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• 1. Joint impairment from arthritis (rheumatoid, osteo and post traumatic).
• 2. Revision of failed femoral head replacements.
• 3. When alternative reconstructive techniques are not viable.
• When arthrodesis is contraindicated. 4.
• 5. Avascular necrosis or fracture of the femoral head.
• 6. Congenital defects that will allow adequate function of the system.

Protract Press-Fit Hip Stem - HA Coated

The provided text is a clearance letter from the FDA for a medical device called the "Protract Press-Fit Hip Stem - HA Coated." It does not contain any information about acceptance criteria, the study design, device performance data, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

Therefore, I cannot provide the requested information based on the input document. The document primarily serves as an official communication from the FDA stating that the device has been deemed "substantially equivalent" to predicate devices and can be marketed. It lists the indications for use but does not detail the technical performance or supporting clinical study data.

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1. Joint impairment from arthritis (rheumatoid, osteo and post traumatic).
2. Revision of failed femoral head replacements.
3. When alternative reconstructive techniques are not viable.
4. When arthrodesis is contraindicated.
5. Avascular necrosis or fracture of the femoral head.
6. Congenital defects that will allow adequate function of the system.

Not Found

I am sorry, but the provided text does not contain information about the acceptance criteria and study details for the "Protract Press Fit Hip Stem" device. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a predicate device already on the market. It lists the indications for use but does not include:

• A table of acceptance criteria or reported device performance.
• Information about sample sizes, data provenance, or expert qualifications for a test set.
• Details on adjudication methods, MRMC studies, or standalone algorithm performance.
• The type of ground truth used or the sample size and ground truth establishment for a training set.

The FDA letter grants market clearance based on substantial equivalence, and typically, the detailed performance data from such studies would be found in the 510(k) submission itself, not in the clearance letter.

Ask a specific question about this device