(127 days)
The Test of Variables of Attention (T.O.V.A.) provides healthcare professionals with objective measurements of attention and inhibitory control, which aid in the assessment of attention deficits, including attention-deficit/hyperactivity disorder (ADHD). T.O.V.A. results should only be interpreted by qualified healthcare professionals.
The Test of Variables of Attention (T.O.V.A.) is an accurate and objective continuous performance test (CPT) that measures the key components of attention and inhibitory control. The T.O.V.A. is used by qualified healthcare professionals in the assessment of attention deficits, including attention-deficit/hyperactivity disorder (ADHD), in children and adults.
The T.O.V.A. is a culture- and language-free, sufficiently long computerized test that requires no left/right discrimination or sequencing. Responses to visual or auditory stimuli are recorded with a specially designed, highly accurate (±1 ms) microswitch. The T.O.V.A. calculates response time variability (consistency), response time (speed), commissions (impulsivity), and omissions (focus and vigilance). These calculations are then compared to a large age- and gender-matched normative sample (over 1,700 individuals for the visual test, and over 2,500 individuals for the auditory test), as well as to a sample population of individuals independently diagnosed with ADHD. These comparison results are used to create an immediately available, easy-to-read report.
The T.O.V.A. system includes: a USB flash drive with software installer for Mac and Windows PCs, a T.O.V.A. USB device, a T.O.V.A. Microswitch, an Installation Guide, a User's Manual, a Clinical Manual, and accessory cables (USB, VGA, and audio cables).
Here's a breakdown of the acceptance criteria and study information for the Test of Variables of Attention (T.O.V.A.) version 9.0 device, based on the provided text:
Acceptance Criteria and Device Performance
The provided text focuses on the device's adherence to safety, essential performance, and electromagnetic compatibility (EMC) standards rather than clinical performance metrics for diagnosing ADHD. The acceptance criteria essentially stem from proving substantial equivalence to the predicate device, the Gordon Diagnostic System Model I (K854903), in these engineering and regulatory aspects.
| Acceptance Criterion (Test) | Reported Device Performance (Results) |
|---|---|
| IEC 60601-1:2005 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance" | The T.O.V.A. passed the state of the art for electrical safety and functional testing. It is considered equivalent or better in safety and functionality compared to the predicate GDS. |
| IEC 60601-1-2:2014 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests" | The T.O.V.A. passed the state of the art for electromagnetic compatibility and electromagnetic immunity testing. It is considered equivalent or better in electrical performance compared to the predicate GDS. |
| T.O.V.A. Verification Testing (Software functionality) | The T.O.V.A. functioned as intended, passing all major verification tests as described in "Section 16 – Software", specifically the "Verification and Validation Summary ("VVS01")". Minor unresolved anomalies were found and listed. The device is deemed equivalent or even more rigorously verified compared to the GDS (for which no equivalent verification tests were listed in its 1989 510(k)). |
Study Information Pertaining to Device Verification and Validation:
The document primarily describes a set of verification and validation activities rather than a clinical study evaluating diagnostic performance. The focus is on demonstrating that the T.O.V.A. 9.0 functions correctly and meets established engineering standards and design requirements.
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Sample Size used for the test set and data provenance:
- IEC 60601-1:2005 & IEC 60601-1-2:2014: These tests involve the physical device itself and do not typically use "patient samples." The "test set" here refers to the device prototypes subjected to standardized electrical and functional tests.
- T.O.V.A. Verification Testing: This involved the T.O.V.A. system (software and hardware). The "test set" refers to the various functions and modules of the software and hardware that were tested according to a detailed matrix of requirements. No human participant data is mentioned for these verification tests.
- Normative Data: While not a "test set" for performance evaluation against a gold standard in the context of device accuracy, the device's internal comparison data uses a large normative sample:
- Visual test: over 1,700 individuals
- Auditory test: over 2,600 individuals
- These normative samples were described as "age- and gender-matched" and "non-ADHD individuals." The provenance (country of origin, retrospective/prospective) is not specified in the provided text.
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Number of experts used to establish the ground truth for the test set and their qualifications:
- For the engineering and software verification tests described (IEC standards, T.O.V.A. Verification Testing), the "ground truth" is defined by the technical specifications of the standards and the design requirements. The "experts" would be the certified test engineers at the third-party facilities (UL, Inc. and Element, Inc.) and The TOVA Company's internal design and quality assurance teams, who assess compliance with these objective standards. Specific qualifications beyond being "third-party test facilities" are not detailed.
