(88 days)
The 16ch T/R Knee Coil is intended for use with GE 1.5T MR systems to produce diagnostic images of the knee that can be interpreted by a trained physician.
The 16ch T/R Knee Coil is a transmit/receive. 16-channel phased array coil designed for magnetic resonance imaging (MRI) using the GE 1.5T MR systems. The 16ch T/R Knee Coil is intended to be used for imaging the knee.
The 16ch T/R Knee Coil is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. All coil elements are enclosed in a rigid plastic housing which is fire-rated, has impact and tensile strength, and has been tested for biocompatibility. The 16ch T/R Knee Coil is provided with patient comfort pads.
This document is a 510(k) premarket notification for a medical device called the "16ch T/R Knee Coil." It is a regulatory submission to the FDA proving substantial equivalence to a predicate device. As such, it does not contain the detailed study information typically found in a clinical trial report or a performance study for AI/CADe devices.
Specifically, this submission is for an imaging coil for an MRI system, not an AI or CADe (Computer-Aided Detection/Diagnosis) device, nor one that interprets images. Therefore, many of the requested categories related to AI/CADe performance, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this type of device.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this device are focused on engineering performance, safety, and imaging quality, rather than diagnostic accuracy by an algorithm.
Here's the relevant information that can be extracted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Materials in human contact must be safe. | All surface materials have a history of safe use in previously-cleared devices. |
| Electrical Safety | Compliance with AAMI/ANSI ES60601-1. | Tested to and found to be compliant with AAMI/ANSI ES60601-1. |
| Electromagnetic Compatibility | Compliance with IEC 60601-2-33. | Tested to and found to be compliant with IEC 60601-2-33. |
| Surface Heating | Surface temperature not exceeding 41°C. | Measured temperature never exceeded the maximum limit of 41°C. |
| Local SAR Limits | Local SAR (Specific Absorption Rate) within IEC 60601-2-33 partial body limits. | Simulation showed local SAR limits are below IEC 60601-2-33 partial body limits. |
| Image Signal-to-Noise Ratio (SNR) | Conformance to predetermined acceptance criteria per NEMA MS 1 and MS 3. | Analyzed per NEMA MS 1 and MS 3 and found to conform to predetermined acceptance criteria. |
| Image Uniformity | Conformance to predetermined acceptance criteria per NEMA MS 1 and MS 3. | Analyzed per NEMA MS 1 and MS 3 and found to conform to predetermined acceptance criteria. |
| Diagnostic Image Quality | Production of diagnostic quality images of the knee. | Clinical images from volunteer scanning demonstrated the production of diagnostic quality images. |
Study that proves the device meets the acceptance criteria:
The document describes the following "Performance data" or studies:
- Biocompatibility Testing: Demonstrated via history of safe use of materials.
- Electrical Safety and Electromagnetic Compatibility Testing: Device was tested to and found compliant with AAMI/ANSI ES60601-1 and IEC 60601-2-33 standards.
- Surface Heating Testing: Measurements showed the surface temperature did not exceed 41°C.
- Finite-Difference Time-Domain Electromagnetic Simulation: Performed to confirm SAR limits were met.
- Bench Performance Testing (SNR and Uniformity): Analyzed per NEMA MS 1 and NEMA MS 3 standards, conforming to predetermined acceptance criteria.
- Clinical Performance Testing: Clinical images from volunteer scanning of the knee were obtained and used to demonstrate diagnostic quality. This was done in accordance with the FDA Guidance for Industry: Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: For the "Clinical Performance Testing," the document mentions "clinical images from volunteer scanning." It does not specify the number of volunteers or images (sample size).
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
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 in the context of this device. The "ground truth" here is about the physical characteristics and image quality of the coil itself, not diagnostic interpretations from images by experts in a comparative study. The device produces images "that can be interpreted by a trained physician," implying the images enable diagnosis, but it does not claim to make diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as this is not a study requiring expert adjudication of diagnostic outcomes.
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 not an AI/CADe device, and no MRMC study, or study involving human readers' diagnostic improvement with AI assistance, was performed or presented.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the "Clinical Performance Testing" related to diagnostic image quality, the "ground truth" is simply the visual assessment that the images are of "diagnostic quality." This is typically a qualitative assessment by qualified personnel (not necessarily a formal "expert consensus" in the sense of a clinical study, but rather a determination that the images fulfill their purpose). For the bench tests (SNR, uniformity, safety), the ground truth is defined by the standards (NEMA, IEC) and physical measurements.
8. The sample size for the training set
- Not applicable. This device does not have a "training set" as it is an MRI coil, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable for the same reason as above.
§ 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.