(28 days)
Used in conjunction with a pulsed dental X-ray machine, the CS 6200 is intended for medical institutions to perform static digital X-ray imaging facilitating the diagnosis of the teeth, jaw, mouth, and other structural diseases.
The CS 6200 is a USB-driven digital intraoral X-ray sensor based on CMOS technology that is specially designed for acquiring real-time high-quality dental diagnostic images. Image data acquired from the device can be transmitted via a USB 2.0 port to a workstation for display and processing.
The provided text is a 510(k) Summary for the iRay Imaging Technology (Haining) Limited Digital Intraoral X-Ray Sensor (Model CS 6200). It does not contain information about acceptance criteria or a specific study proving the device meets these criteria in the format requested.
The document focuses on demonstrating substantial equivalence to a predicate device (iRay Technology Co., Ltd. PlutoX Digital Intraoral X-Ray Imaging System, K210312) through non-clinical testing. It outlines the technological characteristics of both the proposed and predicate devices and states that non-clinical studies were performed to show equivalence in various performance aspects.
Specifically, it mentions:
- Nonclinical Considerations: "According to the Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, the non-clinical studies have been performed and the results have shown that the CS 6200 are substantially equivalent to the predicate devices on the Market (K210312): Dose to output signal transfer function, Signal to noise ratio, uniformity, Defect, Minimum triggering dose rate, Modulation transfer function (MTF), Spatial resolution, Low contrast resolution and Image Acquisition time."
- Clinical Consideration: "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterizes all performance aspects of the device based on well-established scientific and engineering principles."
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, expert involvement, or adjudication methods for clinical studies, as the submission explicitly states that clinical data was not required or provided. The study performed was a non-clinical equivalence study based on technical specifications and performance measurements, not a human reader or image interpretation study.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.