(13 days)
The 3.0T 4-Channel Cervico-Thoracic-Lumbar (CTL) Array Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the spine (cervical, thoracic and lumbar regions) in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The 3.0T 4-Channel Cervico-Thoracic-Lumbar (CTL) Array Coil is designed for use with the GE Medical Systems 3.0Tesla MRI scanner.
The 3.0T 4-Channel Cervico-Thoracic-Lumbar (CTL) Array Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic, and lumbar regions of the spine. The 3.0T 4-Channel Cervico-Thoracic-Lumbar (CTL) Array Coil is designed for use with the GE 3.0T scanner manufactured by GE Medical Systems, Inc.
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 vield information that can be useful in the determination of a diagnosis.
The 3.0T 4-Channel Cervico-Thoracic-Lumbar (CTL) Array Coil is a multi-element phased array receive- only 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 elements and associated circuitry are enclosed in a housing made of plastic materials, which are fire rated and have high impact and tensile strength.
The provided document is a 510(k) summary for a Magnetic Resonance Imaging Accessory (3.0T 4-Channel Cervico-Thoracic-Lumbar (CTL) Array Coil). It focuses on establishing substantial equivalence to predicate devices for safety and effectiveness and does not describe a study involving an algorithm or AI. Therefore, many of the requested categories related to algorithm performance, ground truth, and human reader studies are not applicable.
Here's the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative sense as might be found for an AI/algorithm. Instead, it demonstrates substantial equivalence by comparing product features and intended use to predicate devices. The "reported device performance" is essentially that its features and indications for use are similar to previously cleared devices, implying it performs equivalently in terms of safety and effectiveness.
| Acceptance Criteria (Demonstrated by Substantial Equivalence) | Reported Device Performance (Claimed Equivalence) |
|---|---|
| Intended Use: Imaging of the spine | Similar to predicate device (Premier III Phased Array CTL Spine Coil, K013595) |
| Indications for Use: Identical to routine MRI imaging | Similar to predicate device (Premier III Phased Array CTL Spine Coil, K013595) |
| Coil Material: Flame Retardant Kydex, PVC, Polyurethane | Similar to predicate device (Premier 9000 8 Channel Phased Array CTL Spine Coil, K031366) |
| Coil Design: Receive-only phased array design | Similar to predicate device (Premier III Phased Array CTL Spine Coil, K013595) |
| Decoupling: RF Chokes with Switching Diodes | Similar to predicate device (Premier III Phased Array CTL Spine Coil, K013595) |
| Prevention of RF Burns: No RF transmission, decoupling, enclosed elements | Similar to predicate device (Premier III Phased Array CTL Spine Coil, K013595) |
| Radio Frequency Absorption: Receive-only coil | Similar to predicate device (Premier III Phased Array CTL Spine Coil, K013595) |
| Formation of Resonant Loops: Decoupling, cable length/stiffness | Similar to predicate device (Premier III Phased Array CTL Spine Coil, K013595) |
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 is a medical device (MRI coil) submission, not an AI/algorithm-based device, so there is no "test set" in the context of data for an algorithm. The evaluation is based on engineering design, material properties, and comparison to existing devices.
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 "ground truth" in the context of expert consensus on image interpretation for an algorithm is described.
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 device is an MRI coil, not an AI system.
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 AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for an MRI coil is its ability to produce diagnostic images safely and effectively, which is evaluated through engineering and clinical testing (not detailed here, but implied by the comparison to known safe and effective predicate devices), rather than by comparing algorithm output to a medical reference standard.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
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.