(128 days)
The carotid coil is a receive-only coil, used for high resolution imaging of the bifurcation of the carotid artery in 1.5T and 3T General Electric, Siemens and Philips Magnetic Resonance Imaging (MRI) systems. Nucleus Excited: Proton 1H Anatomic regions: Carotid. The Carotid Coil is used for obtaining diagnostic images of carotid in magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
Carotid Coil is a phased array, receive-only coil. It consists of eight elements optimized for high signal-to-noise ratio. Semi-flexible design makes the coil reliable and comforts the patient. The enclosure, which may contact the patient, is made up of biocompatible material.
The provided document is a 510(k) Summary for a Magnetic Resonance Diagnostic Device, Carotid Coil. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its clinical performance against specific acceptance criteria for diagnostic accuracy.
Therefore, many of the requested items (e.g., acceptance criteria for diagnostic performance, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for test/training set, training set sample size) are not applicable or not provided in this type of submission document, as it is a submission for a medical device (coil) used for imaging, not a diagnostic algorithm.
Here's a breakdown of what can be extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not outline specific acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) of a device that interprets images. The "performance tests" mentioned refer to technical parameters of the coil itself.
| Acceptance Criteria (Technical) | Reported Device Performance (Technical) |
|---|---|
| Bio-compatibility tests | Complies with ISO 10993-5 and ISO 10993-10 |
| IEC60601-1 compliance tests | Complies with UL 60601-1 |
| Safety and Effectiveness | Proved safe and effective by performance tests, biocompatibility tests, and IEC60601-1 compliance tests; substantially equivalent to predicate device. |
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 / Not Provided. This document describes a physical medical device (an MRI coil), not a diagnostic algorithm that processes data. Therefore, there is no "test set" in the context of diagnostic performance evaluation. The "performance tests" refer to the engineering and technical performance of the coil.
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. See point 2.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. 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
- No. This is not a study of an AI or diagnostic algorithm, but a physical MRI coil. An MRMC study would not be relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical MRI coil, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. The "ground truth" concept as applied to diagnostic algorithms is not relevant for this submission about an MRI coil. The "ground truth" for the coil's performance would be its technical specifications verified by engineering tests.
8. The sample size for the training set
- Not Applicable / Not Provided. This is a physical MRI coil, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. See point 8.
Additional Information provided in the 510(k) Summary:
- Device Type: Magnetic Resonance Imaging Coil (receive-only, phased array, 8 elements).
- Intended Use: High resolution imaging of the bifurcation of the carotid artery in 1.5T and 3T GE, Siemens, and Philips MRI systems. Nucleus Excited: Proton 1H.
- Indications for Use: Obtaining diagnostic images of the carotid for interpretation by a trained physician to assist in diagnosis.
- Predicate Device: Carotid Coil, manufactured by Shanghai Chenguang Medical Technologies Co., Ltd. (510k number K092962).
- Demonstration of Performance: Substantial equivalence was demonstrated through:
- Performance tests (technical specifications of the coil).
- Bio-compatibility tests (compliance with ISO 10993-5 and ISO 10993-10).
- IEC60601-1 compliance tests (compliance with UL 60601-1).
- Conclusion: The device is considered safe and effective and substantially equivalent to the predicate device based on similarities in design features, overall indications for use, and technological characteristics.
§ 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.