The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration.

Device Description

Jupiter is a computer workstation used for the display, processing, filming, and communication of Emission Tomography images (data) and hybrid imaging. It also includes capabilities to perform image corrections based on Attenuation Tomography and to provide registration of anatomical and physiological images. It consists of a Microsoft Windows 2000 based PC workstation (high resolution color monitor, keyboard, mouse, and RW-CD for archiving), an Ethernet network connection and system software. Optional DVD and optical disk archive devices are also available. The system conforms to the following mandatory and voluntary standards: CISPR 11; IEC 801, UL 2601-1, IEC 60601-1 and associated collateral standards, and applicable sections of 21 CFR Subchapter J

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the GE Medical Systems Jupiter Processing and Review Workstation. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results and acceptance criteria for specific performance metrics in the way a traditional clinical trial might.

Therefore, the document does not contain the specific information requested in most of the categories (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth information for training/testing).

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified	Not specified
General Equivalence to Predicate Device: The Jupiter Workstation is expected to have the same technological characteristics, comparable key safety and effectiveness features, the same basic design, construction, and materials, and the same intended use as the predicate device (GE eNTEGRA Processing and Review Workstation).	The submitter concluded that the Jupiter Processing and Review Workstation is substantially equivalent to the currently cleared eNTEGRA Processing and Review Workstation, based on the documented design and development process, conformity to quality systems (21 CFR 820, ISO 9001/EN 46001), and compliance with applicable medical device safety and performance standards.
Electrical, Mechanical, and Radiation Safety: Conformity to applicable medical device safety and performance standards.	The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards, including CISPR 11; IEC 801, UL 2601-1, IEC 60601-1, and applicable sections of 21 CFR Subchapter J.

Explanation: This 510(k) primarily asserts substantial equivalence based on technical specifications and adherence to general safety and quality standards, not on specific performance metrics like accuracy, sensitivity, or specificity relative to a diagnostic task. The "acceptance criteria" here are broad regulatory and technical compliance points.

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

Sample Size: Not specified.
Data Provenance: Not specified.

Explanation: The submission describes an evaluation of electrical, mechanical, and radiation safety, and conformance to standards. It does not refer to a "test set" of patient data or images in the context of diagnostic performance.

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

Number of Experts: Not applicable / Not specified.
Qualifications of Experts: Not applicable / Not specified.

Explanation: As there's no mention of a diagnostic performance test set, there is no discussion of experts establishing ground truth for such a set.

4. Adjudication method for the test set

Adjudication Method: Not applicable / Not specified.

Explanation: No diagnostic performance test set is described, so no adjudication method is mentioned.

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

MRMC Study: No.

Explanation: This device is a workstation for display, processing, and review of imaging data. It is not an AI-assisted diagnostic tool or an algorithm intended to directly aid reader performance in the sense of an MRMC study. It's a foundational platform.

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

Standalone Performance Study: No.

Explanation: This device is a workstation, not a standalone diagnostic algorithm. Its function is to facilitate human review and processing of images.

7. The type of ground truth used

Type of Ground Truth: Not applicable / Not specified for diagnostic performance.

Explanation: The "ground truth" implicitly referred to relates to the correctness of the workstation's functionality (e.g., proper display, processing capabilities, compliance with technical standards), not to diagnostic outcomes from patient images.

8. The sample size for the training set

Sample Size: Not applicable / Not specified.

Explanation: This device is a software/hardware system, not a machine learning algorithm that typically requires a "training set" of data in the context of diagnostic performance. Its development likely involved standard software engineering and testing, not AI model training.

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

Ground Truth Establishment: Not applicable / Not specified.

Explanation: As above, this concept doesn't apply directly to the development described for this workstation.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document indicates that the acceptance criteria are met through:

Conformance to Quality Systems: The design and development process of the manufacturer conforms to 21 CFR 820 and ISO 9001/EN 46001 quality systems.
Safety and Performance Standards Compliance: The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards. Specifically mentioned standards include CISPR 11, IEC 801, UL 2601-1, IEC 60601-1, and applicable sections of 21 CFR Subchapter J.
Substantial Equivalence to Predicate Device: The core of the submission is the demonstration that the Jupiter Workstation is substantially equivalent to the previously marketed GE eNTEGRA Processing and Review Workstation (K000395) in terms of technological characteristics, safety, effectiveness, design, construction, materials, and intended use. This equivalence argument is the primary "proof" provided for regulatory acceptance in this 510(k) context.

In essence, the study proving the device meets the acceptance criteria is a technical and regulatory compliance assessment, not a clinical diagnostic performance study.

Summary

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KO2 4137

Special 510{k} Premarket Notification GE Medical Systems - Jupiter Processing and Review Workstation December 9, 2002

JAN 1 5 2003

GE Medical Systems

ELGEMS Ltd. 10 Hayozma St., P.O. Box 170 Tirat Hacarmel, 30200, Israel

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR 807.87(h)

Submitter:	GE Medical Systems3000 N. Grandview Blvd.Waukesha, WI 53188
Contact Person:	Hemy NeumanQuality, Safety and Regulatory ManagerTelephone: +972-4-856-3667; Fax: +972-4-857-7664
Date Prepared:	November 24, 2002
Device Name:	Jupiter Processing and Review WorkstationSystem, Image Processing, Radiological, 21 CFR 892.2050, 90-KPS
Marketed Device:	GE Medical System's eNTEGRA Processing and Review Workstation510(k) Number K000395, currently in commercial distribution (firstintroduced under the name Einstein).

Device Description:

Indications for Use:

Comparison with Predicate Device:

The GE Jupiter Processing and Review Workstation is a modification of, and is comparable and substantially equivalent to the currently marketed GE eNTEGRA Processing and Review Workstation (first introduced under the name Einstein - K000395). This system has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same basic design, construction, and materials, and has the same intended use as the predicate device.

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Special 510(k) Premarket Notification GE Medical Systems - Jupiter Processing and Review Workstation December 9, 2002

Summary of Studies:

The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards.

Conclusion:

Intended use and fundamental scientific technology are the legally marketed GE eNTEGRA Processing and Review Workstation. The design and development process of the manufacturer conforms to 21 CFR 820, and ISO 9001/ EN 46001 quality systems. The device conforms to applicable medical device safety and performance standards. Results of the testing and standards conformance described above demonstrate, in the opinion of GE Medical Systems, that the Jupiter Processing and Review Workstation is substantially equivalent to the currently cleared eNTEGRA Processing and Review Workstation.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a bird or abstract human figure with three curved lines forming its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2003

Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems 3000 N. Grandview Blvd. WAUKESHA WI 53188

Re: K024137

Trade/Device Name: Jupiter Processing and Review Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 9, 2002 Received: December 16, 2002

Dear Dr. Kroger:

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.

Nancy 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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Special 510(k) Premarket Notification GE Medical Systems - Jupiter Processing and Review Workstation December 9, 2002

STATEMENT OF INTENDED USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

K024137

Device Name: Jupiter Processing and Review Workstation

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)

Over-The-Counter Use

Daniel G. Glynn

(Division Sign-Off) Division of Reproductive and Radiological Devi 510(k) Numbe

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).