FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

The absorbable VICRYL™ Mesh may be used wherever temporary wound support is required. VICRYL™ Mesh may be cut to the shape or size desired for each specific application.

Device Description

VICRYL™ (polyglactin 910) Mesh is a synthetic absorbable sterile copolymer made from glycolide and L-lactide. The copolymer is identical in composition to that used in VICRYL™ (polyglactin 910) synthetic absorbable suture.

Two weave configurations are available, knitted and woven. VICRYL™ Knitted Mesh is more porous than VICRYL™ Woven Mesh and may be used in instances in which compliant and stretchable support material is desired.

AI/ML Overview

This document, an FDA 510(k) Premarket Notification for VICRYL™ Mesh (K201143), does not describe a study involving an AI/image analysis device. It is a submission for a surgical mesh, and the basis for its clearance is substantial equivalence to a previously cleared device (K191373), with the only change being a revision to the Instructions for Use labeling.

Therefore, many of the requested elements for describing the acceptance criteria and study proving device performance (e.g., sample size for test/training sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment) are not applicable to this specific FDA submission.

However, I can extract the general acceptance criteria and "performance" of this device within the context of a 510(k) clearance, which is based on demonstrating substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance (in the context of Substantial Equivalence for a Medical Device)

Since this document is a 510(k) clearance for a surgical mesh and not an AI/image analysis device, the concept of "acceptance criteria" and "device performance" is framed in terms of demonstrating substantial equivalence to a legally marketed predicate device. The primary "acceptance criteria" for a 510(k) submission like this is that the new device is as safe and effective as a predicate device and does not raise new questions of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for Substantial Equivalence)	Reported Device Performance (as stated in the 510(k) Summary)
Fundamental Scientific Technology: Be of the same type of technology.	Both the subject device (VICRYL™ Mesh) and the predicate device (VICRYL™ Mesh, K191373) are synthetic absorbable sterile copolymers.
Intended Use: Have the same intended use.	Both devices are intended for use wherever temporary wound support is required.
Materials: Be composed of the same materials.	Both are made from glycolide and L-lactide copolymer, identical to that used in VICRYL™ (polyglactin 910) synthetic absorbable suture.
Design: Have similar design characteristics (e.g., two weave configurations available: knitted and woven).	Both devices have two weave configurations available (knitted and woven). 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Construction: Be constructed using the same manufacturing processes.	The subject mesh is manufactured within the existing manufacturing processes for the predicate device. No changes to manufacturing, packaging, sterilization processes, or shelf life.
Performance Characteristics: Exhibit comparable performance.	The devices function in the same manner. No changes to performance characteristics were noted or implied by the change only in labeling. 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Impact of differences: Any differences do not raise new questions of safety or effectiveness.	The only stated difference is a revision to the Instructions for Use (labeling) to provide additional clarity to the Indications statement. This change does not alter the fundamental characteristics or function of the device and thus does not raise new questions of safety or effectiveness.

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

Not Applicable. This 510(k) submission did not involve a "test set" in the sense of a dataset for evaluating an AI algorithm's performance. The clearance was based on substantial equivalence, meaning the device itself (VICRYL™ Mesh) was deemed equivalent to a previously cleared version.
Data Provenance: Not applicable as no new clinical or non-clinical testing data were generated or relied upon for this specific submission, other than the updated labeling. The core "data" supporting this clearance is the demonstration of sameness to the predicate device and the predicate's existing clearance history.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not Applicable. No ground truth establishment by experts was required for this 510(k) given that no new performance data was submitted or required. The review process is primarily regulatory and technical comparison to a predicate, not clinical validation of performance with a study.

4. Adjudication Method for the Test Set:

Not Applicable. No test set requiring adjudication was used.

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

Not Applicable. This is not an AI/image analysis device. Therefore, no MRMC study comparing human readers with and without AI assistance was performed.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance:

Not Applicable. This is not an AI/image analysis device. Therefore, no standalone algorithm performance was assessed.

7. Type of Ground Truth Used:

Not Applicable. No clinical "ground truth" (e.g., pathology, outcomes data) was used or generated for this submission as it was based on substantial equivalence and a labeling change for an existing device. The "ground truth" in a regulatory sense here is the established safety and effectiveness of the predicate device.

8. Sample Size for the Training Set:

Not Applicable. As this is not an AI/image analysis device, there was no "training set."

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

Not Applicable. As there was no "training set," there was no ground truth to establish for it.

§ 878.3300 Surgical mesh.