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RTHawk is an accessory to 1.5T and 3.0T whole-body magnetic devices (MRDD or MR). It is intended to operate alongside, and in parallel with, the existing MR console to acquire traditional, real-time and accelerated images. The Heart Vista Cardiac Package is a collection of RTHawk Apps designed to acquire, reconstruct and display cardiovascular MR (CMR) images.

RTHawk 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.

RTHawk is intended for use as an accessory to the following MRI systems:

Manufacturers: GE Healthcare (GEHC), Siemens Healthineers Field Strength: 1.5T and 3.0T GE Software Versions: 12, 15, 16, 23, 24, 25, 26 Siemens Software Versions: N4/VE; NX/VA

RTHawk is a software system designed from the ground up to provide a platform for efficient real-time MRI data acquisition, data transfer, image reconstruction, and interactive scan control and display of static and dynamic MR imaging data.

RTHawk is an accessory to clinical 1.5T and 3.0T MR systems, operating alongside, and in parallel with, the MR scanner console with no permanent physical modifications to the MRI system required.

RTHawk is designed to run on a stand-alone linux-based computer workstation, color monitor, keyboard and mouse. It is designed to operate alongside, and in parallel with, the existing MR console with no hardware modifications required to the MR system or console. This RTHawk Workstation is sourced by the Customer in conformance with HeartVista-provided specifications, and verified prior to installation.

A private ethernet network connects the RTHawk workstation to the MR scanner computer. When not in use, the RTHawk workstation may be detached from the MR scanner with no detrimental, residual impact upon MR scanner function, operation, or throughput.

The RTHawk application is written to run on top of the Linux operating system, much like application software for word processing, accounting, graphics, etc. Additional software is installed on the MR scanner computer, for receiving communications and control commands from RTHawk, and for directing MRI raw data to RTHawk for image reconstruction, display and processing.

RTHawk is an easy-to-use, yet fully functional, MR Operating System environment. The RTHawk operating system has been designed to provide a platform for the real-time acquisition, control, reconstruction, display, and storage of high-quality static and dynamic MRI images and data.

Data is continuously acquired and displayed. By user interaction or data feedback, fundamental scan parameters can be modified. Real-time and high-resolution image acquisition methods are used throughout RTHawk for scan plane localization, for tracking of patient motion, for detection of transient events, for on-the-fly, sub-second latency adjustment of image acquisition parameters (e.g., scan plane, flip angle, field-of-view, etc.) and for image visualization.

Conventional MR scanners queue an entire scan ahead of time and provide for little or no modification to a scan already in progress. Conversely, the RTHawk software prepares scan waveforms just as they are needed. RTHawk's efficient management of pulse sequence waveforms and instructions for modifying those pulse sequence waveforms uses the entire scanning interval for preparation of the next sequence. Scan parameters may be manipulated in real time, while providing all checks necessary to assure patient safety. Additional features are provided to automate and facilitate the set of tasks performed during a typical cardiac exam.

RTHawk makes extensive use of spiral image acquisition techniques to maximize scan efficiency. While conventional scans acquire data line-by-line in a Cartesian grid, RTHawk collects data more efficiently in a spiral pattern. Spiral-pattern raw data must be reformatted for correct reconstruction and display, requiring additional computing resources and image correction procedures to reduce image artifacts and distortions, ensuring high-quality reconstructed images.

RTHawk implements the conventional MRI concept of anatomy- and indication-specific Protocols (e.g., ischemia evaluation, valvular evaluation, tissue characterization, etc.). Protocols are pre-set by HeartVista, but new protocols can be created and modified by the end user.

RTHawk Apps (Applications) are composed of a pulse sequence, predefined fixed and adjustable parameters, reconstruction pipeline(s), and a tailored graphical user interface containing image visualization and scan control tools. RTHawk Apps may provide real-time interactive scanning, conventional (traditional) batch-mode scanning, accelerated scanning, or calibration functions, in which data acquired may be used to tune or optimize other Apps.

