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The patient-specific Bodycad Unicompartmental Knee System (Bodycad UKS) is indicated for unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with:
· joint impairment due to osteoarthritis or traumatic arthritis of the knee.
· varus deformity of the knee, and
· as an alternative to tibial osteotomy in patients with unicompartmental OA.
The patient-specific Bodycad UKS components fit within an envelope of dimensions that are specific to each patient. The Bodycad UKS femoral component and tibial baseplate are intended fixation. A Bodycad screw must be used for fixation of the femoral component.

The Bodycad Unicompartmental Knee System (BUKS) is a patient-specific prosthesis that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patient-specific femoral and tibial components and single-use cutting quides are manufactured from CAD and CAM files generated from Bodycad software, which are based on MRI or CT images of the patient's knee and input from the surgeon. The BUKS is for cemented use only and is sterilized by gamma radiation.
The subject of this 510(k) notification is a line extension and design update that includes a new tibial baseplate that is compatible with the BUKS system (K163700, K181302) and instruments that are compatible with the new tibial baseplate.
Materials: Wrought Cobalt-28Chromium-6Molybdenum Alloy (CoCrMo; ASTM F1537-11) for the femoral component and screw, wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (Ti6Al4V ELI; ASTM F136-13) for the tibial baseplate, locking pin, and screw, Ultra-High-Molecular-Weight Polyethylene (UHMWPE; F648-14) for the tibial insert.

The provided text is a 510(k) summary for the Bodycad Unicompartmental Knee System. This document is a regulatory submission for a medical device and describes its intended use, technological characteristics, and a comparison to predicate devices to demonstrate substantial equivalence.

Based on the content, the document does NOT describe the acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based medical device. This document is for a physical medical implant (a knee system) and the performance data presented relates to mechanical testing and surgeon-user validation for the physical device, not an AI or software algorithm.

Therefore, I cannot extract the requested information regarding AI/algorithm performance, acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies.

The document primarily focuses on demonstrating the substantial equivalence of a physical knee implant (Bodycad Unicompartmental Knee System) to previously cleared predicate devices through design comparison and mechanical performance testing, not on the performance of a software algorithm or AI.

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