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XRT-7.0 option was added to CT Twin flash. The option adds an Xray tube with 7.0 MHU anode heat capacity to the options list.
This document does not describe an AI/ML powered device and therefore lacks the information necessary to answer the questions about acceptance criteria and study details for such a device.
The document describes an X-ray tube option (XRT-7.0) for CT scanners. It's an engineering change to a piece of hardware (increasing the anode heat capacity of an X-ray tube).
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance related to an AI/ML algorithm.
- Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or types of ground truth, as these are concepts relevant to evaluating AI/ML models, not hardware components.
- Information on training sets or how their ground truth was established, as this is also specific to AI/ML model development.
The "Effectiveness" section explicitly states: "The effectiveness of the device was not significantly changed in respect to the predicate device. CT Twin flash: The increased heat capacity is more convenient to use due to shorter delays for tube cooling." This further confirms it's a hardware enhancement related to operational convenience, not a new diagnostic or analytical capability powered by AI.
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JAN 17. 1967
Summary of Safety and Effectiveness
1. Device Name
XRT-7.0 option for CT scanners.
2. Submitter
Elscint Inc., 505 Main Str. Hackensack, NJ 07601.
3. New Features Description
XRT-7.0 option was added to CT Twin flash. The option adds an Xray tube with 7.0 MHU anode heat capacity to the options list.
4. Predicate Device
CT-Twin flash submitted in "HRSW Option for CT-Twin Flash", K945512.
5. Safety
The safety of the device is equivalent to the safety of the predicate device, CT Twin flash.
The 7.0 MHU tube option is mechanically and electrically very similar to the previous X-ray tubes and the software driver is the same.
6. Effectiveness
The effectiveness of the device was not significantly changed in respect to the predicate device. CT Twin flash: The increased heat capacity is more convenient to use due to shorter delays for tube cooling.
7. Substantial Equivalency Statement
Based on the above considerations, it is Elscint's opinion that CT scanners with the added XRT-7.0 option is substantially equivalent in safety and effectiveness to its predicate device, CT-Twin flash submitted in "HRSW Option for CT-Twin Flash", K945512.
§ 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.