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The specific intended use of the St. Leger total knee implant is for patients suffering from pain and/or deformity of the knee joint. The pathological conditions include, but are not parted to severe degenerative arthritis, traumatic arthritis, inflammatory arthritis, and rheumatoid arthritis. The symptomatic problems include pain, decreased ambulation, inability to work, perform activities of daily living. The resulting physical deformities include loss of knee extension, knee flexion, genu valgum and genu varus. The implant may be used in revision knee surgery due to loosening, infection, or prior implant failure if the proper accompanying conditions are present and the surgeon is able to make the necessary anatomical conditions for acceptable alignment and fixation.

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I apologize, but the provided text is a 510(k) premarket notification letter from the FDA regarding a St. Leger Total Knee Implant. This document does not describe a study that uses acceptance criteria to prove the performance of a device in the context of AI/ML or diagnostic accuracy.

The letter pertains to the substantial equivalence determination for a medical device (a knee implant), focusing on its classification, intended use, and limitations (e.g., cemented use only, minimum polyethylene thickness). It does not contain information about:

• Acceptance criteria for performance metrics (like sensitivity, specificity, accuracy)
• Results of a performance study
• Sample sizes for test sets or training sets
• Data provenance
• Expert qualifications or ground truth establishment
• Multi-reader multi-case studies or standalone algorithm performance

Therefore, I cannot fulfill your request for information about acceptance criteria and a study proving device performance based on the provided text.

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