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 2020tc Imager™ is intended to image the distribution of radionuclides 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

Mirage XP is an automated processing and interpretation software package. This software will be available as standard software on the Digirad imaging systems and/or as a standalone software package on a workstation or a laptop. The enhancements to previous versions of software include automated processing, preference based selections, improved EF algorithm and segment scoring for quantification and interpretation.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (SPECT Imaging System with new software). It describes the changes to the device (software update), its intended use, and the conclusion from testing. However, it does not include specific acceptance criteria, detailed study results, or information about ground truth establishment, expert adjudication, or training/test set sample sizes as requested in the prompt.

The core conclusion from the provided text is that the new software functions as intended and produces images equivalent to previous versions, without impacting safety or effectiveness. This is a general statement rather than a detailed performance report against specific criteria.

Therefore, I cannot populate the table and answer all questions based on the provided text alone. I will indicate where information is Not Available (N/A) from the text.

Acceptance Criteria and Device Performance Study Summary

The provided 510(k) summary focuses on a software update (Mirage XP, equivalent to Segami's Mirage 5.6) for existing Digirad SPECT imaging systems. The study detailed in the summary is primarily a functional verification and equivalence assessment rather than a detailed performance study against numerical acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (as implied or stated)	Reported Device Performance
Functional Equivalence	The new Mirage XP software can be installed and functions as intended on Digirad imaging systems.	Confirmed. Software installs and functions as intended.
Safety	Use of Mirage XP software (with existing acquisition/reconstruction) does not result in known anomalies impacting safety.	No known anomalies impacting safety.
Effectiveness	Use of Mirage XP software (with existing acquisition/reconstruction) does not result in known anomalies impacting effectiveness, including operator usage and human factors.	No known anomalies impacting effectiveness, including operator usage and human factors.
Image Quality	Quality of images produced with Mirage XP software is equivalent to those seen in previous versions of Mirage software used on Digirad imaging systems.	Image quality is equivalent to previous versions of Mirage software.
Automated Processing	Specific performance criteria for enhancements (e.g., speed, accuracy of segmentation, EF algorithm improvements) are not specified.	Enhancements include automated processing, preference-based selections, improved EF algorithm, and segment scoring for quantification and interpretation. No specific performance metrics or acceptance criteria for these improvements are provided in this summary.

2. Sample size used for the test set and the data provenance

Sample Size: Not Available (N/A). The document states "Testing was done," but does not specify the number of cases, scans, or an exact test set size.
Data Provenance: Not Available (N/A). The document does not mention the country of origin of the data or whether the data was retrospective or prospective. It only implies that the testing was likely conducted internally by Digirad Corporation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not Available (N/A).
Qualifications of Experts: Not Available (N/A).
The comparison for image quality ("equivalent to those seen in previous versions") suggests an internal subjective assessment, but no details on expert involvement are provided.

4. Adjudication method for the test set

Adjudication Method: Not Available (N/A). No information on adjudication methods for the test set (e.g., 2+1, 3+1, none) is provided.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, an MRMC comparative effectiveness study was not done or reported in this summary. The device in question is software for SPECT imaging system processing and interpretation, which includes "automated processing, preference based selections, improved EF algorithm and segment scoring for quantification and interpretation," but it's not explicitly described as an "AI assistance" device in the context of improving human reader performance.
Effect Size: Not Available (N/A). Since an MRMC study was not reported, there's no information on the effect size of human reader improvement with or without AI assistance.

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

Yes, implicitly. The software "Mirage XP is an automated processing and interpretation software package." The statement that "Mirage XP software can be installed and functions as intended" and produces "equivalent" images suggests that the algorithm's standalone functional and image output capabilities were assessed. However, no specific standalone performance metrics (e.g., detection sensitivity/specificity for particular conditions) were provided, as the focus was on functional equivalence to previous versions.

7. The type of ground truth used

Type of Ground Truth: Not explicitly stated. The comparison is primarily against the performance of previous versions of the software and images, implying a "referent standard" of previously accepted image quality and processing outputs. It does not mention an independent ground truth like pathology, outcomes data, or a consensus of multiple expert interpretations for clinical findings.

8. The sample size for the training set

Sample Size for Training Set: Not Available (N/A). This document is about a new release of pre-existing software. Information on the training set used during the development of Mirage 5.6 (or Mirage XP) is not included in this 510(k) summary.

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

Ground Truth Establishment for Training Set: Not Available (N/A). As the training set size and details are not provided, neither is information on how its ground truth was established.

Summary

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

K070542

Appendix 2: 510(k) Summary

A. Sponsor

MAR 2 3 2007

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

B. Date Prepared: February 23, 2007

C. Device Name

Trade Name: Cardius 1 XPO, Cardius 2 XPO, Cardius 3 XPO, and 2020tc SPECT Imaging System

Classification Name: System, Emission Tomography

D. Description of Changes

The proposed change involves use of a newer release of Segami Corporation's Mirage processing software on Digirad SPECT imaging systems. Previously cleared and marketed models of Digirad gamma cameras have always included earlier cleared releases of Mirage processing software as noted in our previous 510(k) submissions. This change seeks approval to market Digirad gamma cameras with Segami Mirage release 5.5, cleared under 510(k) #K043441, January 13, 2005, and later updated to release 5.6 by Segami Corporation. This release of Mirage software operates under a Windows XP operating system, and will be referred to as "Mirage XP" in this submission and Digirad labeling material (user manual, literature, etc). Mirage XP (Digirad's marketing name) and Segami's Mirage 5.6 are the same software program.

E. Intended Use

The intended uses of the Cardius series 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:

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

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

(2) Cardius-1 and Cardius-2 SPECT Imaging System cleared on February 5, 2003 under 510(k) #K030085.
Cardius-1, Cardius-2, Cardius-3, and 2020tc SPECT Imaging Systems cleared on July (3) 13, 2005 under 510(k) #K051549
Cardius-1, Cardius-2, Cardius-3, and 2020tc SPECT Imaging Systems cleared on (4) October 4, 2005 under 510(k) #K052430

G. Conclusions Drawn from Testing

Testing was done confirming that the new Mirage XP software can be installed and functions as intended on Digirad imaging systems. Use of the Mirage XP software in conjunction with previously cleared acquisition software and OSEM reconstruction techniques results in no known anomalies in the devices that impact safety or effectiveness, including operator usage and human factors. The quality of the images produced with the Mirage XP software is equivalent to those seen in previous versions of Mirage software used on Digirad imaging systems.

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

Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Joel Tuckey VP Quality Digirad Corporation 13950 Stowe Drive POWAY CA 92064-8803

K070542 Re:

Trade/Device Name: Cardius 1 XPO, Cardius 2 XPO, Cardius 3 XPO, and 2020tc SPECT Imaging Systems Regulation Number: 21 CFR §892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: February 23, 2007 Received: February 26, 2007

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.

Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. There are three stars below the word "Centennial". The text "Food and Drug Administration" is written around the perimeter of the circle.

Protecting and Promoting Public Health

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

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.

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 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}------------------------------------------------

Indications for Use 510(k) Number (if known): 100 KO70542 Device Name: Cardius 1 XPO, Cardius 2 XPO, Cardius 3 XPO, and 2020tc SPECT Imaging Systems

Indications for Use:

Cardius 1 XPO, Cardius 2 XPO, Cardius 3 XPO Imaging Systems:

2020tc SPECT Imaging System:

David h. Segmen

(Division Sian-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number .

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

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.