The GE Vision Nuclear Medicine Workstation is a nuclear medicine image display and processing workstation. It consists of a personal computer (PC) or UNIX workstation, monitor, keyboard, mouse, modem, and network interface.

AI/ML Overview

The provided documents for the GE Vision Nuclear Medicine Workstation (K012568) do not contain detailed acceptance criteria or a study that specifically proves the device meets such criteria.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (GE Vision POWERstation Nuclear Medicine Workstation, K912573) based on similar technological characteristics, safety features, design, and intended uses.

Here's an analysis of the information provided, framed around your requested points, highlighting what is present and what is absent:

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

Acceptance Criteria	Reported Device Performance
No specific quantitative acceptance criteria for performance are listed in the document. The submission focuses on substantial equivalence to a predicate device.	The device has the "same technological characteristics," is "comparable in key safety and effectiveness features," "uses the same basic design," and has the "same intended uses as the 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)

Not applicable / Not provided. The submission explicitly states: "Clinical Tests: None required." The assessment of the device is based on its similarity to a predicate device and adherence to safety standards, not on clinical performance testing with a specific test set.

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)

Not applicable / Not provided. No test set or ground truth establishment by experts is mentioned, as clinical performance testing was not required for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided. No test set or ground truth establishment by experts is mentioned, so no adjudication method was used.

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

No. A MRMC comparative effectiveness study was not done. The device is a "nuclear medicine image display and processing workstation," not an AI-powered diagnostic tool, and the submission predates widespread AI in medical imaging.

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

No. A standalone performance study was not done. The device's function is explicit: "intended for use in the display and analysis of planar and tomographic nuclear medicine images," implying a human-in-the-loop system. Performance testing for an algorithm-only component is not mentioned.

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

Not applicable / Not provided. As no clinical testing was performed, no ground truth was established for performance evaluation.

8. The sample size for the training set

Not applicable / Not provided. No training set is mentioned as this is a workstation for display and analysis, not an AI/machine learning device requiring a training set.

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

Not applicable / Not provided. Given that no training set is mentioned, the method for establishing its ground truth is also not applicable.

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

The "study" that proves the device meets "acceptance criteria" (which are generally defined as substantial equivalence to the predicate device and adherence to safety standards) is a documentary review and comparison rather than a clinical performance study.

The core of the submission (K012568) is a 510(k) Special Premarket Notification by GE Medical Systems. The "study" essentially consists of the following components:

Comparison to a Predicate Device: The primary basis for clearance is demonstrating that the GE Vision Nuclear Medicine Workstation is "of a comparable type and substantially equivalent" to the previously marketed GE Vision POWERstation Nuclear Medicine Workstation (K912573). This comparison argues for equivalence in:
- Technological characteristics
- Key safety and effectiveness features
- Basic design
- Intended uses (display and analysis of planar and tomographic nuclear medicine images).
Safety and Standards Conformance: The device was evaluated for electrical and radiation safety and deemed to conform with applicable medical device safety standards.
Quality System Compliance: The design and development process of GE Medical Systems conforms with 21 CFR 820, ISO 9001, and EN 46001 quality systems.

Conclusion stated by GE Medical Systems: "The the opinion of GE Medical Systems that the GE Vision Nuclear Medicine is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market."

FDA's finding: "We have reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent... for the indications for use stated in the enclosure."

In essence, for this specific submission, the "proof" is a successful demonstration of substantial equivalence to an existing legally marketed device, supported by adherence to safety standards and quality management systems, rather than a clinical performance study with defined acceptance criteria and a test set.

Summary

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Special 510(k) Premarket Notification GE Medical Systems - GE Vision Nuclear Medicine Workstation 31-July-2001

K012568

SEP = 6 2001 Attachment B Summary of Safety and Effectiveness

Prepared in accordance with 21 CFR Part 807.92(c).

GE Medical Systems

General Electric Company 8380 Darrow Road, Twinsburg, OH 44087

Submitter:	GE Medical Systems - SMV8380 Darrow RoadTwinsburg, OH 44087
Contact Person:	Kevin MurrockEngineering Technical ServicesTelephone: 330-487-6635; Fax: 330-405-7684
Date Prepared:	31-July-2001
Device Name:	GE Vision Nuclear Medicine Workstation.Emission Computed Tomography System, 21 CFR 892.1200, 90-KPS
Marketed Device:	GE Vision POWERstation Nuclear Medicine Workstation, 510(k) Number K912573,currently in commercial distribution.
Device Description:	The GE Vision Nuclear Medicine Workstation is a nuclear medicine image display andprocessing workstation. It consists of a personal computer (PC) or UNIX workstation,monitor, keyboard, mouse, modem, and network interface.

Indications for Use: The GE Vision Nuclear Medicine Workstation is intended for use in the display and analysis of planar and tomographic nuclear medicine images.

Comparison with Predicate Device: The GE Vision Nuclear Medicine Workstation is of a comparable type and substantially equivalent to the currently marketed GE Vision POWERstation Nuclear Medicine Workstation. It has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same basic design, and has the same intended uses as the predicate device.

Summary of Studies: The device has been evaluated for electrical, and radiation safety, and conforms with applicable medical device safety standards.

Clinical Tests: None required.

Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. Intended uses and fundamental scientific technology are the same as the legally marketed GE Vision POWERstation Nuclear Medicine Workstation. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and EN 46001 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with factory surveillance. The the opinion of GE Medical Systems that the GE Vision Nuclear Medicine is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 6 2001

Mr. Kevin M. Murrock Manager, Engineering Technical Services GE Medical Systems General Electric Company 8380 Darrow Road TWINSBURG OH 44087

Re: K012568

GE Vision Nuclear Medicine Workstation (Emission Computed Tomography System) Dated: July 31, 2001 Received: August 9, 2001 Regulatory Class: II 21 CFR 892.1200/Procode: 90 KPS

Dear Mr. Murrock:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we hevice is wbstantially equivalent (for the indications for use stated in the enclosure) to legally marketed in interstate becomments of the May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in eccordate 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 If your of root to to to 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 31 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) prematket 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 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. B odon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Special 510(k) Premarket Notification GE Medical Systems - GE Vision Nuclear Medicine Workstation 31-July-2001

STATEMENT OF INTENDED USE

K012568 510(k) Number (if known): __

Device Name: GE Vision Nuclear Medicine Workstation

Indications for Use

The GE Vision Nuclear Medicine Workstation is intended for use in the display and analysis of planar and tomographic nuclear medicine images.

(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_

Nancy Brandon

(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012568

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.