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Revision Femoral Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.

The Revision Femoral Stem consists of a femoral stem and a modular neck, assembled together through a taper coupling stabilized by means of a safety screw. When used in total hip arthroplasty, the Revision Femoral Stem prosthesis is intended for use with modular femoral heads and compatible acetabular cups. When used in partial hip arthroplasty, the Revision Femoral Stem prosthesis is intended for use with a Lock Bipolar Head. The stem is made of Ti6Al4V (ASTM F1472 – ISO 5832-3). The stem is straight, with a tapered profile, round finned section and a rounded tip to facilitate insertion. The external surface of the stem features a macro-roughened finishing obtained by sandblasting. Diameters ranging from 14 to 24 mm, with increases of 2 mm, for a total of 6 diameters are available. Two lengths (140 or 200 mm) for each diameter of the stem are available. The neck is made of Ti6A14V (ASTM F1472 – ISO 5832-3). The same material is also used for the safety screw. which also has a small pin made of UHMWPE (ISO 5834-2. ASTM F648) to help prevent loosening of the safety screw. Two (2) versions of the neck are available , one with a CCD angle of 131° and another with a CCD angle of 135°. Both the neck versions are available in 7 different heights. Distally, the external surface of the neck component features a macro-roughened finishing obtained by sandblasting: proximally, the surface of the neck component is polished to reduce the chance of polyethylene wear particles if the neck accidentally rubs against the polyethylene of the acetabular component.

This document is an FDA 510(k) clearance letter for a medical device (Revision Femoral Stem). It primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing. Therefore, it does not contain information about the performance of a device that relies on AI/ML or require extensive clinical efficacy studies typically needed for new technologies or those without clear predicates.

Consequently, I cannot provide the detailed information requested in the prompt, as the document explicitly states:

• "Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of Revision Femoral Stem to the predicate devices."

This means there's no data in this document for acceptance criteria related to AI/ML performance, no test set, no ground truth establishment, no human expert involvement for adjudication, no MRMC study, and no standalone algorithm performance.

The document discusses non-clinical testing such as fatigue testing and fretting evaluation, but these are for the mechanical properties of the hip implant itself, not for an AI/ML algorithm's performance.

If you have a document about an AI/ML medical device, I would be happy to analyze it against your criteria.

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