(29 days)
To be used in conjunction with GEHC 3.0T Magnetic Resonance Scanners to produce diagnostic and interventional planning images of the breast that can be interpreted by a trained physician. When used with biopsy components, this device permits access to the breast anatomy for interventional procedures that can be performed by a trained physician.
The NeoCoil 3.0T 16ch Breast Coil is a phased array coil for imaging structures of the breast, axilla and chest wall. The 3.0T 16ch Breast Coil is a three part receive-only coil designed to provide high resolution imaging. The.3.0T 16ch Breast Coil includes a coil support structure, patient support structure, biopsy components and comfort pads.
The NeoCoil 3.0T 16ch Breast Coil is tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation.
The provided text describes the NeoCoil 3.0T 16ch Breast Coil and its performance testing to support its substantial equivalence to a predicate device. However, it does not describe a study that proves a device meets specific acceptance criteria in the context of an AI/algorithm-driven diagnostic device. The device in question is a magnetic resonance imaging (MRI) coil, which is a hardware component, not an AI or software device.
Therefore, many of the requested categories for AI/algorithm performance and study design are not applicable to the information provided for this hardware device.
Here's an attempt to extract the relevant information and indicate where the requested details are not present due to the nature of the device:
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 when unplugged in MRI scanner) | 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 (meet Toshiba performance requirements, adequate 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 | Performance adequate to support Indications for Use | Pass: No adverse events were reported. The 3.0T 16ch Breast Coil demonstrated performance adequate to support the Indications for Use. (Ability to produce diagnostic and interventional planning images of the breast, axilla, and chest wall.) |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not explicitly stated for specific tests. The document mentions "clinical performance testing" but does not quantify the number of patients or images.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It only mentions "clinical data in this section exhibits a mix of technical factors and anatomy".
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a hardware device (MRI coil) and its performance is evaluated based on physical measurements (temperature, RF properties) and image quality metrics (SNR, uniformity) rather than specific diagnostic outcomes requiring expert consensus on a test set of cases. The "Indications for Use" mention interpretation by a "trained physician," but this is for general clinical use, not for establishing ground truth in a performance study of the coil itself.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. See point 3.
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 an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable in the context of diagnostic accuracy for a specific disease. The "ground truth" for this device's performance involves objective physical measurements and adherence to engineering and imaging standards (e.g., temperature limits, signal-to-noise ratios, image uniformity as per NEMA MS 6-2008).
8. The sample size for the training set:
- Not Applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. This is not an AI 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.