(21 days)
The detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.
The detector functions by intercepting X-ray photons. Then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. The electrical signals are then digitally converted to display an image on the monitor.
The detector should be connected to a computer and X-ray generator for transfer of diagnostic images. The functions of the EverestView 4343X are supported by software and the software is of Moderate level of concern. The main function of software is image acquisition and transfer and it doesn't have functions of image post-processing. The detectors can be used for dynamic imaging (fluoroscopy) that is same as Predicate Device.
The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary for an X-ray Flat Panel Detector (EverestView 4343X) and focuses on demonstrating substantial equivalence to a predicate device (CareView 1800RF) based on technological characteristics and safety testing.
It does include a comparison table of technical specifications between the proposed and predicate devices, which could be interpreted as comparative performance metrics, but these are not explicitly presented as acceptance criteria for a study proving clinical effectiveness.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding specific studies (sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) as this information is not present in the provided text.
§ 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.