The HBldb product is to be used by qualified medical professionals for the post-hoc statistical evaluation of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP).

Device Description

The Human Brain Index Software (HBldb) product is a software program for the post-hoc statistical analysis and comparison with a reference data (the Human Brain Index Reference Database (HBIRD)) of the human electroencephalogram (EEG) including spontaneous oscillations of the human brain potentials and event-related potentials (ERPs). The EEG is recorded on a separate device under the standardized HBIdb conditions and is transferred to the HBIdb in EDF+ format for

display .
. spectral analysis and
analysis of event-related potentials .
comparison of the gathered parameters against the Human Brain Index Reference Database . (HBIRD), and
compilation of a report. .
Results of comparison of individual EEG/ERP parameters with the database are intended for use as an aid to diagnosis. No medication or treatment is applied based on this comparison alone. The results have to be considered only in conjunction with other clinical findings.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the HBIdb software:

Important Note: The provided document is a 510(k) summary for a medical device. This type of submission focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than proving efficacy or meeting specific performance acceptance criteria through clinical trials. Therefore, the information typically found in a clinical study report regarding detailed acceptance criteria, effect sizes, and deep dives into ground truth establishment is largely absent. The "acceptance criteria" here implicitly refer to demonstrating equivalence in intended use, technology, and performance with predicate devices.

Acceptance Criteria and Reported Device Performance

Since this is a 510(k) summary, formal "acceptance criteria" in the sense of specific numerical thresholds for performance metrics are not explicitly stated. The comparison is made against predicate devices, focusing on equivalency of features and intended use. The "device performance" is therefore implicitly that it functions similarly to the predicate devices.

Feature / Criterion (Implicitly "Acceptance Criteria")	HBIdb Software Performance (Reported)
Intended Use	Used by qualified medical professionals for post-hoc statistical evaluation of human EEG, utilizing evoked response potentials (ERP). Intended for use on children and adults from age 7 to 80 years.
EEG Data Comparison against Normative Database	Yes (Functions as intended to compare EEG data against a normative database).
ERP/EP Data Comparison against Normative Database	Yes (Functions as intended to compare ERP/EP data against a normative database).
Population	7 to 80 years (Comparable to predicate devices: 6-90 years, Birth-82 years, Unknown, 6-90 years).
Product Code	GWQ (Matches predicate devices).
Classification	882.1400 (Matches predicate devices).
ICA based Artifact Correction	Yes (This is a distinguishing feature from predicates, indicating advanced capability, not a "performance" metric in this context).
Decomposition of ERPs into Independent Components	Yes (This is a distinguishing feature from predicates, indicating advanced capability, not a "performance" metric in this context).
Software Development and Validation Standards	Developed and validated according to IEC 62304:2007. Software documentation and testing provided in accordance with FDA guidance for "Content of Premarket Submissions for Software Contained in Medical Devices." All software functions tested using specific EEG test files. Verification and validation performed on Windows XP 32 bit, Vista 32 bit, Windows 7 32 and 64 bit. Security dongle validated with a special utility.

Study Information:

