(186 days)
The E3 and Profile system is an electrodiagnostic device used to generate photic signals and to measure and display the electrical signals generated by the retina and the visual nervous system. It displays digitized electroretinogram (ERG), visual evoked potential (VEP) and sensory electro-oculogram (EOG) signals, power spectra and topographic maps. These functions are controlled and interpreted by trained medical professionals, for use with patients who are experiencing visual system abnormalities.
Photopic stimuli are presented to the patient using LEDs or a monitor, using various number of elements in separately stimulated fields. Various modes are available for preferential stimulation of different retinal mechanism and isolation of signal from different retinal lavers. Data is recorded by up to 5 recording channels using conventional EEG electrodes (not provided with the device). During the period of time that the system is acquiring data (1-20 minutes), there is a real time display of the raw and processed data presented to the user. Once the resulting individual waveforms are acquired, the signals are analyzed by software using algorithms for spatial filtering and artifact rejection. Data may be presented in a number of forms, including waves recorded at each of the points tested, color plots, or 3D topographical representation.
The provided text describes the regulatory clearance of a medical device, the E3 and Profile system, but it does not contain the detailed information necessary to answer the questions about acceptance criteria and study proving device performance in the context of an AI/ML device.
The document states:
- The device is an electrodiagnostic device used to generate photic signals and to measure and display electrical signals generated by the retina and visual nervous system (ERG, VEP, EOG).
- It displays digitized signals, power spectra, and topographic maps.
- These functions are controlled and interpreted by trained medical professionals.
- The device was tested against various IEC and ISO standards related to medical electrical equipment, risk management, usability, and software life cycle.
Crucially, there is no mention of an AI/ML component in the E3 and Profile system, nor any studies that would involve AI-specific acceptance criteria, human reader improvement with AI assistance, standalone AI performance, or ground truth establishment relevant to AI model training and testing. The "software" mentioned appears to be for data acquisition, processing, and display, interpreted by human experts, rather than an AI performing diagnostic tasks.
Therefore, I cannot provide the requested information. The document focuses on establishing substantial equivalence to a predicate device based on device features and specifications and intended use, not on the performance of an AI algorithm against specific acceptance criteria.
§ 882.1890 Evoked response photic stimulator.
(a)
Identification. An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.(b)
Classification. Class II (performance standards).