The cardiac position emission tomography (PET) analysis tool, HeartSee is a software package intended for use by nuclear medicine and nuclear cardiology physicians and technologists to facilitate image interpretation. Archiving of output data will be supported for clinical diagnostics, quality control, and research.

HeartSee is intended for processing of DICOM images, visual analysis and quantification of relative myocardial tracer uptake, and quantification of absolute myocardial blood flow and CFR when applied to diagnostic cardiac PET images in patients with suspected or known coronary artery disease.

Device Description

The cardiac positron emission tomography (PET) analysis tool HeartSee is a software package intended for use by nuclear medicine and nuclear cardiology physicians and technologists to facilitate image interpretation. Archiving of output data will be supported for clinical diagnostics, quality control, and research.

HeartSee contains two fundamental components. First, the software can import cardiac PET images in DICOM format from any camera manufacturer. These images can be reoriented to cardiac axes to produce standard tomographic and topographic displays of relative uptake. A trained, licensed physician can interpret these processed images as per standard practice.

Second, the CFR software can quantify absolute myocardial blood flow per unit tissue (cc/min/gm) in stress and rest PET cardiac images and quantitatively assess the coronary flow reserve (CFR).

To compute coronary flow reserve (CFR) - the ratio of increased blood flow (stress) to baseline blood flow (rest) – three inputs are required: integrated arterial activity in the early part after bolus injection, average myocardial activity in the late part after bolus injection, and correction factors for partial volume effects of the PET scanner. The first number comes from a region of interest (ROI) drawn in the thoracic aorta or left atrium on images taken soon after radionuclide bolus administration. The second number comes from the topographic maps of myocardial uptake acquired later after radiotracer injection. The third number varies by PET camera and will be initialized in a user preference file.

HeartSee is a software package that uses standard, industrial computing hardware and applications.

AI/ML Overview

This device is HeartSee, a cardiac PET analysis software.

Please note that the provided document is a 510(k) summary, which often provides less granular detail on study designs compared to full study reports or publications. Therefore, some information may not be explicitly available and will be noted as such.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state formal acceptance criteria with numerical thresholds. Instead, it relies on demonstrating substantial equivalence to predicate devices (K090178 and K113754). This typically means the new device performs similarly well or not worse than the predicates.

However, the document mentions specific validation studies for its two main functionalities:

Acceptance Criteria (Inferred from Substantial Equivalence and Validation)	Reported Device Performance
Component 1: Reorient to Cardiac Axes & Tomographic/Topographic Displays	Demonstrated through visual analysis capabilities and the interpretation by a trained, licensed physician as per standard practice. (No specific quantitative metric for "acceptance" is provided, but implies visually acceptable reconstruction).
Component 2: Quantification of Absolute Myocardial Blood Flow (MBF) and Coronary Flow Reserve (CFR)	Correlation with Reference Standard: - For absolute MBF, the study comparing MBF from 82 patients processed by the new algorithm showed "excellent agreement (r=0.99, P<0.0001)" with MBF previously calculated by an independent algorithm (the predicate K113754). - For CFR, the study showed "excellent agreement with CFR calculated by the independent algorithm".

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

Test Set Sample Size: 82 patients.
Data Provenance: The document does not explicitly state the country of origin. It mentions data from patients with coronary artery disease and "cardiac PET images acquired at our institution." Given the contact information for K. Lance Gould, M.D. at the University of Texas Medical School at Houston, it is highly likely the data is from the USA.
Retrospective or Prospective: The wording "MBF from 82 patients processed by the new algorithm was compared to MBF previously calculated by an independent algorithm" suggests that the data was retrospective, as the "previously calculated" values imply existing data.

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

The ground truth for the quantitative component (MBF and CFR) was established by an "independent algorithm" (presumably cfrQuant, predicate K113754), not directly by human experts in the sense of adjudication. Therefore, the concept of "number of experts" for establishing this specific ground truth isn't applicable in the traditional sense here.

For the visual interpretation component, the document states: "A trained, licensed physician can interpret these processed images as per standard practice." This implies standard clinical practice where a single (or multiple, depending on practice) trained, licensed physician would interpret the images. However, no specific number of experts or their qualifications for a formal ground truth establishment for this visual component are detailed in the 510(k) summary.

