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Joint replacement is indicated for patients suffering from disability due to:

• · Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural head;
• Rheumatoid arthritis;
• · Correction of functional deformity;
• Femoral fracture

This device may also be indicated in the salvage of previously failed surgical attempts. The EMPOWR Dual Mobility™ system has the additional indication of joint replacement due to dislocation risks.

The constrained acetabular component is indicated for primary or revision at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for who all other options to constrained acetabular components have been considered.

The ceramys™ femoral head system represents the latest generation of prosthetic femoral heads used in hip arthroplasty.

The ceramys™ femoral head system is applicable for use in total hip arthroplasty and the prosthetic replacement of femoral neck fractures. It offers a femoral head design with a reproducible surgical technique carefully developed to enable consistent and accurate implantation.

The ceramys™ femoral head system is composed of ceramys™ femoral heads, ceramys™ choice sleeved femoral heads, and ceramys™ choice sleeves. The ceramys™ femoral head system consists of alumina toughened zirconia ceramic heads and titanium adapter sleeves that connect to femoral stems using a 12/14 taper. The ceramys™ choice femoral heads and sleeves can be used with a well fixed stem in revision hip arthroplasty. The femoral head spherical diameter will be offered as 28, 32, 36, 40, and 44 mm and the femoral head center is offered in 4 increments ranging from -4 to +8 mm.

The provided text describes a 510(k) premarket notification for the ceramys™ femoral head system. This notification is for a medical device and not an AI/ML software. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not explicitly present in the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device through:

• Biocompatibility testing: Conducted according to FDA guidance and ISO standards for permanent implantation.
• Performance testing: A comprehensive list of tests performed to FDA recognized standards and internal protocols specific to the ceramys™ femoral head system. These tests cover mechanical properties, material composition, and other performance aspects relevant to the physical device.

Key points from the document regarding the device and its testing:

• Device Name: ceramys™ femoral head system
• Regulation Number: 21 CFR 888.3353 (Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis)
• Regulatory Class: Class II
• Intended Use/Indications for Use: Joint replacement for patients with noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, femoral fracture, and salvage of failed surgical attempts.
• Comparison to Predicate: The subject device is compared to the BIOLOX® delta Ceramic Femoral Head (K082844). While diameters and offsets are similar, the ceramic material formulation is different.
• No AI/ML Component: The submission does not mention any AI/ML components or software in the device description or testing.
• No Clinical Studies or Animal Studies: The document explicitly states "No animal data submitted" and "No clinical data submitted."

Therefore, it is not possible to extract the requested information about acceptance criteria or studies related to AI/ML device performance from this document. The acceptance criteria for this device would be embedded within the specific standards listed for performance testing (e.g., ISO 7206-10:2018, ASTM F1875-14) and would relate to the physical and mechanical properties of the femoral head system, not to an AI's diagnostic or predictive accuracy.

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