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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.

Ask a specific question about this device

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:

Manufacturer: GE Healthcare (GEHC) Field Strength: 1.5T and 3.0T Scanner Software Versions: 12, 15, 16, 23, 24, 25, 26

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 as 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 be made 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. Additional features are provided to automate and facilitate the set of tasks performed during a typical cardiac exam.

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.

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 Protocols. Protocols are pre-set by HeartVista, but new protocols can be created and modified by the end user.

RTHawk Apps (Applications) are comprised 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) 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 pushbutton 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

Here's a breakdown of the acceptance criteria and the study information derived from the provided text for the RTHawk, HeartVista Cardiac Package (K183274):

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria for device performance for the novel features introduced in K183274 compared to its predicate. Instead, it focuses on the device's adherence to regulatory standards and its functional equivalence/enhancements.

The "Performance Data - Discussion of Non-Clinical Tests" section (Page 7-8) lists the types of non-clinical tests performed, which essentially serve as verification that the device functions correctly and safely. The acceptance criteria for these would be compliance with the listed standards and satisfactory results for internal quality assurance measures.

Acceptance Criteria (Implied by Non-Clinical Tests & Compliance to Standards):

Note: The document only states "First level controlled" for SAR and dB/dt, implying compliance with safety limits but not giving specific numerical values. Similarly, for SNR and uniformity, it states "Compliant with," indicating favorable results without providing raw performance metrics.

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

The provided document does not explicitly describe a "test set" in terms of patient data for evaluating the clinical performance of the device's new features (like automated segmentation or new cardiac apps). The focus of the performance data discussion is on non-clinical engineering and software validation.

Therefore, information regarding:

• Sample size used for the test set: Not provided in terms of patient data.
• Data provenance (country of origin, retrospective/prospective): Not provided.

The "verification testing" mentioned on page 7 refers to internal software and system testing, not necessarily clinical validation with patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Since the document does not detail a clinical study with patient data for algorithm performance, there is no information provided regarding:

• Number of experts used to establish ground truth: Not mentioned.
• Qualifications of those experts: Not mentioned.

Ground truth is only implicitly referred to in the context of a "trained physician" interpreting images to assist in diagnosis (page 2, Indications for Use).

4. Adjudication Method for the Test Set

As there is no specific clinical test set described, there is no information provided regarding an adjudication method.

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

The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. There is no information about human readers improving with AI assistance vs. without AI assistance. This submission focuses on the device's functional and safety equivalence and expanded features rather than its impact on physician performance.

6. Standalone (Algorithm Only) Performance Study

The information provided does not explicitly present a standalone performance study of the algorithm (e.g., for automated segmentation) with quantitative metrics. The new features like "Automated myocardial segmentation" are listed as enhancements but no performance data for these specific features in standalone mode is provided in this summary.

7. Type of Ground Truth Used for Performance Evaluation

Given the lack of a detailed clinical performance study in the provided text for the novel features, the type of ground truth used is not specified. The document leans heavily on compliance with engineering and safety standards, and functional equivalence to the predicate device. For potential future clinical performance assessments of features like "Automated myocardial segmentation," pathology or expert consensus would typically be used as ground truth, but this is not detailed here.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size for a training set. This K183274 submission is an update to a previously cleared device (K170090) and details software enhancements and new "Apps." While machine learning components (like the automated segmentation or artifact detection) would typically involve training data, this specific summary does not disclose those details.

9. How Ground Truth for the Training Set Was Established

Similar to point 8, since no training set information is provided, how the ground truth for any potential training set was established is also not detailed in this document.

Ask a specific question about this device

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:

Manufacturer: GE Healthcare (GEHC) Field Strength: 1.5T and 3.0T Scanner Software Versions: 12, 15, 16, 23, 24, 25

RTHawk is a software platform intended for the efficient real-time MRI data acquisition, data transfer, image reconstruction, and interactive scan control and display of static and dynamic MR imaging data.

