DANA provides clinicians with objective measurements of reaction time (speed and accuracy) to aid in the assessment of an individual's medical or psychological state. Factors that may affect the measurement of reaction time include, but are not limited to concussion, head injury, insomnia, post traumatic stress disorder (PTSD), depression, attention deficit hyperactivity disorder (ADHD), memory impairment, delirium, prescription and non-prescription medication, some nutritional supplements, as well as a variety of psychological states (e.g. fatigue and stress).

DANA also delivers and scores standardized psychological questionnaires. DANA results should be interpreted only by qualified professionals.

Device Description

DANA is a mobile application indicated to provide clinicians with objective measurements of reaction time (speed and accuracy) and standardized health assessments to aid in the assessment of an individual's medical or psychological state. DANA results should be interpreted only by qualified professionals.

DANA was developed on a mobile platform to improve the access and availability of reaction time tests and standardized health assessments through (1) custom configuration of the system by clinicians based on their need and discretion; and (2) allowing for objective health assessments both in-clinic and out-of-clinic settings.

AI/ML Overview

The provided document is a 510(k) summary for the DANA device, an unclassified mobile-based task performance recorder. It compares DANA to a predicate device (QbTest) and mentions software testing, but it does not contain the detailed information necessary to fully address all parts of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.

Specifically, the document does not include:

A table of acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy, precision, recall for diagnostic devices, or specific reaction time performance metrics like mean, standard deviation, error rate, etc.).
Details on sample size for a test set, data provenance, ground truth establishment for a test set, or adjudication methods.
Information on Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance studies.
Details on sample size for the training set or how ground truth for the training set was established.

The document primarily focuses on demonstrating substantial equivalence to the predicate device based on intended use and technological characteristics, and mentions general software testing.

Given the limitations of the provided text, I will answer the questions to the best of my ability, indicating where information is not present.

Acceptance Criteria and Study Details for DANA Device

1. A table of acceptance criteria and the reported device performance

The provided document does not contain a table of acceptance criteria or specific reported device performance metrics for the DANA device (e.g., accuracy of reaction time measurement, consistency, precision, etc.). The 510(k) summary states that "Differences in the design and performance of DANA from the QbTest do not affect either the safety or effectiveness of DANA for its intended use," which is a high-level statement for substantial equivalence, but it does not quantify performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a sample size for a "test set" or provide details on data provenance (country of origin, retrospective/prospective study design). The summary mentions "Software testing was conducted in accordance with FDA's May 2005 guidance document," which relates to software validation rather than clinical performance testing with a specific test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not mention the use of experts to establish ground truth for a test set or their qualifications. The DANA device is described as providing "objective measurements of reaction time (speed and accuracy)" and scoring "standardized psychological questionnaires." These types of measurements typically rely on predefined algorithms and the user's interaction directly with the device, rather than subjective expert interpretation for ground truth. The interpretation of DANA results is specified to be done by "qualified professionals," but this is about result usage, not ground truth establishment for performance validation of the device itself.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method as no specific test set requiring such expert adjudication is detailed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The DANA device provides objective measurements and scores questionnaires, it is not described as an AI-driven assistive tool for human readers in a diagnostic context that would typically warrant an MRMC study to measure improvement with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes DANA as a "mobile application indicated to provide clinicians with objective measurements of reaction time (speed and accuracy) and standardized health assessments." This implies a standalone (algorithm-only) performance in terms of generating these raw measurements and scores. The device takes inputs (user interactions) and produces outputs (reaction time data, questionnaire scores) without a specific "human-in-the-loop" component in the measurement generation process itself, though human interpretation of the results is required. However, no specific "standalone study" with detailed metrics is described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document does not explicitly state the type of ground truth used for validating the device's performance because the nature of the device (measuring reaction time and scoring questionnaires) implies that its "ground truth" relates to the accuracy and reliability of its internal clock, input detection, and scoring algorithms, rather than a diagnostic 'truth' like pathology. For reaction time, the ground truth would be the actual time elapsed between stimulus and response, measured by highly accurate timing mechanisms. For questionnaires, the ground truth would be the correct application of the scoring rules. No validation study details are provided to elaborate on how these internal "ground truths" were confirmed.

