IdentEvent by OPTIMA NEUROSCIENCE, INC.

IdentEvent® is a software-only product with an algorithm intended to analyze previously acquired, adult (≥18 years) scalp EEG signals and mark events that may correspond to electrographic seizures for the purpose of reviewing prolonged EEG traces. The marked events are reviewed, possibly deleted, and interpreted by qualified clinical practitioners who will exercise professional judgment in using the information.

IdentEvent also includes the display of the quantitative EEG parameters Amplitude Variation and Maximum Frequency, which are intended to help the user analyze the EEG waveform after it has been collected.

IdentEvent requires the use of EEGs recorded with at least a 16-channel scalp montage following the standard 10/20 electrode placement system. IdentEvent does not provide any diagnostic conclusion about the patient's condition to the user.

Device Description

AI/ML Overview

This document is a 510(k) summary for the IdentEvent 2.0A device. However, it does not include detailed information regarding the acceptance criteria, specific study results, sample sizes for test and training sets, expert qualifications, or adjudication methods in the level of detail requested in the prompt.

The document primarily focuses on the FDA's substantial equivalence determination for the device, its indications for use, and regulatory information. It describes the IdentEvent 2.0A as a software-only product with an algorithm intended to analyze previously acquired, adult (≥18 years) scalp EEG signals and mark events that may correspond to electrographic seizures for the purpose of reviewing prolonged EEG traces. It also mentions the display of quantitative EEG parameters (Amplitude Variation and Maximum Frequency).

Therefore, based solely on the provided text, a complete answer as requested is not possible. However, I can infer some information from the "Indications for Use" section and general knowledge of medical device submissions to construct a partial answer and highlight what's missing.

Here's an attempt to answer the questions based on the provided document and common expectations for such submissions, specifying what is not explicitly stated:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria or provide a table of reported device performance metrics (e.g., sensitivity, specificity, PPV, NPV). These details would typically be found in the more comprehensive 510(k) submission summary or a separate performance study report, which is not included here. The "Indications for Use" section describes the function of the device rather than its performance against specific clinical benchmarks.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document.

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

This information is not provided in the document.

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

The document does not explicitly state if an MRMC study was done, nor does it provide an effect size for human reader improvement with AI assistance. The device's indication "for the purpose of reviewing prolonged EEG traces" by "qualified clinical practitioners who will exercise professional judgment in using the information" suggests it's an assistive tool, implying human-in-the-loop use. However, a formal comparative effectiveness study where improvement is quantified is not detailed.

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

The document does not explicitly state if a standalone performance study was done. The indication that "The marked events are reviewed, possibly deleted, and interpreted by qualified clinical practitioners" strongly suggests that the device is intended for human-in-the-loop use, rather than a standalone diagnostic tool. Typically, studies for such devices would evaluate the algorithm's marking accuracy, which is a standalone performance aspect, but the actual performance metrics are not given here.

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

The document does not explicitly state the type of ground truth used for validation. Given the device targets electrographic seizures, the ground truth would most likely be established by expert consensus of qualified clinical practitioners (e.g., neurologists, epileptologists) reviewing the raw EEG data, potentially combined with clinical outcomes or other diagnostic information if available.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document. It would typically be established by expert review and annotation of the EEG data, similar to the test set ground truth.

Summary of what's provided vs. missing:

Provided: Device name (IdentEvent 2.0A), Regulation Number (21 CFR 882.1400), Regulation Name (Electroencephalograph), Regulatory Class (Class II), Product Code (OMB, OLT), Indications for Use (analyzes previously acquired adult scalp EEG signals to mark events corresponding to electrographic seizures, displays Amplitude Variation and Maximum Frequency, requires 16-channel scalp montage), Type of Use (Prescription Use).
Missing from this document: All specific details about acceptance criteria, performance metrics (sensitivity, specificity, accuracy), sample sizes (test and training), data provenance, expert qualifications for ground truth, adjudication methods, MRMC study results, or specific standalone study results. These details are critical for a full understanding of the device's validation.

Summary

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

November 5, 2015

Optima Neuroscience, Inc. Ryan Kern CEO 11930 Research Circle Alachua, Florida 32615

Re: K150688

Trade/Device Name: IdentEvent 2.0A Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMB, OLT Dated: September 18, 2015 Received: September 24, 2015

Dear Ryan Kern:

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,

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

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Indications for Use

510(k) Number (if known) K150688

Device Name IdentEvent® 2.0A

Indications for Use (Describe)

			Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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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).