(41 days)
The Wireless/Wired Yushan X-Ray Flat Panel Detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The Yushan X-Ray Flat Panel Detector is not intended for mammography, fluoroscopy, tomography, and angiography applications.
InnoCare's Yushan X-Ray Flat Panel Detector (Yushan V14C, Yushan V14G) is a portable digital detector system. The Yushan X-Ray Flat Panel Detector is designed to be used in any environment that would typically use a radiographic cassette for examinations of adults. The detector models support both wireless and wired/tethered data communication between the detector and the system. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams. The Yushan X-Ray Flat Panel Detector is currently indicated for general projection radiographic applications and offers two different detector types in terms of scintillator materials (gadolinium oxysulfide (GOS) and cesium iodide (Csl)). The Yushan X-Ray Flat Panel Detector sensor can automatically collects x-ray images from an x-ray source. The Yushan X-Ray Flat Panel Detector sensor collects xrays and digitizes the images for their transfer and display to a computer. The sensor does not have an x-ray source, which is provided and controlled by independent system manufacturers. The sensor includes a flat panel for x-ray acquisition and digitization and a computer (including proprietary processing software) for processing, annotating and storing x-ray images. The SDK(software development kit) software library runs on a PC workstation and provides the interface for system manufacturer to control the Yushan X-Ray Flat Panel Detector. SDK initiates the taking of X-ray images from the Yushan X-Ray Flat Panel Detector, through the Sensor Driver application. Once an X-ray is taken, Sensor Driver reads it from the flat panel and transfers it to SDK. Then the user interface which designed by the system manufacture will take the image data from SDK for further image process and display.
The provided text is a 510(k) summary for the InnoCare Optoelectronics Corp.'s Yushan X-Ray Flat Panel Detector. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data and technical comparisons.
There is no information regarding the acceptance criteria for an AI/ML powered device, nor a study proving an AI/ML device meets such criteria. The device described is a digital X-ray detector, not an AI/ML algorithm.
Therefore, I cannot provide the requested information from the provided text. The document clearly states:
- Clinical Performance Data: No clinical study has been performed.
- The software level of concern for the Yushan X-Ray Flat Panel Detector has been determined to be moderate... Please be noted that the software is not based on the predicate device. (This refers to the SDK, not an AI/ML algorithm)
The request asks about an "AI vs without AI assistance" study, "standalone algorithm only" performance, and ground truth establishment for a training set, all of which are pertinent to AI/ML devices. This document does not describe such a device or studies related to it.
§ 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.