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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.

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.

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

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.

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VICRYL™ Mesh may be used wherever temporary wound or organ support is required (kidney, liver, spleen). VICRYL™ Mesh may be cut to the shape or size desired for each specific application.

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.

VICRYL™ Knitted Mesh, which is more porous than VICRYL™ Woven Mesh, may be used in instances in which compliant and stretchable support material is desired.

The provided document is a 510(k) Premarket Notification for the VICRYL™ Mesh device. It asserts substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a study with performance metrics.

Therefore, many of the requested categories regarding acceptance criteria, study design, ground truth, and statistical analysis are not applicable (N/A) because this type of submission focuses on demonstrating equivalence to existing devices, not on presenting novel performance data from a clinical or analytical study with defined acceptance criteria.

Here's a breakdown based on the information available:

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

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

• N/A. This 510(k) submission does not describe a test set or data provenance for a performance study. It's a regulatory submission demonstrating substantial equivalence based on technological characteristics and intended use, not clinical performance data.

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)

• N/A. As no test set performance study is described, there's no mention of experts establishing ground truth.

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

• N/A. No test set performance study is described, therefore no adjudication method.

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

• N/A. This is a medical device (surgical mesh), not an AI-based diagnostic tool. No MRMC study was conducted or described.

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

• N/A. This is a physical medical device (surgical mesh), not an algorithm.

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

• N/A. No new performance study requiring ground truth is described. The basis for clearance is substantial equivalence to legally marketed predicate devices, meaning their known safety and effectiveness serve as the "ground truth" for the category.

8. The sample size for the training set

• N/A. This 510(k) submission pertains to a physical medical device (surgical mesh) and does not involve an algorithm or an AI model with a training set.

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

• N/A. As there is no training set for an algorithm, there's no ground truth establishment for it.

Summary of the 510(k) Submission:

The submission for VICRYL™ Mesh (K191373) focuses on demonstrating substantial equivalence to two predicate devices: VICRYL™ (Polyglactin 910) Mesh (K810428) and VICRYL™ Mesh Bag (K051701).

The core argument for equivalence is:

• Technological Characteristics: Both the subject and predicate devices are synthetic absorbable sterile copolymers made from glycolide and L-lactide.
• Intended Use: All devices are designed for temporary wound or organ support (kidney, liver, spleen) and can be cut to size.
• Manufacturing and Sterilization: The subject mesh is manufactured within existing processes for the predicate device, with no changes to manufacturing, packaging, sterilization, or shelf life.
• Differences: The only notable difference for the subject device is a revision to the Instructions for Use (IFU) to clarify indications and align with evolving regulatory expectations.

Therefore, Ethicon, Inc. did not conduct a performance study with acceptance criteria and a test set to "prove the device meets the acceptance criteria" in the manner typically expected for a novel device or AI algorithm. Instead, they demonstrated that their device is fundamentally the same as already cleared devices, making it "as safe and effective as the predicates."

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VICRYL Mesh bag may be used wherever temporary wound or solid organ support is required (kidney, liver, spleen).

VICRYL Mesh Bag consists of a VICRYL Mesh adapted to the form and size of kidney, spleen, or liver and tied with VICRYL sutures (dyed and undyed). The integrated strands of VICRYL sutures are threaded along the periphery of the mesh, which facilitates its use as organ support for the kidney, spleen, or liver. The VICRYL Mesh is prepared from polyglactin 910, a synthetic absorbable copolymer of glycolide and lactide, derived respectively from glycolic acid and lactic acids. The mesh is prepared from uncoated, undyed fiber identical in composition to that used in VICRYL (polyglactin 910) synthetic absorbable suture, which has been found to be inert, nonantigenic, and nonpyrogenic and to elicit only a milc tissue reaction during absorption.

The provided document describes a medical device called the VICRYL Mesh Bag. Since this is a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a predicate device, not necessarily to establish de novo safety and effectiveness through extensive performance studies against acceptance criteria in the same way a PMA device would.

Here's an analysis of the provided information, focusing on the absence of typical acceptance criteria and study data often found in AI/diagnostic device submissions:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The submission for the VICRYL Mesh Bag does not define explicit acceptance criteria or report specific device performance metrics in the way a diagnostic or AI device would (e.g., sensitivity, specificity, AUC). Instead, the submission focuses on demonstrating substantial equivalence to an existing predicate device (VICRYL Mesh). The "performance data" section states that "Prior data supporting the predicate device demonstrate that VICRYL Mesh Bag performs as intended," implying that the performance of the new device is inherent in its similarity to the established predicate.

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

• Sample Size: Not applicable. No specific "test set" of patient data was used to evaluate the VICRYL Mesh Bag's performance against defined metrics.
• Data Provenance: Not applicable. The performance is inferred from the predicate device's existing data and the design similarity.

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

• Not applicable. There was no "ground truth" to establish for a test set in the context of this device's submission. The device is a surgical mesh for support, not a diagnostic tool requiring expert interpretation of results.

4. Adjudication Method for the Test Set:

• Not applicable. No adjudication was necessary as there wasn't a diagnostic outcome being evaluated by experts.

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

• Not applicable. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance. The VICRYL Mesh Bag is a physical surgical implant.

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

• Not applicable. This device is not an algorithm or AI system.

7. Type of Ground Truth Used:

• Not applicable. The performance is based on the known characteristics and prior data of the predicate VICRYL Mesh for surgical support. The "ground truth" here is the established safety and efficacy of the material as an absorbable surgical mesh.

8. Sample Size for the Training Set:

• Not applicable. This device is not an AI/ML model that requires a training set. The "design" of the VICRYL Mesh Bag is a physical modification (pre-shaping) of an existing, approved material.

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

• Not applicable.

Summary of Approach in the Document:

The provided document details a 510(k) Premarket Notification for the VICRYL Mesh Bag. The core of a 510(k) submission, as evidenced here, is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (in this case, VICRYL Mesh).

Instead of presenting new clinical study data with acceptance criteria, the manufacturer (Ethicon, Inc.) argued that:

• The new device (VICRYL Mesh Bag) has "similar technological characteristics" to the predicate (VICRYL Mesh).
• The VICRYL Mesh Bag is "essentially VICRYL Mesh that has been preshaped to specific sizes."
• "Prior data supporting the predicate device demonstrate that VICRYL Mesh Bag performs as intended."

This approach relies on the established safety and effectiveness of the predicate device and argues that the minor modification (pre-shaping) does not raise new questions of safety or effectiveness. Therefore, the "acceptance criteria" and "study data" are implicitly tied to the regulatory framework of demonstrating substantial equivalence rather than independent performance evaluation against predefined numerical thresholds.

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