(63 days)
Sepramesh™ IP Bioresorbable Coating - Permanent Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
Sepramesh™ IP Bioresorbable Coating - Permanent Mosh (Sepramesh™ IP) is a dualcomponent (absorbable and non-absorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. Sepramesh™ IP is co-knitted using polypropylene and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a polypropylene surface and PGA surface. The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and a polyethylene glycol (PEG) based hydrogel.
The fascial side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, encouraging tissue ingrowth, similar to polypropylene mesh alone. The visceral side of the mesh provides a hydrophilic bioresorbable layer, separating the mesh from underlying tissue and organ surfaces during the critical wound-healing period resulting in minimal tissue attachment and visceral adhesions to the mesh. Shortly after placement, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days. The absorption of the PGA fibers is essentially complete between 50 and 80 days. The polypropylene mesh is permanent and allows for tissue ingrowth.
The provided submission describes a medical device, Sepramesh™ IP Bioresorbable Coating - Permanent Mesh, seeking 510(k) clearance. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving specific performance against an acceptance criterion in a clinical study. Therefore, the information requested regarding acceptance criteria and a study proving device performance in the context of an AI/human-in-the-loop study is not applicable.
Here's a breakdown of why this information isn't present in this specific document:
- Device Type: Sepramesh™ IP is a surgical mesh for soft tissue repair, not an AI or diagnostic imaging device. Its clearance pathway is based on material properties, design, and intended use comparison to existing devices.
- 510(k) Clearance: The 510(k) process is about demonstrating "substantial equivalence," meaning that the new device is as safe and effective as a legally marketed device. It typically relies on comparisons of technological characteristics, materials, and intended use, often supported by bench testing and sometimes animal studies, rather than large-scale clinical trials with specific performance endpoints like those seen in AI device submissions.
Therefore, many of the requested categories related to AI performance, human reader studies, and large-scale test datasets do not apply to this specific 510(k) submission.
Here is the information that can be extracted from the provided text, recognizing the nature of a 510(k) for a surgical mesh:
1. A table of acceptance criteria and the reported device performance:
This document does not present a table of specific acceptance criteria in the way one might see for an AI device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" for a 510(k) of this nature involve demonstrating substantial equivalence to predicate devices, focusing on:
- Materials: Comparison of polypropylene, PGA, HA, CMC, PEG.
- Design: Dual-component mesh with two sides (fibroblastic response side and bioresorbable separation layer).
- Intended Use: Reconstruction of soft tissue deficiencies, such as hernia repair.
- Performance (General): Bioresorption profile of coating and PGA fibers, permanent nature of polypropylene mesh, tissue ingrowth, minimal tissue attachment/adhesions.
The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This statement from the FDA serves as the "reported device performance" in the context of the 510(k) process – that it meets the "acceptance criteria" of being substantially equivalent.
2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI device or a diagnostic device; therefore, there isn't a "test set" in the sense of patient data for performance evaluation. The substantial equivalence is based on component comparison and intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for the reasons stated above.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the reasons stated above.
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. Sepramesh™ IP is a surgical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices and the demonstration that the new device shares similar technological characteristics and performs similarly.
8. The sample size for the training set: Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established: Not applicable. This is not a machine learning or AI 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.