- Regarding the normative data used by the device (not to test the device's diagnostic accuracy directly), the text mentions "a sample population of individuals independently diagnosed with ADHD." However, it does not specify the number or qualifications of experts who established these independent ADHD diagnoses.
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Adjudication method for the test set:
- For the engineering and software verification tests, the adjudication method is typically direct assessment against the defined standard or requirement. There isn't an "adjudication method" in the sense of multiple experts reviewing cases to establish a clinical ground truth.
- For the normative data and the "independently diagnosed with ADHD" population, the adjudication method for the ADHD diagnosis itself is not described.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study is mentioned in the provided text. The T.O.V.A. device provides objective measurements to aid in assessment by healthcare professionals; it is not described as an AI-assisted diagnostic tool where human readers improve with its assistance in the typical sense of interpreting images or complex data with AI overlays. Its function is to generate objective metrics for a clinician's interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The T.O.V.A. is described as providing "objective measurements" that "aid in the assessment of attention deficits." It explicitly states that "T.O.V.A. results should only be interpreted by qualified healthcare professionals." This indicates it's designed as a tool for a human-in-the-loop workflow, not as a standalone diagnostic device. Therefore, a standalone performance study in a diagnostic capacity would not be applicable or described for this device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the engineering tests, the ground truth is compliance with the IEC 60601-1 and IEC 60601-1-2 standards and the device's own design specifications (for verification testing).
- For the context of the device's internal comparisons, it uses a "normative sample" of "non-ADHD individuals" and a "sample population of individuals independently diagnosed with ADHD." The ground truth for these populations is derived from clinical diagnosis (likely expert consensus or established diagnostic criteria for ADHD), though the specifics are not detailed.
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The sample size for the training set:
- The document does not describe a machine learning algorithm that requires a "training set" in the conventional sense. The T.O.V.A. functions by comparing an individual's performance to existing "normative data." This normative data could be considered analogous to a "training set" for establishing typical ranges.
- Visual normative data: 1,714 individuals
- Auditory normative data: 2,680 individuals
- The document does not describe a machine learning algorithm that requires a "training set" in the conventional sense. The T.O.V.A. functions by comparing an individual's performance to existing "normative data." This normative data could be considered analogous to a "training set" for establishing typical ranges.
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How the ground truth for the training set was established:
- For the normative data (analogous to a training set), the ground truth for these individuals was established as "non-ADHD individuals." This implies that they were clinically confirmed not to have ADHD. The specific diagnostic process or criteria used to classify these "non-ADHD" individuals are not detailed in the provided text. It is reasonable to assume this was established through standard clinical diagnostic procedures, excluding individuals with an ADHD diagnosis.
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Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 17, 2017
The TOVA Company Chris Holder, CEO 2828 SW Corbett Ave. Suite 128 Portland. Oregon 97201
Re: K170082
Trade/Device Name: Test of Variables of Attention (T.O.V.A) version 9.0 Regulatory Class: Unclassified Product Code: LQD Dated: April 12, 2017 Received: April 17, 2017
Dear Chris Holder:
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 devicerelated 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.
