(115 days)
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
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material Properties | Material testing was performed to demonstrate that the material properties are suitable for the intended use. |
| Device Performance | Bench testing was performed to demonstrate that the devices as manufactured meet the performance specifications. Test results demonstrate that the device meets the specifications and is acceptable for clinical use. |
| Biocompatibility | Biocompatibility testing in accordance with ISO 10993-1 recommended standards was conducted, and results demonstrated that the device is biocompatible according to these standards. |
| In-vivo Response (Animal) | Animal testing demonstrates that the mesh exhibits a well-tolerated long-term histomorphologic response with good integration with surrounding tissue, minimal foreign body response, and no evidence of device degradation or adjacent tissue necrosis. |
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.
§ 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.