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The MotoBAND™ CP Implant System is indication and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. When used for these indications, the MotoBAND™ Implant System with the exception of the MTP plates and 2-hole plate may be used with the MotoCLIPTM Implant System.

The MotoBAND™ CP Implant System is comprised of implant plates and instruments, having various features and sizes to accommodate differing patient anatomy. Plate geometries include valgus options of 0°, 5° and 10°, dorsiflexion options of 0°, 2.5°, 5°, 7.5° and 10° and options to use either a 15mm or 18mm nitinol clip. MotoBAND™ CP Implant System is compatible with MotoCLIP™ Staple.

The provided FDA K173710 document for the MotoBAND™ CP Implant System does not contain the information requested regarding acceptance criteria and study details for a medical device that relies on AI or software for its performance evaluation (e.g., image analysis, diagnostic support devices).

The MotoBAND™ CP Implant System is a physical medical device (metallic bone fixation fastener, plate system) used for orthopedic fixation. Its substantial equivalence determination is based on:

• Theoretical analysis: Predicting torsional, pullout, and plate bending strengths.
• Comparison to predicate devices: Showing that the subject device's predicted performance is substantially equivalent to previously cleared devices (K152306, K160300).
• Materials: Stating the material used (titanium alloy).
• Indications for Use: Matching the scope of the predicate devices.

Therefore, the document does not include:

1. A table of acceptance criteria and reported device performance related to AI/software metrics (e.g., sensitivity, specificity, accuracy).
2. Sample sizes for test sets (as there's no diagnostic test set).
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication methods.
5. MRMC studies or effect sizes for human readers.
6. Standalone algorithm performance.
7. Types of ground truth (as it relates to diagnostic accuracy).
8. Training set sample sizes or ground truth establishment for training data.

The performance testing mentioned in the document refers to mechanical integrity and strength tests for the physical implant, not data-driven performance of a diagnostic or AI-enabled device.

In summary, this document is irrelevant to the prompt's request for information about a study that proves a device meets acceptance criteria related to AI or data-driven performance.

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