The HeartView system is an internet-based application intended for use by nuclear medicine or radiology practitioners and referring physicians for the automated processing, review, quantification, and multidimensional review of nuclear medicine cardiology medical images, and specifically, radionuclides distributed in the body using planar and tomographic short axis images.

HeartView may be used in various clinical settings including a hospital, clinic, imaging center, physician office, or remote locations.

The HeartView system implements algorithms for automatic quantification of myocardial perfusion single photon emission computerized tomography (SPECT) as well as quantification of ejection fraction, wall motion, and thickening from gated myocardial perfusion SPECT images.

Gated results are presented as 3D plots that can be used to depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes, including quantitative assessments of cardiac function (e.g., systolic and diastolic function, regional wall thickening, wall motion, transient ischemic dilation, and phase analysis).

Device Description

The HeartView platform is a comprehensive internet-based application designed to process, review, and automatically perform quantitative analysis of cardiac nuclear medicine procedures. HeartView implements algorithms for automatic quantification of myocardial perfusion SPECT, as well as quantification of ejection fraction, wall motion, and thickening from gated myocardial perfusion SPECT. The algorithm takes short axis slices reconstructed from raw datasets of gated and averaged acquisitions in rest and stress, and operates in multi-dimension (3D), rather than processing individual slices separately. For gated datasets, it processes the dataset as a whole rather than processing each frame separately, which adds additional knowledge to the algorithm for its computations, and allows enforcement of the constraint that the mid-myocardium volume is constant during the whole heart beat cycle.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the VidiStar HeartView, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with specific numerical thresholds for performance metrics. Instead, it describes a comparative performance study against a predicate device. The implied acceptance criterion is that the subject device (VidiStar HeartView) is "comparable to the predicate device in terms of qualitative and quantitative output."

Performance Aspect	Acceptance Criterion (Implied)	Reported Device Performance
Quantitative Output	Equivalent to predicate device (Xeleris 3.1) in software-calculated values	Found to be comparable to the predicate device (precision utilizing statistical software)
Qualitative Output	Equivalent to predicate device in subjective clinical reading	Found to be comparable to the predicate device (clinical review by a blinded independent cardiologist)

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

Test Set Sample Size: Not explicitly stated. The document mentions "anonymized patient imaging studies" were used.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). It only mentions "anonymized patient imaging studies."

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

Number of Experts: One.
Qualifications of Expert: "blinded independent cardiologist." No further detail on experience level (e.g., years of experience) is provided.

4. Adjudication Method for the Test Set

Adjudication Method: "clinical review by a blinded independent cardiologist." This suggests a single reader assessment rather than an adjudication process involving multiple experts for consensus.

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

MRMC Study: No, an MRMC comparative effectiveness study was not explicitly described. The study involved a single "blinded independent cardiologist" for qualitative comparison and statistical comparison of software-calculated values.
Effect Size of Human Readers with vs. without AI: Not applicable, as an MRMC study and AI-assisted performance evaluation of human readers were not conducted or reported.

6. Standalone (Algorithm Only) Performance Study

Standalone Performance: Yes, a standalone performance assessment was done for quantitative output. The device's algorithms for "automatic quantification of myocardial perfusion SPECT, as well as quantification of ejection fraction, wall motion, and thickening" were compared against the predicate device's software-calculated values using statistical software.

7. Type of Ground Truth Used

Quantitative Ground Truth: The "ground truth" for quantitative output was established by the software-calculated values of the predicate device (Xeleris 3.1 Processing and Review Workstation). This implies that the predicate device's outputs were considered the reference for comparison.
Qualitative Ground Truth: For qualitative assessments, the "ground truth" was established by the "subjective clinical reading" of a "blinded independent cardiologist," compared against the predicate device. This suggests the cardiologist's assessment of either the raw images or the predicate device's output served as the reference for evaluating the subject device's qualitative output.

8. Sample Size for the Training Set

Training Set Sample Size: Not mentioned. The document primarily focuses on the validation/comparison study.

9. How Ground Truth for the Training Set Was Established

Training Set Ground Truth: Not mentioned. Since the training set size is not provided, neither is details on how its ground truth was established.

Summary

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Image /page/0/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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure in profile, composed of three overlapping shapes.

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

November 25, 2015

Vidistar, LLC % Ms. Kathryn Becker Principal Translational Science Solutions, LLC 92 Hasell Street #401 CHARLESTON SC 29401

Re: K152822

Trade/Device Name: Vidistar HeartView Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: LLZ Dated: September 29, 2015 Received: September 30, 2015

Dear Ms. Becker:

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 (reporting of medical device-related adverse events) (21 CFR 803); 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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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 at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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 yours,

Robert Ocks

Robert 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) K152822

Device Name

VidiStar HeartView

Indications for Use (Describe)

The HeartView system is an internet-based application intended for use by nuclear medicine or ractitioners and referring physicians for the automated processing, review, quantification, and multidimensional review of nuclear medicine cardiology medical images, and specifically, radionuclides distributed in the body using planar and tomographic short axis images.

