The Aspect A-2000 EEG Monitor with BIS 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. EEG BIS Monitor, model A-2000 is an easy to use, nicroprocessor-based, 2 channel maximum, EEG monitoring system. It aso, interoprobes.bor of the brain by data acquisition of EEG of the anesthetized or sedated patient, as well as monitoring the effects of certain anesthetic agents by use of the processed parameter BIS.

The system configuration consists of the monitor, digital signal converter (DSC), cables, electrodes, and an optional printer.

AI/ML Overview

The provided FDA 510(k) summary for the Aspect A-2000 EEG Monitor with BIS primarily focuses on demonstrating substantial equivalence to predicate devices and the addition of a new feature (Burst Count). It does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and a study proving those criteria are met.

Here's an analysis of the available information and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated in the document. The general acceptance appears to be "meets its performance specifications and validation test requirements, and is safe for its intended use." No specific quantitative metrics (e.g., accuracy thresholds, sensitivity/specificity targets) for the device's core functions (EEG monitoring, BIS calculation, or the new Burst Count feature) are provided.
Reported Device Performance: The document states, "Results indicate the device meets its performance specifications and validation test requirements." However, no specific performance data (e.g., accuracy, precision, correlation with clinical outcomes, or specific metrics for Burst Count) are reported.

Acceptance Criteria	Reported Device Performance
Not explicitly defined in terms of quantitative metrics for device function.	"Results indicate the device meets its performance specifications and validation test requirements, and is safe for its intended use."
(Presumably, the Burst Count feature should accurately count EEG bursts.)	No specific performance data for Burst Count accuracy is provided.

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

Sample Size: Not specified. The document mentions "Software validation" and "Verification of new feature," but does not detail the size of any test sets (e.g., number of patients, number of EEG recordings) used for these validations.
Data Provenance: Not specified. It's unclear if the data used for testing (if any clinical data was involved) was retrospective or prospective, or its country of origin.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
This level of detail is typically only provided if the device's performance relies heavily on human interpretation as a gold standard, which isn't the primary focus of this submission (which is comparing a software update to an existing device).

4. Adjudication method for the test set

Adjudication Method: Not specified.

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 MRMC study is mentioned. This submission is for a software update to an existing EEG monitor, not an AI-assisted diagnostic tool that would typically involve human readers. The device provides processed parameters (BIS, Burst Count) directly to the clinician, rather than requiring human interpretation of raw data assisted by AI.
Effect Size: Not applicable as no such study was performed or reported.

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

Standalone Performance: The testing described ("Software validation" and "Verification of new feature") implicitly indicates standalone algorithm performance was assessed for the new Burst Count feature and the overall software. However, no specific metrics or results of this standalone performance are provided beyond the general statement that "Results indicate the device meets its performance specifications."

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

Type of Ground Truth: Not specified for the software validation or verification of the new feature. For EEG processing devices, ground truth might involve simulated EEG signals, carefully annotated clinical EEG recordings verified by neurologists, or comparison to established gold-standard algorithms if available. This document does not elaborate.

8. The sample size for the training set

Sample Size: Not specified. This submission is about a software update for a device; it doesn't describe the development/training of new AI models. The original BIS algorithm would have been developed using a training set, but that information is not part of this 510(k) for a software update.

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

Ground Truth Establishment: Not specified. Similar to point 8, this information pertains to the original development of the BIS algorithm, not the current software update.

Summary of what is present:

Device Name: A-2000™ EEG Monitor with BIS (with Burst Count added in this update).
Intended Use: Monitoring the state of the brain via EEG, aiding in monitoring effects of anesthetic agents to reduce awareness with recall in adults during general anesthesia and sedation.
Type of Study Conducted: Software validation, verification of new feature (Burst Count), hazard analysis, and risk assessment.
Conclusion: The device meets performance specifications and validation requirements, is safe for intended use, and is substantially equivalent to predicate devices.

