The Cardius product models are intended for use in the generation of cardiac studies, including planar and Single Photon Emission Computed Tomography (SPECT) studies, in nuclear medicine applications.

Device Description

The Cardius model cameras are gantry (open gantry, upright seated) devices designed for single- (Cardius-1) or dual-detector (Cardius-2) cardiac nuclear imaging studies. The device includes an acquisition/processing station, a gantry, one or two detectors, and a gantrymounted patient imaging chair. The patient imaging chair is mechanized to accommodate patient loading and cardiac centering in the detector field of view.

The imaging chair motion control allows for acquisition of Cardiac SPECT and planar studies, including static, dynamic, gated/non-gated SPECT (circular orbit only).

AI/ML Overview

The provided text describes the regulatory clearance for the Digirad Cardius-1 and Cardius-2 SPECT imaging systems, focusing on their substantial equivalence to predicate devices. However, it does not contain the detailed information required to fill in all sections of the requested acceptance criteria and study design.

Specifically, the document states: "Comprehensive verification and validation testing was performed with the Cardius-1 and Cardius-2 devices including; hardware, software, electrical safety, and clinical imaging. All test results met pre-defined acceptance criteria. The quality of the clinical images produced were similar to the quality of the images produced by the predicate devices."

This statement confirms that testing was done and acceptance criteria were met, but it does not provide the specific acceptance criteria, reported device performance metrics, or details about the clinical study itself.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The text only states that "All test results met pre-defined acceptance criteria" and "The quality of the clinical images produced were similar to the quality of the predicate devices." It does not specify what those acceptance criteria were (e.g., specific sensitivity, specificity, image quality metrics) or the exact reported performance against those criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document vaguely mentions "clinical imaging" as part of the testing. There is no information on the sample size of any test set, the country of origin of data, or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided. No information is given about how ground truth was established or by whom.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. No information on adjudication is present.

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

Cannot be provided. The device is a SPECT imaging system, not explicitly an AI/CAD device for interpretation. The document doesn't mention any MRMC study or AI assistance.

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

Not applicable/Cannot be determined. This device is an imaging system (hardware and software for acquisition and basic processing), not a standalone diagnostic algorithm. No information about algorithm-only performance is available.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be provided. The document does not specify the type of ground truth used for any clinical testing.

8. The sample size for the training set

Cannot be provided. There is no mention of a "training set." The device is an imaging system, and while it would have been developed using some data, the text doesn't describe a formal "training set" in the context of an AI/ML algorithm.

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

Cannot be provided. As there's no mention of a training set, there's no information on how its ground truth was established.

Summary of available information:

The document focuses on establishing substantial equivalence to predicate devices (Digirad 2020tc SPECT Imaging System and ADAC Forte). The primary evidence cited for meeting acceptance criteria is that "All test results met pre-defined acceptance criteria" and "The quality of the clinical images produced were similar to the quality of the images produced by the predicate devices." This implies that the acceptance criteria primarily revolved around demonstrating performance similar to or not worse than existing cleared devices, rather than establishing absolute performance benchmarks with detailed clinical study metrics as would be expected for a novel diagnostic algorithm.

Summary

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APPENDIX 1. 510(k) SUMMARY

A. Sponsor

FEB 0 5 2003

Digirad Corporation 9350 Trade Place San Diego, California 92126-6334 Contact Person: Corey Stewart Tel: (858) 537-2118 Fax: (858) 549-9789

Date Prepared: 1/06/03 B.

C. Device Name

Trade Name: Cardius-1, Cardius-2

Classification Name: System, Emission Tomography

Device Description D.

The imaging chair motion control allows for acquisition of Cardiac SPECT and planar studies, including static, dynamic, gated/non-gated SPECT (circular orbit only).

E. Intended Use

The Cardius-1 and Cardius-2 are intended for use in the generation of cardiac studies, including planar and Single Photon Emission Computed Tomography (SPECT) studies, in nuclear medicine applications.

ட். Predicate Device

The Cardius systems are substantially equivalent in design and intended use to the Digirad 2020tc SPECT Imaging System and the ADAC Forte (cardiac applications only).

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G. Summary of Substantial Equivalence

The Cardius -1 and Cardius- 2 devices are substantially equivalent to the predicate devices in intended use, physical characteristics, performance specifications and safety characteristics.

H. Testing

Comprehensive verification and validation testing was performed with the Cardius-1 and Cardius-2 devices including; hardware, software, electrical safety, and clinical imaging All test results met pre-defined acceptance criteria. The quality of the clinical images produced were similar to the quality of the images produced by the predicate devices.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, with three profiles overlapping to create a sense of depth and community.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Corey Stewart Ouality Assurance Manager

Re: K030085

FEB 0 5 2003

Trade/Device Name: Cardius-1 and Cardius-2 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: January 7, 2003 Received: January 9, 2003

Dear Mr. Stewart:

Digirad Corporation

SAN DIEGO CA 92126-6334

9350 Trade Place

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.

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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

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 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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 yours,

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

Page 2

to proceed to the market.

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APPENDIX 2. INDICATION FOR USE STATEMENT

510(k) Number (if known): K 030085

Device Name:

Cardius-1, Cardius-2

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

OR Over-the-Counter Use

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030085

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.