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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 femoral head;
• rheumatoid arthritis;
• correction of functional deformity;
• femoral fracture.
  This device may also be indicated in the salvage of previously failed surgical attempts. It is to be used for cementless applications only.

The modification consists of a change to Encore Medical's acetabular liner to from Description: UHMWPe to highly cross-linked UHMWPe. Additionally, this application addresses a size addition to Encore Medical's current acetabular liners, acetabular shells, and femoral heads.

The provided document is a 510(k) summary for a medical device (Foundation® (FMP™) Porous Coated Acetabular System and Hip Stem) that received FDA clearance in 2007. This type of submission is for substantial equivalence to existing predicate devices, not for demonstrating novel performance through extensive clinical studies as is typically done for AI/ML devices or new technologies with acceptance criteria.

Therefore, the document does not contain the requested information regarding acceptance criteria, device performance metrics, sample sizes for test/training sets, expert ground truth establishment, or multi-reader multi-case studies.

Here's why the requested information is absent:

• Type of Device: The device is a hip implant (acetabular system and hip stem), a physical medical device. The 510(k) pathway for such devices primarily focuses on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device in terms of intended use, technological characteristics, and safety/effectiveness. This typically involves engineering and material testing, biocompatibility assessments, and comparison of design features, rather than clinical efficacy studies with specific performance metrics like those for diagnostic AI/ML tools.
• Date: The clearance date is December 2007. The rigorous requirements for AI/ML device validation, including detailed performance metrics, ground truth methodologies, and MRMC studies, are much more recent developments in regulatory science.
• 510(k) Process: The 510(k) process for this type of device generally relies on demonstrating equivalence through non-clinical testing (e.g., mechanical testing for wear, fatigue, pull-out strength; biocompatibility testing) and comparison to the predicate, rather than primary clinical trials with "acceptance criteria" for a specific performance metric like sensitivity or specificity.

Based on the provided text, I cannot fill out the requested table or answer the specific questions about acceptance criteria, study details, and AI/ML-related performance metrics. The document is a regulatory notice of clearance for a conventional medical device modification, not a study report detailing AI performance.

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