8. The sample size for the training set

The document does not mention a training set sample size. AI/ML software often uses training sets, but the description of DANA focuses on objective measurement and standardized questionnaire scoring, which may not heavily rely on complex supervised machine learning models requiring large labeled training sets in the same way an image recognition AI would. The software testing mentioned is more likely related to functional and performance testing against specifications rather than AI model training.

9. How the ground truth for the training set was established

Since no training set is mentioned (see point 8), the document does not provide information on how ground truth for a training set was established.

Summary

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

October 15, 2014

AnthroTronix, Inc. Dr. Corinna Lathan Chief Executive Officer 8737 Colesville Road. Suite L-203 Silver Spring, MD 20910

Re: K141865

Trade/Device Name: DANA Regulation Number: Unclassified Device Classification Name: Recorder, Attention Task Performance Regulatory Class: Unclassified Product Code: LQD Dated: July 9, 2014 Received: July 10, 2014

Dear Dr. Lathan:

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

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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 (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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.

Sincerely yours.

Felipe Aquel -S

Carlos L. Peña, PhD, MS for 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) K141865

Device Name DANA

Indications for Use (Describe)

DANA also delivers and scores standardized psychological questionnaires. DANA results should be interpreted only by qualified professionals.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY 1.0

Submitter Information:

Company:	AnthroTronix, Inc.8737 Colesville Road, Suite L203Silver Spring, MD 20910
Contract Person:	Corinna E. Lathan, PhD, PECEOAnthroTronix, Inc.Tel: (240) 498-9471Fax: (301) 585-9075Email: cori.lathan@atinc.com

Device Information:

Trade Name:	DANA
Common Name:	Mobile Based Task Performance Recorder
Classification Name:	Recorder, Attention Task Performance
Device Class:	Unclassified
Predicate Device:	QbTest (K122149)Qbtech ABUnclassified

Device Description:

Indications for Use:

DANA provides clinicians with objective measurements of reaction time (speed and accuracy) to aid in the assessment of an individual's medical or psychological state. Factors that may affect the measurement of reaction time include, but are not limited to concussion, head injury, insomnia, post traumatic stress disorder (PTSD), depression, attention deficit hyperactivity disorder (ADHD), memory impairment, dementia, delirium, prescription and non-prescription medication, some nutritional supplements, as well as a variety of psychological states (e.g. fatique and stress).

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DANA also delivers and scores standardized psychological questionnaires. DANA results should be interpreted only by qualified professionals.

Comparison to Predicate Device:

DANA is substantially equivalent to QbTest (manufactured by Obtech AB; K122149). DANA and the QbTest share the same intended use as Attention Task Performance Recorders. DANA and the QbTest are similar in terms of technological characteristics as both electronically record objective performance measurements (speed and accuracy) as the patient responds to stimuli presented on the screen by either clicking a button or touching the screen. The QbTest differs from DANA in that a computer is used to administer the test, as compared to DANA, which uses a mobile device. The QbTest also differs in technology from DANA in that the QbTest includes an infrared camera to monitor patient movement, which factors into the performance measurements. DANA does not include an infrared camera to monitor patient movement, and therefore does not use physical activity in providing performance measurements. Differences in the design and performance of DANA from the QbTest do not affect either the safety or effectiveness of DANA for its intended use.

Supporting Information:

Software testing was conducted in accordance with FDA's May 2005 guidance document entitled, "Guidance for Industry and FDA Staff. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Conclusion:

DANA falls within the generic type of device requlated by the LQD Product Code (Recorder, Attention Task Performance). Differences in the design and performance of DANA from the QbTest do not affect either the safety or effectiveness of DANA for its intended use. Therefore, DANA is substantially equivalent to the QbTest.

Regulation Number and Section

N/A