(410 days)
Computed Tomography X-Ray Scanners generally support three modes of imaging:
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Multiple contiguous slices: conventional CT where individual slices of axial data are acquired, with the table advancing a set distance until a volume of interest is covered.
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Helical Scanning: a volume of interest is scanned continuously while the patient table is advanced longitudinally, until a desired volume of data is acquired.
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Dynamic scanning: a single slice location is scanned repeatedly over a period of time.
Using the Real-Time Reconstruction System (RTRS) Option, the scanner effectively operates in the dynamic scan mode with the added flexibility of table and/or gantry movement during scanning. Under the control of the operating physician the RTRS is intended to speed up interventional procedures typically performed on CT. By permitting the operator to view the scanned area in virtual real time the RTRS is intended to support existing CT system clinical uses by offering enhanced operator flexibility coupled with the potential of reduced scan time.
The TSXF-001A is an optional upgrade kit available for the Xpress/SX CT system (TSX-011A/50). The kit consists of hardware and software that can be field installed by a qualified Field Service Engineer. When equipped with this option, the Xpress/SX system will have the capability to reconstruct and display axial slices at the rate of six images per second, effectively emulating a real-time display presentation. Additionally, an added control panel provides table-side control of x-ray initiation and termination, table longitudinal and vertical motion, and gantry tilt.
The provided text is a 510(k) summary for a medical device (TSXF-001A), which is an optional upgrade kit for an existing CT system. This document focuses on describing the device, its intended use, and comparing it to a predicate device.
It does not contain information about acceptance criteria, a specific study proving device performance against those criteria, sample sizes, expert involvement, or ground truth establishment.
Therefore, I cannot populate the requested table and answer the questions based solely on the provided input. The document appears to be a basic regulatory submission outlining the device's characteristics rather than a detailed performance study report.
No information is available in the provided text for the following:
- A table of acceptance criteria and the reported device performance: The document does not define specific acceptance criteria or report performance metrics against such criteria. It describes features and intended improvements in efficiency.
- Sample size used for the test set and the data provenance: No test set is described, nor any associated sample size or data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No experts or ground truth establishment are mentioned.
- Adjudication method for the test set: No test set or adjudication method is described.
- 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: No MRMC study is mentioned. This device is an upgrade to a CT system, not an AI-assisted diagnostic tool in the sense of image interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a CT system upgrade, not an isolated algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is mentioned.
- The sample size for the training set: No training set is mentioned.
- How the ground truth for the training set was established: No training set or ground truth establishment is mentioned.
The document indicates that the system is intended to "speed up interventional procedures" and "support existing CT system clinical uses by offering enhanced operator flexibility coupled with the potential of reduced scan time." However, it does not provide quantitative data from a study to back these claims against predefined acceptance criteria.
§ 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.