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for a "test set" in terms of subject data. It states, "For verification and validation of the product, all software functions were tested by means of specific EEG test files." This implies a set of pre-defined, synthetic, or existing EEG data files were used to test the software's functionality, not necessarily a clinical dataset for performance evaluation.
- Data Provenance: Not specified for these "specific EEG test files." Given the manufacturer is German, the test environment and data could be internal or from Germany, but this is not directly stated. The data used for the Human Brain Index Reference Database (HBIRD) is not described here, only that the device compares against it.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The testing described focuses on software functionality (verification and validation against IEC and FDA guidance), not on diagnostic accuracy of the device's output against a clinical "ground truth" established by experts. The HBIdb product aids diagnosis but doesn't provide a definitive diagnosis on its own.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Since the testing was for software functionality rather than clinical diagnostic performance adjudicated by experts, no such method is mentioned.
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:
- No. An MRMC comparative effectiveness study was not performed or described in this 510(k) summary. This type of study demonstrates clinical utility with human readers, which is beyond the scope of this type of premarket submission which is focused on substantial equivalence.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The testing performed was "standalone" in that it validated the software's functions (e.g., display, spectral analysis, ERP analysis, comparison against the HBIRD, report compilation) using "specific EEG test files." This focused on the algorithm's correct execution and output formation, not on diagnostic accuracy by itself. The device is an "aid to diagnosis" and meant to be used by "qualified medical professionals," indicating that human interpretation is always in the loop for diagnosis.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the software's functional testing, the "ground truth" would be the expected output or behavior of the software for the "specific EEG test files" based on its design specifications and algorithms. This is a technical ground truth, not a clinical diagnostic ground truth. The HBIdb compares data against a Human Brain Index Reference Database (HBIRD), which is a form of ground truth (normative data), but the method of establishing that database's ground truth is not detailed in this document.
The sample size for the training set:
- Not specified. The document does not mention a "training set" for the HBIdb software itself. This suggests the software is likely rule-based or statistical in nature, comparing inputs against a pre-established "reference database" (HBIRD), rather than a machine learning model that requires a distinct training phase with labeled data. The HBIRD itself would have been built from a large sample, but its size is not in this document.
How the ground truth for the training set was established:
- Not applicable, as a distinct "training set" for a machine learning model is not described. The HBIdb compares data against the Human Brain Index Reference Database (HBIRD). How the "ground truth" for this normative database (HBIRD) was established (e.g., participant selection, EEG acquisition protocols, data processing, statistical methods for defining "normative ranges") is beyond the scope of this 510(k) summary and not provided.

Summary

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MAR - 9 2012

510(k) summary

General Information

1 APPLICANT

Date: March 5th, 2012

Name: Corscience GmbH & Co. KG

Address: Henkestr. 91 D-91052 Erlangen Germany

Contact person in the U.S.: Address

Telephone: FAX: E-Mail:

Monroeville, PA 15146 412 – 372 – 8571 412 — 372 — 8575 rpkarem@somnotech.com

Patrik R. Karem SOMNO TECH, L.L.C.

700-706 Seco Rd.

Contact person in Germany: Karlheinz Trost Telephone: FAX: E-Mail:

01149 9131 977986 – 518 01149 9131 977986 – 59 trost@corscience.de

K. Vrost

Signature:

2 TRADE NAME

HBIdb

3 COMMON NAME OR CLASSIFICATION NAME

Electroencephalograph

4 ESTABLISHMENT REGISTRATION NUMBER

3005488716

5 FACILITY ADDRESS

Corscience GmbH & Co. KG Henkestr. 91 D-91052 Erlangen Germany

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6 DEVICE CLASSIFICATION

6.1 Classification

This is a class II device

6.2 Classification panel

PANEL: NEUROLOGY

Product Code: GWQ

6.3 Regulation Number

882.1400

7 PREDICATE DEVICES DESCRIPTIONS

7.1 Names

BRC Software Product NeuroGuide Analysis System Neurograph Evoked Potentials System Neurometric Analysis System

7.2 Predicate Device Companies

BRC: BRC Operations Pty. Ltd, P.O. Box 737 Broadway, Sydney, NSW 2007 Australia NeuroGuide: Applied Neurosciece Inc., 228 176th Terrace Drive, St. Petersburg, FL 33708 NeuroGraph: Thuris Corp., 110 Glenn Way # 6, San Carlos, CA 94070 Neurometric: NXLINK, Ltd., 1706 Gaillard PI., Richland, WA 99352

7.3 Predicate Device 510(k)#

BRC: K050192 NeuroGuide: K041263 NeuroGraph: K010669 Neurometric: K974748

8 DEVICE DESCRIPTION

display .
. spectral analysis and
analysis of event-related potentials .
comparison of the gathered parameters against the Human Brain Index Reference Database . (HBIRD), and
compilation of a report. .

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Results of comparison of individual EEG/ERP parameters with the database are intended for use as an aid to diagnosis. No medication or treatment is applied based on this comparison alone. The results have to be considered only in conjunction with other clinical findings.

