(80 days)
The 16ch T/R Hand Wrist Coil is intended for use with GE 3.0T MR systems to produce diagnostic images of the hand and wrist that can be interpreted by a trained physician.
The 16ch T/R Hand Wrist Coil is a transmit/receive, 16-channel phased array coil designed for magnetic resonance imaging (MRI) using the GE 3.0T MR systems. The 16ch T/R Hand Wrist Coil is intended to be used for imaging the hand and wrist.
The 16ch T/R Hand Wrist 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 provided text describes the performance data for the 16ch T/R Hand Wrist Coil, a magnetic resonance diagnostic device. Below is a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | All surface materials on the 16ch T/R Hand Wrist coil that are intended to come into direct or indirect contact with patient biological tissues, cells, or body fluids have a history of safe use in previously-cleared devices. |
| Electrical Safety | Compliant with AAMI/ANSI ES60601-1 and IEC 60601-2-33. |
| Electromagnetic Compatibility | Compliant with AAMI/ANSI ES60601-1 and IEC 60601-2-33. |
| Surface Heating | Measured temperature of the surface of the coil never exceeded the maximum limit of 41°C, in accordance with AAMI/ANSI ES60601-1. |
| Local SAR Limits | Finite-difference time-domain electromagnetic simulation showed local SAR limits for the coil are below the IEC 60601-2-33 partial body limits. |
| Signal-to-Noise Ratio (SNR) | Analyzed per NEMA MS 1 and found to conform to predetermined acceptance criteria. |
| Uniformity | Analyzed per NEMA MS 3 and found to conform to predetermined acceptance criteria. |
| Diagnostic Image Quality | Clinical images from volunteer scanning of the hand and wrist demonstrated that the 16ch T/R Hand Wrist coil produces diagnostic quality images of the intended anatomy. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for the "clinical images from volunteer scanning." The term "volunteer scanning" suggests a prospective collection of data.
- Data Provenance: The document states "clinical images from volunteer scanning of the hand and wrist were obtained from the 16ch T/R Hand Wrist coil." The specific country of origin is not mentioned, but the manufacturing company (Quality Electrodynamics, LLC.) is based in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: The document states images "can be interpreted by a trained physician," but does not specify the qualifications of the physician(s) who established ground truth for the test set.
4. Adjudication Method for the Test Set
- The document does not describe an adjudication method for the test set. It mentions images were used to "demonstrate that the 16ch T/R Hand Wrist coil produces diagnostic quality images," implying an assessment of image quality, but not a specific adjudication process involving multiple readers or complex diagnostic decision-making.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- The document does not mention that an MRMC comparative effectiveness study was done.
- The study focuses on the coil's performance in isolation ("standalone") to demonstrate its ability to produce diagnostic quality images.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- Yes, a standalone performance assessment was conducted for the device itself and its physical and image quality characteristics. The bench testing (SNR, uniformity) and the clinical imaging demonstrating diagnostic quality are evaluations of the device's inherent performance. There's no AI algorithm mentioned, so "algorithm only" isn't directly applicable in the usual sense for AI/ML devices. Instead, it's the raw performance of the imaging hardware.
7. Type of Ground Truth Used for the Test Set
- The ground truth for the clinical image quality assessment appears to be based on an expert assessment of "diagnostic quality." This implies a qualitative judgment by a presumably trained physician (as per the Indications for Use) that the images are sufficient for diagnosis. It is not pathology, or explicit outcomes data.
8. Sample Size for the Training Set
- No training set is applicable or mentioned in the context of this device. This is a medical device for MR imaging hardware (a coil), not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable as there is no training set for this 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.