HeartView may be used in various clinical settings including a hospital, clinic, imaging center, physician office, or remote locations.

The HeartView system implements algorithms for automatic quantification of myocardial perfusion single photon emission computerized tomography (SPECT) as well as quantification, wall motion, and thickening from gated myocardial perfusion SPECT images.

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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510(K) SUMMARY

Submission Date:	September 24, 2015
Submitter Information:
Submitted By:	VidiStar, LLCPO Box 8539Greenville, SC 29604
Contact Person:	Craig Walker, MHAChief Executive OfficerVidiStar, LLCTel: (512) 797-1910Fax: (864) 349-2169
Email:	craig.walker@VidiStar.com
Device Information:

Trade Name:	HeartView
Common Name:	Nuclear Medicine Workstation
Classification Name:	System, Image Processing, Radiological21 CFR 892.2050
Regulatory Class:	Class II
Product Code:	LLZ
Predicate Device:	Xeleris 3.1 Processing and Review Workstation (K130884)GE HealthcareClass II (21 CFR 892.2050; Product Code LLZ)
Device Description:	The HeartView platform is a comprehensive internet-basedapplication designed to process, review, and automaticallyperform quantitative analysis of cardiac nuclear medicineprocedures. HeartView implements algorithms forautomatic quantification of myocardial perfusion SPECT,as well as quantification of ejection fraction, wall motion,and thickening from gated myocardial perfusion SPECT.The algorithm takes short axis slices reconstructed fromraw datasets of gated and averaged acquisitions in rest andstress, and operates in multi-dimension (3D), rather thanprocessing individual slices separately. For gated datasets,

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	it processes the dataset as a whole rather than processing each frame separately, which adds additional knowledge to the algorithm for its computations, and allows enforcement of the constraint that the mid-myocardium volume is constant during the whole heart beat cycle.
Intended Use:	The HeartView software application is intended to provide an automated processing, review, quantification, and multidimensional review of nuclear medicine cardiology medical images, and specifically, radionuclides distributed in the body using planar and tomographic short axis images. HeartView may be used in various clinical settings including a hospital, clinic, imaging center, physician office, or remote locations. HeartView implements algorithms for automatic quantification of myocardial perfusion single photon emission computerized tomography (SPECT) as well as quantification of ejection fraction, wall motion, and thickening from gated myocardial perfusion SPECT images.
Indications for Use:	The HeartView system is an internet-based application intended for use by nuclear medicine or radiology practitioners and referring physicians for the automated processing, review, quantification, and multidimensional review of nuclear medicine cardiology medical images, and specifically, radionuclides distributed in the body using planar and tomographic short axis images.
	HeartView may be used in various clinical settings including a hospital, clinic, imaging center, physician office, or remote locations.
	The HeartView system implements algorithms for automatic quantification of myocardial perfusion single photon emission computerized tomography (SPECT) as well as quantification of ejection fraction, wall motion, and thickening from gated myocardial perfusion SPECT images.
	Gated results are presented as 3D plots that can be used to depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes, including quantitative assessments of cardiac function (e.g., systolic

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and diastolic function, regional wall thickening, wall motion, transient ischemic dilation, and phase analysis). Comparison to The device and the predicate device are both image Predicate Device post processing workstations devices that provide Technology: similar features of visualization and quantitative analysis and do not raise any new questions of safety or effectiveness. Performance Data: The following performance data were provided in support of the substantial equivalence determination: Software Verification and Software verification and validation testing were Validation Testing: conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, as a malfunction of, or a latent design flaw in, the software device could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to minor injury. Comparative performance testing was conducted to Comparative Testing: demonstrate that the subject device is equivalent to the predicate device for the review of nuclear studies in terms of quantitative (software-calculated values) and qualitative (subjective clinical reading) output. To support this performance claim, anonymized patient imaging studies were compared quantitatively (precision utilizing statistical software) and qualitatively (clinical review by a blinded independent cardiologist) . The subject device was found to be comparable to the predicate device in terms of qualitative and quantitative output. Additional Information: Performance Standards: The subject device is in compliance with the following voluntary performance and safety standards: . NEMA PS 3.1 - 3.20 (2011) Digital Imaging and Communications in Medicine (DICOM) Set ISO/IEC 10918-1 First edition 1994-02-15 Information . technology- Digital compression and coding of continuous-tone still images: Requirements and

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	guidelines [including: Technical Corrigendum 1 (2005)]
Other Standards:	The present 510(k) was prepared in consideration of the following guidance documents:
	Guidance for the Submission of Premarket Notifications for Medical Image Management Devices (2000) Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005) Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (2014)
Conclusion:	Based on conformance to FDA recognized voluntary consensus standards, development under applicable FDA guidance, and the extensive product testing described within this 510(k) premarket notification, VidiStar provides evidence that its HeartView system is as safe and effective, and performs in a substantially equivalent manner to GE Healthcare's Xeleris 3.1 Processing and Review Workstation.

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Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).