(154 days)
MINIMESH® polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.
Minimesh® is a non-absorbable polypropylene mesh constructed from knitted monofilaments of extruded polypropylene.
Minimesh® polypropylene mesh is constructed using a warp-knit process to a unique design that permits the mesh to be cut into any desired shape or size without unraveling.
It maintains excellent isotropic properties arising from its knitted construction.
Minimesh® polypropylene mesh has the necessary strength, flexibility, durability and surgical adaptability. These properties permit the correct adaptation to the various stresses encountered in the body.
The device is supplied sterile.
The provided text describes the 510(k) Notification for Mpathy Medical Devices, Ltd.'s Minimesh® polypropylene mesh, but it does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML device.
This document pertains to a traditional medical device (surgical mesh) and focuses on substantial equivalence to predicate devices, safety testing (biocompatibility per ISO 10993), and compliance with FDA guidance for surgical mesh.
Therefore, I cannot provide the requested information for an AI/ML device based on the given input. The categories requested, such as "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," and "training set sample size and ground truth establishment," are all relevant to the evaluation of AI/ML-driven medical devices and are not discussed in this 510(k) for a physical surgical mesh.
§ 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.