The Sensor is a single patient use, disposable, pre-gelled 6 electrode array that is applied directly to the patient's forehead to record electrophysiological signals. It has an electronic smart card memory device in the tab area that contains configuration and identification information.

AI/ML Overview

This 510(k) submission (K062692) is for a medical device called the "BIS Bilateral Sensor," a cutaneous electrode. The submission primarily focuses on establishing substantial equivalence to a predicate device (K002734, Aspect Enhanced XP BIS Sensor) rather than presenting a detailed de novo clinical study with specific acceptance criteria and performance results directly related to an AI/algorithm.

The document indicates that the device is a simple cutaneous electrode for recording electrophysiological (EEG) signals. The "study" referenced in the 510(k) summary is a comparison of similarities and differences between the new device and the predicate device. It does not describe a clinical study in the format typically used to prove performance against acceptance criteria for an AI or algorithm-based device.

Therefore, many of the requested points for describing an AI/algorithm study are not applicable to this submission, as it's for a sensor, not an AI or algorithm.

Here's an attempt to answer the questions based on the provided text, while acknowledging the inherent limitations due to the nature of the device and submission:

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

Based on the provided text, no specific "acceptance criteria" for performance metrics like sensitivity, specificity, or AUC are mentioned, as this is a sensor and not an AI/algorithm with such output. The "performance" described is in terms of substantial equivalence to the predicate device.

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported Device Performance
Same indications for use	Met: "The indications for use remain the same as the Enhanced Sensor."
Same intended use	Met: "The intended use is the same as the predicate device."
Same fundamental scientific technology	Met: "The fundamental scientific technology remains the same as the Enhanced Sensor predicate device."
Incorporates the same basic design	Met: "incorporates the same basic design"
Same BIS channels (2)	Met: "2 channels of BIS"
Incorporates the same materials and biocompatibility	Met: "incorporates the same materials and biocompatibility"
Same shelf life	Met: "has the same shelf life"
Packaged using the same materials and processes	Met: "is packaged using the same materials and processes"
Incorporates smart card memory device	Met: "incorporates smart card memory device"
Modifications do not raise new questions of safety or effectiveness	Met: "Aspect Medical Systems believes these modifications do not raise new questions of safety or effectiveness." (This is a claim made by the submitter, not an objective finding presented in the document.)

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 as this submission relates to a physical device (sensor) and its substantial equivalence to a predicate, not a dataset-driven AI/algorithm performance study. No test set for an algorithm is mentioned.

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 applicable. There is no "test set" in the context of an AI/algorithm study described in this submission, and thus no ground truth established by experts.

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

This information is not applicable. No adjudication method is described as there is no test set for an AI/algorithm.

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. This is a submission for a sensor, not an AI algorithm. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or reported.

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

This information is not applicable. This is a submission for a sensor, not an algorithm.

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

This information is not applicable. There is no ground truth data described in the context of an AI/algorithm performance study.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/algorithm.

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

This information is not applicable. There is no "training set" and no ground truth establishment for it mentioned.

Summary

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

K062692
Page 1 of 2

DEC 1 3 2006

Appendix E

510(k) Summary

Date:	September 7, 2006
	Aspect Medical Systems, Inc., 141 Needham St., Newton, MA 02464
Contact Person:	Renee Gould (617) 559-7788
Proprietary Name:	BIS Bilateral Sensor
Common Name:	Electrode, Cutaneous Electrode
Classification:	Class II device. Refer to 21 CFR 882.1320
Product Code:	GXY
PredicateDevice:	K002734, Aspect Enhanced XP BIS Sensor cleared September 14,2000
Device Description:	The Sensor is a single patient use, disposable, pre-gelled 6 electrodearray that is applied directly to the patient's forehead to record electro-physiological signals. It has an electronic smart card memory devicein the tab area that contains configuration and identificationinformation.
Indications for Use:	The BIS Bilateral Sensor is applied directly to the patient's skin toenable recordings of electrophysiological (such as EEG) signals.
Similarities:
• same indications for use,
• same intended use,
• same fundamental scientific technology,
• incorporates the same basic design,
• 2 channels of BIS,
• incorporates the same materials and biocompatibility,
• has the same shelf life,
• is packaged using the same materials and processes, and
• incorporates smart card memory device.
Differences:
•	addition of montage on the other side of the head,

addition of the 2 electrodes, and .
4 channels of EEG collected. .

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

K062692
Page 2 of 2

In summary, the BIS Bilateral Sensor is substantially equivalent to the predicate device. Aspect Medical Systems believes these modifications do not raise new questions of safety or effectiveness. The intended use is the same as the predicate device. The indications for use remain the same as the Enhanced Sensor. The fundamental scientific technology remains the same as the Enhanced Sensor predicate device.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aspect Medical Systems, Inc. % Ms. Renee Gould Director, Regulatory, Quality Assurance 141 Needham Street Newton, Massachusetts 02464

Rc: K062692

Trade/Device Name: BIS Bilateral Sensor Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: November 9, 2006 Received: November 13, 2006

Dear Ms. Gould:

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.

DEC 1 3 2006

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.

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

Page 2 – Ms. Renee Gould

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 our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. 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 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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

Enclosure

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

Appendix C

Indications for Use Statement

510(k) Number (if known)

K062692

Device Name

BIS Bilateral Sensor

Indications For Use

The BIS Bilateral Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.

Prescription Use X (Per 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 nice Evaluation (ODE) DRH O

Mark H. Mcllwra

Page of

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Numb

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).