The Photon Energy Recovery (PER) Option is intended for image quality and quantification improvement by scatter reduction in planar and tomographic nuclear medicine images. This option enables Gated SPECT acquisition in multi-energy window format which allows normal GSPECT processing along with PER scatter correction on the summed data. It can be used for acquisitions of single or multi-peak isotope as well as simultaneous multi-isotope images.

Device Description

The Photon Energy Recovery (PER) option is a software application for reducing the Compton scatter contribution in nuclear images. This enables scatter correction of single as well as multipeak isotope imaging. In addition it allows for the correction of cross-talk down scatter in simultaneous multiisotope imaging. The method is based on a spectral deconvolution analysis using iterative recurrent linear regressions on nuclear spectra. These spectra are broken down into multiple energy windows. This submission provides an extension on the PER features of the currently legally marketed device, GE Vision Nuclear Medicine Workstation - K012568.

AI/ML Overview

The provided text describes a 510(k) submission for the GE Photon Energy Recovery (PER) Option, a software application designed to reduce Compton scatter in nuclear images for improved image quality and quantification. However, the document does not contain a detailed study proving the device meets specific acceptance criteria. Instead, it makes a general statement about substantial equivalence to a predicate device.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in the format of a table or defined metrics. It broadly states that the device is intended for "image quality and quantification improvement by scatter reduction." The "reported device performance" is summarized as:

Acceptance Criteria (Implied)	Reported Device Performance
Image quality improvement by scatter reduction	PER corrected simultaneous dual-isotope images are similar to conventional single isotope images.
Quantification improvement by scatter reduction	PER corrected simultaneous dual-isotope images are similar to conventional single isotope images.
Functionality in single isotope imaging	Enabled
Functionality in multi-peak isotope imaging	Enabled
Functionality in simultaneous multi-isotope imaging	Enabled
Gated SPECT acquisition in multi-energy window format	Enabled
Normal GSPECT processing with PER scatter correction on summed data	Enabled

2. Sample size used for the test set and the data provenance

The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply states, "Bench and clinical data show that the PER corrected simultaneous dual-isotope images are similar to the conventional single isotope images." This is a very high-level summary and lacks specifics about the study design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document.

4. Adjudication method for the test set

This information is not provided in the document.

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

There is no mention of an MRMC comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. The PER Option is described as a software application for image processing, not a tool for direct human-in-the-loop decision support that would typically be evaluated with an MRMC study in this context.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

While not explicitly called a "standalone study," the statement "Bench and clinical data show that the PER corrected simultaneous dual-isotope images are similar to the conventional single isotope images" implies an assessment of the algorithm's performance in generating images. However, the specifics of this assessment (metrics, methodology) are not detailed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not specify the type of ground truth used. The comparison is made against "conventional single isotope images," implying that these uncorrected images might serve as a baseline or reference, but not necessarily a "ground truth" in the sense of a definitive diagnosis or outcome.

8. The sample size for the training set

The document does not provide any information about a training set since the PER Option is likely based on spectral deconvolution analysis, which might not involve machine learning training in the same way as some other AI algorithms. If there was a training phase for any parameters, it's not described.

9. How the ground truth for the training set was established

As no training set is described, information on how its ground truth was established is also absent.

In summary:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and broadly describes the device's intended function. It lacks the detailed study information typically found in submissions for novel AI/ML devices that require rigorous performance evaluation against specific acceptance criteria. The claim of "similarity to conventional single isotope images" serves as the primary evidence of effectiveness, but the methodology, sample sizes, and detailed results of this comparison are not provided.

Summary

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K023932

GE Medical Systems

DEC 1 1 2002

10. 510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807,87(h))

Device Name Proprietary Device Name:

GE Photon Energy Recovery (PER) Option

Establishment Name and Registration Number of Submitter

Name:	ELGEMS Ltd.
Registration Number:	9613299
Corresponding Official:	Hemy Neuman, Quality and RegulatoryELGEMS Ltd.4 Hayozma St.P.O. Box 170Tirat Hacarmel 30200ISRAELHemy.neuman@med.ge.com+972-4-857-7664 fax+972-4-856-3667 phone

Device Classification Classification Code: Panel Identification: Classification Name:

90 KPS Radiology System, Emission Computed Tomography (per 21CFR 892.1200) Nuclear Medicine Imaging system Class II Product

Common Name: Classification Class:

Reason for 510(k) Submission Modification of legally marketed device.

Identification of Legally Marketed Equivalent Devices GE Vision Nuclear Medicine Workstation - K012568

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510(k) Summary of Safety and Effectiveness, GE PER Option, Page 2

Device Description

Description of Change or Modification

The original PER application featured in the predicate device. GE Vision Nuclear Medicine Workstation (K012568), focuses on Compton scatter reduction for improved contrast and better spatial resolution. The new PER application extends this capability for nuclear cameras by enabling gated SPECT acquisition in multi-energy window format, allowing normal GSPECT processing along with PER scatter correction on the summed data.

The following features are included in the PER Option:

Scatter correction for single isotope Static, SPECT, and . Gated scans
. Scatter and cross-talk correction for simultaneous dual and multi-isotope imaging

Intended Use of Device

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Summary of Studies

Bench and clinical data show that the PER corrected simultaneous dualisotope images are similar to the conventional single isotope images.

Conclusion

In the opinion of ELGEMS Ltd., the Photon Energy Recovery (PER) Option is substantially equivalent in terms of safety and effectiveness to the PER capabilities featured in the legally marketed GE Vision Nuclear Medicine Workstation (K012568).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

Public Health Service

9200 Corporate Boulevard Rockville MD 20850

ELGEMS. Ltd. % Mr. Jeff D. Rongero Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, NC 27709-3995

Re: K023932

. Trade/Device Name: GE Photon Energy Recovery (PER) Option . Regulation Number: 21 CFR 892:1200. Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 85 KPS Dated: November 25, 2002 Received: November 26, 2002

Dear Mr. Rongero:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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 regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Henry C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INTENDED USE

510(k) Number (if known):

K023932

Device Name: GE Quasar System

Indications for Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801-109)

OR Over-The-Counter Use

David A. Lynn

Reproductive, Abdominal,

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.