(30 days)
The 3.0T AIR MP M is a receive only RF coil designed for use with GE 3.0T MRI systems to produce diagnostic images on general human anatomy including extremities. The nucleus detected is hydrogen.
The 3.0T AIR MP L is a receive only RF coil designed for use with GE 3.0T MRI systems to produce diagnostic images on general human anatomy including extremities. The nucleus detected is hydrogen.
The 3.0T AIR MP M is a receive-only coil designed to provide optimum signal-to noise and uniform coverage of general human anatomy including extremities and are designed for use with GE 3.0T MRI Systems. This is a 20 element coils tuned to image proton nuclei. Each coil element has an integrated preamplifier to improve image quality. The 3.0T AIR MP M is provided with P-connectors. The coil has 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.
The 3.0T AIR MP L is a receive-only coil designed to provide optimum signal-to noise and uniform coverage of general human anatomy including extremities and are designed for use with GE 3.0T MRI Systems. This is a 21 element coils tuned to image proton nuclei. Each coil element has an integrated preamplifier to improve image quality. The 3.0T AIR MP L is provided with P-connectors. The coil has 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.
The provided text describes a 510(k) premarket notification for an MRI coil, not an AI/ML medical device. Therefore, much of the requested information regarding acceptance criteria, study design for performance, and ground truth for AI algorithms is not applicable.
However, I can extract the relevant information about the device itself and the non-clinical testing conducted to demonstrate substantial equivalence, which serves as the "proof" the device meets certain criteria for safety and performance.
Device Description and Intended Use:
The devices are the 3.0T AIR MP M (20 elements) and 3.0T AIR MP L (21 elements), which are receive-only RF coils designed for use with GE 3.0T MRI systems to produce diagnostic images on general human anatomy, including extremities. The nucleus detected is hydrogen.
1. Table of acceptance criteria and the reported device performance
Since this is an MRI coil, "acceptance criteria" and "device performance" are primarily related to safety, electromagnetic compatibility, and image quality as demonstrated through non-clinical testing against recognized standards. The document states the device performs "as intended" based on these tests.
| Acceptance Criteria (based on standards/testing) | Reported Device Performance |
|---|---|
| Safety Standards | |
| AAMI/ANSI ES60601-1 (general medical electrical equipment safety) | Complies with standard |
| IEC 60601-1-2 (electromagnetic compatibility) | Complies with standard |
| IEC 60601-2-33 (MR equipment specific safety) | Complies with standard |
| NEMA MS 6 (MR image quality standards) | Complies with standard, performs as intended (implies acceptable IQ) |
| NEMA MS 9 (MR image quality standards) | Complies with standard, performs as intended (implies acceptable IQ) |
| Biocompatibility (ISO 10993) | Successful biocompatibility track record |
| Network Blocking Analysis | Testing conducted |
| Heat Testing | Testing conducted |
| Quality Assurance Measures | |
| Risk Analysis | Applied to development |
| Requirements Reviews | Applied to development |
| Design Reviews | Applied to development |
| Unit level testing (Module verification) | Applied to development |
| Integration testing (System verification) | Applied to development |
| Performance testing (Verification) | Applied to development |
| Safety testing (Verification) | Applied to development |
| Simulated use testing (Validation) | Applied to development |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "The subjects of this premarket submission, the 3.0T AIR MP M and 3.0T AIR MP L, do not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission." This indicates that there was no formal "test set" in the context of a clinical study for performance evaluation. The "sample clinical images" would likely be for illustrative purposes rather than a statistically powered test set for performance metrics. Therefore, details about sample size (beyond "sample images"), data provenance, retrospective/prospective nature are not provided and likely not relevant for this type of device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no formal clinical test set or ground truth establishment by experts for performance evaluation was conducted or required.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no formal clinical test set or ground truth establishment was conducted or required.
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
Not applicable. This is an MRI coil, not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an MRI coil, not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no formal ground truth was established for a clinical performance study. The "ground truth" for this type of device is implicitly tied to its ability to produce diagnostic quality images that are comparable to a predicate device, as verified through physical and electrical testing against recognized standards.
8. The sample size for the training set
Not applicable. This is an MRI coil, not an AI/ML device. There is no "training set" in this context. The development process involves engineering and quality assurance, not machine learning model training.
9. How the ground truth for the training set was established
Not applicable. This is an MRI coil, not an AI/ML device.
§ 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.