The BRC software product is to be used by qualified medical professionals for the posthoc statistical evaluation of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP).

Device Description

The BRC software product is composed of the following major components: BRC The DRC software produisition Software and the BRC Neuromarker Analysis Software. Neuromarker Data Acquisition Software is used to collect the data gathered at BRC I he Nedromancer Data requisition protocols and equipment are utilized at each nechsed laboratory to ensure uniformity of collected data. The data is then transmitted to the DRC Central Analysis Facility where the Neuromarker Analysis Software is used to DIC Central Interfall Pagainst the Brain Resource International Database (BRID). The process the gatibled and againta from approximately 2,400 normative (i.e., without a database Currently contains ada cohol abuse, or serious medical condition) participants. The results of the processed data is compiled into an individualized report called the NeuroMarker Report.

The BRC Cognition Acquisition Software is one component of the BRC NeuroMarker The DRC Cognition Frequence is loaded on a computerized touchscreen system and used to gather cognitive patient performance information. This data is transmitted from used to gamer cogment person personal Analysis Facility for processing and formatting into report form (IntegNeuro Report).

The BRC software product is to be used by qualified medical professionals for the posthoc statistical evaluation of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP).

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study performed, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, no specific acceptance criteria or quantitative performance metrics are mentioned for the BRC Software Product. The document primarily focuses on establishing substantial equivalence to predicate devices, outlining the device description, intended use, and technological characteristics.

Therefore, the table would look like this:

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

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

The document mentions that the BRC Neuromarker Analysis Software processes data against the Brain Resource International Database (BRID), which "currently contains data from approximately 2,400 normative (i.e., without a database Currently contains ada, cohol abuse, or serious medical condition) participants."

Sample Size for Test Set: Although the document refers to this database as a "normative" one against which processed data is compared, it is not explicitly stated as a "test set" in the context of validating the device's performance against specific acceptance criteria. The 2,400 participants are described as providing a normative database for comparison, not as a dedicated test set for performance evaluation in the typical sense of a validation study.
Data Provenance: The document does not explicitly state the country of origin of the data. However, the manufacturer is BRC Operations Pty. Ltd, located in Sydney, NSW, Australia, which might suggest data could originate from Australia or be internationally sourced for the "Brain Resource International Database." The data is described as being "collected at each network laboratory."
Retrospective or Prospective: The document does not specify whether the data in the BRID is retrospective or prospective.

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

The document does not provide any information about experts being used to establish a "ground truth" for a test set. The 2,400 participants are described as "normative" individuals without specific conditions, suggesting their data serves as a baseline for comparison rather than requiring expert labeling for a specific outcome.

4. Adjudication Method for the Test Set

No information is provided regarding an adjudication method for a test set.

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

The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The device is a "software product" for statistical evaluation of EEG/ERP, and the submission is focused on establishing substantial equivalence to predicate devices that are also software products for similar analysis.

6. Standalone (Algorithm Only) Performance Study

The document describes the BRC software product as performing "posthoc statistical evaluation" of EEG/ERP data by comparing it against a normative database. This implicitly describes the algorithm's standalone function (processing data and generating a report). However, the document does not report specific performance metrics from a standalone study, such as sensitivity, specificity, accuracy, or AUC. The focus is on the functional equivalence and comparison against normative data rather than a detailed performance validation against an adjudicated ground truth in a standalone study.

7. Type of Ground Truth Used

The "ground truth" for the comparison performed by the device is essentially the normative data from the Brain Resource International Database (BRID). This database contains data from "approximately 2,400 normative (i.e., without ... alcohol abuse, or serious medical condition) participants." The device compares incoming patient data against this established normative range. This is akin to using a healthy control group's data as a baseline for statistical comparison. It is not expert consensus, pathology, or outcomes data in the sense of labeling specific conditions.

