(29 days)
The 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, and 1.5T 30ch AIR AA are receive only RF coils designed for use with GE 1.5T MRI systems to produce diagnostic images on general human anatomy including extremities. The nucleus detected is hydrogen.
The 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA and 1.5T 30ch AIR AA are receive-only coils designed to provide optimum signal-to noise ratio and uniform coverage of general human anatomy including extremities and are designed for use with GE 1.5T MRI Systems. These are 20, 21, 16, and 30 element coils tuned to image proton nuclei. Each coil element has an integrated preamplifier to improve image quality. These coils are provided with P-connectors. The coils have a soft material to conform to the patient's anatomy and maximize patient comfort. Due to the flexibility of the coils, a coil holder may be used to assist in securing the coil in place.
This document describes the 510(k) premarket notification for GE Healthcare Coils. It focuses on establishing substantial equivalence for several new 1.5T MRI receive-only RF coils: 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, and 1.5T 30ch AIR AA, compared to a predicate device (3.0T Anterior Array, K172695).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical performance metrics for the new coils that are then compared against specific thresholds. Instead, it describes compliance with various safety and performance testing standards and states a general conclusion of substantial equivalence in performance to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety Testing | |
| AAMI/ANSI ES60601-1 | Complies |
| IEC 60601-1-2 | Complies |
| IEC 60601-2-33 | Complies |
| NEMA MS 6 | Complies |
| NEMA MS 9 | Complies |
| Maximum B1 peak | Tested |
| Network blocking analysis | Tested |
| Heat Testing | Tested |
| Biocompatibility (ISO 10993) | Successful track record |
| Performance Testing | |
| Adequate Image Quality | Clinical images included that support diagnostic use; non-clinical tests demonstrate devices perform as intended, comparable to predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a separate "test set" with a defined sample size for quantitative evaluation in the same way a clinical trial would. Clinical images were included in the submission, implying a small set for demonstration, but no specific count or details of patient cases used for formal performance evaluation are provided.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be internal GE Healthcare evaluations rather than external multi-center trials. The clinical images are for demonstration, not a formal prospective or retrospective study for device performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document states that the new coils produce "diagnostic images...that can be interpreted by a trained physician" (referencing the Siemens predicate's IFU), but it doesn't detail external expert review for the submitted clinical images or the "ground truth" establishment process.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. Given the lack of a formally described "test set" and expert review process for ground truth, an adjudication method is not mentioned.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This submission is for MRI coils, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. This submission is for MRI coils, which are hardware components, not an algorithm. Therefore, no standalone algorithm performance was evaluated.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The concept of "ground truth" in the context of diagnostic accuracy (e.g., pathology as ground truth for a CAD system) is not directly applicable here. The submission focuses on demonstrating the functional equivalence of image quality and safety for the coils. Clinical images were included, presumably to visually demonstrate acceptable image quality, but without a formal ground truth comparison for diagnostic accuracy of specific conditions. The ground truth for safety and performance is based on compliance with established engineering and medical device standards.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. These are hardware devices (MRI coils), not machine learning algorithms that require training sets.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for these hardware devices.
§ 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.