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.

Device Description

The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PET imaging processing and review. The Indication/Intended Use and the fundamental scientific technology of the modified device has not been changed and the same as those described in the unmodified predicate device. CSMC Cardiac Suite will be marketed as a comprehensive application suite that includes QPS+QGS (Quantitative Perfusion SPECT + Ouantitative Gated 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), ARG/QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA), Motion Correction (MOCO), Automated Reconstruction (AutoRECON), CSView (Cedars-Sinai Viewer) and QPET. QPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets them. Instead, it describes a 510(k) premarket notification for the "CSMC Cardiac Suite 2017" software, which asserts substantial equivalence to a previously cleared device (CSMC Cardiac Suite v2015- Nuclear Medicine Software, K141652).

While "software validation, which confirms all features of the device were compliant with the software requirements" is mentioned, it is a general statement and does not provide specifics that would allow for a comprehensive answer to your questions regarding acceptance criteria, study design, or performance metrics.

Therefore, many of your requested items cannot be extracted from the given text.

Here's an attempt to answer what can be inferred or directly stated from the provided document, with many sections marked as "Not provided in the text."

Acceptance Criteria and Device Performance

The document does not explicitly state specific quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or agreement metrics) or report detailed device performance against such criteria. The "Performance Data" section merely states: "Support of the substantial equivalence of the CSMC Cardiac Suite was provided as a result of software validation, which confirms all features of the device were compliant with the software requirements."

Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance (Not Explicitly Stated)
Not provided in the text.	The device underwent "software validation, which confirms all features of the device were compliant with the software requirements." No specific performance metrics (e.g., accuracy, precision, recall) are reported.

Study Details

Sample size used for the test set and the data provenance: Not provided in the text.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the text.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided in the text.
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: Not provided in the text. The document refers to the device as a "stand-alone software solution" and states "The results provided should be reviewed by qualified healthcare professionals." It does not describe a study involving human readers or their improvement with AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states, "The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PET imaging processing and review." However, it does not explicitly describe a standalone performance study with specific metrics that would compare its outputs to a ground truth, independent of human review. The "software validation" mentioned is very general.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided in the text.
The sample size for the training set: Not provided in the text.
How the ground truth for the training set was established: Not provided in the text.

Summary of what is known:

The submission is for the "CSMC Cardiac Suite 2017," a software for automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasets.
It is a "stand-alone software solution."
The basis for substantial equivalence is primarily on its similarity in intended use, principle of operation, and technological characteristics to a previously cleared device (K141652).
"Software validation" was performed to confirm compliance with software requirements. This is a general statement about software quality assurance, not a specific clinical performance study.
The results from the device "should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians)." This indicates it's an aid, not a definitive diagnosis.

The document focuses on establishing substantial equivalence to a predicate device rather than detailing a specific clinical performance study with defined acceptance criteria and results.

Summary

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November 3, 2017

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Cedars-Sinai Medical Center % Geoff Pollard Sr. Project Manager 8700 Beverly Blvd LOS ANGELES CA 90048

Re: K172609

Trade/Device Name: CSMC Cardiac Suite 2017 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS Dated: August 8, 2017 Received: August 31, 2017

Dear Geoff 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael D. O'Hara For

Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172609

Device Name CSMC Cardiac Suite 2017

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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6. 510(k) Summary

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT:	Cedars-Sinai Medical Center, Department of Medicine,Artificial Intelligence in Medicine Program
DATE PREPARED:	27 October 2016
CONTACT PERSON:	Geoff Pollard, Program Manager8700 Beverly BlvdLos Angeles, CA 90048Phone: 310.423.4663
TRADE NAME:	Cedars-Sinai Cardiac Suite Nuclear Medicine Software
CLASSIFICATIONNAME:	Emission Computed Tomography System
DEVICECLASSIFICATION:	Class II
REGULATIONNUMBER	892.1200
PRODUCT CODE	KPS
PREDICATE DEVICES:	CSMC Cardiac Suite- Nuclear Medicine Software (K141652)

Substantially Equivalent To:

The CSMC Cardiac Suite v2017- Nuclear Medicine Software is substantially equivalent in intended use, principal of operation and technological characteristics to the previously cleared CSMC Cardiac Suite v2015- Nuclear Medicine Software (K141652).

Description of the Device Subject to Premarket Notification:

As with the original (K141652) Cedars-Sinai Cardiac Suite, the modified Cedars-Sinai Cardiac Suite (non-viewer) minimum system requirements include a computer with at least 2GB RAM, 200MB hard disk space for software installation, a display resolution of 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 (10, Vista, 7, 8 & 8,1), Windows Server (2008, 2012 & 2016) Mac OS X, Linux (SUSE 11) The viewer component of the Cedars-Sinai Cardiac Suite minimum system requirements is iPad (4th generation & air) and iPad Mini. The Cedars-Sinai Cardiac Suite operates on

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camera independent reconstructed SPECT and/or PET image files. CSMC Cardiac Suite will be marketed as a comprehensive application suite that includes QPS+QGS (Quantitative Perfusion SPECT + Ouantitative Gated 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), ARG/QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA), Motion Correction (MOCO), Automated Reconstruction (AutoRECON), CSView (Cedars-Sinai Viewer) and QPET. QPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies.

Indication 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, or general nuclear medicine physicians) trained in the use of medical imaging devices.

Technological Characteristics:

The modified CSMC Cardiac Suite- Nuclear Medicine Software has the same technological characteristics and is similar in data display and analysis compared to the predicates. The table below illustrates the similarities and differences in Technological Characteristics between the devices.

	Modified CSMC Cardiac Suite	CSMC Cardiac Suite (K141652)
Use
Patient population	Patients who are undergoingNuclear Medicine CardiologySPECT or PET procedure	SAME
User	Radiologists, cardiologists, orgeneral nuclear medicinephysicians	SAME
Use environment	Multiple settings including thehospital, clinic, doctors office, orremotely	SAME
Features
Quantitative Gated SPECT	Yes	SAME
Quantitative Perfusion SPECT	Yes	SAME
Quantitative Blood Pool SPECT	Yes	SAME
Quantitative PET	Yes	SAME
Correction of motion artifact	Yes	SAME
Reconstruction Package	Yes	SAME
iPad Viewer	Yes	SAME
Cedars-Sinai Viewer	Yes	N/A

Page 12 of 38 Premarket Notification

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Performance Data

Support of the substantial equivalence of the CSMC Cardiac Suite was provided as a result of software validation, which confirms all features of the device were compliant with the software requirements.

Basis for Determination of Substantial Equivalence:

Upon reviewing and comparing intended use, design, principle of operation and overall technological characteristics, the CSMC Cardiac Suite is determined by Cedars-Sinai Medical Center to be substantially equivalent to existing legally marketed device.

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.