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The Optima™ MR450w 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 Optima™ MR450w 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 1.5 GE Optima MR450w features a superconducting magnet operating at 1.5 Tesla. The data acquisition system accommodates up to 32 independent receive channels in various increments, and multiple independent coil elements per channel during a single acquisition series. 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, oblique and double oblique planes, using various pulse sequences and reconstruction algorithms. The Silenz Imaging Application using the 3D Radial Pulse sequence reduces the acoustic noise that is generated during an MR examination. This application is compatible on the Optima MR450w system with GEM configuration. The 1.5T GE Optima MR450w is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

Here's an analysis of the provided text regarding the Optima MR450w, focusing on acceptance criteria and supporting studies:

It is important to note that the provided text is a 510(k) Summary for a modification to an existing MRI device (addition of the Silenz Imaging Application to the Optima MR450w). As such, it primarily focuses on demonstrating substantial equivalence to the predicate device, rather than proving novel clinical efficacy or establishing new clinical performance targets as would be the case for an entirely new device.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria or a table of performance metrics for the Optima MR450w with the Silenz application in the traditional sense of a clinical performance study (e.g., sensitivity, specificity, accuracy against a gold standard).

Instead, the acceptance criteria are implicitly met by demonstrating compliance with recognized standards and by verification and validation activities ensuring the device performs as intended and is equivalent to the predicate.

The reported device performance is qualitative, focused on maintaining existing standards and functionality:

Study Details

The document explicitly states that no external clinical studies were required to support substantial equivalence. The "studies" mentioned are internal verification and validation activities.

1. Sample size used for the test set and the data provenance:
* Test Set Sample Size: Not specified. The document mentions "Internal scans were conducted as part of validation for workflow and image quality." It does not provide a number of scans or distinct subjects/patients used for these internal tests.
* Data Provenance: "Internal scans" implies the data was generated within GE Healthcare, likely on their own systems for testing purposes. The country of origin and whether it was retrospective or prospective is not specified, but typically, internal validation scans are prospective as they are specifically generated for testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not specified. The document highlights "Testing on unit level," "Integration testing," and "Performance testing" with "passing results per the pass/fail criteria defined in the test cases." It also mentions "Simulated use testing."
* The interpretation of images is for "a trained physician" to yield information for diagnosis, but this refers to the intended use of the device, not the ground truth establishment for the internal validation studies.

3. Adjudication method for the test set:
* Not applicable/Not specified. The internal validation focused on technical performance rather than clinical diagnostic accuracy requiring adjudicated ground truth for a test set. The validation used "pass/fail criteria defined in the test cases."

4. 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 MRMC comparative effectiveness study was done.
* This device is an MRI scanner, and the "Silenz Imaging Application" is a feature to reduce acoustic noise, not an AI or CAD system intended to assist human readers in diagnosis. Therefore, the concept of improving human readers with AI assistance does not apply here.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
* Not applicable in the context of an "algorithm only" performance study for diagnostic AI. The device is a whole-body MRI scanner. Its performance is inherent in the image acquisition and reconstruction, not a standalone diagnostic algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* For the internal validation "workflow and image quality" scans, the ground truth would likely be based on technical specifications, industry standards for image quality, and expert review (though not explicitly detailed) of the acquired images to confirm they met predefined quality metrics (e.g., signal-to-noise ratio, spatial resolution, artifact levels, and successful noise reduction). It would not be clinical ground truth like pathology or outcomes data.

7. The sample size for the training set:
* Not applicable. This device is an MRI scanner, not a machine learning algorithm that requires a "training set" in the typical sense for diagnostic AI. While the internal development of the Silenz application (which likely involves signal processing and perhaps some optimization algorithms) would have utilized data, it's not described as a "training set" for a diagnostic AI.

8. How the ground truth for the training set was established:
* Not applicable, as there is no "training set" for a diagnostic AI algorithm in this context.

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The Optima™ MR450w 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 Optima™ MR450w 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 1.5T GE Optima MR450w features a superconducting magnet operating at 1.5 Tesla. The data acquisition system accommodates up to 32 independent receive channels in various increments, and multiple independent coil elements per channel during a single acquisition series. 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, oblique and double oblique planes, using various pulse sequences and reconstruction algorithms. The Optima MR450w is proposed to be marketed with an added XP Gradient configuration compatible with systems that have the GEM Coil Suite option. The 1.5T GE Optima MR450w is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

The GE Optima MR450w is a magnetic resonance diagnostic device and does not have specific computational acceptance criteria like an AI-powered diagnostic tool. Instead, the "acceptance criteria" are based on compliance with voluntary standards and the satisfactory performance across a range of technical and safety tests.

