(35 days)
The Premier III Linear Phased Array CTL Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic and lumbar regions of the spine. The Premier III Linear Phased Array CTL Coil is designed for use with the GE Signa 3.0T scanner manufactured by GE Medical Systems, 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 defermination of a diagnosis.
The Premier III Linear CTL Spine Coil is a multi-element phased array receive only coil. The coil has a rigid enclosure. The open, patient friendly design eases patient handling and positioning and maximizes patient comfort. 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, specifically a Magnetic Resonance Imaging accessory (Premier III Linear Phased Array CTL Spine Coil). This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific acceptance criteria in the manner you've requested.
Therefore, the information required to build the table and answer the study-related questions (sample size, experts, adjudication, MRMC, standalone, ground truth type and training set details) is not present in the provided text. The document is a regulatory submission for a device component, emphasizing its similarity in design and function to previously cleared devices. It does not contain clinical study data or performance metrics in the way a diagnostic AI device submission would.
Here's a breakdown of what could be extracted if such data were present, and why it's missing in this case:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable/Not provided. The document doesn't define specific performance acceptance criteria (e.g., sensitivity, specificity, image quality metrics) for the coil itself. Instead, it relies on demonstrating that the new coil's design and features are "similar to" or "identical to" predicate devices, implying that if the predicate devices meet performance standards (which they are presumed to as legally marketed devices), then this new device, being substantially equivalent, also implicitly meets those standards for its intended use.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided. There is no mention of a test set or any performance study involving patient data. This is a device component.
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 provided. No study or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided. No test set or adjudication process is mentioned.
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 document is for an MRI coil, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant here.
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not provided. No ground truth establishment is described.
8. The sample size for the training set
Not provided. No training set is mentioned as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established
Not provided. No training set or ground truth establishment is described.
In summary: The provided document is a 510(k) premarket notification for an MRI coil, which focuses on demonstrating substantial equivalence to existing predicate devices. It does not contain the kind of performance study data (acceptance criteria, test/training sets, expert adjudication, etc.) that would typically be found in a submission for a diagnostic algorithm or a device requiring new clinical performance studies.
§ 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.