The ANAM Test System: Military Battery provides clinicians with objective measurements of cognitive performance in military populations ages 18 to 65 years, to aid in the assessment of an individual's level of cognitive functioning. The ANAM Test System should only be used as an adjunctive tool for evaluating cognitive function.

Device Description

ANAM Test System: Military Battery is a software only device that provides clinicians with objective measurements of cognitive performance in military populations, to aid in the assessment of an individual's level of cognitive function. The software is downloaded from the Vista LifeSciences website and is for use on a Dell Latitude E6440 Laptop. The laptop is not provided as part of the device, but is purchased separately by the user. Each ANAM battery consists of a collection of pre-selected modules that are administered in a sequential manner.

AI/ML Overview

The ANAM Test System: Military Battery is a software-only device designed to provide objective measurements of cognitive performance in military populations (ages 18 to 65 years) as an adjunctive tool for evaluating cognitive function.

Here's an analysis of the provided information regarding its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state formal acceptance criteria with numerical thresholds. Instead, the "Performance Data" section discusses the general demonstration of concurrent validity with traditional neuropsychological tests. The "Summary / Conclusion of Substantial Equivalence Rationale" further states that "ANAM provides a reliable measure of cognitive function."

To present this in a tabular format based on the given information:

Acceptance Criterion (Implicit)	Reported Device Performance
Demonstrate Concurrent Validity with Traditional Neuropsychological Tests	The 510(k) included results of numerous studies demonstrating correlations with traditional neuropsychological tests.
Provide a Reliable Measure of Cognitive Function	The results of these studies "demonstrate that ANAM provides a reliable measure of cognitive function."
Aid in the assessment of an individual's level of cognitive functioning	The device is indicated to "aid in the assessment of an individual's level of cognitive functioning" and is considered "substantially equivalent to the predicate device."

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

The document states, "The 510(k) included the results of numerous studies that examined the concurrent validity of ANAM as a clinical tool by documenting correlations with traditional neuropsychological tests."

Sample Size: The exact sample size for the test set(s) is not specified. The mention of "numerous studies" suggests multiple datasets were used, but no specific numbers are given.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. The target population is "military populations ages 18 to 65 years," suggesting the data would likely be from military personnel.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

The document does not provide information on the number of experts used to establish ground truth or their qualifications. The ground truth appears to be derived from "traditional neuropsychological tests," implying that the interpretation of these tests by qualified neuropsychologists or clinicians would form the reference standard, but this is not explicitly stated or detailed.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the test set. Since the "performance data" describes correlations with traditional neuropsychological tests, it's likely that the results of these established tests served as the reference, rather than a separate adjudication process of the ANAM results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned. The evaluation focused on the device's standalone performance in correlation with traditional neuropsychological tests to establish substantial equivalence, not on how human readers' performance improves with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation was done. The "Performance Data" section describes "the results of numerous studies that examined the concurrent validity of ANAM as a clinical tool by documenting correlations with traditional neuropsychological tests." This implies that the device's output (scores) was directly compared or correlated with the output of established cognitive tests, operating as a standalone algorithm. The device "provides clinicians with objective measurements," and "ANAM does not provide a recommendation that the patient is impaired vs. unimpaired. Clinical interpretation... includes comparison with the normative database." This further reinforces its role as a standalone measurement tool.

7. The Type of Ground Truth Used

The ground truth used appears to be the results or scores from "traditional neuropsychological tests." The studies aimed to establish "concurrent validity" by showing correlations between ANAM's measurements and these established tests, which serve as the accepted standard for assessing cognitive function.

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. It focuses on the validation studies that demonstrate concurrent validity with established tests. The device utilizes a "military normative database" for interpreting results, but the size or development of this database is not detailed regarding "training."

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

The document does not provide information on how the ground truth for any training set was established. The focus is on the validation of the ANAM system by correlating its output with "traditional neuropsychological tests." If a "military normative database" was used for training or calibration, the method for establishing its ground truth (e.g., through large-scale testing of healthy military populations by neuropsychologists) is not described.

Summary

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

August 28, 2015

Vista Lifesciences, Inc. c/o Calley Herzog Senior Consultant Biologics Consulting Group, Inc. 400 N. Washington St. Suite 100 Alexandria, Virginia 22314

Re: K150154

Trade/Device Name: ANAM Test System: Military Battery Regulation Number: 21 CFR 882.1470 Regulation Name: Computerized Cognitive Assessment Aid Regulatory Class: Class II Product Code: PKQ Dated: July 30, 2015 Received: July 31, 2015

Dear Ms. Herzog:

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

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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 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 yours,

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) K150154

Device Name ANAM Test System: Military Battery

Indications for Use (Describe)

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

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for ANAM Test System: Military Battery is provided below.

Device Common Name:	Computerized Cognitive Assessment Aid
Device Proprietary Name:	ANAM Test System: Military Battery
Applicant:	Vista LifeSciences, Inc.PO Box 4670Parker CO 80134Phone: 888.733.8804 Ext. 1www.vistalifesciences.com
Contact:	Lori WhiteQuality Systems Program ManagerVista LifeSciences, Inc.PO Box 4670Parker CO 80134Phone: 888.733.8804 Ext. 1Email: lori.white@vistalifesciences.com
Prepared by:	Calley HerzogSenior ConsultantBiologics Consulting Group, Inc.400 N. Washington St. Suite 100Alexandria, VA 22314Email: cherzog@bcg-usa.comPhone: 720-883-3633Fax: 703-548-7457
Date Prepared:	July 30, 2015
Classification Regulation:	882.1470
Panel:	Neurology
Product Code:	PKQ
Predicate Device:	DEN130033, Cerebral Assessment Systems Cognivue

Indication for Use:

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Device Description:

The software is downloaded from the Vista LifeSciences website and is for use on a Dell Latitude E6440 Laptop. The laptop is not provided as part of the device, but is purchased separately by the user. Each ANAM battery consists of a collection of pre-selected modules that are administered in a sequential manner.

