(109 days)
Endoform® Plastics and Reconstructive Matrix is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
Endoform® Plastics and Reconstructive Matrix is an advanced collagen matrix comprised of natural >70%, non-reconstituted collagen. Endoform® Plastics and Reconstructive Matrix is designed to be fixed, via sutures, staples or tacks to the surrounding tissue, at the discretion of the attending physician for applications in plastic and reconstructive surgery. For example, the device can be surgically implanted to reinforce damaged or ruptured soft tissue membranes and reinforce muscle flaps. The device is supplied sterile and dry in a variety of sizes and thicknesses, which can be trimmed by surgeons to meet the individual patient's needs. Endoform® Plastics and Reconstructive Matrix is laminated via a proprietary process termed 'lug lamination', which is a physical means of fabricating the devices, such that the individual sheets of the device are physically bonded to one another as opposed to using embroidery to sew the laminate of collagen matrix sheets.
The provided text describes a 510(k) premarket notification for a medical device (Endoform® Plastics and Reconstructive Matrix) and primarily focuses on proving its substantial equivalence to legally marketed predicate devices. This type of submission relies on demonstrating that the new device is as safe and effective as a predicate device, rather than proving de novo safety and efficacy through extensive clinical trials for novel devices.
Therefore, the information you've requested about acceptance criteria, efficacy studies, expert adjudication, MRMC studies, standalone algorithm performance, and training set details are not applicable in the context of this 510(k) submission as it is not a study proving the device meets acceptance criteria for a novel AI/software medical device.
The "acceptance criteria" presented here are in the context of bench testing and biocompatibility, not "device performance" in the sense of diagnostic accuracy or clinical outcomes that typically require such detailed study methodologies.
Let's break down what is available in the provided document, and then explain why the requested information is absent.
1. Table of acceptance criteria and reported device performance (based on the provided text):
The document does not explicitly present acceptance criteria in a quantitative table with corresponding "reported device performance" in the way one would for a diagnostic or AI device's clinical performance. Instead, it describes bench tests performed to demonstrate that the device meets "all product specifications for the intended use." The "acceptance criteria" for these tests would be the pre-defined product specifications, which are not detailed numerically in this summary.
| Acceptance Criteria (Implied / Test Performed) | Reported Device Performance (Summary in Document) |
|---|---|
| Tensile Strength (Product Specification) | Meets product specifications |
| Suture Retention (Product Specification) | Meets product specifications |
| Biochemical Composition (Product Specification) | Meets product specifications |
| Endotoxin Levels (Product Specification) | Meets product specifications |
| Dimensional Verification (Product Specification) | Meets product specifications |
| Ball Burst (Product Specification) | Meets product specifications |
| Modulus of Elasticity (Product Specification) | Meets product specifications |
| Delamination Evaluation (Product Specification) | Meets product specifications |
| Sterility Assurance Level (SAL) of 10⁻⁶ | Achieved |
| Biocompatibility (ISO 10993-1) | Concluded biocompatible (based on reference device safety) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the sample sizes used for each of the bench tests mentioned (tensile strength, suture retention, etc.).
- Data Provenance: Not applicable in the context of this submission. The tests are bench tests of the manufactured device, not retrospective or prospective clinical data from human patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the sense of clinical diagnoses or outcomes, is not being established for bench tests of a surgical mesh. The "truth" for these tests are the physical/material properties of the device itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept is for clinical or image-based studies where human readers might disagree. Bench tests rely on standardized measurement methods.
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 or diagnostic tool. No MRMC study was performed or required.
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 (expert consensus, pathology, outcomes data, etc.):
- For the bench tests, the "ground truth" refers to the established physical and chemical properties measured according to standardized methods. For biocompatibility, it's assessed against ISO 10993-1 standards and by leveraging the established safety of a reference device. For the overall submission, the "ground truth" for substantial equivalence relies on the regulatory approval and safety profile of the predicate device.
8. The sample size for the training set:
- Not applicable. There is no AI model or algorithm being trained for this device.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this device.
Explanation of the 510(k) Process and Why This Information is Absent:
The document is a 510(k) Pre-Market Notification. For a device submitted under a 510(k), the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device. This means the device is as safe and effective as another legally marketed device, and does not raise new questions of safety and effectiveness.
- No De Novo Clinical Efficacy Study: The document explicitly states: "There was no clinical testing required to support the indications for use as they are equivalent to the predicate device." This is a key characteristic of the 510(k) pathway for devices like surgical meshes that are considered "well-understood" and have similar predicate devices.
- Focus on Bench Testing and Biocompatibility: The "performance testing" described is confined to bench tests (tensile strength, suture retention, etc.) and biocompatibility. These tests confirm that the manufacturing process is consistent and that the material properties are similar to the predicate, and that the material does not pose new biological risks.
- Leveraging Predicate Device Data: The safety and performance of the proposed device are "based on the in vivo performance of the predicate and reference devices." This means the FDA relies on the existing track record and regulatory history of the predicate devices rather than requiring new, extensive clinical trials for the new device.
- Not an AI/Software Device: The concepts of "multi-reader multi-case studies," "standalone algorithm performance," "training set," and "adjudication methods" are typically relevant for Software as a Medical Device (SaMD) or AI-powered devices where the performance criterion is diagnostic accuracy, image interpretation, or clinical decision support. The Endoform® Plastics and Reconstructive Matrix is a physical surgical mesh, not a software product.
§ 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.