QbTest is indicated to be used to aid in the clinical assessment of ADHD. QbTest results should be interpreted by qualified health care professionals only.

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.

Device Description

QbTest is a non-invasive test that has been developed to provide precise quantitative assessment of the capacity for 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. QbTest 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 QbTest is a computer-assisted attention and impulse control task and simultaneous recording of activity using an infrared camera for motion measurements.

The system consists of the following components:

Client software
Responder button (also referred to as responder unit)
Infrared camera
Reflective motion marker
User manual
Technical manual
Stimulus card
Camera stand
Measuring tape
QbTest Behaviour Rating Scale
In addition, the user must have access to a remote server that generates test reports

AI/ML Overview

The provided FDA 510(k) summary for QbTest v3.5 is a predicate device comparison, rather than a typical AI/ML medical device submission with specific performance acceptance criteria for an algorithm. Therefore, the information typically found for AI/ML device validation studies (like sensitivity/specificity, ROC curves, MRMC studies, precise ground truth establishment for a test set, etc.) is largely absent.

The submission focuses on demonstrating substantial equivalence to a previously cleared device (QbTest K040894) and the Gordon Diagnostic System (K854903) by showing similar intended use, technological characteristics, and safety/performance based on normative data collection and prior published clinical studies of the device and its predecessor.

Here's an attempt to answer your questions based on the provided text, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Strict "acceptance criteria" as you'd find in an AI/ML device validation (e.g., minimum sensitivity or specificity) are not stated in this 510(k) summary. The performance is demonstrated through:

Acceptance Criteria (Implied)	Reported Device Performance
Demonstrated safety and effectiveness (as per predicate)	System tested to EN60601-1 and EN60601-1-2 standards.
Provision of objective measurements for hyperactivity, impulsivity, and inattention	QbTest provides measurements in these domains.
Aid in clinical assessment of ADHD	Four published studies evaluated clinical validity.
Reliability (test-retest consistency)	Two test-retest studies completed.
Normative data for interpretation (age/gender-specific)	Normative database of 1307 individuals (6-60 years).

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

Sample Size for Clinical Validation/Normative Data:
- "Normative tests have been gathered from several different cohorts resulting in a normative database of 1307 individuals between 6 and 60 years with an even age and gender distribution." This 1307-individual dataset serves as the primary "reference" or "test set" against which individual patient performance is compared. It's not a "test set" in the sense of an independent validation set for algorithm performance, but rather a normative reference.
- The submission also mentions "four published studies which have evaluated the clinical validity of the QbTest for its intended use population" and "two test-retest studies." The individual sample sizes for these specific studies are not provided in this summary.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the general nature of normative data collection often implies a prospective or at least a systematic retrospective collection from a defined population. The submitter is Swedish (Qbtech AB, Stockholm, Sweden), which might suggest some data from that region, but this is speculative.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Ground Truth for QbTest: The QbTest itself generates the objective measurements of hyperactivity, impulsivity, and inattention. The "ground truth" for ADHD diagnosis isn't established by individual experts reviewing test data; rather, the test aids qualified healthcare professionals in making the diagnosis.
The "normative database" would have been collected from individuals (both with and without diagnosed ADHD, presumably) where their diagnostic status would have been established by qualified clinicians, but the number and qualifications of these clinicians are not specified.
The "four published studies" and "two test-retest studies" would have involved clinical professionals to manage and interpret the data, but no specific count or qualifications are provided in this summary.

4. Adjudication Method for the Test Set

Not applicable in the typical sense of expert review for an algorithm's output. The QbTest itself produces quantitative output. Any diagnostic "ground truth" used in the underlying clinical studies (if those studies involve comparing QbTest outputs to clinical diagnoses) would likely follow standard clinical diagnostic procedures, which may involve adjudication, but this is not described in the 510(k) summary.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, an MRMC study is not mentioned or described. This type of study (human readers with and without AI assistance) is typically performed for imaging or diagnostic algorithms that directly influence a human reader's interpretation. QbTest provides quantitative data that aids a clinician, rather than directly modifying their interpretation of, for example, an anatomical image.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in essence. The QbTest itself is a standalone device that measures parameters (hyperactivity, impulsivity, inattention). Its performance is assessed by how well these measurements are collected and how consistently they reflect a person's behavior/performance. The "clinical validity" studies assess the utility of these measurements in aiding ADHD assessment, which is analogous to a standalone performance evaluation of the device's output. The summary refers to "four published studies which have evaluated the clinical validity of the QbTest for its intended use population."

7. Type of Ground Truth Used

Clinical Diagnosis/Phenotype (implicit): For the "clinical validity" studies, the "ground truth" would likely be a clinical diagnosis of ADHD (or lack thereof) made by qualified professionals, following established diagnostic criteria (e.g., DSM criteria). The QbTest's output is then correlated with or assessed for its ability to discriminate based on this clinical "ground truth."
Observed Behavior/Performance (inherent): For the test-retest reliability studies, the ground truth is the inherent stability of an individual's performance and behavior on the test over time.
Normative Data: The "normative database" itself serves as a "ground truth" for what is considered typical performance for a given age and gender.

8. Sample Size for the Training Set

Not Applicable / Not Explicitly Stated. The QbTest described is a direct measurement system, not a machine learning algorithm that is "trained" on a dataset in the conventional sense. The "normative database" of 1307 individuals functions more like a reference set rather than a "training set" for an AI model.

