(432 days)
The Vision Monitor MonCvONE system is a non-invasive medical device used to generate photic stimulations and to register the responses including electrical responses generated by the retina and the visual nervous system in addition to psychophysical and pupillary responses. It displays digitized electroretinogram (ERG), visual evoked potential (VEP), sensory electro-oculogram (EOG), light and dark adapted perimetry thresholds, dark adaptometry, full field stimulus threshold (FST), photo aversion thresholds (PAT), pupillometry as curves, power spectra and topographic maps. These functions are controlled and interpreted by trained medical professionals.
Photopic stimuli are presented to the patient on a hemispherical cupola. Various modes are available for preferential stimulation of different visual functions. Electrophysiological data is recorded by up to 5 recording channels using conventional EEG electrodes (not provided with the device). Psychophysical responses are recorded with a press button and pupillometry responses recorded with an eye tracker.
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 operator. Once the resulting individual responses 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.
Here's an analysis of the provided text, outlining the acceptance criteria and the study details for the Vision Monitor-MonCvONE device:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance/Testing Description |
|---|---|---|
| Safety | Compliance with ISO/EN 60601-1-2 | The stimulator and amplifier comply with ISO/EN 60601-1-2. Patient eye exposure to light is measured and represents no risk. |
| Risk Management | Compliance with ISO 14971: 2012 | Tested to ISO 14971: 2012 Medical devices Application of risk management to medical devices. |
| Basic Safety & Essential Performance | Compliance with IEC 60601-1: 2012 | Tested to IEC 60601-1: 2012 Medical devices General requirements for safety and essential performances. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2: 2014 | Tested to IEC 60601-1-2: 2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. |
| Usability Engineering | Compliance with IEC 62366-1: 2015 | Tested to IEC 62366-1: 2015 Medical devices Application of usability engineering. |
| Software Life Cycle | Compliance with IEC 62304: 2015 | Tested to IEC 62304: 2015 Medical device. Software life cycle. Software verification tested against specifications. |
| Light Hazard Protection | Compliance with ANSI Z80.36-2016 | Tested to ANSI Z80.36-2016 Light hazard protection for ophthalmic instruments. |
| Technical Function (Hardware/Firmware/Software) | Internal component tests, packaging, labeling against specifications. | Technical tests included internal hardware, firmware, and software component tests, packaging, and labeling tests. Software verification performed. Specific reports: "012 Vision electrophysiology software test report," "013 Sensory EOG software test report." |
| Functional Performance | Flash and pattern ERG/VEP functionality, Sensory EOG functionality | Functional tests: "014_Flash and pattern ERG and VEP functional tests.pdf," "015 Sensory EOG functional tests.pdf." |
| Compatibility | Compatibility with PC and accessories | Compatibility tests with PC and accessories used: "016 PC compatibility," "017 Accessories compatibility." |
| Substantial Equivalence | Same intended use, similar indications, technological characteristics, and principles of operation to predicate. | Bench testing demonstrated the device is as safe, as effective, and performs as well or better than the legally marketed predicate device (RETI-Port/SCAN systems, K023525). Differences in indications (psychophysical and pupillometry) do not alter the intended diagnosis use or safety/effectiveness. |
Study Details
Based on the provided text, the submission describes non-clinical testing rather than a clinical study involving human patients to establish the device's performance against ground truth.
-
Sample size used for the test set and the data provenance:
- The document describes non-clinical bench testing including technical, functional, and compatibility tests. It does not mention a test set of patient data with a specific sample size. The testing focuses on the device's adherence to standards and its internal components' functionality.
- Data provenance: Not applicable as no patient data test set is described.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document describes engineering and safety testing against defined standards and specifications, not interpretation of medical data by experts to establish ground truth for a test set.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no mention of a test set requiring adjudication. The testing described is based on engineering principles and regulatory standards.
-
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. The document does not describe an MRMC study, nor does it indicate that the device involves AI for interpretation by human readers. The device generates and displays physiological data; "These functions are controlled and interpreted by trained medical professionals."
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document describes the device as a system that generates photic stimulations and registers responses, with software for analysis and display. However, it explicitly states, "These functions are controlled and interpreted by trained medical professionals." This indicates that the device is intended for use with human-in-the-loop interpretation, and no standalone (algorithm-only) performance claim or study is detailed. The described tests are about the device's performance in generating and recording data, and its software's functionality, not its diagnostic accuracy in an unsupervised manner.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the described testing is based on engineering specifications, regulatory standards (e.g., IEC 60601-1, ISO 14971), and functional requirements for generating, recording, and processing electrophysiological signals. There is no mention of a clinical ground truth (like pathology or expert consensus on patient cases) being used for the performance claims in this submission.
-
The sample size for the training set:
- Not applicable. The device is a measurement and display system, not an AI or machine learning algorithm that requires a training set of data.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned for this device.
§ 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).