(13 days)
The QD Head Speeder with NV Speeder Attachment is designed to provide Magnetic Resonance Images of the brain, cervical spine, and soft tissue and vasculature of the head, neck, and upper chest. The QD Head Speeder with NV Speeder Attachment is designed for use with the ExcelArt 1.5 MRI system manufactured by Toshiba Medical Systems, Inc. The indications for use are the same as for standard imaging: The 1.5T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The QD Head Speeder with NV Speeder Attachment is a multi-element phased array, receive-only coil. The coil consists of three sections: a main coil base, a sliding head section, and a removable anterior coil section. The open, patient friendly design minimizes claustrophobic effects and maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.
The provided text describes a Magnetic Resonance Imaging (MRI) Accessory, specifically the QD Head Speeder with NV Speeder Attachment. It is a receive-only phased array RF coil intended for obtaining diagnostic images of the brain, cervical spine, and soft tissue and vasculature of the head, neck, and upper chest.
However, the document is a 510(k) Premarket Notification Summary for a medical device. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a specific study proving those criteria are met for the newly introduced device via quantitative metrics.
Therefore, the requested information regarding detailed acceptance criteria, specific device performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies is not available in the provided text.
The summary focuses on comparing the new device's design, intended use, and functionality to previously cleared predicate devices (e.g., Millennium 9000 Phased Array Neurovascular Coil and Excalibur 9000 TotalSENSE™ Quad Array Head Coil) to establish substantial equivalence. The "Safety and Effectiveness" section is mentioned, but its content is not provided in the extract.
The document implicitly "proves" the device meets acceptance criteria by demonstrating its substantial equivalence to already approved devices, which are presumed to have met their own safety and effectiveness criteria.
Summary of available information based on the provided text:
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Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantitative performance metrics for the new device. The implicit acceptance criterion is substantial equivalence to predicate devices regarding intended use, indications for use, and design features.
- Reported Device Performance: Not quantified. The performance is described in terms of its intended function (imaging the brain, cervical spine, etc.) and its design features (receive-only phased array, specific materials, decoupling mechanism, RF absorption characteristics). The document states "The indicators for use are the same as for standard imaging," implying its performance should be comparable to standard MRI.
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Sample size used for the test set and the data provenance: Not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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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, as this is an MRI coil, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is an MRI coil. Its performance is inherent to the image acquisition, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. The "ground truth" for an MRI coil's performance typically refers to its ability to produce diagnostic quality images, which would be assessed by radiologists. However, specific details are absent.
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The sample size for the training set: Not applicable, as this is hardware, not a machine learning model.
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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.