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The SIGNA Voyager is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan time imaging. The SIGNA Voyager is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images and/or spectra, dynamic images, and parametric maps of the internal structures and organs of the entire body. Body structures for evaluation include, but are 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 Voyager reflect the spatial distribution and/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 Voyager system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The system uses a combination of time-varying magnetic 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 and oblique planes, using various pulse sequences and reconstruction algorithms. The system is offered as a new system installation, in either a fixed or a mobile configuration. The system features a 1.5T superconducting magnet with a 70cm bore size.

This document, K192426, is a 510(k) premarket notification for a magnetic resonance diagnostic device (MRI scanner), the SIGNA Voyager / SIGNA Voyager Quantum, submitted by GE Healthcare (Tianjin) Company Limited.

Based on the provided text, there is no specific information regarding acceptance criteria and a study that proves the device meets those criteria in the context of an AI/algorithm performance study. The document is a 510(k) summary focusing on demonstrating substantial equivalence to a predicate device (SIGNA Voyager K161567) and does not detail the evaluation of an AI algorithm's performance with respect to specific diagnostic criteria.

Instead, the summary emphasizes:

• Compliance with voluntary standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, and applicable NEMA MS standards for MRI.
• Quality assurance measures: Risk Analysis, Requirements Reviews, Design Reviews, Unit-level testing, Integration testing, Performance testing, Safety testing, and Simulated use testing.
• Lack of clinical studies required for substantial equivalence: "The subject of this premarket submission, SIGNA Voyager, did not require clinical studies to support substantial equivalence."
• Human subject scanning for design validation: "Scanning of human subjects on the SIGNA Voyager 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." This is for validating the device's performance (e.g., image quality, signal-to-noise ratio, scan times), not for evaluating an AI's diagnostic accuracy or impact on human reader performance.

Therefore, I cannot populate the requested tables and information about AI algorithm performance, as the provided document does not describe such a study or related acceptance criteria. The 510(k) is for the MRI hardware itself and its modifications, not an AI diagnostic adjunct.

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The SIGNA Voyager is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan time imaging. The SIGNA Voyager is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images and/or spectra, dynamic images, and parametric maps of the internal structures and organs of the entire body. Body structures for evaluation include, but are 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 Voyager reflect the spatial distribution and/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 Voyager system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The system uses a combination of time-varying magnetic 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 and oblique planes, using various pulse sequences and reconstruction algorithms. The system is offered as a new system installation, in either a fixed or a mobile configuration. The system features A 1.5T superconducting magnet with a 70cm bore size.

The document describes the SIGNA Voyager, a Magnetic Resonance Diagnostic Device. However, it does not provide specific acceptance criteria in a table format with reported device performance or details of a dedicated study to prove it meets acceptance criteria as might be expected for an AI/CADe device.

Instead, the document focuses on substantial equivalence to predicate devices (SIGNA Pioneer and Optima MR450w 1.5T). The "Performance Data" section primarily discusses non-clinical tests and a summary of clinical images, rather than a detailed clinical study with quantifiable acceptance criteria.

Based on the provided text, here is an attempt to answer your questions, highlighting where information is not available:

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

No explicit table of acceptance criteria with corresponding device performance metrics is provided for the SIGNA Voyager in this document. The document states:

"The sample clinical images demonstrate the acceptable diagnostic imaging performance of the SIGNA Voyager including the additional enhanced software features and all coils. The image quality of SIGNA Voyager is substantially equivalent to that of the predicate device."

This statement implies that the acceptance criterion was "acceptable diagnostic imaging performance" and "substantially equivalent image quality to the predicate device", which was demonstrated through clinical images. However, specific quantitative metrics for "acceptable diagnostic imaging performance" are not defined.

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 mentions "The sample clinical images," but does not specify the sample size for these images, nor does it provide details about data provenance (country of origin, retrospective/prospective nature).

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)

This information is not provided in the document. It states that images are "interpreted by a trained physician," but does not detail the number or qualifications of experts involved in establishing ground truth for any test set mentioned.

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

This information is not provided in the document.

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

A MRMC comparative effectiveness study, especially concerning AI assistance, is not mentioned. The SIGNA Voyager is a magnetic resonance diagnostic device, not an AI/CADe device in the context typically requiring such studies for performance evaluation. The "enhanced software features" are not characterized as AI for diagnostic assistance.

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

This is not applicable for the SIGNA Voyager, as it is a diagnostic imaging device, not a standalone algorithm. Its performance inherently involves human interpretation.

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

The document states that images and/or spectra, "when interpreted by a trained physician yield information that may assist in diagnosis." This implies that the basis for "acceptable diagnostic imaging performance" would be physician interpretation, acting as a form of expert consensus or clinical judgment. However, the exact methodology for establishing ground truth for the "sample clinical images" is not explicitly detailed.

8. The sample size for the training set

The document discusses "The sample clinical images" for demonstrating performance, but it does not mention any training set or details regarding the development process that would involve a training set (which would be typical for an AI/ML device, but not explicitly stated for this MR device).

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

As no training set is mentioned in the context of device performance evaluation, this information is not applicable/provided.

Summary of Device Performance (as stated in the document, without specific metrics):

• Intended Use: Produce axial, sagittal, coronal, and oblique images and/or spectra, dynamic images, and parametric maps of the internal structures and organs of the entire body.
• Performance Claim: "The sample clinical images demonstrate the acceptable diagnostic imaging performance of the SIGNA Voyager including the additional enhanced software features and all coils."
• Equivalence Claim: "The image quality of SIGNA Voyager is substantially equivalent to that of the predicate device."

In essence, this 510(k) summary focuses on demonstrating substantial equivalence through descriptions of technological characteristics, adherence to voluntary standards, quality assurance measures during development, and a general statement about clinical image quality compared to predicates, rather than extensive clinical study results with detailed acceptance criteria and quantitative performance metrics.

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