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510(k) Data Aggregation
(107 days)
Wireless Audio System
The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate patient communication in MRI environments at 3 Tesla field strength and below.
The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The Wireless Audio System is intended to be used by healthcare professionals.
The NeoCoil Wireless Audio System is a modular system comprised of wireless patient headphones, a remote audio data source unit, and communications infrastructure.
The provided text describes the NeoCoil Wireless Audio System, a device for patient communication and entertainment in MRI environments. It includes details about the device's performance testing and comparison to a predicate device.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Performance |
|---|---|---|
| Max B1 in first fault conditions | Pre-defined performance standards | PASS: Wireless Audio 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: Wireless Audio System does not adversely impact MR image SNR and Uniformity. |
| Coherent Noise Test | Pre-defined performance standards | PASS: Wireless Audio System does not introduce image artifacts noise in center frequency range of compatible field strengths. |
| Noise Reduction | Pre-defined performance standards | PASS: ≥29 dBA NRR (ANSI S3.19-1974) |
| Quality of Service and Coexistence Test | Pre-defined performance standards | PASS: Wireless Audio System provides adequate quality of service for patient communication during MRI scanning. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Clinical data submitted exhibits a mix of pulse sequences and imaging options in the axial, sagittal and coronal planes". However, it does not specify the sample size for the test set or the country of origin of the data. It implies the data is prospective clinical performance testing as it refers to "No adverse events were reported during clinical performance testing".
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide information on the number of experts used to establish ground truth for the test set or their qualifications.
4. Adjudication Method
The document does not specify an adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide an effect size for human readers improving with AI vs. without AI assistance. The device is an audio system, not an AI diagnostic tool.
6. Standalone Performance Study
The document details various standalone performance tests (bench and clinical) of the NeoCoil Wireless Audio System. These tests assess the system's impact on MRI image quality, safety parameters (RF heating, B1 fields), noise reduction, and quality of service for communication. It demonstrates the algorithm's (device's) standalone performance by showing it meets pre-defined acceptance criteria for these aspects.
7. Type of Ground Truth Used for Test Set
For the bench tests, the ground truth appears to be based on pre-defined performance standards and objective measurements (e.g., measuring temperature, SNR, uniformity, noise levels, NRR, quality of service).
For the clinical performance testing, the ground truth seems to be based on the observation that the device "does not adversely affect MR image production in the worst-case environment" and that "No adverse events were reported." This suggests qualitative assessment by clinicians or technicians during actual MRI scans, evaluating image quality and patient safety.
8. Sample Size for the Training Set
The document does not mention a training set size. This device is not an AI/ML model that would typically have a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set in the context of an AI/ML device, this information is not applicable and not provided in the document.
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