The Skull Based InstaTrak System is intended for image guided assistance during skull base surgical procedures. It is intended to be used during skull base surgery involving procedures on the base of the brain (junction of the face and neurocranium).

Device Description

The InstaTrak System is an image guidance system indicated for use during skull base procedures. The Skull Base InstaTrak System is identical in principles of operation to the InstaTrak System cleared under K960330 and the Pediatric InstaTrak System cleared under K981998, which are indicated for use during nasal surgery. Using the Skull Base InstaTrak System, the surgeon can readily identify the immediate location and position of the surgical instrument during skull base procedures. The Skull Base InstaTrak System assists the surgeon in avoiding critical nerves and other anatomical structures. The Skull Base InstaTrak System includes several new components that were not included in K960330 or K981998, such as a head frame, transmitter arm, extended straight sterile pointer, mouth gag, pharyngeal retractor and nasal speculum. The remainder of the components used in the Skull Base System are identical to those described in the original submission. The additional components do not affect the overall operation of the system as the principles of operation are identical to that described in K960330. Like that system, the Skull Base InstaTrak System is an image guided surgery system that employs a computer with a top mounted swiveling monitor, software and an electromagnetic tracking system. The System uses a Sun SPARC STATION™. The System's proprietary software builds a CT model by taking axial CT images and reconstructing the coronal and sagittal views. The electromagnetic tracking system correlates the movement of surgical instruments to the CT model. The tip of the instrument is displayed as a set of cross hairs in the axial, coronal, and sagittal planes on the InstaTrak System monitor. With the InstaTrak System, CT images are used to assist the surgeon in guiding the position of the instrument during skull base surgery.

The Skull Base and InstaTrak Systems allow pre-operative viewing of the patients' CT images, contextual visualization of the pathology, intra-operative localization, screen display outputs for video recording and positional guidance. The system is operated by acquiring an axial CT scan while the patient wears the InstaTrak System headset and associated instruments. The axial images are then transferred via a network connection or cartridge to the InstaTrak System. The Headset position which stays fixed relative to the patients' anatomy, is automatically identified in the CT images by an image processing algorithm. Coronal and sagittal images are reconstructed and along with the Axial images, provide the CT model that will be used as a road map in surgery.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document {3} states: "Testing was performed using the new components of the Skull Base InstaTrak System to determine if the new components affected device accuracy. The results showed that the device performed within the specification while using the new components."

While the document explicitly states that the device "performed within the specification," it does not provide the specific numerical acceptance criteria or the reported device performance metrics. It only refers to a general "specification" for accuracy.

Acceptance Criteria	Reported Device Performance
Accuracy: Not explicitly stated, but implies meeting a predefined accuracy specification.	The device performed within the specification while using the new components. (Specific numerical accuracy or metrics are not provided in this summary.)

Study Details

The provided 510(k) summary offers limited details about the study. Here's what can be inferred:

Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective). The summary only states that "Testing was performed using the new components."
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 mention the involvement of experts for establishing ground truth during the accuracy testing.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. Given the nature of accuracy testing for an image guidance system, it's likely physical measurements against a known standard were used rather than expert adjudication in the traditional sense, but this is not explicitly stated.
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 guidance system that assists surgeons, not an AI-driven diagnostic tool that impacts human reader performance in interpreting images. The study focused on the device's accuracy with new components.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance assessment was effectively done regarding the device's accuracy. The testing aimed to determine if the new components affected device accuracy {3}. This implies evaluating the system's ability to accurately track instruments relative to the CT model, which is a standalone function of the device. However, the exact methodology (e.g., phantom studies, cadaver studies) is not detailed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. For "accuracy" testing of an image guidance system, the ground truth would likely involve physical measurements against precisely known spatial references or benchmarks (e.g., phantom models with known dimensions and fiducial markers) rather than expert consensus on medical findings, pathology, or outcomes data.
The sample size for the training set:
- Not applicable as this is not an AI/Machine Learning device that undergoes training in the conventional sense. The "training" for such a system would involve engineering and calibration, not a data-driven training set.
How the ground truth for the training set was established:
- Not applicable for the same reason as above.

Summary

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

K982994

1. SPONSOR/APPLICANT NAME, ADDRESS

Visualization Technology, Inc. 200 Research Drive Wilmington, MA 01887

Contact Person:

Lewis J. Levine Director of Software Development (978) 933-1000 Telephone:

DATE OF SUMMARY PREPARATION:

August 26, 1998

1. DEVICE NAME
  Skull Base InstaTrak System Proprietary Name: Common/Usual Name: Interactive CT Image Guided Surgical System Computed Tomography X-Ray System Classification Name:

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

InstaTrak System, subject of K960330, the Pediatric InstaTrak System, subject of K981998 and the Viewing Wand manufactured by ISG Technologies, Inc., subject of K911783.

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4. DEVICE DESCRIPTION

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5. INTENDED USE

The Skull Base InstaTrak System is an image guided device for use during skull base surgical procedures. It is intended to be used during skull Base surgery involving procedures on the base of the brain (junction of the face and neurocranium).

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

The Visualization Technology, Inc.'s Skull Base InstaTrak System is substantially equivalent to the Adult InstaTrak System, subject of K960330, and the Viewing Wand manufactured by ISG Technologies, Inc., subject of K911783.

The proposed Skull Base InstaTrak System and the ISG Technologies Viewing Wand devices are both intraoperative image-guidance systems intended for skull base surgery.

The Skull Base InstaTrak System is identical in technological characteristics to the InstaTrak System cleared under K960330. The Skull Base InstaTrak System uses electromagnetic position sensing, patient headset and automatic headset registration as the original InstaTrak.

The Skull Base InstaTrak System, the Adult InstaTrak System and the Viewing Wand all use a computer, monitor and hard disk storage system. The InstaTrak devices use an electromagnetic sensor to determine the location of the pointing instrument being used by the surgeon whereas the predicate ISG device uses a six-jointed, six-degree-offreedom mechanical articulated arm with an electro-goniometer, which functions as a 3-D digitizer.

Their are several new components in the Skull Base System as described in the Device Description Section of this submission. The new components include a nasal specula, mouth gag, pharyngeal retractor, straight extended aspirator, sterile disposable pointer, transmitter arm and head frame. The new components used in the Skull Base InstaTrak System have been added simply to accommodate the skull base surgical use. The nasal speculum, mouth gag, pharyngeal retractor are exempt from the 510(k) premarket notification process.

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

Testing was performed using the new components of the Skull Base InstaTrak System to determine if the new components affected device accuracy. The results showed that the device performed within the specification while using the new components.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized design of three human profiles facing to the right, with flowing lines extending from the profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 6 1998 NOV

Director of Software Development

Visualization Technology, Inc.

Lewis J. Levine

Re:

K982994 Skull Base InstaTrak System Dated: August 26, 1998 Received: August 27, 1998 Regulatory class: II 21 CFR 892.1750/Procode: 90 LLZ

Dear Mr. Levine:

200 Research Drive Wilmington, MA 01887

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 Fecteral 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 QS 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/cdrividsmadsmamain.html".

Sincerely yours,

Lillian Yih

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

Enclosure

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510(k) Number (if known): K 98 2994

Device Name: Visualization Technology, Inc. Skull Base 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)

Daniel G. Rogersm

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

8/26/98

Over-The-Counter Use

(Optional Format 1-2-96)

CONFIDENTIAL

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).