(8 days)
Proxy Biomedical MOTIFMESH™ Soft Tissue Patch is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.
Proxy Biomedical MotifMesh 100 Soft Tissue Patch is a non-absorbable, inert, sterile, porous surgical soft tissue patch produced from expanded polytetrafluoroethylene. 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" +/- 0.001" in thickness and exhibits high burst strength and tensile strength. Use of MOTIFMESHTM Soft Tissue Patch allows a fibroblastic response through the interstices of the implant, forming a fibrous wall.
The provided document is a 510(k) summary for a medical device (surgical mesh). This type of document is a premarket notification to the FDA, demonstrating substantial equivalence to a predicate device. It primarily focuses on regulatory approval based on comparison to existing technology, rather than detailed clinical studies with acceptance criteria and AI performance metrics.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not present in the provided text.
The document states:
- SUMMARY of TESTING: "Bench test data reveal MOTIFMESH TM Soft Tissue Patch has mechanical and material characterization values that are substantially equivalent to the predicate devices. The biocompatibility test results show that the material used in the design and manufacture of the device is non-toxic and non-sensitizing to biological tissues consistent with their intended use."
This indicates that the "study" conducted for this submission was primarily focused on bench testing for mechanical, material characterization, and biocompatibility, to demonstrate substantial equivalence to an already cleared predicate device (MOTIFMESH™ Soft Tissue Patch with the hexagonal shape previously cleared under K050678). This is typical for Class II medical devices seeking 510(k) clearance and does not involve AI performance metrics or the types of clinical studies you are asking about.
§ 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.