(29 days)
The Magnetom Symphony Quadrature Head Coil is a quadrature transmit receive coil used for obtaining diagnostic images of the head at the 1.5Tesla field strength in Magnetic Resonance Imaging. The indications for use are the same as for standard MR imaging. The Magnetom Symphony Head Coil is designed for use with the Siemens Magnetom Symphony 1.5Tesla MRI Scanner.
The Magnetom Symphony Head Coil is designed to manoutions retic Resonance Images of the brain, cervical spine, soft tissues and provide wagnetie head, neck and upper chest. The Magnetom Symphony Head Coil is designed for use with the Magnetom Symphony 1.5Tesla scanner manufactured by Siemens Medical Systems.
The 1.5Tesla MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, Intagoo that: (1) conceptrameters (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 Magnetom Symphony Head Coil is a 16 z-element quadrature transmit receive coil. The coil elements and associated circuitry are enclosed to prevent any exposure to patient or environment. The coil electronics are enclosed in a rigid former. The former is a split top design with latching device and a large open viewing window on the top. The coil design facilitates the scanning of patients with different head sizes and maximizes patient comfort and ease of use.
This document describes a medical device, the Magnetom Symphony Head Coil, and its substantial equivalence to previously cleared devices. It does not contain information about a study with acceptance criteria and device performance in the way typically associated with AI/ML diagnostic devices. The submission indicates the device's adherence to established safety and performance characteristics of similar MRI coils, rather than a clinical trial validating a diagnostic algorithm.
Therefore, the requested information elements (1-9) regarding acceptance criteria, study details, human-in-the-loop performance, and training set information are not available in the provided text.
Specifically:
- 1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on comparing the new coil's features and safety aspects to predicate devices.
- 2. Sample sized used for the test set and the data provenance: Not provided. The review is based on device specifications and comparison to predicates, not a clinical test set.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no diagnostic test set in this context.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 is not an AI-assisted diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware component (MRI coil).
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
The provided text details the regulatory clearance (510(k)) of an MRI head coil, focusing on its technical specifications, intended use, and comparison to predicate devices, rather than a performance study of a diagnostic algorithm.
§ 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.