SmartScore 3.5/4.0/4.5 are non-invasive software options that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease. SmartScore 3.5/4.0/4.5 may be used to monitor the progression/regression of calcium in coronary arteries overtime, which may aid in the prognosis of cardiac disease.

Device Description

SmartScore 3.5/4.0/4.5 are a family of software options that runs on the Advantage Windows (AW) (K960613) workstation and allows the user to detect calcifications in CT images. These Regions of Interest can be selected manually, or semi-automatically. It provides calculation of the calcium score using multiple scoring algorithms. The software also provides the ability to generate patient reports, and maintain a patient database for future reference.

AI/ML Overview

This document, K020929, describes the GE SmartScore 3.5, 4.0, and 4.5 software options, which are intended to evaluate calcified plaques in coronary arteries from CT images. The submission aims to demonstrate substantial equivalence to a predicate device (CT Coronary Artery Calcification Scoring (CACS), K982004). However, the provided text does not include specific acceptance criteria or an explicit study that proves the device meets such criteria.

The document primarily focuses on:

Product Identification: Device name, classification, manufacturer, and distributor.
Device Description: Software options running on the Advantage Windows (AW) workstation for detecting calcifications, calculating calcium scores using multiple algorithms, generating patient reports, and maintaining a patient database.
Indications for Use: Non-invasive evaluation of calcified plaques in coronary arteries, monitoring progression/regression of calcium over time, and aiding in the prognosis of cardiac disease.
Comparison with Predicate: Stating substantial equivalence to CT Coronary Artery Calcification Scoring (CACS) (K982004).
Adverse Effects on Health: Addressed by software development processes, validation, verification, and adherence to standards.
Conclusions: No new potential safety risks and performs as well as devices currently on the market.
FDA Clearance Letter: Confirming the substantial equivalence determination.

Based on the provided text, the following information is either not present or cannot be extracted:

Table of Acceptance Criteria and Reported Device Performance: This information is not provided. The document states "Software Development, Validation and Verification Process to ensure performance to specifications," but the specifications themselves or the performance against them are not detailed.
Sample Size used for the test set and data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
Adjudication method for the test set: Not mentioned.
Multi-reader multi-case (MRMC) comparative effectiveness study and effect size: Not mentioned. The focus is on demonstrating substantial equivalence to a predicate device, not on comparing reader performance with and without AI assistance.
Standalone (algorithm-only) performance: While the device is software-only and performs calculations, a specific standalone performance study with metrics is not described. The validation and verification process is mentioned in general terms.
Type of ground truth used: Not mentioned.
Sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

In summary, the document does not contain the detailed study information regarding acceptance criteria, performance metrics, dataset characteristics (sample size, provenance, ground truth establishment, expert qualifications), or specific study designs (MRMC, standalone) that would typically be expected for a comprehensive description of device validation. The submission relies on claiming substantial equivalence to a predicate device, implying that the predicate's performance is acceptable and the new device performs similarly.

Summary

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

Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a circular frame. The letters and the frame are in black, creating a strong contrast against the white background.

APR 0 3 2002

GE Medical Systems General Electric Company P O Box 414 Milwaukee, WI 53201

K020929

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).

Submitter Larry A. Kroger, Ph.D. Senior Regulatory Program Manager Telephone: (262) 544-3894, FAX: (262) 544-3863 Date Prepared: February 8, 2002

PRODUCT IDENTIFICATION

Name: SmartScore 3.5, SmartScore 4.0, SmartScore 4.5 Classification Name: Accessory to Computed Tomography System Classification Panel 892 - Radiology Classification Number: 892.1750 Manufacturer : General Electric Medical Systems 283, rue de la Minière 78533 Buc Cedex, FRANCE Distributor: General Electric Medical Systems, Milwaukee, WI Marketed Devices SmartScore 3.5/4.0/4.5 are substantially equivalent to the device listed below: Model: CT Coronary Artery Calcification Scoring (CACS) Manufacturer: General Electric Medical Systems, Milwaukee, WI 510(k) #: K982004

Device Description:

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

Indications for Use:

SmartScore 3.5/4.0/4.5 are non-invasive software options that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease. SmartScore 3.5/4.0/4.5 may be used to monitor the progression of calcium in coronary arteries overtime, which may aid in the prognosis of cardiac disease.

Comparison with Predicate:

SmartScore 3.5/4.0/4.5 are software options that can be used to evaluate calcium scoring in coronary arteries. The functional features of this package are substantially equivalent to that of the following device:

Device Name	FDA Clearance Number
CT Coronary Artery Calcification Scoring(CACS)	K 982004

Adverse Effects on Health :

The potential hazards are identified in a risk management summary (hazard analysis) and are controlled by:

· Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements.
8
· Adherence to industry and international standards.

Conclusions:

SmartScore 3.5/4.0/4.5 does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the SmartScore 3.5/4.0/4.5 to be equivalent to those of CT Coronary Artery Calcification Scoring (CACS) (K982004).

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

Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and appears to be a title or heading. The words are all capitalized and evenly spaced.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 0 3 2002

Re: K020929

GE Medical Systems % Mr. Wolfram Gmelin Technical Manager TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Trade/Device Name: SmartScore 3.5, SmartScore 4.0, SmartScore 4.5 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: March 18, 2002 Received: March 22, 2002

Dear Mr. Gmelin:

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.

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

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 vours.

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

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

STATEMENT OF INTENDED USE

510(k) Number (if known):

Device Name: SmartScore 3.5, SmartScore 4.0, SmartScore 4.5

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. Legerom

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K020929

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.