(35 days)
SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: Plastic and reconstructive surgery, Muscle flap reinforcement, Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias, Reinforcement of soft tissues repaired by sutures or sutures anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. SurgiMend is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.
SurgiMend is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
This 510(k) premarket notification for SurgiMend Collagen Matrix for Soft Tissue Reconstruction does not contain a study that proves the device meets specific acceptance criteria in the way described in the request. This document is a Summary of Substantial Equivalence, not a clinical study report with performance metrics against acceptance criteria.
The purpose of a 510(k) submission is to demonstrate that the device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or different technological characteristics that do not raise different questions of safety and effectiveness. It does not typically involve the setting of specific quantitative performance acceptance criteria or a study designed to prove the device meets these criteria in the context of device performance as one might expect for a diagnostic or AI-driven device.
Therefore, many of the requested fields cannot be directly extracted from this document as they are not relevant to a 510(k) submission for a surgical mesh.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission does not establish or report specific quantitative acceptance criteria for device performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and biocompatibility.
| Acceptance Criteria (Quantitative Performance Metric) | Reported Device Performance |
|---|---|
| Not applicable to this 510(k) submission | Not applicable to this 510(k) submission |
The closest the document comes to "performance" is the biocompatibility assessment.
Biocompatibility Assessment:
- Criteria: Demonstrated biocompatibility (no cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, intramuscular toxicity, hemolysis, and pyrogenicity).
- Reported Performance: "A rigorous biocompatibility assessment performed by an independent laboratory demonstrated the biocompatibility of SurgiMend."
- Viral Inactivation: "The manufacturing methods for SurgiMend have also been tested by an independent laboratory to assure appropriate levels of viral inactivation."
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable. This 510(k) submission did not involve a "test set" in the context of evaluating a device's performance against specific metrics using collected data (e.g., patient images or clinical outcomes). The evaluation was primarily a comparison to predicate devices and laboratory biocompatibility testing.
- Data provenance: Not applicable in the context of clinical data for performance evaluation. Biocompatibility testing was performed by "an independent laboratory."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No "ground truth" was established for a "test set" in this type of submission. The safety and effectiveness are inferred from the substantial equivalence to predicate devices and biocompatibility testing.
4. Adjudication method for the test set
- Not applicable. There was no test set requiring adjudication in this 510(k) submission.
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 a diagnostic imaging device or an AI-assisted tool. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a surgical mesh, not an algorithm.
7. The type of ground truth used
- Not applicable. No ground truth in the sense of clinical outcomes, pathology, or expert consensus on data was used for performance evaluation of the device in this submission. The "truth" for this submission is related to the established safety and effectiveness of the predicate devices and the direct demonstration of biocompatibility for SurgiMend.
8. The sample size for the training set
- Not applicable. There is no concept of a "training set" for this type of medical device submission (a surgical mesh).
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth establishment for it.
In summary: This 510(k) document is a regulatory submission for a surgical mesh, demonstrating substantial equivalence to already approved predicate devices and reporting on standard biocompatibility testing. It does not present a clinical study with detailed performance metrics, acceptance criteria, or ground truth establishment as would be required for different types of devices, especially those involving diagnostics or AI.
§ 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.