SAGE 7 is a package of software tools for MR spectroscopic data processing and display. SAGE 7 is indicated for use for a wide variety of MR spectroscopic data management tasks, including file handling, display, processing/modeling, analysis, storage and hard copy output. The resultant spectroscopic presentations, when interpreted by a trained physician, can provide physiological / chemical information that can be useful in determining a diagnosis.

Device Description

The GE SAGE 7 Spectroscopy Analysis Software is designed to operate on GE Signa Horizon Systems and GE Advantage Windows workstations. It provides a toolkit of software applications to handle a wide variety of tasks associated with spectroscopy data management. The SAGE (Spectroscopy Analysis GE) package provides the capability for the trained clinical spectroscopist to reconstruct, analyze, and display spectra and spectroscopic images to provide information to support a diagnosis. SAGE 7 provides a tool for the spectroscopist to process raw spectroscopy data into spectra or spectroscopic images, view them, and optionally perform numerical analyses to obtain spectroscopic parameters (ex. peak positions, widths, heights, areas, etc.).

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets particular performance metrics beyond a general equivalence claim. The document is a 510(k) summary for a software enhancement (SAGE 7 Spectroscopy Analysis option) and primarily focuses on demonstrating substantial equivalence to a predicate device (SA/GE Analysis option).

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the SAGE 7 Spectroscopy Analysis option was evaluated against the International medical equipment safety standard IEC 601-2-33 ("Particular requirements for the safety of magnetic resonance equipment for medical diagnosis"). It concludes that the device is "comparable to the SA/GE Spectroscopy option."

However, no specific performance metrics (e.g., accuracy, sensitivity, specificity, processing speed, output consistency) or acceptance criteria (e.g., "must achieve X% accuracy," "processing time must be less than Y seconds") are mentioned or reported for either the SAGE 7 or the predicate device in this document. The "performance" is implicitly tied to safety and substantial equivalence to an already marketed device.

Acceptance Criteria	Reported Device Performance
Compliance with International medical equipment safety standard IEC 601-2-33	Evaluated against IEC 601-2-33.
Comparability to predicate device (SA/GE Analysis option) regarding basic operations and indications for use.	Determined to be comparable. Basic operations (Fourier transform, phasing, peak-picking, integration, fitting) are not significantly changed. No new indications for use or potential hazards.
Functionality in processing, analysis, and display of MR spectroscopic data.	Provides a toolkit for reconstruction, analysis, and display of spectra and spectroscopic images. Allows for numerical analyses (peak positions, widths, heights, areas, etc.).

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective clinical data). The evaluation appears to be based on a comparison of features and capabilities rather than a performance study on a specific dataset.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not mention any experts being used to establish ground truth for a test set.

4. Adjudication Method:

Given that no test set or ground truth establishment is described, there is no mention of an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention an MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The focus is on the software tool itself, not its impact on human interpretation.

6. Standalone Performance Study:

A standalone performance study (algorithm only) as typically understood (e.g., reporting metrics like accuracy, sensitivity, specificity on a dataset) is not described. The "Summary of Studies" section refers to evaluation against a safety standard and comparison to a predicate device, not a performance study using a defined algorithm output and ground truth. The device is described as "a toolkit of software applications," and its output (spectroscopic presentations) is intended to be "interpreted by a trained physician."

7. Type of Ground Truth Used:

Since no specific performance study is detailed, no specific ground truth type (e.g., expert consensus, pathology, outcomes data) is mentioned as being used for evaluation.

8. Sample Size for the Training Set:

The document does not mention a training set size. The device is described as "software tools" and "spectroscopy analysis option," implying it's an analytical tool rather than a machine learning model that typically undergoes a training phase with a specific dataset.

9. How Ground Truth for the Training Set Was Established:

As no training set is mentioned, there is no information on how ground truth for a training set was established.

Summary

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K984167

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

JAN 1 2 1999

SUMMARY OF SAFETY AND EFFECTIVENESS

o This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
o Identification of Submitter Larry A. Kroger, Ph.D., 414-544-3894, November 19, 1998
o Identification of the Product SAGE 7 Spectroscopy Analysis Option

Manufactured by:	GE Medical Systems3200 N. Grandview Blvd.Waukesha, WI 53188
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0 Marketed Devices
The SAGE 7 Spectroscopy Analysis option is an enhancement to the currently marketed SA/GE Analysis option in distribution since the reclassification of Magnetic Resoncance Diagnostic devices (ref. 53 FR 5078, Feb. 1, 1989).
Device Description
0

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

SUMMARY OF SAFETY AND EFFECTIVENESS

o Indications for Use

0 Comparison with Predicate

The SAGE 7 Spectroscopy Analysis option is an enhancement to the SA/GE Analysis option. The basic operations (ex. Fourier transform, phasing, peak-picking, integration, fitting, etc.) have not significantly changed, and are provided in both SAGE 7 and the SA/GE Analysis option. What has changed is the sophistication of the user interface. In addition, the increased computational capability of modern workstations have made possible as routine operations some sophisticated curve-fitting algorithms that were impractical on older computer hardware.

o Summary of Studies

The SAGE 7 Spectroscopy Analysis option was evaluated to International medical equipment safety standard IEC 601-2-33 titled Particular requirements for the safety of magnetic resonance equipment for medical diagnosis. The SAGE 7 Spectroscopy Analysis option is comparable to the SA/GE Spectroscopy option.

0 Conclusions
It is the opinion of GE that the SAGE 7 Spectroscopy Analysis option is substantially equivalent to the SA/GE Spectroscopy option. SAGE 7 does not include any new indications for use, nor does use of this device result in any new potential hazards.

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Rockville MD 20850

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Food and Drug Administration 9200 Corporate Boulevard

JAN 1 2 1999

Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414 . W-709 Milwaukee, WI 53201

Re: K984167

SAGE 7 Spectroscopy Dated: November 19, 1998 Received: November 20, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNI

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 legally marketed predicate 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 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 requirements, as set forth in the Quality System Regulation (QS) 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 vour 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting 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: SAGE 7 Spectroscopy

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seymon

(Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological I 510(k) Number

Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use_

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.