(77 days)
QbTest provides clinicians with objective measurements of hyperactivity, impulsivity, and inattention to aid in the clinical assessment of ADHD. QbTest results should be interpreted only by qualified professionals.
The QbTest is a 15 minute, non invasive test that has been developed to provide precise quantitative assessment of the capacity of children to pay attention to visual stimuli while inhibiting their loco motor activity and controlling their urge to respond impulsively. There are three cardinal disturbances in Attention-Deficit Hyperactivity Disorder (ADHD) impaired attention, hyperactivity and impulsivity. QbTest 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 QbTest is a computer-administered go/not-go vigilance response task combined with motion capture.
The system consists of the following components;
• Client PC software
• Connection box
• Responder button
• Camera for motion measurement
• Reflective marker
• USB and serial cable
The provided 510(k) summary for the QbTest device does not contain a detailed study demonstrating acceptance criterion, or tables of acceptance criteria and reported device performance. It focuses on establishing substantial equivalence to a predicate device (OPTAx System K020800) and outlines the device's intended use and technical characteristics.
However, based on the information provided, we can infer some details and highlight the missing information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the given 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device by stating that the QbTest "provides the same or similar functions and has a similar design" and that "The new characteristics do not affect safety or effectiveness." It also mentions "Performance Testing" for the camera (EN60825-1:1994) and the system (EN 60601-1 and EN 60601-1-2), which are safety and electrical compatibility standards, not clinical performance acceptance criteria for ADHD assessment.
To completely answer this question, a clinical study summary with specific performance metrics (e.g., sensitivity, specificity, accuracy, precision for hyperactivity, impulsivity, and inattention measurements) and their corresponding acceptance thresholds would be required.
2. Sample Size Used for the Test Set and Data Provenance
This information is not explicitly provided in the given 510(k) summary. The document does not describe a specific clinical performance test set, its sample size, or the provenance (country of origin, retrospective/prospective) of any clinical data used to support the device's effectiveness.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given 510(k) summary. Since no specific clinical performance test set or ground truth establishment method is described, details about experts or their qualifications are absent.
4. Adjudication Method for the Test Set
This information is not provided in the given 510(k) summary. Given the absence of a described clinical test set, an adjudication method would not be detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
This information is not provided in the given 510(k) summary. The document does not mention any MRMC studies or a comparison of human reader performance with and without AI assistance. The QbTest described is an objective measurement tool for ADHD, not an AI-assisted diagnostic aid for human readers in the context of image interpretation, which is typical for MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The QbTest, as described, is a standalone algorithm/device for objective measurement. The "Intended use" states, "QbTest provides clinicians with objective measurements...to aid in the clinical assessment of ADHD." It's an independent diagnostic aid, not a component meant to be integrated into a human's judgment process during real-time interpretation. Therefore, its performance would inherently be "standalone." However, a specific study detailing its standalone performance independent of human interpretation for making a diagnosis is not described here. The provided text refers to the device itself as providing the objective measurements.
7. The Type of Ground Truth Used
This information is not explicitly provided in the given 510(k) summary. For a device like QbTest, ground truth for "hyperactivity, impulsivity, and inattention" would typically involve:
- Clinical diagnosis of ADHD (or absence of ADHD) made by qualified clinicians using established diagnostic criteria (e.g., DSM-IV, DSM-5).
- Behavioral observations or other psychometric assessments.
The document implicitly suggests that the QbTest measurements aid in this clinical assessment, implying that the clinical assessment itself (likely expert consensus based on established criteria) serves as the ground truth against which the QbTest's utility is evaluated, but no study details are given.
8. The Sample Size for the Training Set
This information is not provided in the given 510(k) summary. There is no mention of a "training set" or a description of machine learning model development, which would typically involve such a set. The QbTest is described as utilizing a "consistent challenge paradigm coupled with detailed real-time measurements of behavior and performance," suggesting its output is based on pre-defined algorithms rather than a trained machine learning model in the modern sense.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned (see point 8), the method for establishing its ground truth is also not provided.
