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MINIMESH® polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, uterological prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.

Minimesh® is a non-absorbable polypropylene mesh constructed from knitted monofilaments of extruded polypropylene. Minimesh® polypropylene mesh is constructed using a warp-knit process to a unique design that permits the mesh to be cut into any desired shape or size without unraveling. Minimesh® polypropylene mesh has the necessary strength, flexibility, durability and surgical adaptability. These properties permit the correct adaptation to the various stresses encountered in the body. The device is supplied sterile.

Here's an analysis of the provided text regarding the Minimesh® polypropylene mesh, focusing on acceptance criteria and study details.

Based on the provided documents (K053361), this submission is a 510(k) for a modification to an existing device (K041632 Minimesh® polypropylene mesh). The nature of the modification is not explicitly detailed in the provided excerpts, but the summary primarily focuses on the device description, indications for use, and stability testing.

Analysis of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This document does not describe an acceptance criteria or a study with specific performance metrics for the device's clinical efficacy or diagnostic accuracy. This is typical for a 510(k) submission for a surgical mesh, especially a modification, where the primary focus is on demonstrating substantial equivalence to a predicate device through material properties, manufacturing processes, and safety, rather than a clinical performance study with defined acceptance criteria for outcomes like diagnostic accuracy.

The "TESTING" section almost exclusively discusses stability studies and not clinical performance.

Here's the information extracted / inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• None provided for a clinical or performance study with a test set of patients/cases. The stability studies would have involved material samples, but the sample size is not specified.
• Data Provenance: Not applicable for a clinical test set. The stability studies would be лабораторные (lab-based) rather than human data.

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

• Not applicable. No clinical test set requiring expert ground truth was described.

4. Adjudication method for the test set

• Not applicable. No clinical test set requiring adjudication was described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is a surgical mesh device, not an AI/imaging diagnostic device. An MRMC study is not relevant to this type of medical device submission.

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

• Not applicable. This is a surgical mesh device, not an algorithm.

7. The type of ground truth used

• For the stability studies, the "ground truth" would be laboratory measurements (e.g., tensile strength, degradation rates) against established specifications for material properties to determine shelf life.
• For the overall device, substantial equivalence relies on comparison to a predicate device (K041632) which would have already established its safety and efficacy for the intended use.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this surgical mesh device.

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

• Not applicable.

Summary of Device and Evidence Type:

The submission for Minimesh® polypropylene mesh (K053361) is a 510(k) for a modification. The evidence presented in these excerpts focuses on:

• Substantial Equivalence: By describing the device properties and indications for use as similar to a legally marketed predicate device (K041632).
• Product Stability/Shelf-Life: Via accelerated and real-time stability studies conducted to support a three-year expiration date. These are lab-based technical tests, not clinical performance studies.

There are no clinical performance studies with specific patient-oriented acceptance criteria or detailed methodologies involving a test set of patients/cases, human readers, or AI algorithms described in the provided documents.

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MINIMESH® polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.

Minimesh® is a non-absorbable polypropylene mesh constructed from knitted monofilaments of extruded polypropylene.

Minimesh® polypropylene mesh is constructed using a warp-knit process to a unique design that permits the mesh to be cut into any desired shape or size without unraveling.

It maintains excellent isotropic properties arising from its knitted construction.

Minimesh® polypropylene mesh has the necessary strength, flexibility, durability and surgical adaptability. These properties permit the correct adaptation to the various stresses encountered in the body.

The device is supplied sterile.

The provided text describes the 510(k) Notification for Mpathy Medical Devices, Ltd.'s Minimesh® polypropylene mesh, but it does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML device.

This document pertains to a traditional medical device (surgical mesh) and focuses on substantial equivalence to predicate devices, safety testing (biocompatibility per ISO 10993), and compliance with FDA guidance for surgical mesh.

Therefore, I cannot provide the requested information for an AI/ML device based on the given input. The categories requested, such as "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," and "training set sample size and ground truth establishment," are all relevant to the evaluation of AI/ML-driven medical devices and are not discussed in this 510(k) for a physical surgical mesh.

Ask a specific question about this device