(57 days)
The 3.0T 16ch AIR AA is a receive-only RF coil designed for use with GE 3.0T MRI systems to produce diagnostic images of general human anatomy, including extremities. The nucleus detected is hydrogen.
The 3.0T 16ch AIR AA is a receive-only coil designed to provide optimum signal-to noise and uniform coverage of general human anatomy including extremities. The coil has 16 elements tuned to image proton nuclei. Each coil element has an integrated preamplifier to improve image quality. The 3.0T 16ch AIR AA is provided with a P-connector that is compatible with GE Healthcare 3.0T MR systems. The coils have a soft material to conforms to the patient's anatomy and maximize patient comfort.
This document describes a 510(k) premarket notification for the GE Healthcare 3.0T 16ch AIR AA, a receive-only RF coil for MRI systems. The submission asserts substantial equivalence to a predicate device (1.5T 16ch AIR AA, K182590) based on non-clinical and clinical testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Defined in FDA Guidance Document "Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway") | Reported Device Performance (Summary from submission) |
|---|---|
| Image Quality: | Met: |
| Image Signal-to-Noise Ratio (SNR) in accordance with NEMA MS-9 | Satisfied performance criteria. |
| Image Uniformity in accordance with NEMA MS-9 | Satisfied performance criteria. |
| Diagnostic Quality Images for various anatomies and pulse sequences | Determined to be of diagnostic quality by a U.S. Board Certified Radiologist. |
| Safety: | Met: |
| Surface heating in accordance with NEMA MS-14 | Satisfied performance criteria. |
| Inspection of decoupling circuitry | Satisfied performance criteria. |
| EMC testing for immunity from electrostatic discharge in accordance with applicable portions of IEC 60601-1-2 | Satisfied performance criteria. |
| General electrical and mechanical safety in accordance with applicable portions of AAMI/ANSI ES 60601-1 and IEC 60601-2-33 | Satisfied performance criteria. |
| Biocompatibility assessment in accordance with the ISO 10993 series of standards | Satisfied performance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Non-Clinical Testing: The document does not specify a "sample size" in terms of number of patients or cases for the non-clinical tests (SNR, Uniformity, Heating, etc.). These tests are typically performed on the device itself under controlled laboratory conditions. The data provenance is implied to be from GE Healthcare's testing facilities.
- Clinical Testing: The document states "sample clinical images have been obtained from various anatomies and using various pulse sequences." The exact number of images, patients, or cases is not specified. The provenance of this data (e.g., country of origin, retrospective or prospective) is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Non-Clinical Testing: Ground truth for non-clinical tests is based on established engineering standards (NEMA, IEC, AAMI/ANSI, ISO). No human experts are explicitly mentioned for establishing ground truth in this context, as measurements are objective.
- Clinical Testing: The diagnostic quality of the sample clinical images was "assessed by a U.S. Board Certified Radiologist." This indicates one expert was used. Their qualification is a "U.S. Board Certified Radiologist." The exact experience level (e.g., 10 years) is not specified.
4. Adjudication Method for the Test Set
- Non-Clinical Testing: Not applicable, as objective standards are used.
- Clinical Testing: Inferred as none, as only one radiologist assessed the images for diagnostic quality. There is no mention of multiple readers or an adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was NOT done. The document explicitly states "sample clinical images have been obtained... and determined to be of diagnostic quality" by a single radiologist. There is no mention of comparing human readers with and without AI assistance, or any effect size. This device is a hardware component (MRI coil), not an AI algorithm designed to assist human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- This question is not directly applicable as the device is an MRI receive coil, which is a hardware component, not an AI algorithm. The performance being evaluated is the image quality and safety of the coil itself. The clinical testing focuses on whether the images produced by the coil are diagnostically acceptable.
7. The Type of Ground Truth Used
- Non-Clinical Testing: Ground truth is based on engineering standards and direct physical measurements (e.g., SNR values, temperature readings, electrical parameters).
- Clinical Testing: Ground truth for image diagnostic quality is based on expert consensus (specifically, the assessment of a U.S. Board Certified Radiologist).
8. The Sample Size for the Training Set
- Not Applicable. This document describes the clearance of a hardware device (an MRI coil), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As mentioned above, this is a hardware device approval, not an AI algorithm.
§ 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.