As an accessory to clinical 1.5T and 3.0T MR systems, RTHawk operates 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, with color monitor, keyboard and mouse. A private ethernet network connects the RTHawk workstation to the MR scanner computer. When not in use, the RTHawk workstation may be disconnected 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 Apps (Applications) are comprised 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) 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
• . 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.

The provided text is a 510(k) Summary for the medical device RTHawk, HeartVista Cardiac Package (K170090). This document focuses on demonstrating substantial equivalence to a predicate device (K153740) rather than presenting a performance study against specific acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria and performance studies in the format of a clinical trial with a test set, ground truth establishment, expert adjudication, or MRMC studies.

The document primarily focuses on:

• Indications for Use: Identical to the predicate device.
• Technological Characteristics Comparison: Demonstrates the core functionalities and structure are the same as the predicate, with a minor update to supported scanner software versions.
• Non-Clinical Tests: Mentions design controls, quality assurance measures (code reviews, design reviews, unit/integration testing, verification testing, safety testing, performance testing, validation testing), and risk management (ISO 14971:2007 compliance).

In summary, the document does not present a study designed to "prove the device meets acceptance criteria" in the sense of a clinical performance study with human readers or standalone algorithm performance. Instead, it argues for substantial equivalence based on identical intended use, similar technological characteristics, and adherence to design control and quality management principles.

Ask a specific question about this device

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:

Manufacturer: GE Healthcare (GEHC) Field Strength: 1.5T and 3.0T Scanner Software Versions: 15, 16, 23, 24, 25

RTHawk is a software platform intended for the efficient real-time MRI data acquisition, data transfer, image reconstruction, and interactive scan control and display of static and dynamic MR imaging data.

As an accessory to clinical 1.5T and 3.0T MR systems, RTHawk operates 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, with color monitor, keyboard and mouse. A private ethernet network connects the workstation to the MR scanner computer. When not in use, the workstation may be disconnected 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 Apps (Applications) are comprised 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 (fraditional) 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
• 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.

This document is a 510(k) summary for the HeartVista Cardiac Package (K153740), a software accessory for MRI systems. It primarily focuses on demonstrating substantial equivalence to a predicate device (RTHawk 1.0.1, K142997). The information provided is about the device's technical specifications and the testing performed to ensure its safety and effectiveness.

Here’s an attempt to extract and present the requested information, understanding that a 510(k) summary often does not contain detailed clinical study reports for acceptance criteria, but rather focuses on technical performance and equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative clinical acceptance criteria for diagnostic performance (e.g., sensitivity, specificity for a particular pathology). Instead, the performance evaluations are focused on technical aspects and subjective diagnostic utility by experts.

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

• Sample Size for Test Set: The document does not specify a numerical sample size for patients or cases used in the performance evaluation (e.g., for "clinical images were acquired using RTHawk").
• Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective in the sense that images were acquired and then evaluated, but it is not detailed if these were pre-existing patient scans or prospectively acquired for the purpose of the study. The phrasing "clinical images were acquired using RTHawk" might suggest prospective acquisition for evaluation, but further specifics are not available.

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

• Number of Experts: Not specified. The document states "radiologist expertise" (plural), indicating more than one.
• Qualifications of Experts: "Trained physician" and "radiologist expertise" are mentioned. No years of experience or specific subspecialty certifications are provided in this summary.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. It only mentions evaluation by "radiologist expertise."

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 MRMC comparative effectiveness study is mentioned for evaluating human reader improvement with or without AI assistance. The device is a software platform intended to acquire, reconstruct, and display images, not explicitly an AI-driven diagnostic aid to human readers in the sense of often-seen AI studies comparing aided vs. unaided performance. The focus is on the diagnostic usefulness of the images produced by the device, not on AI-assisted interpretation.

