(23 days)
To be used in conjunction with GEHC 1.5T Nagnetic Resonance Scanners to produce diagnostic and interventional planning images of the breast that can be interpreted by a trained physician. When used with biopsy accessories, this device permits access to the breast anatomy for interventional procedures that can be performed by a trained physician.
The NeoCoil 1.5T 16ch Breast Coil is a phased array coil for imaging structures of the breast, axilla and chest wall. The 1.5T 16ch Breast Coil is a three part receive-only coil designed to provide high resolution imaging. The 1.5T 16ch Breast Coil includes a coil support structure, patient support structure, biopsy components and comfort pads.
The information provided does not describe an AI/ML device but rather a Magnetic Resonance Specialty Coil (NeoCoil 1.5T 16ch Breast Coil). Therefore, most of the requested information (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and ground truth for training set) is not applicable or cannot be extracted from the given text.
However, I can provide the acceptance criteria and reported device performance from the "Testing" section for the medical device in question.
1. Table of acceptance criteria and the 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 (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 | Pass: B1 field inhomogeneity meets performance requirements and demonstrates adequate active and passive transmit decoupling. |
| NEMA MS 6-2008 (SNR and Image Uniformity) | Pre-defined performance standards | Pass: SNR and Image Uniformity are consistent with the requirements for Indications for use. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable/Not provided. The document describes a physical device validation and does not refer to a "test set" in the context of an AI/ML model for data analysis or diagnostic performance. Clinical testing was performed, but specific sample sizes and data provenance details (country of origin, retrospective/prospective) are not mentioned.
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. This device is an MRI coil, not an AI/ML diagnostic algorithm that requires expert-established ground truth for its performance evaluation in the described manner.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/Not provided.
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/Not provided. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable/Not provided. This is a hardware component (MRI coil).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable/Not provided. The performance testing for this device focuses on physical characteristics, safety (temperature, RF fields), and imaging quality (SNR, uniformity) determined by engineering standards and clinical observation, not diagnostic ground truth as defined for AI/ML algorithms. Clinical testing "demonstrated performance adequate to support the Indications for Use," implying that the images produced were suitable for interpretation by a trained physician, which is the "Indication for Use."
8. The sample size for the training set:
Not applicable/Not provided. This is a hardware device, not an AI/ML algorithm.
9. How the ground truth for the training set was established:
Not applicable/Not provided. This is a hardware 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.