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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria / Performance Metric	Predicate Device (ISG Viewing Wand) Performance (Range)	Pediatric InstaTrak System Performance
Mean Accuracy	1.8 mm to 4.8 mm	2.28 mm
95% Confidence Interval of the Mean	1.1 mm to 1.6 mm	0.78 mm
Headset Reproducibility	Not specified for predicate	Acceptable for both large and small spherical ear inserts

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.

Summary

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K981998

AUG 21 1998

510(k) Summary for Visualization Technology, Inc. Pediatric InstaTrak System

SPONSOR/APPLICANT NAME, ADDRESS 1.

Visualization Technology, Inc. 39G Sixth Road Woburn, MA 01801

Contact Person:

Robert Murfitt, Ph.D. Director of Regulatory Affairs and Quality Assurance (781) 938-8920 Telephone:

DATE OF SUMMARY PREPARATION:

June 5, 1998

DEVICE NAME 2.

Pediatric InstaTrak System Proprietary Name: Interactive CT Image Guided Surgical System Common/Usual Name: Computed Tomography X-Ray System Classification Name:

IDENTIFICATION OF THE PREDICATE OR LEGALLY MARKETED DEVICE(S) TO 3. WHICH EQUIVALENCE IS BEING CLAIMED

Adult InstaTrak System, subject of K960330 and the Viewing Wand manufactured by ISG Technologies, Inc., subject of K911783.

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DEVICE DESCRIPTION 4.

5. INTENDED USE

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

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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.

A STATEMENT OF HOW THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE 6. COMPARE TO PREDICATE OR LEGALLY MARKETED DEVICE(S) CITED

FOR 510(k)S WHERE DETERMINATION OF EQUIVALENCE IS BASED ON 7. PERFORMANCE DATA

Pediatric Headset Reproducibility Clinical Testing

Testing was performed to determine the clinical pediatric headset reproducibility on a total of 61 pediatric patients. One large and one small headset was equipped with spherical ear inserts and one large and one small headset was equipped with conical ear inserts. The small headset was to be used for patients with a head circumference ≤520 mm and the large for patients with a head circumference > 520 mm. The testing showed acceptable results for both size headsets with spherical ear inserts only.

Clinical Testing was also performed using the Adult InstaTrak System at four clinical sites. Although this testing was performed on the InstaTrak System intended for adults, it applies to the proposed Pediatric System since the two systems are essentially identical except for minor dimension changes. Results of

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this study indicated the mean accuracy of the device to be 2.28 mm with a 95% confidence interval of the mean of 0.78 mm. This compares to values of 1.8 mm to 4.8 mm for the mean accuracy of the ISG Viewing Wand while using various operating modalities and registration techniques. Under these conditions, the 95% confidence interval of the mean for the predicate device varied from 1.1 mm to 1.6 mm.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 21 1998

Visualization Technology, Inc. Mary McNamara-Cullinane c/o Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re:

K981998 Pediatric InstaTrak System Dated: June 5, 1998 Received: June 8, 1998 Regulatory class: II 21 CFR 892.1750/Procode: 90 LLZ

Dear Ms. McNamara-Cullinane:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

Kilian Yin

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): 11981998

Device Name: Visualization Technology, Inc. Pediatric InstaTrak System

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Schmidt A. Seigman

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic

Radiological Devices
510(k) Number K981998

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Visualization Technology, Inc. 510(k) Pediatric InstaTrak System

6/2/98

CONFIDENTIAL

Page v

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).