(62 days)
The 16ch T/R Hand Wrist Coil is intended for use with GE 1.5T 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 1.5T 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 is a 510(k) summary for a medical device (16ch T/R Hand Wrist Coil) and does not describe an AI/ML powered device or a study involving such a device where acceptance criteria are set for AI performance metrics. Instead, it describes performance testing for a magnetic resonance imaging (MRI) coil.
Therefore, I cannot extract the requested information regarding AI device acceptance criteria, study details, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The document discusses various performance tests relevant to an MRI coil, which are outlined below for completeness, but these do not directly address the prompt's request for AI device specific information.
1. Table of Acceptance Criteria and Reported Device Performance (Non-AI related):
| Performance Metric | Acceptance Criteria | Reported Performance |
|---|---|---|
| Biocompatibility | Materials have a history of safe use in cleared devices | All surface materials a history of safe use |
| Electrical Safety | Compliant with AAMI/ANSI ES60601-1 and IEC 60601-2-33 | Found to be compliant |
| Surface Heating | Measured temperature not to exceed 41°C | Never exceeded 41°C |
| SAR Limits | Local SAR limits below IEC 60601-2-33 partial body limits | Simulation showed local SAR limits are below IEC 60601-2-33 partial body limits |
| SNR and Uniformity | Conform to predetermined acceptance criteria | Found to conform to predetermined acceptance criteria per NEMA MS 1 and NEMA MS 3 |
| Diagnostic Quality Images | Produce diagnostic quality images of the intended anatomy | Clinical images from volunteer scanning demonstrated diagnostic quality images |
The following information cannot be extracted from the provided text as it pertains to AI/ML powered devices, which is not the subject of this 510(k) summary:
- Sample sizes used for the test set and the data provenance: Not applicable to a physical MRI coil. Clinical images were obtained from volunteer scanning, but the sample size is not specified for the diagnostic quality assessment.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for an MRI coil is its ability to produce good images for clinical interpretation, not an AI-derived diagnosis. The images are interpreted by a "trained physician".
- Adjudication method: Not applicable.
- 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.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For the clinical image assessment of the coil, the "ground truth" is that the images are of "diagnostic quality" as interpreted by a trained physician. This is an outcome of the coil's performance, not a predefined ground truth for an algorithm.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.