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 507EL monitor measures and displays real time physiological data of the patient, including waveforms and numerical data. The 507EL can be used to monitor one or more of the following parameters: ECG, Noninvasive BP (NIBP), SpO3, Temperature, and Respiration. For all these vital parameters, the 507EL will be capable of limit alarms and alerts, printing of strip chart recordings and storing trends for retrospective review.

AI/ML Overview

The provided text is a 510(k) summary for the Criticare Systems, Inc. Model 507EL Vital Signs Monitor, submitted to the FDA in 2002. This document is a premarket notification asserting substantial equivalence to a predicate device, not a detailed study report on acceptance criteria and performance of a novel AI/ML device. Therefore, much of the requested information regarding AI/ML device studies (e.g., sample sizes for test/training sets, ground truth establishment for AI/ML, MRMC studies, standalone performance of an algorithm) is not applicable or available in this document.

However, based on the provided text, I can extract information related to the device's performance claims and how its equivalence was established.

Acceptance Criteria and Device Performance (as inferred from the document):

Acceptance Criteria Category	Specific Standard/Requirement	Reported Device Performance Summary (from text)
Safety	UL 544 Medical Electrical Safety	"The 507EL monitor complies with..." (Claimed compliance)
	IEC 601-1-2 EMC Compliance	"The 507EL monitor complies with..." (Claimed compliance)
	ISO 10993-5,10-11 Biocompatibility	"The 507EL monitor complies with..." (Claimed compliance)
Performance - NIBP	EN 60601-2-30 NIBP Safety	"The 507EL monitor complies with..." (Claimed compliance). "The 507EL monitor is substantially equivalent to the predicate devices." (Implies NIBP performance is equivalent to predicate, which has satisfactory field experience).
	EN1060-1 NIBP Performance	"The 507EL monitor complies with..." (Claimed compliance)
	EN 1060-3 NIBP Performance (including EN 475 Alarm Performance)	"The 507EL monitor complies with..." (Claimed compliance)
	AAMI SP-10 NIBP Performance	"The 507EL monitor complies with..." (Claimed compliance)
Performance - ECG	IEC 60601-2-27 ECG Safety	"The 507EL monitor complies with..." (Claimed compliance). "The 507EL monitor is substantially equivalent to the predicate devices." (Implies ECG performance is equivalent to predicate, which has satisfactory field experience).
	AAMI EC-13 Basic ECG Performance	"The 507EL monitor complies with..." (Claimed compliance)
Performance - Oximetry	EN 865 Oximetry Performance (Equivalent to ASTM F 1415)	"The 507EL monitor complies with..." (Claimed compliance). "The 507EL monitor is substantially equivalent to the predicate devices." (Implies SpO2 performance is equivalent to predicate, which has satisfactory field experience).
Overall Equivalence	Equivalence to predicate device (CSI Model 2200 Scholar Vital Signs Monitor K944860)	"The 507EL monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate device." "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 507EL monitor."

Study Information (Based on a 510(k) submission for a non-AI/ML device):

