ISG FAMILY OF VIEWING WANDS

• K Number: K970865
• Device Name: ISG FAMILY OF VIEWING WANDS
• Manufacturer: I.S.G. TECHNOLOGIES, INC.
• Date Cleared: 1997-06-04 ( 86 days)
• Product Code: HAW , 84H
• Regulation Number: 882.4560
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: K960714 , K954276

Intended Use

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:

1. 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.

2. 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.

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):

   • N/A. No information on experts or ground truth for a test set is provided.

4. 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.

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:

   • 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.

6. 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.

7. 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.

8. 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.

9. 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.

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).