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Exprt™ Revision Hip System 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 EXPRT™ Revision Hip System includes non-porous distal femoral stem implants and nonporous proximal body implants, with bolt, all made from titanium alloy (Ti6Al4V) per ASTM F1472. System specific instrumentation allows the surgeon to prepare the bone to accept the EXPRT™ Revision Hip System implants.

This document is a 510(k) summary for the EXPRT™ Revision Hip System, a medical device. It does not describe an AI/ML medical device, and therefore the requested information regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of AI/ML performance metrics, is not present.

The document is a regulatory submission for a traditional medical device (a hip replacement system). The "acceptance criteria" and "study" mentioned here refer to the non-clinical and pre-clinical testing required for substantial equivalence, not performance metrics for an AI algorithm.

Here's a breakdown of why the requested information cannot be extracted from this document:

• No AI/ML Component: The device is a physical hip implant (EXPRT™ Revision Hip System). There is no mention of any AI or machine learning component.
• "Acceptance Criteria" Context: For a physical device like a hip implant, "acceptance criteria" typically relate to mechanical strength, biocompatibility, material properties, and manufacturing quality, not diagnostic performance or AI model accuracy.
• "Study" Context: The document mentions "Non-Clinical Testing: ROM testing and distal fatigue testing," and "Endotoxin Assessment," which are standard tests for orthopedic implants to determine their mechanical integrity and safety. It explicitly states, "Clinical Testing: Clinical testing was not required." This indicates that the substantial equivalence was based on non-clinical data comparing it to existing predicate devices.

Therefore, it is impossible to provide the requested information in the format specified because it pertains to an AI/ML context that is not applicable to this document.

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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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