The BraiNet® Kit components are used by medical professionals and paraprofessionals to simplify placement of electroencephalograph (EEG) electrodes on the scalp. The electrodes connect to medical equipment in support of brain electrophysiology recording. The BraiNet® Kit is provided to the user non-sterile, with the exception of the subdermal EEG needle electrodes which are provided sterile and prepackaged. The BraiNet® Kit & individual components is a single patient use, disposable device.

AI/ML Overview

This 510(k) summary does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and the comprehensive study design. This is a very common scenario for 510(k) submissions, especially for predicate-based devices, which often rely on substantial equivalence rather than extensive de novo clinical trials.

The document primarily focuses on establishing substantial equivalence to a predicate device for a new EEG electrode cap and cutaneous electrodes. There isn't information about specific performance acceptance criteria for the device beyond its functional equivalence to the predicate, nor a detailed study proving it meets such criteria in a quantitative sense described by your request.

Here's an analysis of what information can be extracted or inferred based on the provided text, and what is explicitly missing:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to predicate devices (Electro-Cap, Infa-Cap for BraiNet; AMBU Disposable Cup Electrode for BrainDisc) for intended use and technology.	"The intended use and technology of the BraiNet® Kit and contents is substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised."
Device supports electroencephalograph (EEG) electrode placement.	Explicitly stated as the "Indications For Use" for the BraiNet Kit.
BrainDisc supports electroencephalograph (EEG) recording.	Explicitly stated as the "Intended Use" for the BrainDisc.
Compliance with general controls (annual registration, listing, GMP, labeling, misbranding/adulteration prohibitions).	FDA's letter states: "You are responsible to determine that the medical devices you use as components...have either been determined as substantially equivalent...or were legally on the market prior to May 28, 1976...The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration."

Missing Information: Specific quantitative performance metrics (e.g., impedance, signal-to-noise ratio, electrode stability over time, ease of application, patient comfort scores) that would typically be associated with detailed acceptance criteria for a medical device. The submission relies on the qualitative judgment of "substantial equivalence" to established predicate devices.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not provided. The document does not describe a specific "test set" or a study involving human subjects or data where performance metrics were quantitatively measured beyond the claim of substantial equivalence.
Data Provenance: Not applicable/Not provided. Since no specific test set data is described, its provenance (country of origin, retrospective/prospective) is not mentioned. The substantial equivalence argument is based on the design and intended use being similar to existing, legally marketed devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable/Not provided. No "ground truth" establishment by experts for a test set is described. The acceptance is based on an administrative review of the device's characteristics against its predicates.
Qualifications of Experts: Not applicable/Not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Adjudication Method: Not applicable/None described. There is no test set or adjudication process mentioned.

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:

MRMC Study: No. This device is an EEG electrode placement kit, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reading improvement with AI assistance is not relevant and was not performed/described.

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

Standalone Performance Study: No. This device is a passive medical device (electrode cap and electrodes); it does not involve algorithms or AI, standalone or otherwise.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Type of Ground Truth: Not applicable/Not explicitly defined. For this type of 510(k) submission, "ground truth" in the sense of a clinical outcome or diagnostic truth is generally not established for the new device. Instead, the "truth" is that the predicate devices are safe and effective for their intended use, and the new device is substantially equivalent to them in design and function. The 510(k) process aims to show that the new device does not raise new questions of safety or effectiveness compared to the predicate.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable/Not provided. This device is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm.

9. How the ground truth for the training set was established:

Ground Truth Establishment for Training Set: Not applicable/Not provided. As with point 8, this concept does not apply to the device described.

Summary of Device Performance (from the document):

The primary "performance" reported in this 510(k) is the assertion that:

"The intended use and technology of the BraiNet® Kit and contents is substantially equivalent to the predicate devices."
"No new questions of safety or effectiveness are raised."

The predicate devices are the Electro-Cap, Infa-Cap (for the BraiNet), and the AMBU Disposable Cup Electrode (for the BrainDisc). The performance of the new device is therefore deemed acceptable because it is considered to perform equivalently to these already cleared devices for their respective intended uses (EEG electrode placement and EEG recording).

Summary

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JAN 1 2 2005

K043009

510(k) Summary of 510(k) Information

Summary of 510(k) Information

Company Name:	Jordan NeuroScience, Inc.399 E. Highland Ave., Suite 316San Bernardino CA 92404
Contact:	Anne Perry
Phone:	909 881-2694
Fax:	909 882-2891
Summary Date:	October 22, 2004
Trade Names:	BraiNet Kit (BraiNet® and BrainDisc™)
Common Name:	Electrode Cap & Subdermal EEG Needle electrodes and Cutaneous EEG electrodes
Classification Name:	21 CFR 882.1320; Product Code: GXY
Predicate Device:	510(k) Number: K780045

Manufacture: Electro-Cap International Trade Name: Electro-Cap, Infa-Cap

1.0 Description of Device

The BraiNet® Kit is provided to the user non-sterile, with the exception of the subdermal EEG needle electrodes which are provided sterile and prepackaged. The BraiNet® Kit & individual components is a single patient use, disposable device.

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2.0 Intended Use

The intended use of the BraiNet® is the same as the predicate Eletro-Cap, Infa-Cap. The BraiNet® template is placed on the scalp to support electroencephalograph (EEG) electrode placement.

The intended use of the BrainDisc™ cutaneous electrode is the same as the predicate AMBU Disposable Cup Electrode. The BrainDisc™ is placed on the scalp to support electroencephalograph (EEG) recording.

3.0 Technological

The BraiNet® is made from commercial grade elastic and Velcro materials common to the garment industry.

The BrainDisc™ is made from medium grade polycarbonate with silver/silverchloride center with attached insulated copper lead wire.

4.0 Conclusions

The intended use and technology of the BraiNet® Kit and contents is substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

JAN 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Anne Perry CFO Jordan NeuroScience, Inc. 399 E. Highland Avenue, Suite 316 San Bernardino, California 92404

Re: K043009

Trade/Device Name: BraiNet® Kit Regulation Number: 21 CFR 882.1320, 21 CFR 882.1350 Regulation Name: Cutaneous electrode; Needle electrode Regulatory Class: II Product Code: GXY and GXZ Dated: October 22, 2004 Received: November 1, 2004

Dear Ms. Perry:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo have roviewed your be determined the device is substantially equivalent to legally marketed relevelocate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of preated at Device Amendments or to devices that have been reclassified in accordance with the the Moureal Do Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the provisions or the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the of the act, of were regarly ents. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before (1.0., annintened) and rares in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 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

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Page 2 - Ms. Anne Perry

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on the labeling regulation, please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). 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) 443-6597, or at its Internet address http://www.fda.gov/cdrh.dsmaldsmamain.html.

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Attachment A

Indications for Use Form

Page 1 of 1

KO43009 510(k) Number (if known): 3004622056 (Specification Developer)

Device Name: BraiNet® Kit

Indications For Use:

The BraiNet® Kit contents are placed on the scalp to support electroencephalograph (EEG) electrode placement.

iriam C. Provost

Division of General, Restorative. and Neurological Devices

510(k) Number K043009

Over-The-Counter Use Prescription Use _ X OR PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional format 1-2-96)

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).