(185 days)
What the user provided is a comprehensive overview of a medical device, which contains the intended use/indications for use. When asked to output the intended use as it appears in this document, the following is provided:
Whole Body Magnet Resonance Imaging
The modification is a new imaging sequence referred to as Echo Planar Imaging (EPI). EPI is an imaging technique which produces multiple gradient echoes after an initial RF excitation, thereby allowing faster imaging than standard gradient echo techniques.
Here's a breakdown of the acceptance criteria and study information for the Elscint EPI for the Gyrex Prestige and Privilege Systems, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: | |
| - Adherence to FDA recommended SAR (Specific Absorption Rate) limits for MRI. | The MRI safety parameters, SAR, dB/dt, Bo, and acoustic noise, are unchanged by the current modification. This implies that the device continues to meet the FDA safety limits as the predicate devices. |
| - Adherence to FDA recommended dB/dt limits for MRI. | Unchanged. |
| - Adherence to FDA recommended Bo limits for MRI. | Unchanged. |
| - Adherence to FDA recommended acoustic noise limits for MRI. | Unchanged. |
| - No new electrical, mechanical, or biocompatibility safety issues introduced. | Electrical, mechanical, and biocompatibility safety issues do not apply to the current modification. |
| - No new software hazards introduced. | No new software hazards have been introduced, so the software level of concern remains minor. |
| - No impact on site planning, installation, or service manuals. | The current modifications do not affect the site planning, installation, or service manuals. |
| - No new safety labeling required. | Do not require any new safety labeling. |
| Effectiveness: | |
| - EPI sequences produce images comparable with other imaging sequences. | The EPI sequences produce images that are comparable with those produced using other imaging sequences. |
| - Utility for particular applications due to faster imaging. | The EPI sequences are limited in resolution, but they are faster than other imaging sequences which makes them useful for particular applications. |
Study Information
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Sample size used for the test set and the data provenance: Not explicitly stated in the provided text. The document refers to "images that are comparable with those produced using other imaging sequences" but does not detail a specific test set. This suggests a more general comparison rather than a formal study with a defined test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed ground truth establishment for a specific test set is not described. The evaluation appears to be a general assessment of image comparability.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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: Not applicable. This device is an imaging sequence modification, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an imaging sequence modification, not an algorithm with standalone performance metrics. The effectiveness is assessed by the quality and utility of the generated images.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated. The "effectiveness" section states that EPI sequences produce images that are "comparable with those produced using other imaging sequences." This implies a qualitative assessment of image quality and diagnostic information content, likely against established clinical standards or the predicate device's image quality. It's an assessment of image fidelity rather than a ground truth for a diagnostic task.
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The sample size for the training set: Not applicable. This document describes a modification to an MRI system's imaging sequence, not a machine learning model that requires a training set.
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How the ground truth for the training set was established: Not applicable.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.