The NOVA is an electrophysiological device that generates photic stimuli, and records, processes and analyzes the resultant visual evoked potential (VEP) signals to provide information about the visual system structural and neural abnormalities.

Device Description

Checkerboard, Horizontal grating, Vertical grating, Sinusoidal grating, Flash, monochromatic pattern onset or color pattern onset Contrast Photic stimuli are presented to the patient on a calibrated computer monitor at various numbers of elements in separately stimulated fields. The fields are varied in spatial size over a number of cycles. The fields are also phase reversed at different temporal frequencies. The signals are analyzed by the software algorithm for spatial/temporal filtering and artifact rejection. Data may be presented in numerical and graphical form. The device also utilizes attention grabbing features specifically for children or non attentive adults. In particular, a picture is presented prior to the onset of the VEP pattern stimulus. During the picture presentation no data is collected. Age appropriate music is also available to patient as well. The music is only intended as an attention facilitator. From a hardware standpoint the NOVA system is identical to that of the Enfant, ® which was cleared under K043491. The only difference between the two devices is the software.

AI/ML Overview

The provided text describes the Diopsys™ NOVA VEP Vision Testing System, focusing on its substantial equivalence to predicate devices rather than proving its performance against specific acceptance criteria through a clinical study. The performance data section refers to verification and validation activities, which are internal engineering tests, not clinical efficacy studies.

Therefore, much of the requested information regarding acceptance criteria, sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from the given document.

However, I can provide what is available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" for clinical performance. Instead, it lists various verification and validation activities for the software and hardware. The "reported device performance" in this context refers to the successful completion of these internal tests.

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
User Interface	Operates as expected	Operates as expected
Software Installation	Installs as expected	Installs as expected
Signal Test Procedure	VEP recordings displayed as expected	VEP recordings displayed as expected
System Configuration	Configures hardware components as expected	Configures hardware components as expected
Calibration Test	VEP stimulus parameters meet specification	VEP stimulus parameters meet specification
Comparison of EEG Response	VEP recording compared to known recording	VEP recording compared to known recording
Electrical Safety	Meets listed IEC standards	IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-26, IEC 60601-2-40 standards met
System Testing	Functionality as per bench testing	Bench testing performed for system, EEG Amplifier, and LCD

2. Sample size used for the test set and the data provenance:

The document describes verification and validation activities, which typically involve internal testing of the device and software, not a clinical "test set" with a specified sample size of patient data.
Data Provenance: Not applicable for these internal engineering tests. No information about country of origin or retrospective/prospective nature of patient data is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The performance data pertains to internal engineering verification and validation, not clinical ground truth established by experts.

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

Not applicable. No clinical test set requiring expert adjudication is mentioned.

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 or comparative effectiveness study is mentioned. The device is a diagnostic tool (VEP system), and the submission focuses on its substantial equivalence to predicate VEP systems, not its impact on human reader performance.

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

The "Performance Data" section describes software verification and validation, including "Comparison of EEG Response Verifies VEP recording compared to known recording." This, along with "Signal Test Procedure VEP recordings are displayed as expected," suggests standalone performance of the algorithm in processing and displaying VEP data. However, it's not a clinical standalone performance study in the context of diagnostic accuracy against a ground truth. It's more about the algorithm functioning as intended with known inputs.

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

For the verification and validation (V&V) activities described, the "ground truth" is primarily based on known specifications, expected behaviors, and known recordings. For example, "Verifies VEP stimulus parameters meet specification" and "Verifies VEP recording compared to known recording." This is not clinical ground truth.

8. The sample size for the training set:

The document does not mention any training data or training set for the device's software/algorithms. This is common for VEP systems, which often use established signal processing techniques rather than machine learning models requiring extensive training data.

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

Not applicable, as no training set is mentioned.

Summary

{0}------------------------------------------------

510(k) Summary

October 14, 2010

MAY - 9 2011

Device Description

Trade Name: Diopsys™ NOVA VEP Vision Testing System VEP vision testing system Common Name: Classification Name: Evoked response photic stimulator Regulation Number: 882.1890 Product Code: GWE Regulatory Class: II

Contact Information

Joseph Fontanetta President/CEO Diopsys, Inc. 16 Chapin Road, Suite 911 Pine Brook, NJ 07058 Tel: (973) 244-0622 Fax: (973) 244-0670

Identification of Legally Marketed Predicate Devices

The Diopsys NOVA VEP Vision Testing System (NOVA), is substantially equivalent to the Diopsys Enfant® Pediatric VEP Vision Testing System (K043491) and the VeriSci Corporation Neucodia System (K081591). The NOVA device is substantially equivalent to the predicate devices with regard to device features, designs, operational procedure, data acquisition conditions, 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. These devices consist of hardware and software to provide photic stimulus and EEG capture and analysis of the evoked response. All the devices are intended to be used by trained medical professionals for the study of visual functions.

