The Acculmage Smartgate Upgrade for AccuScore 1.0 is an additional The Accumlage Onlangate Openalic Imaging Workstation with AccuScore, AccuAnalyze, AccuShade, AccuVRT and AccuMIP plugwin 7 locaboore, Accuring is not currently marketed, and the AccuMIP ins. The Accuremade play ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . play-in-15-ourrently-our-en-in-stating Tool enhancement for AccuScore Accumage Onlangulo Opgrado Stimas scoring for gated images, thus minimizing adverse effects of heart movement.

AI/ML Overview

The provided text is a 510(k) Summary for the AccuImage SmartGate Upgrade. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's description, intended use, and general safety considerations.

The document does NOT contain information regarding:

Specific acceptance criteria for device performance.
A detailed study proving the device meets acceptance criteria.
Reported device performance metrics.
Sample sizes for test sets or their data provenance.
Number of experts or their qualifications for ground truth establishment.
Adjudication methods.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study results.
Standalone performance study results.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

Instead, the document states:

Substantial Equivalence: The AccuImage Smartgate Upgrade Option is substantially equivalent to GE Medical Systems HiSpeed Lxi with SmartScore and the Vital Images Vscore with Gating options. This is the primary method of validation presented.
Performance Testing: "All software testing specified in the Software Product Development Plan will be successfully completed prior to market release." However, no details of this testing or its results are provided.
Software Development: The software was "designed, developed, verified and validated according to which procedure for developing and approving product organizations, software colling and testing, validation testing and field maintenance." Again,
no specifics on the results of these processes are given.
Hazard Analysis: Performed throughout development, concluding that the "Level of Concern" is "Minor" and that no failures are expected to materially contribute to patient death or injury.

In summary, the provided text does not contain the specific information requested in your prompt regarding acceptance criteria, study details, and performance metrics. It's a regulatory submission focused on substantial equivalence rather than a detailed performance study report.

Summary

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

SEP 2 5 2001

510(k) Summary

K 012/06

Company Identification 1.

Acculmage Diagnostics Corporation 400 Grandview Drive South San Francisco, CA 94080 Phone (650) 875-0192 Fax (650) 875-0194 Contact Person: Oscar Gils Carbó Email oscar@accuimage.com Establishment Registration No. 2953774

2. Official Correspondent

Gary J. Allsebrook Regulatory Management Services 16303 Panoramic Way San Leandro CA 94578-1116 Phone (510) 276-2648 Fax (510) 276-3559 Email: regman1@home.com

3. Date of Submission July 3, 2001

1. Device Name

Proprietary Name:	Acculmage SmartGate Upgrade: AcculmageEKG Gating Tool Enhancement for AccuScore1.0.
Classification Name:	90JAK – CT, Image Processing
Device/Usual Name:	Gated Calcification Scoring of CT images.

5. Substantial Equivalence

The Acculmage Smartgate Upgrade Option is Substantially Equivalent to GE Medical Systems HiSpeed Lxi with SmartScore and the Vital Images Vscore with Gating options.

Page 1 of 3

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

KO12106
Page 2 of 3

Device Description and Intended Use 6.

Device Description

Intended Use

Heart calcium scoring for gated CT images to minimize effects of heart movements.

Software Development: 7.

The software was designed, developed, verified and validated according The soltware was assigned procedures specify individuals within the to which procedule for developing and approving product organizations, software colling and testing, validation testing and field maintenance.

Performance Testing:

All software testing specified in the Software Product Development Plan will be successfully completed prior to market release.

8. Hazard Analysis

Hazard analysis on this product has been performed throughout the l definition, design, coding and testing phases of product development and implementation. This process has emphasized:

identification of potential hazards, their causes, and their effects; .
development of methodologies to control the occurrence of hazards . and to constrain their effects; and
Determine any effect on patient safety and system effectiveness. .

The potential hazards associated with this software product are no different The potomian nazar PACS components . These are primarily related to than those of computer system components, and may be variously obviated by

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

Koi2106
Page 3 of 3

decisions taken by the customers of this product. None of these failures are expected to materially contribute to patient death or injury.

It is our conclusion that there is no hardware or software component, operating in a properly configured environment, whose failure or latent design defect would be expected to result in death or injury of a patient. Thus the "Level of Concern" is "Minor".

Safety Concerns 9.

The hardware is "off-the-shelf" and complies with applicable electrical safety standards for standard PC hardware and peripherals.

Substantial Equivalence Comparison Chart 10.

The following product(s) provides functions, which are substantially equivalent to this product:

Manufacturer	GE MedicalSystems	Vital Images	Acculmage
ProductName	HiSpeed LX/iwith SmartScore	Vscore withAutoGate option	AcculmageSmartgate Upgrade
510(k)Number	K980169	K003230
ComputerPlatform	Not Known	PC / Windowsworkstation	Pentium / Windowsworkstation
Gating Optionfor CalciumScoring	HiSpeed LX/iwith SmartScoreoption	Match cardiac CTimages with thecorresponding EKGsignal. This allowsthe physician toselect imagesacquired when theheart was still.	Match cardiac CTimages with thecorresponding EKGsignal. This allowsthe physician toselect imagesacquired when theheart was still.
Type of CTscanners forwhich it isapplicable	LightSpeed andHiSpeed GE CTscanners	EBCT andstandard CT	EBCT andstandard CT
Types ofGating	Prospective andRetrospectiveGating	Images with eitherassociated EKGsignal or image-derived cardiacmotion signal	Images with eitherassociated EKGsignal or image-derived cardiacmotion signal

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

Image /page/3/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines. The symbol is black, and the text is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 5 2001

AccuImage Diagnostics Corporation % Mr. Gary Allsebrook Official Correspondent Regulatory Management Services 16303 Panoramic Way SAN LEANDRO CA 94578-1116

Re: K012106

Trade/Device Name: AccuImage SmartGate Upgrade Gated Calcification Scoring for CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: 90 JAK Dated: July 3, 2001 Received: July 6, 2001

Dear Mr. Allsebrook:

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.

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

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

{5}------------------------------------------------

510(k) Number (if known): KO12106

Device Name:

AccuImage SmartGate Upgrade: AccuImage EKG Gating Tool Enhancement for Accuscore 1.0

Indications For Use:

Heart calcium scoring for gated CT images to minimize effects of heart movements.

(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 901.109)

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Nancy C. Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012106

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.