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The Surgetics ENTact Endonasal Navigation System is intended for use as an aid to the surgeon for precisely locating anatomical structures either during open or percutaneous ENT/endonasal or sinus procedures.

The Surgetics ENTact Endonasal Navigation System is specifically designed for use in ENT/endonasal and sinus procedures. It allows the surgeon to locate surgical instruments (e.g., aspirator) on three planes (axial, frontal) on a preoperative CT scan in real-time. The system uses an infrared camera for localization and guidance of the surgical instrument. Additionally, a surgical planning capability using the Consultics Station is provided which allows the surgeon to pre-operatively plan the surgery.

The provided 510(k) summary for the "Surgetics ENTact Endonasal Navigation System" offers limited details regarding acceptance criteria and performance studies. Based on the available text, here's a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The Surgetics ENTact Endonasal Navigation System was tested for compliance with electrical safety and electromagnetic compatibility standards. In addition, summaries of accuracy testing using phantoms and clinical experience with the system were provided."

However, specific acceptance criteria (e.g., maximum allowable error in millimeters for accuracy) and the detailed results of these tests (e.g., the exact accuracy achieved in phantom studies) are not provided in this summary. Therefore, a complete table cannot be generated from the given information.

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

• Sample Size for Test Set: Not specified. The document mentions "summaries of accuracy testing using phantoms" and "clinical experience with the system" but does not give any numbers for the phantoms used or the number of patients/cases in the clinical experience.
• Data Provenance: The location of the submitter is France (Praxim "Le Grand Sablon" 4. Avenue de l'Obiou 38 700 La Tronche France). This suggests the development and potentially some of the testing occurred in France.
  • Retrospective/Prospective: Not specified. The nature of "clinical experience" is not detailed enough to determine if it was retrospective or prospective.

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

• Not specified. The summary does not provide any information about experts involved in establishing ground truth for any testing.

4. Adjudication method for the test set:

• Not specified. No information is given about how discrepancies, if any, were resolved during testing.

5. 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:

• No, this type of study was not done or reported. The device is an "Image guided surgical navigation system." It aids the surgeon in precisely locating anatomical structures in real-time during procedures by tracking surgical instruments on a pre-operative CT scan. It's not an AI-assisted diagnostic tool for human readers, so an MRMC study comparing human readers with and without AI assistance is not applicable to this device's function as described.

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

• Yes, implicitly in the phantom accuracy testing. The "accuracy testing using phantoms" would likely represent a standalone performance evaluation of the navigation system's ability to track and display instrument positions relative to the phantom, without direct human intervention in the tracking mechanism itself. However, specific metrics and results are not detailed.

7. The type of ground truth used:

• For the "accuracy testing using phantoms," the ground truth would likely be precisely known physical dimensions and coordinates of fiducials or targets on the phantom. Phantoms are designed with known geometries to allow for direct measurement of deviation from the true position.
• For "clinical experience," the ground truth is not specified. In a surgical navigation context, ground truth during clinical experience might involve comparing the system's displayed position to the actual anatomical location as perceived by the surgeon, or potentially to post-operative imaging if available, but this is speculative given the lack of detail.

8. The sample size for the training set:

• Not applicable / Not specified. This device is an image-guided navigation system, not a machine learning model that typically undergoes a distinct "training phase" on a dataset in the way an AI diagnostic algorithm would. Its underlying technology (optical infrared tracking, 3D CT image processing) operates based on established physical and computational principles, not by learning from a large "training set" of labeled data.

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

• Not applicable / Not specified. As noted above, this device doesn't appear to use a training set in the machine learning sense. Its functionality is based on direct measurement and processing.

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