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Proxy Biomedical VITAMESH™ surgical mesh is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing

The synthetic mesh is constructed of knitted filaments of an alternative polypropylene resin. This material change does not affect the device description (or the device description on the package and instructions for use.) The proposed VitaMESH™ with the material supplier change is knitted by the same process as the predicate VitaMESH™, which interlinks each fiber junction and which provides for elasticity in both directions are.

The document describes a 510(k) summary for the VitaMESH™ Macroporous PP Surgical Mesh. The submission is based on a material supplier change for the polypropylene resin used in the mesh. The primary goal is to demonstrate that the device, with the new material, is substantially equivalent to the predicate device (VitaMESH™ Macroporous PP Surgical Mesh, K060520).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document doesn't provide a direct "acceptance criteria" table in the form of specific numerical thresholds for each test. Instead, it states that the tests were performed to show that the device with the alternative polypropylene continues to meet specifications or that the properties are the same as the predicate device. The performance is reported as meeting these specifications or showing substantial equivalence.

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 mechanical, microbiological, or chemical test. It generally refers to "VitaMESH™ units manufactured using an alternative polypropylene resin." The provenance is implied to be from Proxy Biomedical Ltd. in Ireland, as they are the submitter and manufacturer. The studies are prospective in the sense that they were conducted specifically for this submission to assess the performance of the device with the new material.

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 device under review is a surgical mesh, not an AI or diagnostic imaging device that requires expert interpretation for ground truth establishment. The evaluation relies on laboratory and in-vitro testing against established international standards and internal specifications.

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

This section is not applicable. As this is a physical medical device, there is no need for adjudication methods typically used in diagnostic studies involving human readers. The performance is objectively measured through standardized lab tests.

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 device is a surgical mesh, not an AI-assisted diagnostic tool. Therefore, MRMC studies and assessment of human reader improvement with AI assistance are irrelevant to this submission.

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

This section is not applicable. This is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.

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

The "ground truth" for this device's performance is based on:

• Industry Standards: I.S. EN ISO 10993-7: 2008 for Ethylene Oxide Sterilization Residuals and I.S. EN ISO 10993-1: 2009 for Biocompatibility.
• Internal Specifications: Proxy Biomedical Ltd.'s own established acceptance criteria for various tests (e.g., bioburden, mechanical properties).
• Comparison to Predicate Device: The primary ground truth is the performance and characteristics of the legally marketed predicate device (VitaMESH™ Macroporous PP Surgical Mesh, K060520) which the new device aims to be substantially equivalent to.

8. The sample size for the training set

This section is not applicable. There is no "training set" in the context of this traditional medical device submission. Machine learning models use training sets, but this is a physical product evaluated through laboratory testing.

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

This section is not applicable for the same reasons as point 8.

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Proxy Biomedical VITAMESH™ surgical mesh is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.

The VITAMESH TM is a non-absorbable, synthetic mesh, constructed of knitted filaments of Polyproylene. The VITAMESH™ is supplied sterile and provided in sheet form to be cut to size and sutured by the surgeon to meet the patient's needs. The mesh is approximately 0.010" thick, and exhibits high burst strength and tensibe strength The VITAMESH™ is knitted by a process which provides for elasticity in both digetions. Use of VITAMESH™ allows a fibroblastic response through the interstices of the implant, forming a strong fibrous wall.

The provided text describes a 510(k) submission for a surgical mesh device, VITAMESH™, and not a diagnostic AI device. Therefore, the questions related to acceptance criteria, study details, sample sizes, ground truth, experts, and MRMC studies, which are standard for AI/ML device evaluations, are not directly applicable to this document.

However, I can extract the information relevant to the device's performance assessment and substantial equivalence claim as presented in the document.

Here's a summary based on the provided text, adapted to the context of a medical device submission rather than an AI/ML diagnostic:

Acceptance Criteria and Study for VITAMESH™ Surgical Mesh

VITAMESH™ is a non-absorbable, synthetic surgical mesh made of knitted polypropylene filaments. Its acceptance criteria and proof of meeting them are based on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility assessments, rather than diagnostic performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated in terms of a numerical count of devices or test samples. The document refers to "Bench test data" and "biocompatibility test results" generally.
• Data Provenance: Not explicitly stated, but assumed to be laboratory testing conducted by or for Proxy Biomedical, Ltd. No information about country of origin, retrospective or prospective nature of data collection, as these are not relevant for bench testing of medical devices in this context.

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

• This question is not applicable as the evaluation is not based on interpreting diagnostic images or clinical scenarios requiring expert ground truth in the traditional sense. The "ground truth" here is the established scientific and engineering principles for material and mechanical performance, and biological response to materials.

4. Adjudication Method for the Test Set

• This question is not applicable as there is no human interpretation or adjudication of diagnostic outputs involved. The "adjudication" is through standardized test methods and comparison to predicate device specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating diagnostic devices (often imaging-based) where human readers interpret cases, and an AI's impact on their performance is assessed. This is not relevant for a surgical mesh device's pre-market submission for mechanical and biocompatibility properties.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This question is not applicable. VITAMESH™ is a physical surgical implant, not an algorithm or AI device. Its performance is inherent in its physical properties, not in a standalone algorithm's output.

7. The Type of Ground Truth Used

• The "ground truth" for VITAMESH™'s evaluation is primarily based on:
  • Validated laboratory test methods: For mechanical properties (burst strength, tensile strength, elasticity) and material characterization.
  • Established biocompatibility standards: For assessing non-toxicity and non-sensitizing properties to biological tissues, likely following ISO 10993 standards.
  • Predicate device specifications: The performance of legally marketed predicate devices (Bard PTFE Mesh, Mersilene Mesh, Bard Mesh) serves as a benchmark for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

• This question is not applicable. This device is not an AI/ML algorithm that requires a "training set." The polypropylene material and knitting process are engineered and manufactured, not "trained."

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

• This question is not applicable, as there is no training set for a physical surgical mesh device.

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