4. Adjudication Method for the Test Set

For the quantitative component (MBF and CFR), the adjudication method was a comparison against a "previously calculated" value from an "independent algorithm" (predicate K113754). This is a direct algorithmic comparison, not a human adjudication method like 2+1 or 3+1.

For the visual interpretation component, no specific adjudication method is described within the context of a validation study for the 510(k) submission.

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, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not described in this 510(k) summary. The validation focused on the standalone performance of the algorithm and its correlation with a predicate algorithm.

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

Yes, a standalone performance study was done for the quantitative components (MBF and CFR). The study directly compared the HeartSee algorithm's output for MBF and CFR to the output of an "independent algorithm" (the predicate device, cfrQuant). The correlations (r=0.99) demonstrate the standalone performance of the HeartSee algorithm.

7. The Type of Ground Truth Used

For MBF and CFR Quantification: The ground truth was "previously calculated" values from an "independent algorithm" (the predicate device, cfrQuant). This can be classified as a form of algorithmic reference standard or established method comparison.
For Visual Interpretation/Image Reorientation: The implied ground truth relies on standard clinical practice and expert interpretation, but a formal ground truth definition for a validation study is not detailed.

8. The Sample Size for the Training Set

The 510(k) summary does not provide information on the sample size used for the training set for the HeartSee device. This type of detail is often not included in 510(k) summaries.

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

The 510(k) summary does not provide information on how the ground truth for the training set was established, as it does not describe the training process or dataset.

Summary

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

April 14, 2015

University of Texas Medical School at Houston % K. Lance Gould, M.D. Professor of Cardiovascular Medicine 6431 Fannin Street, Suite MSB 4.256 HOUSTON TX 77030

Re: K143664

Trade/Device Name: HeartSee Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: December 22, 2014 Received: January 15, 2015

Dear Dr. Gould:

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.

Michael O'Hara

for

Robert Ochs, Ph.D. Acting 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)

K143664

Device Name

HeartSee

Indications for Use (Describe)

HeartSee contain two fundaments. First, the software can import cardiac PET images in DICOM format from any PET camera from any camera manufacturer. These images can be reoriented to cardiac axes to produce standard tomographic and topographic displays of relative uptake. A trained, licensed physician can interpret these processed images as per standard practice.

Second, the CFR software can quantify absolute myocardial blood flow per unit tissue (cc/min/gm) in stress and rest PET cardiac images and quantitatively assess the coronary flow reserve (CFR).

Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D)

D Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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5. 510(k) Summary

Owner/Contact:

K. Lance Gould, M.D. Professor of Cardiovascular Medicine University of Texas Medical School at Houston 6431 Fannin St., Room MSB 4.256 Houston, TX 77030 Phone 713-500-6611 Fax 713-500-6615 Email K.Lance.Gould@uth.tmc.edu

Date of preparation: December 22, 2014

Device trade name: HeartSee

Common name: Cardiac Positron Emission Tomography (PET) Analysis Software

Classification names: emission computed tomography system (21 CFR 892.1200, Product Code KPS)

Devices claimed for equivalence:

K090178, NeuSoft Positron Attrius scanner (CARDIAC software . component)
K113754, cfrQuant

General description: The cardiac positron emission tomography (PET) analysis tool HeartSee is a software package intended for use by nuclear medicine and nuclear cardiology physicians and technologists to facilitate image interpretation. Archiving of output data will be supported for clinical diagnostics, quality control, and research.

Second, the CFR software can quantify absolute myocardial blood flow per unit tissue (cc/min/gm) in stress and rest PET cardiac images and quantitatively assess the coronary flow reserve (CFR).

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in the late part after bolus injection, and correction factors for partial volume effects of the PET scanner. The first number comes from a region of interest (ROI) drawn in the thoracic aorta or left atrium on images taken soon after radionuclide bolus administration. The second number comes from the topographic maps of myocardial uptake acquired later after radiotracer injection. The third number varies by PET camera and will be initialized in a user preference file.

Intended use: HeartSee is intended for processing of DICOM images, visual analysis and quantification of relative myocardial tracer uptake, and quantification of absolute myocardial blood flow and CFR when applied to diagnostic cardiac PET images in patients with suspected or known coronary artery disease.

Technological characteristics: HeartSee is a software package that uses standard, industrial computing hardware and applications.

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.