(84 days)
The Champion 5000 Peripheral Vascular Coil is a multi-element phased array RF coil, used for obtaining diagnostic images of the vasculature and soft tissue anatomy extending from the torso to the foot region, in Magnetic Resonance Imaging Systems. The Champion 5000 Peripheral Vascular Coil is designed for use with the Altaire 0.7T MRI system manufactured by Hitachi Medical Systems America, Inc. The indications for use are the same as for standard MR Imaging.
The Champion 5000 Peripheral Vascular Coil is designed to provide Magnetic Resonance Images of the vasculature and soft tissue anatomy, extending from the torso to the foot region. Champion 5000 Peripheral Vascular Coil is designed for use with the Hitachi Altaire 0.7T scanner manufactured by Hitachi Medical Systems America, Inc.
The 1.5T 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 Champion 5000 Peripheral Vascular Coil is a multi-element phased array receive-only coil. The coil consists of five sections: a main coil base, three removable top part sections, and a removable foot section. The open, patient friendly design minimizes claustrophobic effects 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.
This document is a 510(k) summary for a Magnetic Resonance Imaging Accessory, specifically the Champion 5000 Peripheral Vascular Coil. It is a premarket notification for a Class II device.
The provided text does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would for a diagnostic algorithm. This document is for a physical medical device (an MRI coil), and its "acceptance criteria" are related to its safety, intended use, and substantial equivalence to previously cleared predicate devices, rather than a quantifiable performance metric like sensitivity or specificity for an AI algorithm.
Therefore, many of the requested elements for describing a study and acceptance criteria related to algorithmic performance cannot be extracted from this document.
However, I can extract information related to the device's characteristics and its comparison to predicate devices, which serve as the basis for its substantial equivalence and "acceptance" by the FDA.
Here's the breakdown of what can be extracted based on the provided text, and where gaps exist:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is an MRI coil and not a diagnostic algorithm, the "acceptance criteria" are framed as comparisons to predicate devices to establish substantial equivalence. Performance is described in terms of functional similarities and safety features.
| Acceptance Criteria (based on predicate device comparison) | Reported Device Performance (Champion 5000 Peripheral Vascular Coil) |
|---|---|
| Intended Use: Imaging of the vasculature and soft tissue anatomy extending from the torso to the foot region. | Similar to Flow 7000 Peripheral Vascular Coil (K982339). The Champion 5000's intended use is the same: imaging of vasculature and soft tissue anatomy from torso to foot region. |
| Indications for Use: Identical to routine MRI imaging. | Similar to Flow 7000 Peripheral Vascular Coil (K982339). The Champion 5000's indications for use are the same as for standard MR Imaging. |
| Coil Enclosure Material: Flame Retardant Polycarbonate / Flame Retardant Polyurethane. | Similar to Profile 7000 Quadrature Volume Neck Coil (K964531), Magna 5000 Phased Array CTL Spine Coil (K000002). Uses Flame Retardant Polycarbonate and Flame Retardant Polyurethane (TD-27702, Polyone U2773 Neutral). |
| Coil Design: Receive-only phased array coil. | Similar to Magna 5000 Phased Array CTL Spine Coil (K000002), Interventional Body Coil (K000437). The Champion 5000 is a multi-element phased array receive-only coil. |
| Decoupling: Switching diode decoupling. | Similar to Magna 5000 Phased Array CTL Spine Coil (K000002), Interventional Body Coil (K000437). Uses switching diode decoupling. |
| Prevention of RF Burns: Does not transmit RF power; decoupling isolates elements; enclosed in non-conductive housing. | Similar to Flow 7000 Peripheral Vascular Coil (K982339). The Champion 5000 does not transmit RF power, uses decoupling, and elements/circuitry are in a non-conductive housing. |
| Radio Frequency Absorption: Receive-only, does not transmit RF power. | Similar to Magna 5000 Phased Array CTL Spine Coil (K000002), Interventional Body Coil (K000437). The coil is receive-only and does not transmit RF power. |
| Formation of Resonant Loop: Decoupling isolates elements; cable length/stiffness prevents looping. | Similar to Flow 7000 Peripheral Vascular Coil (K982339). Decoupling isolates elements, and cable properties prevent looping. |
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 document describes an MRI coil, not a diagnostic algorithm that would typically use a "test set" of data in the sense of patient images for performance evaluation. The "testing" referred to is likely engineering validation and verification of the physical device's characteristics against its design specifications and safety requirements, often in a laboratory or simulated environment, rather than a clinical dataset for performance metrics.
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. See point 2. Ground truth in this context would relate to the physical properties and safety of the coil, not diagnostic interpretations from images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 2.
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 algorithm. Therefore, no MRMC study or AI-assisted improvement metrics would be relevant here.
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 a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable / Inferred as engineering specifications and regulatory standards. For an MRI coil, the "ground truth" for its safety and effectiveness would be established through engineering tests verifying its physical, electrical, and RF safety properties, as well as its ability to produce images (signal-to-noise ratio, uniformity, etc.) that are comparable to predicate devices. This is based on objective measurements and established standards for MRI hardware, rather than medical ground truths like pathology.
8. The sample size for the training set
- Not Applicable. This device is an MRI coil, not an AI algorithm that would have a "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.