Device Description

{1}------------------------------------------------

stimulus. During the picture presentation no data is collected. Age appropriate music is also available to patient as well. The music is only intended as an attention facilitator. From a hardware standpoint the NOVA system is identical to that of the Enfant, ® which was cleared under K043491. The only difference between the two devices is the software.

Indications for Use

र :

Parameter	Diopsys NOVA	EnfantK043491	NeucodiaK081591
Indicationsfor Use	The NOVA is anelectrophysiologicaldevicethat generates photicstimuli, and records,processes and analyzesthe resultant visualevokedpotential (VEP) signals toprovide information aboutvisual system structuraland neuralabnormalities.	The Enfant is a noninvasive medical device toscreen without dilation orsedation, for visual disordersin infants and pre schoolchildren. The system usesvisual evoked potentials toprovide information about thevisual pathway function andabout optical or neuralabnormalities related to vision.	The Neucodia system isan electrophysiologicaldevice that generatesphotic stimuli, andrecords, processes andanalyzes the resultantvisual evoked potential(VEP) signals for thestudy of central visualfunctions.
TargetPopulation	Infants, pre-schoolchildren, children andadults	Infants and pre-school children	Normal observers,individuals at-risk forvisual pathwaydysfunction or withconfirmed ophthalmicdisorders
Where used	Hospitals, Clinics andphysician offices	Hospitals, Clinics andphysician offices	Hospitals, clinics,physicians' offices andresearch laboratories
IntendedUsers	Physicians and trainedmedical technicians	Physicians and trainedmedical technicians	Vision researchers,neurologists, eye-careprofessionals, and trainedmedical technicians
Energy Used	110V	110V	110V
Design	Synchronized DataCollection (externalmodule), Transient VEP	Synchronized Data Collection,(internal module), SteadyState VEP	Synchronized DataCollection, Steady Stateand Transient VEP
ElectricalsafetyStandardsmet	IEC 60601-1IEC 60601-1-2IEC 60601-1-4IEC 60601-2-26IEC 60601-2-40	IEC 60601-1IEC 60601-1-2IEC 60601-1-4IEC 60601-2-26IEC 60601-2-40	IEC 60601-1IEC 60601-1-2IEC 60601-1-2-26ISO 15004-2
DataCollected	EEG signals	EEG signals	EEG signals

Comparison to Cleared Devices

{2}------------------------------------------------

Performance Data

Software: Verification and Validation

1 ). User Interface User interface operates as expected.
2). Software Installation Process Software installs as expected.
3). Signal Test Procedure VEP recordings are displayed as expected.
4). System Configuration Software configures hardware components as expected.
5). Calibration Test Verifies VEP stimulus parameters meet specification.
6), Comparison of EEG Response Verifies VEP recording compared to known recording.

Safety Testing: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-26, IEC 60601-2-40

System Testing: Bench testing for the system, EEG Amplifier and LCD.

Conclusion

The NOVA is substantially equivalent to the predicate Enfant and Neucodia based on safety and efficacy testing.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle is depicted in black, and the text is also in black against a white background. The overall design is simple and recognizable, representing the department's role in public health and human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Medgra, LLC c/o Mr. Richard Hettenbach President 44 Countrywood Drive Morris Plains, NJ 07950

MAY - 9 2011

Re: K101763

Trade/Device Name: Diopsys™ NOVA VEP Vision Testing System Regulation Number: 21 CFR 882.1890 Regulation Name: Evoked Response Photic Stimulator Regulatory Class: Class II Product Code: GWE Dated: October 14, 2010 Received: October 18, 2010

Dear Mr. Hettenbach:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

{4}------------------------------------------------

Page 2 - Mr. Richard Hettenbach

Please be advised that FDA's issuance of a substantial equivalence determination does 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Melvin R. Feldstein, M.D.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

Page 1 of 1

510(k) Number (if known): K101763

Diopsys™ NOVA VEP Vision Testing System Device Name:

The NOVA is an electrophysiological device that generates Indications For Use: photic stimuli, and records, processes, and analyzes the resultant visual evoked potential (VEP) signals to provide information about the visual system structural and neural abnormalities.

Intended Use Population		Yes	No
Adults		X
All pediatric patients age < 21 years old?			X
Neonate/Newborn	(Birth to 28 days)		X
Infant	(29 days - < 2 years old)	X
Child	(2 years - < 12 years old)	X
Adolescent	(12 years - < 18 years old)	X
Transitional Adolescent A¹	(18 years - < 21 years old)		X
Transitional Adolescent B²	(18 years - < 21 years old)	X

Compared to adults > 21 years old, this group receives special considerations (e.g., different device design or testing, different protocol procedures, etc.)

2 No special considerations compared to adults > 21 years old

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K101763

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).