The indications for use for the Atlas Monitor, model numbers 200, 210, and 220, include the monitoring of the following human physiological vital signs:

O Blood Oxygenation (SpO2) measurement
O ECG waveform derived from 3 or 5 Lead measurement
Q Respiration rate/waveform derived from ECG or CO2
□ Temperature measurement via YSI 400 series probes
വ Non Invasive Blood Pressure (NIBP) measurement
CO₂, End-tidal sidestream/waveform
O Heart Rate derived from selected source (ECG, SpO2)

The target populations are adult and pediatric populations. The monitor is intended for use within the healthcare facility setting.

Device Description

The Atlas Monitor (including model numbers 200, 210, and 220) is a multiparameter device used to monitor human physiological vital signs. It combines a CRT to display ECG and CO2 waveforms and LED's for other numeric values. An optional printer is available on models 200 and 210 and it comes standard for 220 model.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Welch Allyn Atlas Monitor based on the provided text, using the specified format:

Acceptance Criteria and Device Performance

The provided document describes the Welch Allyn Atlas Monitor as substantially equivalent to predicate devices for monitoring various physiological vital signs. As such, the acceptance criteria are mainly tied to safety standards and functional performance comparable to legally marketed predicate devices. The document does not provide a table with specific numerical acceptance criteria (e.g., accuracy ranges for SpO2, NIBP) and corresponding reported performance metrics for this particular device. Instead, it states that the device "performs within its design parameters as well as the legally marketed predicate devices" and conforms to several safety standards.

Therefore, a table of specific numerical acceptance criteria and reported device performance cannot be generated directly from the provided text. The effectiveness is summarized qualitatively, stating the device utilizes "currently available technology found in many legally marketed devices" and "performs within its design parameters."

Study Information

Based on the provided "510(k) SUMMARY," the primary "study" proving the device meets acceptance criteria is a demonstration of substantial equivalence to predicate devices and adherence to relevant safety standards. This is typical for a 510(k) submission. No detailed clinical trial or performance study with specific metrics, sample sizes, or expert involvement is described in the provided document.

Here's a breakdown of the requested information, acknowledging the limitations based on the provided text:

A table of acceptance criteria and the reported device performance

As explained above, the provided document does not contain a discrete table with numerical acceptance criteria and reported performance metrics for the Atlas Monitor. The effectiveness summary is qualitative, indicating conformity to design intent and legal predicate devices.
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a test set sample size or data provenance for performance evaluation. The "completed design reviews and scheduled testing" are mentioned, but no specifics about the nature or scope of this testing are provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

No information is provided regarding the use of experts to establish ground truth for a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

No information is provided regarding adjudication methods for a test set.
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 device is a vital signs monitor, not typically an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned in the document.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The document does not describe a standalone algorithm performance study. The device is a "multiparameter device used to monitor human physiological vital signs," implying direct measurement and display, rather than a separate algorithm's performance being evaluated.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The concept of "ground truth" in the context of diagnostic accuracy (like pathology for imaging) is not directly applicable or discussed for this vital signs monitor in the provided text. The primary "truth" being evaluated is the device's ability to accurately measure physiological parameters compared to established, legally marketed predicate devices and safety standards.
The sample size for the training set

The document does not describe a "training set" as would be used in machine learning or AI development. The device's design is based on "currently available technology."
How the ground truth for the training set was established

Since a "training set" is not described, the method for establishing its ground truth is not provided.

Summary

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"510(k) SUMMARY" Summary of Safety and Effectiveness

Submitter's Name & Address:	Welch Allyn Inc.4341 State Street RoadSkaneateles Falls, New York 13153
Contact Person & Telephone:	Zoran I. Psenicnik(315) 685-4400
Date Summary Prepared:	Friday, November 06, 1998
Device Name:	Classification Name - Monitor, Cardiac (including cardiotachometerand rate alarm)Common/Usual Name - Vital Signs MonitorProprietary Name - Atlas Vital Signs Monitor
Predicate Device:	Welch Allyn Inc., Clinical Vital Signs Monitor model 52STP-E1 (ref.510(k) #K951193), BCI International Inc., Capnocheck Plus model9004 (ref. 510(k) #K970209, and the Datascope Corp.,Passport Monitor Model XG (ref. 510(k) #K911598).

