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The current modification to the Gyrex 2T-Prestige consists of the addition of software to enable the production of 'H spectra are produced using the existing MRI hardware.
The spectroscopy software includes automated shimming, water suppression, transmitter calibration, central frequency calibration, phase correction and display, and higher level spectral processing functions.
This document is a 510(k) summary for a device called "Gyrex 2T Prestige 'H Spectroscopy Option." It's a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.
Based on the provided text, there is no study described that proves the device meets specific acceptance criteria in the way you've outlined. This document is a regulatory submission focused on demonstrating substantial equivalence, not on presenting a clinical or performance study with detailed acceptance criteria and results.
Here's why and what information can be extracted:
- Acceptance Criteria/Performance Table: Not applicable because no performance study is described. The document only states "The effectiveness of the system is similar to that of the GE Hydrogen Spectroscopy Option - PROBE (the predicate device)." It doesn't quantify this similarity or list specific performance metrics it had to meet.
- Sample size and data provenance: No performance study is described, so no sample size or data provenance is provided.
- Number of experts and qualifications: No performance study is described that involved experts establishing ground truth.
- Adjudication method: Not applicable as no performance study with ground truth adjudication is described.
- MRMC comparative effectiveness study: Not applicable as no such study is described.
- Standalone performance: Not applicable as no standalone performance study is described. The submission focuses on the addition of software to existing MRI hardware to enable 'H spectroscopy.
- Type of ground truth: Not applicable as no performance study with ground truth is described.
- Sample size for training set: Not applicable as no machine learning model requiring a training set is described. The modification is described as "software to enable the production of 'H spectra."
- Ground truth for training set: Not applicable as there's no training set described.
Summary of available information related to your questions:
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Table of acceptance criteria and reported device performance:
- Acceptance Criteria: Implicitly, the device must perform similarly in effectiveness to the predicate device (GE Hydrogen Spectroscopy Option - PROBE). No specific quantitative criteria are listed.
- Reported Device Performance: Stated as "The effectiveness of the system is similar to that of the GE Hydrogen Spectroscopy Option - PROBE (the predicate device)." No specific performance metrics or data are provided.
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Sample size used for the test set and the data provenance: Not provided. The document does not describe a performance study with a 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; no ground truth establishment for a test set is described.
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Adjudication method for the test set: Not applicable; no test set or adjudication process is described.
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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: No MRMC study is described.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No standalone performance study, as typically understood for AI algorithms, is described. The modification is software to enable 'H spectroscopy, implying instrumental performance rather than independent algorithmic performance.
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The type of ground truth used: Not applicable; no ground truth (expert consensus, pathology, outcomes data, etc.) is mentioned in the context of a performance study.
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The sample size for the training set: Not applicable; no training set for a machine learning model is mentioned.
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How the ground truth for the training set was established: Not applicable; no training set is mentioned.
Conclusion:
This 510(k) summary focuses on demonstrating that a software addition to an existing MRI system (Gyrex 2T Prestige) to enable 'H spectroscopy is "substantially equivalent" in safety and effectiveness to predicate devices. It achieves this by arguing that:
- Safety aspects (BoodB/dt, acoustic noise, SAR) are unaffected or equivalent to the predicate.
- Software hazards were minimized by design and testing.
- Effectiveness is similar to the GE Hydrogen Spectroscopy Option - PROBE.
It does not provide details of a new performance study with specific acceptance criteria that the new device had to meet and detailed results quantifying its performance against those criteria. The "study" here is the regulatory submission process itself, where the claim of "similarity" is the main argument for effectiveness.
§ 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.