(28 days)
The Polarean XENOVIEW 3.0T Chest Coil is to be used in conjunction with compatible 3.0T Magnetic Resonance Imaging (MRI) scanners and approved xenon Xe 129 hyperpolarized for oral inhalation of lung ventilation in adults and pediatric patients aged 12 years and older.
The Polarean XENOVIEW 3.0T Chest Coil (hereafter Chest Coil) is a flexible, single channel, transmit-receive (T/R) RF coil tuned to 123xe frequency on a 3.0T MRI magnetic field in order to image 129Xe nuclei while the patient is positioned inside a compatible multi-nuclear-capable MRI scanner. The Chest Coil is intended to be worn by a patient who inhales hyperpolarized 100%e gas (XENOVIEW) to obtain an MR image of the regional distribution of hyperpolarized 199xe in the lungs. The coil is constructed of a durable, flexible circuit board material within which the antenna elements and all electronic components are contained. These components are electrically isolated from the rest of the coil packaging by being enclosed within suitable non-conductive. water-rated, and flame-rated materials. A layer of padding is located on either side of the coil circuitry to provide patient comfort and protection against potential heating generated by circuitry components. The RF coil is a "fixed matching and tuning device" (i.e. not tunable by the operator), thereby eliminating the need to tune and match it for every patient.
The provided document describes the Polarean XENOVIEW 3.0T Chest Coil (subject device) and its substantial equivalence to a predicate device (K231647). The submission focuses on adding compatibility with General Electric Healthcare (GEHC) 3T MR750 and Premier MRI scanners.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative table format with corresponding reported device performance for a diagnostic measurement. Instead, it outlines performance and safety standards against which the device was tested. The "performance" here refers to the device's functional integrity and safety within an MRI environment, rather than a diagnostic accuracy performance (e.g., sensitivity, specificity).
Implicit Acceptance Criteria and Demonstrated Performance:
| Acceptance Criteria Category | Specific Standard/Test Adhered To | Reported Device Performance |
|---|---|---|
| Performance - Bench Tests | NEMA MS 6-2008 (R2014): Signal-to-Noise Ratio & Image Uniformity | Testing repeated; "confirm the safety and performance" |
| NEMA MS 8-2016: Specific Absorption Rate (SAR) | Testing repeated; "confirm the safety and performance" | |
| NEMA MS 14-2019: RF Coil Heating | Testing repeated; "confirm the safety and performance" | |
| Electrical Safety & Electromagnetic Compatibility | IEC 60601-1:2005/(R)2012 and A1:2012: Basic Safety & Essential Performance | Testing repeated; "confirm the safety and performance" |
| IEC 60601-2-33:2015: Basic Safety & Essential Performance of MR Equipment | Testing repeated; "confirm the safety and performance" | |
| IEC 60601-1-2:2020: Electromagnetic Compatibility | Testing repeated; "confirm the safety and performance" | |
| Biocompatibility | ISO 10993-1:2018: Biocompatibility (general) | Testing performed; "confirm the safety and performance" |
| ISO 10993-5:2009: Cytotoxicity | Testing performed; "confirm the safety and performance" | |
| ISO 10993-10:2010: Sensitization | Testing performed; "confirm the safety and performance" | |
| ISO 10993-10:2010: Irritation | Testing performed; "confirm the safety and performance" |
Note: The document states "confirm the safety and performance" for each category, but does not provide specific numerical outcomes or thresholds that were met. The acceptance is implied by the statement that the device was "verified and validated in accordance with documented Verification & Validation plans and protocols to ensure conformance with established performance criteria" and the conclusion that it is "as safe, as effective, and performs as well as or better than" the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical tests were required to demonstrate substantial equivalence." This means there was no patient-based test set for evaluating diagnostic or clinical performance. The testing was non-clinical (bench testing) and therefore, concepts of sample size, data provenance (country of origin, retrospective/prospective) are not applicable in the context of clinical studies for this device.
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)
This information is not applicable as no clinical studies were performed, and thus no ground truth derived from expert review or clinical outcomes was established for a test set. The validation was based on engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no clinical studies were performed, and thus no expert adjudication of clinical data was needed.
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
This information is not applicable. The device is a physical MRI coil, not an AI-powered diagnostic tool, and no clinical studies were required or conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical MRI coil, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" was adherence to established international and national standards for medical device safety and performance, specifically related to MRI coils (e.g., NEMA, IEC, ISO standards). There was no clinical ground truth established from patient data.
8. The sample size for the training set
This information is not applicable as no algorithmic training was involved. The device is a physical MRI coil.
9. How the ground truth for the training set was established
This information is not applicable as no algorithmic training was involved.
§ 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.