This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor.

Device Description

The 8600 monitor measures and displays real time physiological data of the patient, including waveforms and numerical data. The 8600 can be configured to monitor one or more of the following parameters: ECG, Noninvasive BP (NIBP), Invasive BP (IBP), SpOz, Temperature, Respiration, CO2, Nominvasive BP (NIDF), Invasive BP Agenta, For all the samini, CO2, N2O, O2 and Halogenated Anesthetic Agents. For all these vital parameters, the 8600 will be capable of limit alams and alerts, printing of strip chart recordings and storing trends for retrospective review.

AI/ML Overview

The provided document (K042569) is a 510(k) summary for the Criticare Systems, Inc. Model 8600 Vital Signs Monitor. It outlines the device description, intended use, comparison to a predicate device, and compliance with standards. However, it does not contain specific study results or detailed acceptance criteria with performance numbers for the device itself. Instead, it relies on demonstrating substantial equivalence to a predicate device and compliance with general performance standards.

Therefore, much of the requested information regarding detailed acceptance criteria, specific study results, sample sizes, expert involvement, and ground truth establishment cannot be extracted directly from this document.

Here's an attempt to answer based on the available information and recognizing the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter / Standard	Acceptance Criteria (Implied)	Reported Device Performance
General Performance	Equivalence to predicate device (CSI Model 8100 / 8500 Vital Signs Monitor K012059)	The 8600 monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate device.
NIBP Performance	Compliance with EN 60601-2-30 (Safety), EN 1060-1, EN 1060-3 (incl. EN 475 Alarm Performance), AAMI SP-10	Compliance with listed standards verified.
ECG Performance	Compliance with EN 60601-2-27 (Safety), AAMI EC-13 (Basic ECG Performance)	Compliance with listed standards verified.
Oximetry (SpO2) Performance	Compliance with EN 865 (Equivalent to ASTM F 1415)	Compliance with listed standards verified.
Capnometry (CO2) Performance	Compliance with EN 864 (Equivalent to ASTM F 1456)	Compliance with listed standards verified.
Invasive Blood Pressure (IBP) Safety	Compliance with EN 60601-2-34	Compliance with listed standards verified.
Oxygen Analyzer Performance	Compliance with EN 13698, EN 12598 (Equivalent to ASTM Fo ASTM)	Compliance with listed standards verified.
Electrical Safety	Compliance with EN 60601-1 Medical Electrical Safety	Compliance with listed standards verified.
EMC Compliance	Compliance with IEC 601-1-2 EMC Compliance	Compliance with listed standards verified.
Biocompatibility	Compliance with ISO 10993-5, 10-11 Biocompatibility	Compliance with listed standards verified.
MR Compatibility	Per its labeling claims.	The 8600 monitor is MR Compatible per its labeling claims.

Important Note: The document states that performance has been "confirmed to be equivalent" and "compliance has been completed." It does not provide the specific quantitative results from these compliance tests or detail what "equivalent" means in terms of a specific delta or accuracy range. The "acceptance criteria" are generally implied by the requirement to meet these recognized standards.

2. Sample Size Used for the Test Set and the Data Provenance

This information is not provided in the 510(k) summary. The document states "field experience" with the predicate device and "equivalence testing" and "applicable objective standards compliance." It does not describe specific clinical studies or test sets with sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the 510(k) summary. The submission relies on compliance with established performance standards, which implicitly require certain testing methodologies, but the details of expert involvement are not disclosed.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Given the nature of a vital signs monitor and the reliance on performance standards, a formal adjudication process using multiple experts for a test set is unlikely to be described at this level of detail.

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 and not provided. The 8600 Vital Signs Monitor is a device that provides physiological data; it is not an AI-powered diagnostic tool that assists human "readers" or interpreters in the way an imaging algorithm would. Therefore, an MRMC study related to AI assistance for human readers is not relevant in this context.

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

The device itself is a standalone monitor. Its performance is assessed against recognized standards for accuracy and reliability of physiological measurements. The document states its performance "has been confirmed to be equivalent to the predicate device" and that it "complies with applicable safety and performance standards." This implies standalone performance testing against those standards.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance of a vital signs monitor, as implied by compliance with standards like EN 1060-1 for NIBP or EN 865 for Oximetry, would typically involve:

Reference Devices: Highly accurate, calibrated reference measurement devices (e.g., invasive arterial lines for IBP, calibrated gas analyzers for CO2/O2, etc.).
Simulators/Phantoms: Calibrated simulators or phantoms for specific parameters (e.g., ECG simulators, NIBP cuffs with controlled pressure waveforms).
Clinical Studies: For parameters like NIBP or SpO2, clinical studies comparing the device's readings to reference measurements in human subjects are often required by the standards.

However, the specific methods for establishing ground truth are not detailed in this 510(k) summary, beyond the mention of compliance with the listed standards.

