(48 days)
To be used in conjunction with Siemens 1.5T MAGNETOM MRI scanners to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis and spine that can be interpreted by a trained physician.
The NeoCoil 1.5T 16-Channel Flex Coils for Siemens is a system of phased array, receiveonly coils. 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 16-Channel Flex Coils for Siemens are tuned to receive RF frequency corresponding to the proton precession in a 1.5 testa magnetic field, which is governed by the Larmor equation.
The provided text describes the 510(k) summary for the NeoCoil 1.5T 16-Channel Flex Coils. This device is a magnetic resonance specialty coil, not an AI/ML powered device, therefore the information requested for AI/ML powered devices, e.g. sample sizes for test and training sets, number of experts used for ground truth, adjudication method, MRMC studies, and standalone performance data, are not applicable or provided in the submission.
However, the document does detail the acceptance criteria and study results for this specific medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Pass/Fail Criteria | Reported Device Performance and Result |
|---|---|---|
| Unplugged Surface Temperature | Acceptable level of risk | 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 | 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 Siemens performance requirements and demonstrates adequate active and passive transmit decoupling. |
| NEMA MS 6-2008 | Pre-defined performance standards | Pass: SNR (Signal-to-Noise Ratio) and Image Uniformity are consistent with the requirements for indications for use. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated with a specific number of cases or patients. The document 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."
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing included "clinical performance testing," which implies prospective data collection, but it does not specify whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as the device is an MRI coil, not an AI/ML algorithm. Ground truth, in the context of diagnostic image interpretation, is typically established by trained physicians interpreting the images produced by the device, as mentioned in the Indications for Use ("...images...that can be interpreted by a trained physician."). The document does not specify the number or qualifications of these physicians for the performance testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable and therefore not provided for this type of medical device (MRI coil). Adjudication methods are typically relevant for studies evaluating human interpretation or AI algorithm performance against a consensus ground truth.
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 MRMC comparative effectiveness study was done, as this device is an MRI coil, not an AI-assisted diagnostic tool. Therefore, the effect size of human readers improving with or without AI assistance is not applicable and not provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- A standalone performance assessment in the context of an AI algorithm is not applicable to this MRI coil. The performance assessment focused on the coil's physical, electrical, and imaging characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench performance tests, the "ground truth" was based on pre-defined performance standards (e.g., maximum temperature, adequate RF decoupling, meeting Siemens performance requirements for B1 field, and NEMA MS 6-2008 standards for SNR and Image Uniformity).
- For the clinical performance testing, the "ground truth" was the ability of the coil to produce diagnostic images that could be interpreted by a trained physician, as per the stated Indications for Use. No specific "expert consensus," "pathology," or "outcomes data" are explicitly mentioned as ground truth for this device's performance evaluation beyond the general statement of "performance adequate to support the Indications for Use."
8. The sample size for the training set:
- This information is not applicable and not provided as the device is an MRI coil, not an AI/ML powered device that requires a training set.
9. How the ground truth for the training set was established:
- This information is not applicable and not provided as the device is an MRI coil, not an AI/ML powered 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.