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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Michael J. Hoffmann -S
for
Carlos L. Peña. PhD, MS 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) K170082
Device Name
Test of Variables of Attention (T.O.V.A.) version 9.0
Indications for Use (Describe)
The Test of Variables of Attention (T.O.V.A.) provides healthcare professionals with objective measurements of attention and inhibitory control, which aid in the assessment of attention deficits, including attention-deficitly disorder (ADHD). T.O.V.A. results should only be interpreted by qualified healthcare 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
| Date: | 04/12/2017 |
|---|---|
| 510(k) Submitter: | The TOVA Company2828 SW Corbett Ave suite 128Portland, OR 97201 USAContact Person: Chris HolderTel 360-661-2899Email: chris@thetovacompany.com |
| Trade Name: | Test of Variables of Attention (T.O.V.A.) version 9.0 |
| Common name: | Continuous Performance Test (CPT) |
| Product Code: | LQD |
| Classification name: | Recorder, attention task performance |
| Device class: | Unclassified |
| Predicate Device: | The Gordon Diagnostic System Model I from Clinical Diagnostics Inc. (K854903) |
| Device Description: | The Test of Variables of Attention (T.O.V.A.) is an accurate and objective continuousperformance test (CPT) that measures the key components of attention and inhibitorycontrol. The T.O.V.A. is used by qualified healthcare professionals in the assessment ofattention deficits, including attention-deficit/hyperactivity disorder (ADHD), in childrenand adults.The T.O.V.A. is a culture- and language-free, sufficiently long computerized test thatrequires no left/right discrimination or sequencing. Responses to visual or auditorystimuli are recorded with a specially designed, highly accurate (±1 ms) microswitch. TheT.O.V.A. calculates response time variability (consistency), response time (speed),commissions (impulsivity), and omissions (focus and vigilance). These calculations arethen compared to a large age- and gender-matched normative sample (over 1,700individuals for the visual test, and over 2,500 individuals for the auditory test), as well asto a sample population of individuals independently diagnosed with ADHD. Thesecomparison results are used to create an immediately available, easy-to-read report.The T.O.V.A. system includes: a USB flash drive with software installer for Mac andWindows PCs, a T.O.V.A. USB device, a T.O.V.A. Microswitch, an Installation Guide, aUser's Manual, a Clinical Manual, and accessory cables (USB, VGA, and audio cables). |
| Indications for Use: | The Test of Variables of Attention (T.O.V.A.) provides healthcare professionals withobjective measurements of attention and inhibitory control, which aid in theassessment of attention deficits, including attention-deficit/hyperactivity disorder(ADHD). T.O.V.A. results should only be interpreted by qualified healthcareprofessionals. |
| TechnologicalCharacteristics: | The T.O.V.A. consists of the TO.V.A. USB Device, the T.O.V.A. Microswitch, and a USBflash drive with software for use on a Mac or Windows PC. The T.O.V.A. has been |
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designed and tested to be safe and effective when used by qualified healthcare professionals.
Performance Data: The T.O.V.A. has been verified and validated in accordance with design controls. The T.O.V.A has passed testing for safety and essential performance under IEC 60601-1:2005 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance" and electromagnetic compatibility under IEC 60601-1-2:2014 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests". In all instances, the T.O.V.A. functioned as intended and the performance observed was as expected.
| Test | Test Method Summary | Results |
|---|---|---|
| IEC 60601-1:2005 “Medicalelectrical equipment - Part 1:General requirements forbasic safety and essentialperformance” | A third-party test facility (UL,Inc.) tested the T.O.V.A. 9system to IEC 60601-1:2005. | The T.O.V.A. passed the state of the art forelectrical safety and functional testing.Although no such testing was done for theGDS, it met the safety and functional testingrequired for 510(k) clearance in 1989. Thus,the T.O.V.A. is equivalent or better in safetyand functionality compared to the GDS. |
| IEC 60601-1-2:2014 “Medicalelectrical equipment - Part 1-2: General requirements forbasic safety and essentialperformance - CollateralStandard: Electromagneticdisturbances - Requirementsand tests” | A third-party test facility(Element, Inc.) tested theT.O.V.A. 9 system to IEC60601-1-2:2014. | The T.O.V.A. passed the state of the art forelectromagnetic compatibility andelectromagnetic immunity testing. Althoughno such testing was done for the GDS, it metthe safety and functional testing required for510(k) in 1989. Thus, the T.O.V.A. isequivalent or better in electrical performancecompared to the GDS. |
| T.O.V.A. Verification Testing | The T.O.V.A. system wastested by the TOVA Companyas described in “Section 16 –Software”, specifically the“Verification and ValidationSummary (“VVS01”)” whichincludes a detailed matrix ofrequirements and theircorresponding tests. | The T.O.V.A. functioned as intended, passingall major verification tests. Minor issues werefound, which are listed in “Section 16 -Software” under Unresolved Anomalies. Noequivalent verification tests were listed forthe GDS, although it met the verificationrequirements for a 510(k) in 1989. Thus, theT.O.V.A. is equivalent or even more rigorouslyverified compared to the GDS. |
Substantial Equivalence:
The T.O.V.A. is substantially equivalent to the Gordon Diagnostic System that was cleared under K854903. The T.O.V.A. has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the T.O.V.A. and its predicate devices raise no new issues of safety or effectiveness. A detailed comparison is shown below.
