(101 days)
ProPatch® is indicated for implantation to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement, and reconstructive procedures.
ProPatch is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including, but not limited to: reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
Non-Joint Related Repair
ProPatch is indicated for implantation to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and reconstructive procedures.
Joint Related Repair
ProPatch is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including, but not limited to: reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
ProPatch Soft Tissue Repair Matrix (ProPatch) is a surgical mesh manufactured from decellularized bovine pericardium. Decellularized tissues undergo chemical microbial and viral inactivation processes, are inspected for freedom from defects, packaged, and terminally sterilized via gamma radiation.
ProPatch is comprised of a single layer, nominally 0.6 mm thick, and is provided as a sterile and non-pyrogenic product that is fully hydrated and ready for use without the need for rinsing or rehydration prior to implantation.
The provided document describes a 510(k) submission for the "ProPatch® Soft Tissue Repair Matrix" and specifically states that no new studies were performed to prove the device meets acceptance criteria. Instead, this submission is for minor changes to the Instructions for Use and a manufacturing change, and the device's equivalence to a previously cleared predicate device (K061892) is asserted based on identical indicated uses and technological characteristics.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a new study is not applicable to this particular 510(k) submission.
Here's an explanation based on the provided text:
- 1. A table of acceptance criteria and the reported device performance: Not applicable. The document does not describe new performance or acceptance criteria for this 510(k) submission. It relies on the prior clearance of the predicate device.
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No new test set or data are mentioned.
- 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. No new ground truth establishment is described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No new test set adjudication is described.
- 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, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical mesh; it is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this submission. The original predicate device's clearance would have relied on appropriate testing for surgical mesh, likely including mechanical properties, biocompatibility, and potentially animal or clinical data, which would have established its "ground truth" for safety and effectiveness.
- 8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
- 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device requiring a training set.
Summary based on the document:
This 510(k) submission (K101587) for the ProPatch® Soft Tissue Repair Matrix is a "Special 510(k)" or similar submission for minor changes (Instructions for Use and minor manufacturing change) to an already cleared device. The manufacturer asserts equivalence to the predicate device K061892 based on "identical indicated uses and technological characteristics." Therefore, this document does not contain information about new studies proving the device meets acceptance criteria, as its substantial equivalence is based on the previously cleared 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.