Search Results

Intended for the replacement of diseased or deficient bone in the proximal femur. It is indicated for: Limb salvage procedures where radical resection and replacement of the bone is required Painful and disabled joint resulting from avascular necrosis osteoarthritis, rheumatoid arthritis or traumatic arthritis Correction of varus, valgus or post traumatic deformity Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Ligament deficiencies Tumor resections Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques Revision of previously failed total joint arthroplasty Trauma The METS® Modular Proximal Femur and its components are for single use only The METS® Modular Proximal Femur and its components are for cemented use only

The single use METS® Modular Proximal Femur is a standard modular system that is intended for the replacement of diseased or deficient bone in the proximal femur. The system is intended for cemented use only and comprises titanium (Ti) components including a trochanter section, shaft with or without an integral extension piece, stem and collar that is available hydroxyapatite (HA) coated or uncoated, stippled or smooth. The trochanter trunnion is made to interchange with Stanmore Implants Worldwide Limited's 28mm and 32mm Ø Cobalt Chrome femoral heads. The METS® Modular Proximal Femur is offered with an optional set of trochanters which are only to be used forhard tissue attachment using a plate and two screws, or Ti or cobalt chromium (CoCr) wire. The materials used in the manufacture of the systems include titanium (Ti), cobalt-chromium-molybdenum (CoCrMo)

I am sorry, but the provided text describes a medical device, the METS® MODULAR PROXIMAL FEMUR, which is a hip joint metal/polymer semi-constrained cemented prosthesis. The information focuses on its classification, intended use, indications for use, and a declaration of substantial equivalence to predicate devices based on non-clinical performance testing and clinical evaluation through published papers and post-market surveillance.

This document does not contain information about:

1. Acceptance criteria and reported device performance in a table format for AI/algorithm-based performance. The document refers to "non-clinical performance testing" for the device's physical attributes (disassembly force testing) and "clinical evaluation... based upon published papers and post market surveillance" to support its substantial equivalence. These are not performance metrics for an AI system.
2. Sample size used for the test set or data provenance related to AI validation.
3. Number or qualifications of experts used to establish ground truth for a test set.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study with human readers and AI assistance.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcome data, etc.) for AI models.
8. Sample size for the training set (for an AI model).
9. How the ground truth for the training set was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving an AI device's performance, as the provided text pertains to a traditional medical implant and its regulatory submission, not an AI or algorithm-based device.

Ask a specific question about this device