Photopic stimuli are presented to the patient on an VGA-screen at a 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 layers. Data are required by up to 8 recording channels using conventional EEGelectrodes. During the period of time that the system is aquiring 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 aquired, 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.

AI/ML Overview

The provided 510(k) summary for the RETIscan/RETIport device does not contain a detailed study design with specific acceptance criteria and performance metrics for the device's diagnostic accuracy or effectiveness in the way one might expect for a modern AI/ML device.

Instead, the submission focuses on substantial equivalence to predicate devices through comparisons of intended use, users, indications, population, environment, physiological data collected, and compliance with recognized standards.

Here's an attempt to structure the available information per your requested categories, acknowledging that much of it will be "Not Applicable" or inferential based on the type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for an existing technology (electrodiagnostic device), the "acceptance criteria" primarily revolve around demonstrating equivalence to predicate devices and meeting safety standards, rather than proving a specific diagnostic accuracy metric.

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance (RETIscan/RETIport)
Intended Use	Generate photic signals & measure/display electrical response from retina/visual nervous system	Yes (Substantially equivalent to predicates)
Intended Users	Ophthalmologists, trained medical technicians & professionals	Yes (Substantially equivalent to predicates)
Indications for Use	Electrophysiological Test Unit for quantifying retinal response, measuring VEP related to retinal response	Yes (Substantially equivalent to predicates)
Intended Population	Patients with ophthalmic conditions	Yes (Substantially equivalent to predicates)
Intended Use Environment	Hospitals, clinics, physician offices	Yes (Substantially equivalent to predicates)
Physiological Data	ERG waveforms, VEP	Yes (Substantially equivalent to predicates)
Electrical Safety	EN60601-1 Standards (IEC601-1-2 for stimulator)	Certificate of compliance received
Stimulator Equivalence	Equivalent stimulation for evoked potential recording (luminance, chromaticity, stimulated visual field size)	All stimulators provide equivalent stimulation for ERG, VEP recording
Patient Safety (Radiation)	Normal visual light radiation, no risk to patient	Level of exposure measured, declared safe
Electromagnetic Compatibility (EMC)	EN 55011: 03.1991	Yes (Substantially equivalent to predicates)

Study Details:

Based on the provided document, the "study" is primarily focused on demonstrating substantial equivalence through a comparison with legally marketed predicate devices and compliance with relevant safety standards. There isn't a "diagnostic performance" study in the sense of accuracy metrics (sensitivity, specificity, AUC) for the device itself.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable. The submission does not describe a clinical performance study with a test set of patient data to assess diagnostic accuracy. The "Effectiveness" section refers to the equivalence of the stimulators themselves, not a study involving patient outcomes or diagnoses.
Data Provenance: Not applicable.

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. As no clinical performance study involving patient data was described for determining diagnostic accuracy, expert-established ground truth for a test set is not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical performance study 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. This is not an AI/ML device, nor is an MRMC study described. The device is an electrodiagnostic tool that provides raw and processed data for interpretation by medical professionals.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is an electrodiagnostic hardware and software system, not solely an algorithm. Its output (ERG/VEP signals, maps) is specifically noted as being "controlled and interpreted by trained medical professionals."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of a diagnostic performance study. The "ground truth" implicitly assumed for electrodiagnostic devices is the accurate capture and display of bioelectrical signals, which is indirectly addressed by demonstrating the stimulator's equivalence and compliance with established standards for such devices.

8. The sample size for the training set

Not applicable. There is no mention of a machine learning model requiring a training set in this 510(k) submission.

9. How the ground truth for the training set was established

Not applicable. No training set is mentioned.

Summary

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K023525

MAR 2 6 2004

10. 510(k) Summary of the RETIscan/ RETIport

ROLAND CONSULT Company Name: Friedrich-Franz-Str. 19 D-14770 Brandenburg, Germany Tel.: +49 3381 382621

Contact Person: Dipl. Ing. Matthias Mai

Legally Marketed Predicate Device

The RETI-Port/RETIscan-System is substiancially equivalent to Doran Maculoscope and the Espion System (K863956) manufactured by DORAN INSTRUMENTS, INC., and the VERIS System (K003442) manufactured by Electro-Diagnostic Imaging, Inc. These are Hardware and Software products. The RETI-Port-Scan device is substantially equvalent 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 photopic stimulus and an analysis of the evoked response data collected.

Device Description

Intended Use

The RETI-Port-Scan 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 spectral and topographic maps. These functions are controlled and interpreted by trained medical professionals.

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Substantial Equivalence

Attribute	RETIscanRETIport	VERIS System	Doran Maculoscopeand the EspionSystem (K863956)
Use:
Intended Use:
Generate photicsignals and measureand display theelectrical responsesignals generated bythe retina and thevisual nervous sytem	Yes	Yes	Yes
Intended Users:
Ophtalmologists andtrained medicaltechnicians andprofessionals	Yes	Yes	Yes
Indications for Use;
ElectrophysiologicalTest Unit forquantifying the retinalresponse, measuring aparameter (VEP)related to retinalresponse	Yes	Yes	Yes
Intended Population:
Patients withophtalmic conditions	Yes	Yes	Yes
Intended use
environment:Hospitals, clinics andphysician offices	Yes	Yes	Yes
Physiological datacollected:ERG waveforms	Yes	Yes	Yes
Compliance with
Recognized standards:
ISO/EN 60601-1-2	Yes	Yes	Yes
EN 55011: 03.1991	Yes	Yes	Yes

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Performance Data

The RETIscan/RETIport System has been tested for electrical safety and has received a certificate of compliance with EN60601-1 Standards.

Safety

The 21" monitor stimulator complies with IEC601-1-2

The Ganzfeld-stimulator and the Miniganzfeld-stimulator complies with IEC 60601-1 The patients eye is exposed to a normal visual light radiation. The level of exposure was measured and represents no risk to the patient.

Effectiveness

All Stimulators provide equivalent stimulation for the purpose of evoked potential (ERG, VEP) recording in all regards (stimulus luminance, chromaticity and size of the stimulated visual field).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three horizontal lines that resemble an abstract human figure.

MAR 2 6 2004

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Matthias Mai Roland Consult Elektrophysiologische Diagnostik SY Friedrich-Franz-Strasse 19 Brandenburg Germany D 14770

Re: K023525

Trade/Device Name: RETIscan RETIport Regulation Number: 21 CFR 882.1890 Regulation Name: Evoked response photic stimulator Regulatory Class: II Product Code: GWE Dated: February 5, 2004 Received: February 9, 2004

Dear Mr. Mai:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determincd the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Matthias Mai

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Muriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K023525

Device Name:

Indications For Use:

RETIscan RETIport

Electrophysiological Test Unit for quantifying the Electrophysiological surfing a parameter (VEP) related to retinal response

Muriam C Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 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).