(39 days)
To be used in conjunction with Toshiba Magnetic Resonance Scanners with DL96 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 1.5T 16ch Flex SPEEDER is 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 1.5T 16ch Flex SPEEDER coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the NeoCoil 1.5T 16ch Flex SPEEDER Coil:
Acceptance Criteria and Device Performance Study
The NeoCoil 1.5T 16ch Flex SPEEDER Coil is a receive-only phased array coil system designed for high resolution imaging. The submission focuses on demonstrating its substantial equivalence to a predicate device (1.5T GEM Flex Coil, K113474) and its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance/Result |
|---|---|---|
| Max B1 in first fault conditions | Pre-defined performance standards | Pass: Coil does not arc or show any signs of voltage breakdown. |
| Surface Temperature in normal and first fault conditions | Pre-defined performance standards | Pass: RF heating is not greater than 39° C in normal or first fault conditions. |
| NEMA MS 6-2008 | Pre-defined performance standards | Pass: SNR (Signal-to-Noise Ratio) and Uniformity are consistent with the requirements for indications for use. |
| Unplugged Surface Temperature | Acceptable level of risk | Pass: Surface temperature rise results in acceptable residual risk after mitigation. |
Note: The document explicitly states, "The device's performance meets the requirements of pre-defined acceptance criteria and intended uses."
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific numerical sample size for the "clinical performance testing" or the test set used for evaluating the acceptance criteria. It mentions:
- "Clinical data submitted exhibits a mix of scanner configurations, pulse sequences, imaging options, field of view and anatomy in the axial, sagittal and coronal planes as recommended in the FDA guidance, Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices."
- This suggests retrospective data across various clinical scenarios, but the specific origins (e.g., country) are not detailed. It implies a diverse set of imaging scenarios rather than a single, controlled prospective study with a defined sample size.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth for any test set. The "Indications for Use" state that images "can be interpreted by a trained physician," implying clinical interpretation, but no details on expert review for the study itself are provided. The study primarily focuses on demonstrating technical performance and equivalence, rather than diagnostic accuracy that would typically require expert ground truth.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set. Given the nature of the tests (bench testing for electrical, thermal, and imaging parameters), expert adjudication of images for diagnostic purposes (which would require a ground truth panel) was likely not the primary method for evaluating these specific acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not conducted or reported in these documents. This device is an MRI coil, not an AI-powered diagnostic algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device itself is a standalone hardware component that produces images, there is no mention of an "algorithm only" performance study in the context of an AI device. The coil's performance was assessed as a standalone component of the MRI system.
7. The Type of Ground Truth Used
For the bench tests evaluating electrical, thermal, and NEMA MS 6-2008 standards:
- The ground truth was based on pre-defined performance standards and objective measurements (e.g., temperature readings, arc detection, SNR and uniformity metrics).
- For the "Unplugged Surface Temperature" test, the ground truth was defined by an "acceptable level of risk."
For the "clinical performance testing":
- The ground truth appears to be a qualitative assessment that the coils "demonstrated performance adequate to support the Indications for Use," implying that the images produced were clinically usable and comparable to what would be expected for diagnostic imaging. There is no mention of a reference standard like pathology, biopsy, or long-term outcomes.
8. The Sample Size for the Training Set
The document does not mention a "training set" as this device is a hardware component and not a machine learning algorithm requiring a separate training phase.
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.