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Ko4o894
JUN 2 2 2004
5:Jk application - QbTest
510(k) Summary of safety and effectiveness
| Date: | 03/26/2004 |
|---|---|
| 510(k) Submitter: | Qbtech ABMimergatan 5SE - 417 64 GöteborgSwedenTel: +46 31-744 90 60Fax: +46 31-22 49 00Contact person: Maria BerglundE-mail: maria.berglund@qbtech.se |
| Trade Name: | QbTest |
| Classification name: | Recorder, attention task performance |
| Product Code: | LQD |
| Predicate Device: | OPTAx System (K020800) |
| Device Description: | The QbTest is a 15 minute, non invasive test that has beendeveloped to provide precise quantitative assessment of thecapacity of children to pay attention to visual stimuli whileinhibiting their loco motor activity and controlling their urge torespond impulsively. There are three cardinal disturbances inAttention-Deficit Hyperactivity Disorder (ADHD) impairedattention, hyperactivity and impulsivity. QbTest provides anaccurate and reproducible measure of a child's capacity ineach of these three domains by utilizing a consistentchallenge paradigm coupled with detailed real-timemeasurements of behavior and performance. Thefundamental core of QbTest is a computer-administeredgo/not-go vigilance response task combined with motioncapture. |
| The system consists of the following components;• Client PC software• Connection box• Responder button• Camera for motion measurement• Reflective marker• USB and serial cable | |
| Intended use: | QbTest provides clinicians with objective measurements ofhyperactivity, impulsivity, and inattention to aid in the clinicalassessment of ADHD. QbTest results should be interpretedonly by qualified professionals. |
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QbTest is substantially equivalent to the OPTAx system (K020800). Comparison of It provides the same or similar functions and has a similar design. technological The new characteristics do not affect safety or characteristics to effectiveness. Both the OPTAx system and QbTest are predicate device : indicated to aid in the assessment of ADHD. Both provide objective measurements of impulsivity, inattention and hyperactivity to aid in this process. Both are microprocessorbased vigilance task recorders with motion detection. Performance Testing: The camera is tested in accordance with EN60825-1:1994. The System is tested in accordance with EN 60601-1 "Electrical Equipment, Part 1: General Safety Requirements" and EN 60601-1-2 "Electromedical equipment, EMC
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or waves, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 2 2004
Ms. Maria Berglund Quality Assurance ObTech AB Mimergatan 5 417 64 Göteborg Sweden
Re: K040894 Trade/Device Name: QbTest Regulatory Class: Unclassified Product Code: LQD Dated: March 26, 2004 Received: April 29, 2004
Dear Ms. Berglund:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becally 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 encrosule) to regars as and the Medical Device Amendments, or 10 commerce prox to may 20, 1970, in eccordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r our may, merelove, mains of the Act include requirements for annual registration, listing of general controlo provider ing 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 If your device is craissimed (tools. Existing major regulations affecting your device can may be subject to suell additions, 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 I least of advised that I Drivisan that your device complies with other requirements of the Act that I DA has made a determination administered by other Federal agencies. You must or any I catal statutes and regations, including, but not limited to: registration and listing (21 Comply with an the 110: 31equirements, 01); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic form in the qualify by evol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Maria Berglund
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin maxioning of substantial equivalence of your device to a legally premarket notification: "The PDA mining sification 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 If you uesn't specific advice for Jour ac 110 %. 4659. Also, please note the regulation entitled, Comaci the Office of Comphanes at (est notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response 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,
Miriam 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): K040894
Device Name: QbTest
Indications For Use:
QbTest provides clinicians with objective measurements of hyperactivity, impulsivity, and inattention to aid in the clinical assessment of ADHD. QbTest results should be interpreted only by qualified professionals.
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)
uriam C. Provost
(Division Bigand Neurological Devices
Page 17 of 95
510(k) Number K040894
N/A