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The SIGNA™ Sprint 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 SIGNA™ Sprint 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™ Sprint 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 70cm bore size. The system is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

Key aspects of the system design:

• Uses the same magnet as a conventional whole-body 1.5T system, with integral active shielding and a zero boil-off cryostat.
• A gradient coil that achieves up to 65 mT/m peak gradient amplitude and 200 T/m/s peak slew rate.
• An embedded body coil that reduces thermal and enhance intra-bore visibility.
• A newly designed 1.5T AIR Posterior Array.
• A detachable patient table.
• A platform software with various PSD and applications, including the following AI features:
  • AIRx™ (Cleared in K183231)
  • AIR™ Recon DL (Cleared in K202238)
  • Sonic DL™ (Cleared in K223523)

The provided text is a 510(k) clearance letter and summary for a new MRI device, SIGNA™ Sprint. It states explicitly that no clinical studies were required to support substantial equivalence. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, ground truth definitions, expert qualifications, and MRMC studies is not available in this document.

The document highlights the device's technical equivalence to a predicate device (SIGNA™ Premier) and reference devices (SIGNA™ Artist, SIGNA™ Champion) and relies on non-clinical tests and sample clinical images to demonstrate acceptable diagnostic performance.

Here's a breakdown of what can be extracted from the document regarding testing, and why other requested information is absent:

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

• Acceptance Criteria (Implicit): The document states that the device's performance is demonstrated through "bench testing and clinical testing that show the image quality performance of SIGNA™ Sprint compared to the predicate device." It also mentions "acceptable diagnostic image performance... in accordance with the FDA Guidance 'Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices' issued on October 10, 2023."
  • Specific quantitative acceptance criteria (e.g., minimum SNR, CNR, spatial resolution thresholds) are not explicitly stated in this document.
• Reported Device Performance: "The images produced by SIGNA™ Sprint 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."
  • No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or detailed image quality scores) are provided in this regulatory summary. The statement "The image quality of the SIGNA™ Sprint is substantially equivalent to that of the predicate device" is the primary performance claim.

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

• Test Set Sample Size: Not applicable/Not provided. The document explicitly states: "The subject of this premarket submission, the SIGNA™ Sprint, did not require clinical studies to support substantial equivalence."
• Data Provenance: Not applicable/Not provided for a formal clinical test set. The document only mentions "Sample clinical images have been included in this submission," but does not specify their origin or nature beyond being "sample."

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)

• Not applicable. Since no formal clinical study was conducted for substantial equivalence, there was no "test set" requiring ground truth established by experts in the context of an effectiveness study. The "interpretation by a trained physician" is mentioned in the Indications for Use, which is general to MR diagnostics, not specific to a study.

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

• Not applicable. No clinical test set requiring adjudication was conducted for substantial equivalence.

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

• No. The document explicitly states: "The subject of this premarket submission, the SIGNA™ Sprint, did not require clinical studies to support substantial equivalence." While the device incorporates AI features cleared in other submissions (AIRx™, AIR™ Recon DL, Sonic DL™), this specific 510(k) for the SIGNA™ Sprint system itself does not include an MRMC study or an assessment of human reader improvement with these integrated AI features. The focus is on the substantial equivalence of the overall MR system.

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

• No, not for the SIGNA™ Sprint as a whole system. This 510(k) is for the MR scanner itself, not for a standalone algorithm. Any standalone performance for the integrated AI features (AIRx™, AIR™ Recon DL, Sonic DL™) would have been part of their respective clearance submissions (K183231, K202238, K223523), not this one.

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

• Not applicable. No formal clinical study requiring ground truth was conducted for this submission.

8. The sample size for the training set

• Not applicable/Not provided. This submission is for the SIGNA™ Sprint MR system itself, not a new AI algorithm requiring a training set developed for this specific submission. The AI features mentioned (AIRx™, AIR™ Recon DL, Sonic DL™) were cleared in previous 510(k)s and would have had their own training and validation processes.

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

• Not applicable/Not provided. As explained in point 8, this submission does not detail the training of new AI algorithms.

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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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SIGNA MAGNUS system is a head-only magnetic resonance scanner designed to support high resolution, high signal-tonoise ratio, diffusion-weighted imaging, and short scan times. SIGNA MAGNUS is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the head, neck, TMJ, and limited cervical spine on patients 6 years of age and older. Depending on the region of interest being imaged, contrast agents may be used.

The images produced by SIGNA MAGNUS 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 MAGNUS is a 3.0T high-performance magnetic resonance imaging system designed to support imaging of the head, neck, TMJ and limited cervical spine. The system supports scanning in axial, coronal, sagittal, oblique, and double oblique planes using a variety of pulse sequences, imaging techniques, acceleration methods, and reconstruction algorithms. The system can be delivered as a new system installation, or as an upgrade to existing compatible whole-body 3.0T MR

Key aspects of the system design:
• An asymmetrically designed, head-only gradient coil that achieves up to 300 mT/m peak gradient amplitude and 750 T/m/s peak slew rate.
• A graduated patient bore size, starting at 74 cm at the entry down to 37 cm at isocenter.
• Uses the same magnet as a conventional whole-body 3.0T system, with integral active shielding and a zero boil-off cryostat.
• Can be installed as a new system or upgraded from an existing compatible whole-body 3.0T MR system.
• A dockable mobile patient table.
• Oscillating Diffusion Encoding (ODEN) - a spectral diffusion technique that uses a sinusoidal diffusion gradient waveform.

The provided text is a 510(k) Summary for the GE Healthcare SIGNA MAGNUS, a magnetic resonance diagnostic device. The summary indicates that this device did not require clinical studies to support substantial equivalence. Therefore, there are no acceptance criteria, performance metrics, sample sizes for test/training sets, expert qualifications, or other details related to clinical performance studies to report for this device, as these were not performed or deemed necessary by the manufacturer for this submission.

The document states:
"The subject of this premarket submission, SIGNA MAGNUS did not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission. The sample clinical images demonstrate acceptable diagnostic image performance of SIGNA MAGNUS in accordance with the FDA Guidance 'Submission of Premarket Notifications fo October 10, 2023. The image quality of SIGNA MAGNUS is substantially equivalent to that of the predicate device."

This means that the substantial equivalence was primarily based on non-clinical tests and a comparison of technological characteristics and indications for use with a predicate device (SIGNA Premier (K193282)). The non-clinical tests focused on safety and performance in compliance with various voluntary standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC 62304, IEC 60601-1-6, IEC 62366-1, IEC62464-1, ISO 10993-1, NEMA MS, NEMA PS3 DICOM).

Due to the absence of a clinical study, the requested information cannot be extracted from the provided text.

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