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The SIGNA Pioneer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions 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.

Depending on the region of interest being imaged, contrast agents may be used.

The images produced by the SIGNA Pioneer reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The SIGNA Pioneer features a 3.0T superconducting magnet with a 70cm bore size.

The RF receiver is equipped with up to 97 RF channels.

The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of nuclei exhibiting magnetic resonance.

The system can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences and reconstruction algorithms.

The SIGNA Pioneer uses multi-drive RF transmit for imaging of the head and body regions.

The SIGNA Pioneer is designed to conform to NEMA DICOM standards.

The provided text is a 510(k) summary for the GE Healthcare SIGNA Pioneer Magnetic Resonance Diagnostic Device. It states that clinical studies were not required to support substantial equivalence for this submission (K160621). Therefore, the document does not contain information regarding detailed acceptance criteria, specific device performance metrics, sample sizes, provenance of data, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance for a study proving the device meets acceptance criteria.

The information provided only discusses the device's intended use, technological specifications, and compliance with voluntary standards, comparing it to a predicate device (SIGNA Pioneer, K143345). The substantial equivalence determination is based on non-clinical tests, design controls, and the fact that the indications for use are identical to the predicate device.

Therefore, it is not possible to provide the requested table and details as the document explicitly states that clinical studies were not used to support this 510(k) clearance.

The relevant statements from the document are:

• "Summary of Clinical Tests: The subject of this premarket submission, SIGNA Pioneer, did not require clinical studies to support substantial equivalence." (Page 4)
• "Scanning of human subjects on the SIGNA Pioneer system has been conducted at GE Healthcare facilities as part of design validation activities in order to ensure that the modified device meets user requirements." (Page 4)

This indicates that while some human subject scanning has occurred for design validation, it was not structured as a clinical study for demonstrating substantial equivalence against specific performance criteria for regulatory purposes.

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