Search Results

The Optima XR646 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and is intended for use in all routine radiography exams.

The device is not intended for mammographic applications.

The Optima XR646 remains a radiographic X-ray system capable of generating radiographic images of human anatomy.

The Optima XR646 is designed to handle radiographic applications using GE's flat-panel wireless digital detector. The digital detector is comprised of amorphous silicon and cesium iodide scintillator. The resulting digital image can be sent through a DICOM network for applications such as printing, viewing and storage.

The Optima XR646 Digital Radiographic Imaging system consists of a WallStand, elevating table, overhead Tube support, X-ray tube, collimator, system controller, X-ray generator, and wireless or tethered digital detector. Various configurations such as Table only, WallStand only, or OTS only are available to meet customer radiographic requirements.

The provided document is a 510(k) Premarket Notification for the GE Optima XR646, a digital radiographic X-ray system. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone study for a new AI-powered diagnostic device.

Therefore, the document does not contain the information required to answer your request fully. Specifically:

• No acceptance criteria for an AI device are mentioned. The document discusses regulatory compliance for an X-ray system.
• No study proving an AI device meets acceptance criteria. The document states that clinical studies were not required to support substantial equivalence for this X-ray system, and changes were verified and validated through bench testing.
• No information on sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details for an AI algorithm. These are all concepts related to the evaluation of AI/ML-driven diagnostic devices, which is not the subject of this 510(k) submission.

The 510(k) submission details the device description, intended use, indications for use, and a comparison to predicate devices, focusing on the system's hardware and basic radiographic image generation capabilities. It highlights that the changes precipitating this 510(k) were related to hardware modifications and software control for the Image Pasting feature, and that these changes were validated through bench testing to ensure they did not introduce new safety or effectiveness issues.

In summary, this document is about the regulatory clearance of an X-ray imaging system, not an AI-powered diagnostic tool, and thus does not include the specific details you requested regarding AI acceptance criteria and studies.

Ask a specific question about this device