(30 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 Mesh (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. Genzyme will offer two versions of the device. The first version utilizes violet dyed PGA fibers. The second version utilizes natural beige PGA fibers instead of the original violet version. The mesh is coated on the PGA surface with a bioresorbable coating of chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and a polyethylene glycol (PEG) based hydrogel.
The uncoated side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, encouraging tissue ingrowth, similar to polypropylene mesh alone. The coated 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 text is a 510(k) summary for a medical device called Sepramesh™ IP Bioresorbable Coating - Permanent Mesh. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.
The 510(k) summary does not contain a study proving the device meets acceptance criteria in the way described in your request. A 510(k) submission typically focuses on demonstrating substantial equivalence to a predicate device, often through a comparison of technological characteristics, materials, and intended use, rather than presenting a new clinical study with specific performance metrics against pre-defined acceptance criteria.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this type of regulatory submission. The document explicitly states: "Per Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Genzyme Corporation is providing a summary of the safety and effectiveness information available for Sepramesh™M IP Bioresorbable Coating - Permanent Mesh (Sepramesh™ IP)." This indicates a review of existing information and a comparison, not a de novo clinical trial with new performance data.
Here's a breakdown of what can be extracted from the provided text, and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the 510(k) summary. The document does not describe specific acceptance criteria (e.g., a certain percentage reduction in adhesions, a specific tensile strength after implantation) or present new performance data from a clinical study to meet such criteria. Instead, it justifies substantial equivalence by comparing the Sepramesh™ IP with a predicate device (K053066) based on broad characteristics like classification, indication, labeling claims, product design, materials, and sizes.
The "Performance" of the device is described qualitatively:
- "The uncoated side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, encouraging tissue ingrowth, similar to polypropylene mesh alone."
- "The coated 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."
These are descriptive statements about the device's function, not quantitative performance metrics against acceptance criteria from a specific study.
2. Sample size used for the test set and the data provenance:
Not applicable/Not provided. This document does not describe a "test set" in the context of an AI/algorithm performance study. It's a regulatory submission for a physical medical device (surgical mesh).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/Not provided. This document does not involve expert review or ground truth establishment for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable/Not provided.
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/Not provided. This is not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable/Not provided. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable/Not provided.
8. The sample size for the training set:
Not applicable/Not provided. This is not a machine learning device, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable/Not provided.
In summary: The provided document is a 510(k) premarket notification for a surgical mesh, demonstrating substantial equivalence to a previously cleared device. It does not contain the details of a study with acceptance criteria, sample sizes, expert involvement, or ground truth establishment as would be found in a performance study for, for example, a diagnostic AI device. The comparison provided (Table 5) focuses on the device's features, intended use, and materials to argue for equivalence, not on quantitative performance metrics.
§ 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.