The Aspect Medical Systems BIS EEG Monitor, A-3000, is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BIS Monitor is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.

The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

Device Description

The Aspect Medical Systems, Inc. BIS EEG Monitor, A-3000 is an easy to use, microprocessor- based, 2 channel maximum, EEG monitoring system.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study description with performance metrics for the A-3000 EEG Monitor. Instead, it focuses on demonstrating substantial equivalence to predicate devices, primarily by highlighting similarities in indications for use, technological characteristics, and stating that "Results indicate the device meets its performance specifications and validation test requirements, and is safe for its intended use." This suggests the "study" was more of a validation against internal specifications rather than a comparative effectiveness or standalone performance study as might be conducted for novel AI devices.

However, based on the information provided, here's an attempt to answer the questions, assuming performance refers to meeting internal specifications rather than clinical efficacy:

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

No explicit quantitative acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy, precision) for the device's core function (EEG monitoring, BIS algorithm output) are provided in the document. The document states:

Acceptance Criteria	Reported Device Performance
Performance specifications met	Device meets its performance specifications and validation test requirements.
Validation test requirements met	Device meets its performance specifications and validation test requirements.
Safe for intended use	Device is safe for its intended use.

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

Test Set Sample Size: Not specified.
Data Provenance: Not specified.

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)

Not applicable. The document does not describe a clinical study involving human assessment for ground truth determination. The testing mentioned (Software Validation, Hazard Analysis and Risk Assessment) appears to be internal engineering and safety validation.

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

Not applicable. No expert-based ground truth adjudication or a test set where such methods would be relevant is described.

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

No MRMC comparative effectiveness study is mentioned. The document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use, not on improving human reader performance with AI assistance.

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

The document implies the device (A-3000 EEG Monitor with BIS algorithm) was tested as a standalone system to ensure it meets its "performance specifications and validation test requirements" and is "safe for its intended use." However, specific details about the nature and results of this standalone testing (e.g., algorithm accuracy against a reference standard) are not provided. The BIS algorithm itself is stated to be identical to the predicate device, implying its performance characteristics are assumed to be consistent.

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

Not explicitly stated. For "Software Validation" and "Hazard Analysis and Risk Assessment," the 'ground truth' would likely refer to internal design specifications, international standards, and safety requirements. For the BIS algorithm itself (which is stated as unchanged from the predicate), its original validation would have established its efficacy, likely against clinical outcomes or expert assessment of anesthetic depth, but these details are not provided for the A-3000 device itself in this submission.

8. The sample size for the training set

Not applicable. This device is an updated version of an existing EEG monitor with an identical BIS algorithm. The document does not refer to a "training set" in the context of machine learning model development. The BIS algorithm's training (if any) would have occurred during its initial development, prior to the predicate device's clearance.

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

Not applicable. See point 8.

Summary

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510(k) SUMMARY

Date Prepared: July 14, 2005

Company Name and Address

Aspect Medical Systems, Inc. 141 Needham St. Newton, MA 02464

Contact People: Christine Vozella Director, Regulatory Affairs/Quality Assurance Telephone (direct dial): (617) 559-7028 Fax #: (617) 559-7948

Device Name

Proprietary Name: A-3000 EEG Monitor with BIS

Common Name: EEG Monitor

Classification

Electroencephalograph (EEG) monitors have been clussified by the Neurological Devices Panel as Class II devices (21 CFR 882.1400)

Predicate Devices

Aspect Medical Systems A-2000 EEG Monitor with BIS This 510(k), #K030267, received FDA clearance 1/15/04

Aspect Medical Systems BISx This 510(k), K040183, received FDA clearance 2/25/04

Device Description

The Aspect Medical Systems, Inc. BIS EEG Monitor, A-3000 is an easy to use, microprocessor- based, 2 channel maximum, EEG monitoring system.

Indications for use

The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the

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reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

Summary of Technological Characteristics Compared to Predicate Device

Similarities

1. Indications for use and intended use are identical
1. System technology characteristics remains the same.
1. Both have, display and/or calculate the following:
- . 2 channel maximum
- Raw EEG .
- BIS (BIS algorithm is the same as the predicate device)
- Suppression Ratio .
- . Artifact detection
- . Alarms, audible and visual
- Message region
- Self tests (automatic and manual) ●
- Trend BIS, SR, SQI, Burst count ●

Differences

Screen is slightly larger, now with color and touch .
EMG display style is vertical, rather than horizontal .
SQI display is a signal strength indicator style, rather than a thermometer �
. Expanded BIS trend options
Housing is slightly larger, and color is two tone ●
USB ports in addition to RS-232 .
. Different operating system
Battery -- (from nickel metal hydride to lithium ion) ●
Host software (data storage, user interface communication) .
. BISx

Summary of Testing

The following tests/analyses have been completed:

0 Software Validation
0 Hazard Analysis and Risk Assessment

Results indicate the device meets its performance specifications and validation test requirements, and is safe for its intended use.

Conclusion:

Based on the above, Aspect Medical Systems believes the BIS Monitor is substantially equivalent to the predicate devices, and is safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 9 2005

Aspect Medical Systems, Inc. c/o Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, Massachusetts 01719

Re: K052362

Trade/Device Name: BIS EEG Monitor, A-3000 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ Dated: August 25, 2005 Received: August 29, 2005

Dear Mr. Devine:

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.

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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Page 2- Mr. Neil E. Devine, Jr.

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) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html

Sincerely vours.

Barbara Buelus
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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Indications for Use

Labels	Values
510(k) Number (if known):	K052362
Device Name:	BIS EEG Monitor, A-3000

Indications For Use:

Prescription Use
(Part 21 CFR 801 Subpart D) X

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)

1-7

Saubare Bucher for MXM
(Division Sign-Off)

and Neurological De

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510(k) Number K052362

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).