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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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