Specific modules included in the ANAM Test System: Military Battery:

1. Demographics
1. Sleepiness Scale
1. Symptoms Checklist
1. Mood Scale
1. TBI Questionnaire
1. Simple Reaction Time
1. Code Substitution Learning
Procedural Reaction Time 8.
1. Mathematical Processing
1. Matching to Sample
1. Code Substitution Delayed
1. Simple Reaction Time (R)

Performance Data:

The 510(k) included the results of numerous studies that examined the concurrent validity of ANAM as a clinical tool by documenting correlations with traditional neuropsychological tests. The results of these studies demonstrate that ANAM provides a reliable measure of cognitive function, and is therefore substantially equivalent to the predicate device.

Substantial Equivalence:

Both devices are computerized assessment aids that use an individual's score(s) on a battery of cognitive tasks to provide an interpretation of the current level of cognitive function. In addition to perceptual and memory function, ANAM may be used as an adjunctive tool for evaluating additional functions including: visuomotor reaction time and processing speed, simple decision making, visual scanning, associative learning, visual-spatial processing, and attention.

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	Proposed Device	Predicate Device
510(k) Number	K150154	DEN130033
Device Name	ANAM Test System: MilitaryBattery	Cognivue
Submitter	Vista LifeSciences, Inc.	Cerebral Assessment Systems
Classification Regulation	Computerized CognitiveAssessment Aid	Computerized CognitiveAssessment Aid
Product Code	PKQ	PKQ
Indication	The ANAM Test System:Military Battery providesclinicians with objectivemeasurements of cognitiveperformance in militarypopulations ages 18 to 65 years,to aid in the assessment of anindividual's level of cognitivefunctioning. The ANAM TestSystem should only be used as anadjunctive tool for evaluatingcognitive function.	Cognivue is an adjunctive toolfor evaluating perceptual andmemory function in individualsaged 55-95 years old.
Platform	PC: Dell Latitude E6440 LaptopComputer, two button USBconnected mouse, and Windows7 operating system.	Computer, monitor, rotatorymanipulandum, printer, andmouse/keyboard are provided ona device cart.
Use Cases	Reports individual test resultsand compares changes inindividual tests over time and/oragainst military normative data.	Reports individual test resultsand compares overallperformance to a cut-off.
	Proposed Device	Predicate Device
Patient Population	Military population	Adults
Age of Users	18-65 years	55-95 years
How Provided	Software only, downloaded	Software is pre-installed oncomputer hardware provided bythe manufacturer.
Reporting features	ANAM Performance Report(APR) provides raw scores andstandard scores (calculated withthe military normative database)for each test within the battery.APR also yields the ANAMComposite Score (ACS)summarizing performance acrossthe test battery.	Cognivue Performance Profilereport yields a single outputmeasure that is an average scoreof the four perception scores andfour memory scores.
Psychometric Properties	ANAM demonstrates constructvalidity with traditionalneuropsychological tests.	Cognivue demonstrates constructvalidity with traditionalneuropsychological tests.
Results Interpretation	ANAM does not provide arecommendation that the patientis impaired vs. unimpaired.Clinical interpretation of theresults includes comparison withthe normative database. ANAMprovides raw scores, standardscores, and reliable changeindices for each test.	Cognivue provides an averagescore that is categorized asunimpaired, impaired, orintermediate/indeterminate basedon comparison with a normativedatabase. Sub-tests may not beevaluated individually.

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Summary / Conclusion of Substantial Equivalence Rationale

Although there are some differences in the modules between ANAM and the predicate device, and ANAM provides a comparison to a normative database, the performance testing demonstrates that ANAM provides a reliable measure of cognitive function, and is therefore substantially equivalent to the predicate device.

Regulation Number and Section

§ 882.1470 Computerized cognitive assessment aid.

(a)
Identification. The computerized cognitive assessment aid is a prescription device that uses an individual's score(s) on a battery of cognitive tasks to provide an interpretation of the current level of cognitive function. The computerized cognitive assessment aid is used only as an assessment aid to determine level of cognitive functioning for which there exists other valid methods of cognitive assessment and does not identify the presence or absence of clinical diagnoses. The computerized cognitive assessment aid is not intended as a stand-alone or adjunctive diagnostic device.(b)
Classification. Class II (special controls). Except when the computerized cognitive assessment aid is intended for diagnostic assessment of specific diseases or conditions and relies on inputs from visual cues, auditory cues, and/or functional use of the hand, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. The special control(s) for this device are:(1) The technical parameters of the device's hardware and software must be fully characterized and be accompanied by appropriate non-clinical testing:
(i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed.
(ii) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's cognitive function, must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed.
(2) The device must be designed and tested for electrical safety.
(3) The labeling must include:
(i) A summary of any testing conducted to demonstrate how the device functions as an interpretation of the current level of cognitive function. The summary of testing must include the following, if available: Any expected or observed adverse events and complications; any performance measurements including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) per the devices intended use; a description of the repeatability of measurements; a description of how the cut-off values for categorization of measurements were determined; and a description of the construct validity of the device.
(ii) A warning that the device does not identify the presence or absence of clinical diagnoses.
(iii) A warning that the device is not a stand-alone diagnostic.
(iv) The intended use population and the intended use environment.
(v) Any instructions technicians must convey to patients regarding the administration of the test and collection of cognitive test data.