8. Sample Size for the Training Set

The document mentions the Brain Resource International Database (BRID) is used for comparison and contains data from approximately 2,400 normative participants. While this database serves as a reference for the software's analysis, the document does not explicitly describe a separate "training set" in the context of machine learning model development. For statistical comparison against normative data, the entire normative database might be considered the "reference" or "training" data in a broader sense, but not a distinct training set for a classified model.

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

For the normative database (BRID) of 2,400 participants, the "ground truth" or defining characteristic is that these participants are "without ... alcohol abuse, or serious medical condition." This suggests that participants were screened and confirmed to be "normative" based on their medical history and absence of specific conditions. The specific methods for establishing this "normative" status (e.g., clinical examination, diagnostic tests, self-reporting) are not detailed in the provided text.

Summary

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K050/92

510(k) Summary BRC Operations Pty. Ltd.

Pag 1 of 3

OCT 2 0 2005 510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR¶807.92(a).

807.92(a)(1)

Submitter Information

The Anson Group7992 Castleway Dr., Indianapolis, IN 46250Phone:(317) 849-1916Facsimile:(317) 577-9070
Contact Person:	Carri Graham
Date:	October 14, 2005
Manufacturer:	BRC Operations Pty.Ltd, P.O. Box 737 BroadwaySydney, NSW 2007 Australia
807.92(a)(2)
Trade Name:	BRC Software Product
Common Name:	Electroencephalograph
Classification Name(s):	Electroencephalograph
Classification Number:	882.1400
807.92(a)(3)	Predicate Device(s)

K974748	Neurometric AnalysisSystem	Nxlink, Ltd
K010669	NeuroGraph	Thuris Corp.
K041263	NeuroGuide	Applied Neuroscience

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510(k) Summary BRC Operations Pty. Ltd.

K050192

Page 2 of 3

807.92 (a)(4)

Device Description

The BRC software product is to be used by qualified medical professionals for the posthoc statistical evaluation of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP).

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510(k) Summary BRC Operations Pty. Ltd.

K050/92

Page 3.83

807.92(a)(5)

Intended Use(s)

The BRC software product is to be used by qualified medical professionals for the posthoc statistical evaluation of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP).

807.92(a)(6)

Technological Characteristics

	BRC SoftwareProductTo be cleared viathissubmission	AppliedNeuroscienceNeuroGuideK041263Exhibit A	Thuris Corp.NeuroGraphK010669Exhibit B	NxLinkNeurometricAnalysisSystem(NAS)K974748Exhibit C
EEG data comparisonagainst normativedatabase	Yes	Yes	Yes	Yes
ERP/EPdata comparisonagainst normativedatabase	Yes	No	Yes	Yes
Population	6 to 90 years	Birth to 82years	Unknown	6 to 90 years
Product code	GWQ-EEG	GWQ-EEG	GWQ-EEG	GWQ-EEG
Classification	882.1400	882.1400	882.1400	882.1400
Indications for Use	See attached	See Exhibit B	See Exhibit A	See Exhibit C
Web Questionnaire	Yes	No	No	No

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and head. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".

OC1 2 0 2005

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BRC Party Limited c/o Carri Graham The Anson Group, LLC 7992 Castleway Drive Indianapolis, Indiana 46250

Re: K050192

Trade/Device Name: BRC Software Product Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Codc: GWQ Dated: October 14, 2005 Reccived: October 18, 2005

Dear Ms. Graham:

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 r ou may) atests provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to organizating of substantial equivalence of your device to a legally premarket notincation: "The PDF Intamigation for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acries ion your as (240) 276-0115. Also, please note the regulation entitled, Colliable of Compulation nation notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionmational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Barbara Bonchuk
for

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K050192

Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ K050192

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The BRC software product is to be used by qualified medical professionals for the post-The BRC sollwate product is to be accu by qualified more of the more of the statistical evalued response potentials (ERP).

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Pomelund for KM

ral. Restorative, Division of G and Neurological Devices

Page 1 of 1

510(k) Number K050192

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).