Device Description, Intended Use & Effectiveness:

The indications for use for the Atlas Monitor, include the monitoring of the following human physiological vital signs:

0 Blood Oxygenation (SpO2) measurement
O ECG waveform derived from 3 or 5 Lead measurement
D Respiration rate/waveform derived from ECG or CO2

D Temperature measurement via YSI 400 series probes

O Non Invasive Blood Pressure (NIBP) measurement
0 CO2 Endtidal sidestream/waveform
D Heart Rate derived from selected source (ECG, SpO3)

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The target populations are adult and pediatric populations. The monitor is intended for use within the healthcare facility setting.

Technological Characteristics:

See attachment "III" for a comparison of the Atlas Monitor to the predicate devices.

Safety:

The system conforms to the following general safety standards:

EN60601.1	Medical Electrical Equipment, Part 1: General requirementsfor Safety. Amendment 1 (1991), Amendment 2 (1995)
EN60601.1.2	Medical Electrical Equipment, Part 1: General requirementsfor safety 2: Electromagnetic Compatibility - Requirementsand tests
CE Mark	Conforms with provisions of European Council Directive93/42/EEC concerning medical devices
	The system also conforms to the following specific safety standards:
EN60601.2.27	Medical Electronic Equipment, Part 2: ParticularRequirements for Safety - Specifications for Safety ofElectrocardiographic Monitoring Equipment
EN60601.2.30	Medical Electronic Equipment, Part 2: ParticularRequirements for Safety - Specifications for Safety ofAutomatic Cycling Indirect BP Monitoring Equipment

Summary of Effectiveness:

The design of this device utilizes currently available technology found in many legally marketed devices. Completed design reviews and scheduled testing ensured that the Atlas Monitor performs within the environment(s) for which it is to be marketed. The safety testing is compliant with the indicated standards. The software design and development (including verification and validation testing) was performed using FDA's Reviewers guidance of Medical Device Software Submissions, May 29 1998 and internal company requirements. On the basis of these results and the above referenced testing it is our determination that the device is safe, effective and performs within its design parameters as well as the legally marketed predicate devices. Welch Allyn Inc. will not market this device if it does not completely meet its design intent and safety functions.

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Image /page/2/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three curved lines representing its wings. The eagle is facing to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 8 1999

Mr. Zoran Psenicnik WelchAllyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153

Re: K984033 Atlas Monitor Regulatory Class: II (two) Product Code: DRT Dated: April 12, 1999 Received: April 14, 1999

Dear Mr. Psenicnik:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements

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concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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, 2 Misbranding by reference to premarket notification? (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Thomas J. Callahan

Thomas J.Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Welch Allyn Atlas Monitor

Indications For Use:

The indications for use for the Atlas Monitor, model numbers 200, 210, and 220, include the monitoring of the following human physiological vital signs:

O Blood Oxygenation (SpO2) measurement
O ECG waveform derived from 3 or 5 Lead measurement
Q Respiration rate/waveform derived from ECG or CO2
□ Temperature measurement via YSI 400 series probes
വ Non Invasive Blood Pressure (NIBP) measurement
CO₂, End-tidal sidestream/waveform
O Heart Rate derived from selected source (ECG, SpO2)

The target populations are adult and pediatric populations. The monitor is intended for use within the healthcare facility setting.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)	for PBT 7/2/99
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	K984033
Prescription Use (Per 21 CFR 801.109)	OR
	Over-The-Counter Use (Optional Format 1-2-96)

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).