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The SIGNA Prime Elite is a whole body magnetic resonance scanner designed to support 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, 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 SIGNA Prime Elite 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.

SIGNA Prime Elite is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan time. The system uses a combination of time-varying magnet fields (Gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. The system can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences, imaging techniques and reconstruction algorithms. The system features a 1.5T superconducting magnet with 60 cm bore size. The system is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

The document does not provide a table of acceptance criteria and reported device performance. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative performance metrics against pre-defined acceptance criteria.

Here's an analysis of the provided information concerning acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

The document does not contain a specific table outlining quantitative acceptance criteria and corresponding reported device performance metrics. It indicates that the SIGNA Prime Elite's image quality performance was compared to the predicate device through bench and clinical testing and found to be "substantially equivalent."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "The subject of this premarket submission, the SIGNA Prime Elite, did not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission."

Therefore, there is no formal test set sample size mentioned for a specific clinical performance study. The "sample clinical images" are used to demonstrate acceptable diagnostic image performance, but details about their sample size, provenance (country of origin), or whether they are retrospective or prospective are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since no formal clinical study with a defined test set and ground truth establishment is described, this information is not provided. The document mentions that images "when interpreted by a trained physician yield information that may assist in diagnosis," but it doesn't specify expert review for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

As there is no formal test set described for a clinical performance study, an adjudication method is not applicable and not mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document states that the SIGNA Prime Elite is a "whole body magnetic resonance scanner." There is no mention of AI assistance or a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The submission is for an imaging device, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a magnetic resonance scanner, not an algorithm that operates standalone without human interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Given that clinical studies were not required and only "sample clinical images" were included to demonstrate acceptable diagnostic image performance, there is no mention of a formally established ground truth type (e.g., expert consensus, pathology, outcomes data) for a test set. The images are expected to be interpreted by a "trained physician."

8. The sample size for the training set

The document describes the SIGNA Prime Elite as a new 1.5T MR system. It is a hardware device with associated software, not a machine learning model. Therefore, the concept of a "training set" in the context of machine learning is not applicable and not mentioned.

9. How the ground truth for the training set was established

As the device is an MR scanner and not an AI/ML model requiring a training set, this information is not applicable and not provided.

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