The HeartVista Workstation with the RTHawk application software is an accessory to 1.5T and 3.0T whole-body magnetic resonance diagnostic devices (MRDD or MR). The HeartVista Workstation with the RTHawk application software is intended to operate alongside, and in parallel with, the existing MR console to acquire real-ime and accelerated images. The Heart Vista Workstation with the RTHawk application software is indicated for Cardiovascular MR (CMR) applications.

The HeartVista Workstation with the RTHawk application software produces static and dynamic transverse, coronal, sagittal, and oblique cross-sectional images that display the internal structures and/or functions of the entire body. The images produced reflect the spatial distribution of nuclei exhibiting magnetic resonance. The magnetic resonance properties that determine image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that may assist in the determination of a diagnosis.

The HeartVista Workstation with the RTHawk application software is intended for use as an accessory to the following OEM, MRI system, and software release versions:

· GE Healthcare (GEHC) Signa HDxt 1.5T, 3.0T. Software versions 15 and 16.

Device Description

The HeartVista Workstation with the RTHawk application software is an accessory to 1.5T and 3.0T whole-body magnetic resonance systems. The HeartVista Workstation with the RTHawk application software is intended to operate alongside, and in parallel with, the existing MR console to acquire real-time and accelerated images. No hardware modifications are required to be made to the MR system or console to support full functionality of the HeartVista Workstation with the RTHawk application software.

The HearlVista Workstation with the RTHawk application software temporarily controls the existing MR system to acquire MRI raw data and related information accordina to pulse sequence programs within the Workstation, Image reconstruction, post-processing, and image display are performed on the Workstation, independent of the MR system or console. No existing GE scanner functionality is removed or modified, and GE scans may be interleaved with HeartVista scans during the same patient exam.

The HeartVista Workstation with the RTHawk application software and dedicated hardware product intended to provide a platform for efficient real-lime MRI data acquisition, data transfer, image reconstructive scan control, and display of static and dynamic MR imaaing data.

The HeartVista Workstation consists of a stand-alone linux-based computer workstation, color monitor, keyboard and mouse. A private ethernet network connects the HeartVisia Workslation to the MR scanner computer. When not in use, the HeartVista Workslation may be detached from the MR scanner with no detrimental, residual impact upon MR scanner function, operation, or throughput.

RTHawk is a linux operating system-level software application that is intended to control the MR scanner, acquiring high quality, real-time MRI image data and performing post-processing. The RTHawk software includes optimized image acquisition applications, a pipelined raw data image reconstruction engine, a rich graphical user interface for interactive scan control, real-time adjustment of pulse sequence parameters, and display of reconstructed images, and drivers and protocols for communications with, and control of, the OEM MR scanner console,

RTHawk applications ("Apps") support real-time interactive imaging, high-resolution imaging, and system tuning and shimming calibration modules. RTHawk apps are currently optimized for cardiovascular MR (CMR) imaging and measurements.

AI/ML Overview

The provided document describes the HeartVista Workstation with RTHawk application software and its 510(k) submission (K133848) for FDA clearance. The performance data section focuses on non-clinical and a brief mention of clinical tests for the device itself, rather than a study proving the device meets a specific set of acceptance criteria for a diagnostic task.

The document highlights the device's technical performance and safety, comparing it to a predicate device (GE Signa Excite 1.5T and 3.0T MR Systems, K041476) to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" for a specific diagnostic task or a detailed "reported device performance" against those criteria in the way one might expect for an AI-powered diagnostic device. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate MR system and compliance with recognized standards.

