(84 days)
The Premier III Phased Array CTL Spine Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the spine region (cervical, thoracic and lumbar anatomy) in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The Premier III Phased Array CTL Spine Coil is designed for use with the GE Medical Systems 3.0Tesla MRI scanner.
The Premier III Phased Array CTL Spine Coil is designed to provide Magnetic Resonance Images of the spine anatomy. The Premier III Phased Array CTL Spine Coil is designed for use with the GE Medical Systems 3.0Tesla scanner.
The indications for use are the same as for standard imaging:
The GE Medical Systems 3.0Tesla 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 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Premier III Phased Array CTL Spine Coil:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Intended Use: Imaging of the spine. | Similar to predicate devices: Premier 7000 C/T/L Spine Coil (K980157) and Magna 5000 CTL Spine Coil (K994345), both manufactured by USA Instruments, Inc. |
| Indications for Use: Identical to routine MRI imaging, specifically for the spine anatomy. The GE Medical Systems 3.0Tesla system is indicated for producing images of proton distribution, NMR parameters (proton density, T1, T2), and soft tissue structure, providing diagnostic information when interpreted by a trained physician. | Similar to predicate devices: Premier 7000 C/T/L Spine Coil (K980157) and Magna 5000 CTL Spine Coil (K994345). The device is designed for use with the GE Medical Systems 3.0Tesla MRI scanner, implying it meets the performance characteristics specific to that system. |
| Safety: | Prevention of RF Burns: Does not transmit RF power. Decoupling isolates coil elements from RF fields during RF transmission. Coil elements and circuitry are enclosed in a non-conductive housing. |
| Radio Frequency Absorption: | Coil is a receive-only coil and does not transmit RF power. |
| Formation of Resonant Loops: | Decoupling isolates coil elements from RF fields during RF transmission. Length of cable and stiffness does not permit looping. |
| Coil Material: ABS Plastic, Polycarbonate Plastic. | Similar to predicate devices: Premier 7000 C/T/L Spine Coil (K980157) and Magna 5000 CTL Spine Coil (K994345). |
| Coil Design: Receive-only phased array design. | Similar to predicate devices: Premier 7000 C/T/L Spine Coil (K980157) and Magna 5000 CTL Spine Coil (K994345). The device is described as a multi-element phased array receive-only coil, shaped to conform to the contours of the spine, designed to maximize comfort and ease of use. |
| Decoupling: RF Chokes with Switching Diodes. | Similar to predicate devices: Premier 7000 C/T/L Spine Coil (K980157) and Magna 5000 CTL Spine Coil (K994345). |
| Compatibility: | Specifically designed for use with the GE Medical Systems 3.0Tesla MRI scanner. This implies compatibility and performance equivalence with that specific system. |
| Overall substantial equivalence to predicate devices. | The device was found by the FDA to be substantially equivalent to legally marketed predicate devices (K980157 and K994345) for the stated indications for use. This is the overarching acceptance criterion and performance demonstration. |
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with explicit performance metrics against predefined acceptance criteria. The "reported device performance" is primarily a statement of similarity to predicate devices already cleared by the FDA.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a test set or test data in the way one would for a clinical performance study of a diagnostic algorithm or new technology. The safety and effectiveness information is presented as a comparison to predicate devices. There is no mention of a specific sample size of images or patients used for performance testing.
Therefore:
- Sample size for test set: Not applicable/not provided in this document.
- Data provenance: Not applicable/not provided in this document. The comparison is feature-based against existing cleared devices, not data-driven.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish ground truth for a test set. This type of evaluation is characteristic of studies assessing the diagnostic accuracy of AI or interpretive devices, which is not the nature of this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable, as no test set or ground truth establishment process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this document. This submission is for an accessory (an RF coil) to an MRI system, not a diagnostic algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone performance study was not conducted or described. This device is a passive RF coil; it does not perform any algorithmic analysis or interpretation.
7. The Type of Ground Truth Used
Not applicable, as no ground truth was established for performance testing of this device. The regulatory pathway here is substantial equivalence based on physical and functional characteristics compared to predicate devices.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware accessory; it does not involve machine learning algorithms that require training sets.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.