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The MR Surgical Option when integrated with the GE Signa® 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used to produce head and whole body magnetic resonance images that are high resolution, high signal-to-noise ratio, with short scan times. The Signa® Excite MR system with Surgical Option is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa® Excite system with Surgical Option reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The GE Signa® Excite system with Surgical Option can provide MR images at various stages of a surgical procedure, and provides the capability to transfer a patient to the MR system table directly from a surgical table, or patient transport system. Images can be obtained using the MR scanner body coil, or local surface coils, and the surface coils used with the integrated system may / can accommodate sterile draping for surgical procedures.

The GE Signa® Excite MR Surgical Option is a MR table and transfer board that allows the patient to be moved from a surgical table to the MR scanner without changing the patient's position. It can be used in conjunction with a surgical table and other MR compatible equipment, such as but not limited to, patient monitoring equipment, IV pole, patient restraints, patient positioning accessories, and skull clamps that can be mounted to the patient transfer board, to facilitate ease of movement between the MR and operating rooms. The GE Signa® Excite MR Surgical Option can be used with single, or multiple surgical tables. The option will seamlessly integrate patient transfer from a surgical table and facilitate imaging within the GE Signa® Excite MR system. The patient, once transferred onto the MR system table, can then be scanned in the same manner as with traditional routine MR imaging. This device allows the GE Signa® Excite MR system to be utilized in a configuration of an integrated Surgical / MR suite.

The provided text describes a 510(k) summary for the GE Signa® Excite MR Surgical Option. However, it does not contain any information about acceptance criteria or a study that evaluates the device's performance against such criteria in the context of diagnostic accuracy, sensitivity, specificity, or similar metrics typically associated with AI/algorithm-based devices.

The device described is a physical component (MR table and transfer board) that allows for patient transfer between a surgical table and an MR scanner. The "Summary of Studies" section only mentions evaluation against "IEC 60601-1 International Medical Equipment Safety standard and IEC 60061-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis." These standards pertain to electrical safety and basic function of MR equipment, not diagnostic performance.

Therefore, I cannot populate the requested table or answer most of the questions because the submission does not include information on:

1. Acceptance criteria for device performance (e.g., diagnostic accuracy, sensitivity, specificity): Not applicable as this is a physical transfer system, not a diagnostic algorithm.
2. Reported device performance for diagnostic metrics: Not applicable.
3. Sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone studies, type of ground truth, training set size, or how training ground truth was established: These are all related to studies evaluating diagnostic or algorithmic performance, which are not detailed in this submission for this device.

Based on the provided text, the device is evaluated for safety and compatibility with existing MR systems, not for improved imaging quality or diagnostic accuracy.

If the request implied that the device should have such studies, the provided text does not contain that information.

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