The BNA™ Analysis System is to be used by qualified medical professionals for the posthoc statistical analysis of the human electroencephalogram ("EEG"), utilizing evoked response potentials ("ERP"). This device is indicated for use in individuals 14 to 24 years of age. The BNA™ Analysis System is to be used with the auditory oddball task only.

Device Description

The BNA Analysis System is an accessory to EEG. The BNA Analysis System is a software device that is used to analyze EEG-ERP data with regards to conventional, well established characteristics of amplitude and latency. Statistical analysis is performed to express the differences between the patient (individual) and a task-matched reference group in the indicated age group in the form of Z-scores. The BNA Analysis System report displays the test results in the following format; (1) Test and Patient Information; (2) ERP waveforms; (3) Summarized patient results - Z-Score Tables, Z-Score Maps and BNA Composite Scores. BNA Composite Scores are a calculation of the global comparison of the individual to the normative group (RBNM) for the following well-established EEG-ERP components: amplitude and absolute time. These calculations are a measure of the overall similarity of the single subject EEG-ERP components to the EEG-ERP components of the normative group (RBNM) based on Z-scores. The BNA scores should not be used as stand-alone information: rather, such scores should complement all of the information included in the report, as well as the clinical evaluation.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the ElMindA Ltd.'s BNA™ Analysis System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on the repeatability of BNA scores as a key performance metric. The acceptance criteria aren't explicitly stated as numerical targets in the same way clinical accuracy metrics (like sensitivity/specificity) often are. Instead, the study aims to demonstrate that the device produces consistent results across identical test sessions. The "acceptance criteria" here implicitly refer to demonstrating acceptable agreement between repeated measurements, as evaluated by Bland-Altman analysis.

Acceptance Criteria (Implied)	Reported Device Performance (Bland-Altman 95% Limits of Agreement)
Demonstrate acceptable repeatability of BNA scores between two identical test sessions within 7 (±3) days.	Frequent Stimulus:
	Amplitude: -45.60 to 53.79
	Absolute Time: -43.16 to 49.20
	Novel Stimulus:
	Amplitude: -44.20 to 45.13
	Absolute Time: -47.85 to 58.74
	Target Stimulus:
	Amplitude: -48.71 to 37.41
	Absolute Time: -53.91 to 40.36

Note on Interpretation: Bland-Altman limits of agreement quantify the range within which 95% of the differences between two measurements are expected to lie. Smaller limits indicate better agreement (repeatability). The document doesn't provide a specific numerical threshold for "acceptable" limits, relying on the overall demonstration of repeatability.

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

Test Set Sample Size: Not explicitly stated. The document mentions "clinical performance testing was conducted to assess the repeatability of the BNA scores," but doesn't give the number of subjects.
Data Provenance: Not specified in terms of country of origin. The study was conducted as part of the regulatory submission for ElMindA Ltd., an Israeli company. The type of study was prospective, as it involved conducting two identical test sessions within a specific timeframe to assess repeatability.

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

This information is not applicable and not provided in the document. The study was a repeatability study comparing the device's own scores across two sessions, not a study evaluating the device's diagnostic accuracy against an expert-established ground truth for a specific condition. The "ground truth" in this context is the subsequent measurement by the same device.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. As explained above, this was a repeatability study, not one requiring adjudication against a clinical ground truth.

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:

This information is not applicable and not provided. This document pertains to a standalone software device that performs post-hoc statistical analysis of EEG/ERP data. It is not an AI-assisted diagnostic tool designed to be used by human readers for interpretation, nor does it conduct comparative effectiveness studies with human readers. The BNA scores are intended to "complement all of the information included in the report, as well as the clinical evaluation," but the study is not designed to measure human reader improvement with the device.

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

Yes, a standalone performance assessment was done. The entire "Performance Data" section describes the assessment of the BNA Analysis System's repeatability, which is an intrinsic characteristic of the algorithm's output (BNA scores) when analyzing EEG-ERP data. The device itself performs the statistical analysis and generates the scores.

7. The Type of Ground Truth Used:

The "ground truth" in this repeatability study is the device's own measurement from the first test session. The study aims to see how repeatable the device's output (BNA scores) is when the same subject undergoes an identical test shortly after. It's a self-assessment of consistency, not a comparison to an external clinical or pathological ground truth.

8. The Sample Size for the Training Set:

This information is not provided in the document. The BNA Analysis System performs statistical analysis relative to a "task-matched reference group in the indicated age group." While this implies a normative dataset was used, the sample size for this reference group (which could be considered analogous to a training or normative dataset) is not detailed.

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

This information is not provided in the document. It mentions that BNA Composite Scores compare the individual to a "normative group (RBNM)." However, it does not explain how this normative group was established, including the criteria for inclusion, data acquisition methods, or any expert review process for defining the "ground truth" or normal range for these parameters.

Summary

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

K121119

510(k) SUMMARY

UL 2 5 2014

ElMindA Ltd.'s BNA™ Analysis System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

ElMindA Ltd. 16 Haminhara St. Beit Bachar Herzliva 46586 lsrael

Phone: 972-9-951-6476 Facsimile: 972-9-951-6477

Contact Person: Dalia Dickman, Ph.D.

