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.

2020tc SPECT Imaging System:

The Digirad 2020tc SPECT Imaging system is intended for use in the generation of both planar and Single Photon Emission Computed Tomography (SPECT) clinical images in nuclear medicine applications. The Digirad SPECT Rotating Chair is used in conjunction with the Digirad 2020tc Imager™ to obtain SPECT images in patients who are seated in an upright position.

Specifically, the 2020te Imager™ is intended to image the distribution of radionuctides in the body by means of a photon radiation detector. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel.

Device Description

The changes to the Digirad 2020tc and Cardius SPECT imaging cameras involve addition of an Image Stabilization System. The proposed Image Stabilization System is used to correct image studies for patient motion in SPECT data acquired with Digirad Nuclear medicine gamma camera systems. The Image Stabilization System consists of two parts: a Hardware component that mounts to the SPECT Imaging System, and a software module that collects data from the hardware and corrects the image data for motion. The resulting motion corrected patient study data is referred to as the Image Stabilized Patient Study. The Image Stabilization system may operate only with the above described Digirad Camera models and is compatible with proprietary Digitad Acquisition Software under the Windows Operating system and standard PC architecture.

The proposed Image Stabilization System performs substantially the same function as the currently cleared Cedar's Sinai Motion Correction Program (MoCo), cleared for use on Digirad SPECT Imaging Systems under Digirad 510(k) #K023110.

The proposed Image Stabilization System automatically produces an Image Stabilized Patient Study, corrected for patient motion, which is available in the existing database. The original image study is produced in an identical manner as in the previously cleared devices. Both studies are stored in the same patient record in the database. Additional minor changes were made to the User Interface screen.

The Image Stabilized Patient Studies produced by the proposed device are identical in file structure to the original, unmodified data set; therefore SeeQuanta 1.2 and the Image Stabilization System are fully compatible with the same database, reconstruction software, and processing software that is used with the "cleared" devices. Hence, there are no changes to these software modules.

This proposed optional software addition will be available to Digirad customers both integrated with the Digirad 2020tc SPECT Imaging System, and Cardius-1, Cardius-2, and Cardius-3 SPECT Imaging Systems, and separately as a retrofit device for existing Digirad Product Customers.

AI/ML Overview

Here's an analysis of the provided text regarding the KD5243D 510(k) submission, focusing on the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on the equivalence of the Image Stabilization System to existing predicate devices, rather than establishing new performance metrics. Therefore, explicit numerical acceptance criteria and a direct comparison table as might be seen for a diagnostic accuracy study are not present. Instead, the "acceptance criteria" are implied to be "similar quality" of corrected images.

Acceptance Criterion (Implied)	Reported Device Performance
Image Quality	The quality of the phantom images corrected with the Image Stabilization System with the modified acquisition software was similar to the quality of the images post-processed corrected using the MoCo Motion Correction program (a predicate device).
Functionality	The Image Stabilization System performs substantially the same function as the currently cleared Cedar's Sinai Motion Correction Program (MoCo) and other predicate devices (Mirage software, Cedars-Sinai BPGS and MoCo).
Design Outputs	Extensive Verification testing was completed on all cleared Digirad SPECT Imaging Systems integrated with the Image Stabilization Device to demonstrate that the design outputs met the design inputs of the proposed Image Stabilization Accessory Device. All software test results met pre-defined acceptance criteria (specific criteria not detailed).
Data Compatibility	Image Stabilized Patient Studies are identical in file structure to the original, unmodified data set, ensuring full compatibility with existing database, reconstruction, and processing software.

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

Sample Size: The text states, "Testing was performed to analyze the content of corrected phantom studies using the Image Stabilization Accessory integrated with the Digirad Cardius-1 camera." It does not specify the number of phantom studies included in this analysis.
Data Provenance: The testing was performed using "phantom studies," indicating simulated or controlled data rather than patient data. The country of origin for this data is not specified but is presumed to be internal testing by Digirad Corporation (USA). The study is prospective in the sense that the new device was used to correct specific phantom data, but the data itself is not from real patients.

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

This information is not provided in the text. Since the testing involved phantom studies and comparison to a predicate device's output, it's unlikely that a panel of medical experts was used to establish ground truth in the traditional sense. The "ground truth" for phantom studies is typically defined by the known characteristics of the phantom and the expected ideal image.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the testing (phantom studies comparing image quality to a predicate), a formal adjudication method like 2+1 or 3+1 is unlikely to have been employed. The comparison was likely a technical assessment of image characteristics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study focused on the technical performance and similarity of image quality for the motion correction system itself, not on the impact of this correction on human reader performance in interpreting patient studies.

