(48 days)
Sepramesh™ IP Bioresorbable Barrier - 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, previously cleared through K040868 utilizes violet dyed PGA fibers. The second version described in this submission utilizes natural beige PGA fibers. The mesh is coated on the PGA surface with a bioresorbable barrier 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.
Here's an analysis of the acceptance criteria and study information for the Sepramesh™ IP Bioresorbable Coating/Permanent Mesh, based on the provided text:
Important Note: The provided document is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing independent clinical efficacy or presenting detailed acceptance criteria and performance data in the same way a clinical trial report would. Therefore, the information provided below will reflect this context.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) summary, explicit "acceptance criteria" for precise numerical performance metrics are not typically presented in the same way as a full clinical study with predefined endpoints. Instead, the acceptance criterion for a 510(k) is usually substantial equivalence to predicate devices. The performance is reported in terms of comparability to these predicates.
| Acceptance Criterion (Based on Substantial Equivalence to Predicates) | Reported Device Performance (Sepramesh™ IP) |
|---|---|
| Biocompatibility and Safety | Considered non-toxic, non-mutagenic, non-sensitizing, biocompatible, and safe. (Based on ISO 10993 and GLP studies) |
| Adhesion Formation | Performed substantially equivalent or better than Bard® Composix® E/X Mesh and Bard® Mesh. Demonstrated minimal tissue attachment and visceral adhesions during the critical wound-healing period due to the coated side. |
| Tissue Ingrowth | Overall performance, including tissue ingrowth, was substantially equivalent to Bard® Composix® E/X Mesh and Bard® Mesh. The uncoated side allows a prompt fibroblastic response through the interstices of the mesh, encouraging tissue ingrowth. Cellular response and tissue ingrowth were comparable to predicates. |
| Physical and Mechanical Characteristics | Substantially equivalent to currently marketed predicate devices for: Mesh thicknessMesh knit characteristicsPore sizeMesh mass/areaSuture retention strengthTear propagation strengthBurst strength |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions an in vivo study in a rabbit hernia repair model. However, the specific number of animals (sample size) used in this animal study is not provided in the excerpt.
- Data Provenance: The study was an in vivo animal study conducted specifically for this submission to evaluate the device's performance. The country of origin is not explicitly stated, but Genzyme Corporation is based in Cambridge, MA (USA). The study is prospective in nature for the purpose of demonstrating substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not detail the number of experts or their qualifications for evaluating the in vivo rabbit study. In animal studies, assessments like adhesion formation, tissue ingrowth, and cellular response are typically performed by veterinary pathologists or other experts in tissue analysis, but this specific information is absent.
4. Adjudication Method for the Test Set
The adjudication method for the in vivo rabbit study is not specified in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was NOT done. This document pertains to a medical device (surgical mesh), not an imaging or diagnostic AI system. MRMC studies are typically used to assess the performance of diagnostic aids (like AI algorithms) in improving human reader interpretation of images. The study described here is an in vivo animal study evaluating the physical and biological interaction of the mesh in a living system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical surgical mesh and not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant here. The in vivo rabbit study evaluates the device itself, not an algorithm's performance.
7. The Type of Ground Truth Used
The ground truth for the in vivo animal study appears to be based on:
- Direct Observation/Measurement: Evaluation of adhesion formation and tissue ingrowth in the rabbit hernia repair model.
- Histopathological Analysis: Assessment of cellular response.
- Standardized Physical Testing: Measurement of mesh thickness, knit characteristics, pore size, mass/area, suture retention strength, tear propagation strength, and burst strength.
8. The Sample Size for the Training Set
Not applicable. The device is a surgical mesh, not an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device does not involve an AI algorithm with a training set.
§ 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.