Acceptance Criteria Category (Implied)	Reported Device Performance (RTHawk)	Predicate Device Performance (GE Signa Excite)
Magnetic Field Strength	1.5T, 3.0T	1.5T, 3.0T
Operating Modes (IEC 60601-2-33)	1st Level Operating Mode	1st Level Operating Mode
Safety Parameter Display	SAR, dB/dt	SAR, dB/dt
Maximum SAR	< 4W/kg whole-body	< 4W/kg whole-body
Maximum dB/dt	1st Level Operating Mode	1st Level Operating Mode
Image Acquisition	Acquires real-time and accelerated images, high quality data.	Acquires images.
Image Reconstruction	Efficient processing of raw data to generate MR images via a flexible, pipelined topology.	Contains similar functional module.
Post-processing/Analysis	Contains image post-processing tools. Optimized for cardiovascular MR (CMR).	Offers similar imaging capabilities and post-processing, including for CMR. Produces spectroscopic images and/or spectra (RTHawk does not).
User Interface/Control	Rich graphical user interface for interactive scan control, real-time adjustment of pulse sequence parameters, display of reconstructed images.	Contains similar functional module.
Safety & Performance Tests	Passed internal design controls, verification, validation, safety (SAR, dB/dt, acoustic noise), and performance (SNR, uniformity) testing.	Compliant with relevant safety and performance standards (implied, as it's the predicate).
Clinical Equivalence	Clinical images were compared to images from the predicate device during the same patient session, evaluated for diagnostic accuracy and image quality.	Serves as the benchmark for comparison.
Compliance with Standards	Complies with ANSI/AAMI ES60601-1, IEC 60601-2-33, MS1-2008, MS3-2008, MS4-2010, MS8-2008, NEMA PS3.1 - 3.20 (2011).	Compliant with relevant standards.

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

The document states, "Clinical images were acquired using RTHawk, and were compared to images acquired on the same patient during the same imaging session using, where possible, equivalent pulse sequences and post-processing as necessary from the predicate device."

Sample Size: Not specified. It only mentions "Clinical images" and "same patient," implying a paired comparison setup.
Data Provenance: Not explicitly stated, but the submission is from HeartVista, Inc. in Menlo Park, CA, USA, so it's likely the clinical data originated from the US or was part of a study conducted with US institutions. The study appears to be prospective in the sense that images were acquired specifically for this comparison using both devices.

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

Number of Experts: Not specified.
Qualifications of Experts: It states, "Images from both devices were evaluated and rated on the basis of diagnostic accuracy and image quality. Where no directly comparable images were available from the predicate device, RTHawk images were evaluated directly based upon radiologist expertise." This indicates that radiologists were involved, but their number and specific experience (e.g., years, subspecialty) are not detailed.

4. Adjudication Method for the Test Set

The document does not provide details on an adjudication method (e.g., 2+1, 3+1). It only states that images "were evaluated and rated" and that RTHawk images were evaluated based on "radiologist expertise" when direct comparison wasn't possible. This suggests individual or potentially consensus-based review, but no formal adjudication process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a proper MRMC comparative effectiveness study was not explicitly described. The document mentions a comparison of "Clinical images" by "radiologist expertise" for diagnostic accuracy and image quality, but it does not detail a structured MRMC study setup with a focus on reader improvement with or without AI assistance. The study seems more focused on demonstrating technical image quality and diagnostic comparability rather than quantifying the impact of RTHawk on human reader performance.
Effect Size of Human Reader Improvement with AI vs. Without AI Assistance: Not applicable, as an MRMC study comparing human reader performance with and without RTHawk assistance was not described.

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

The RTHawk software itself is an accessory that controls the MR scanner and processes images. The "clinical tests" described focused on the quality and diagnostic utility of the images produced by RTHawk when interpreted by radiologists. The product is an imaging system accessory, not an AI diagnostic algorithm meant to perform a diagnosis independently. Therefore, the concept of "standalone performance" for a diagnostic algorithm isn't directly applicable in the same way. The performance evaluated was of the image acquisition and processing system.

7. The Type of Ground Truth Used

The ground truth for the clinical comparison was effectively based on radiologist expertise interpreting the images. In cases where paired comparisons were made, the "ground truth" implicitly referred to the diagnostic information obtainable from the images from both the RTHawk and the predicate device, evaluated by radiologists. Where direct comparison wasn't available, RTHawk images were evaluated directly by radiologist expertise. There is no mention of pathology or long-term outcomes data being used as ground truth for this comparison.

8. The Sample Size for the Training Set

The document is for the RTHawk application software, which is described as an accessory to MR systems that performs real-time data acquisition, reconstruction, and display. It does not explicitly mention a "training set" in the context of machine learning, suggesting that RTHawk itself is not primarily an AI diagnostic algorithm "trained" on a dataset in the way modern AI devices are. Instead, the "training" (development) of the RTHawk applications ("Apps") involved optimization, presumably through engineering and testing, potentially using internal data or phantoms to refine pulse sequences and reconstruction.

If any machine learning models were implicitly part of its reconstruction or post-processing, details about their training sets are not provided.

