AutoSPECT® produces images, which depict the three-dimensional distribution of radiopharmaceutical tracers in a patient. This software is intended to provide enhancements to gamma camera emission image processing by automating previously manual image processing functions, providing manual and automated motion correction, providing enhanced reconstruction algorithms that include resolution recovery, scatter correction, noise compensation, and attenuation correction via application of a transmission dataset.

Device Description

AutoSPECT is a software application that produces images, which depict the threedimensional distribution of radiopharmaceutical tracers in a patient via automatic or manual processing. One or more cardiac SPECT, gated SPECT, or MCD cardiac data sets may be processed automatically using AutoSPECT. Additionally, one or more non-cardiac SPECT, gated SPECT, or MCD data sets may be processed manually. AutoSPECT contains basic data-processing algorithms that have been cleared previously; in addition to enhanced data reconstruction algorithms that include scatter correction, resolution recovery, map-based attenuation correction, and OSEM (Astonish SPECT) reconstruction.

The AutoSPECT software option may be used on images from a gamma camera system that are DICOM 3.0 compatible. The following data sets may be used:

Cardiac, brain, or other (bone, liver, etc.) SPECT datascts .
. Gated SPECT datasets
. Vantage SPECT datasets
SPECT-CT datasets .
Total Body SPECT datasets
MCD and MCD-AC datasets .

AutoSPECT provides the user three options for automatically processing cardiac datasets: AutoAll, Auto Recon, and Auto Reorient. Each option is described in greater detail in the software description section.

AutoSPECT also allows the user to process non-cardiac SPECT and MCD datasets. In this case, the operator manually positions the reconstruction limit lines to reconstruct transverse data sets. If necessary, the data set can be reoriented manually by positioning the azimuth, elevation, and twist lines to the desired locations.

In addition, the capability of processing groups of SPECT data sets in a batch mode fashion is provided. Once the operator has selected the datasets and determined the processing method, AutoSPECT processes the first dataset, followed by all remaining datasets without further interaction from the user.

AutoSPECT application runs on Microsoft Windows XP Professional environment. The minimum hardware requirements is listed:

. Intel x86/Pentium class processor > 1 GHz ;
Graphics capability must meet or exceed 1280x1024 pixels with 32 bit pixel . depth;
. 30 Gb of disk space (minimum);
. 512 Mb of DRAM (minimum);
. 10/100 BaseTX Ethernet interface;
. Port capable of supporting a dongle;
. CD drive- capable of reading and writing:
56Kbps modem (minimum) .

AI/ML Overview

This document is a 510(k) summary for the AutoSPECT® device, a software application for processing gamma camera emission images. The submission aims to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria with specific quantitative metrics or a study demonstrating the device meets those criteria. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on similar intended use and technological characteristics, rather than establishing new performance criteria through a specific study with defined acceptance thresholds.

The "performance" described is largely qualitative, focusing on enhanced reconstruction algorithms.

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

The document does not specify a test set size nor the provenance (e.g., country of origin, retrospective/prospective) of any data used for testing. The submission is a comparison to a predicate device and description of new features, not a report on a clinical performance study with a test set.

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

Not applicable. The document does not describe a study involving a test set with expert-established ground truth.

4. Adjudication Method for the Test Set:

Not applicable. The document does not describe a study involving a test set with an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

No, an MRMC comparative effectiveness study is not mentioned or described in this document. The submission focuses on device features and comparison to a predicate, not human reader performance with or without the AI.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

No, a standalone algorithm performance study is not mentioned or described. The document describes a software application that processes images for human interpretation, not a fully automated diagnostic system.

7. The Type of Ground Truth Used:

Not applicable. The document does not describe a study involving any form of ground truth for performance evaluation.

8. The Sample Size for the Training Set:

Not applicable. The document does not provide details of a training set as it describes a software application and its features, not a machine learning model developed with a training dataset.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As no training set is mentioned, the method for establishing its ground truth is also not applicable.

Summary

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OCT 2 9 2004

Ko 42903

510(k) SUMMARY SAFETY AND EFFECTIVENESS

A.	Submitted By:	ADAC Laboratories540 Alder Dr.Milpitas, CA 95035
	Contact:	Joy M. SacmarTel: (408) 468-3053Fax: (408) 468-3050
B.	Device Trade Name:	AutoSPECT®
	Common Name:	Gamma Camera Systems
	Classification Name:	Emission Computed Tomography System
	Device Class:	21 CFR 892.1200, Class II
	Product Code:	90 KPS
C.	Date prepared:	September 30, 2004
D.	Predicate Device (s):
	Manufacturer	Product Name
	ADAC Laboratories	AutoSPECT Plus with Instill Motion Correction
		510(k) No.
		K992317

E. Intended Use:

F. Device Description:

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The AutoSPECT software option may be used on images from a gamma camera system that are DICOM 3.0 compatible. The following data sets may be used:

Cardiac, brain, or other (bone, liver, etc.) SPECT datascts .
. Gated SPECT datasets
. Vantage SPECT datasets
SPECT-CT datasets .
Total Body SPECT datasets
MCD and MCD-AC datasets .

AutoSPECT application runs on Microsoft Windows XP Professional environment. The minimum hardware requirements is listed:

. Intel x86/Pentium class processor > 1 GHz ;
Graphics capability must meet or exceed 1280x1024 pixels with 32 bit pixel . depth;
. 30 Gb of disk space (minimum);
. 512 Mb of DRAM (minimum);
. 10/100 BaseTX Ethernet interface;
. Port capable of supporting a dongle;
. CD drive- capable of reading and writing:
56Kbps modem (minimum) .

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G. Technological Comparison:

AutoSPECT and the predicate, AutoSPECT Plus with InStill Motion Correction, have similar indication for use, utilize similar methods for motion correction, reconstruction, and display of images. AutoSPECT like the predicate device also has the tools for automated and manual processing of images. AutoSPECT will provide new enhanced data reconstruction algorithms that include scatter correction, resolution recovery, map-based attenuation correction, and OSEM (Astonish SPECT) reconstruction. The similarities and differences between AutoSPECT and the predicate device are described in detail in predicate comparison section of this pre-market notification.

H. Conclusion:

AutoSPECT is substantially equivalent to the following predicate device, AutoSPECT Plus with InStill Motion Correction (K992317) based on similar intended use and technological comparison.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized image of an eagle with three wing-like shapes, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

OCT 2 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ADAC Laboratories c/o Ms. Denise Klinker Regulatory Affairs Specialist Underwriters Laboratories Inc.® 1655 Scott Blvd. SANTA CLARA CA 95050

Re: K042903

Trade/Device Name: AutoSPECT® Regulation Number: 21 CFR §892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: October 14, 2004 Received: October 15, 2004

Dear Ms. Sacmar:

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 the enal stars of 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 reguirements 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 additional controls. Existing major regulations affecting your Apple rany to 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.

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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.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Nancy C. brogdon

Nancy C. I rogdon 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):

AutoSPECT

Device Name:

Indications For Use:

AutoSPECT® produces images, which depict the three-dimensional distribution of radiopharmaceutical tracers in a patient. This software is intended to provide renhancements to gamma camera emission image processing by automating previously manual image processing functions, providing manual and automated motion correction, manual image processing struction algorithms that include resolution recovery, scatter providing noise compensation, and attenuation correction via application of a transmission dataset.

Over-The-Counter Use AND/OR Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon
vision Sign-Off)
ision of Reproductive, Abdominal,
I Radiological Devices
(k) Number K042903

Page 1 of

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.