(30 days)
Optoacoustic's MRI Multi-Channel Optical Communication System (MOC) is intended to facilitate audio communications and stimulation during a scanning session. System devices provide real-time Scanner noise reduction and/or noise cancellation, while enabling multiple concurrent dialogs.
Optoacoustic's MRI Multi-Channel Optical Communication System (MOC) is intended to facilitate audio communications and stimulation during a scanning session. System devices provide real-time Scanner noise reduction and/or noise cancellation, while enabling multiple concurrent dialogs. The MRI MOC comprises the following main component devices: IMROC, IMROC IR Wireless, and OptoACTIVE. Sub-component devices include Optical Headsets, Control/Mixing Console, Electro-Optical Unit (EOU), IR Transceiver Unit, Battery Recharging Unit, Hygienic Pop Screens, and Hygienic Earpad Covers.
The provided document describes the Optoacoustics Ltd. MRI Multi-Channel Optical Communication System (MOC). It does not present specific acceptance criteria or a detailed study proving the device meets those criteria with numerical performance values. Instead, it describes a comprehensive performance testing program that was conducted to ensure the system meets its specifications and does not raise new safety or effectiveness issues compared to predicate devices. The document also states that clinic performance studies were performed but does not elaborate on the results.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from context) | Reported Device Performance (as stated in the document) |
|---|---|
| Electrical Safety and Electromagnetic Compatibility (e.g., compliance with IEC 60601-1 and IEC 60601-1-2 standards) | "The Electrical Safety and Electromagnetic compatibility of the MOC were tested by external laboratories and testing results demonstrate that the System is in compliance with the requirements of the IEC 60601-1 (and amendments), and IEC 60601-1-2 standards." |
| Device meets its specifications (e.g., facilitating audio communications, stimulation, real-time scanner noise reduction/cancellation, multiple dialogs) | "Comprehensive performance evaluation studies were conducted to ensure that the MOC meets its specifications." "Comprehensive clinical performance studies were conducted to ensure that the MOC performs effectively, in full accordance with its indications and intended use." "The MRI Multi-Channel Optical Communication (MOC) System is substantially equivalent to the predicates... in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards." |
| Reduced potential risks to pre-determined acceptance criteria (ISO 14971 compliance) | "Risk analysis activities were conducted in accordance with requirements of ISO 14971 'Medical devices - Application of risk management to medical devices' (2007). As concluded from the Risk Analysis procedure, the potential risks of the MOC have been reduced to pre-determined acceptance criteria and the residual risk deemed acceptable." |
| Substantial Equivalence to Predicate Devices (for safety and effectiveness) | "Based on these performance testing results, as well the verification and validation processes and an analysis of the similarities and differences presented above, it can be concluded that the MOC is substantially equivalent to the predicate devices without raising new issues of safety or effectiveness." |
2. Sample size used for the test set and the data provenance:
- The document mentions "Comprehensive clinical performance studies were conducted," but does not specify the sample size for any test set (clinical or otherwise) or provide details on the data provenance (e.g., country of origin, retrospective or prospective nature).
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 in the document. The device is for communication and noise reduction, not diagnostic imaging, so traditional "ground truth" established by experts for image interpretation wouldn't typically apply in the same way.
4. Adjudication method for the test set:
- This information is not provided in the document.
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:
- This information is not applicable as the device is not designed for diagnostic image interpretation by human readers with or without AI assistance. It is a communication system accessory for MRI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that "Comprehensive performance evaluation studies" and "Comprehensive clinical performance studies" were conducted. However, it does not explicitly detail a "standalone" performance study in the context of an algorithm's performance without human interaction. The device's nature (communication system) inherently involves human interaction.
7. The type of ground truth used:
- The document does not explicitly state the "type of ground truth used." For a communication and noise reduction system, "ground truth" would likely relate to objective measurements of audio clarity, noise reduction levels, and successful communication, rather than pathology or outcomes data in a diagnostic sense.
8. The sample size for the training set:
- This information is not provided. Given the nature of the device as a communication system and not an AI/machine learning diagnostic tool, a "training set" in the traditional sense might not be applicable or explicitly mentioned.
9. How the ground truth for the training set was established:
- This information is not provided and is likely not relevant in the context of this 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.