The GE Discovery ST System is intended for head and whole body attenuation of The OE Disorion Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.

The Discovery ST is to be used by trained health care professionals for imaging the rne Broom of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, (frolloodial) and follow up of lesions, disease and organ function such as (but not Staging, rootaging, and ivascular disease, and brain dysfunction. This device can also assist in radiotherapy planning.

The Discovery ST can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.

Device Description

The Discovery ST is an integrated multi-slice Computed Tomography and Positron Emission Tomography scanner. In addition to providing CT and PET stand-alone capabilities, it uses the CT images to correct for non-uniform attenuation of the PET images and it uses integrated CT and PET images to localize emission activity in the patient anatomy. Discovery ST has capabilities for imaging all available PET tracers and CT contrast agents and can provide inherently registered anatomical and functional information via an integrated user interface. It can also be used as a stand-alone head and whole body multislice computed tomography diagnostic imaging system.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information derived from the provided text for the GE Discovery ST System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text, a 510(k) summary for a medical device (GE Discovery ST System), does not explicitly state quantitative "acceptance criteria" in the way one might see for performance metrics like sensitivity, specificity, or image resolution thresholds. Instead, the submission focuses on demonstrating substantial equivalence to a previously marketed device (GE Discovery LS System).

Therefore, the "acceptance criteria" are implied by the regulatory requirement for substantial equivalence, meaning the device must perform at least as well as or similarly to the predicate device for its intended uses. The "reported device performance" is framed in terms of its ability to achieve these intended uses, supported by data from the predicate device and existing scientific literature.

Acceptance Criterion (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (as stated in the 510(k) Summary)
Intended Use: - Head and whole body attenuation corrected PET imaging. - Localization of emission activity using integrated PET and CT images.	The Discovery ST shares the same intended use statement as the predicate device (GE Discovery LS System, K040172). Discovery LS bench and clinical data demonstrate the ability of Discovery ST to: - Image injected radiopharmaceuticals for assessment of metabolic (molecular) and physiologic functions. - Use integrated CT and PET images to localize metabolic activity and FDG uptake in patient anatomy.
Functionality for Medical Assessment: - Aid in evaluation, diagnosis, staging, restaging, and follow-up of lesions, disease, and organ function (e.g., cancer, cardiovascular disease, brain dysfunction). - Assist in radiotherapy planning.	Numerous published medical and scientific articles document the use of PET and PET-CT in evaluation of cancer, cardiovascular disease, and brain dysfunction. (This supports the clinical utility of the underlying technology shared by both systems.)
Stand-alone CT capabilities: - Function as a stand-alone head and whole body multislice computed tomography diagnostic imaging system.	The Discovery ST can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system. (Functionality is presented as being equivalent to a stand-alone CT system.)
Overall Safety and Effectiveness: Substantially equivalent to the predicate device.	"In the opinion of General Electric Medical Systems, the Discovery ST System with the above revised intended use is substantially equivalent in terms of safety and effectiveness to the currently marketed Discovery LS System with the same intended use, 510(k) K040172."

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

Sample Size for Test Set: Not explicitly stated as a distinct "test set" with a defined sample size. The submission refers to "Discovery LS bench and clinical data" as supporting evidence to demonstrate the ability of the Discovery ST. The specific number of patients or scans in this data is not provided.
Data Provenance: The data used is from "Discovery LS bench and clinical data." This indicates that the data is likely retrospective, collected from studies performed with the predicate device (Discovery LS). The country of origin is not specified, but since GE Medical Systems is located in Milwaukee, WI, it's reasonable to infer a U.S. origin, though global data is also possible for large manufacturers.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The statement "Discovery LS bench and clinical data demonstrate the ability..." implies that medical professionals were involved in interpreting the clinical data, but their number and specific qualifications are not detailed. The reliance on "Numerous published medical and scientific articles" also points to a broader consensus among the scientific and medical community.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Given the nature of a 510(k) summary relying on existing data and substantial equivalence, a formal adjudication process for a new test set designed specifically for the Discovery ST is not described.

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, an MRMC comparative effectiveness study was not reported for this device. The device itself is an imaging system (PET/CT scanner), not an AI-assisted diagnostic tool that would typically involve improving human reader performance.
Effect Size of AI Assistance: Not applicable, as no AI assistance component is described or evaluated in this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable in the context of an imaging device. The device (Discovery ST System) is the standalone technology; its "performance" is in generating images and providing localization of activity. It operates as an imaging system, not an algorithm providing interpretations independently of a human. The text highlights its ability to operate as a "stand-alone head and whole body multislice computed tomography diagnostic imaging system," which refers to its capability to function as a CT scanner on its own, not an algorithm's standalone performance.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the clinical utility of PET and PET-CT imaging (which the device performs) is established through:
- Clinical Data/Outcomes: "Discovery LS bench and clinical data" implies comparisons to clinical findings or known conditions.
- Pathology/Expert Consensus (Implied): The "evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function" (e.g., cancer) by trained healthcare professionals typically relies on correlation with pathology, surgical findings, and expert clinical judgment as ground truth for disease presence and extent.
- Published Medical and Scientific Articles: The reliance on these articles indicates that the fundamental principles and established clinical utility of PET and PET-CT for various conditions serve as a broad scientific ground truth.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable in the context of this 510(k) submission. This submission is for an imaging system (hardware and associated software for image acquisition and reconstruction), not a machine learning model that undergoes explicit "training." The "bench and clinical data" from the predicate device serve as evidence of the underlying technology's capability, rather than a training set for a new algorithm.

