(71 days)
The AutoQUANT , Quantitative Perfusion SPECT (QPS), and Quantitative Gated SPECT (QGS) applications are intended to enable a fully automated review and quantification of Cardiac SPECT data.
AutoQUANT is a software application designed to enable a fully automated, comprehensive review and quantification of Cardiac SPECT data within a suite of applications. AutoQUANT can operate as an independent single application or can be integrated into an application containing Quantitative Perfusion SPECT (QPS) and/or Quantitative Gated SPECT (QGS). 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.
Quantitative Perfusion SPECT (QPS) is a software application designed for the review and quantification of myocardial perfusion SPECT short axis data. QPS can operate as an independent single application or as an embedded function packaged with AutoQUANT. Using the QPS application, myocardial rest and stress short axis projections (standard and gated Cardiac SPECT) can be reviewed and compared, the extent and volume of cardiac defects can be calculated, and 3D and 2D perfusion maps can be generated. The QPS application can also be used to create a user-definable Normal database (with definable normal limits) for review, quantification, and comparison.
Quantitative Gated SPECT (QGS) is a software application designed to view and analyze processed SPECT short axis or gated short axis data sets. QGS can operate as an independent single application or as an embedded function packaged with AutoQUANT. Using the QGS application, myocardial gated short axis projections can be reviewed and compared, the extent and severity of cardiac defects can be calculated, and 3D and 2D wall thickening, wall motion and regional ejection fraction maps can be generated. The application can be used to display the left ventricular endocardial and epicardial surfaces; polar maps indicating perfusion, wall thickening, wall motion, and regional ejection fraction: standard cardiac SPECT short axis and horizontal slices; and 3D cardiac surfaces and volumes from gated SPECT data. When using gated SPECT data, the left ventricular volume and left ventricular ejection fraction (LVEF) can be automatically calculated or regions may be manually specified for calculation. When using non-gated short axis SPECT data, the left ventricular volume can be calculated automatically or manually.
I am sorry, but the provided text from the 510(k) notification does not contain information about specific acceptance criteria or a detailed study that proves the device meets those criteria.
The document states:
"Testing was conducted to demonstrate that each software application functioned as per its specifications. All tests passed with the actual results matching the expected results."
This statement confirms that some testing was done to ensure the software met its specifications, but it does not provide:
- Specific acceptance criteria: It doesn't define what "per its specifications" entails in terms of quantifiable metrics or performance thresholds (e.g., accuracy, precision, error rates for cardiac measurements).
- A detailed study description: There is no information on the methodology of the testing, such as sample size, data provenance, ground truth establishment, or any comparative effectiveness studies.
Therefore, I cannot extract the requested information in the format you provided. The document primarily focuses on the device description, indications for use, and a general statement about software functional testing, rather than a clinical or performance validation study with specific acceptance criteria.
§ 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.