(49 days)
The Premier III Phased Array CTL Spine Coil is a receive- only phased array RF coil, used for obtaining diagnostic images of the cervical, thoracic, and lumbar regions of the spine in Magnetic Resonance Imaging Systems. The Premier III Phased Array CTL Spine Coil is designed for use with the Intera 3.0T MRI system manufactured by Philips Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.
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 Philips 3.0T Intera MR scanner manufactured by Philips 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 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) summary for a Magnetic Resonance Imaging Accessory, specifically the Premier III Phased Array CTL Spine Coil. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria and detailed performance metrics as would be found in a clinical trial for a novel AI device or a device requiring new clinical evidence.
Therefore, many of the requested sections (2-9), which are typical for studies proving meeting acceptance criteria for AI/diagnostic devices, cannot be directly answered from the provided text. The device described is a hardware component (an MRI coil), and its "performance" is primarily assessed by comparing its features and intended use to existing, legally marketed predicate devices, ensuring it doesn't raise new questions of safety or effectiveness.
Here’s what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for a study. Instead, it presents a comparison of the new device's features and safety aspects against predicate devices to establish substantial equivalence. The "performance" is inferred from these comparisons being "similar."
| Acceptance Criteria (Inferred / Stated implicitly as "Similar to predicate") | Reported Device Performance |
|---|---|
| Intended Use: Imaging of the spine. | Similar to predicate device (K030042) |
| Indications for Use: Identical to routine MRI imaging. | Similar to predicate device (K030042) |
| Coil Material: Polycarbonate Plastic, Flame Retardant Polyurethane | Similar to predicate device (K030042) |
| Coil Design: Receive-only phased array design. | Similar to predicate device (K030042) |
| Decoupling: Switching diode decoupling. | Similar to predicate device (K980157) |
| 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. | Similar to predicate device (K030042) |
| Radio Frequency Absorption: Coil is a receive-only coil and does not transmit RF power. | Similar to predicate device (K030042) |
| Formation of Resonant Loops: Decoupling isolates coil elements from RF fields during RF transmission. Length of cable and stiffness does not permit looping. | Similar to predicate device (K030042) |
Regarding the study proving the device meets acceptance criteria:
The provided document describes a 510(k) Premarket Notification process, which is a regulatory pathway to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device. This process typically relies on comparing design, materials, intended use, and safety features rather than extensive clinical studies with specified acceptance criteria as might be seen for novel diagnostic algorithms or drugs.
The "study" described here is essentially a comparison to predicate devices to prove substantial equivalence.
2. 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. The document does not describe a test set, clinical trial, or data of patients. The evaluation is based on design and technical specifications compared to predicate 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 / Not provided. No ground truth establishment by experts for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No adjudication method for a test set 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
- No, not done. This device is an MRI hardware component (a coil), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware component, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No specific ground truth type is mentioned as this is a device for substantial equivalence, not a diagnostic accuracy study.
8. The sample size for the training set
- Not applicable / Not provided. The concept of a "training set" is not relevant to the evaluation of this hardware device.
9. How the ground truth for the training set was established
- Not applicable / Not provided. The concept of "ground truth for the training set" is not relevant here.
§ 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.