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

How Ground Truth for Training Set Was Established: Not applicable, as there is no mention of a "training set" for a machine learning model. The underlying principles and performance characteristics of PET and CT imaging are well-established in clinical medicine and physics.

Summary

{0}------------------------------------------------

GE Healthcare

JUN 1 5 2004

KC41220 May 4, 2004

510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))

Device Name

Proprietary Device Name:

GE Discovery ST System

Establishment Name and Registration Number of Submitter

Name:	General Electric Medical Systems
Registration Number:	2126677
Corresponding Official:	Larry Kroger
	General Electric Medical Systems
	P.O. Box 414
	Milwaukee, WI 53201
Device Classification
Device Classification
Classification Code:	90 KPS
Panel Identification:	Radiology
Classification Name:	Emission Computed Tomography System(per 21CFR 892.1200)
Common Name:	Nuclear Medicine Imaging system
Classification Class:	Class II Product

Reason for 510(k) Submission

Modification of legally marketed device.

Identification of Legally Marketed Equivalent Devices

K040172 GE Discovery LS System

Device Description

Description of Change or Modification

The Discovery ST CT-PET System is the same system as described in 510(k) K022872 except that the intended use statement has been revised.

Image /page/0/Picture/18 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circle. There are three small, teardrop-shaped elements placed around the perimeter of the circle, evenly spaced. The logo is black and white.

{1}------------------------------------------------

GE Healthcare

510(k) Summary of Safety and Effectiveness May 4, 2004 Page 2

Intended Use of Device

The GE Discovery ST System is intended for head and whole body attenuation The OE Disorion Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.

The Discovery ST can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.

Summary of Studies

Discovery LS bench and clinical data demonstrate the ability of Discovery ST to image injected radiopharmaceuticals for the assessment of metabolic (molecular) and infootod radiophantial of the body and the ability of Discovery ST to use integrated CT prryclored in the localize metabolic activity and FDG uptake in the patient anatomy.

Numerous published medical and scientific articles document the use of PET and PET-CT in evaluation of cancer, cardiovascular disease, and brain dysfunction.

Conclusion

In the opinion of General Electric Medical Systems, the Discovery ST System with the above revised intended use is substantially equivalent in terms of safety and affectiveness to the currently marketed Discovery LS System with the same intended use, 510(k) K040172.

Image /page/1/Picture/11 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circle. The letters are stylized and connected, and there are three small, teardrop-shaped embellishments around the circle's perimeter.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

(JUN 1 5 2004

Mr. David Duersteler Safety and Regulatory Engineering GE Healthcare Technologies General Electric Company P.O. Box 414 MILWAUKEE WI 53201

Re: K041220

Trade/Device Name: GE Discovery ST System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.1750 Regulatory Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 KPS and JAK Dated: May 4, 2004 Received: May 10, 2004

Dear Mr. Duersteler:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your beceible of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreatives to tegans actment date of the Medical Device Amendments, or to commerce prior to May 2011 and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic rice (716) that 80 hovice, subject to the general controls provisions of the Act. The I ou may, therefore, mainted 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 If your device is classinod (600 as 870) cols. Existing major regulations affecting your device can may oc subject to satil additions, Title 21, Parts 800 to 898. In addition, FDA may ou found in the Obacements 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 that I DX has made a ceremanulations administered by other Federal agencies. You must comply or any I cochar statutes and reguirements, including, but not limited to: registration and listing (21 CFR Part with an the Ale - Foquirements, a
807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the 807), labeling (21 CFR Part 820), good 820); and if applicable, the electronic product quality Systems (QB) issions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin marketing your antial equivalence of your device to a legally premarket notification. The PDA miding of besomments
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 If you desire specific advice for your dones on one of the following numbers, based on the regulation number at the top of the 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 Additionally, for questions on the promotion and Other of Compliance at (301) 37 1 1057. 1223) you may obtain. Other general by reletence to premarker (21 Section ) = (21 Section of Som the Division of Small information on your responsionities and one Assistance at its toll-free number (800) 638-2041 or Mandiacturers, International and Geness http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brydon

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

Enclosure

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image contains the words "STATEMENT OF INTENDED USE" and "Indication for". The words are written in a bold, sans-serif font. The words "INTENDED" have a line through them.

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: GE Discovery ST System

Indications for Use

The GE Discovery ST System is intended for head and whole body attenuation of The GE Discovery ST System to internety (PET) imaging and localization of corrected Position Enlission Tomography (Par) images of integrated PET and CT images.

The Discovery ST is to be used by trained health care professionals for imaging The Discovery of is to be assure ficals in the body for the assessment of the distribution of facilophiannesologic functions. This can assist in the metabolic (molecular) and priyologic renotic disease and evaluation, blaghosis, staging, restaging, che read capt over cardiovascular disease, and organ function. This device can also assist in radiotherapy planning.

The Discovery ST can also be used as a stand-alone head and whole body The Discovery Of Can Blography (CT) diagnostic imaging system.

(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. Syverson

(Division Sian-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number __

Regulation Number and Section

N/A