(65 days)
MOTIFMESH™ Soft Tissue Patch is intended to assist in the repair and/or reinforcement of hemia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.
MOTIFMESH™ Soft Tissue Patch is a nonabsorbable, inert, sterile, macro porous surgical soft tissue patch Produced from polytetrafluoroethylene. The MotifMesh TM Soft Tissue Patch is designed to facilitate the reinforcement and repair of damaged or ruptured soft tissue structures. The implant has a structure characterized by closed cell openings in a high strength film. The construction allows the soft tissue patch to be stretched in both directions, to accommodate and reinforce tissue defects. The soft tissue patch measures 0.006''+/. 001" in thickness and exhibits high burst strength and tensile strength. Use of MOTIFMESH™ Soft Tissue Patch allows a fibroblastic response through the interstices of the implant, forming a strong fibrous wall.
The provided text describes a 510(k) summary for the MOTIFMESH™ Soft Tissue Patch. The submission focuses on demonstrating substantial equivalence to predicate devices based on mechanical characterization and biocompatibility testing. The document does not contain specific acceptance criteria, reported device performance metrics in a structured table, details on sample sizes for test sets, data provenance, ground truth establishment for a test set, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), or a standalone algorithm performance study. It also doesn't specify a training set or how its ground truth was established.
Therefore, many of the requested fields cannot be filled based on the provided text.
Here's a breakdown of what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical characterization values substantially equivalent to predicate devices (Bard PTFE Mesh, Mersilene Mesh, Bard Mesh) | "Bench test data reveal the applicant device has mechanical characterisation values, which are substantially equivalent to the predicate devices." |
| Material non-toxic to biological tissues | "The biocompatibility test results show that the material used in the design and manufacture of the device are non-toxic..." |
| Material non-sensitizing to biological tissues | "...and non-sensitizing to biological tissues consistent with their intended use." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (likely from internal lab testing at Proxy Biomedical, Ltd. in Ireland, but not explicitly stated).
- Retrospective or Prospective: Not specified.
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 this is a medical device for physical repair, not an image analysis or diagnostic device requiring expert interpretation of a test set. Ground truth relates to mechanical properties and biocompatibility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for the type of testing described (mechanical and biocompatibility).
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 a diagnostic device or an AI-assisted device. The study described is a bench test and biocompatibility study for a surgical mesh.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For mechanical characterization: Benchmark values of predicate devices (Bard PTFE Mesh, Mersilene Mesh, Bard Mesh).
- For biocompatibility: Established biocompatibility standards and testing methodologies (e.g., ISO 10993 series, though not explicitly mentioned, implied by "non-toxic and non-sensitizing"). The "ground truth" would be the successful passing of these tests according to predefined criteria for toxicity and sensitization.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set. The "training" here would be for the manufacturing process to consistently produce the device.
9. How the ground truth for the training set was established
- Not applicable due to the nature of the device (surgical mesh, 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.