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The Navitrack™ System - Optical TKR CT-Less is indicated for use as a stereotaxic instrument to assist in the positioning of Total Knee Replacement components intra-operatively.

It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, and in precisely positioning the alignment instruments relative to these axes by displaying their locations.

The Navitrack™ System - Optical TKR CT-Less device consists of a computer workstation, an optical tracking system, surgical instruments, and tracking devices. It is designed to assist the surgeon in the placement of Total Knee Replacement (TKR) components. Intra-operatively, the tracking devices are attached to the femur and the tibia, and to the alignment and pointing instruments, in order to track and display their relative locations in real-time. The pointing instruments are used to digitize the relative locations of anatomical landmarks that are commonly used clinically for TKR alignment. In the case of the femoral head landmark, it is computed by the system as based on a motion analysis of the femur. From the landmarks the system then computes and displays the alignment axes. The alignment instrument is then navigated and positioned relative to these axes on each bone which in turn sets the placement of the cutting guides.

This device, the Navitrack™ System - Optical TKR CT-Less, is a stereotaxic instrument for assisting in Total Knee Replacement (TKR) surgery. However, the provided text does not contain detailed acceptance criteria or a specific study proving the device meets them. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data and technological comparisons.

Here's a breakdown of the information available and what is missing, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. The text mentions "non-clinical tests" but gives no details about sample size (e.g., number of cadaveric knees, number of in-vitro scenarios), country of origin, or whether the data was retrospective or prospective.

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

This information is not provided in the document. The nature of "non-clinical tests" suggests an experimental setup, but there's no mention of expert involvement for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not provided in the document. Since there's no mention of human experts establishing ground truth or evaluating device outputs in a comparative manner, an adjudication method is not described.

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

This information is not provided in the document. The submission does not describe an MRMC study comparing human readers with and without AI assistance. The device is an intra-operative navigation system, not an AI-based diagnostic tool designed for human reader interpretation improvement.

6. Standalone (Algorithm Only) Performance Study

Yes, a form of standalone performance was assessed. The "non-clinical tests" focused on the "accuracy and performance of the system" itself to verify it was "adequate to perform as intended." This implies evaluating the algorithm's output (e.g., calculated alignment axes, instrument positioning) in a controlled setting without human-in-the-loop performance measurement. However, specific details of these tests (e.g., methodology, metrics, results) are not detailed beyond the general statement.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for these "non-clinical tests." For a stereotaxic instrument assisting in TKR, ground truth would likely involve:

• Physical measurements/Metrology: Highly accurate physical measurements of anatomical landmarks, cuts, and component positions using precision instruments in a controlled lab setting (e.g., based on CAD models, CMM measurements, or highly accurate pre-scans).
• Simulated anatomical models: Using synthetic bones or cadaveric specimens where true anatomical axes and landmarks are known or can be precisely defined.

8. Sample Size for the Training Set

This information is not provided in the document. The device description does not explicitly mention a "training set" in the context of machine learning, as it appears to be a rule-based or model-based navigation system rather than a deep learning AI model requiring a large training dataset.

9. How Ground Truth for the Training Set Was Established

This information is not provided in the document. As mentioned above, a "training set" in the modern AI sense is not explicitly discussed. If there were calibration or model development data, the method for establishing their ground truth is not described.

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