Search Results

Joint replacement is indicated for patients suffering from disability due to:

• noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
• rheumatoid arthritis;
• correction of functional deformity;
• femoral fracture;
  This device may also be indicated in the salvage of previously failed surgical attempts.

The modification consists of a change to the Instructions for Use to minimize the necessity for multiple IFU's and to update the contents to reflect current practice.

This submission (K121024) is a 510(k) premarket notification for a modification to the Instructions for Use (IFU) for several hip stem devices. The intent is to minimize the necessity for multiple IFUs and to update their content to reflect current practice.

Based on the provided document, there are no acceptance criteria or studies related to device performance in the context of AI/ML or diagnostic accuracy. This submission explicitly states "Non-Clinical Testing: None Provided" and "Clinical Testing: None provided."

The modifications relate to the labeling and administrative aspects of the device's usage instructions, not to any new or changed functional aspects that would require performance criteria or testing. The FDA's review in this case is focused on substantial equivalence to predicate devices based on indications, sterilization, and intended use, as documented on page 2.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types because these concepts are not applicable to the nature of this 510(k) submission.

Ask a specific question about this device