to membrane attachment and thus attachment between surfaces that it covers and surrounding tissue." The specific sample sizes, country of origin, or whether these historical studies were retrospective or prospective are not detailed in this document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not applicable. No new test set was created or evaluated for this labeling modification. The ground truth for the underlying material's performance was established via existing animal studies and clinical literature, but no details on expert panels for these historical studies are provided.

4. Adjudication Method for the Test Set:

Not applicable. No new test set or adjudication process was performed for this labeling modification.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. This submission focuses on labeling changes, not comparative performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This is not an AI/algorithm-based device.

7. Type of Ground Truth Used:

The document refers to "Reports of data from animal studies and from clinical experiences documented in the literature." This suggests that the ground truth for the material's efficacy in preventing tissue attachment was established through a combination of animal study outcomes and clinical outcomes data from human experiences.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that uses a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. This is not an AI/machine learning device.

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