8. The Sample Size for the Training Set

This information is not applicable and not provided. Vital signs monitors, especially from 2004, typically rely on established signal processing algorithms and hardware engineering rather than machine learning models that require "training sets" in the modern AI sense.

9. How the Ground Truth for the Training Set was Established

This information is not applicable and not provided for the same reasons as point 8. The device's underlying technology likely involves well-understood physiological sensing and signal processing, not a "training set" with associated ground truth as understood in contemporary AI/ML development.

Summary

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K042569
page 1 of

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SEP 2 9 2004

15 September 2004

510K Summary

Model 8600 Vital Signs Monitor

Contact: Alex Kaplan Director of QA & RA Criticare Systems, Inc. 20925 Crossroads Circle Waukesha, WI 53186 USA 262-798-8282 Voice 262-798-8290 FAX

Trade Name: 8600 Vital Signs Monitor

Common Name: Vital Signs Monitor

Classification Name: Monitor, Physiological, Patient (74 MWI)

Substantial Equivalence is claimed to : CS1 Model 8100 / 8500 Vital Signs Monitor (K012059)

Device Description:

The 8600 monitor measures and displays real time physiological data of the patient, including waveforms and numerical data. The 8600 can be configured to monitor one or more of the following parameters: ECG, Noninvasive BP (NIBP), Invasive BP (IBP), SpOz, Temperature, Respiration, CO2, Nominvasive BP (NIDF), Invasive BP
Agenta, For all the samini, CO2, N2O, O2 and Halogenated Anesthetic Agents. For all these vital parameters, the 8600 will be capable of limit alams and alerts, printing of strip chart recordings and storing trends for retrospective review.

Intended Use:

Comparison with predicate device:

Criticare Systems Inc. has developed and distributed physiological monitoring devices worldwide since its inception in 1984. The 8600 monitor utilizes existing core technologics from the predicate monitor for patient monitoring of ECG, NIBP, IBP,

@2000 Criticare Systems, Inc All Rights Reserved

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K042569
page 2 of 2

Resp, SpO3, Temp, CO2, NoO, O2 and Halogenated Anesthetic Agents. The 8600 monitor is MR Compatible per it's labeling claims. The patient data collected by the 8600 monitor is displayed for the user on a flat pancl display as on the predicate device. The 8600 monitor utilizes Active TFT LCD color display technology. Membrane key pancls and rotary push button navigation provides a user interface equivalent to the predicate device. The packaging design of the 8600 monitor is molded plastic and aluminum and allows for it to be either a stationary monitor or to be used during patient translocation within the healthcare facility, as did the predicate 8100 / 8500 monitor.

Determination of Substantial Equivalence:

The 8600 monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate device. Additionally, the 8600 complies with applicable safety and performance standards (detailed below) for each monitoring modality and verification of compliance has been completed. The patient monitoring technologies present in the 8100 monitor have been in clinical use for at least six years in the gredicate devices. CSI's field experience with these modalities in the predicate device has been satisfactory. This combination of equivalence testing, applicable objective standards compliance and field experience substantiates a high level of confidence in the safety and efficacy of the 8600 monitor.

Therefore, the 8600 monitor is substantially equivalent to the predicate device.

Compliance to standards and regulations:

The 8600 Vital Signs Monitor complies with the following national and international standards:

Safety

EN 60601-1 Medical Electrical Safety IEC 601-1-2 EMC Compliance ISO 10993-5,10-11 Biocompatibility

Performance

EN 60601-2-30 NIBP Safety EN 1060-1 NIBP Performance EN 1060-3 NIBP Performance {including EN 475 Alarm Performance} AAMI SP-10 NIBP Performance EN 60601-2-27 ECG Safety AAMI EC-13 Basic ECG Performance EN 865 Oximetry Performance (Equivalent to ASTM F 1415) EN 864 Capnometry Performance (Equivalent to ASTM F 1456) EN 60601-2-34 Invasive Blood Pressure Safety EN 13698 O EN 12598 Oxygen Analyzer Performance (Equivalent to ASTM Fo AST

@2000 Criticare Systems, Inc All Rights Reserved

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circle with text around the perimeter and a stylized eagle in the center. The eagle is depicted with three curved lines representing its body and wings.

SEP 2 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Criticare Systems, Inc. c/o Mr. Alex Kaplan Director QA & RA 20925 Crossroads Circle Suite 100 Waukesha, WI 53186-4054

Re: K042569

Trade Name: Vital Signs Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: II (two) Product Code: MWI Dated: September 18, 2004 Received: September 21, 2004

Dear Mr. Kaplan:

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.

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Page 2 - Mr. Alex Kaplan

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 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 (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,

Bhimmer for

Bran D. Zuckerman, M. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) NUMBER (IF KNOWN) : _

Vital Signs Monitor DEVICE NAME:

Indications for Use

Prescription Use
X
(Per 21 CFR 801.109)

Over - the - Counter - Use (Optional Format 1-2-96)

B.Brummer
Lesse sign-on

510(k) Numb

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

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).