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

Yes, a standalone performance evaluation was conducted. The text describes "Testing was performed to analyze the content of corrected phantom studies using the Image Stabilization Accessory" and "extensive Verification testing was completed on all cleared Digirad SPECT Imaging Systems integrated with the Image Stabilization Device to demonstrate that the design outputs met the design inputs." This indicates the algorithm's performance in correcting phantom images was evaluated independently.

7. The Type of Ground Truth Used

The ground truth used was based on phantom studies and comparison to the output of predicate device software (MoCo). For a phantom, the "ground truth" is the known ideal image of the phantom without motion artifacts. The acceptance criterion was that the corrected phantom images from the new system were "similar in quality" to those corrected by the predicate MoCo program.

8. The Sample Size for the Training Set

This information is not provided. The submission describes the addition of a new hardware and software module for image stabilization. It does not mention whether this module uses a machine learning algorithm that requires a training set. If it's a traditional image processing algorithm, a "training set" in the machine learning sense might not apply.

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

Since a training set is not mentioned and it's unclear if machine learning was used, the method for establishing its ground truth is not applicable/not provided.

Summary

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KD5243D

OCT 4 - 2005

Appendix 2: 510(k) Summary

A. Sponsor

Digirad Corporation 13950 Stowe Drive Poway, California 92064 Contact Person: Joel Tuckey Tel: (858) 726-1527 Fax: (858) 726-1700

B. Date Prepared: September 2, 2005

C. Device Name

Trade Name: Cardius-1, Cardius-2, Cardius-3, 2020tc SPECT Imaging System Classification Name: System, Emission Tomography

D. Description of Changes

This proposed optional software addition will be available to Digirad customers both integrated with the Digirad 2020tc SPECT Imaging System, and Cardius-1, Cardius-2, and

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Cardius-3 SPECT Imaging Systems, and separately as a retrofit device for existing Digirad Product Customers.

ய் Intended Use

The intended uses of the Cardius and 2020tc cameras have not changed, and are summarized in the "Indications for Use" form included with this submission.

F. Cleared/Predicate Device

The proposed change is a modification to the following Digirad cleared devices:

(1) 2020tc SPECT Imaging System and the SPECTour Chair (SPECT Imaging System), cleared on November 9, 1998 under 510(k) #K982855; and

(2) Cardius-1 and Cardius-2 SPECT Imaging System cleared on February 5, 2003 under 510(k) #K030085.
(3) Cardius-1, Cardius-2, Cardius-3, and 2020tc SPECT Imaging Systems cleared on July 13, 2005 under 510(k) #K051549

The Image Stabilization System Accessory when integrated with the cleared 2020tc and Cardius Model Digirad SPECT Imaging Systems has the same function as the following predicate devices: the Motion Correction function module of Mirage software device (Segami Corporation, #K972886) and Digirad Cedars-Sinai Motion Correction (MoCo) Software Program device (#K023110), which is currently used on the Digirad 2020tc and Cardius models SPECT imaging Systems to carry out patient motion correction to the postprocessed data.

Additionally, the proposed Image Stabilization System also performs the same functions as the MoCo Motion Correction Software in the following predicate devices: Cedars-Sinai BPGS and MoCo cleared under K010509 for GE/SMV America, and QPS/BPGS/MoCo Processing Applications cleared under K003264 for ELGEMS Ltd.

Conclusions Drawn from Testing G.

Testing was performed to analyze the content of corrected phantom studies using the Image Stabilization Accessory integrated with the Digirad Cardius-1 camera. Also extensive Verification testing was completed on all cleared Digirad SPECT Imaging Systems integrated with the Image Stabilization Device to demonstrate that the design outputs met the design inputs of the proposed Image Stabilization Accessory Device. Testing included comprehensive phantom image verification and validation studies with modified acquisition software. All software test results met pre-defined acceptance criteria. The quality of the phantom images corrected with the Image Stabilization System with the modified acquisition software was similar to the quality of the images post-processed corrected using the MoCo Motion Correction program.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized wing feathers.

Public Health Service

OCT 4 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Joel Tuckey VP Quality Digirad Corporation 13950 Stowe Drive POWAY CA 92064-8803 Re: K052430 Trade/Device Name: Cardius-1, Cardius-2, Cardius-3, 2020c SPECT Imaging System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: September 2, 2005 Received: September 6, 2005

Dear Mr. Tuckey:

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 (Premarket Approval), it may be subject to such 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 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/industry/support/index.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

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Indications for Use KD52430 510(k) Number (if known): nea Device Name: Cardius-1, Cardius-2, Cardius-3, 2020tc SPECT Imaging System

Indications for Use:

Cardius-1, Cardius-2, Cardius-3:

2020tc SPECT Imaging System:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel L. Suppron

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.