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

As noted above, a distinct "training set" with established ground truth for a machine learning model is not described. The RTHawk "Apps" are optimized for cardiovascular MR (CMR) imaging and measurements. This optimization process would typically involve engineering and signal processing expertise, likely leveraging known physics of MRI and potentially clinical experience in cardiovascular imaging, rather than a formal "ground truth" derived from a specific labelled dataset for training an AI model.

Summary

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Image /page/0/Picture/1 description: The image shows the word "HEARTVISTA" in a stylized, bold, black font. The letters are blocky and have a futuristic or technological appearance. The word is presented in all capital letters and is the central focus of the image.

510(k) Summary

RTHawk

510(k) Number: K133848

Submitted in accordance with the requirements of SMDA 1990 and 21CFR807.92.

1.0 Medical Establishment Registration

Medical Establishment Registration No .: pending

2.0 Contact Information

James Jochen Rogers FDA Regulatory Affairs, Quality Assurance, and Clinical Studies T: 724 713.2298 E: jr@heartvista.com

Establishment Name and Address 3.0

HeartVista, Inc. 998 Hamilton Ave Menlo Park, CA 94025

4.0 Submission Date

December 16, 2013, revised June 19, 2014

5.0 Device Information

Trade/Proprietary Name: RTHawk, or HeartVista Workstation with RTHawk Common Name: RTHawk

Model Number(s):

0 9001 HeartVista Workstation with RTHawk
0 9002 RTHawk

Regulation Number: 892.1000 Regulation Name: Magnetic resonance diagnostic device (MRDD) Regulatory Class: Class II Device Classification Name: System, Nuclear Magnetic Resonance Imaging Classification Panel: Radiology Classification Product Code(s): LNH

Predicate Device(s) 6.0

510(k) #	Device	510(k) Sponsor	510(k) ClearanceDate
K041476	GE Signa Excite 1.5T and 3.0T MR Systems	GE Healthcare	6/17/2004

Device Description 7.0

HeartVista, Inc. · 598 Hamiton Avenue, Mento Park CA 94025 · 1650; 336-6543 · www.heartvista.com

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MR system or console to support full functionality of the HeartVista Workstation with the RTHawk application software.

Reference #	Title
ANSI/AAMI ES60601-1:2005/(R)2012+C1+A2	Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance (IEC 60601-1:2005, MOD)Section 14 Programmable Electrical Medical Systems (PEMS)
IEC 60601-2-33 Ed 3.0 (2010-03)	Medical electrical equipment - Part 2-33: Particular requirementsfor the basic safety and essential performance of magneticresonance equipment for medical diagnostic (radiology).
MS1-2008	Determination of Signal-to-Noise Ratio (SNR) in DiagnosticMagnetic Resonance Imaging
MS3-2008	Determination of Image Uniformity in Diagnostic MagneticResonance Images
MS4-2010	Acoustic Noise Measurement Procedure for Diagnostic MagneticResonance Imaging Devices
MS8-2008	Characterization of the Specific Absorption Rate (SAR) forMagnetic Resonance Imaging Systems
NEMA PS3.1 - 3.20 (2011)	Digital Imaging And Communications In Medicine (DICOM) Set.

RTHawk has been designed to comply with the FDA Recognized Consensus Standards listed in the table below, as applicable to device features and components:

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8.0 Indications for Use

The HeartVista Workstation with the RTHawk application software is an accessory to 1.5T and 3.01 whole-body magnetic resonance diagnostic devices (MRDD or MR). The HeartVista Workstation with the RTHawk application software is intended to operate alongside, and in parallel with, the existing MR console to acquire real-lime and accelerated images. The HeartVista Workstation with the RTHawk application software is indicated for Cardiovascular MR (CMR) applications.

The HeartVista Workstation with the RTHawk application software is intended for use as an accessory to the following OEM, MRI system, and software release versions:

O GE Healthcare (GEHC) Signa HDxt 1.5T, 3.0T. Software versions 15 and 16.

