(27 days)
The TxRx Knee 15 Flare MR Coil 3.0T is intended for use with Siemens 3.0T MR systems to produce diagnostic images of the knee that can be interpreted by a trained physician.
The TxRx Knee 15 Flare MR Coil 3.0T is a transmit/receive, 15-channel phased array coil designed for magnetic resonance imaging (MRI) using the Siemens 3.0T MR systems. The TxRx Knee 15 Flare MR Coil 3.0T is intended to be used for imaging the knee. The TxRx Knee 15 Flare MR Coil 3.0T 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 510(k) premarket notification for a medical device called the "TxRx Knee 15 Flare MR Coil 3.0T." This document primarily focuses on demonstrating substantial equivalence to a predicate device and safety and performance characteristics for regulatory approval, rather than a detailed study for meeting specific clinical acceptance criteria of an AI-powered diagnostic device.
Therefore, many of the requested details regarding acceptance criteria, study design for AI models, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for training and test sets cannot be extracted from this document. This document pertains to an MRI coil, which is a hardware component, not an AI diagnostic algorithm.
However, I can extract information related to the acceptance criteria and performance testing that were outlined for this hardware device.
Here's the information that can be extracted, and notes on what cannot be found:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance | Comments |
|---|---|---|---|
| Biocompatibility | Safe use in cleared devices | Surface materials have a history of safe use in previously cleared devices. | This is a qualitative assessment based on material history, not a specific quantitative metric. |
| Electrical Safety | AAMI/ANSI ES60601-1 | Found to be compliant. | Standard for medical electrical equipment. |
| EMC (Electromagnetic Compatibility) | IEC 60601-2-33 | Found to be compliant. | Specific standard for MRI equipment. |
| Surface Heating | Max 41°C | Never exceeded 41°C. | Tested in accordance with AAMI/ANSI ES60601-1. |
| SAR (Specific Absorption Rate) | Partial body limits per IEC 60601-2-33 | System controls SAR limits below IEC 60601-2-33 partial body limits. | Tested per NEMA MS-8. |
| SNR (Signal-to-Noise Ratio) & Uniformity | Conform to predetermined acceptance criteria per IEC 62464 | Conformed to predetermined acceptance criteria. | IEC 62464 is a standard for quality control of MRI systems. The specific "predetermined acceptance criteria" are not detailed in this document. |
| Image Quality (Clinical) | Produce diagnostic quality images of the intended anatomy | Produced diagnostic quality images of the knee from volunteer scanning. | Assessed for "diagnostic quality" by implied interpretation, as the images "can be interpreted by a trained physician." |
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: The document mentions "clinical images from volunteer scanning of the knee" but does not specify the number of volunteers or images.
- Data Provenance: Not specified, but generally, for hardware performance studies conducted by manufacturers for U.S. FDA submission, the volunteer scans would typically be prospective and likely from the manufacturer's testing facilities or affiliated sites, often within the U.S., but this is not explicitly stated.
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)
- The document states that the images "can be interpreted by a trained physician," implying that qualified medical professionals would interpret the images. However, it does not specify the number of experts, their qualifications, or how a "ground truth" was established for the purpose of validating image quality. The assessment appears to be a general determination that the images are of diagnostic quality.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. There is no mention of an adjudication method as the study described is not focused on diagnostic accuracy comparisons requiring multiple expert reads and reconciliation.
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
- No, an MRMC study was not done. This document describes the testing of an MRI hardware coil, not an AI-powered diagnostic tool. Therefore, there is no mention of human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone algorithm performance study was not done. This document concerns a hardware device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the hardware performance, the "ground truth" for image quality was based on the ability of "trained physicians" to interpret the images for diagnostic purposes. This is a form of expert assessment of image utility, but not a formal "ground truth" in the sense of a definitive diagnosis (e.g., pathology report) against which a diagnostic algorithm would be measured.
8. The sample size for the training set
- Not applicable/Not specified. This document is about a hardware device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/Not specified. As there is no AI algorithm being described, there is no training set or ground truth establishment for such a set.
§ 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.