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

• Yes, a standalone performance was done in the sense that the device itself (RTHawk producing images) was evaluated for its technical performance (SNR, uniformity) and for the diagnostic usefulness of the images it produced, before human interpretation for a diagnosis. The evaluation of image quality by radiologists ("diagnostically useful") represents a form of standalone assessment of the device's output.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• For the "clinical images were acquired using RTHawk, and were evaluated directly based upon radiologist expertise and found to be diagnostically useful," the ground truth can be inferred as expert opinion/consensus on image quality and diagnostic utility. There is no mention of pathology, long-term outcomes, or detailed clinical diagnostic ground truth used for comparison.

8. The Sample Size for the Training Set

• The document does not provide information about a "training set" sample size. Given this is a 510(k) summary for an MRI software platform primarily focused on image acquisition, reconstruction, and display, it's unlikely to feature a machine learning model with a distinct training set in the way a modern AI diagnostic device would. Its "training" would be more akin to software development and validation.

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

• As no specific training set for a machine learning model is mentioned, there is no information on how its ground truth would have been established. The development of the pulse sequences and reconstruction pipelines would rely on established MRI physics principles and engineering validation, rather than annotated training data in the context of typical AI/ML.

Ask a specific question about this device

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-time and accelerated images. The HeartVista Workstation with the RTHawk application software is indicated for Cardiovascular MR (CMR) applications.

The Heart Vista 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 Heart Vista 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

• · GE Healthcare (GEHC) DVMR 1.5T, 3.0T. Software version 24

The HeartVista Workstation with RTHawk application software are a software and dedicated hardware product intended 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.

The HeartVista Workstation consists of 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 be made to the MR system or console. A private ethernet network connects the HeartVista Workstation to the MR scanner computer. When not in use, the HeartVista Workstation 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 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.

The provided text does not contain detailed acceptance criteria or a study that explicitly demonstrates the device meets specific performance criteria in terms of accuracy, sensitivity, or specificity. The document is primarily a 510(k) summary for the HeartVista Workstation with RTHawk, focusing on its substantial equivalence to a predicate device and adherence to recognized consensus standards.

However, based on the non-clinical tests and performance data discussion, we can infer some aspects relevant to performance.

Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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 for Test Set: Not explicitly stated. The phrase "same patient" implies a within-subject comparison but doesn’t provide the number of patients or images.
• Data Provenance: Not explicitly stated. It's unclear if the data was retrospective or prospective, or the country of origin. "Clinical images were acquired" suggests prospective acquisition for the study, but this is not confirmed.

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

• Number of Experts: Not explicitly stated. The text mentions "radiologist expertise" (singular or plural not specified) for evaluating images without direct comparison to the predicate.
• Qualifications of Experts: Not explicitly stated, beyond "radiologist expertise." No experience level (e.g., "10 years of experience") is provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The statement "Images from both devices were evaluated and rated on the basis of diagnostic accuracy and image quality" and "RTHawk images were evaluated directly based upon radiologist expertise" does not describe a specific adjudication process (like 2+1 or 3+1). It implies a subjective rating by radiologists.

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

• MRMC Comparative Effectiveness Study: No, this type of study was not described. The study focused on comparing RTHawk images to predicate device images and radiologist evaluation of RTHawk images. It does not assess human reader performance with or without AI assistance. The RTHawk is described as an accessory for image acquisition and processing, not as an AI-assisted diagnostic tool for humans, in the context of this 510(k).

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

• Standalone Performance: The study evaluated the images produced by RTHawk (the algorithm/system), rated for diagnostic accuracy and image quality. This can be considered a form of standalone evaluation of the image output, as the "radiologist expertise" assessment would be against the RTHawk images themselves. However, it's not a quantitative measure of performance like sensitivity/specificity often seen in standalone AI algorithm studies.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for image quality and diagnostic accuracy appears to be based on:
  • Comparison to images from a predicate device (assumed to represent a clinical standard).
  • Radiologist expertise (subjective evaluation by trained physicians).
  • This is not pathology, or long-term outcomes data.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not mentioned or described in the provided document. The 510(k) summary focuses on the device's substantial equivalence and non-clinical testing rather than specific AI model training details.

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

• How Ground Truth for Training Set Was Established: Not mentioned, as training set details are not provided.

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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.

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.

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.

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.

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