(474 days)
QbCheck provides health care professionals with objective measurements of hyperactivity, and inattention to aid in the clinical assessment of ADHD and in the evaluation of treatment interventions in patients with ADHD. Q6Check results should be interpreted only by qualified health care professionals.
QbCheck is a non-invasive test that has been developed to provide precise quantitative assessment of the capacity of an individual to pay attention to visual stimuli and inhibit impulses. There are three cardinal disturbances in Attention-Deficit Hyperactivity Disorder (ADHD); impaired attention, hyperactivity and impulsivity. QbCheck provides an accurate and reproducible measure of an individual'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 QbCheck is a computer-assisted attention and impulse control task and simultaneous recording of activity. QbCheck is an online solution and no extra hardware is needed as the test is performed on the user's own computer. For the activity tracking analysis QbCheck uses the built in camera in the user's laptop or a separate web camera on the user's desktop computer. QbCheck consists of the following;
● QbCheck client and server software
. Online test with instructions, a continuous performance task (CPT) and motion measurement technology through web camera.
- Access to a remote server which generates test results .
- Secure access to a result report
- User manual ●
- Technical manual
- QbCheck Behavior Observation Form .
The QbCheck device provides objective measurements of hyperactivity, impulsivity, and inattention to aid in the clinical assessment and treatment evaluation of ADHD.
Here's a breakdown of the acceptance criteria and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state numerical acceptance criteria in a dedicated table format with reported performance. However, it states that QbCheck is substantially equivalent to its predicate device, QbTest (K133382). This implies that its performance is considered comparable to the predicate for its intended use. The primary difference highlighted is the use of a webcam for motor activity tracking instead of an infrared camera and reflective marker, and the use of the spacebar instead of a responder button.
The substantial equivalence determination is the "acceptance criterion" in this context, demonstrating that the device performs as intended and is as safe and effective as a legally marketed device.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for a specific "test set" solely to demonstrate performance against acceptance criteria for this K143468 submission. However, it references a comparison to the predicate device, QbTest (K133382). Clinical studies for the predicate would contain this information.
Regarding data provenance for QbCheck, the document states: "For the activity tracking analysis QbCheck uses the built in camera in the user's laptop or a separate web camera on the user's desktop computer." This implies the data is generated from users performing the test. The document does not specify country of origin or whether studies were retrospective or prospective for this specific submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not detail the number or qualifications of experts used to establish ground truth for a test set for the QbCheck device itself. The interpretation of QbCheck results is stated to be "only by qualified health care professionals," which implies that clinical judgment from trained professionals would form the basis of actual ADHD diagnosis and evaluation.
4. Adjudication Method for the Test Set:
Given the information provided, there is no mention of an adjudication method (like 2+1, 3+1) for a test set directly comparing QbCheck's output against a "ground truth" established by experts. The focus of this 510(k) summary is on demonstrating substantial equivalence to the predicate device through technological comparison and intended use similarity.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The submission focuses on substantial equivalence based on technical characteristics and intended use similar to the predicate QbTest.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The document describes QbCheck as a "computer-assisted attention and impulse control task and simultaneous recording of activity." Its results are intended to "aid in the clinical assessment," and "QbCheck results should be interpreted only by qualified health care professionals." This structure implies it is a tool to be used with human interpretation, not a standalone diagnostic that makes decisions without human-in-the-loop performance. Therefore, a standalone study without human interpretation of results would not be appropriate for its indicated use.
7. The Type of Ground Truth Used:
The document makes no explicit mention of the type of ground truth (e.g., expert consensus, pathology, outcomes data) used in a study to establish the diagnostic accuracy of QbCheck itself. The predicate device, QbTest, and by extension QbCheck, provide "objective measurements of hyperactivity, impulsivity, and inattention," which aid in clinical assessment of ADHD. The "ground truth" for ADHD diagnosis typically involves a comprehensive clinical evaluation by qualified healthcare professionals based on diagnostic criteria (e.g., DSM-5), which may include parental/teacher reports, clinical interviews, and behavioral observations, in addition to objective measures like those provided by QbCheck.
8. The Sample Size for the Training Set:
The document does not specify the sample size used for any training set for QbCheck.
9. How the Ground Truth for the Training Set Was Established:
The document does not specify how ground truth for any training set was established.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 22, 2016
QbTech AB Hans Boström, MSc., PhD. Medical Director Kungsgatan 29 Stockholm, Sweden 11156
Re: K143468
Trade/Device Name: ObCheck Regulation Number: Unclassified Device Classification Name: Recorder, Attention Task Performance Regulatory Class: Unclassified Product Code: LQD Dated: March 14, 2016 Received: March 15, 2016
Dear Dr. Boström:
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.
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
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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.
for
Sincerely yours,
William J.
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Date: 2016.0
Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143468
Device Name QbCheck
Indications for Use (Describe)
QbCheck provides health care professionals with objective measurements of hyperactivity, and inattention to aid in the clinical assessment of ADHD and in the evaluation of treatment interventions in patients with ADHD. Q6Check results should be interpreted only by qualified health care professionals.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary of Safety and Effectiveness
| Date: | December 3, 2014 |
|---|---|
| 510(k) Submitter: | Qbtech ABKungsgatan 2911156 StockholmSwedenTel: +46 706339209Fax: +46 8 790 09 78Contact person: Hans BoströmE-mail: hans.bostrom@qbtech.com |
| Trade Name: | QbCheck |
| Classification name: | Recorder, attention task performance |
| Product Code: | LQD |
| Predicate Device: | QbTest (K133382) |
| Device Description: | QbCheck is a non-invasive test that has been developed to provide precise quantitative assessment of the capacity of an individual to pay attention to visual stimuli and inhibit impulses. There are three cardinal disturbances in Attention-Deficit Hyperactivity Disorder (ADHD); impaired attention, hyperactivity and impulsivity. QbCheck provides an accurate and reproducible measure of an individual'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 QbCheck is a computer-assisted attention and impulse control task and simultaneous recording of activity. QbCheck is an online solution and no extra hardware is needed as the test is performed on the user's own computer. For the activity tracking analysis QbCheck uses the built in camera in the user's laptop or a separate web camera on the user's desktop computer. QbCheck consists of the following;● QbCheck client and server software |
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. Online test with instructions, a continuous performance task (CPT) and motion measurement technology through web camera.
- Access to a remote server which generates test results .
- Secure access to a result report
- User manual ●
- Technical manual
- QbCheck Behavior Observation Form .
Intended use: QbCheck provides healthcare professionals with objective measurements of hyperactivity, impulsivity, and inattention to aid in the clinical assessment of ADHD and in the evaluation of treatment interventions in patients with ADHD. QbCheck results should be interpreted only by qualified healthcare professionals.
| Comparison oftechnologicalcharacteristics topredicate device: | QbCheck is substantially equivalent to QbTest (KK133382).It provides the same functions and the test has anidentical design. Instead of a responder button, the t |
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esttaker uses the spacebar to respond to targets and instead of an infrared camera and a reflective motion marker, the test-takers motor activity during the test is registered by the web camera.
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