The Quantitative Gated SPECT (QGS) and Quantitative Perfusion SPECT (QPS) programs are intended for use in the display and quantification of myocardial perfusion and functional parameters from cardiac SPECT data.

Device Description

The OGS/OPS programs are independent. standalone software applications developed by Cedars-Sinai Medical Center for the display and quantification of cardiac SPECT data. The programs will run on the computer systems with a PC architecture, the Microsoft® Windows® operating systems and a third party X-server software.

The QGS/QPS programs take reconstructed tomographic slices of the left ventricle generated from gated and/or non-gated cardiac SPECT studies and display the images along with automatically generated quantification.

QPS analyzes myocardial perfusion by quantifying defect extent and severity using gender and isotope-specific normal limits. 2D and 3D perfusion maps are automatically generated.

QGS analyzes myocardial function by quantifying global and regional ejection fraction, wall thickening, and left ventricular volume at end-diastole and end-systole. 2D and 3D images of perfusion and thickening are generated.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Digirad QGS and QPS software:

The provided document is a 510(k) summary for the Digirad QGS (Quantitative Gated SPECT) and QPS (Quantitative Perfusion SPECT) software. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness through a comprehensive set of acceptance criteria and a dedicated study designed purely for that purpose. Instead, it relies on functionality tests and clinical validation performed previously by Cedars-Sinai Medical Center.

Based on the provided text, here's the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Functionality	Each software application functioned as per its specifications.
Platform Compatibility	QGS and QPS programs ran on computer systems with the proposed platform using a standard Cedars-Sinai test case.
Accuracy/Matching Previous Results	The test passed with the actual results matching the Cedars-Sinai results.

Note: The document does not explicitly state numerical acceptance criteria (e.g., minimum sensitivity, specificity, or correlation thresholds). The "acceptance criteria" here are implied by the successful completion of the functionality and platform tests and the agreement with Cedars-Sinai results.

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

Sample Size for Test Set: Not explicitly stated for the "standard Cedars-Sinai test case" used for platform testing.
Data Provenance:
- The "standard Cedars-Sinai test case" used for platform testing originated from Cedars-Sinai Medical Center.
- The clinical validation was conducted by Cedars-Sinai Medical Center and published in the Journal of Nuclear Medicine. The location and retrospective/prospective nature of the data for this clinical validation are not specified in this 510(k) summary itself, but it can be inferred that it would be patient data, likely retrospective, used in the published study.

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

The document does not provide details on the number or qualifications of experts specifically for establishing the ground truth of the "standard Cedars-Sinai test case" used for platform compatibility. It merely states the test passed, meaning the device's output matched "Cedars-Sinai results," implying a reference standard already established by Cedars-Sinai.
For the clinical validation study mentioned, this information would be found in the Journal of Nuclear Medicine publication, but it is not included in this 510(k) summary.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly detailed. For the platform test, it seems to be a direct comparison of the device's output against pre-established "Cedars-Sinai results." This doesn't inherently suggest an adjudication process by multiple experts for the test case itself, but rather a verification against an already determined ground truth.

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

No MRMC Comparative Effectiveness Study was explicitly conducted or reported in this 510(k) summary. The submission emphasizes standalone software functionality and clinical validation, not reader performance with or without AI assistance. The device is for "display and quantification," which assists human readers but the document doesn't measure this assistance effect size.

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

Yes, a standalone performance was done. The functionality tests and the platform compatibility test demonstrate the algorithm's performance independent of a human-in-the-loop. The QGS/QPS programs themselves are described as "independent, standalone software applications." Their output is compared directly to specifications and known results, indicating standalone operation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the platform compatibility test, the ground truth was "Cedars-Sinai results." This suggests a pre-established reference standard, likely derived from expert analysis of the medical images or prior validated software results for that specific test case.
For the clinical validation referenced, the ground truth would typically be established based on accepted clinical standards for myocardial perfusion and function analysis, which could include expert interpretation, follow-up data, or comparison to other validated diagnostic methods. This detail is not in the 510(k) summary, but in the cited publication.

