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The Biomerix Composite Surgical Mesh is intended for repair and/or reinforcement of soft tissues where weakness exists in plastic and reconstructive surgery.

Biomerix Composite Surgical Mesh is a non-absorbable porous polymer scaffold (polycarbonate polyurethane urea) incorporating knitted polypropylene monofilament fibers.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify the exact sample sizes for the material testing, bench testing, biocompatibility testing, or animal testing. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective) for any of these tests.

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

This information is not applicable and not provided in the document. The studies described are focused on material, mechanical, and biological properties of the device, not on diagnostic or clinical interpretation by human experts.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document, as the studies are not based on human interpretation or consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided in the document. The device is a surgical mesh, not an AI-assisted diagnostic tool.

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

This information is not applicable and not provided in the document. The device is a physical surgical implant, not an algorithm.

7. The type of ground truth used

• Material Properties: The ground truth would be established by industry standards and engineering specifications for material strength, elasticity, porosity, etc.
• Device Performance (Bench Testing): The ground truth would be established by the device's pre-defined performance specifications (e.g., tensile strength, burst strength, suture retention strength as relevant for a surgical mesh).
• Biocompatibility: The ground truth is established by the criteria outlined in ISO 10993-1 standards (e.g., absence of cytotoxicity, sensitization, irritation).
• In-vivo Response (Animal Testing): The ground truth is established through histological examination and expert pathology assessment for parameters like tissue integration, foreign body response, and degradation, relative to expected normal healing and established safety benchmarks for implantable materials.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. The device is a physical product, not an AI model that requires a training set.

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

This information is not applicable and not provided in the document.

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Biomerix Composite Surgical Mesh is intended to assist in the repair and/or reinforcement of hernia and other soft tissue defects requiring additional support of a nonabsorbable implant during and after wound healing.

Biomerix Composite Surgical Mesh is a non-absorbable porous polymer scaffold (polycarbonate polyurethane urea) incorporating knitted polypropylene monofilament fibers.

The provided text describes the Biomerix Composite Surgical Mesh, a medical device, and its journey through FDA 510(k) clearance. However, the document does not contain information about "acceptance criteria" in the format of specific performance metrics (e.g., sensitivity, specificity, accuracy) or details about a study designed to prove the device meets these criteria in the context of an AI-powered diagnostic or decision support system.

The content focuses on demonstrating substantial equivalence to predicate devices through various tests relevant to a surgical mesh, rather than the performance of a software algorithm.

Here's a breakdown of the available information given the context of the provided text, and where specific requested information is missing:

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

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics (e.g., sensitivity, specificity, or specific thresholds for biomechanical properties). The acceptance criteria are broadly implied by the tests performed to establish substantial equivalence.
• Reported Device Performance:

  Test Category	Performance Outcome
  Material Testing	Demonstrates material properties are suitable for intended use.
  Bench Testing	Demonstrates that manufactured devices meet performance specifications. Test results show the device meets specifications and is acceptable for clinical use.
  Biocompatibility Testing	Performed per ISO 10993-1. Demonstrates the material is safe and biostable.
  Animal Testing	Exhibits a well-tolerated long-term histomorphologic response with good integration, minimal foreign body response, and no evidence of device degradation or adjacent tissue necrosis.

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 for Test Set: Not specified. The document refers to "material testing," "bench testing," "biocompatibility testing," and "animal testing" but does not provide specific sample sizes for these tests.
• Data Provenance: Not specified. The studies are described as lab-based (material, bench, biocompatibility) and animal studies. There is no mention of human clinical data or its provenance.

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)

• Number of Experts & Qualifications: Not applicable/not specified. The "ground truth" for a surgical mesh involves physical, chemical, and biological properties, not a diagnostic interpretation by human experts. The assessment of animal study results would likely be done by veterinary pathologists or similar experts, but the number and qualifications are not detailed.

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

• Adjudication Method: Not applicable/not specified. This concept typically applies to the resolution of discrepant readings in medical image analysis or similar diagnostic tasks, which is not the focus of this device's testing.

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

• MRMC Study: No. This is a surgical mesh, not an AI-powered diagnostic device. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.

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

• Standalone Performance: Not applicable. This device is a physical surgical mesh, not an algorithm or software.

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

• Type of Ground Truth: The "ground truth" for this device's performance would be established through:
  • Physical/Chemical Standards: For material and bench testing (e.g., tensile strength, pore size, degradation rate under specific conditions).
  • Biological Standards/Pathology: For biocompatibility and animal testing (e.g., tissue integration, foreign body response, inflammation levels assessed via histopathology).
  • ISO Standards: For biocompatibility (ISO 10993-1).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Ground Truth Establishment for Training Set: Not applicable. As there is no AI/machine learning component, there is no training set or associated ground truth.

Summary:

The provided 510(k) summary for the Biomerix Composite Surgical Mesh details the regulatory pathway for a conventional medical device (surgical mesh) by demonstrating substantial equivalence to predicate devices. The performance data presented consists of material, bench, biocompatibility, and animal testing results, all aimed at proving the safety and effectiveness of the physical implant. The questions about AI, algorithms, expert consensus, and reader studies are not relevant to this type of device or the information contained in this 510(k) document.

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