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.

AI/ML Overview

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.

Summary

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K960714

Image /page/0/Picture/1 description: The image shows a logo with the letters "ISC" in a stylized font. The letters are white and are set against a black rectangular background. To the right of the rectangle, the word "PROCESSING" is written vertically along a curved line, suggesting a circular or semi-circular design element. The overall design is simple and bold, with a focus on the acronym "ISC".

510(k) SUMMARY

Contact Information

Name and Address of Manufacturer:	ISG Technologies, Incorporated6509 Airport RoadMississaugaOntarioCanada
	L4V 1S7
Telephone numbers:	(905) 672 2100 ext. 3601 800 724 5970 ext.360
Facsimile number:	(905) 672 2307
Name of Contact Person:	Robin A. Owen, Ph.D.Medical ScientistDepartment of Clinical DevelopmentISG Technologies
Date:	16th February, 1996

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General Information

Classification:

The ISG family of viewing wands are substantially equivalent to other devices within the classification of diagnostic devices (21 CFR 092.1750) that have been reviewed under the previsions of the Medical Device Amendments and are being marketed in interstate commerce. Such devices have been classified as Class II devices.

Classification Name:

Diagnostic Device - Computer Tomography X-ray System (Accessory)

Common/Usual Name:

Image Processing/Surgical Navigation System

Proprietary Name:

ISG Family of Viewing Wands

Predicate Devices:

The Family of Viewing Wands as described in this submission is substantially equivalent to the Allegro Viewing Wand by ISG Technologies Inc. which was the subject matter of 510(k) file #K911783 and which is currently being marketed by ISG Technologies, Incorporated. The Family of Viewing Wands also incorporates some of the features that were previously provided by the CAMRA Allegro workstation (#K901679).

The Family of Viewing Wands incorporates components that are substantially equivalent to other legally marketed devices, including the Zeiss MKM (Multiple Coordinate Manipulator ) system (#K942233); the Radionics OAS (Operating Arm System) neurosurgery planning and guidance system (#K951262); and the Codman Acustar I Advanced Surgical Navigation System (#K944612).

Performance Standards:

There are currently no Section 514 performance standards applicable to systems of this type. Standards are defined and tested under the specifications included in this submittal.

Description of the Device:

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Process and display pre-operative radiographic images on a monitor. .
Provide intra-operative image control based upon the position and orientation of a user directed ● probe
Allow for the optional integration and usage of different position sensing technologies . (articulated arm, infrared freehand) and surgical probes (hand-held pointers, surgical microscope).
Store/retrieve image data on computer access media i.e. hard disks, archive media. .
Transmit data over local and wide area networks .

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The components of the Family of Viewing Wands along with their intended functionality are listed as follows:

Workstation - The workstation is designed to store, process and display radiographic image data 1. such that a physician can view and interact with this data electronically in order to derive corroborative information related to the specific anatomy of the patient.

Localizing device - The localizing device is designed to provide spatial localization information 2. related to both the orientation of a probe and the probe tip. This information is used by the workstation to control the display of the diagnostic image data, such that a physician can intra-operatively view that data in relation to the patient.

Communications Device - The communications device is designed to transmit image data from one workstation to another using the industry standard TCP/IP protocol over industry standard networks and transmission lines: Ethernet, Token ring, T1, ISDN, FDDI, ATM, POTS, etc. For transmission over local area networks (LAN) the communication device is industry standard interface hardware built into the workstation itself e.g. an ethernet card.
Archive Storage/Retrieval Device - The archive storage/retrieval device is designed to assume responsibility for ensuring access to a reusable copy of image data. The Family of Viewing Wands does not perform any direct image scanning operations. Image data can be imported from a wide variety of scanners, either through a direct interface or through data transfer using an industry standard storage medium. Examples include floppy disks, hard disks, magnetic tape, optical disks, WORM media (Write Once Read Many), etc. The Family of Viewing Wands supports most industry standard storage devices. Device selection is not inherently restricted by the Family of Viewing Wands, but is associated with the workstation configuration.

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).