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The Depuy AML® Hip Prosthesis is intended for use in total hip arthroplasty (THA) in either a cementless or cemented application. Total hip arthroplasy is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

The AML® Hip Stem is indicated for cementless use with fixation by biological tissue ingrowth into the porous coating as well as cemented use and fixation in which the porous coating serves as a means to augment the fixation of the prosthesis to the bone cement.

The subject device, DePuy AML® Hip Prosthesis, is manufactured from ASTM F-799 Forged Controlled-Carbon Cobalt-Chromium-Molybdenum alloy and has a sintered cobalt-chrome molybdenum alloy bead porous coating (Porocoat@) applied to the stem. The porous coating is applied to the entire stem with the exception of the tapered stem tip region. The stems are available in 10.5 and 12.0 mm sizes.

This appears to be a 510(k) premarket notification for a medical device (DePuy AML® Hip Prosthesis), specifically for demonstrating substantial equivalence to previously cleared devices. 510(k) submissions typically do not contain detailed clinical study data with acceptance criteria for device performance in the way that a clinical trial of a novel therapy would, especially for an AI-powered device.

The provided text does not contain any information about acceptance criteria or a study proving that the device meets those criteria, particularly in the context of an AI/ML-powered device.

Therefore, I cannot fulfill the request to provide the detailed information about acceptance criteria, study design, sample sizes, ground truth establishment, or MRMC studies, as this information is not present in the provided document.

Here's why and what can be extracted based on the nature of the document:

• Type of Device: The device is a "Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis" (a hip implant). This is a physical medical device, not an AI/ML diagnostic or assistive tool.
• Regulatory Pathway: This is a 510(k) submission, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, not to prove the safety and effectiveness of a novel device through extensive clinical trials.
• Focus of the Document: The document focuses on:
  • Device description (materials, design, sizes).
  • Intended use and indications for use.
  • Comparison to predicate devices to establish substantial equivalence based on intended use, indications, sterilization methods, packaging, and design.
  • FDA's letter of clearance.

Therefore, I must state that the requested information (acceptance criteria, study details for performance evaluation, sample sizes, expert qualifications, etc., as typically associated with AI/ML device validation) is NOT present in the provided text.

If this were a submission for an AI/ML-powered device, the content would be drastically different, focusing on metrics like sensitivity, specificity, AUC, F1-score, and rigorous validation studies.

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