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The NanoOrtho NanoKnee® System is indicated for restoring either compartment of a knee that has been affected by the following:

1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
2. Correction of femoral deformity;
3. Revision procedures where other treatments or devices have failed; and
4. Treatment of fractures that are unmanageable using other techniques.
   The NanoOrtho NanoKnee® System components are single use and are intended for implantation with or without bone cement.

The NanoOrtho NanoKne® is a unicompartmental knee system that includes porous coated and non-porous coated, cast CoCr, symmetric femoral components in sizes 1-6; and Ti6Al4V, symmetric, porous coated and non-porous coated tibial baseplate components in sizes 1-6. The tibial inserts are offered in standard UHMWPE, symmetric design, Constrained+, in sizes 1-6 and 5 thicknesses per size 9,10,11,12,14mm.

I apologize, but this document does not contain the specific information you requested regarding acceptance criteria and a study proving device performance.

The document is a 510(k) Premarket Notification from the FDA for the NanoOrtho NanoKnee® System. It focuses on establishing substantial equivalence to previously marketed devices (predicates) based on design features, materials, and indications for use.

While it mentions "Performance Testing" and lists several ASTM standards (e.g., ASTM F3140-17, ASTM F2083-12, ASTM F1223-14), these sections only state that "The results confirm that all components of the NanoOrtho NanoKnee® System are substantially equivalent to the predicate devices." It does not provide specific acceptance criteria, reported device performance values, sample sizes, ground truth establishment methods, or details about expert involvement or comparative effectiveness studies.

The document primarily states that the NanoOrtho NanoKnee® System is equivalent to predicate devices based on laboratory (bench) testing, but it does not detail the specific results, quantitative acceptance criteria, or the methodology of a "study" in the sense of clinical trials or AI performance evaluations.

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