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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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The OrthoPilot® Next Generation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to position endoprosthesis in arthroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for endacement surgery (such as total knee, revision 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, an ultrasound module, 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 computer can also accept spatial input for anatomical landmarks from an ultrasound unit. 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) summary for the "Aesculap OrthoPilot Next Generation" surgical navigation system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of diagnostic or interpretive performance.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy, human reader improvement with AI) cannot be extracted from this document, as it describes a computer-assisted surgical navigation system and not an AI-driven diagnostic device.

However, I can extract information related to the device's performance data based on the context of a surgical navigation system, which focuses on verification and validation of changes to the device.

Here's what can be gathered:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific quantitative acceptance criteria (e.g., error margins in millimeters or degrees for navigation) and corresponding reported device performance. Instead, it mentions that the device was verified and validated for certain aspects.

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

The document does not detail specific "test sets" in the diagnostic sense, nor does it provide sample sizes (e.g., number of procedures, patients, or data points) for the verification and validation activities mentioned. Data provenance (country of origin, retrospective/prospective) is also not discussed. The performance data refers to testing conducted on the device components and software.

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

This information is not applicable and not provided. The device is a surgical navigation system, and "ground truth" for its performance would likely be related to precision and accuracy measurements in a lab or cadaveric setting, not expert consensus on diagnostic images.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable and not provided.

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 and not provided. This device is not an AI-driven diagnostic tool to assist human readers. It is a computer-assisted surgical navigation system.

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

This concept doesn't directly apply here in the context of a diagnostic algorithm. The device, being a surgical navigation system, works with human surgeons in the loop. Its "standalone performance" would be its inherent accuracy and precision in guiding instruments, which is what "navigation performance" verification and validation would cover. However, specific details of this testing are not given.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not specify the type of "ground truth" for the verification and validation of the navigation system's performance. For a surgical navigation system, "ground truth" would typically involve highly precise measurements of physical placement, angles, or trajectories compared to ideal or calibrated values. This might be established through metrology equipment or other highly accurate measurement systems in a controlled environment.

8. The sample size for the training set

Not applicable and not provided. This document does not describe an AI/machine learning model that requires a training set. The software is proprietary and provides anatomical information to the surgeon.

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

Not applicable and not provided, as there is no mention of a training set for an AI/ML model.

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