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The MotoCLIP™HiMAX™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.

MotoCLIP™/HiMAX™ Implant System is a staple system which gives the surgeon a means of bone fixation in the management of bone fractures and reconstruction surgery. The MotoCLIP™/HiMAXIM Implant System is a line extension of the previously cleared CrossCLIP™ System K142727. After clearance, CrossRoads re-branded the CrossCLIP™ System to the MotoCLIPTMTM Implant System.

The MotoCLIP™/HiMAX™ Implant System gives the surgeon a means for fixation of fractures, fusions, and osteotomies of the foot, ankle, and hand. The MotoCLIP™/HiMAX™ Implant System includes implants and the related instrumentation needed for implantation. The implants are made from implant grade Nitinol per ASTM F2063.

The only modifications being made in this submission are changes in the geometry of the implants and associated instruments.

This document describes the MotoCLIP™/HiMAX™ Implant System, which is a staple system for bone fixation in hand and foot osteotomy and joint arthrodesis. The submission is a line extension of the previously cleared CrossCLIP™ System (K142727).

Here's a breakdown of the acceptance criteria and study information provided in the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a tabulated format with numerical targets. Instead, the performance evaluations are centered around demonstrating substantial equivalence to a predicate device (CrossCLIP™ Implants, K142727). The core acceptance is that the device does not introduce a new worst case and meets or exceeds the strength of the worst-case implant in the previously cleared system.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified for the theoretical analysis (FEA) or pull-out testing. The description only refers to "worst case" analysis and "the subject device."
• Data Provenance: Not specified. It's an engineering analysis and bench testing, likely conducted internally by the manufacturer or a contracted lab. There's no mention of patient data (retrospective or prospective) for this type of device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission concerns a mechanical device (bone fixation staple). The "ground truth" for its performance is established through biomechanical testing and engineering analysis, not expert clinical interpretation of images or patient outcomes.

4. Adjudication method for the test set

Not applicable, as this is a mechanical performance study, not a clinical study involving human judgment or interpretation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device (implantable staple), not an AI/imaging diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This describes a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for demonstrating substantial equivalence and acceptable performance for this device is based on bench testing and theoretical engineering analysis (FEA), specifically:

• Predicted compression force
• Maximum strain
• Pull-out strength

These are compared against the known performance characteristics of the predicate device.

8. The sample size for the training set

Not applicable. This is not a study involving machine learning or statistical modeling that would require a "training set." The data comes from engineering simulations and physical bench tests.

9. How the ground truth for the training set was established

Not applicable, for the same reasons as #8.

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