The CSM monitor is intended for use in monitoring the hypnotic state of the brain by data acquisition of EEG signals of the anaesthetized or sedated patient in all areas of the hospital.

Device Description

The Cerebral State Monitor (CSM) is a non-invasive measurement tool for use by trained healthcare professionals to measure the level of consciousness (LOC) in all areas of the hospital. Based on EEG, an index (CSI) is calculated, which is used in the estimation of LOC. The CSM displays the CSI but does not perform any data interpretation (i.e., all data interpretation is performed by a physician).

AI/ML Overview

The provided document is a 510(k) summary for the Cerebral State Monitor (CSM) and the FDA clearance letter. It states that the device is substantially equivalent to predicate devices but does not contain detailed information about acceptance criteria or specific studies showcasing performance data in the structured format requested. The document explicitly states: "The CSM displays the CSI but does not perform any data interpretation (i.e., all data interpretation is performed by a physician)". This indicates that the device itself is a measurement tool and not an AI or algorithm-driven diagnostic device as implied by some of the questions.

Therefore, many of the requested details, such as sample sizes for test and training sets, the number and qualifications of experts, adjudication methods, MRMC studies, standalone performance details, and how ground truth for training was established, are not present in this regulatory document.

However, based on the information available, I can construct a table for the acceptance criteria and intended use, and provide what limited information is available regarding performance.

Acceptance Criteria and Device Performance (Based on available information)

Acceptance Criteria	Reported Device Performance	Comments
Intended Use: The CSM is intended for use in monitoring the state of the brain by data acquisition of EEG signals of the anaesthetized or sedated patient in all areas of the hospital. The CSM is a non-invasive measurement tool to be used by a trained professional to measure the level of consciousness during general anaesthesia or sedation by use of CSI.	The document states, "The performance data indicate that the Cerebral State Monitor - CSM meets all specified requirements, and is substantially equivalent to the predicate devices."	The specific "specified requirements" or performance metrics (e.g., accuracy, precision) that were met are not detailed in this summary. The substantial equivalence claim suggests it performs comparably to the predicate devices.
Technological Characteristics: Comparable to predicate devices (Danmeter A/S AEP Monitor K010965 and Aspect Medical Systems A-2000 EEG Monitor with BIS K974496).	A comparison of the technological characteristics...demonstrate that the Cerebral State Monitor - CSM is equivalent to the marketed predicate devices.	Specific functional or technical specifications are not enumerated in this summary statement.
Safety: Device must meet general safety requirements for medical devices.	Implied by FDA clearance. The 510(k) clearance confirms the device is safe and effective for its stated indications for use, based on substantial equivalence.
Effectiveness: Device must be effective for its intended use.	Implied by FDA clearance. Stated as "substantially equivalent to the predicate devices," suggesting similar effectiveness.	The document explicitly states that the CSM displays an index (CSI) but does not perform any data interpretation. All interpretation is performed by a physician. This is a crucial distinction from an AI-driven diagnostic device.

Study Details and Data Provenance

Sample size used for the test set and the data provenance: Not specified in the provided document. As the device is primarily a measurement tool and does not perform "data interpretation," it is unlikely a "test set" in the context of an algorithm's diagnostic performance was used or described in this type of submission. Performance is assessed against technical specifications and equivalence to predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. Ground truth in the context of diagnostic accuracy is not directly applicable here as the device does not perform diagnosis. The document states "all data interpretation is performed by a physician."
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable based on the information provided.
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: Not applicable. The CSM is a monitoring device that provides an index (CSI) for human interpretation; it is not described as an AI-assisted diagnostic tool designed to improve human reader performance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document states, "The CSM displays the CSI but does not perform any data interpretation (i.e., all data interpretation is performed by a physician)." This confirms that the device is not designed for standalone diagnostic performance; it is a measurement tool.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified as the device does not perform diagnosis. The "ground truth" for a monitor typically relates to the accuracy and reliability of its measurements against established physiological standards or reference devices, which is not detailed here. The "level of consciousness" is a clinical assessment made by a physician using various inputs, including the CSI.
The sample size for the training set: Not specified and likely not applicable in the context of an AI training set, as the device is not described as an AI/ML algorithm for diagnosis.
How the ground truth for the training set was established: Not specified and likely not applicable for the reasons stated above.