8. The Sample Size for the Training Set

Not provided. The software was "developed by Cedars-Sinai Medical Center," implying extensive use of their data for development and internal validation, but no specific training set size is mentioned in this document.

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

Not provided. Given the development by a medical center, it's highly probable the ground truth for any training data used would have been established by clinical experts (e.g., cardiologists, nuclear medicine specialists) at Cedars-Sinai, often through expert consensus, review of patient outcomes, or comparison to other diagnostic modalities. However, the 510(k) summary does not detail this.

Summary

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Digirad Corporation, Traditional [510(k)] Submission Digirad Corporation, Traditional [570(IS)] Buchasitative Perfusion SPEC

Appendix F. 510(k) Summary

JUN 1 5 2001

510(k) Summary 00

8.1 Identification:
8.1.1 Date of Application: May 18, 2001

8.1.2 Applicant's and Name and Address:

Corey Stewart Quality Control Manager Digirad Corporation 9350 Trade Place San Diego, CA 92126

8.1.3 Telephone and Fax Numbers of the Applicant

Telephone: (858) 537 - 2118 Fax: (858) 549 - 9789 Email: cstewart@digirad.com

8.1.4 Signature
Signature
Cory Stewart

Date 5/18/01

8.2 Device name and classification
8.2.1 Classification Code: 90 KPS
8.2.2 Panel Identification: Radiology
8.2.3 Proprietary Name: Quantitative Gated SPECT (QGS) Quantitative Perfusion SPECT (QPS)

SK4G

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Digirad Corporation, Traditional [510(k)] Submission QGS (Quantitative Gated SPECT) and QPS (Quantitative Perfusion SPECT)

8.2.4 Common Name:

Gamma Camera System

8.2.5 Classification Name:

System. Emission Computed Tomography

8.2.6 Classification Class:

Class II Product

8.2.7 Substantial Equivalence

The proposed device and the predicate devices have the same indication for use and functionalities. The QGS and OPS proposed is the same application as the QGS and QPS sponsored by SMV America. The QGS and QPS proposed shall be analyzing the same data as the existing Digirad 2020tc SPECT Imaging System.

Table 8.1	Predicate devices
-----------	-------------------	--

	Existing Digirad2020tc SPECTImaging System	QGS/QPSSponsor: SMVAmerica
Product Code	90 KPS	90 KPS
510(k)Number	K982855	K003358

8.2.8 Device Description

QPS analyzes myocardial perfusion by quantifying defect extent and severity using gender and isotope-specific normal limits. 2D and 3D perfusion maps are automatically generated.

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8.2.9 Intended Use

8.2.10 Testing

Functionality tests were conducted to demonstrate that each software application functioned as per its specifications. Computer platform test was performed by running QGS and QPS programs on computer systems with proposed platform using a standard Cedars-Sinai test case. The test passed with the actual results matching the Cedars-Sinai results.

Clinical validation on QGS and OPS programs has been conducted by Cedars-Sinai Medical Center and published in the Journal of Nuclear Medicine, Vol. 41, No.4, April 2000.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like strokes. The bird is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 5 2001

Corey Stewart Quality Control Manager DIGIRAD Corporation 9350 Trade Place San Diego, CA 92126-6334 Re: K011572

QGS (Quantitative Gated SPECT) and QPS (Quantitative Perfusion SPECT) Dated: May 18, 2001 Received: May 21, 2001 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS

Dear Mr. Stewart:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the We'ne 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). 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 (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, to sadel additional controlly equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements to compry with the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding r mi reter will and really 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. 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 807.97). Other general information on your chance, "Misolanding of received from the Division of Small Manufacturers 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 (s)

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APPENDIX G. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K_011572

Device Name:

QGS (Quantitative Gated SPECT) and QPS (Quantitative Perfusion SPECT)

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, Prescription Use and Radiological Devices 510(k) Number

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.