(97 days)
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.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.