(62 days)
Intended for use in the treatment of hernias where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support including urethral slings, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, and sacrocolposuspension.
DermMatrix is a sterile, chemically treated, pyrogen free, non-perforated porcine skin that has both the epidermal and subdermal sides removed.
The provided text for K021160, concerning the DermMatrix Surgical Mesh, focuses on establishing substantial equivalence to predicate devices, rather than a de novo study proving the device meets specific acceptance criteria through quantitative performance metrics. The submission is a 510(k) summary, which typically demonstrates equivalence to existing legally marketed devices, not necessarily de novo performance.
Therefore, many of the requested details regarding acceptance criteria, specific performance metrics, and study methodologies for proving those metrics are not present in the provided document.
Here's an attempt to answer based on the available information, noting where data is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated with quantitative targets) | Reported Device Performance (Summary from submission) |
|---|---|---|
| Technological Characteristics | "Identical to the predicate device (DermMatrix)" | Confirmed to be identical to the predicate DermMatrix Surgical Mesh. |
| Material Safety/Biocompatibility | (Not explicitly stated with quantitative targets, implied by predicate equivalence) | "Biocompatibility... have demonstrated that the device is safe and effective for its intended use" |
| Mechanical/Physical Performance | (Not explicitly stated with quantitative targets for tensile strength, elasticity, degradation, etc.) | "Bench testing... have demonstrated that the device is safe and effective for its intended use" |
| Clinical Effectiveness | (Not explicitly stated with quantitative targets for success rates, complication rates in specific procedures) | "Numerous clinical experiences have demonstrated that the device is safe and effective for its intended use" |
| Substantial Equivalence | Demonstrated to be "substantially equivalent to the predicate devices" (Carbon Medical Technologies DermMatrix [K993459], Tissue Science Laboratories Permacol [K992556], Cook Biotech, Inc. Surgisis Sling [K992159]). | FDA concurrence that the device is "substantially equivalent" to legally marketed predicate devices for the stated indications for use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific "test set" or a new clinical study with a defined sample size for the DermMatrix Surgical Mesh to prove its performance against acceptance criteria. The claim is based on:
- Technological equivalence to an existing predicate DermMatrix device (K993459), suggesting that the earlier data on K993459 would be relevant.
- "Biocompatibility, bench testing and numerous clinical experiences" are cited generally, but without specific study details (sample size, data provenance, retrospective/prospective nature).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the submission. The submission does not detail a study where ground truth was established by experts for a specific test set for the new DermMatrix device.
4. Adjudication Method for the Test Set
This information is not provided as there is no described test set or study requiring expert adjudication for this 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or presented in the provided 510(k) summary. This type of study is more common for diagnostic imaging AI systems comparing human performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the DermMatrix Surgical Mesh is a physical medical device (surgical mesh), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. Type of Ground Truth Used
Given that this is a 510(k) submission for a physical medical device, the "ground truth" for demonstrating safety and effectiveness for substantial equivalence is primarily based on:
- Established performance and safety of predicate devices: The FDA's substantial equivalence determination relies on the predicates' existing record of safety and effectiveness, supported by their indications for use, technological characteristics, and clinical history.
- Bench testing: In vitro laboratory tests confirming material properties and mechanical performance.
- Biocompatibility testing: Standardized tests to ensure the material does not elicit adverse biological responses.
- "Clinical experiences": This vague term likely refers to general medical knowledge, published literature on similar devices, and potentially post-market surveillance data for the predicate devices, rather than a new, specific clinical trial for this particular submission.
8. Sample Size for the Training Set
This information is not applicable. The DermMatrix Surgical Mesh is a physical medical device. The concept of a "training set" is relevant to machine learning algorithms, which are not involved in this device submission.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above (physical medical device, no machine learning algorithm).
§ 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.