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OviTex PRS (Long-Term Resorbable) is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one time use.

OviTex PRS (Long-Term Resorbable) is a surqical mesh manufactured by layering sheets of ovine forestomach matrix to create multi-layer configurations of devices sewn together with resorbable Poly(lactic-co-glycolic Acid) ("PLGA") suture for use in plastic and reconstructive surgery. The 2-8 ply devices are available in surface areas up to 434 cm² in various shapes.

This document is a 510(k) Premarket Notification from the FDA for the OviTex PRS (Long-Term Resorbable) surgical mesh. While it discusses the device's characteristics and its comparison to a predicate device, it does not contain information about the acceptance criteria and study that proves the device meets specific performance criteria in the way typically expected for an AI/ML medical device.

The document indicates that substantial equivalence was not based on an assessment of clinical performance data. Instead, it relies on preclinical, mechanical, and biocompatibility testing to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested points cannot be answered from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document states: "New bench testing included mechanical strength, suture retention, endotoxin, and compliance testing. Results of the testing confirms that the proposed device meets all product specifications." However, it does not provide the specific acceptance criteria (e.g., tensile strength > X N, suture retention > Y N) or the quantitative reported device performance for these tests.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Bench Testing (Mechanical, Suture Retention, Endotoxin, Compliance): The sample sizes for these tests are not provided. Data provenance is not specified beyond "Preclinical testing."
• Biocompatibility Assessment: Not specified.
• Implantation Study: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the type of studies described (mechanical, biocompatibility, implantation) for a surgical mesh. These studies do not typically involve experts establishing ground truth in the way an AI/ML diagnostic device would for image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for the types of studies described.

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

No, an MRMC study was not done. This device is a surgical mesh, not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Bench Testing: Engineering specifications and standardized test methods.
• Biocompatibility: ISO 10993 standards and toxicological risk assessment.
• Implantation Study: Histopathological evaluation of tissue response compared to the predicate, as per ISO 10993-6. This could be considered a form of "pathology" ground truth. The study concluded that the subject device was "classified as a non-irritant" and had "advanced to complete resorption by 78 weeks."

8. The sample size for the training set

Not applicable. This device does not use an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary Table (Limited Information Available from Document):

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