The CSMC Cardiac Suite is intended to enable an automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasets. CSMC Cardiac Suite may be used in multiple settings including the hospital, clinic, doctors office, or remotely. The results provided should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.

Device Description

The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PET imaging processing and review. Cedars-Sinai Cardiac Suite minimum system requirements include a computer with at least 1GB RAM, 50MB hard disk space for software installation, a display resolution at least 1024x768 with 16-bit color, a network adapter, a mouse (or other pointer device; trackpad, trackball, etc.) and one of the following operating systems: Windows XP Professional. Windows Vista Professional. Windows 7 Professional. The Cedars-Sinai Cardiac Suite operates on camera independent reconstructed SPECT and/or PET image files. CSMC Cardiac Suite will be marketed as a comprehensive application suite that includes QGS (Quantitative Gated SPECT), QPS (Quantitative Perfusion SPECT) and CSImport applications. This allows automatic processing and review of quantitative and qualitative information generated by nuclear medicine studies. Purchasable Options consist of Quantitative Blood Pool SPECT (QBS), QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA), Motion Correction (MOCO) and QPET. QPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies.

AI/ML Overview

Acceptance Criteria and Device Performance Study for Cedars-Sinai Cardiac Suite (K100714)

The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PET imaging processing and review, including applications such as QGS, QPS, QBS, QARG, CSImport, MoCo, and QPET. The device's substantial equivalence to predicate devices (AutoQUANT® Plus and Cedars-Sinai BPGS and MoCo Software Programs) was demonstrated through performance testing.

1. Acceptance Criteria and Reported Device Performance

The core of the performance testing revolved around demonstrating that the algorithms in the CSMC Cardiac Suite operate identically to those in the predicate devices.

Acceptance Criteria	Reported Device Performance
Functional Equivalence: Each software application functions as per its specifications.	QPS Verification: 1211 tests passed, 0 failed. QGS Verification: 1211 tests passed, 0 failed. QBS Verification: 632 tests passed, 0 failed. QARG Verification: 1161 tests passed, 0 failed. CSImport Verification: 111 tests passed, 2 failed (These two failures are likely acceptable as the overall submission was cleared). MOCO Verification: 23 tests passed, 0 failed. Installation Verification: 82 tests passed, 0 failed. Regression Tests: 912 tests passed, 0 failed (across multiple daily runs).
Algorithmic Equivalence: All algorithms (with the exception of two new ones: "Quality Score" and "RV algorithm") produce the same results as previous versions of the software (predicate devices).	A set of 16 studies had their algorithm results compared to those of the predicate device. These comparisons were included in regression tests, which consistently passed (912 tests passed, 0 failed). This implies identical results for the algorithms common to both the device and its predicates.
New Algorithms Functionality: The two new algorithms ("Quality Score" and "RV algorithm") are integrated and perform as expected as part of the updated QPS / QGS.	The document states that the updated version of QPS and QGS includes an improved contouring algorithm based on a quality score and RV (right ventricle) extraction and analysis. The comprehensive nature of the functional and regression tests (which passed) suggests these new features are functional and integrated correctly.

2. Sample Size and Data Provenance

Test Set Sample Size: 16 studies were used for direct comparison of algorithm results between the device and its predicate. Beyond this, thousands of tests were conducted for functional and regression testing, but the specific number of unique patient cases for these tests is not explicitly stated.
Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the data was retrospective or prospective, but given the nature of comparing to predicate device results, it's highly likely to be retrospective data that was previously processed by the predicate devices.

3. Number of Experts and Qualifications for Ground Truth

The document does not indicate the involvement of experts for establishing ground truth for the test set in the context of clinical interpretation or diagnosis. The focus was on the performance of the algorithms themselves compared to predicate device results, not against a human-derived clinical ground truth for a diagnostic outcome.

4. Adjudication Method

Not applicable. The study focused on algorithmic equivalence to predicate devices, not on a diagnostic outcome requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The study aimed to demonstrate that the device's algorithms operate identically to previously cleared predicate devices.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop performance) study was effectively done. The performance testing section directly addresses the functionality and output of the software's algorithms, comparing them to predicate device outputs. The statement, "With the exception of two new algorithms ("Quality Score" and "RV algorithm") all algorithms operate identically (i.e. produce the same results) as with previous versions of the software (referenced in predicate devices)", indicates a standalone evaluation of the algorithmic output.

7. Type of Ground Truth Used

The ground truth used for the algorithmic equivalence testing was the results generated by the predicate devices (AutoQUANT® Plus and Cedars-Sinai BPGS/MoCo Software Programs). For the functional verification tests (QPS, QGS, etc.), the ground truth was the expected output or behavior defined by the software's specifications.

8. Sample Size for the Training Set

The document does not provide any information regarding a "training set" or its sample size. This suggests that the device was not developed using traditional machine learning supervised training paradigms that require distinct training sets, or at least, such details were not considered relevant for this 510(k) submission focused on substantial equivalence to existing devices. The new algorithms ("Quality Score" and "RV algorithm") are mentioned, but their development methodology (including if they involved new training) is not detailed.

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

Not applicable, as no training set information is provided or implied in the document.

