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The MyHip Planner software is intended for image processing and pre-operative planning of acetabular cup and femoral stem positioning for Total Hip Arthroplasty (THA). The device assists the user in assessing potential leg length and offset differences as well as potential range of motion impingement.

The MyHip Verifier software is intended to assist in the intra-operative evaluation of leg length and offset differences as well as acetabular cup positioning for anterior approach Total Hip Arthroplasty when the patient is positioned supine.

The MyHip Planner is a software whose output is a patient-specific preoperative plan based on CT scans and aimed at evaluating the effects of different devices and positioning options on the patient's hip joint biomechanics in terms of leg length and offset.

The MyHip Verifier is a software whose output is an intra-surgical numerical evaluation of the implant positioning based on fluoroscopy and aimed at evaluating the effects in terms of leg length and offset of cup and stem positioning.

Both software are intended to be used in Primary Hip Arthroplasty and they are compatible with Windows and Mac OS operating system. MyHip Verifier is also compatible with Ubuntu operating system.

The provided text describes the MyHip Planner & Verifier device and its regulatory submission (K200350). However, the information regarding specific acceptance criteria for performance, detailed study results proving the device meets these criteria, sample sizes for test and training sets, the number and qualifications of experts, adjudication methods, MRMC studies, or the type of ground truth beyond general "validation" and "verification" is not explicitly present in this document.

The document states:

• "Based on the risk analysis, software verification and validation were conducted according to written protocols with defined acceptance criteria."
• "The following tests are being provided in support of a substantial equivalence determination: MyHip Planner software verification and validation; MyHip Planner validation through retrospective analysis; MyHip Verifier software verification and validation; MyHip Verifier validation through in-vitro and cadaver testing."
• "No clinical studies were conducted."

This indicates that some performance data was generated to support the substantial equivalence claim, but the detailed breakdown requested in the prompt (specific acceptance criteria, reported performance, sample sizes, expert details, etc.) is not included in the provided FDA 510(k) summary. The document focuses on regulatory aspects and comparison to predicate devices, not the granular details of the performance study itself.

Therefore, I cannot fully answer your request based solely on the provided text. The information requested would typically be found in detailed study reports submitted to the FDA, which are not part of this 510(k) summary document.

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