(28 days)
The Toshiba 1.5T QD Head Coil (MJQH-147A) is intended for use with a 1.5T Vantage Titan MRI system to produce diagnostic images of the head anatomy that can be interpreted by a trained physician.
The Toshiba 1.5T QD Head Coil is designed for use with the Toshiba Vantage Titan 1.5T MRI system manufactured by Toshiba Medical Systems Corporation.
The provided text describes the 510(k) premarket notification for the Toshiba 1.5T QD Head Coil. This document focuses on demonstrating substantial equivalence to a predicate device for a medical imaging accessory (a head coil for an MRI machine), rather than evaluating the performance of an AI/ML-driven device or diagnostic algorithm.
Therefore, much of the information requested in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set size, ground truth for training set) is not applicable or cannot be extracted from this type of regulatory submission for a medical device accessory like an MRI coil.
However, I can extract the acceptance criteria and reported device performance from the provided text as it relates to the technical specifications of the head coil.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to industry standards and the predicate device. The reported device performance is that it was found compliant with these standards and demonstrated substantial equivalence.
| Acceptance Criteria Category/Standard Used | Reported Device Performance |
|---|---|
| Safety and Essential Performance (General) | Complied with IEC 60601-1 (2nd and 3rd Edition), Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. |
| Magnetic Resonance Equipment Safety (Specific) | Coil SAR (Specific Absorption Rate) complied with the requirements of IEC 60601-2-33, Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (3rd Edition). |
| Image Quality (Signal-to-Noise Ratio) | Measured according to NEMA MS-1 2008, Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging. (The specific SNR value is not provided, only that it was measured according to the standard). |
| Image Quality (Image Uniformity) | Measured according to NEMA MS-3 2008, Determination of Image Uniformity in Diagnostic Resonance Imaging. (The specific uniformity value is not provided, only that it was measured according to the standard). |
| Overall Equivalence for Intended Use, Design, and Materials to predicate (Siemens 1.5T/3T CP Head Coil) | The device has the same intended use, is of the same design, and is constructed of the same materials as the predicate device. Stated to be "substantially equivalent." |
Note: The document states that the SNR and image uniformity were measured according to NEMA standards, but it does not explicitly provide the numerical acceptance thresholds or the measured performance values for these parameters. The "reported device performance" in this context is the statement of compliance with the measurement methodology and the overall conclusion of substantial equivalence.
The following questions are not applicable to this type of device and submission (an MRI head coil accessory) and thus cannot be answered from the provided text:
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
This 510(k) submission is for hardware (a medical device accessory), not a diagnostic algorithm or AI software, which typically involves performance metrics against "ground truth" established by experts or pathology for diagnostic accuracy. The "study" referenced here consists of engineering tests and measurements against established electrical, safety, and imaging quality standards, and a direct comparison of its technical specifications and intended use against a legally marketed predicate device.
§ 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.