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The Optima XR646 HD 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 the system is intended for use in all routine radiography exams. Optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image.
The device is not intended for mammographic applications.

The Optima XR646 HD is designed to be a lower cost version of the predicate device, the Discovery XR656 HD (K172869). Like the Discovery XR656 HD, the Optima XR646 HD is a radiographic X-ray system capable of generating radiographic images of human anatomy.
The Optima XR646 HD is designed to support radiographic applications using previously cleared flat panel wireless digital detectors. The system generates digital images for general radiography by means of its X-Ray image chain. The resulting digital image can be sent through a DICOM network for applications such as printing, viewing and storage.

The provided text is a 510(k) Premarket Notification from GE Healthcare for their Optima XR646 HD device. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study of an AI/ML algorithm's performance against specific acceptance criteria.

The acceptance criteria described in the request are common for evaluations of AI/ML-driven medical devices (e.g., studies measuring diagnostic accuracy, reader performance improvement, etc.). However, the content of this 510(k) submission does not include such a study.

Instead, the submission for the Optima XR646 HD focuses on:

• Technological Equivalence: The device employs the same fundamental scientific technology as its predicate and reference devices (Discovery XR656 HD and Optima XR646, respectively).
• Identical Intended Use and Indications for Use: The new device is intended for the same purposes as the predicate.
• Hardware Changes: The primary difference is a change from five-axis motorized motion to one-axis motorized motion in the Overhead Tube Suspension (OTS), which affects the image pasting function's acquisition method (parallel sequence instead of rotating the x-ray tube).
• Compliance with Standards: The device complies with relevant IEC and DICOM standards.
• Quality Assurance Measures: Standard development processes like risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, performance, safety, simulated use) were applied.
• No Clinical Studies Required: The submission explicitly states, "The subject of this premarket submission, Optima XR646 HD, does not require clinical studies to support substantial equivalence". This is a key point, as it indicates that no formal clinical trial or reader study (as implied by the questions regarding MRMC, human-in-the-loop, etc.) was deemed necessary by the manufacturer for this particular submission.

Therefore, I cannot provide the requested table and study details because the provided document does not contain an AI/ML device performance study. The device described is a traditional X-ray system, and its substantial equivalence is based on engineering changes and compliance with established standards, not on a new AI/ML algorithm requiring performance validation in the manner described by your questions.

In summary, there is no information in the provided document to answer the specific questions about acceptance criteria, test set details, expert ground truth, MRMC studies, or standalone algorithm performance, as these methodologies are typically applied to AI/ML software as a medical device (SaMD) or AI-augmented devices, which is not what this 510(k) describes.

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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.

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