The HeartVista Cardiac Package is a collection of RTHawk APPs that enables the performance of a comprehensive cardiovascular MR (CMR) study in a clinically feasible amount of time. These APPs are designed and optimized to acquire, reconstruct, and display CMR images, with features including:

• . On-the-fly, sub-second latency adjustment of image acquisition parameters (e.g., scan plane, flip angle, field-of-view, etc.)
• . Real-time imaging, enabling less reliance on ECG gating and artifact suppression techniques. Real-time imaging may be used for scan plane localization, instantaneous tracking of patient motion, and clinical user observation of transient events
• . Scan automation tools including automatic push-button localization of standard cardiac views, automatic determination of inversion time, automatic detection of artifacts, and automated myocardial segmentation
• . High spatial resolution imaging, including single breath-hold, multi-slice high-resolution GRE app offering near total heart coverage
• Free-breathing, multi-slice SSFP and GRE apps that rapidly acquire high-quality images - potentially useful for patients who suffer from arrhythmia or who cannot hold their breath
• . Multi-slice dynamic SR GRE app with one heartbeat temporal resolution for time-course imaging.
• Continuous flow quantification

The conventional MRI concept of anatomy- and indication-specific Protocols is implemented within the HeartVista Cardiac Package. APPs within the HeartVista Cardiac Package are organized into basic Protocols pre-set by HeartVista. The clinical user may modify APP parameters from default values within their ranges. These modified APPs may be saved into new or existing user-created Protocols to create unique CMR-indicated protocols tailored to the user's clinical interests.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a specific table detailing acceptance criteria for performance metrics (such as accuracy, sensitivity, specificity, etc.) for the HeartVista Cardiac Package. However, it implicitly states that the device meets safety and performance standards by complying with recognized consensus standards and successfully completing verification and validation testing.

The document focuses on demonstrating substantial equivalence to a predicate device (K183274) through a comparison of technological characteristics and a discussion of non-clinical tests.

Implied Acceptance Criteria and Reported Device Performance:

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

The provided document refers to "Verification testing, including System and Manual testing" and "Validation testing" as part of the non-clinical tests. However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for any test set. The evaluation focuses on technical performance and comparison to a predicate device, not on diagnostic accuracy against a clinical ground truth established by experts.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method like 2+1 or 3+1, as it does not involve an assessment of diagnostic performance dependent on expert interpretation consensus.

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

An MRMC comparative effectiveness study was not performed or reported in the provided document. The submission focuses on the technical capabilities and safety of the device as an accessory to MRI systems, rather than its impact on human reader performance. Therefore, there is no mention of an effect size for human readers improving with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document does not explicitly describe a standalone diagnostic performance study of the algorithm without human-in-the-loop performance. The RTHawk and HeartVista Cardiac Package are presented as tools and accessories to MRDDs, generating images to be "interpreted by a trained physician" to assist in diagnosis. The focus is on image acquisition, reconstruction, and display capabilities, and compliance with technical and safety standards.

7. Type of Ground Truth Used

Given the nature of the submission (technical capabilities, safety, and substantial equivalence to an existing device for image acquisition and processing), the "ground truth" used for testing would primarily relate to technical specifications, image quality metrics (SNR, uniformity), and functional correctness rather than clinical outcomes or pathology.

For example:

• Safety parameters: Compliance with established physical limits (e.g., SAR, dB/dt) verified by measurement against standards.
• Image quality: Metrics like SNR and uniformity measured against industry standards (MS1-2008, MS3-2008).
• Functionality: Verification that the software performs its intended tasks (e.g., acquiring data, reconstructing images, displaying correctly, adjusting parameters as expected) through system and manual testing.

There is no mention of pathology, outcomes data, or expert consensus on clinical diagnoses as ground truth for this submission.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size for a training set. While the device includes features such as "automatic push-button localization of standard cardiac views," "automatic determination of inversion time," "automatic detection of artifacts," and "automated myocardial segmentation," typical of AI/ML applications, there is no mention of how these automated features were developed or trained, nor the data used for such training.

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

Since no training set is mentioned, the document does not describe how ground truth for a training set was established.

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