(112 days)
The GEM Option for 1.5T MRI systems is a set of receive-only RF surface coils designed for use with 1.5T MRI systems manufactured by GE Healthcare. The GEM Option for I .5T MRI systems is indicated for use for: head, neck, brachial-plexus, spine, pelvis, hips, prostate, abdominal, cardiac, lower extremities, blood vessels, and long bone imaging. The nucleus detected is hydrogen.
The GEM Option for 1.5T MRI systems consists of a set integrated receive-only RF coils designed for use with 1.5T MRI systems manufactured by GE Healthcare. This coil set includes a head and neurovascular array, an anterior imaging array, a peripheral-vascular lower leg array, and a posterior imaging array integrated into the MR table for complete head-to-foot coverage. The coils can be used individually or combined to provide the anatomical coverage desired. The combined use of the entire GEM suite will facilitate high-resolution, high-SNR whole-body imaging from the top of the head down to the feet.
This document describes a 510(k) premarket notification for the "GEM Option for 1.5T MRI systems" by GE Healthcare. The device consists of integrated receive-only RF coils for 1.5T MRI systems. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (K091536, Optima MR450w) through non-clinical tests and clinical imaging, rather than presenting a standalone study with specific acceptance criteria and detailed performance metrics of a novel AI device.
Therefore, many of the requested elements for describing the acceptance criteria and a study proving device performance, particularly those related to AI algorithm performance (e.g., sample size for test/training sets, ground truth establishment, expert consensus, MRMC studies, standalone performance), are not applicable to the content provided. The document focuses on regulatory compliance, electrical safety, EMC, biocompatibility, and qualitative substantial equivalence for a hardware component rather than a diagnostic AI software.
Based on the provided text, here is what can be extracted and what information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance and Compliance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 (all applicable sections) | Compliant with all applicable sections |
| Compliance with IEC 60601-2-33 (all applicable sections) | Compliant with all applicable sections | |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (all applicable sections including electrostatic discharge) | Compliant with all applicable sections (i.e. electrostatic discharge) |
| Biocompatibility | Compliance with ISO 10993-1 (determination of post market acceptability of materials) | Determination of post market acceptability of materials (implies compliance) |
| Performance/Substantial Equivalence | Clinical images demonstrate substantial equivalence of performance to predicate device (Optima MR450w, K091536) | Clinical images are used to demonstrate substantial equivalence of performance. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified. The document states "Clinical images are used to demonstrate substantial equivalence of performance," but no details on the number of cases or subjects are provided.
- Data provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as the reported study relies on clinical image review for qualitative substantial equivalence, not a quantitative measure requiring expert-established ground truth for an AI algorithm. No "ground truth" as typically understood for AI evaluation is mentioned.
4. Adjudication method for the test set
- Not applicable for the same reasons as point 3.
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, an MRMC comparative effectiveness study was not done. This device is a hardware component (RF coils) for an MRI system, not an AI software. The provided text does not describe any human-in-the-loop AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a hardware component, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The substantial equivalence is determined by comparing clinical images produced by the new coils to those from a predicate device, focusing on image quality and the ability to perform the intended use. There is no mention of a specific ground truth (like pathology or outcomes data) typically associated with diagnostic accuracy studies of AI. The assessment seems to be qualitative based on engineering and imaging principles.
8. The sample size for the training set
- Not applicable. This is a hardware device submission, not an AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. This is a hardware device submission, not an AI algorithm, so there is no "training set" or associated ground truth establishment process.
§ 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.