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TissueMend™ is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal, inguinal, diaphragmatic, femoral, scrotal, umbilical, and incisional hernias: colon, rectal, urethral, and vaginal prolapse; muscle flap reinforcement; reconstruction of the pelvic floor; and procedures such as sacrocolposuspension and urethral sling.

TissueMend™ Soft Tissue Repair Matrix is a remodelable collagen matrix derived from bovine skin to be used to reinforce soft tissues where weakness exists. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed and sutured by the surgeon to meet the individual patient's needs.

Here's a breakdown of the acceptance criteria and study information based on the provided text, though it's important to note that this is a 510(k) summary for a medical device, not an AI/ML software. Therefore, many of the requested categories (like number of experts, MRMC studies, training set details) are not applicable or won't be found in this type of document.

Acceptance Criteria and Device Performance for TissueMend™ Soft Tissue Repair Matrix

The document describes a medical device, not an AI/ML algorithm. Therefore, "acceptance criteria" here refers to the characteristics that demonstrate substantial equivalence to predicate devices and biocompatibility, rather than performance metrics like sensitivity or specificity for an algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Study Information (as applicable to a medical device 510(k) rather than AI/ML)

This 510(k) summary focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than a clinical efficacy study for a novel treatment. The "study" here refers to the assessments conducted to establish this equivalence and safety.

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

• Sample Size: Not applicable in the context of this 510(k) summary for a medical device's technical characteristics and biocompatibility. The biocompatibility tests would have involved in vitro and in vivo animal models, but specific "sample sizes" for these studies are not detailed in this high-level summary. There is no "test set" in the sense of patient data for an algorithm.
• Data Provenance: Not explicitly stated for each test, but the biocompatibility assessment was performed by an "independent certified laboratory." This implies standard international testing protocols.

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)

• Not applicable. This information is for AI/ML algorithms where expert review defines the "ground truth." For a physical medical device, "ground truth" relates to its inherent material properties, biocompatibility, and functional performance, which are assessed through laboratory tests and comparisons to established standards and predicate devices.

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

• Not applicable. This refers to consensus methods for expert labeling in AI/ML. For medical device testing, results are typically objective measurements or observations from standardized protocols.

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

• Not applicable. MRMC studies are specific to AI/ML software where human readers are involved in interpreting images or data. This document is for a physical surgical mesh.

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

• Not applicable. This refers to the performance of an AI/ML algorithm.

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

• For Biocompatibility: The "ground truth" is established biological safety standards and responses to material exposure (e.g., cell viability, immune response, genotoxicity, systemic toxicity). These are determined via established laboratory test methods (e.g., ISO standards for biocompatibility).
• For Performance/Equivalence: The "ground truth" for the device's physical and functional characteristics is its ability to directly reinforce soft tissue and its resorbability, as measured through material science tests and comparison to the known characteristics of the predicate devices.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML algorithm.

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

• Not applicable. There is no "training set" for this medical device.

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