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The OrthoPilot® Next Generation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to position endoprosthesis in athroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for endoprosthesis replacement surgery (such as total knee, unicondylar knee, and total hip systems) and provides intraoperative measurement. It indicates angles and positions for implant placement.

Aesculap's OrthoPilot® Next Generation is a computer assisted surgical navigation system that uses proprietary software to provide anatomical information to a surgeon. The hardware in the system consists of the following primary components: stereotaxic camera, computer (w/ monitors), rigid bodies (transmitters), passive markers, power supply, various tagged instruments, transport cart and stand. The computer accepts input from the transmitters on the rigid bodies either mounted to the patients bones or mobile to palpate anatomical landmarks in conjunction with a camera to monitor the spatial location of the transmitters in relation to each other and/or instruments. The software modules for the OrthoPilot® Next Generation consist of modules for both a knee suite and a hip suite.

The provided text is a 510(k) premarket notification for a medical device called "OrthoPilot® Next Generation." This type of document is a submission to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, a 510(k) submission primarily focuses on demonstrating substantial equivalence, not on providing detailed clinical trial or performance study data with acceptance criteria in the way a PMA (Premarket Approval) application would. The document states:

"There is no change to previous performance data for the OrthoPilot® Next Generation navigation system."

"The intended use and fundamental scientific technology of the OrthoPilot® Next Generation Navigation system remain unchanged including the integration of passive marker spheres cleared as part of K141694. The only difference is an update to the knee software modules (TKA, TKR and UKA) for the integration of passive marker spheres cleared as part of K141694 and the other minor improvements."

This indicates that the current submission (K153396) is for minor software updates and relies on prior clearances (K080547 and K141694) for performance data. Therefore, the detailed information requested regarding acceptance criteria, specific study designs, sample sizes, ground truth establishment, and MRMC studies for this specific submission is not present in the provided text, as this type of information would have been part of the original submissions that established the performance of the core device.

The document refers to compliance with software development standards (IEC 62304) and FDA guidance for software in medical devices, which are process-oriented rather than providing specific performance metrics.

Based only on the provided text, I cannot furnish the detailed information requested in your prompt. The document does not describe a new comprehensive study to prove the device meets specific acceptance criteria for a new clinical performance claim. It is an "update" submission for minor changes building on previously cleared devices.

If this were a PMA application or a de novo submission, or if the original 510(k) for K080547 or K141694 were provided, that information might be available. However, for K153396, the performance is essentially tied to the previous clearances.

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