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

Not Applicable / Not Explicitly Stated. As it's not an ML training set, the concept of establishing ground truth for training doesn't apply directly. The "normative database" was established by collecting data from "several different cohorts" of individuals between 6 and 60 years old. The methods for this collection are described as being in the "technical manual," but not detailed here. Presumably, these were "healthy" or "typically developing" individuals to establish the "norm."

Summary of Limitations based on the provided text:

This 510(k) summary is typical for a non-AI/ML device that is seeking clearance based on substantial equivalence to an existing predicate. It heavily relies on prior clearance and existing clinical literature demonstrating the utility of the type of device. It does not provide the detailed information about AI/ML validation studies that are now common in submissions for software as a medical device (SaMD) utilizing AI/ML algorithms.

Summary

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

K122149

510(k) Summary

Date:	17 July
-------	---------

OCT 1 7 2012

Qbtech AB 510(k) Submitter:

Kungsgatan 29 11156 Stockholm Sweden Tel: +46 706339209 Fax: +46 8 Contact person: Hans Boström E-mail: hans bostrom@qbtech se
2012

Trade Name: QbTest

Classification name: Recorder, attention task performance

LQD Product Code:

QbTest (K040894) and Gordon Diagnostic System (K854903) Predicate Device:

Description	GordonDiagnosticSystem (K854903)	QbTest (K040894)	QbTest v3.5
Intended use	The GordonDiagnostic System(GDS) aids in thediagnosis ofattention deficits,especially AttentionDeficit HyperactivityDisorder (ADHD). Itprovides reliable,objectiveinformation aboutan individual's	QbTest (K040894)provides clinicians withobjective measurements ofhyperactivity, impulsivity,and inattention to aid in theclinical assessment ofADHD. QbTest resultsshould be interpreted onlyby qualified professionals.	QbTest v3.5 providesclinicians with objectivemeasurements ofhyperactivity, impulsivity,and inattention to aid in theclinical assessment ofADHD. QbTest resultsshould be interpreted onlyby qualified professionals.

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

ability to sustain
attention and exert
self-control.

Device Description: QbTest is a non-invasive test that has been developed to provide precise quantitative assessment of the capacity for 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. QbTest 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 QbTest is a computer-assisted attention and impulse control task and simultaneous recording of activity using an infrared camera for motion measurements.

The system consists of the following components:

· Client software
· Responder button (also referred to as responder unit)
· Infrared camera
· Reflective motion marker
· User manual
Technical manual
Stimulus card
· Camera stand
· Measuring tape
· QbTest Behaviour Rating Scale

· In addition, the user must have access to a remote server that generates test reports

Indications for Use: QbTest is indicated to be used to aid in the clinical assessment of ADHD. QbTest results should be interpreted by qualified health care professionals only.

Intended use:

Comparison of

QbTest is substantially equivalent to the original QbTest

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

technologicalcharacteristics topredicate device:	(K040894).It provides the same or similar functions and has a similardesign. Both the current version of QbTest and theoriginal version of QbTest (K040894) are indicated to aidin the assessment of ADHD. Both provide objectivemeasurements of impulsivity, inattention and hyperactivityto aid in this process. Both are microprocessor-basedvigilance task recorders with motion detection.The current version of QbTest can also be used inadolescents and adults as Gordon Diagnostic System(K854903).
Performance Testing:	The camera is tested in accordance with EN60825-1:1994. The Systemis tested in accordance with EN 60601-1 "Electrical Equipment, Part 1:General Safety Requirements" and EN 60601-1-2 "Electromedicalequipment, EMC"
Clinical Testing:	Normative tests have been gathered from several different cohortsresulting in a normative database of 1307 individuals between 6 and 60years with an even age and gender distribution. The characteristics ofthis norm database and the methods to generate age and genderspecific comparisons are described in the technical manual. There arefour published studies which have evaluated the clinical validity of theQbTest for its intended use population. In addition, two test-reteststudies have been completed to demonstrate the reliability of theQbTest.
Conclusions:	QbTest v3.5 is substantially equivalent to the original QbTest(K040894). It provides the same or similar functions and has a similardesign. Both the original QbTest (K040894) and QbTest v3.5 areindicated to aid in the assessment of ADHD. Both provide objectivemeasurements of impulsivity, inattention and hyperactivity to aid in thisprocess. Both are microprocessor-based vigilance task recorders withmotion detection.

QbTest v3.5 can be used also in adolescents and adults as can the Gordon Diagnostic System (K854903).

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

The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs at least as safely and effectively as the legally marketed device identified above.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

OCT 17 2012

Qbtech AB % Mr. Hans Bostrom Medical Director Kungsgatan 29 11156 Stockholm Sweden

Re: K122149

Trade/Device Name: QbTest v3.5 Regulation Number: Unclassified Regulation Name: Recorder, Attention Task Performance Regulatory Class: Class II Product Code: · LQD Dated: July 17, 2012 Received: July 19, 2012

Dear Mr. Bostrom:

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.

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

Page 2 - Mr. Hans Bostrom

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 (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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Debra Falls

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

{6}------------------------------------------------

STATEMENT FOR INDICATIONS FOR USE

510 (k) Number (if known):

K122149

Device Name:

QbTest

Indications for Use:

QbTest provides clinicians with objective measurements of hyperactivity, 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 GFR 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 K122149

Regulation Number and Section

N/A