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| Gordon Diagnostic System (GDS) | Test of Variables of Attention (T.O.V.A.) | |
|---|---|---|
| 510(k) Number | K854903 | K170082 |
| FDA CODE | LQD | LQD |
| FDA Class | Unclassified | Unclassified |
| Intended Use | The GDS aids in the diagnosis ofattention deficits, especiallyAttention Deficit HyperactivityDisorder (ADHD). It providesreliable, objective informationabout an individual's ability tosustain attention and exert self-control. | The Test of Variables of Attention (T.O.V.A.)provides healthcare professionals with objectivemeasurements of attention and inhibitorycontrol, which aid in the assessment of attentiondeficits, including attention-deficit/hyperactivitydisorder (ADHD). T.O.V.A. results should only beinterpreted by qualified healthcare professionals. |
| Normative study | Visual: Ages 4 to 16. | Visual: Ages 4 to 80. |
| range | Auditory: Ages 4 to 16. | Auditory: Ages 6 to 29. |
| Adults: Labeling says "Published | ||
| norms are also available for adults, | ||
| college students, geriatric | ||
| populations..." | ||
| Norming Data | Normative data are based uponprotocols of over 1,300 non-hyperactive boys and girls aged 4-16 years. | Normative data are based on 1,714 (visual) and2,680 (auditory) non-ADHD individuals ages 4 to80. |
| Device Description | This device aids in the diagnosis ofattention deficits, especiallyAttention Deficit HyperactivityDisorder (ADHD). It providesreliable, objective informationabout an individual's ability tosustain attention and exert self-control. This practical, reliable, andwell-researched device enhancesthe accuracy and relevance of acomprehensive evaluation forattention deficits andimpulsiveness. | The Test of Variables of Attention (T.O.V.A.) is anaccurate and objective continuous performancetest (CPT) that measures the key components ofattention and inhibitory control. The T.O.V.A. isused by qualified healthcare professionals in theassessment of attention deficits, includingattention-deficit/hyperactivity disorder (ADHD),in children and adults.The T.O.V.A. is a culture- and language-free,sufficiently long computerized test that requiresno left/right discrimination or sequencing.Responses to visual or auditory stimuli arerecorded with a specially designed, highlyaccurate (±1 ms) microswitch. The T.O.V.A.calculates response time variability (consistency),response time (speed), commissions (impulsivity),and omissions (focus and vigilance). Thesecalculations are then compared to a large age-and gender-matched normative sample (over1,700 individuals for the visual test, and over2,600 individuals for the auditory test), as well asto a sample population of individualsindependently diagnosed with ADHD. Thesecomparison results are used to create animmediately available, easy-to-read report |
| Gordon Diagnostic System (GDS) | Test of Variables of Attention (T.O.V.A.) | |
| The T.O.V.A. system includes: a USB flash drivewith software installer for Mac and Windows PCs,a T.O.V.A. USB device, a T.O.V.A. Microswitch, anInstallation Guide, a User's Manual, a ClinicalManual, and accessory cables (USB, VGA, andaudio cables). | ||
| Length of test | 8-9 minutes. | 10.8 to 21.6 minutes. |
| ContinuousPerformance Test(CPT) | Yes (A-X task). | Yes (Go/No Go task). |
| Visual stimuli | Yes (numeric digits). | Yes (geometric shapes). |
| Auditory stimuli | Yes (sound samples). | Yes (tones). |
| Technology | Real-time, microcontroller-based,portable stand-alone unit. | Real-time, microcontroller-based, portable stand-alone unit, with USB connection to a Mac orWindows PC. |
| Subject responsemechanism | Microswitch. | Microswitch. |
| Timing accuracy | Unknown; estimated at ± 10milliseconds. | Accurate timing to ±1 milliseconds. |
| Statistics gathered | Omissions (false negatives),Commissions (false positives), andResponse Times (not includingvariability) | Omissions (false negatives),Commissions (false positives),Response Times (including variability). |
| Report | Printed on thermal printer. | Printed or PDF output. |
| Accessories | Auditory module, printer. | Flash drive and off-the-shelf USB, audio, andvideo cables. |
| Software | Firmware only, not updateable. | Firmware and software, fully updateable. |
| Platforms | Stand-alone device only. | Windows PCs running Windows 7 - 10.Mac computers running Mac OS X 10.8 - 10.12 |
| Standards withwhich the DeviceComplies | No electrical safety or EMC testdata listed in 510(k). | IEC 60601-1: 2012 and IEC 60601-1-2:2014 |
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N/A