(14 days)
The 3.0T 8-Channel CTL Spine Array is a receive-only phased arrav 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 8-Channel CTL Spine Array is designed for use with the Siemens Medical Systems 3.0T MRI scanner.
The 3.0T 8-Channel CTL Spine Array is designed to provide Magnetic Resonance Images of the cervical, thoracic, and lumbar regions of the spine when used with the Siemens 3.0T scanner manufactured by Siemens 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 body. When interpreted by a trained physician, these images can be useful in the determination of a diagnosis.
The 3.0T 8-Channel CTL Spine Array 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, K042186, is a 510(k) premarket notification for a medical device: the 3.0T 8-Channel CTL Spine Array. This application seeks to demonstrate substantial equivalence to a legally marketed predicate device rather than providing extensive independent performance studies with detailed acceptance criteria and clinical outcomes.
Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, and multi-reader multi-case studies is not explicitly available in this type of regulatory submission. The focus here is on demonstrating similarity to an already approved device.
Here's how to interpret the provided information in the context of your request:
Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" in this context refers to demonstrating that the new device shares fundamental technological characteristics and intended use with a predicate device, thereby implicitly meeting the safety and effectiveness standards already established for the predicate.
| Acceptance Criteria Category (Implied by 510(k) Equivalence) | Reported Device Performance (Comparison from K042186) |
|---|---|
| Intended Use Equivalence | - Imaging of the spine. |
- Similar to the Premier III Phased Array CTL Spine Coil (K030042), which is also for imaging the spine. |
| Indications for Use Equivalence | - Identical to routine MRI imaging (diagnostic images of the spine in MRI systems). - Similar to the Premier III Phased Array CTL Spine Coil (K030042), with indications for use being the same as standard MR Imaging. |
| Material Composition Equivalence | - Coil Material: Flame Retardant PVC, Flame Retardant Polyurethane, Flame Retardant Polycarbonate (fire-rated plastic materials with high impact and tensile strength). - Similar to K030042. |
| Coil Design Equivalence | - Receive-only phased array design, shaped to conform to spine contours. - Similar to K030042. |
| Decoupling Mechanism Equivalence | - Decoupling: RF Chokes with Switching Diodes. - Similar to K030042. |
| RF Burn Prevention Equivalence | - Does not transmit RF Power, decoupling isolates elements during RF transmission, elements/circuitry enclosed in non-conductive housing. - Similar to K030042. |
| Radio Frequency Absorption Equivalence | - Receive-only coil, does not transmit RF power. - Similar to K030042. |
| Prevention of Resonant Loops Equivalence | - Decoupling isolates coil elements, cable length and stiffness prevent looping. - Similar to K030042. |
| Compatibility | - Designed for use with Siemens Medical Systems 3.0T MRI scanner. - (Not explicitly compared to predicate for compatibility in the provided text, but implied as part of the overall system for which it's intended). |
Study Information (Based on 510(k) Submission Type)
1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. This 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device through technical and functional comparisons, not through a new clinical performance study with a distinct test set of patient data. The safety and effectiveness are inferred from the predicate.
2. 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 / Not provided. Since there wasn't a new clinical performance study with a test set requiring new ground truth, this information is not part of this submission.
- Implicitly, the predicate device would have undergone such evaluations to establish its safety and effectiveness, which would have involved experts.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. As no new test set was used to establish ground truth for this device, no adjudication method is detailed.
4. 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:
- No. This device is a passive MRI accessory (a receive-only RF coil), not an AI-powered diagnostic algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a hardware component (an MRI coil), not a standalone algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. For this 510(k) submission, the "ground truth" for demonstrating safety and effectiveness relies on the established safety and performance of the predicate device (Premier III Phased Array CTL Spine Coil, K030042). The new device is shown to be technically similar and intended for the same uses, implying it performs equivalently to the predicate.
7. The sample size for the training set:
- Not applicable / Not provided. This is not an AI/machine learning device, so the concept of a "training set" is not relevant.
8. How the ground truth for the training set was established:
- Not applicable / Not provided. As this is not an AI/machine learning device, there is no training set or associated ground truth establishment for a training set.
In summary, for a 510(k) submission like K042186 for a hardware component such as an MRI coil, the "study" is primarily a comparative analysis of the device's technical specifications and intended use against a legally marketed predicate device. The acceptance criteria are essentially met by demonstrating substantial equivalence to the predicate in terms of safety and effectiveness, based on similar technology, materials, design, and intended use. New clinical studies with patient data, ground truth establishment, or multi-reader reviews are typically not part of such a submission unless there are significant technological differences or new indications for use.
§ 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.