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The R120™ Modular 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, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. The Total Hip System is intended for use with and without bone cement.

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The provided text is an FDA 510(k) clearance letter for a medical device (R120™ Modular Total Hip System - Line Extension). It does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.

The document primarily focuses on:

• Confirming that the device is substantially equivalent to legally marketed predicate devices.
• Outlining the regulatory classification and general controls applicable to the device.
• Stating the intended indications for use.

Therefore, I cannot provide the requested information based on the input text. The text does not detail any performance studies, test sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

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The R120™ Modular Total Hip System is indicated for use in total or partial hip replacement The X120 - Northering sovere pain and disability due to structural damage in the hip joint from rheumatoid atthritis, 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 opplysis, that encation a. The Total Hip System is intended for use with and without bone cement.

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I am sorry, but based on the text provided, I cannot answer your request. The document is a 510(k) approval letter from the FDA for a total hip system, not a study report or technical specification document that would contain the detailed information you are asking for regarding acceptance criteria and device performance studies. The letter only states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not provide details about the specific studies conducted or their results.

Ask a specific question about this device