Here's a breakdown of the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states: "The subject of this premarket submission, Optima MR450w did not require external clinical studies to support substantial equivalence. Internal scans for workflow and image quality data were used for clinical validation."

This indicates that internal, retrospective data was used, but no specific sample size for a "test set" in the context of clinical performance evaluation is mentioned. The focus was on engineering verification and validation rather than a clinical trial.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The document does not describe a process of establishing ground truth for a clinical test set with expert adjudicators. Clinical validation was based on "internal scans for workflow and image quality data," implying internal review by presumably qualified GE personnel rather than a formal expert consensus process as seen in clinical AI studies.

4. Adjudication Method for the Test Set:

Not applicable. No formal adjudication method is described, as the device did not undergo external clinical studies requiring expert consensus on a clinical test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document explicitly states: "The subject of this premarket submission, Optima MR450w did not require external clinical studies to support substantial equivalence." Therefore, no MRMC study comparing human readers with and without AI assistance was performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. The Optima MR450w is a diagnostic imaging device, not an AI algorithm. Its performance is inherent in the image quality it produces, which is then interpreted by a trained physician. The "standalone" performance is the image quality itself, which was validated through the non-clinical tests listed.

7. Type of Ground Truth Used:

For the non-clinical performance tests (SNR, geometric distortion, etc.), the "ground truth" would be established by validated measurement standards and engineering specifications. For the "internal scans for workflow and image quality data," the ground truth would be based on established imaging protocols and subjective expert evaluation of image characteristics by internal GE staff. No pathology or outcomes data is mentioned as ground truth for this submission.

8. Sample Size for the Training Set:

Not applicable. The Optima MR450w is a hardware device (MRI scanner) with associated pulse sequences and reconstruction algorithms. It is not an AI algorithm that requires a "training set" in the conventional machine learning sense. Its design and algorithms are based on established physics and engineering principles, not statistical learning from a dataset.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no "training set" in the machine learning context for this device.

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The Optima MR450w is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique anatomical images, spectroscopic data, parametric maps, or dynamic images of the structures or functions of the entire body. The indication for use includes, but is 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 Optima MR450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and spectra, when interpreted by a trained physician yield information that may assist in diagnosis.

The 1.5T GE Optima MR450w features a superconducting magnet operating at 1.5 Tesla. The data acquisition system accommodates up to 32 independent receive channels in various increments, and multiple independent coil elements per channel during a single acquisition series. 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, oblique and double oblique planes, using various pulse sequences and reconstruction algorithms.. The 1.5T GE Optima MR450w is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

The GE Optima MR450w is a whole-body magnetic resonance scanner. The provided text, a 510(k) summary, outlines its safety and performance characteristics in comparison to a predicate device, the GE Discovery® MR450 System (K083147).

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria or a direct "reported device performance" table in the format usually seen for diagnostic algorithms. Instead, it refers to compliance with established standards (NEMA, IEC, ISO) and states that performance parameters were "measured and documented through testing to NEMA, IEC or ISO standards."

However, based on the Summary of Studies section, the performance parameters evaluated and implicitly deemed acceptable are:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set" in the context of an algorithm or AI model evaluation. The studies described are physical performance and safety tests of the MR scanner itself. Therefore, sample sizes for medical images or patient data are not relevant or provided here. The tests are in accordance with NEMA, IEC, or ISO standards, which dictate the procedures and specifications for evaluating MR system performance and safety.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable. The studies concern the fundamental physical and electrical performance of the MR scanner, not the diagnostic accuracy of interpretations based on images from the device. Ground truth, in this context, would be established by validated measurement equipment and adherence to engineering and safety standards, rather than expert interpretation of medical images.

4. Adjudication Method for the Test Set:

Not applicable, as there's no "test set" of medical images or diagnostic interpretations being adjudicated. The tests are objective measurements against published standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, an MRMC comparative effectiveness study was not done. This document describes the substantial equivalence of a new MR scanner model to a predicate device, focusing on its physical and safety performance. It does not involve human readers interpreting images with or without AI assistance, nor does it measure the effect size of AI on human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:

No, a standalone algorithm performance study was not done. The device is an MR imaging hardware system, not an AI algorithm.

7. The Type of Ground Truth Used:

The ground truth for the evaluations described is based on established engineering, safety, and performance standards as defined by organizations like NEMA, IEC, and ISO. These standards dictate acceptable ranges and methodologies for measuring parameters such as SNR, geometric distortion, SAR, and acoustic noise. The "truth" is whether the device's measured performance falls within the specified limits of these standards.

8. The Sample Size for the Training Set:

Not applicable. The document is about the hardware and core functionality of an MR scanner, not an AI or machine learning model. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable, for the same reasons as above.

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