The OPTAx System provides clinicians with objective measurements of hyperactivity, impulsivity and inattention to aid in the clinical assessment of ADHD. OPTAx results should be interpreted only by qualified professionals.

Device Description

OPTAx (Optical Tracking and Attention test) is a 15 minute non-invasive, office-based test that was developed to provide precise quantitative assessment of the capacity of children to pay attention to visual stimuli, while inhibiting their locomotor activity and controlling their impulsive responses. The three core symptoms of Attention-Deficit Hyperactivity Disorder (ADHD) are : impaired inattention, hyperactivity, and impulsivity. OPTAx provides an accurate and reproducible measure of a child's capacity in each of these three domains by utilizing a consistent challenge paradigm, coupled with detailed real-time measurements of behavior and performance. The fundamental core of OPTAx is a computer-administered GO/NO-GO vigilance response task.

The OPTAx System consists of the following components:

. IMac computer and peripherals (printer and adapters)
Pre-installed OPTAx software program ●
. Motion analysis camera and peripherals
Data analysis software on the OPTAx secure server .

AI/ML Overview

Unfortunately, the provided text does not contain detailed information about the acceptance criteria or the specific clinical study that proves the OPTAx System meets such criteria.

The document is a 510(k) summary for the OPTAx System, primarily focusing on its substantial equivalence to a predicate device (Gordon Diagnostic System, K854903) for the purpose of aiding in the clinical assessment of ADHD.

Here's a breakdown of what is available and what is missing based on your request:

What is Available:

Device Description: OPTAx is a 15-minute non-invasive, office-based test for quantitative assessment of attention, inhibition of locomotor activity, and control of impulsive responses in children. It uses a computer-administered GO/NO-GO vigilance response task.
Intended Use: To provide clinicians with objective measurements of hyperactivity, impulsivity, and inattention to aid in the clinical assessment of ADHD.
Comparison to Predicate: Both OPTAx and the Gordon System aid in ADHD assessment by providing objective measurements of impulsivity and inattention; OPTAx additionally provides objective measurements of hyperactivity. Both are microprocessor-based vigilance task recorders.
Performance Testing Mention: "Bench testing of the camera to EN 60825-1-1994, safety standards has been performed. Clinical testing has also been performed on the OPTAx System." This statement acknowledges clinical testing but provides no details about it.

What is Missing (and thus cannot be provided in the requested format):

Table of Acceptance Criteria and Reported Device Performance: This information is not present. The document does not define specific performance metrics (e.g., sensitivity, specificity, accuracy, precision for different symptoms) or the targets for these metrics that would constitute "acceptance criteria." Consequently, no "reported device performance" against such criteria is listed.
Sample Size used for the test set and data provenance: The document mentions "Clinical testing has also been performed," but does not specify the sample size used, the characteristics of the test set, or its provenance (e.g., country of origin, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and qualifications: This information is not provided.
Adjudication method for the test set: Not mentioned.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: The document does not describe such a study. Since the device is a diagnostic aid providing objective measurements rather than an AI-assisted reader, the concept of "human readers improve with AI vs without AI assistance" does not directly apply in the way it would for image interpretation AI.
Standalone performance (algorithm only without human-in-the-loop performance): While the OPTAx system provides "objective measurements," the document implies these are intended to aid clinical assessment by qualified professionals, suggesting a human-in-the-loop scenario for interpretation. However, specific standalone performance metrics for the algorithm itself are not detailed.
Type of ground truth used: Not specified. Given the intended use to "aid in the clinical assessment of ADHD," the ground truth would likely involve clinical diagnosis of ADHD, but the method for establishing this (e.g., expert clinical diagnosis, diagnostic interviews, outcome data over time) is not discussed.
Sample size for the training set: Not mentioned. The document primarily discusses the device and its intended use, not the development or training of its underlying algorithms.
How the ground truth for the training set was established: Not mentioned.

Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on intended use and technological characteristics. It lacks the detailed information regarding specific performance acceptance criteria and the results of clinical studies against those criteria that you are requesting. The statement "Clinical testing has also been performed" is a high-level acknowledgment without further substantiation in this particular document.

Summary

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JUN 1 0 2002

Kozogoo

OPTAx Systems Inc. 510K Summary of Safety and Effectiveness June 6, 2002

Sponsor Name OPTAx Systems Inc. 20 Mall Rd. Suite 210 Burlington, MA 01803

2. Device Name

Proprietary Name: OPTAx System Common/Usual Name: RECORDER, ATTENTION TASK PERFORMANCE

Identification of Predicate or Legally Marketed Device 3.

Gordon Diagnostic System cleared under K854903.

Device Description 4.

OPTAx (Optical Tracking and Attention test) is a 15 minutenon-invasive, office-based test that was developed to provide precise quantitative assessment of the capacity of children to pay attention to visual stimuli, while inhibiting their locomotor activity and controlling their impulsive responses. The three core symptoms of Attention-Deficit Hyperactivity Disorder (ADHD) are : impaired inattention, hyperactivity, and impulsivity. OPTAx provides an accurate and reproducible measure of a child's capacity in each of these three domains by utilizing a consistent challenge paradigm, coupled with detailed real-time measurements of behavior and performance. The fundamental core of OPTAx is a computer-administered GO/NO-GO vigilance response task.

The OPTAx System consists of the following components:

. IMac computer and peripherals (printer and adapters)
Pre-installed OPTAx software program ●
. Motion analysis camera and peripherals
Data analysis software on the OPTAx secure server .

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રું. Intended Use

Comparison of Technological Characteristics 6.

Both the Gordon and OPTAx Systems are indicated to aid in the diagnosis and assessment of ADHD. Both provide objective measurements of impulsivity and inattention to aid in this process; OPTAx also provides objective measurements of hyperactivity.

Both are microprocessor-based vigilance task recorders.

Performance Testing

Bench testing of the camera to EN 60825-1-1994, safety standards has been performed. Clinical testing has also been performed on the OPTAx System.

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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 eagle or bird symbol, composed of three curved lines that suggest the head and wings. The bird is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

JUN 1 0 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OPTAx Systems, INC. c/o Ms. Debbie Iampietro QRC Consulting 7 Tiffany Trail Hopkinton, MA 01748

Re: K020800 Trade/Device Name: OPTAx System Regulatory Class: Unclassified Product Code: LQD Dated: March 8, 2002 Received: March 12, 2002

Dear Ms. Iampietro:

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.

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 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); 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 - Ms. Debbie Iampietro

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,

s. Stephen Rhodes

elia 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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K020800 – Additional Information .

K020800 510(k) Number (if known):

Device Name: OPTAx System

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)	X	OR	Over-The-Counter Use
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Signature
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number	K020800
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Regulation Number and Section

N/A