(90 days)
CT-MASS has been developed for the objective and reproducible analysis of multi-slice, multi-phase left and right ventricular function from cardiac CT data sets. The CT-MASS software package can be used to semi-automatically calculate and display various parameters such as: EDV, BSV, stroke volume, ejection factor, peak ejection and filling rates, myocardial mass, regional wall thickness, as well as well as wall thickening/thinning, and regional wall motion. This is including the axial to short axis reformat.
When interpreted by a trained physician these parameters may be useful in supporting the determination of a diagnosis.
CT-MASS is a professional state-of-the-art analytical software tool designed for UNIX, Linux as well as Windows platforms. CT-MASS facilitates the import and visualization of multi-slice, multi-phase CT data sets encompassing the cardiac chambers via CD-Rom and digital network. This CT-MASS functionality is independent of the CT equipment vendor. CT-MASS provides objective and reproducible global and regional two-, three- and four-dimensional clinically relevant parameters describing left and right ventricular heart function, such as ventricular volumes, regional wall thickness and wall thickening/thinning CT-MASS is intended to support all clinicians, i.e. cardiologists, radiologists, and referring physicians involved in the noninvasive assessment of heart function.
This 510(k) submission for CT-MASS does not contain a specific section detailing the acceptance criteria and a study proving the device meets those criteria with a table of performance metrics. The submission focuses on substantial equivalence to predicate devices and provides general information about verification and validation tests and evaluations by hospitals and literature, but it lacks the granular detail requested.
However, based on the provided text, we can infer some information due to the device's nature as an analytical software tool for cardiac function. The core of its safety and effectiveness relies on its ability to objectively and reproducibly analyze cardiac CT data.
Here’s an attempt to construct the response based on the available information and typical expectations for such a device, while clearly identifying what is stated and what is inferred or missing:
Acceptance Criteria and Device Performance Study for CT-MASS
This 510(k) submission (K033774) for CT-MASS does not explicitly define a table of acceptance criteria or present a detailed study with specific performance metrics against those criteria. The submission primarily focuses on demonstrating substantial equivalence to predicate devices (K013422 "CardIQ Function" and K020796 "CardIQ Analysis III") and asserts that "potential hazards are controlled by a risk management plan for the software development process... including hazard analysis, verification and validation tests." It also mentions "Evaluations by hospitals and literature" support the safety and effectiveness.
Given the intended use of "objective and reproducible analysis of multi-slice, multi-phase left and right ventricular function," the acceptance criteria would implicitly relate to the accuracy and reproducibility of the calculated cardiac parameters.
1. Table of Acceptance Criteria and Reported Device Performance
As specific acceptance criteria and detailed performance metrics are not provided in the submitted document, the table below represents inferred or expected criteria for this type of device, with no reported performance values available in this submission.
| Acceptance Criterion (Inferred/Expected) | Reported Device Performance (Not provided in submission) |
|---|---|
| Accuracy of Ventricular Volumes | (e.g., within X% of ground truth) |
| - End-Diastolic Volume (EDV) | Not reported |
| - End-Systolic Volume (ESV) | Not reported |
| Accuracy of Ejection Fraction (EF) | (e.g., within X% of ground truth) |
| - EF | Not reported |
| Accuracy of Myocardial Mass | (e.g., within X% of ground truth) |
| - Myocardial Mass | Not reported |
| Reproducibility of Measurements | (e.g., CV |
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.