(25 days)
Wireless digital flat panel detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental applications.
Mars1013X Wireless Digital Flat Panel Detector (Hereinafter referred to as Mars1013X) is the kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 33.18cm×25.28cm. The sensor plate of Mars1013X is direct-deposited with CsI(Cesium Iodide) scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface. The major function of the Mars1013X is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. Both kinds of detectors are the key component of DR system, enable to complete the digitalization of the medical X-ray imaging with the DR system software. iRay SDK(include iDetector) is intended to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to be used directly by other users beside DR system manufacturers.
The provided text is a 510(k) summary for the iRay Technology Taicang Ltd. Wireless Digital Flat Panel Detector (Mars1013X). It describes the device, its intended use, and its comparison to predicate devices to demonstrate substantial equivalence.
However, the document does NOT contain information about specific acceptance criteria related to a study proving the device meets those criteria in the context of AI/algorithm performance. It primarily focuses on the device's physical and technical specifications, electrical safety, biological evaluation, and comparison to predicate devices, but not on clinical performance metrics that would typically be established for an AI-powered diagnostic device.
The provided text describes a "Wireless Digital Flat Panel Detector", which is a hardware component for X-ray imaging, not an AI or algorithmic diagnostic device. Therefore, the questions related to AI-specific acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance are not applicable to the information contained in this document.
The document states:
- "Mars1013X Wireless Digital Flat Panel Detector is the kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 33.18cm×25.28cm"
- "The major function of the Mars1013X is to convert the X-ray to digital image, with the application of high resolution X-ray imaging."
The performance metrics discussed (Spatial Resolution, MTF, DQE) are physical imaging characteristics of the detector itself, not diagnostic performance of an AI analyzing the images.
Therefore, it is not possible to extract the requested information regarding acceptance criteria and a study proving an AI device's performance from the provided text. The document pertains to the clearance of an X-ray detector, not an AI diagnostic algorithm.
§ 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.