Summary

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JAN 2 1 2005

K 042315

SUMMARY OF SAFETY AND EFFECTIVENESS Cerebral State Monitor - CSM

SUBMITTER INFORMATION

A.	Company Name:	Danmeter A/S
B.	Company Address:	Kildemosevej 13DK-5000 Odense C
C.	Company Phone:Company Fax:	+45 63 11 29 30+45 63 11 29 31
D.	Contact Person:	Hanne NielsenQuality ManagerDanmeter A/S
E.	Date Summary Prepared:	August 19, 2004

DEVICE IDENTIFICATION

A.	Generic Device Name:	Electroencephalograph
B.	Trade/Proprietary Name:	Cerebral State Monitor - CSM
C.	Classification:	Class II
D.	Product Code:	OLW, OMC, DRT

SUBSTANTIAL EQUIVALENCE

The Cerebral State Monitor - CSM is of comparable type and is substantially equivalent to the following predicate devices:

Predicate Device	Manufacturer	510(k) No.	Date Cleared
AEP Monitor	Danmeter A/S(Reg. by: AlarisMedical Systems)	K010965	6/27/2001
A-2000 EEGMonitor with BIS	Aspect MedicalSystems	K974496	2/6/1998

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DEVICE DESCRIPTION

The following accessories are provide with the CSM:

Danmeter Neuro Sensors
9V Alkaline battery ●
Skin preparation
Rechargeable 9V NiMH battery (Optional) .
CSM Power (Optional) Mains Power supply ●
CSM Capture (Optional) PC-SW. This software allows the physician to . format data on a PC, for documentation purposes.
CSM Link (Optional) Wireless link to RS232 to host computer .
CSM Printer (Optional) Thermal printer for documentation purposes ●

INTENDED USE

The CSM is intended for use in monitoring the state of the brain by data acquisition of EEG signals of the anaesthetized or sedated patient in all areas of the hospital. The CSM is a non-invasive measurement tool to be used by a trained professional to measure the level of consciousness during general anaesthesia or sedation by use of CSI.

TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the Cerebral State Monitor -CSM and the predicate devices has been performed. The results of this comparison demonstrate that the Cerebral State Monitor - CSM is equivalent to the marketed predicate devices.

PERFORMANCE DATA

The performance data indicate that the Cerebral State Monitor - CSM meets all specified requirements, and is substantially equivalent to the predicate devices.

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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 consists of a stylized eagle or bird-like symbol, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

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

Mr. Hanne Nielsen Quality Manager Danmeter A/S Kildemosevej 13 DK-5000 Odense C Denmark

APR - 9 2012

Re: K042315

Trade/Device Name: Cerebral State Monitor Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLW, OMC, ORT Dated (Date on orig SE ltr): December 1, 2004 Received (Date on orig SE ltr): December 3, 2004

Dear Mr. Nielsen:

This letter corrects our substantially equivalent letter of January 21, 2005.

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/ReportalProblem/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.

Sincerely vours.

Kesia 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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DEVICE SPECIFICATIONS

INDICATIONS FOR USE

510(k) Number:	K042315 (To Be Assigned by FDA)
Device Name:	Cerebral State Monitor - CSM
Indications for use:	The CSM monitor is intended for use in monitoring thehypnotic state of the brain by data acquisition of EEGsignals of the anaesthetized or sedated patient in all areasof the hospital.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

メ Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Muriam C. Provost

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

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510(k) Number_________________________________________________________________________________________________________________________________________________________________

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).