The Family of Viewing Wands, (including cranial and spinal applications) is comprised of a medical workstation and an integrated position sensing probe, is intended to be used pre-operatively and intraoperatively to perform the following functions:

process and display pre-operatively radiographic images on a monitor; .
provide intra-operative image information based on the position and orientation of a user directed . probe:
allow for the optical integration and usage of different position sensing technologies (e.g. articulated arm, infrared freehand) and surgical probes (handheld pointers);
store/retrieve image data on computer access media (e.g. hard disks, archive media); and
transmit data over local area and wide area networks.

The Family of Viewing Wands is intended to be used pre-operatively:

when more than one approach (e.g. entry point, transtony, craniotomy size, screw placement) is being considered:
when determining the size of any instrumentation:

and intra-operatively, when:

the target, trajectory, or approach is in a region with few anatomical landmarks (e.g. subcortical brain) or with complex anatomy (e.g. scoliosis, fractures, deformity);
the target, traiectory, or approach is not entirely exposed (e.g. costerior approach for screw placement):
the target, trajectory, or approach is in a region where the normal landmarks have been distorted either by disease (e.g. degenerative disease, osteophytes) or by previous surgery;
the target, trajectory, or approach is in close proximity to critical structures (e.g. venous sinuses, air sinuses, spinal nerve roots or blood vessels) which must be avoided or negotiated; or
a the target's delineation is important and will not move significantly during the approach (e.g. skull based tumors, sinus diseases, corpus callosotomies, spinal cord tumors).

The Family of Viewing Wands is indicated for patients who have space-occupying lesions or malformations (both soft tissue and osseous) in the head.

It is also indicated for patients who require decompressive or reconstructive surgery of the spine, or who have imaged space-occupying lesions or malformations in the spine.

The Family of Viewing Wands is contraindicated for patients suspected of having Creutzfeld-Jakob's disease if adequate sterilization of the instrument cannot be assured.

Device Description

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 intraoperative 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.

AI/ML Overview

This document is a 510(k) summary for the ISG Family of Viewing Wands, a medical imaging workstation integrated with a position-sensing user-directed probe. It describes the device, its intended use, and its substantial equivalence to other devices.

The document does not contain information regarding detailed acceptance criteria, study methodologies, or performance metrics that would be typically found in a clinical study report. It is a regulatory submission for premarket notification, focusing on the device description, indications for use, and a claim of substantial equivalence to a predicate device (Stealth Station - K954276).

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance. The document explicitly states that the spinal application is a "line (application) extension" and is substantially equivalent to existing devices, implying that specific clinical studies demonstrating performance against novel acceptance criteria may not have been required for this particular submission.

Summary of available information relevant to your request, and what is missing:

Table of acceptance criteria and the reported device performance:
- N/A. This document does not specify acceptance criteria for performance nor does it report detailed performance metrics. It asserts substantial equivalence to a predicate device.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. No information on a test set sample size or data provenance is provided.
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):
- N/A. No information on experts or ground truth for a test set is provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No information on adjudication methods for a test set is provided.
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:
- N/A. No MRMC study is mentioned. This device is a surgical navigation system, not an AI-assisted diagnostic tool for human readers in the context of comparative effectiveness.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. The device is described as an "integrated with a position-sensing user directed probe," inherently implying human interaction. Standalone algorithm performance is not applicable or discussed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. Ground truth for any testing is not mentioned. The system correlates pre-operative CT/MR imaging data with the intraoperative situation, implying the 3D imaging data itself serves as a reference.
The sample size for the training set:
- N/A. This document does not describe a machine learning algorithm requiring a training set in the modern sense. It's a system for image-guided surgery.
How the ground truth for the training set was established:
- N/A. Not applicable, as there's no mention of a traditional machine learning training set.

In summary, this 510(k) submission focuses on demonstrating substantial equivalence to a predicate device and describing the device's functionality and intended use rather than providing detailed clinical study results with acceptance criteria.

Summary

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Image /page/0/Picture/0 description: The image shows a logo with the letters "ISC" stacked vertically inside a black rectangle. The words "VISUAL DATA" are written along the bottom left curve of the rectangle, and the word "PROCESSING" is written along the top right curve of the rectangle. The text is in a sans-serif font and is white against the black background.

K970865

JUN - 4 1997

510(K) SUMMARY

I. COMPANY & CONTACT PERSON

ISG TECHNOLOGIES, INC. 6509 Airport Road Mississauga L4v-1S7 Ontario, Canada

II. DEVICE NAME AND CLASSIFICATION

Family of Viewing Wands

Classification: Stereotatic Instrument (21 CFR 882.4560)

III. DESCRIPTION OF DEVICE

IV. INTENDED USE

V. SUBSTANTIAL EQUIVALENCE

The spinal application as described in this submission is a line (application) extension to the Family of Viewing Wands (K960714) and is substantially equivalent to other devices (Stealth Station - K954276) within the classification of diagnostic devices (21CFR 882.4560) that have been reviewed under the provisions of the Medical Device Amendments and are being marketed in interstate commerce.

COPYRIGHT 1997 ISG TECHNOLOGIES, INC.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 4 1997

Mr. Charles Hall Director, Clinical Development ISG Technologies, Inc. 6509 Airport Road Mississauga, Ontario CANADA L4V 1S7

Re : K970865 Trade Name: ISG Family of Viewing Wands Requlatory Class: II Product Code: 84HAW Dated: March 4, 1997 Received: March 10, 1997

Dear Mr. Hall:

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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 920) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GM2 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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.

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Page 2 - Mr. Charles Hall '

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number (if known):

K970865

Device Name:

ISG Family of Viewing Wands

Indications For Use:

process and display pre-operatively radiographic images on a monitor; .
provide intra-operative image information based on the position and orientation of a user directed . probe:
allow for the optical integration and usage of different position sensing technologies (e.g. articulated � arm, infrared freehand) and surgical probes (handheld pointers);
store/retrieve image data on computer access media (e.g. hard disks, archive media); and �
transmit data over local area and wide area networks. e

Circumstances: ��

The Family of Viewing Wands is intended to be used pre-operatively:

when more than one approach (e.g. entry point, transtony, craniotomy size, screw placement) is being t considered:
when determining the size of any instrumentation: .

continued ...

mor 25 197 11:24

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomas J. Callahan

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K970865

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Formst 1-2-96)

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.. Circumstances, continued:

1 2017 08:21

and intra-operatively, when:

the target, trajectory, or approach is in a region with few anatomical landmarks (e.g. subcortical brain) . or with complex anatomy (e.g. scoliosis, fractures, deformity);

the target, traiectory, or approach is not entirely exposed (e.g. costerior approach for screw . placement):
the target, trajectory, or approach is in a region where the normal landmarks have been distorted either . by disease (e.g. degenerative disease, osteophytes) or by previous surgery;
the target, trajectory, or approach is in close proximity to critical structures (e.g. venous sinuses, air . sinuses, spinal nerve roots or blood vessels) which must be avoided or negotiated; or
a the target's delineation is important and will not move significantly during the approach (e.g. skull based tumors, sinus diseases, corpus callosotomies, spinal cord tumors).

Disease or Conditions:

The Family of Viewing Wands is indicated for patients who have space-occupying lesions or malformations (both soft tissue and osseous) in the head.

It is also indicated for patients who require decompressive or reconstructive surgery of the spine, or who have imaged space-occupying lesions or malformations in the spine.

The Family of Viewing Wands is contraindicated for patients suspected of having Creutzfeld-Jakob's disease if adequate sterilization of the instrument cannot be assured.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).