The DDAT OMT is intended to be used to observe, record and measure eye movements in patients during ocular motor testing. The DDAT OMT is intended for use by qualified medical personnel trained in the use of nystagmographs.

Device Description

The DDAT OMT is a computer based medical device comprising of a Computer, a Display Monitor for viewing eye movements, a Lightbar which provides the stimulus for the eye movement and a client amplifier that tracks the patient's eye movement.

AI/ML Overview

The provided document is a 510(k) summary for the DDAT OMT device, a nystagmograph. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics typically found in a PMA submission or a comprehensive independent study report.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and MRMC studies is not available in this 510(k) summary.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the 510(k) summary. 510(k) submissions typically rely on demonstrating substantial equivalence to a predicate device through technical comparisons, rather than presenting a performance study against predefined quantitative acceptance criteria for parameters like sensitivity, specificity, accuracy, etc.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the 510(k) summary. There is no mention of a clinical "test set" in the context of a performance study. The submission focuses on comparison to a predicate device (CHARTR® ENG/VNG Diagnostic System, K991497).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the 510(k) summary. As no specific clinical test set or performance study is detailed, there's no mention of experts establishing ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not provided in the 510(k) summary. The DDAT OMT is described as a "computer based medical device comprising of a Computer, a Display Monitor for viewing eye movements, a Lightbar which provides the stimulus for the eye movement and a client amplifier that tracks the patient's eye movement." There is no indication of AI assistance or an MRMC study comparing human readers with and without such assistance. This device is an nystagmograph, which records and measures eye movements, not an AI-powered diagnostic aid for interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not provided in the 510(k) summary. There's no mention of an algorithm-only performance study. The device is a measurement tool intended for use by "qualified medical personnel trained in the use of nystagmographs," implying human-in-the-loop operation.

7. The Type of Ground Truth Used

This information is not provided in the 510(k) summary. There is no mention of a performance study requiring a distinct "ground truth." The submission focuses on equivalence to a predicate device.

8. The Sample Size for the Training Set

This information is not provided in the 510(k) summary. As it's not an AI/ML device that requires a training set in the typical sense, this information is not relevant to the content of this 510(k) submission.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the 510(k) summary.

Summary of what the document DOES provide:

Device Name: DDAT OMT
Intended Use: Used to observe, record and measure eye movements in patients during ocular motor testing. Intended for use by qualified medical personnel.
Predicate Device: CHARTR® ENG/VNG Diagnostic System (K991497) marketed by ICS Medical Corporation.
Basis for Equivalence: "No significant differences between the DDAT OMT and the predicate device that would adversely affect the use of the device. The DDAT OMT is substantially equivalent to the predicate device in design, function, materials, and indications for use/intended use."

The 510(k) summary format does not generally require the detailed clinical study data and performance metrics you've requested. Its purpose is to demonstrate that a new device is "substantially equivalent" to an already legally marketed device, meaning it's as safe and effective.

Summary

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Premarket Notification Submission DDAT OMT

October 28,2004

KOSOO98

510(k) SUMMARY

Submitted by:	DDAT (UK) LtdCamden HouseWarwick RoadKenilworthWarwickshire CV8 1TH
Telephone:	+44 (0) 1926 514060
Fax:	+44 (0) 1926 514060
Contact Person:	Kevin Eyres, CEO
Date summary prepared:	October 28, 2004
Registration Number:	3004059926
Trade Name of Device:	DDAT OMT
Common Name:	Nystagmograph
Classification Name:	Nystagmograph
Product Code:	GWN
Regulation number:	21 CFR 882.1460
Device Class	Class II
Substantial equivalence:	The DDAT OMT is substantially equivalent to theCHARTR® ENG/VNG Diagnostic Systemmarketed by ICS Medical Corporation (File numberK991497).There are no significant differences between theDDAT OMT and the predicate device that wouldadversely affect the use of the device. The DDATOMT is substantially equivalent to the predicatedevice in design, function, materials, andindications for use/intended use.
Description of Device:	The DDAT OMT is a computer based medicaldevice comprising of a Computer, a DisplayMonitor for viewing eye movements, a Lightbarwhich provides the stimulus for the eye movementand a client amplifier that tracks the patient's eyemovement.
Indications For Use:	The device is used to observe, record andmeasure eye movements in patients during ocularmotor testing.The DDAT OMT is intended for use by qualifiedmedical personnel trained in the use ofnystagmographs.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2005

DDAT (UK), Ltd. C/o Ms. Chantel Carson Underwriters Laboratories Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

Re: K050098

Trade/Device Name: DDAT OMT Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: II Product Code: GWN Dated: May 16, 2005 Received: May 16, 2005

Dear Ms. Carson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your your be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conimered pror to may 20, 2017) in accordance with the provisions of the Federal Food, Drug, uc vices that have been recuire approval of a premarket approval application (PMA). and Costicule 710-1710-11-18, subject to the general controls provisions of the Act. The Tou may, morerere, mains of the Act include requirements for annual registration, listing of general controls proving 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 your device is elaboritional controls. Existing major regulations affecting your device it may be subject to saon additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the over ents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Tease of advised that I Drivisian that your device complies with other requirements of the Act that I DA has made a actor regulations administered by other Federal agencies. You must or any I catal statutes and states 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 (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quant) 850ccions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Chantel Carson

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 (240) 276-0115 . 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/industry/support/index.html.

Sincerely yours,

Les A. T.

Miriam C. Provost, Ph.D. from Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification Submission DDAT OMT

October 28,2004

Indications for Use

KO50098

510(k) Number (if known):

Device Name:

DDAT OMT

Indications for Use:

The DDAT OMT is intended to be used to observe, record and measure eye movements in patients during ocular motor testing.

The DDAT OMT is intended for use by qualified medical personnel trained in the use of nystagmographs.

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Per 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)

virlon Sign-Oif) Viston of General, Restorative nd Neurological Devices

50098

Regulation Number and Section

§ 882.1460 Nystagmograph.

(a)
Identification. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.(b)
Classification. Class II (performance standards).