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The Surgetics ORTHO OSTEOLOGICS navigation system is an optically based surgical navigation system. It is intended for use as an aid to the surgeon in tracking bone structures and instruments on a 3D model of the patient's bone which is generated through acquiring multiple landmarks. The system is indicated to assist a surgeon to control the lower limb axis during osteotomy procedures.

Examples of orthopedic surgical procedures include, but are not limited to: Open wedge osteotomy for the lower limb Closed wedge osteotomy for the lower limb

The Surgetics ORTHO OSTEOLOGICS Navigation System consists of the following major components and subsystems:

• The Surgetics Station, consisting of a mobile computer system and an optical . localizer
• Ancillary instruments and reflective markers used for reference and . calibration.
• HTO Monitoring Software for, but not limited to open and closed wedge . osteotomy for the lower limb

The provided text describes performance testing for the Surgetics ORTHO OSTEOLOGICS navigation system, focusing on its accuracy.

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly refers to "summaries of accuracy testing" but does not explicitly state specific numerical acceptance criteria for accuracy, nor does it provide the exact reported performance values in a table format. It simply states that "summaries of accuracy testing using phantoms, specimen bench testing, and clinical experience with the system were provided."

Without explicit acceptance criteria in the document, I cannot create such a table.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not explicitly stated. The document mentions "accuracy testing using phantoms, specimen bench testing, and clinical experience," implying a test set was used, but the size of these sets is not provided.
• Data Provenance: Not explicitly stated. The manufacturer is based in France ("Praxim "Le Grand Sablon" 4, Avenue de l'Obiou 38 700 La Tronche France"), suggesting the testing may have occurred there or in other countries, but this is not specified. It is likely prospective as it involves new testing for the device's clearance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not explicitly stated. The document mentions "clinical experience," which implies input from medical professionals (surgeons), but the exact number or their specific qualifications (e.g., years of experience, specialty) are not provided.

4. Adjudication Method for the Test Set:

Not explicitly stated. There is no mention of any specific adjudication method (e.g., 2+1, 3+1, none) used for interpreting the test results or establishing ground truth.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

Not explicitly stated. The document does not mention an MRMC comparative effectiveness study involving human readers with and without AI assistance, nor does it report any effect size. The system is a surgical navigation aid, not primarily an interpretative AI tool for diagnostic images.

6. Standalone Performance:

Yes, a standalone performance assessment was conducted. The "accuracy testing using phantoms, specimen bench testing" refers to evaluating the algorithm's performance in a controlled environment, which constitutes standalone (algorithm only) testing. The system's purpose is to provide navigation guidance, and its accuracy in doing so is a measure of its standalone performance.

7. Type of Ground Truth Used:

The ground truth for the standalone testing would likely be:

• Phantom Data: Precisely known measurements/geometries on the phantom as the ground truth against which the system's measurements are compared.
• Specimen Bench Testing: Likely involved comparing the system's measurements/tracking against a known gold standard (e.g., high-precision manual measurements or other validated measurement systems) on cadaveric or animal specimens.
• Clinical Experience: While not detailed, "clinical experience" would typically involve surgeons using the system and assessing its practical accuracy and utility during actual procedures, likely against their surgical judgment and possibly intraoperative imaging or direct measurements.

8. Sample Size for the Training Set:

Not explicitly stated. The document does not provide any information regarding the training set size or methodology for the development of the navigation system's algorithms.

9. How Ground Truth for the Training Set Was Established:

Not explicitly stated. Since training set details are omitted, the method for establishing ground truth for any potential training data is also not provided.

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