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Total and partial hip replacement is indicated for patients suffering from disability due to:

• noninflammatory degenerative joint diseasc including osteoarthritis and avascular necrosis of the . natural femoral head;
• . rheumatoid arthritis;
• . correction of functional deformity;
• femoral fracture

This device may also be indicated in the salvage of previously failed surgical attempts.

The Vitality and Keystone are designed for a cementless application while the Alfa II, R120, and R120PC are designed for either cemented or cementless applications.

The modification consists of use of a ceramic femoral head with the hip stem. The material used in the ceramic femoral head is the same as other legally marketed predicate devices.

. ne Vitality, Keystone, Alfa II, R120 and R120PC are all designed for total hip joint replacement.

The provided document is a 510(k) premarket notification for a medical device manufacturer seeking clearance to market a modified hip stem product. It describes the device, its intended use, predicate devices, and the FDA's clearance letter. However, this document does not contain information related to acceptance criteria, device performance metrics, or a study proving that a device meets such criteria as would be expected for an AI/ML-based medical device.

The product in question is a ceramic femoral head used in conjunction with existing hip stems (Vitality, Keystone, Alfa II, R120, R120PC). The clearance is based on substantial equivalence to predicate devices, and the manufacturer explicitly states "Clinical Testing: None provided." The type of testing performed was "Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions."

Therefore, I cannot provide the requested information. The document focuses on mechanical properties and material compatibility, not on the performance metrics of an AI/ML system.

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