(141 days)
The MiniCAT 2D is a diagnostic x-ray system for general radiographic x-ray imaging of the head and neck for use in hospitals, clinics, medical imaging centers, and medical practices.
The MiniCAT 2D is a dedicated X-ray imaging device that acquires a 360° rotational X-ray sequence and produces two dimensional views. MiniCAT 2D provide immediate access to images at the patient's point-of-care resulting in faster diagnosis and treatment. The MiniCAT 2D system consists of a high voltage x-ray generator, 360-degree rotational overhead gantry, x-ray tube assembly, x-ray controller, fixed detector panel, and x-ray controls containing a "power distribution unit and operator PC (user interface)."
This document does not contain information about the acceptance criteria and study that proves the device meets the acceptance criteria for a new AI/algorithm feature. Instead, it is a 510(k) summary for a general X-ray system (MiniCAT 2D) seeking substantial equivalence to a predicate device (Carestream DRX-Evolution).
The document details the device description, indications for use, and a comparison of technological characteristics to the predicate device to demonstrate substantial equivalence, rather than providing performance data for a specific algorithm or AI component.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.