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The Exactech Alteon Modular Dual Mobility (MDM) System is a component of the Alteon Acetabular System. The Alteon MDM System is indicated for skeletally mature individuals undergoing surgery for hip replacement due to osteoarthritis, theumatoid arthritis, osteonecrosis or post-traumatic degenerative problems of the hip. The Alteon Modular Dual Mobility System is also potentially indicated for ankylosing spondylitis, congenital hip dysplasia and to restore mobility resulting from previous fusion. The Alteon MDM System is also indicated for use in primary or revision patients at a high risk of hip dislocation.

The Alteon Acetabular System is intended for press-fit fixation.

The Alteon® MDM System provides modular implants for use in total hip arthroplasty (THA) to restore patient joint function. The Exactech® Alteon® Modular Dual Mobility (MDM) System is intended for use in total hip replacement as an interface between the acetabulum and femoral heads. The Alteon® MDM liners and inserts are manufactured from CoCr alloy and Ultra-High Molecular Weight Polyethylene containing vitamin E (alpha tocopherol), respectively. The Alteon® MDM liners and inserts are each available in seven configurations. The Alteon® MDM insert inner diameter (femoral head compatibility) includes 22mm or 28mm, while the Alteon® MDM liners are compatible with acetabular shells with outer diameters 46-68mm.

This document describes the Exactech® Alteon® Modular Dual Mobility (MDM) System, a medical device, and its 510(k) submission for FDA clearance. However, the provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an Artificial Intelligence (AI) / Machine Learning (ML) enabled medical device.

The document details the device's indications for use, technological characteristics, and non-clinical testing performed to demonstrate substantial equivalence to predicate devices for regulatory clearance. The non-clinical tests are standard for orthopedic implants, such as biocompatibility, wear analysis, mechanical testing (fretting/corrosion, impingement, lever-out, axial push-out, torque out, offset pull-out), and range of motion analysis.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance (algorithm only) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This device is a physical orthopedic implant, not an AI/ML software device, and thus the type of studies and acceptance criteria you are asking about (related to AI/ML performance) are not applicable to this 510(k) submission.

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