(86 days)
The VERIS system is an electodiagnostic 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) and visual evoked potential (VEP) signals, power spectra, and topographic maps. These functions are controlled and interpreted by trained medical professionals. The device is intended for use in the diagnosis and management of retinal ischemic diseases, diabetic retinopathy, and central or branch vein occlusion.
Photic stimuli are presented to the patient on a CRT screen up to 60 degrees at 241 elements in separately stimulated fields. Various modes are available for preferential stimulation of different retinal mechanisms and isolation of signal from different retinal layers. Data is acquired by 2 recording channels using conventional EEG electrodes (not provided with the device). During the period of time that the system is acquiring data (4-16 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 representations.
The provided text describes the 510(k) submission for the VERIS System. However, it does not contain specific acceptance criteria, reported device performance metrics against those criteria, or details of a study proving the device meets acceptance criteria.
The document focuses on demonstrating substantial equivalence to predicate devices, electrical safety compliance, and intended use. Performance data is limited to a statement about electrical safety testing.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I describe a study proving the device meets such criteria based on the information given. The document does not describe a clinical performance study with details about sample size, expert ground truth, adjudication methods, or MRMC studies.
Here's what can be extracted from the provided text regarding what was done:
1. A table of acceptance criteria and the reported device performance
- No specific acceptance criteria or reported device performance metrics are provided in the document.
- The document states: "The VERIS System has been tested for electrical safety and has received a certificate of compliance with EN60601-1-2:1993 and EN55011:1991 Standards." This indicates compliance with electrical safety standards, which can be considered an "acceptance criterion" met. However, no specific performance metrics beyond "compliance" are given.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The document does not detail a clinical performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The document does not detail a clinical performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. The document does not detail a clinical performance study.
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
- No MRMC study was done (or at least, none is described). The VERIS system is an electrodiagnostic device, not an AI-assisted diagnostic tool in the modern sense. It processes and displays signals for interpretation by human professionals.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone performance study is described. The device is explicitly stated to be "controlled and interpreted by trained medical professionals."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The document does not detail a clinical performance study requiring ground truth for diagnostic accuracy. The basis for validation was substantial equivalence to predicate devices, implying similar physiological signal acquisition and display capabilities.
8. The sample size for the training set
- Not applicable. The document does not describe an AI or machine learning model that would require a training set. The "algorithms for spatial filtering and artifact rejection" are mentioned, but no details about their development or training are provided.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI/ML model is described.
§ 886.1630 AC-powered photostimulator.
(a)
Identification. An AC-powered photostimulator is an AC-powered device intended to provide light stimulus which allows measurement of retinal or visual function by perceptual or electrical methods (e.g., stroboscope).(b)
Classification. Class II.