(79 days)
Relief of pain and disability, and restoration of hip function within patients who have radiographic evidence of good bone stock in the femoral head and acetabulum, the bearing surface and supportive bone structure of the acetabulum being normal.
This prosthesis is also intended for patients having deformities of the hip that do not lend themselves to conventional total hip replacement such as previously failed femoral osteotomy, previous fracture, or early deformities of the proximal end of the femur. These make it anatomically impossible to use a conventional femoral component. As above the acetabulum should be essentially normal.
These devices are intended for use with hip joints in which the concentricity of the bearing surface, and supportive bone structure of the acetabulum, is essentially normal.
Selection of the implant from the available range of sizes provides reasonably precise articulation.
The devices are used to resurface the head of the femur, and so reinstate function of the hip joint following the degenerative effects of osteo and rheumatoid arthritis, post traumatic disease and avascular necrosis.
The Cormet 2000 Hemi Hip Metallic Resurfacing Prostheses consists of 5 sizes ranging from 40 to 56mm diameter in 4mm increments.
These devices are intended for use with bone cement and have been designed to replace only a small portion of the of the worn femoral head. Stable and immobile fixation of the implant provides stress bearing contact at the bone / prosthetic interface.
The Cormet 2000 Hemi Hip Metallic Resurfacing Prostheses are manufactured from Cobalt Chromium Molybdenum alloy in accordance with ISO 5832-4/BS 7252/4 : 1997 - 'Specification for cobalt-chromium-molybdenum casting alloy', and is cast in accordance with BS 7254 Pt.5 1990- Specification for production of castings made of cobalt-chromium-molybdenum alloy'.
The Cormet 2000 Hemi Hip Metallic Resurfacing Prostheses are manufactured in accordance with BS EN 12010 : 1998 - 'Non-active Surgical Implants - Joint Replacement Implants -Particular Requirements', BS EN ISO 14630:1998 - General requirements for non-active surgical implants and BS EN 12563:1999 Non active surgical implants - Joint replacements - Specific requirements for hip joint replacement implants.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance as it relates to a typical medical device submission for AI/ML.
The provided document is a 510(k) summary for the Cormet 2000 Hemi Hip Metallic Resurfacing Prostheses, a physical hip implant device. The FDA letter states that the device is "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This regulatory pathway means that the device's safety and effectiveness were primarily established by demonstrating its similarity to existing cleared devices, rather than through a new clinical effectiveness study with specific acceptance criteria related to AI performance metrics.
Therefore, I cannot extract the information required in your request about acceptance criteria for AI/ML performance, sample sizes, ground truth establishment, or multi-reader multi-case studies. These concepts are not applicable to the type of device and regulatory submission described in the input.
§ 888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic resurfacing prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral resurfacing component made of alloys, such as cobalt-chromium-molybdenum.(b)
Classification. Class II.