(27 days)
The GXR-Series Diagnostic X-Ray System, (Models GXR-SD, GXR-S, SGXR-S, FDR Smart FGXR-S), is a stationary X-ray imaging system, for the purpose of acquiring X-ray images of the desired parts of a patient's anatomy. This device is not intended for mammography or bone density applications.
The GXR-Series Diagnostic X-Ray System, (Models GXR-SD, GXR-S, SGXR-S, FDR Smart FGXR-S) is comprised of 2 main configurations: GXR-SD and GXR-S, with SGXR-S, FDR Smart FGXR-S being different brand names for GXR-S. Both configurations are designed to diagnose the human body by providing radiographic x-ray image with anatomical structure.
GXR-S, SGXR-S, FDR Smart FGXR-S (analog) and GXR-SD (digital) have the same xray hardware components. However, the GXR-SD model contains image management (PACS) software and a flat panel digital detector. Interoperability is defined in the DICOM Conformance Statement which is part of the device labeling and is based upon NEMA PS 3.1 - 3.20 (2016). Digital Imaging and Communications in Medicine (DICOM) Set DICOM Standard.
The GXR-S does not have image management software and does not have a digital detector.
The GXR-SD, GXR-S, SGXR-S, FDR Smart FGXR-S, models consist of a high voltage (HV) generator, a tube support unit, an X-ray beam limiting device, patient table, wall Bucky stand, and an x-ray tube, that operates on a high-frequency inverter method.
The operator control console is designed to be simple and user-friendly, and the user can select or change x-ray parameters easily using a large graphic LCD panel display and a soft membrane switch. The GXR Series, high frequency X-ray generator features accuracy, reproducibility and long-term stability with capacitor assisted general line power supply. The APR (Anatomical Programming) and the optional AEC (Automatic Exposure Control) features gives the user control of exposure factors, automatically optimized for the radiological study selected.
RADMAX Digital Imaging Software (K182537) by DRGEM, is used in the GXR-SD model to serve as an interface to the hardware and images. Anatomical view-based digital image processing automatically optimizes and enhances the quality of the captured images.
The provided document, a 510(k) Premarket Notification summary for the GXR-Series Diagnostic X-Ray System, does not contain the detailed information typically presented in a study proving a device meets acceptance criteria for an AI/CADe (Computer-Aided Detection/Diagnosis) system.
This document describes a traditional X-ray system, not an AI software. The performance data highlighted is primarily related to non-clinical testing, electrical safety, EMC (Electromagnetic Compatibility), and conformance to various medical device standards (e.g., IEC 60601 series, ISO 14971, NEMA PS 3.1 DICOM). These are standard requirements for X-ray hardware, not for AI software performance in diagnostic tasks.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/CADe system from this document. The sections you asked for, such as sample sizes for test and training sets, expert qualifications, and MRMC studies, would be found in a submission for an AI-powered diagnostic device, which this is not.
The "Performance Data" section in the document specifically mentions "Nonclinical Testing" and lists several international standards for electrical safety and electromagnetic compatibility (EMC), as well as software lifecycle processes (IEC 62304) and risk management (ISO 14971). It concludes that "Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met." However, it does not specify what those acceptance criteria for clinical performance are, as it is a hardware device.
If you have a document describing an AI/CADe device, please provide that, and I will be able to answer your questions.
§ 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.