KINEMATIC POSITIONERS by GE MEDICAL SYSTEMS, INC.

The Indications for Use for the Signa Profile Kinematic Positioner Options expands the capability of the Signa Profile System. The Kinematic Positioner accommodates and improves imaging of the ankle, wrist, cervical-spine and surrounding structures in a dynamic and kinematic motions.

Device Description

The Kinematic Positioners provide support for the ankle, wrist and cervical spine for MR scanning. They have two usage's; one is for a scan when the scanned area is fixed, and the other is while the scanned area is moving.

AI/ML Overview

This document describes the Signa Profile Kinematic Positioner Options, an accessory for MR scanning. It is not a software or AI device, and therefore, the requested information about acceptance criteria, study details for a device meeting those criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth definitions are not applicable to this product.

The provided document is a 510(k) summary for a physical medical device. It focuses on demonstrating substantial equivalence to a predicate device and compliance with safety standards, not on performance metrics typically associated with AI or software-driven diagnostic tools.

Here's a breakdown of the information that is available in the document, acknowledging that most of your request is not relevant for this type of product:

Summary of Device and Evaluation:

The Signa Profile Kinematic Positioner Options are physical accessories designed to support the ankle, wrist, and cervical spine during MR scanning. They facilitate imaging of these areas in dynamic and kinematic motion.

Key takeaway for your request: Because this is a mechanical accessory and not a diagnostic software, the concepts of "acceptance criteria" for diagnostic performance (like sensitivity, specificity, etc.), "ground truth," "expert readers," and "AI assistance" do not apply.

General Information Present in the Document:

Device Name: Signa Profile Kinematic Positioner Options
Manufacturer: GE Yokogawa Medical Systems, Ltd.
Submitter: GE Medical Systems
FDA K-number: K972704
Submission Date: July 17, 1997
Marketed Devices: Stated as substantially equivalent to the currently marketed Signa Profile System (software and electronics).
Device Description: Provides support for the ankle, wrist, and cervical spine for MR scanning, with two usages: fixed scanned area and moving scanned area.
Indications for Use: Expands the capability of the Signa Profile System, accommodating and improving imaging of the cervical spine, wrist, ankle, and surrounding structures in dynamic and kinematic motion.
Summary of Studies: The options were evaluated for safety to International Safety Standards IEC 601-1 and IEC 601-2-33.
Conclusions: The device performed to stated specifications and is in compliance with the IEC Standards. GE concludes the options are substantially equivalent to the presently marketed Signa Profile System and do not result in new potential hazards.

Regarding your specific numbered requests, and why they cannot be answered from this document:

A table of acceptance criteria and the reported device performance: Not applicable. This document refers to compliance with safety standards (IEC 601-1, IEC 601-2-33), not diagnostic performance metrics. There are no "reported device performance" values like sensitivity or specificity.
Sample size used for the test set and the data provenance: Not applicable. There was no "test set" in the context of diagnostic performance data. The device was evaluated against safety standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for diagnostic performance was established.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for diagnostic performance.
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: Not applicable. This is not an AI device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not a standalone algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No ground truth was needed for this type of product evaluation.
The sample size for the training set: Not applicable. This is a physical device, not an AI model.
How the ground truth for the training set was established: Not applicable.

In essence, the "study" mentioned for this device was a safety evaluation against established international standards (IEC 601-1 and IEC 601-2-33), not a diagnostic performance study.

Summary

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K972704
Sept 29, 1997

GE Medical Systems

P.O. Box 414, W-709 Milwaukee, WI 53201 USA

SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is submitted in . accordance with the requirements of 21 CFR Part 807.87(h).
Identification of Submitter ● Larry A. Kroger, Ph.D., 414-544-3894, July 17, 1997
Identification of the Product . Signa Profile Kinematic Positioner Options

GE Yokogawa Medical Systems, Ltd. Manufacturer Address: 4-7-127, Asahigaoka, Hino-Shi Tokyo, 191 Japan

Marketed Devices ●

The Signa Profile Systems on which the Kinematic Positioner Options are used are substantially equivalent to the currently marketed Signa Profile System (software and electronics).

. Device Description

Indications for Use ●

The Indications for Use for the Signa Profile Kinematic Positioner Options expands the capability of the Signa Profile System. The Kinematic Positioners accommodates and improves imaging of the cervical spine, wrist, ankle and surrounding structures in a dynamic and kinematic motion.

Summary of Studies .
The Signa Profile Kinematic Positioner Options were evaluated to the International Safety Standards IEC 601-1 and IEC 601-2-33. The options performed to stated specifications and are in compliance with the IEC Standards.
Conclusions .
It is the opinion of GE that the Signa Profile Systems on which the Kinematic Positioner Options are used are substantially equivalent to the presently marketed Signa Profile System. These options do not result in any new potential hazards.

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Food and Orug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 1997

Larry A. Kroger, Ph.D. Acting Manager, Safety & Regulatory Compliance GE Medical Systems, Inc. P.O. Box 414, W-709 Milwaukee, WI 53201

Re:

K972704 Kinematic Positioners ( Magnetic Resonance Diagnostic System Options) Dated: July 17, 1997 Received: July 18, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Dr. Kroger:

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, 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and hat, 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 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 marked 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 yitro 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/dsmamain.html".

Sincerely yours,

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):_

Device Name: Signa Profile Kinematic Positioner Options

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vlind A. Seymon
(Division Sign-Off)

Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

N/A