(522 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 129Xe 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 129Xe gas (XENOVIEW) to obtain an MR image of the regional distribution of hyperpolarized 129Xe 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 is a 510(k) summary for the Polarean XENOVIEW 3.0T Chest Coil. It details the device's characteristics, its intended use, and its comparison to a predicate device to establish substantial equivalence. However, this document does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-driven medical device performance study. The device in question is a chest coil, which is a hardware component used in MRI, not an AI algorithm.
Therefore, many of the requested elements (like MRMC studies, standalone algorithm performance, number of experts for ground truth, training set details) are not applicable to this type of device submission and are not present in the provided text.
The document focuses on demonstrating substantial equivalence to a predicate device through:
- Bench testing: Verifying the coil's physical and electrical performance (e.g., signal-to-noise ratio, SAR, RF coil heating).
- Electrical Safety and Electromagnetic Compatibility (EMC) testing: Ensuring safety standards compliance.
- Biocompatibility testing: Confirming the materials are safe for human contact.
Below, I'll address the applicable points based on the provided text, and explicitly state when information is not available or not relevant for this type of device.
Acceptance Criteria and Device Performance (for a hardware component)
The document specifies conformance to various standards as part of its verification and validation. These can be considered the "acceptance criteria" for a hardware device like an MRI coil.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Measured by Conformance to Standards) | Reported Device Performance (as stated in the document) |
|---|---|
| Performance – Bench Testing: | "Bench testing was performed... to confirm the safety and performance of various components of the Chest Coil in accordance with the following standards:" (Implicitly, the device met these standards) |
| - NEMA MS 6-2008 (R2014) for Signal-to-Noise Ratio and Image Uniformity for Single-Channel, Non-Volume Coils | Conformance demonstrated |
| - NEMA MS 8-2016 for Characterization of the Specific Absorption Rate (SAR) for MRI Systems | Conformance demonstrated |
| - NEMA MS 14-2019 for Characterization of Radiofrequency (RF) Coil Heating in MRI Systems | Conformance demonstrated |
| Electrical Safety and Electromagnetic Compatibility: | "Electrical Safety and Electromagnetic Compatibility testing was performed... to confirm the safety and performance of various components of the Chest Coil in accordance with the following standards:" (Implicitly, the device met these standards) |
| - IEC 60601-1 (Basic Safety and Essential Performance) | Conformance demonstrated |
| - IEC 60601-2-33:2015 (Basic Safety and Essential Performance of MR Equipment) | Conformance demonstrated |
| - IEC 60601-1-2:2014 (Electromagnetic Compatibility) | Conformance demonstrated |
| Biocompatibility: | "Biocompatibility testing was performed per ISO 10993-1:2018 to confirm the safety and performance of various components of the Chest Coil in accordance with the following standards:" (Implicitly, the device met these standards) |
| - ISO 10993-5:2009 (Cytotoxicity) | Conformance demonstrated |
| - ISO 10993-10:2010 (Sensitization) | Conformance demonstrated |
| - ISO 10993-10:2010 (Irritation) | Conformance demonstrated |
Regarding the study proving the device meets acceptance criteria:
The document broadly states that the device was "verified and validated in accordance with documented Verification & Validation plans and protocols to ensure conformance with established performance criteria." It lists the types of tests performed and the standards they conform to.
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Sample sized used for the test set and the data provenance:
- Sample Size: Not specified for hardware testing. This usually involves testing a certain number of manufactured units or prototypes to ensure reproducible performance.
- Data Provenance: Not applicable in the context of clinical image data. These are engineering and safety tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of AI/ML, refers to expert-labeled data. For hardware testing, the "ground truth" is adherence to engineering specifications and safety standards, which is assessed by qualified engineers and testing facilities, not medical experts.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is relevant for image interpretation or diagnosis consensus, not hardware testing.
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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. The device is an MRI chest coil, a hardware component, not an AI algorithm intended to assist human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is hardware, not an algorithm. Bench testing mentioned would be "standalone" in the sense of testing the hardware component itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For hardware, the "ground truth" is defined by the technical specifications, performance limits, and safety standards (e.g., NEMA standards, IEC standards, ISO standards for biocompatibility). Test results are compared directly to these established limits.
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The sample size for the training set:
- Not applicable. The device is a hardware component; there is no "training set" in the machine learning sense.
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How the ground truth for the training set was established:
- Not applicable. There is no training set. Engineering specifications and regulatory standards serve as the basis for evaluation.
§ 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.