(15 days)
AutoQUANT® Plus applications are intended to enable an automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasets. AutoOUANT® Plus may be used in multiple settings including the hospital, clinic, doctors office, or remotely via dial up. The results provided should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.
AutoQUANT® Plus is a suite of applications for the processing and review of Cardiac SPECT and blood pool SPECT datasets. AutoOUANT® Plus is composed of the following applications: AutoQUANT® (K980715) [AutoQUANT integrates 2 functionalities, Quantitative Perfusion SPECT (QPS) and Quantitative Gated SPECT (QGS) into a single application for LV (Left Ventricle) extraction and analysis], Quantitative Blood Pool SPECT (QBS) (K022428), and optionally QARG (for reporting purposes). Previously, the marketing clearance for QBS (K022428) was scparate and is now being combined with the AutoOUANT Plus 510(k) being submitted.
AutoQUANT® is a software application designed to enable an automated, comprehensive review and quantification of Cardiac SPECT data. AutoQUANT® integrates 2 functionalities, Quantitative Perfusion SPECT (OPS) and Quantitative Gated SPECT (QGS) into a single application for LV (Left Ventricle) extraction and analysis. AutoQUANT® provides a tool to review and quantify all types of Cardiac SPECT data sets (perfusion and/or gated) to determine the location, orientation, and anatomical extent of the left ventricle of the heart, to construct 3D contour maps of the heart, and to calculate the heart volume (for the left ventricular wall), the lung/heart ratio, and transient ischemic dilation (TID). Physicians use this information to assess the anatomical and physiological functionality of the heart and analyze the presence of myocardial defects through comprehensive imaging modalities.
Also included in AutoQUANT Plus is Quantitative Blood Pool SPECT (QBS). OBS is an interactive standalone software application for the automatic segmentation and quantification of gated short axis blood pool (red blood cells, RBC) SPECT. The application can be used for automatic generation of left and right ventricular endocardial surfaces and valve planes from three-dimensional (3D) gated short axis blood pool images; automatic calculation of left and right ventricular volumes and ejection fractions; calculation and display of polar maps representing wall motion and parametric values (FFH amplitude and phase); two-dimensional (2D) image display using standard American College of Cardiology (ACC) cardiac SPECT conventions; and 3D image display. It also provides the following functionalities: ability to combine isosurfaces extracted from the data with the calculated endocardial surfaces in various ways (endocardial borders displayed as wireframes, shaded surfaces, both, or parametric); ability to map parametric values (First Fourier Harmonic (FFH) amplitude and phase) on the surfaces; ability to display parametric images (FFH amplitude and phase) for gated planar, gated raw projections and gated short axis images; ability to display cine loops of the original images; ability to generate count-based quantitative values using the automatically- and semi automatically-computed surfaces as ROIs and user-selectable thresholds; ability to generate and display phase histograms for FFH phase images and to display the mean and standard deviation of the peaks corresponding to atrial and ventricular voxels. After ventricular segmentation, a phase histogram for each ventricle is also computed and displayed; and ability to display normalized images for all gated images (i.e., images that do not exhibit count drop-off caused by arrhythmia). In addition, QBS supports manual identification of the left-ventricular (LV) region, to separate it from the right ventricle (RV) in cases where the automatic algorithm fails or returns unsatisfactory results; ability to generate filling rates from interpolated time-volume curves; and the ability to rotate, zoom, and cine surfaces.
In addition, an automatic report generation (ARG) feature has been added to AutoQUANT® Plus. This option in AutoOUANT produces consistent PDF (or text) reports based on a series of form elements within AutoQUANT . The tool consists of an additional window within AutoQUANT and does not alter any quantitative values. This is designed to reduce transcription errors and automate workflow. A separate QARG application allows searching and management of the ARG database, which requires all data to be manually entered. There are no algorithmic functions within the ARG/QARG feature.
The provided text is a 510(k) summary for the AutoQUANT® Plus device. It describes the device's intended use, its components, and its substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria, details of a study proving those criteria were met, or most of the other requested information related to detailed performance studies.
Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.
Based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided 510(k) summary. Acceptance criteria and specific performance metrics are typically detailed in a separate performance study report, which is not part of this summary document. The 510(k) summary focuses on "substantial equivalence" to predicate devices rather than proving performance against specific acceptance criteria.
| Acceptance Criteria (e.g., Sensitivity, Specificity, Accuracy) | Reported Device Performance |
|---|---|
| Not available in document | Not available in document |
Regarding the study that proves the device meets the acceptance criteria:
The provided document describes the device and its intended use but does not include details of a study designed to prove the device meets specific acceptance criteria. Instead, it relies on a "Technological Comparison" to predicate devices to establish "substantial equivalence."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size for the test set: Not mentioned.
- Data provenance: Not mentioned. The document primarily discusses the software applications and their functionalities, not specific datasets used for testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Number of experts: Not mentioned.
- Qualifications of experts: Not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication method: Not mentioned.
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 study: Not mentioned. The document does not describe any studies involving human readers or their improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies standalone functionality for the segmentation and quantification aspects (e.g., "automatic segmentation and quantification," "automatic generation of left and right ventricular endocardial surfaces"). However, it does not explicitly provide performance metrics from a standalone study. The intended use states "results provided should be reviewed by qualified healthcare professionals," suggesting a human-in-the-loop context for clinical decision-making.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of ground truth: Not mentioned.
8. The sample size for the training set:
- Sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established:
- How ground truth was established: Not mentioned.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.