(27 days)
The Toshiba 3T 32CH Head SPEEDER Coil is intended for use with the Toshiba Vantage Titan 3T MRI system to produce diagnostic images of the head that can be interpreted by a trained physician.
The Toshiba 3T 32CH Head SPEEDER Coil is designed for use with a Vantage Titan 3T System, manufactured by Toshiba Medical Systems Corporation.
Here's an analysis of the provided 510(k) summary regarding the Toshiba 3T 32CH Head SPEEDER Coil:
This 510(k) submission (K122638) is for a magnetic resonance imaging (MRI) coil, not an AI/algorithm-based device. Therefore, many of the typical acceptance criteria and study methodologies applicable to AI devices (e.g., human-in-the-loop, standalone performance, training set details, expert consensus for ground truth on clinical images) are not relevant here.
The device is a hardware component (an MRI coil) that works with an existing MRI system. Its performance is primarily assessed through technical specifications and physical safety, not diagnostic accuracy in the way an AI algorithm would be.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance/Method |
|---|---|---|
| Safety | Compliance with general medical electrical equipment standards | Tested to and found compliant with IEC 60601-1 (second and third editions) - "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance". |
| Image Quality | Signal-to-Noise Ratio (SNR) | SNR was measured according to NEMA MS 9-2008, "Characterization of Phased Array Coils for Diagnostic Resonance Images." |
| Image Quality | Image Uniformity | Assessed in accordance with NEMA MS-3 2008, "Determination of Image Uniformity in Diagnostic Magnetic Resonance Images." |
| Substantial Equivalence | Comparison to predicate device | The device was deemed substantially equivalent to the 1.5T Atlas SPEEDER Head-Neck Coil (K083160) because it's also a phased-array, receive-only coil with similar functionality, despite differences in channel count, anterior attachments, and compatible MR system field strength (3T vs. 1.5T). |
Study Details (as applicable to an MRI Coil)
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Sample size used for the test set and the data provenance:
- The document implies that the "test set" for the coil's performance was physical testing and measurements according to NEMA and IEC standards, rather than a clinical dataset of patient images.
- The sample size for these technical tests is not specified in terms of "cases" or "patients" but would refer to the number of measurements taken or the number of coils tested.
- Data provenance isn't applicable in the clinical sense (e.g., country of origin of patient data, retrospective/prospective) as these are engineering and performance tests on the device itself.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable. Ground truth in this context refers to established engineering standards (IEC, NEMA) and physical measurements, rather than expert interpretation of clinical images. The "experts" would be the engineers and technicians performing the tests according to the specified standards.
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Adjudication method for the test set:
- Not applicable for the type of testing performed (physical and engineering standards compliance).
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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:
- No. This is an MRI coil, not an AI algorithm. MRMC studies are designed for assessing the diagnostic performance of AI or new imaging techniques involving human interpretation.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm; it is a hardware component.
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The type of ground truth used:
- For safety: Compliance with the established safety standards (IEC 60601-1).
- For image quality (SNR, Uniformity): Measurements against specified limits and methodologies defined by NEMA standards (NEMA MS 9-2008, NEMA MS-3 2008). This is an objective technical measurement, not a clinical "ground truth" like pathology or outcomes.
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The sample size for the training set:
- Not applicable. This device does not use an AI algorithm and therefore does not have a "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this hardware device.
Summary for K122638:
This 510(k) submission is for an MRI receive coil. The "acceptance criteria" revolve around the safety and technical performance of the hardware device itself, as evaluated against established international and national engineering standards (IEC, NEMA), rather than clinical diagnostic accuracy or AI performance. The study is a non-clinical technical evaluation demonstrating compliance with these standards and substantial equivalence to a predicate device. The document does not involve AI, clinical image interpretation studies, or patient data in the context of performance testing.
§ 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.