(237 days)
The NeoColl PCE system is intended to provide audio entertainment and facilitate patient communication in MBL environments at 3 tesla field strength and below.
The NeoCoil Patient Communication and Entertainment (PCE) System is intended to provide audio entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The PCE System is intended to be used by healthcare professionals.
The NeoCoil Patient Communication and Entertainment System is a modular system comprised of wireless patient headphones, a remote audio data source unit, patient alert, and communications infrastructure.
The NeoCoil Patient Communication and Entertainment (PCE) System is intended to provide audio entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The device's performance meets the requirements of pre-defined acceptance criteria and intended uses.
Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Max B1 in first fault conditions | Pre-defined performance standards | PASS: Patient Communication and Entertainment System 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 41° C. |
| NEMA MS 6-2008 | Pre-defined performance standards | PASS: Patient Communication and Entertainment System does not adversely impact MR image SNR and Uniformity |
| Coherent Noise Test | Pre-defined performance standards | PASS: Patient Communication and Entertainment System does not introduce image artifacts noise in center frequency range of compatible field strengths. |
| Noise Reduction | Pre-defined performance standards | PASS: >20 dBA NRR (ANSI S3.19-1974) |
| Quality of Service and Coexistence Test | Pre-defined performance standards | PASS: Patient Communication and Entertainment System provides adequate quality of service for patient communication during MRI scanning. |
Study Details
- Sample size used for the test set and the data provenance: The document mentions "clinical performance testing" and indicates that "No adverse events were reported during clinical performance testing." However, it does not specify the exact sample size for the test set or the country of origin of the data. It implies a prospective or at least observed clinical use during testing to ensure no adverse effects.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the document.
- Adjudication method for the test set: This information is not provided in the document.
- 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: An MRMC comparative effectiveness study was not conducted, as this device (Patient Communication and Entertainment System) is not an AI-driven diagnostic or interpretative tool for medical images, but rather a patient comfort and communication system during MRI.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a system involving hardware and interaction with human operators and patients. Therefore, a standalone algorithm-only performance assessment is not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device's performance is based on fulfilling pre-defined engineering and safety standards related to MRI compatibility, communication quality, and noise reduction. It's not a diagnostic device, so ground truth like pathology or expert consensus on image interpretation is not relevant. The clinical performance testing focused on ensuring the device "does not adversely affect MR image production in the worst-case environment" and that "no adverse events were reported."
- The sample size for the training set: This is not applicable, as this is not a machine learning or AI-driven device requiring a training set.
- How the ground truth for the training set was established: This is not applicable.
§ 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.