Search Results

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.

Ask a specific question about this device