Summary

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K100714 APR - 1 2011

21. 510(k) SUMMARY - SAFETY AND EFFECTIVENESS

Applicant / Contact:

Cedars-Sinai Medical Center Department of Medicine Artificial Intelligence in Medicine Program 8700 Beverly Blvd. Los Angeles, CA 90048 Tel: 310-423-4663 Fax: 310-423-0173

Preparer / Consultant:

Erik Rodriguez Global Regulatory Solutions 2143 Country Place Escondido, CA 92026 (858) 722-3353 erodriguez@grsolutions.us

A. Submitted By:

Cedars-Sinai Medical Center Department of Medicine Artificial Intelligence in Medicine Program 8700 Beverly Blvd. Los Angeles, CA 90048 Tel: 310-423-4663 Fax: 310-423-0173

Contact Person: Mr. Geoff Pollard, Project Manager (At Address Above)

B. Device Trade Name:	CSMC Cardiac Suite
Common Name:	Nuclear Medicine Software Application
Classification Name:	Emission Computed Tomography System
Device Class:	21 CFR 892.1200, Class II
Product Code:	90 KPS

March 3, 2010 C. Date prepared:

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D. Predicate Device(s): AutoQUANT® Plus and Cedars-Sinai BPGS and
MoCo Software Programs

Manufacturer	Product Name	510(k) No.
ADAC Laboratories	AutoQUANT® Plus	K060020
GE/SMV America	Cedars-Sinai BPGS/MoCo Software Programs	K010509

PRODUCT NAME	510(k)NUMBER	CLEARANCEDATE	MANUFACTURER
AutoQUANT® Plus	K060020	January 20, 2006	ADAC Laboratories540 Alder Dr.Milpitas, CA 95035
Cedars-Sinai BPGSand MoCo SoftwarePrograms	K010509	April 27, 2001	GE/SMV America8380 Darrow RoadTwinsburg, OH 44087

E. Intended Use:

F. Device Description:

CSMC Cardiac Suite will be marketed as a comprehensive application suite that includes QGS (Quantitative Gated SPECT), QPS (Quantitative Perfusion SPECT) and CSImport applications. This allows automatic processing and

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review of quantitative and qualitative information generated by nuclear medicine studies. Purchasable Options consist of Quantitative Blood Pool SPECT (QBS), QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA), Motion Correction (MOCO) and QPET. QPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies.

G. Technological Comparison:

CSMC CARDIAC SUITE has similar indications for use and overall function and performs in a similar manner with respect to data display and analysis to both predicates listed herein. Cardiac Suite is also equivalent to AutoQUANT Plus, QPS, QGS, QBS, QARG applications (K060020) and MoCo (K010509).

H. Testing:

Testing was conducted to demonstrate that each software application functioned as per its specifications. The summary of all verification tests are listed in the table below. Unresolved Anomalies are referenced herein:

Test Description	Date	Build	Pass	Fail
Known Issues	2010-03-01	N/A	N/A	10
QPS Verification	2009-12-24	13291	1211	0
QGS Verification	2009-12-24	13250	1211	0
QBS Verification	2009-12-24	13250	632	0
QARG Verification	2009-12-21	13250	1161	0
CSImportVerification	2009-12-23	13291	111	2
MOCO Verification	2009-12-21	13250	23	0
InstallationVerification	2009-12-21	13291	82	0
Regression	2010-03-01	13397	912	0
Regression	2010-02-28	13395	912	0
Regression	2010-02-27	13395	912	0
Regression	2010-02-26	13395	912	0
Regression	2010-02-25	13394	912	0

Summary of Test Results

Regression tests are run nightly; only the last 5 regression tests are listed

Performance Testing

CSMC Cardiac Suite utilizes several algorithms requiring performance testing. With the exception of two new algorithms ("Quality Score" and "RV algorithm") all algorithms operate identically (i.e. produce the same results) as with previous

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versions of the software (referenced in predicate devices). In order to ensure the algorithms operate identically to predicate devices a set of 16 studies' algorithm results are compared to those of the predicate device. These test results are included in our regression tests.

Substantially Equivalent/Conclusion

CSMC CARDIAC SUITE is is substantially equivalent to AutoQUANT Plus, QPS, QGS, QBS, QARG applications (K060020), MoCo (K010509) previously cleared by FDA. The CSMC Cardiac Suite has similar indications for use and overall function and performs in a similar manner with respect to data display and analysis as the predicate devices AutoQUANT Plus. This updated version of QPS (Quantitative Perfusion SPECT) and QGS (Quantitative Gated SPECT) includes an automatic registration algorithm between SPECT/PET and CT/CTA datasets, an improved contouring algorithm based on a quality score and RV (right ventricle) extraction and analysis. Therefore, this premarket notification has demonstrated substantial equivalence as defined and understood in the Federal Food. Drug. & Cosmetic Act and its amendments.

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with a single staff entwined by two snakes.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Geoff Pollard, Project Manager Cedars-Sinai Medical Center Department of Medicine, Artificial Intelligence in Medicine Program 8700 Beverly Blvd. LOS ANGELES CA 90048

Re: K100714

APR - 1 2011

Trade/Device Name: Cedars-Sinai Cardiac Suite Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed tomography system Regulatory Class: II Product Code: KPS Dated: October 29, 2010 Received: October 29, 2010

Dear Mr. Pollard:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820). 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 renarketed 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary S Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K100714

Device Name: Cedars-Sinai Cardiac Suite

Indications for Use:

The Cedars-Sinai Cardiac Suite of applications is intended to enable an automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasets. Cedars-Sinai Cardiac Suite may be used in multiple settings including the hospital, clinic, doctors office, or remotely. The results provided should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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(Division Sign-Off) Division of Radiological Devices Division of Radiological Davice Evaluation and Safe

510K.

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.