(705 days)
OptiMesh is intended to maintain the relative position of bone graft material (such as autograft or allograft) within a vertebral body defect (e.g. tumor) that does not impact the stability of the vertebral body and does not include the vertebral endplates.
OptiMcsh is a sterile, three-dimensional surgical mesh container made of knitted polyester yarn and offered in a range of sizes. The device is packaged in double Tyvek/Mylar pouches and a cardboard carton, and terminally sterilized.
The provided document is a 510(k) premarket notification letter and summary for a surgical mesh device called OptiMesh. It does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/ML device (e.g., performance metrics like sensitivity, specificity, accuracy against a ground truth).
Instead, this document is focused on establishing substantial equivalence to a predicate device based on intended use, materials, and configuration. The "performance data" mentioned in the "Technological Characteristic Comparisons" section likely refers to bench testing or material property tests to show the device's physical properties are safe and effective for its intended mechanical function, not a clinical performance study with human subjects or AI-driven analysis.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device evaluation.
However, I can provide what is available or infer from the document:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or reported device performance in terms of clinical outcomes (e.g., success rates, complication rates) or AI-specific metrics (e.g., accuracy, sensitivity). The "acceptance" in this context refers to the FDA finding of substantial equivalence.
| Criteria (Implied) | Reported Performance (Implied from Substantial Equivalence) |
|---|---|
| Substantially equivalent to predicate in intended use | Yes, for maintaining bone graft material in a vertebral body defect. |
| Substantially equivalent to predicate in materials | Yes, polyester yarn for mesh, similar to predicate. |
| Substantially equivalent to predicate in configuration | Yes, 3D surgical mesh container. |
| No new concerns about safety or effectiveness | Performance data provided to demonstrate this (details not included). |
2. Sample size used for the test set and the data provenance
No clinical test set or data provenance is detailed in this document. The evaluation is based on technological characteristics comparison to predicate devices, not human subject data for performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set or ground truth derived from expert review is described.
4. Adjudication method for the test set
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, this type of study is not mentioned as this device is a surgical mesh, not a diagnostic or AI-assisted interpretation device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical device (surgical mesh), not software/AI.
7. The type of ground truth used
For the purpose of substantial equivalence, the "ground truth" is established by the predicate device's characteristics and its prior regulatory approval. The safety and effectiveness of the predicate device implicitly serves as the benchmark.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device requiring a training set.
9. 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.