(169 days)
The GraftPatch® is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.
GraftPatch® is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists, e.g., hernia repairs. The device is composed of heat-laminated layers of crosslinked porcine collagen. GraftPatch® is similar in design, materials, function, and intended use to other surgical meshes which are currently in U.S. commercial distribution.
The provided 510(k) summary for the GraftPatch® device does not contain specific acceptance criteria or a detailed study description in the way one might expect for a diagnostic or AI-driven device. This submission focuses on establishing substantial equivalence to predicate surgical meshes.
Therefore, many of the requested data points (such as acceptance criteria tables, sample sizes, expert qualifications, and AI-specific study details) are not explicitly present in the provided text.
Here's an attempt to answer the questions based on the available information:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Material Composition | Not explicitly stated (e.g., tensile strength, pore size, degradation rate) | Composed of heat-laminated layers of crosslinked porcine collagen. Similar to predicate devices. | The submission implies that the material characteristics are equivalent to predicate devices, but specific quantitative criteria are not listed. |
| Functionality | Functionality in soft tissue reinforcement (e.g., in hernia repairs) | Animal implant studies were performed to confirm the functionality. Results demonstrated suitability for intended use. | Specific functional tests, quantitative outcomes, or pass/fail criteria from animal studies are not provided. The statement is qualitative. |
| Biocompatibility | Conformance with Tripartite and ISO 10993 recommendations | Biocompatibility testing was conducted. Results demonstrated suitability for intended use. | Specific biocompatibility tests performed (e.g., cytotoxicity, sensitization, irritation) and their pass/fail criteria are not detailed. The statement highlights compliance with standards. |
| Design Similarity | Similar design to predicate surgical meshes. | "GraftPatch® is similar in design...to other surgical meshes." | No specific design parameters (e.g., dimensions, weave pattern) are compared against explicit criteria. This is a descriptive comparison. |
| Intended Use Similarity | Intended use aligns with predicate surgical meshes for soft tissue reinforcement. | "GraftPatch® is similar in...intended use to other surgical meshes." | The stated indication for use matches that of typical surgical meshes. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The submission mentions "Animal implant studies" and "Biocompatibility testing." However:
- Sample Size: Not specified for any of the studies mentioned.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be pre-market internal testing.
- Retrospective or Prospective: These would likely be considered prospective studies designed to support the 510(k).
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. This device is a surgical mesh, not an diagnostic imaging device. "Ground truth" in the context of expert consensus for diagnostic interpretation is irrelevant here. The studies involved animal model evaluations and material biocompatibility testing. The "experts" would be the scientists and veterinarians conducting and evaluating these technical studies. Their specific number and qualifications are not listed in the 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is typically relevant for studies involving human interpretation (e.g., radiology reads) where discrepancies need to be resolved. For animal implant and biocompatibility studies, the evaluation would follow established scientific and regulatory protocols for data collection and interpretation.
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
Not applicable. This device is a surgical mesh and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC comparative effectiveness study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve any algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the studies mentioned:
- Animal Implant Studies: The "ground truth" would be determined by direct observation in the animal models, potentially histology/pathology of explanted tissues, and clinical signs of the animals over time.
- Biocompatibility Testing: The "ground truth" for biocompatibility is established by the results of standardized tests conforming to Tripartite and ISO 10993 recommendations (e.g., cell viability, irritation scores, immunological responses).
8. The sample size for the training set
Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable as this is not an AI/ML 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.