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• 1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia.
• Inflammatory degenerative joint disease such as rheumatoid arthritis. 2.
• 3. Correction of function deformity.
• 4. Revision procedures where other treatments or devices have failed.
• 5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques.

This device is a single use implant and intended for cementless use only except cemented stem which is designed for cemented use only.

The U2 Ti Porous Coated Matrix Stem is single use component intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty. U2 Ti Porous Coated Matrix Stem, made from a Ti-6Al-4V alloy conforming to ASTM F136-13/ISO 5832-3:1996, is a modular stem with 12/14 neck taper and 130° neck angle. The proximal part of each femoral stem is coated with porous coating in thickness 600±100 um using -45+60 mesh of CP Ti powder (ASTM F1580-12). The bulleted geometry stem tip of U2 Ti Porous Coated Matrix Stem helps reduce distal point loading while creating a smooth transition zone for load transfer. This stem system is available in thirteen sizes. U2 Ti Porous Coated Matrix Stem can be used with U1, U2 Acetabular components (K994078, K050262, K12177, K111546), U-Motion II Acetabular System components (K122185, K132455) and UNITED Femoral Head (K994078, K022520, K122504, K103497, K111546, K112463, K122185) for total hip replacement. For hip hemi-arthroplasty, U2 Ti Porous Coated Matrix Stem can be used in conjunction with Bipolar products (K101670).

The provided text describes a medical device, the U2 Hip Stem, Ti Porous Coated, Matrix, and its 510(k) summary, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood for AI/algorithm-based devices. This document is for a physical orthopedic implant.

Therefore, I cannot fulfill the request as it pertains to AI device acceptance criteria and studies. The document describes:

1. Device Type: A hip stem (orthopedic implant).
2. Regulatory Pathway: 510(k) premarket notification, indicating substantial equivalence to a predicate device.
3. Non-clinical Performance Data: Mentions stem fatigue, neck fatigue, and mechanical properties of the porous coating surface. These tests comply with FDA guidance for femoral stem prostheses.
4. Clinical Performance Data: Explicitly states "None provided as a basis for substantial equivalence."

Key points missing (and why they are missing based on the document):

• Acceptance Criteria Table: Not applicable as this is a physical implant, not an AI/algorithm with performance metrics like sensitivity, specificity, etc.
• Sample Size for Test Set, Data Provenance, Experts for Ground Truth, Adjudication, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Sample Size, Ground Truth for Training Set: All these points are relevant to AI/algorithm performance studies and are not found in this document because it concerns a physical medical device (hip stem). The "studies" mentioned are mechanical tests, not clinical evaluations or algorithm performance assessments.

If you have a document describing an AI/algorithm-based medical device, I would be happy to analyze it according to your requested format.

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