9 INDICATIONS FOR USE

The HBIdb product is to be used by qualified medical professionals for the post-hoc statistical evaluation of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP). The HBIdb product is intended for use on children and adults from age 7 to 80 years.

10 REQUIRED COMPONENTS

HBIdb Software .
User manual .
SW dongle .

Optional accessory

None .

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11 SUMMARY TABLE OF COMPARISONS

	HBI softwareproductTo be clearedviathissubmission	BRC softwareproduct(K050192)	NeuroGuideAnalysisSystem(K041263)	NeuroGraphEvokedPotentialSystem(K010669)	NeurometricAnalysisSystem(K974748)
Intended Use	The HBIdbproduct is tobe used byqualifiedmedicalprofessionalsfor the post-hoc statisticalevaluation ofthe humanelectroencephalogram(EEG),utilizingevokedresponsepotentials(ERP). TheHBIdb productis intended foruse onchildren andadults fromage 7 to 80years.	The BRCsoftware productis to be used byqualifiedmedicalprofessionals forthe post-hocstatisticalevaluation of thehuman electro-encephalogram(EEG), utilizingevokedresponsepotentials(ERP).	TheNeuroGuideAnalysisSystemproduct is tobe used byqualifiedmedicalprofessionalsfor the post-hoc statisticalevaluation ofthe humanelectro-encephalogram (EEG).	TheNeuroGraphEvokedPotentialSystem(NeuroGraphEPS) is for useby qualifiedmedicalprofessionalsand is intendedto record anddisplay electro-encephalogram(EEG) andevoked potential(EP) data inprivatepractices, clinicsor hospitalenvironments toassist in thediagnosis andmonitoring ofcentral andperipheralnervous systemdisorders	TheNeurometricAnalysisSystemproduct is tobe used byqualifiedmedicalprofessionalsfor the post-hoc statisticalevaluation ofthe humanelectroencephalogram(EEG).
EEGdatacomparisonagainstnormativedatabase	Yes	Yes	Yes	Yes	Yes
ERP/EP datacomparisonagainst norm.database	Yes	Yes	No	Yes	No
Population	7 to 80 years	6 to 90 years	Birth to 82 y.	Unknown	6 to 90 years
Product code	GWQ	GWQ	GWQ	GWQ	GWQ
ClassificationICA basedartifactCorrection	882.1400Yes	882.1400No	882.1400No	882.1400No	882.1400No
Decompositionof ERPs intoindependentcomponents	Yes	No	No	No	No

All software products are to be used by qualified medical professionals for the post-hoc statistical evaluation of the human electro-encephalogram (EEG) and compare the obtained EEG data against a normative database.

The age groups of all products are similar so that the software can be used on EEGs of subjects from childhood until old age.

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12 SUMMARY OF DEVICE TESTING

The HBIdb product has been developed and validated according to the standard IEC 62304:2007. Software documentation and testing was provided in accordance with the FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

For verification and validation of the product, all software functions were tested by means of specific EEG test files. Verification and validation were performed on an IBM compatible computer on the following operating systems: Windows XP 32 bit, Vista 32 bit, Windows 7 32 and 64 bit. The security dongle was validated by means of a special utility supplied by the producer of the dongle.

The standard ISO 10993-1 does not apply to this product because it is a pure software product.

13 CONCLUSIONS

Based on the above, Corscience GmbH & Co. KG concludes, that the HBldb product is substantially equivalent to legally marketed predicate software products.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Public Health Service

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

Corscience GmbH & Co. KG c/o Mr. Karlheinz Trost Quality Management and Regulatory Affairs 700-706 Seco Road Monroeville, PA 15146

MAR - 9 2012

Re: K112077

Trade/Device Name: Human Brain Index Software (HBIdb) Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLU Dated: January 30, 2012 Received: January 31, 2012

Dear Mr. Trost:

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.

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Page 2 - Mr. Karlheinz Trost

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 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,

Emili. Hemmi, MD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): イバノ2077

Device Name: _ Human Brain Index Software (HBIdb)

Indications For Use:

The HBldb product is to be used by qualified medical professionals for the post-hoc statistical evaluation of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP).

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K112077

Page 1 of

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).