The intended use of the GE Discovery NM/CT 570c system is primarily to perform combined cardiac SPECT and CT diagnostic imaging applications, including CT-based SPECT attenuation correction and functional-anatomical mapping (registration and fusion).

The GE Discovery NM/CT 570c system intended uses include performing nuclear cardiac imaging procedures for detection and imaging of racer uptake in the patient body for clinical diagnostic purposes as well as performing general Head & Body Computed Tomography (CT) applications

Device Description

The GE Discovery NM/CT 570c system is a back-to-back combination of the Ventri 1.1 SPECT scanner (K080124) and the LightSpeed 7.1 CT scanner (K061817), sharing a common LightSpeed 7.1 patient table. In addition to providing CT and SPECT standalone capabilities, it uses the CT images to correct for non-uniform attenuation of the SPECT images and to facilitate localization of the emission activity in the patient anatomy.

AI/ML Overview

The provided document describes the GE Discovery NM/CT 570c system, a combination of SPECT and CT imaging systems. However, the available text does not contain detailed acceptance criteria, specific study results in terms of numerical performance metrics, or information regarding sample sizes, data provenance, expert qualifications, or adjudication methods for studies typically associated with AI/algorithm performance claims.

The submission is for a device system (hardware and associated software), not specifically an AI-driven diagnostic device as per modern understanding. Therefore, many of the requested categories like "multi-reader multi-case comparative effectiveness study" or "standalone algorithm performance" are not applicable in this context.

Here's an attempt to fill in the table and provide information based only on the provided text, with many fields necessarily marked as "Not Applicable" or "Not Provided."

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Not Explicitly Stated as Numerical)	Reported Device Performance (as described in the text)
SPECT-CT Attenuation Correction	Expected to improve uniformity and localization of SPECT images.	"Data acquired with uniform phantom shows that SPECT-CT attenuation-corrected images are more uniform than SPECT images without attenuation correction."
Localization Capabilities	Expected to facilitate localization of emission activity.	"The images also demonstrate the localization capabilities of the SPECT-CT."
Safety and Effectiveness	Substantially equivalent to predicate devices (Ventri 1.1, LightSpeed 7.1, Infinia LightSpeed, Xeleris 2).	"substantially equivalent in terms of safety and effectiveness to the legally marketed Ventri 1.1 (K080124), the legally marketed LightSpeed 7.1 (K061817), the legally marketed Infinia LightSpeed (K061817) and the legally marketed Xeleris 2 Processing and Review Workstation (K051673), based upon similar intended use and system performances."
Intended Use	Perform combined cardiac SPECT and CT diagnostic imaging, including CT-based SPECT attenuation correction and functional-anatomical mapping, and general Head & Body CT applications.	The device's capabilities are described as fulfilling these intended uses.

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

Sample Size: Not provided. The document mentions "Data acquired with uniform phantom," indicating a phantom study was conducted. No patient sample size for a test set is mentioned.
Data Provenance: The study was conducted with a "uniform phantom." No country of origin for data or retrospective/prospective nature is specified, although phantom studies are typically controlled laboratory experiments.

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

Number of Experts: Not provided.
Qualifications of Experts: Not provided. The evaluation appears to be based on physical phantom data and direct measurement/observation of image characteristics (uniformity, localization) rather than expert interpretation of patient images for ground truth.

4. Adjudication method for the test set

Adjudication Method: Not applicable/Not provided. The evaluation described involves a "uniform phantom" and is focused on the physical performance of the system (attenuation correction, localization) rather than a diagnostic performance study requiring expert adjudication of clinical cases.

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, not applicable. This submission predates widespread AI in medical imaging devices and does not describe any human-in-the-loop diagnostic assistance features or related studies. The device is a scanner system, not an AI diagnostic tool.
Effect size: Not applicable.

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

Standalone Performance: Not applicable as per the modern definition of an "algorithm only" device. The "data acquired with uniform phantom" is essentially a technical validation of the system's performance (attenuation correction, localization) in a controlled setting, which could be considered a form of standalone performance for the system as a whole, but not an AI algorithm.

