(49 days)
The Premier III Phased Array CTL Spine Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic, and lumbar regions of the spine. The Premier III Phased Array CTL Spine Coil is designed for use with the Siemens 3.0T Magnetom Trio MR scanner manufactured by Siemens Medical Solutions, Inc.
Anatomic Regions: cervical, thoracic, and lumbar regions of the spine. Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The 3.0T 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 Premier III Phased Array CTL Spine Coil is a twelve element receive only phased array coil. The coil is shaped to conform to the contours of the spine and has been designed to maximize comfort and ease of use. 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 is a 510(k) premarket notification for a medical device: the Premier III Phased Array CTL Spine Coil. This document establishes substantial equivalence to a predicate device, not through a clinical performance study with acceptance criteria, but by demonstrating that its technical characteristics and intended use are similar to a previously cleared device.
Therefore, many of the requested categories (acceptance criteria, study details, sample sizes, expert involvement, ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission. The document focuses on comparing the new device's features to a predicate device to prove it is equally safe and effective.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
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Acceptance Criteria: Not explicitly stated as performance metrics in the way one might expect for a diagnostic algorithm. For a device like an MRI coil, "acceptance criteria" are typically related to meeting established engineering and safety standards, and demonstrating performance comparable to a predicate device. The primary "performance" here is its ability to produce diagnostic images.
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Reported Device Performance:
- Intended Use: Imaging of the spine.
- Indications for Use: Identical to routine MRI imaging (same as standard MR Imaging).
- Coil Design: Receive-only phased array design, twelve elements.
- Safety Features: Switching diode decoupling, additional RF fuses, enclosed in a non-conductive housing, does not transmit RF power, decoupling isolates elements during RF transmission, cable length/stiffness prevents looping.
- Compatibility: Designed for use with the Magnetom Trio 3.0T MRI system (Siemens Medical Solutions, Inc.).
The document asserts that these features are "Similar to the Premier 7000 Phased Array C/T/L Spine Coil manufactured by USA Instruments, Inc. (K980157)." This "similarity" is the core of its demonstrated performance and safety for regulatory purposes, implying it performs equivalently to the predicate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. This 510(k) notification does not describe a clinical performance study with a test set of patient data. The evaluation is based on technical comparisons to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. No test set or ground truth established by experts is described in this document for the purpose of a clinical performance evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No test set or expert adjudication 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, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is an MRI coil, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth for a clinical performance study is described. The "ground truth" for regulatory clearance is the established safety and effectiveness of the predicate device (Premier 7000 Phased Array C/T/L Spine Coil).
8. The sample size for the training set
- Not Applicable. There is no mention of a training set as this is not an AI/algorithm device.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is 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.