(148 days)
Hermesh 7 monofilament polypropylene mesh may be used for repair of abdominal wall hernia, including inguinal, femoral, and incisional, in open or laparoscopic abdominal procedures.
Hermesh 7 prosthesis are non- absorbable monofilament polypropylene meshes constructed from knitted monofilaments of extruded polypropylene. They are warp knitted in such a way that the mesh may be cut into preshaped designs without unraveling. They maintain excellent isotropic properties because of its knitted construction. Hermesh 7 polypropylene meshes have the necessary strength, flexibility, and durability for the various stresses which may be encountered in the body. The devices are supplied as sterile, single-use surgical meshes.
The provided 510(k) summary for Hermesh 7 does not contain information about acceptance criteria or a study proving that the device meets these criteria in the context of an AI/ML medical device.
This document describes a conventional surgical mesh device, not an AI/ML device. Therefore, the questions related to AI/ML device performance metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies are not applicable to the information provided.
The "Testing" section mentions various biocompatibility and sterilization tests conducted to show the safety, efficacy, and performance of the device, in compliance with ISO 10993 and FDA guidance for surgical mesh. These tests are standard for physical medical devices and do not involve AI/ML performance evaluation.
Summary of information that can be extracted, albeit not in the AI/ML context requested:
| Characteristic | Description |
|---|---|
| Acceptance Criteria | Not specified in the provided text in terms of quantitative performance metrics for device function. The document states compliance with ISO 10993 and FDA guidance for surgical mesh. |
| Reported Device Performance | For a traditional surgical mesh, "performance" is generally demonstrated through biocompatibility, mechanical strength, and sterility, rather than metrics like sensitivity, specificity, or AUC. The document lists tests performed: Mutagenicity, Cytotoxicity, Hemolysis, Sensitization, Systemic Toxicity, Ethylene Oxide Residual |
§ 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.