Date Prepared: July 18, 2014

Proprietary Name of Device and Name/Address of Sponsor

BNA™ Analysis System

Common or Usual Name/ Classification Name

Electroencephalogram ("EEG")

Regulation Number

· 882.1400

Product Code

OLU

Predicate Devices

Neuroguide Analysis System (K041263) Neuromarker Data Acquisition and Analysis Software (K050192) Human Brain Index Software (K112077)

Intended Use / Indications for Use

Technological Characteristics / Principles of Operation

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

(individual) and a task-matched reference group in the indicated age group in the form of Z-scores.

The BNA Analysis System report displays the test results in the following format; (1) Test and Patient Information; (2) ERP waveforms; (3) Summarized patient results - Z-Score Tables, Z-Score Maps and BNA Composite Scores.

BNA Composite Scores are a calculation of the global comparison of the individual to the normative group (RBNM) for the following well-established EEG-ERP components: amplitude and absolute time. These calculations are a measure of the overall similarity of the single subject EEG-ERP components to the EEG-ERP components of the normative group (RBNM) based on Z-scores. The BNA scores should not be used as stand-alone information: rather, such scores should complement all of the information included in the report, as well as the clinical evaluation.

Performance Data

Clinical performance testing was conducted to assess the repeatability of the BNA scores between two identical test sessions that were conducted within 7(±3) days of each other. In order to assess the repeatability of the BNA scores, Bland-Altman analysis was performed. This analysis was performed for the three stimuli of the auditory oddball task and two BNA parameters (amplitude and absolute time) for each stimulus as shown in the table below.

				Lower Bland-Altman 95%	Upper Bland-Altman 95%
		MeanDifference	STD of theDifference	Limit ofAgreement	Limit ofAgreement
Stimulus	Parameter
Frequent	Amplitude	4.10	25.35	-45.60	53.79
	Absolute Time	3.02	23.56	-43.16	49.20
Novel	Amplitude	0.46	22.79	-44.20	45.13
	Absolute Time	5.44	27.19	-47.85	58.74
Target	Amplitude	-5.65	21.97	-48.71	37.41
	Absolute Time	-6.78	24.05	-53.91	40.36

Mean BNA Difference between Visits, Mean Standard Deviation (STD) of the Difference and Bland-Altman 95% Limits of Agreement by Stimulus and Parameter

The subject device software was developed, verified and validated according to the software development requirements as defined in the IEC 62304 and General Principles of Software Validation; Final Guidance for Industry and FDA Staff (FDA, CDRH, 11/1/02).

Substantial Equivalence

The BNA™ Analysis System is as safe and effective as the Neuroguide Analysis System (K041263), the Neuromarker Data Acquisition and Analysis Software (K050192), and the Human Brain Index Software (K112077). The BNATM Analysis System has the same intended uses/indications for use, and similar technological characteristics and principles of operation as the identified

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

predicate devices (see table below). The minor technological differences between the BNA™ Analysis System and its predicate devices raise no new Section the DRAT - Analysis of Jolen and Re products as not not.
issues of safety or effectiveness. Performance data demonstrate that the BNA™ Analysis System is as safe and effective as the cleared predicate devices. Thus, the BNATM Analysis System is substantially equivalent.

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

Comparison Table

	BNA ANALYSIS SYSTEMSUBSTANTIAL EQUIVALENCE CHART
Indications for Use	BNAT™ Analysis System	Human Brain IndexSoftware (K112077)	Neuroguide AnalysisSystem (K041263)	Neuromarker DataAcquisition and AnalysisSoftware (K050192)
	The BNAT™ AnalysisSystem is to be used byqualified medicalprofessionals for the post-hoc statistical analysis ofthe humanelectroencephalogram("EEG"), utilizing evokedresponse potentials("ERP"). This device isindicated for use inindividuals 14 to 24 years ofage. The BNAT™ AnalysisSystem is to be used withthe auditory oddball taskonly	The HBIdb product is to beused by qualified medicalprofessionals for the post-hoc statisticalevaluation of the humanelectroencephalogram(EEG), utilizing evokedresponse potentials (ERP).The HBIdb product isintended for use onchildren and adults fromage 7 to 80 years.	For clinical use theNeuroGuide Analysissystem is to be used byqualified medical or clinicalprofessionals for thestatistical evaluation of thehumanelectroencephalogram(EEG).	The BRC software productis to be used by qualifiedmedical professionals forthe post-hocstatistical evaluation of thehumanelectroencephalogram(EEG), utilizing evokedresponse potentials (ERP).

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

and the comments of the comments of

. . . . .

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

Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" in a circular arrangement. The text is written in all capital letters.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W(%6-G609 Silver Spring, MD 20903-0002

July 25, 2014

ElMindA Ltd. Dalia Dickman. PhD VP Clinical & Regulatory Affairs 16 Haminhara Street Beit Bachar Herzliya 46586 lsrael

રિટ: K121119

Trade/Device Name: BNA™ Analysis System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLU Dated: September 3. 2013 Received: September 3, 2013

Dear Dr. Dickman:

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 cither 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 mav publish further announcements concerning your device in the Federal Register.

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

Page 2 - Dalia Dickman, PhD

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 not 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 election is 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,

Carlos L. Pena -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K121119

Device Name BNA Analysis System

Indications for Use (Describe)

The BNA Analysis System is to be used by qualified medical professionals for the post-hoc statistical analysis of the human electroencephalogram ("EEG"), utilizing evoked response potentials ("ERP"). This device is indicated for use in individuals 14 to 24 years of age. The BNA Analysis System is to be used with the auditory oddball task only.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

Carlos L. Pena -S

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not respond to, a collection of information unless it displays a currently valid OMB number."

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).