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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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