(24 days)
To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.
The NeoCoil 3T 16ch Flex SPEEDER Coils are a receive-only phased array coil system designed to provide high resolution imaging for the upper and lower extremities, chest. abdomen, pelvis, head, neck, and spine. The system is compatible with 2D, 3D, parallel and isotropic imaging, as well as, coil signal intensity correction. The system consists of:
- Two formable, flexible and detachable antennae of different size that can be . wrapped or orientated flat, in order to accommodate various anatomic shapes and sizes.
- . Optional accessories designed for patient comfort and reduced motion artifacts.
The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation.
Here's a breakdown of the acceptance criteria and study information for the NeoCoil 3T 16ch Flex SPEEDER Coils, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Unplugged Surface Temperature | Acceptable level of risk (not greater than 41°C) | Pass: Surface temperature is not greater than 41°C when the coil is left unplugged in the MRI scanner. |
| Surface Temperature | Pre-defined performance standards (RF and Eddy current heating not greater than 41°C) | Pass: RF and Eddy current heating is not greater than 41°C. |
| Blocking Network Analysis | Adequate transmit decoupling | Pass: Blocking network demonstrates adequate active and passive transmit decoupling. |
| B1 Field Distortion | Pre-defined performance standards (meets Toshiba performance requirements and demonstrates adequate active and passive transmit decoupling) | Pass: B1 field inhomogeneity meets Toshiba performance requirements and demonstrates adequate active and passive transmit decoupling. |
| NEMA MS 6-2008 (SNR and Image Uniformity) | Pre-defined performance standards (consistent with requirements for indications for use) | Pass: SNR and Image Uniformity are consistent with the requirements for indications for use. |
| Clinical Performance Testing | Adequate performance to support the Indications for Use, with no adverse events. | Pass: The clinical data demonstrated performance adequate to support the Indications for Use. No adverse events were reported during clinical performance testing. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the numerical sample size for the "test set" in terms of number of patients or images. It mentions "Clinical data in this section exhibits a mix of technical factors and anatomy in the axial, sagittal and coronal planes." This suggests a varied, but unspecified, sample for clinical testing.
The data provenance is not explicitly stated as 'country of origin' or 'retrospective/prospective'. However, given that it's a 510(k) submission for a device to be marketed in the USA, and the testing involves compliance with standards like NEMA MS 6-2008, it's highly likely that the testing was conducted prospectively to demonstrate performance for regulatory clearance, primarily in a research or clinical setting relevant to MRI device evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical performance testing. It simply states that the images "can be interpreted by a trained physician," which is a general statement about the intended use of the diagnostic images rather than the ground truth establishment process for the study itself.
4. Adjudication Method for the Test Set:
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the clinical performance test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement:
An MRMC comparative effectiveness study was not done. This device is an MRI coil, not an AI-powered diagnostic algorithm. The testing focuses on the physical performance and imaging capabilities of the hardware. Therefore, there is no mention of AI assistance or its effect size on human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This question is not applicable. The device is an MRI coil, which is hardware, not a software algorithm. Therefore, "standalone (algorithm only)" performance is not relevant.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
For the clinical performance testing, the "ground truth" implicitly relies on the ability of the images generated by the coil to be "interpreted by a trained physician" for diagnostic purposes. This suggests that the ground truth would be based on clinical interpretation by physicians, likely in comparison to established diagnostic standards or findings from other imaging modalities if specific pathologies were being assessed. However, the document does not explicitly detail the method for establishing "ground truth" beyond meeting diagnostic quality for interpretation. The primary focus of the performance tests (SNR, image uniformity, B1 field distortion) is on the physical imaging capabilities of the coil.
8. The Sample Size for the Training Set:
This question is not applicable. The NeoCoil 3T 16ch Flex SPEEDER Coils are hardware (an MRI coil), not a machine learning or AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable as there is no training set for an MRI coil.
§ 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.