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• Noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, ● osteoarthritis, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis.
• Failed previous surgery where pain, deformity, or dysfunction persists. .
• Revision of previously failed hip arthroplasty. .

The Wagner Cone Prosthesis stem is a straight, collarless stem system designed for uncemented fixation. The surface of the prosthesis is rough blasted, and it has a tapered shape with an angle of five degrees. The stem has eight longitudinal ribs, and it is available in two different CCD angles, 125° and 135°. The stems are available in twelve diameters, ranging from 13 to 24 mm.

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.

The provided text is a 510(k) premarket notification for the "Wagner Cone Prosthesis® System." It focuses on:

• Summary of Safety and Effectiveness: This section primarily establishes substantial equivalence to predicate devices.
• Device Description: Describes the physical characteristics of the prosthesis.
• Intended Use: Lists the medical conditions the device is designed to treat.
• Comparison to Predicate Device: Highlights similarities with previously cleared devices.
• Performance Data (Nonclinical and/or Clinical): States that non-clinical tests (Stem and Neck Fatigue Testing, Biocompatibility Testing, and Burst Strength Testing of Ceramic Femoral Heads) were completed, but explicitly mentions "Clinical data and conclusions were not needed for this device."

Therefore, I cannot provide the requested information. The document does not discuss a study with a test set, ground truth establishment, expert adjudication, or other metrics typically associated with proving a device meets acceptance criteria derived from clinical or AI performance studies. The scope of this document is limited to demonstrating substantial equivalence for regulatory clearance, not detailed performance metrics against specific acceptance thresholds.

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The Wagner Cone Prosthesis is intended for prosthetic replacement of the proximal portion of the femur in total hip arthroplasty. This device is intended for cementless application where primary fixation occurs predominantly in the distal region. Specific diagnostic indications for use of the Wagner Cone Prosthesis are:

• patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis;
• those patients with failed previous surgery where pain, deformity, or dysfunction persists;
• revision of previously failed hip arthroplasty.

This stem is a titanium-aluminum-niobium alloy conical configuration with a taper. The design features a circular cross-section with eight equally spaced conical longitudinal flutes down the long axis of the stem for rotational stability. The stem's core diameter tapers gradually from the proximal end to the distal end.

The provided document is a 510(k) premarket notification for the Wagner Cone Prosthesis, a hip joint implant. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information regarding acceptance criteria, device performance metrics, or study results in the context of AI/ML device evaluation.

The 510(k) approval process for orthopedic implants typically relies on demonstrating substantial equivalence to a legally marketed predicate device through:

• Design comparisons: Showing the new device has similar materials, design features, and operating principles to approved predicate devices.
• Functional analyses: Testing the physical and mechanical properties of the device (e.g., strength, fatigue life, wear resistance) to show it performs comparably to or better than predicate devices. These tests are usually conducted in a laboratory setting according to recognized standards (e.g., ISO, ASTM).
• Performance tests: These refer to mechanical and material tests, not clinical performance in the sense of a diagnostic or predictive AI/ML model.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details related to AI/ML device performance from this document. The questions you've asked (sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are highly relevant to AI/ML device submissions but are not addressed in this type of traditional medical device 510(k) summary.

Ask a specific question about this device