(16 days)
AutoQUANT® Plus applications are intended to enable an automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasets. AutoQUANT® 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 (K040326) was composed of the following applications: AutoQUANT® (K040326) [AutoOUANT 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) and optionally QARG (for reporting purposes).
The modified AutoQUANT® Plus is a suite of applications for the processing and review of Cardiac SPECT and PET datasets. AutoQUANT® Plus is composed of the following applications: AutoQUANT® (K040326) [AutoQUANT integrates 2 functionalities, Quantitative Perfusion SPECT (QPS) and Quantitative Gated SPECT (QGS) into a single application for LV (Left Ventricle) extraction and analysis). AutoQUANT Plus will be marketed as AutoQUANT NM, which combines the following two separate sets of functionality: AutoQUANT - optimized for SPECT studies and OPET - optimized for PET studies. Both sets of functionality offer a comprehensive application suite that includes QGS (Quantitative Gated SPECT) and OPS (Quantitative Perfusion SPECT) applications. This allows automatic processing and review of quantitative and qualitative information generated by nuclear medicine studies. QPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies. AutoQUANT NM can also be purchases separately as AutoOUANT (for SPECT study data) or QPET (for PET study data). Purchasable Options consist of Quantitative Blood Pool SPECT (QBS), QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA, and Prone-Supine (Prone+) for SPECT studies.
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. A new Phase toggle on the OGS page gives access to phase information for gated datasets. Stress-Rest Registration is a direct method for detecting changes between stress and rest images. It is a practical and fully automatic algorithm for quantification of stress-induced changed from paired stress and rest scans and does not use protocol-specific databases. A new technique to create cardiac "motionfrozen" perfusion or viability images, by warping ECG-gated images to the end-diastolic position has been added. Such "motion-frozen" perfusion and viability images have improved resolution and contrast by removing blurring effect caused by cardiac motion. Prone-supine quantification allows quantification of perfusion on prone images as well as combined quantification of prone/supine datasets by applying heuristic rules, which allow automatic elimination of image artifacts based on the relative defect locations on prone and supine images. The new shape index parameter defines 3D left ventricular (LV) geometry derived from LV contours in end systolic and end diastolic phases.
The AutoQUANT application provides Normal Files database for stress, rest, and gender criteria for Dual Isotope and Mibi (Te-Sestamibi): The new version of QPS includes the simplified algorithm for the quantification of myocardial perfusion, using normal limits created from studies of low-likelihood normal patients only. The new algorithm has been validated in a large group of patients demonstrating equivalent diagnostic performance despite the use of simplified normal limits. In addition, to Dual Isotope and Mibi Mibi using the new simplified algorithm, the following additional databases are being provided Vantage MibiMibi, Thallium Stress/Rest, Astonish ½ Time Dual, and Astonish ½ Time Mibi. Optional Normals databases offered are Rubidium for PET, Ammonia for PET. QPS provides the ability for User Generated Normal Files using the simplified method. The new version of QPS also includes a new variable, Total Perfusion Deficit (TPD), which combines defect extent and severity values. For backward compatibility reasons, the old QPS perfusion quantification method, which displays individual defect extent and severity values, can be accessed by checking off PFQ option in the QPS Application Defaults. All the functional QGS values (ejection fraction, LV volumes etc) and contour definitions are the same as before.
Quantitative Blood Pool SPECT (QBS) is an optional application. QBS 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); twodimensional (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 man 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 leftventricular (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.
The ability to load and display PET, CT, CTA datasets in AutoQUANT® Plus have been added as an option. Qualitative displays are now provided functional PET data and CT/CTA anatomical datasets. In addition, nuclear image fusion package has been added for both SPECT/CT and PET/CT hybrid applications. A SPECT/CT fusion package including SPECT/CT/CTA Fusion Page, that allows for display of segmented and labeled coronary vessels with perfusion SPECT 3D data. A PET/CT fusion package including PET/CT/CTA Fusion Page, that allows for display of segmented and labeled coronary vessels with PET 3D data. Functionality includes orthogonal planes using alpha blending. roving window and synchronized cursor. It allows users to perform quality control of SPECT/CT/CTA or PET/CT/CTA alignment and has generic multimodality fusion capabilities. This feature provides display of fused images in a visual format. Additionally, included for PET analysis is the Hibernating Myocardium Assessment (mismatch and viability); This module allows quantitative assessment of "hibernating myocardium" by quantification of changes between PET perfusion and viability images in hypo-perfused area. Scar and Mismatch parameters are reported as a percentage of the Left Ventricle and are displayed in polar coordinates or a 3D surface display.
The provided text is a 510(k) Summary for the AutoQUANT® Plus device. It describes the device's functionality and its intended use but does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device (AutoQUANT® Plus, K040326), rather than presenting performance metrics against specific acceptance thresholds.
Here's why the requested information cannot be extracted from this document:
- No Acceptance Criteria: The document does not define any specific performance metrics (e.g., sensitivity, specificity, accuracy, precision, etc.) that the device must achieve.
- No Performance Study Results: While it mentions that "The new algorithm has been validated in a large group of patients demonstrating equivalent diagnostic performance," it does not provide any quantitative results, sample sizes for such a validation, details of ground truth establishment, or expert qualifications. It only states an equivalence, not a direct measurement against a predefined acceptance criterion.
- Focus on Substantial Equivalence: The primary purpose of a 510(k) summary is to establish that a new device is as safe and effective as a legally marketed predicate device, not to present a detailed performance study against acceptance criteria.
To answer your request, a different type of document, such as a detailed design validation report or a clinical study report, would be necessary.
§ 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.