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.

Device Description

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.

AI/ML Overview

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.

Summary

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Electro-Diagnostic Imaging, Inc. 510(k) Notification November 4, 1998

Image /page/0/Picture/1 description: The image contains a sequence of handwritten alphanumeric characters. The sequence appears to be "K983983". The characters are written in a cursive style, with some connections between the numbers.

510(k) Summary for the VERIS System Prepared November 4. 1998 FEB 3 1599

Company Name: Electro-Diagnostic Imaging, Inc. 1206-D West Hillsdale Blvd. San Mateo, California 94403 Telephone 650 341 5054

Contact Person: Erich E. Sutter Ph.D.

A. Legally Marketed Predicate Device

The VERIS System is substantially equivalent to UTAS-E 2000 Visual Eletrodiagnostic System (K760199) manufactured by LKC Technologies, Inc., the Tomey PE400 Portable ERG System (K932571) manufactured by Tomey and the Maculoscope and The Espion Systems, (K863956) both manufactured by Doran (aka Diagnosys LLC). These are all hardware and software products. The EDI device is substantially equivalent to the predicate devices with regard to device features and specifications, as well as intended use. All devices are visual evoked response test systems with similar operating requirements, that are based on standard clinical procedures. Devices consist of hardware and software to provide a photic stimulus and an analysis of the evoked response data collected.

B. Device Description

C. Intended Use

The VERIS 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) and visual evoked potential (VEP) signals, power spectra and topographic maps. These functions are controlled and interpreted by trained medical professionals.

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D. Substantial Equivalence

Product Name	Predicate Devices			Submission Device
Doran Maculoscopeand The EspionSystem (K863956)	UTAS-E 2000 (and3000) VisualElectrodiagnosticSystems (K760199)	Tomey PE400Portable ERG andVEP System(K932571)	EDI VERIS ERGand VEP System
IntendedUse	Generate photic signalsand measure anddisplay the electricalresponse signalsgenerated by the retinaand the visual nervoussystem	Generate photic signalsand measure and displaythe electrical responsesignals generated by theretina and the visualnervous system	Generate photic signalsand measure anddisplay the electricalresponse signalsgenerated by the retinaand the visual nervoussystem	Generate photicsignals and measureand display theelectrical responsesignals generated bythe retina and thevisual nervous system
IntendedUsers	Ophthalmologists andtrained medicaltechnicians	Ophthalmologists andtrained medicaltechnicians	Ophthalmologists andtrained medicaltechnicians	Ophthalmologists andtrained medicaltechnicians
Indicationsfor Use	Diagnosis andmanagement of retinalischemic diseases,diabetic retinopathy,central or branch veinocclusion	Diagnosis andmanagement of retinalischemic diseases,diabetic retinopathy,central or branch veinocclusion	Diagnosis andmanagement of retinalischemic diseases,diabetic retinopathy,central or branch veinocclusion	Diagnosis andmanagement of retinalischemic diseases,diabetic retinopathy,central or branch veinocclusion
IntendedPopulation	Patients withophthalmic conditions	Patients with ophthalmicconditions	Patients withophthalmic conditions	Patients withophthalmic conditions
Site of Use	Hospital, clinics andphysician offices	Hospital, clinics andphysician offices	Hospital, clinics andphysician offices	Hospital, clinics andphysician offices
DataCollected	ERG waveforms	ERG waveforms	ERG waveforms	ERG waveforms

E. Performance Data

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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three wavy lines emanating from a central point. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1999 FEB

Sheila W. Pickering Ph.D. Electro- Diagnostic Imaging, Inc. 2081 Longden Circle Los Altos, California 94024

Re: K983983 Trade Name: EDI Veris System Regulatory Class: II Product Code: 86 HLX Dated: November 5, 1998 Received: November 9, 1998

Dear Dr. Pickering:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - Sheila W. Pickering Ph.D.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on.the.promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Roerl forential

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K983983

FDA Submission Cover Sheet

510(k) Number (if known):

Device Name: VERIS System

Indications For Use:

Evenette Bean

510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence Of CDRH, Office Of Device Evaluation (ODE) Prescription Use_ 1 OR Over-The-Counter Use _ (Per 21CFR 801)

Regulation Number and Section

§ 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.