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The Pediatric InstaTrak System is an image guided device for use during endoscopic nasal surgery. It is intended to be used during the treatment of acute and chronic sinusitis, endoscopic dacryocystorhinostomy, optic nerve and orbital decompression, the removal of polyps, the biopsy and removal of tumors, and the repair of CSF leaks, pituitary disorder and encephalocele.

The Pediatric InstaTrak System is intended for image guided assistance during nasal surgery in pediatric patients. It is intended to be used during the treatment of acute and chronic sinusitis, endoscopic dacryocystorhinostomy, optic nerve and orbital decompression, the removal of polyps, the biopsy and removal of tumors, and the repair of CSF leaks, pituitary disorder and encephalocele.

The InstaTrak System intended for pediatrics is identical to the InstaTrak System intended for adults with the exception of a slight modification to the head set component. The headset assembly, verification pad, and aspirator components have been modified for the Pediatric InstaTrak System. The dimensions of these components of the InstaTrak System have been modified to accommodate the smaller head size of pediatric patients. As described in the original submission, the headset is a single use disposable device made of acetal plastic. The headset is held in place on the patient by spring tension at the three points of contact, the external ear canals, and the bridge of the nose. The headset serves as a foundation for anchoring the electromagnetic transmitter in a fixed location with respect to the patients head to compensate for patient motion during the surgical procedure. The transmitter is attached to the headset prior to surgery by a rotating toggle that is inserted through a slot in the middle of the rectangular section. The headset allow s the device to maintain its registration therefore avoiding the need for re-registration during the surgical procedure. It also continues to perform accurately even while the patient's head is moving during the surgical procedure.

The only change between the Pediatric InstaTrak System and the Adult InstaTrak System is a minor change in dimensions of the headset, straight aspirator and verification pad to accommodate the smaller head size of pediatric patients. This is an insignificant modification not affecting safety or effectiveness of the device.

The headset is first worn by the patient during the CT scan and is removed immediately after the scan. Prior to surgery, the transmitter is attached to the headset and the headset is again placed on the patient. This avoids the problem of adhesive based fiducials which requires the CT scan do be done very near the time of surgery to avoid displacement or loss of the markets.

The modifications to the headset dimensions do not affect safety or effectiveness of the device since the intended use and placement are identical to that summarized above and described in more detail in K960330.

The Pediatric InstaTrak System is identical in technological characteristics to the Adult InstaTrak System except for the size of the headset. The Pediatric InstaTrak System and the Viewing Wand are similar in that they both use an articulated mechanical arm. The proposed Pediatric InstaTrak System and the predicate devices are similar in intended use in that they are all intraoperative imageguidance systems. The Viewing Wand links a positioning probe to an image display with a patients CT or MRI image data. The Pediatric InstaTrak System, the Adult InstaTrak System and the Viewing Wand all use a computer, monitor and hard disk storage system. Both the pediatric and adult InstaTrak Systems have fewer indications/features, using only CT images and fewer screen image displays than the predicate Viewing Wand.

Here's an analysis of the acceptance criteria and supporting studies for the Visualization Technology, Inc. Pediatric InstaTrak System based on the provided document:

Acceptance Criteria and Device Performance for Visualization Technology, Inc. Pediatric InstaTrak System

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the Pediatric InstaTrak System's performance (2.28 mm mean accuracy, 0.78 mm 95% CI) compares favorably to the predicate device, implying that achieving accuracy within or better than the predicate's range was the implicit acceptance criterion. The headset reproducibility was a new pediatric-specific test, and "acceptable results" was the stated outcome.

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

• Sample Size (Pediatric Headset Reproducibility): 61 pediatric patients.
• Sample Size (Clinical Testing for Accuracy): Not explicitly stated how many patients were in the "Adult InstaTrak System" study, merely that it was conducted at "four clinical sites." The 95% confidence interval reported (0.78 mm) suggests a reasonably sized study, but the precise number of subjects or cases is not provided.
• Data Provenance: The document does not specify the country of origin for the data. The clinical testing for accuracy was performed on the Adult InstaTrak System, which is stated to be "essentially identical except for minor dimension changes." This implies a prospective study given it was clinical testing, but it wasn't specifically conducted on the Pediatric InstaTrak System for the accuracy data. The pediatric headset reproducibility study was also clinical testing, suggesting a prospective design.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for either the pediatric headset reproducibility or the accuracy clinical testing. The accuracy data likely relates to measuring the physical accuracy of the system's tracking against known points or a gold standard measurement, which may not inherently require expert consensus in the same way as, for example, image interpretation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set. Given the "accuracy" and "reproducibility" metrics, it's more likely that direct physical measurements were taken and compared to a known standard or repeated measurements, rather than requiring subjective expert adjudication.

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, an MRMC comparative effectiveness study was not done.
• The device is an image-guided surgical system, not an AI-powered diagnostic or assistive tool for "human readers." Its purpose is to guide surgeons during procedures, not to help "readers" interpret images. Therefore, the concept of improving human reader performance with or without AI assistance is not applicable to this device type.

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

• Yes, the performance metrics reported (mean accuracy, 95% confidence interval of the mean, headset reproducibility) represent a standalone measurement of the device's physical tracking and stability. These measurements quantify the system's intrinsic performance in accurately localizing instruments in relation to patient anatomy, independent of the surgeon's skill or decision-making process. The "human-in-the-loop" aspect for this device is the surgeon using the guidance, but the reported data refers to the system's measurement capabilities.

7. The Type of Ground Truth Used

• For Accuracy: The ground truth for accuracy testing would typically involve a known standard, such as a phantom with precisely measured fiducial markers, or a highly accurate coordinate measuring machine (e.g., optical tracking system or robotic arm) for comparison. The document does not explicitly state the specific method but implies a systematic approach to measure the physical deviation of the tracking system.
• For Reproducibility: Ground truth for reproducibility would involve repeated measurements under consistent conditions to assess the device's ability to consistently report the same position over time or after re-application.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set. This device is a mechanical/electromagnetic tracking system, not an AI or machine learning model that typically requires a distinct training set. If any statistical models were used in its internal workings, the data used to parameterize those models is not disclosed.

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

As no training set is mentioned or applicable in the context of this device's reported evaluation, this question is not relevant.

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