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510(k) Data Aggregation
(168 days)
OTI Alumina Ceramic Femoral Head 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, post traumatic arthritis, collagen disorders, avascular necrosis, traumatic arthritis, congenital hip dysplasia, protrusio acetabuli, slipped Capital Femoral Epiphysis, failed previous fusion, where acetabular reconstruction is not possible, and revision of previously failed hip arthroplasty.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device conformance to such criteria, or any details regarding a medical imaging AI device. The document is a 510(k) clearance letter from the FDA for a non-AI medical device: OTI Alumina Ceramic Femoral Head System – Line Extension, which is a hip joint prosthesis.
Therefore, I cannot provide the requested information as it is not present in the given input.
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(94 days)
OTI Alumina Ceramic Femoral Head 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, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
Not Found
This is a 510(k) premarket notification letter for a medical device (OTI Alumina Ceramic Femoral Head System), not a study report. Therefore, it does not contain information about acceptance criteria, device performance from a study, sample sizes, ground truth establishment, or multi-reader multi-case studies.
The document indicates that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed. This determination is based on a comparison to existing devices rather than a new study detailing specific performance metrics against acceptance criteria.
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