(253 days)
The SURGIMESH®WN implant is recommended for reinforcement of hernia defects. The hernia repair could be, for example, inguinal hernia, femoral or crural hernia or ventral hernia. The SURGIMESH®WN implant is indicated for use via an extraperitoneal approach either by open or laproscopic surgery.
The SURGIMESH®WN consists of non-absorbable synthetic mesh, made of nonknitted, non-woven fibers of polypropylene. SURGIMESH®WN mesh is supplied sterile and is available in rectangular and anatomic forms in order to meet the individual patient's surgical needs.
The provided text describes the regulatory clearance of a surgical mesh device, SURGIMESH®WN, and its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, detailed results from a study proving those criteria, or information on AI performance or ground truth generation methods.
The "Performance Data" section states: "Pre-clinical and clinical performance testing was conducted. Tissue integration, biocompatibility, product structure, and final product specifications were all tested, in addition to two clinical studies that were performed. In all instances, the SURGIMESH®WN functioned as intended and the results observed were as expected."
This general statement indicates that studies were performed and that the device met its intended function, but it lacks the quantitative details required to fill out the requested table and answer the specific questions about acceptance criteria and study design.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's what can be answered based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not explicitly stated in text) | Reported Device Performance (General Statement in text) |
|---|---|
| Not available in the provided text. | "In all instances, the SURGIMESH®WN functioned as intended and the results observed were as expected." (P. 1, "Performance Data" section) |
| Tissue integration standards (e.g., degree of fibroblast infiltration, inflammatory response) | "Tissue integration... were all tested" (P. 1) |
| Biocompatibility standards (e.g., cytotoxicity, sensitization) | "Biocompatibility... were all tested" (P. 1) |
| Product structure specifications (e.g., tensile strength, pore size, material composition) | "Product structure... were all tested" (P. 1) |
| Final product specifications (e.g., sterilization effectiveness, dimensional stability) | "Final product specifications were all tested" (P. 1) |
| Clinical outcome measures (e.g., hernia recurrence rates, infection rates) | "two clinical studies that were performed" (P. 1) |
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 in the provided text. The text mentions "two clinical studies," but no sample sizes are given for these studies.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
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)
- Not applicable as the device is a surgical mesh, not an AI device requiring expert ground truth for image interpretation or similar tasks. The evaluations would typically be based on objective measures, clinical outcomes, and histological analysis rather than expert consensus on interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. This typically applies to studies requiring expert review or interpretation, which is not described for this device.
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
- No. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Based on the description of "Tissue integration, biocompatibility, product structure, and final product specifications," the ground truth likely involved:
- Histopathology/Pathology: For tissue integration and biocompatibility (e.g., microscopic examination of tissue response).
- Physical and Mechanical Testing: For product structure and final product specifications (e.g., tensile strength testing, pore size measurement).
- Clinical Outcomes Data: For the "two clinical studies" (e.g., hernia recurrence, complications, patient satisfaction).
8. The sample size for the training set
- Not applicable. This is not an AI device that uses a "training set" in the machine learning sense. The "training set" in the context of a medical device development would refer to data used for initial R&D and optimization, which is not detailed here.
9. How the ground truth for the training set was established
- Not applicable as this is not an AI device.
§ 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.