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The Ventralex ST Hernia Patch is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, including repair of hernias and deficiencies caused by trocars.

Device Description

The proposed device. Ventralex ST Hernia Patch, is a self-expanding bioresorbable coated, partially absorbable, sterile prosthesis, containing 2 distinct layers stitched with PTFE monofilament, forming a positioning pocket and strap. The top layer is knitted polypropylene mesh, 0.004" in monofilament diameter, and the bottom layer is Sepramesh IP Mesh. Sepramesh IP Mesh is co-knitted using polypropylene (PP) and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a PP surface and a PGA surface. The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. The fascial side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, allowing for tissue ingrowth into the mesh. The visceral side of the mesh is a bioresorbable coating the mesh from underlying tissue and organ surfaces to minimize tissue attachment to the mesh. Shortly after placement, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days. A depth marker on the positioning strap for the small Ventralex ST Hernia Patch is designed to facilitate placement of the small patch through a trocar. The device contains Sorbaflex Memory Technology which provides memory and stability to the device, facilitating ease of initial insertion, proper placement, and fixation of the device. The Sorbaflex Memory Technology is comprised of an extruded polydioxanone (PDO) absorbable monofilament that is contained within a knitted polypropylene mesh tube. The Sorbaflex PDO monofilament fully degrades in vivo by means of hydrolysis. Absorption is essentially complete in 6-8 months.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Ventralex ST Hernia Patch, focusing on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria with a new study. Therefore, the concept of "acceptance criteria" as applied to a new diagnostic accuracy study or a clinical trial for a new therapeutic device is not directly applicable in the same way.

However, the sponsor did perform various tests to show that the new device characteristics perform similarly to the predicate devices. I will interpret "acceptance criteria" as a comparison of the new device's performance to that of its predicate devices to demonstrate substantial equivalence for safety and effectiveness. The "study" refers to these comparative bench and preclinical tests.

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

Test Category	Specific Test	Acceptance Criteria (Implicit)	Reported Device Performance
Physical Characteristics	Mesh Weave	Similar to predicate devices	Similar to predicate devices
	Mesh Pore Size	Similar to predicate devices	Similar to predicate devices
	Device Density	Similar to predicate devices	Similar to predicate devices
	Device Thickness	Similar to predicate devices	Similar to predicate devices
	Device Stiffness	Similar to predicate devices	Similar to predicate devices
Performance Evaluations	Burst Strength	Similar to predicate devices	Similar to predicate devices
	Suture Pullout Strength	Similar to predicate devices	Similar to predicate devices
	Strap Strength	Similar to predicate devices	Similar to predicate devices
	PDO Ring Weld Tensile Strength	Similar to predicate devices	Similar to predicate devices
	PGA Pullout Strength	Similar to predicate devices	Similar to predicate devices
	Dry Bond Strength	Similar to predicate devices	Similar to predicate devices
	Mass/Area Measurements	Similar to predicate devices	Similar to predicate devices
	Deployment/Hydrogel Disruption Testing	Similar to predicate devices	Similar to predicate devices
Preclinical Studies (Pigs)	Peritoneal Tissue Attachment	Comparable to predicate devices	Overall performance studies in pigs indicated comparability
	Percent Area Coverage	Comparable to predicate devices	Overall performance studies in pigs indicated comparability
	Mesh Contracture	Comparable to predicate devices	Overall performance studies in pigs indicated comparability
	Tissue Ingrowth	Comparable to predicate devices	Overall performance studies in pigs indicated comparability
	Host Inflammatory/Fibrotic Response	Comparable to predicate devices	Overall performance studies in pigs indicated comparability
Degradation Study (Rats)	Host Inflammatory/Fibrotic Response	Acceptable and similar during degradation of materials	In vivo degradation study in rats indicated acceptable response and absorption
	Absorption Characteristics	Acceptable and similar for bioresorbable coating, PGA fibers, and PDO monofilament during degradation	In vivo degradation study in rats indicated acceptable response and absorption
Biocompatibility	Biocompatibility (ISO 10993)	Meets ISO 10993 standards	Device is biocompatible per ISO 10993 standards

Note: The document states "The results demonstrate that the proposed device is substantially equivalent to the currently marketed predicate devices," implying that the performance of the proposed device met the implicit acceptance criteria of being similar or comparable to the predicate devices across all tested parameters.

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

The document does not explicitly state the specific sample sizes for each bench test (e.g., number of patches tested for burst strength) or for the preclinical animal studies (number of pigs or rats).

Provenance: This was a premarket regulatory submission; therefore, the data would have been generated prospectively by the manufacturer (Davol Inc., a subsidiary of C.R. Bard, Inc.) for the purpose of demonstrating substantial equivalence.
Country of Origin: The submitter's address is Warwick, RI, USA. The testing was presumably conducted either within the US or at facilities commissioned by the US-based manufacturer. The document does not specify the exact locations of the test facilities.

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 section is not applicable. The studies performed were bench and preclinical in vivo (animal) studies, not studies requiring human expert interpretation or ground truth establishment in the clinical diagnostic sense. Performance was measured by objective physical/mechanical tests and observations in animal models by scientists/researchers involved in the studies.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human expert consensus scenarios, typically in diagnostic imaging or clinical trials. The studies described here are laboratory and animal studies with objective measurements or observations by trained personnel, not human interpretation requiring adjudication.

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

This section is not applicable. The submission is for a surgical mesh device, not a diagnostic AI device requiring human reader interpretation or assistance. Therefore, no MRMC study was performed, and no effect size regarding human reader improvement with AI is relevant to this submission.

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

This section is not applicable. The submission is for a physical surgical device, not a standalone algorithm.

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

For the bench tests, the "ground truth" was established by the physical and mechanical properties of the predicate devices. The new device's performance was measured against these established properties. For the preclinical animal studies, the "ground truth" was established by histological examination (for tissue ingrowth, inflammatory response, degradation) and gross observation (peritoneal tissue attachment, percent area coverage, mesh contracture) based on established scientific and veterinary pathology standards.

8. The sample size for the training set

This section is not applicable. This submission describes bench and animal studies for a physical medical device, not a machine learning model. There is no "training set" in the context of this regulatory submission.

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

This section is not applicable for the reasons stated in point 8.

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