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The ISG Family of Viewing Wands is comprised of a medical imaging workstation that is integrated with a position-sensing user directed probe. This allows for the provision of information pertaining to the current position of the probe related to the surrounding anatomy by correlating pre-operative CT and/or MR imaging data with the intra-operative situation. Once a patient's CT or MR images have been transferred to the workstation, the patient is correlated to that image dataset. The system then displays the orientation of the probe and the position of the tip on the corresponding image, updating the display in real-time as the probe is moved.

The provided 510(k) summary for the ISG Family of Viewing Wands does not contain the detailed information required to answer all parts of your request, specifically regarding acceptance criteria, a dedicated study proving performance against those criteria, or details about training and ground truth for such a study.

This document describes a surgical navigation system that correlates pre-operative CT/MR images with intra-operative probe position. Its function is to display the orientation and position of a probe on corresponding images in real-time. It is not an algorithm designed to diagnose conditions or interpret medical images in an automated fashion, but rather a tool to aid a surgeon. Therefore, the concept of "device performance" in this context is likely related to accuracy of localization and real-time display, rather than diagnostic metrics like sensitivity, specificity, or AUC.

Here's a breakdown of what can be extracted based on the input:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state specific acceptance criteria or report performance metrics in a quantitative manner (e.g., accuracy, precision) for the Family of Viewing Wands. It states: "Standards are defined and tested under the specifications included in this submittal." However, these specifications are not provided in the excerpt.

Given the device's function, potential implied performance characteristics would involve:

• Localization Accuracy: How precisely the system can determine and display the probe tip's position relative to the imaging data.
• Real-time Update Speed: How quickly the display updates as the probe moves.
• Image Processing and Display Quality: How accurately the pre-operative images are rendered and how well the probe's position is superimposed.

The remaining questions relate to a 'study' that would prove the device meets acceptance criteria. Since no such study with quantifiable performance metrics is described, many of these questions cannot be answered from the provided text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not specified. The document does not describe a clinical or technical validation study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not specified. As there's no described test set or study aiming to establish diagnostic performance, there's no mention of experts establishing a ground truth for interpretation.

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

• Not applicable/Not specified.

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

• No. This is a surgical navigation system, not an AI diagnostic algorithm for image interpretation. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device's described function and is not mentioned.

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

• Not applicable/Not specified in detail. The device is a system that works with a human operating a probe. Its function is to provide information to the human, not to act standalone in a diagnostic capacity. While its internal localization algorithms would function "standalone" in terms of computing coordinates, there's no standalone performance evaluation described as if it were a diagnostic AI.

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

• Not specified. For a surgical navigation system, "ground truth" would likely involve highly precise physical measurements of probe tip location compared to the system's displayed location, potentially using phantoms or cadaveric models. This is not detailed in the provided text.

8. The sample size for the training set

• Not applicable/Not specified. This device isn't described as using machine learning or AI that requires a "training set" in the conventional sense (e.g., for image classification). Its core functionality is based on known physical principles of position sensing and image display.

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

• Not applicable/Not specified. (See point 8).

Summary of Device and its Purpose:

The ISG Family of Viewing Wands is a surgical navigation system. Its primary function is to:

• Process and display pre-operative radiographic images (CT and/or MR).
• Provide real-time intra-operative tracking of a user-directed probe, correlating its position and orientation with the pre-operative imaging data.

It is classified as a Class II diagnostic device accessory and is substantially equivalent to existing viewing wands and surgical navigation systems on the market. The submission focuses on describing its components (workstation, localizing device, communications, archive storage) and general functionality, rather than presenting a performance study with detailed acceptance criteria and results.

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