The SleepScreen and ApnoeScreen Cardio are portable physiological signal recording devices intended to be used for testing patients suspected of having sleep-related breathing disorders. They are intended to be used under the direction of a physician. The devices may be used in the home, clinic, doctor's office or hospital.

The SleepScreen and ApnoeScreen Cardio, or any of the accessories supplied with it, are not to be used, alone or in combination, as an apnea monitor or as a component in an apnea monitoring system.

The SleepScreen and ApnoeScreen Cardio, or any of the accessories supplied with it, are not to be used, alone or in combination, as a life support device, a life support system, or as a critical component in a life support device or life support system.

The SleepScreen and ApnoeScreen Cardio are non-life-supporting portable physiological signal recording devices intended to be used for testing patients 7 years and older suspected of having sleep-related breathing disorders. The SleepScreen and ApnoeScreen Cardio are intended to measure and record oxygen saturation, pulse rate, body position, snoring, respiratory airflow, respiratory effort, PLM, EEG, EMG, EOG and ECG data. The devices may be used in the home, clinic, doctor's office or hospital.

The SleepScreen and ApnoeScreen Cardio are not intended for use as an apnea monitor or as a component in an apnea monitoring system. Additionally, the SleepScreen and ApnoeScreen Cardio are not intended to be used alone or in combination with another product as a life support device, a life support system, or as a critical component to a life support device or system. There is no claim of compatibility with diagnostic imaging equipment.

Device Description

The ApnoeScreen Cardio is the ApnoeScreen Pro (K000396) with the addition of two AC channels. The additional AC channels may be used to record electro-oculargram (EOG), electromyogram (EMG), electroencephalogram (EEG) and/or electrocardiogram (ECG).

The SleepScreen is the ApnoeScreen Pro (K000396) with the addition of eight AC channels. The additional AC channels may be used to record electrooculargram (EOG), electromyogram (EMG), electroencephalogram (EEG) and/or electrocardiogram (ECG).

AI/ML Overview

The provided document, K021138, for the SleepScreen and ApnoeScreen Cardio devices, describes their intended use and comparison to a predicate device but does not contain detailed information regarding specific acceptance criteria for performance metrics, the results of a formal clinical study to prove these criteria, or any of the detailed aspects of such a study as requested in the prompt.

Instead, the document states:

"Summary of Performance Testing: Performance testing was conducted in the laboratory to confirm compliance to device specifications; all functions were verified to operate as designed and intended, and measured parameters met required ranges and accuracies. Testing to internationally accepted standards for electrical safety and electromagnetic compatibility were performed: the SleepScreen/ApnoeScreen Cardio complied with the requirements of these standards."

This statement indicates that laboratory-based performance testing was conducted against device specifications and international standards for electrical safety and electromagnetic compatibility. However, it does not provide the specific numerical acceptance criteria or the reported performance data in a quantifiable manner, nor does it detail a clinical study as typically understood for AI/algorithm-based devices.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a traditional medical device submission focusing on hardware functionality, safety, and equivalence to a predicate device, rather than the performance of an algorithm against ground truth data.

Based on the provided text, here's what can be inferred or explicitly stated:

Table of Acceptance Criteria and Reported Device Performance: This information is not provided in a quantifiable table format. The document generally states that "measured parameters met required ranges and accuracies" and that the device complied with electrical safety and electromagnetic compatibility standards, but no specific numerical targets or results are given.
Sample size used for the test set and the data provenance: This information is not provided. The "performance testing" described appears to be laboratory-based functional testing, not a clinical study with a defined patient test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. As no clinical test set is detailed, the concept of establishing ground truth by experts is not addressed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not 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: This information is not provided. The device is a physiological signal recording device, not an AI-assisted diagnostic tool as implied by an MRMC study.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This information is not provided. The device is described as recording physiological signals, implying human interpretation of these signals for diagnosis. It is not an AI algorithm performing standalone diagnoses.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not provided.
The sample size for the training set: This information is not provided. The device does not appear to involve machine learning or AI that would require a "training set."
How the ground truth for the training set was established: This information is not provided.

In summary, the provided document is a 510(k) premarket notification for a physiological signal recording device. It focuses on demonstrating substantial equivalence to a predicate device and confirming basic laboratory performance, electrical safety, and electromagnetic compatibility. It does not detail the type of clinical performance study or AI algorithm validation that would require the specific information requested in the prompt.

Summary

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Image /page/0/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically 'KA21138'. The characters are handwritten in a dark ink, and they appear to be part of a code or identification number. The writing style is somewhat stylized, with distinct shapes for each character.

Summary of Safety and Effectiveness

FEB 1 2 2003

Date of Preparation: April 4, 2002

Submitter: Erich Jaeger GmbH Leibnizstrae 7 D-97201 Hoechberg Germany

Contact: Brian Long SensorMedics Corp. Phone: 800-231-2466 x8521 Fax: 714-283-8439

Device Trade Name: SleepScreen/ApnoeScreen Cardio

Device Common/Classification Name: The SleepScreen/ApnoeScreen Cardio is an Erich Jaeger GmbH device classified under 73MBZ, "Ventilatory Effort Recorder, per Requlation No. 868.2375.

Predicate Device: ApnoeScreen Pro (K000396)

Intended Use:

The SleepScreen and ApnoeScreen Cardio, or any of the accessories supplied with it, are not to be used, alone or in combination, as an apnea monitor or as a component in an apnea monitoring system.

Device Description:

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Comparison to Predicate Device:

The SleepScreen/ApnoeScreen Cardio is not significantly different from the predicate device. ApnoeScreen Pro (K000396). Simply, eight AC channels are now available for the SleepScreen and only two of the eight channels are available for the ApnoeScreen Cardio.

Summary of Performance Testing:

Performance testing was conducted in the laboratory to confirm compliance to device specifications; all functions were verified to operate as designed and intended, and measured parameters met required ranges and accuracies. Testing to internationally accepted standards for electrical safety and electromaqnetic compatibility were performed: the SleepScreen/ApnoeScreen Cardio complied with the requirements of these standards.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and the future. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 2003

Erich Jaeger GmbH C/O Mr. Brian Long SensorMedics Corporation 22705 Savi Ranch Parkway Yorba Linda, California 92887-4645

Re: K021138

Trade/Device Name: SleepScreen and ApnoeScreen Cardio Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: December 23, 2002 Received: December 24, 2002

Dear Mr. Long:

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 vour 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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Page 2 - Mr. Long

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.

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 vour 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 (301) 594-4646. 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 yours.

Susan Purser

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) NUMBER: K021138

DEVICE NAME: SleepScreen and ApnoeScreen Cardio

INDICATIONS FOR USE:

(PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)
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(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number	K021138
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Over-The Counter Use (Optional Format 1-2-96)
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Regulation Number and Section

§ 868.2375 Breathing frequency monitor.

(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).