(11 days)
For use with a Toshiba Excelart Vantage Atlas or Vantage Titan MR scanner to produce diagnostic images of the brain, cervical spine, and soft tissue and vasculature of the head, neck and upper chest that can be interpreted by a trained physician.
The Atlas SPEEDER Head-Neck coil is a phased array, multi-channel, receive-only coil. The coil consists of a rigid posterior head base and a flexible posterior chest assembly that are used in combination with various removable rigid assemblies selected based on the anatomy of interest. Foam pads also aid in positioning and enhance patient comfort.
The provided text is a 510(k) summary for the "1.5T Atlas SPEEDER Head-Neck Coil." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria related to its performance in creating diagnostic images.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document. The 510(k) process for this type of device (a coil for an MRI scanner) primarily relies on showing that the new device is as safe and effective as a legally marketed predicate device, often through a comparison of design, materials, and intended use, rather than extensive clinical performance studies with specific numerical acceptance criteria.
Here's what can be extracted from the provided text, and what cannot:
1. Table of acceptance criteria and the reported device performance
- Not Available. The document does not provide a table of acceptance criteria or quantitative performance metrics for the coil's image quality or diagnostic accuracy. The basis for equivalence is primarily structural and functional similarity to a predicate device.
2. Sample size used for the test set and the data provenance
- Not Applicable. No test set or clinical study demonstrating performance against specific criteria is described. The 510(k) is based on comparison to an existing device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No test set or ground truth establishment is described. The device's images are intended to be "interpreted by a trained physician," implying general medical practice rather than a specific expert panel for a study.
4. Adjudication method for the test set
- Not Applicable. No test set or adjudication process is described.
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
- Not Applicable. This device is an MRI coil, not an AI-powered diagnostic tool. No MRMC study or AI-related effectiveness is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is an MRI coil, not an algorithm or standalone diagnostic tool in that sense. Its purpose is to acquire images for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth for image interpretation or diagnostic accuracy is described as part of this 510(k). The device's output (images) are for diagnostic interpretation by a physician.
8. The sample size for the training set
- Not Applicable. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. No training set is mentioned.
Summary of available information from the 510(k) document:
- Device Name: 1.5T Atlas SPEEDER Head-Neck Coil
- Intended Use: For use with a Toshiba Excelart Vantage Atlas or Vantage Titan MR scanner to produce diagnostic images of the brain, cervical spine, and soft tissue and vasculature of the head, neck and upper chest that can be interpreted by a trained physician.
- Equivalent Device (Predicate): 1.5T QD Head Speeder Coil manufactured by USA Instruments Inc. (K041487).
- Basis for Equivalence: The new coil and the predicate device have similar designs and are constructed of similar materials. Their intended uses are identical. The main differences are the number of channels and the number of removable assemblies.
- Conclusion: Quality Electrodynamics believes the 1.5T Atlas SPEEDER Head-Neck coil is substantially equivalent to the predicate device, and its use does not introduce any new potential hazards.
In essence, this 510(k) is a declarative statement of substantial equivalence based on physical and functional comparison to a legally marketed device, not a report of a rigorous performance study with quantifiable acceptance criteria.
§ 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.