Missing Information:

The 510(k) summary is designed to establish substantial equivalence, not to provide a detailed scientific publication of clinical trial results. Therefore, it lacks the specifics on acceptance criteria, sample sizes, expert involvement, and ground truth establishment that you've requested. This level of detail is generally found in more comprehensive clinical study reports submitted to the FDA, or in peer-reviewed scientific literature that might accompany such device development, but it is not typically summarized in the 510(k) filing itself unless a specific clinical study was integral to the equivalence argument for a new device or a major change. In this case, the change is described as a software modification to add a Burst Count feature to an already cleared device.

Summary

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K030267 1/3

510(k) SUMMARY VII

Date Prepared: 1/24/03 Updated: 10/28/03

Company Name and Address

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

Contact People:

Christinc Vozella Regulatory Affairs Telephone (direct dial): (303) 926-5624 Fax#: (303) 604-6477

Paul J. Manbeg, PhD Vice President, Clinical, Regulatory Affairs, QA Telephone (direct dial): (617) 559-7076 Fax#: 617-559-7948

Devicc Name

Proprietary Name: A-2000™ EEG Monitor with BIS.

Common Namc: EEG Monitor

Classification

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

Prodicate Devices

Aspect Medical Systems A-2000 EEG Monitor with BIS This 510(k), #K011534, received FDA clearance 6/15/01

Aspect Medical Systems A-2000 EEG Monitor with BIS This 510(k), #K031694, received FDA clearance October 10, 2003

Device Description

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K030267 2/3

The system configuration consists of the monitor, digital signal converter (DSC), cables, electrodes, and an optional printer.

Intended Use

Summary of Technological Characteristics Compared to Predicate Device

Similarities

BIS Monitors (predicate and the subject of this 510(k)) are software devices that monitor the state of the brain by data acquisition of EEG of the anesthetized or sedated patient. They also aid in monitoring the effects of certain anesthetic agents by use of the processed parameter BIS.

They have the same hardware and software designs, signal flow, self-test capabilities (automatic and manual), alarms, and identical Digital Signal Converters (DSC).

The system technology remains the same. That is, EEG signals are transformed from analog to digital, processed within the hardware components using similarly designed hardware and software. System self checks and other tests such as impedance checks are still completed, and alarms are similar. None of the differences affect the system technology, or the safety and effectiveness of the BIS Monitor.

Differences

Due to customer request, software is heing modified to add Burst Count, which provides a measurement of the number of EEG bursts per minute. Burst count will be added to the BIS log screen.

Software will be updated to revision 1.3.

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Summary of Testing

The following tests/analyses have been completed:

Software validation 1)
Verification of new feature 2)
Hazard Analysis and risk assessment 3)

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 Aspect Medical Based on the above, Aspect Modical by equivalent to the predicate devices, and is safe and effective for its intended use.

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

Aspect Medical Systems, Inc. c/o Ms. Christine Vozella Regulatory Affairs 141 Needham Street Newton, Massachusetts 02464

Re: K030267

Trade/Device Name: Aspect A-2000 EEG Monitor with BIS Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLW, OMC, ORT Dated (Date on orig SE Itr): October 28, 2003 Received (Date on orig SE ltr): October 29, 2003

- 2 C ស្ថិតនៅក្នុង ស្រុកក្រ

Dear Ms. Vozella:

This letter corrects our substantially equivalent letter of January 15, 2004.

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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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.

for

Sincerely yours.

Kevia Alexander

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

K030267 510(k) Number (if known):

Aspect Medical Systems A-2000 EEG Monitor with BIS Device Name:

Indications For Use:

The Aspect A-2000 EEG Monitor with BIS is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. supervision of a licensed heatheader prositional or excitats within a hospital of The BIS Monitor is intended for use on addit and pockation would be and the brain by data acquisition of EEG signals.

The BIS may be used as an aid in monitoring the effects of certain ansociated with the The BIS may be used as an all in moments and stression may be associated with the of BIS monitoring to nelp guide ancinneded and in adults during general unesthesia and sedation.

ਮ Frescription Use (Parl 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 CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

Page 1 of ___________

Number K030267

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).