Sample size used for the test set and the data provenance:
- Test set size: Not specified. The document refers to "equivalence testing" and compliance with performance standards, which would involve testing the device against those standards and comparing its performance to the predicate. However, details on the patient numbers or specific data sets used for these tests are not provided in this summary.
- Data provenance: Not explicitly stated as "data provenance." The document mentions that the patient monitoring technologies have been in "clinical use for at least six years in the predicate device," and CSI's "field experience with these modalities in the predicate device has been satisfactory." This suggests that the predicate device's performance (and by extension, the new device's claim of equivalence) is supported by retrospective clinical use and field data, but for the 507EL's specific testing, the provenance of the test data (e.g., country, retrospective/prospective) is not detailed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a traditional medical device, not an AI/ML device requiring expert ground truth for interpretation. Ground truth for physiological measurements is typically established by reference instruments or established clinical methodologies.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not an AI/ML device relying on human expert adjudication for its output.
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. This is not an AI/ML device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device itself is a standalone vital signs monitor. Its "performance for each monitoring modality has been confirmed to be equivalent to the predicate device" through "equivalence testing" and "applicable objective standards compliance." This implies the device's output (ECG, NIBP, SpO2, Temp, Resp measurements) was evaluated directly against established methods and standards, without necessarily "human-in-the-loop performance" in the context of an AI/ML algorithm's output interpretation. The "user" is a "professional health care provider" responsible for interpreting the data, but this refers to the clinical use of the monitor's displayed data, not an evaluation of an AI algorithm's assistance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For physiological measurements like NIBP, ECG, SpO2, and Temperature, ground truth is typically established by:
  - Reference standard measurements: e.g., invasive blood pressure for NIBP, a gold-standard ECG recording device for ECG, co-oximetry for SpO2, or a calibrated thermometer for temperature.
  - Clinical validation protocols: specific testing methodologies outlined in the referenced performance standards (e.g., AAMI SP-10 for NIBP, AAMI EC-13 for ECG, EN 865/ASTM F 1415 for Oximetry) dictate how ground truth is obtained and used for evaluating device accuracy. The document states compliance with these standards.
The sample size for the training set:
- Not applicable. This device does not employ machine learning that would require a "training set." Its core technologies are established and were already in "clinical use for at least six years in the predicate device."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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KOL2435 F.12-

AUG 1 4 2002

19 July 2002

510K Summary

Model 507EL Vital Signs Monitor

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

507EL Vital Signs Monitor Trade Name:

Vital Signs Monitor Common Name:

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

CSI Model 2200 Scholar Vital Signs Substantial Equivalence is claimed to : Monitor (K944860)

Device Description:

Intended Use:

Comparison with predicate device:

Criticare Systems Inc. has developed and distributed physiological monitoring devices worldwide since its inception in 1984. The 507EL monitor utilizes existing core technologies from the predicate Scholar 2200 monitor for patient monitoring of ECG,

/ ﻞ

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NIBP, Resp, SpO2, and Temp. The patient data collected by the 507EL monitor is displayed for the user on a flat panel display and LEDs as on the predicate device. The 507EL monitor utilizes Passive LCD or Active TFT LCD color display technologies in combination with LED numeric displays. Membrane key panels provide a user interface equivalent to the predicate device. The packaging design of the 507EL monitor is molded plastic 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 Scholar 2200.

Determination of Substantial Equivalence:

The 507EL monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate device. Additionally, the 507EL 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 507EL monitor have been in clinical use for at least six years in the predicate device, the Scholar 2200 monitor. 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 507EL monitor.

Therefore, the 507EL monitor is substantially equivalent to the predicate devices.

Compliance to standards and regulations:

The 507EL Vital Signs Monitor complies with the following national and international standards:

Safety

UL 544 Medical Electrical Safety IEC 601-1-2 EMC Compliance ISO 10993-5,10-11 Biocompatibility

Performance

EN 60601-2-30 NIBP Safety EN1060-1 NIBP Performance EN 1060-3 NIBP Performance {including EN 475 Alarm Performance} AAMI SP-10 NIBP Performance IEC 60601-2-27 ECG Safety AAMI EC-13 Basic ECG Performance EN 865 Oximetry Performance (Equivalent to ASTM F 1415)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three distinct head profiles, suggesting a sense of community or collaboration. The bird is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is rendered in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2002

Criticare Systems, Inc c/o Mr. Alex Kaplan Manager of QA & RA 20925 Crossroads Circle Waukesha, WI 53186

Re: K022435

Trade Name: Vital Signs Monitor Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulation Number: 21 CFR 870.2300 Regulatory Class: Class II (two) Product Code: DRT Dated: July 19, 2002 Received: July 25, 2002

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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

Elisa Diaz Sn

/Bram D. Zuckerman, N 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) :

DEVICE NAME: Vital Signs Monitor

Indications for Use

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

X
Prescription Use
(Per 21 CFR 801.109)
OR
(Division Sign
Division of Cardiovascular
and Respiratory Dences

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

lar

510(k) Number

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).