(71 days)
The DePuy Protrusio Cage is intended to be used to reinforce a deficient or weakened medial acetabular wall to prevent the protrusion of an acetabular cup prosthesis into the abdominal cavity and may be indicated for use in cases involving acetabular revision procedures, severe osteoporosis, Protrusio Acetabuli, or a shallow acetabular roof.
The DePuy Protrusio Cage is a rimmed metal shell with multiple holes and ischial "wings". It is intended to reinforce weak acetabula by transferring stress away from the medial wall to the stronger acetabular rim. The wings and rim of the cage can be fixed to solid bone using Titanium bone screws. The reinforcement provided by the Protrusio cage allows improved fixation of an acetabular cup prosthesis, which can be fixed inside the Protrusio cage using bone cement. The DePuy Protrusio cage is available in diameters of 52, 56 and 60mm in right and left configurations. The Titanium bone screws have a diameter of 6.5mm and are available in lengths of 20, 25, 30, 35, 40, 45, 50, 55 and 60mm.
This document does not describe an AI/ML device or a study involving acceptance criteria and device performance in the context of AI.
The provided text is a 510(k) summary for a medical device called "DePuy Protrusio Cages," which is a surgical mesh intended to reinforce a deficient acetabular wall. The summary describes the device's intended use, description, and basis for substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth, or MRMC studies, as these concepts are specifically relevant to the evaluation of AI/ML-driven medical devices and are not discussed in this document.
§ 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.