Search Results

The OTI Femoral Lock Total Hip System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusion acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the "OTI Femoral Lock Total Hip System." This document establishes that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market.

However, the provided text does not contain any information about:

• Acceptance criteria for device performance.
• A study proving the device meets acceptance criteria.
• Reported device performance.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for the training set was established.

This document is a regulatory approval letter based on "substantial equivalence" to a predicate device, meaning it's deemed as safe and effective as a similar device already on the market. It does not outline specific performance metrics or clinical study results in the way a newer, novel device approval or studies for AI/software devices might.

Therefore, the requested information cannot be extracted from the provided text.

Ask a specific question about this device