(326 days)
The Biomerix Surgical Mesh is intended for the reinforcement of the soft tissues which are repaired by suture or suture anchors during rotator cuff repair surgery.
The mesh is not intended to replace normal body structure or provide full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchor systems used to attach the tissue to the bone, provide mechanical strength for tendon repair.
The Biomerix Surgical Mesh is a non-absorbable mesh manufactured from a polycarbonate polyurethane-urea matrix and standard polyester suture. The Biomerix Surgical Mesh is provided sterile for single use.
The provided text describes a 510(k) summary for the Biomerix Surgical Mesh, which is a medical device. This type of regulatory submission typically focuses on demonstrating "substantial equivalence" to existing legally marketed devices, rather than establishing specific acceptance criteria and proving performance against them in the same way one might for a novel diagnostic AI algorithm.
Therefore, the information required to populate the requested table and study details (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance of an algorithm) is not present in the provided document. The document details the device's physical and biological characteristics and compares them to predicate devices.
Here's a breakdown of why the requested information cannot be extracted from the given text:
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Nature of the Device: The Biomerix Surgical Mesh is a physical implant (a non-absorbable mesh). It's not an AI/ML diagnostic or predictive algorithm. Therefore, concepts like "acceptance criteria" based on metrics like sensitivity, specificity, accuracy, or AUC, and studies involving "test sets," "training sets," "ground truth established by experts," "adjudication methods," "MRMC studies," or "standalone (algorithm only) performance" are not applicable to this type of device.
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Regulatory Pathway (510(k)): A 510(k) submission establishes substantial equivalence. This means the manufacturer shows their device is as safe and effective as a legally marketed predicate device. The performance data section focuses on material testing, bench testing, biocompatibility, and animal testing to demonstrate the material properties and functionality are suitable and comparable to predicates, not that an algorithm performs against a diagnostic criterion.
Based on the provided text, the requested information is not available.
However, I can extract the closest information related to performance and testing:
Acceptance Criteria and Device Performance (Not applicable in the typical AI/ML sense)
| Acceptance Criteria (Not explicitly stated for diagnostic performance) | Reported Device Performance (Focus on material/bench/animal testing) |
|---|---|
| Material Properties suitability for intended use | Material testing performed to demonstrate suitability |
| Meet performance specifications | Bench testing performed; results demonstrate device meets specifications and is acceptable for clinical use |
| Biocompatibility (safety and biostability) | Extensive biocompatibility testing per ISO 10993-1 performed; demonstrates material is safe and biostable |
| Ability to support tissue ingrowth and mechanically reinforce repair | Animal testing demonstrates ability of mesh to support tissue ingrowth and mechanically reinforce repair as compared to surgical controls, without adverse clinical effects |
Study Details (Again, not in the context of an AI/ML algorithm)
- Sample size used for the test set and the data provenance: Not applicable. The "tests" were material, bench, and animal studies. Specific sample sizes and provenance for these different types of non-human studies are not detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth (e.g., successful ingrowth, mechanical reinforcement, biocompatibility) would be established by standard methods in materials science, biomechanics, and toxicology, reported and interpreted by the relevant scientific and engineering personnel conducting the tests. Expert consensus for interpreting medical images is not relevant here.
- Adjudication method for the test set: Not applicable.
- 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, as this is not an AI/ML diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used:
- Material properties: Measured values from physical and chemical tests.
- Bench performance: Engineering specifications and measured performance data.
- Biocompatibility: ISO 10993-1 standards and experimental results (e.g., cytotoxicity, sensitization, irritation, implantation effects).
- Animal studies: Histological analysis, mechanical testing of repaired tissue, gross observations from animal models, compared to surgical controls.
- The sample size for the training set: Not applicable. This device does not have a "training set" in the machine learning sense.
- How the ground truth for the training set was established: Not applicable.
§ 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.