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The Orthopilot® HTO module is designed to assist an orthopedic surgeon to navigate the two bone cuts to form the wedge for correction of the leg axis.

Orthopilot® HTO (High Tibia Osteotomy) module uses transmitters that are mounted to the patients bones, or are flexible to palpate landmarks and a camera to monitor the spatial location of those transmitters in relation to each other and the medical instruments. These locations are used to locate the centers of rotation of the femur head, ankle and knee. These measurements allow for greater accuracy than mechanical methods of ascertaining cutting angles. The HTO module is only a tool to navigate the instruments for the bone cuts. It is not linked to any specific implant.

The provided document is a 510(k) summary for the Aesculap Orthopilot® HTO module, indicating its purpose is to gain marketing clearance. However, it explicitly states there are no performance standards for such devices and references conformity to applicable ASTM and ISO standards generally. No specific acceptance criteria or detailed study results are included in this document to demonstrate the device meets any particular performance criteria.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample sized used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document primarily focuses on establishing substantial equivalence to existing devices (Orthopilot® 2 Navigation Platform, Kinamed Orthopilot®, Stryker Navigation System-Knee Module, Brainlab Vector Vision Knee) rather than presenting a detailed performance study with specific metrics and acceptance criteria.

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