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The Bard® Ventralex™ Hernia Patch is intended for use in all forms of hernia repair requiring reinforcement with a nonabsorbable support material. The small Bard® Ventralex™ Hernia Patch (4.3 cm / 1.7") is also intended to repair soft tissue deficiencies, including deficiencies caused by trocars.

The proposed Ventralex Hernia Patch is a self-expanding, sterile prosthesis, containing two primary layers of polypropylene mesh stitched with polytetrafluoroethylene (PTFE) monofilament to an expanded polytetrafluoroethylene (ePTFE) sheet. The mesh component is non-absorbable; however, the device contains a fully absorbable recoil ring using SorbaFlex™ Memory Technology, an absorbable polydioxanone (PDO) monofilament.

The mesh is constructed from knitted polypropylene monofilament and forms a strong, porous, support material. The top layer of mesh has a mesh strap and forms a positioning pocket with the second mesh layer. The propylene mesh side promotes tissue in-growth and repairs the defect. The strap and pocket facilitate placement, positioning and fixation of the device. For a reference point, the small Ventralex Hernia Patch is constructed with a depth marker on the positioning strap. The depth marker is polypropylene monofilament dyed with a blue colorant to indicate the position of the device relative to the end of the laparoscopic trocar sleeve. After fixation to the abdominal wall, excess positioning strap material above the fixation line and at the level of the fascia is cut off and discarded.

A layer of ePTFE is stitched with PTFE monofilament thread and edge heat sealed to the polypropylene mesh. The ePTFE layer minimizes tissue attachment to the device. The SorbaFlex Memory Technology is comprised of an absorbable PDO monofilament welded to form a ring. The PDO monofilament recoil ring provides memory and stability to the device, facilitating ease of initial insertion, proper placement, and fixation of the device. The PDO monofilament fully degrades by means of hydrolysis in vivo in 6 - 8 months. The PDO monofilament ring is placed within a mesh tube constructed from a knitted polypropylene monofilament. The purpose of the mesh tube is to contain the PDO monofilament recoil ring during the degradation process.

This document is a 510(k) Premarket Notification for a medical device, specifically a surgical mesh for hernia repair. It is a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study proving the device meets specific acceptance criteria in the sense of clinical performance metrics.

Therefore, many of the requested categories (acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable to this type of regulatory submission, as it focuses on material and design equivalence, not clinical efficacy or diagnostic accuracy.

Here's an breakdown based on the provided text, addressing the applicable points:

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

The document does not present a table of specific acceptance criteria in the way one might for a diagnostic AI or imaging device's performance metrics (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" for this 510(k) submission are implicitly met by demonstrating substantial equivalence to predicate devices through various tests.

The reported device performance is described qualitatively rather than with quantitative metrics against predefined numerical thresholds.

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated with numerical values. The text refers to "bench testing results," "in vivo simulated use experiments," and "whole system simulated use testing in an animal model." These are typically qualitative or small-scale engineering/animal studies rather than large clinical test sets with defined sample sizes for statistical inference.
• Data Provenance: The document does not specify country of origin for any data. The studies are described as "bench testing" and "in vivo simulated use experiments" (animal model), implying laboratory-based or preclinical studies. They are prospective in the sense that they were performed specifically for this 510(k) submission or referenced from previous predicate device submissions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a medical device 510(k) for a physical implant, not a diagnostic or AI algorithm requiring expert ground truth for interpretation. The "ground truth" here is the physical and biological performance of the device itself (e.g., does it recoil, is it biocompatible, does the material degrade as expected).

4. Adjudication method for the test set

Not applicable. This type of submission does not involve human readers interpreting data that would require an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

Not applicable. This is a medical device 510(k) for a physical implant, not a diagnostic or AI algorithm.

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

Not applicable. This is a medical device 510(k) for a physical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" implicitly used for this device involves:

• Bench Testing Standards: Acceptance against predefined engineering specifications for material properties, mechanical performance (e.g., recoil to a flat position), and physical integrity.
• Biocompatibility Standards: Compliance with ISO 10993 standards for biological evaluation of medical devices.
• In Vivo Observations (Animal Model): Direct observation of device behavior in a biological system (e.g., "whole system simulated use testing in an animal model") to ensure it meets user needs.
• Resorption Studies: Chemical and biological analyses to confirm the degradation profile of the absorbable component.

8. The sample size for the training set

Not applicable. This is a medical device 510(k) for a physical implant, not an AI algorithm that requires a training set. The device manufacturing processes would have internal validation data, but this is not typically disclosed as a "training set" in a 510(k) summary.

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

Not applicable for the same reasons as #8.

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