7. The type of ground truth used

Ground Truth Type: For the phantom study, the "ground truth" implicitly refers to the known physical properties and uniformity of the phantom. For clinical applications, substantial equivalence relies on the established performance of the predicate devices. There is no mention of expert consensus, pathology, or outcomes data being used for the performance evaluation detailed in the summary.

8. The sample size for the training set

Sample Size for Training Set: Not provided. This being a conventional imaging system rather than an AI/machine learning device, the concept of a "training set" for an algorithm, as typically defined, is not directly applicable.

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

Ground Truth for Training Set: Not applicable. As above, there is no mention of an AI algorithm training set. The device functions based on established physics and engineering principles for SPECT and CT imaging, with software for processing and fusion.

Summary

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K083504

DEC 1 2 2008

510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(b)) 10.

Summary Date

September 4, 2008

Device Name

Proprietary Device Name: GE Discovery NM/CT 570c

Establishment Name and Registration Number of Submitter

Name: Registration Number: Corresponding Official:

GE MEDICAL SYSTEMS F.I. HAIFA 9613299 Laurence Bigio; Site QA Manager GE Medical Systems F.I. Haifa 4 Hayozma St. P.O. Box 170 Tirat Hacarmel 30200 ISRAEL Laurence.bigio(@med.ge.com +972-4-8563633 (Tel) +972-4-857-7664 (Fax)

Device Classification

Classification Name:

Common Name:

Classification Code: Panel Identification: Classification Class:

System Emission Computed Tomography (per 21CFR 892.1200) System Computed Tomography (per 21CFR 892.1750) Single Photon Emission Computed Tomography Computed Tomography X-Ray 90 KPS & 90 JAK Radiology Class II Product

Type of Submission

Traditional

Reason for 510(k) Submission

Modification of legally marketed devices.

Identification of Legally Marketed Equivalent Devices

Device Name	K Number	Feature
Ventri 1.1	K080124	SPECT system
LightSpeed 7.1	K061817	CT system
Xeleris 2	K051673	Processing and Review Workstation forSPECT, CT and Hybrid SPECT-CT
Infinia LightSpeed	K043381	Hybrid SPECT-CT

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510(k) Summary of Safety and Effectiveness, GE Discovery NM/CT 570c, Page 2

Device Description

Description of Change or Modification

The LightSpeed 7.1 CT System (K061817), the Ventri 1.1 SPECT System (K080124) and the Xeleris 2 Processing and Review Workstation (K051673), had been modified to accommodate for the GE Discovery NM/CT 570c system, by including means to align gantries, share emergency stop circuits, a common table and additional processing software for use of CT for purposes of SPECT attenuation correction.

Intended Use of Device

The GE Discovery NM/CT 570c system intended uses include performing nuclear cardiac imaging procedures for detection and imaging of radioisotope tracer uptake in the patient body for clinical diagnostic purposes as well as performing general Head & Body Computed Tomography (CT) applications

Summary of Studies

Data acquired with uniform phantom shows that SPECT-CT attenuation-corrected images are more uniform than SPECT images without attenuation correction. The images also demonstrate the localization capabilities of the SPECT-CT.

Conclusion

In the opinion of GE MEDICAL SYSTEMS F.I. HAIFA, the GE Discovery NM/CT 570c system is substantially equivalent in terms of safety and effectiveness to the legally marketed Ventri 1.1 (K080124), the legally marketed LightSpeed 7.1 (K061817), the legally marketed Infinia LightSpeed (K061817) and the legally marketed Xeleris 2 Processing and Review Workstation (K051673), based upon similar intended use and system performances.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 12 2008

GE Medical Systems F.I. Haifa % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062

Re: K083504

Trade/Device Name: GE Discovery NM/CT 570c Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: November 24, 2008 Received: November 26, 2008

Dear Mr. Devine:

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 such 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.

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Page 2

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Jorpe In Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _K 083504

Device Name: GE Discovery NM/CT 570c

Indications for Use:

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices	Page __ of __
(Posted November 13, 2003)
510(k) Number	K083504

Page 30 of 36 GE Discovery NMCT 570c 510k Premarket Notification Sept4.doc

DOC0483859, Rev 1.0

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.