Technological Characteristics Comparison to Predicate Device 9.0

The RTHawk software is comprised of the following functional modules, and the predicate device's Operating System contains the same or similar functional modules:

C Acquisition - responsible for the transfer of MR raw data from the MR scanner to the HeartVista Workstation
O . Analysis contains the image post-processing tools
Application HeartVista APPs. Each APP is comprised of a pulse sequence, user parameters, a o reconstruction pipeline, and a specific user interface
O Information System - the central repository of all relevant MRI system configuration, patient, study, scan, etc., parameters associated with the current patient study
Reconstruction responsible for the efficient processing of raw data to generate MR images 0 via a flexible, pipelined topology
Scan Control responsible for the real-time network transfer of controlling orders for APPs, APPs 0 parameters modifications, and dynamic information from the MR host in response to user or program requests
Sequencer creates and provides a specific set of pulse sequence waveforms to control the o MR scanner
Storage obtains current patient and scan information, performs non-volatile local storage, O exports images and data in DICOM format, and logs events.
Visualization implements all aspects of the user iterface, including APP selection, controls to O modify APP parameters, image display, graphical slice prescription, and image review, save, and export.

There are subtle differences between the RTHawk's and the predicate device's intended use; the predicate device produces spectroscopic images and/or spectra, while RTHawk does not.

Both RTHawk and the predicate device offer pulse sequences with high resolution, high signal-tonoise ratio, and short scan times. HeartVista APPs are currently optimized for cardiovascular MR (CMR) applications, and the predicate device's pulse sequences and post-processing offer the same or similar imaging capabilities, including the same indications for use.

Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner.

www

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10.0 Performance Data - Discussion of Non-Clinical Tests

Design controls quality assurance measures during the development of RTHawk include:

O Code reviews
Design reviews o
Unit and integration level testing O
Verification testing, including System and Manual testing O
Safety testing, including SAR, dB/dt, and acoustic noise 0
Performance testing, including SNR and uniformity O
O Validation testing

Risk management, compliant with ISO 1497 ::2007, identified hazards, sequences of events, and resultant harms; developed, implemented, and tested isk-controlling miligations; and evaluated residual risks.

	RTHawk	Predicate Device
Magnet field strength	1.5T, 3.0T	1.5T, 3.0T
Operating ModesIEC 60601-2-33 (2010-03)	1st Level Operating Mode	1st Level Operating Mode
Safety Parameter Display	SAR, dB/dt	SAR, dB/dt
Max SAR	<4W/kg whole-body	<4W/kg whole-body
Max dB/dt	1st Level Operating Mode	1st Level Operating Mode

11.0 Safety Parameters

12.0 Performance Data - Discussion of Clinical Tests

Clinical images were acquired using RTHowk, and were compared to images acquired on the same patient during the same imaging session using, where possible, equivalent pulse sequences and postprocessing as necessary from the predicate device. Images from both devices were evaluated and rated on the basis of diagnostic accuracy and image quality. Where no directly comparable images were available from the predicate device, RTHawk images were evaluated directly based upon radiologist expertise.

13.0 Conclusions

Based upon safety and performance testing and compliance with voluntary standards, the Company believes that the HeartVista Workstation with RTHawk application software is substantially equivalent to the predicate device, and does not raise any new questions of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 25, 2014

HEARTVISTA, INC C/O JAMES ROGERS FDA REGULATORY AFFAIRS, QUALITY ASSURANCE 998 HAMILTON AVE MENLO PARK, CA 94025

Re: K133848

Trade/Device Name: RTHawk, or HeartVista Workstation with RTHawk Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: May 29, 2014 Received: June 5, 2014

Dear Mr. Rogers:

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 (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Rogers

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara

for

Janine Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K133848

Device Name

RTHawk, or HeartVista Workstation with RTHawk

Indications for Use (Describe)

The HeartVista Workstation with the RTHawk application software produces static and dynamic transverse, coronal, sagittal, and oblique cross-sectional images that display the internal structures and/or functions of the entire body. The images produced reflect the spatial distribution of nuclei exhibiting magnetic resonance. The magnetic resonance properties that determine image appearance are proton density, spin-lattice relaxation time (TI), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that may assist in the determination of a diagnosis.

The HeartVista Workstation with the RTHawk application software is intended for use as an accessory to the following OEM, MRI system, and software release versions:

· GE Healthcare (GEHC) Signa HDxt 1.5T, 3.0T. Software versions 15 and 16.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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

A charge and considered consisted and a provinces and a provinces and a province of
		FOR FDA USE ONLY

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

Michael D. O'Hara

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.