(129 days)
Electrophysiological Test Unit for quantifying the response to visual stimulation by measuring the Visual Evoked Potential.
The Visionsearch1 System consists of specialist software and the supporting computer and peripherals. The System displays multifocal visual patterns to evoke response in the retina which are transmitted to the visual cortex. The System then detects responses in the visual cortex using specific, validated third party EEG electrodes and biological amplifier. After analyzing the EEG, the System displays the electrical response from each segment of the retina. It also allows the user to compare the response time between eyes and compare an individual's measurements to those from a set of data that the user has compiled as reference.
The Visionsearch1 System is an electrophysiological test unit intended for quantifying responses to visual stimulation by measuring Visual Evoked Potentials (VEP).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria or a specific study to prove the device meets these criteria in the traditional sense of a clinical trial with performance metrics like sensitivity, specificity, or accuracy.
Instead, the submission for the Visionsearch1 System focuses on demonstrating substantial equivalence to a predicate device, the RETIScan/RETIPort (K023525). The effectiveness is asserted through compliance with established standards and comparison of technological characteristics.
| Feature / Criterion | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance / Justification |
|---|---|---|
| Intended Use | Generate photic signals and measure and display the electrical response signals generated by the retina and the visual nervous system, particularly for mfVEP measurement. | "Same as predicate" - Electrophysiological Test Unit for quantifying the response to visual stimulation by measuring the Visual Evoked Potential (mfVEP functionality subset). |
| Indications for Use | Electrophysiological Test Unit for quantifying the retinal response and measuring parameters (VEP and ERG) related to retinal response. | "Same as Predicate for mfVEP functionality subset" - The Visionsearch1 System is specifically for "...quantifying the response to visual stimulation by measuring the Visual Evoked Potential." (from Indications for Use statement). It does not perform ERG. |
| Technological Characteristics | Similar principle of operation, physiological data collected (VEP), stimulus characteristics (luminance, chromaticity, field of view), and software functions for data display, analysis, and comparison to the predicate device. | Principle of operation: "Same as predicate, except: Only 56 segments are used (nasal field segments are not included). More advanced patient fixation – a wireless device is used for patient feedback instead of verbal communication, and a 'multi response' /' multi button' fixation system is supported." |
| Physiological data collected: VEP waveforms (Predicate also collects ERG). | ||
| Stimulus: "Stimulus provided is essentially identical (in terms of luminance, chromaticity and size of the stimulated visual field) to that of the predicate." | ||
| Software Functions: "Same as predicate" including stimulus provision, acquisition, waveform display, noise detection, scaling/correlation for amplitude/latency, numerical/graphical display, comparisons, export/import, and printing. | ||
| Safety | Compliance with applicable electrical and biological safety standards (IEC 60601-1-2, IEC 60601-1), design control (ISO 13485, 21 CFR 820.30), and software lifecycle processes (IEC 62304:2006). | "The Visionsearch1 device complies with applicable standards for electrical and biological safety." Developed in accordance with design control requirements of ISO 13485:2003 and 21 CFR 820.30. Software development per IEC 62304:2006. Electrical components in contact with patient conform to IEC60601-1-2:2007. Isolation transformer complies with IEC 60601-1. |
| Effectiveness (Validation) | Independent verification of software functionality and data capture/analysis effectiveness. | "The effectiveness of data capture and analysis is validated through development under IEC 62304 software life cycle controls and independent laboratory verification of software functionality." |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical performance study with a specific "test set" in terms of patient data. The validation discussed is primarily related to software functionality and technical equivalence.
- No "test set" of patient data is explicitly mentioned for performance evaluation.
- The data provenance is not applicable as no specific patient data test set is used to demonstrate performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical test set with ground truth established by experts is described in this submission.
4. Adjudication method for the test set
Not applicable. No clinical test set requiring adjudication is described.
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
Not applicable. The Visionsearch1 System is a diagnostic device for measuring VEP, not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device's submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This submission does not detail a standalone performance study in the context of an algorithm's diagnostic output. The device itself is standalone in terms of generating and analyzing electrophysiological signals. Its "performance" is assessed through its technical specifications, compliance with standards, and functional equivalence to the predicate, rather than an independent diagnostic accuracy study using a clinical dataset. The "independent laboratory verification of software functionality" implies a form of standalone testing, but not clinical performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of a clinical performance study for diagnostic accuracy. The "ground truth" for the device's development and validation appears to be the established technical and functional performance of the predicate device and compliance with regulatory standards for medical device software and safety.
8. The sample size for the training set
Not applicable. The Visionsearch1 System measures physiological responses, it is not an AI/ML algorithm that is "trained" on a dataset of patient images or clinical data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML algorithm described.
§ 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).