(315 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, hernias, suture-line reinforcement, and reconstructive procedures.
ProPatch® is indicated for the reinforcement, where weakness exists, 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, quadricens, or other tendons.
ProPatch Soft Tissue Repair Matrix (ProPatch) is a surgical mesh manufactured from bovine pericardium. Decellularized tissues undergo chemical microbial reduction and viral inactivation processes, are inspected for freedom from defects, packaged, and terminally sterilized via gamma radiation.
ProPatch is comprised of a single tissue 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 K110581 is a 510(k) summary for the ProPatch® Soft Tissue Repair Matrix. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria and performance metrics for a new, innovative device. Therefore, the information requested might not be fully present in the context of this specific document.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstrated Equivalence to Predicate) | Reported Device Performance (Found to be substantially equivalent to predicate) |
|---|---|
| Tensile Properties | The proposed device's tensile properties were found to be substantially equivalent to the predicate device. |
| Tear Propagation Resistance | The proposed device's tear propagation resistance was found to be substantially equivalent to the predicate device. |
| Bursting Strength | The proposed device's bursting strength was found to be substantially equivalent to the predicate device. |
| Suture Retention Strength | The proposed device's suture retention strength was found to be substantially equivalent to the predicate device. |
| Decellularization Efficiency (cellular content of finished devices) | The decellularization observed in the proposed device was equivalent to that observed in the predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the testing, nor does it provide information about the data provenance (e.g., country of origin, retrospective or prospective nature of the data). The testing described is in-vitro biomechanical testing and decellularization efficiency assessment, not clinical study data involving patients.
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)
This is not applicable as the document describes a 510(k) submission for a surgical mesh, which relies on demonstrating substantial equivalence through laboratory testing rather than expert-derived ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the document describes a 510(k) submission for a surgical mesh, focusing on physical and biological properties. There is no mention of adjudication methods, which are typically relevant for diagnostic studies involving human assessment.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic devices, which is not the nature of the ProPatch® Soft Tissue Repair Matrix.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance assessment was not done. This concept is applicable to AI algorithms, not a physical medical device like a surgical mesh. The "performance" here refers to the device's biomechanical and de-cellularization properties as compared to a predicate, not an algorithm's output.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" in this context is the established properties of the predicate device. The studies aimed to demonstrate that the new device's properties (tensile, tear, bursting, suture retention, and decellularization) are substantially equivalent to those of the predicate device. This is based on objective, quantifiable laboratory measurements.
8. The sample size for the training set
This is not applicable. The ProPatch® Soft Tissue Repair Matrix is a physical surgical mesh, not an artificial intelligence or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 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.