The NPB3900 Series Patient Monitors are multi-parameter patient monitors that are used to monitor ECG waveforms, heart rate, noninvasive blood pressure, (systolic, diastolic, and mean arterial pressure), functional arterial oxygen saturation, and temperature for adult and pediatric patients in all hospital areas and hospital type facilities and for patient transport in the hospital and in ambulances.

Device Description

The NPB3900 Series Patient Monitors is a compact, lightweight monitor for measuring, processing, storing, and displaying information derived from four physiological measurements:

Electrocardiogram (ECG). A three lead ECG is acquired and a . waveform can be displayed real-time on the LCD screen or permanently recorded on the optional strip chart recorder. The design of the ECG function is derived directly from the predicate device, the NPB-4000.
Pulse Oximetry (SpO2). Functional Oxygen Saturation is calculated . from the ratio of light transmissivity through the capillary bed at two wavelengths. The SpO2 subsystem uses the same printed wiring board, including microprocessor and imbedded firmware that is used in the predicate device, the NPB-4000.
The temperature is measured using thermistor probes and a . "predictive" algorithm to enable temperature measurements to be completed more quickly. The temperature subsystem uses technology licensed from the manufacturer of the Welch Allyn SureTemp® Portable Thermometer, which was cleared for marketing under premarket notification K943695 and K964643.
Blood pressure is measured noninvasively (NIBP) by the oscillometric . method. The design of the NIBP subsystem is an enhanced version of the NIBP subsystem used in the predicate device, the NPB-4000.
An optional thermal printer records waveforms, digital vital signs, and . tabular trends on a 50-mm wide strip chart.
The NPB3900 series monitors are powered by internal sealed lead-acid batteries. A fully charged battery will power the monitor for four hours.

AI/ML Overview

The provided text describes a 510(k) submission for the Analogic Corporation NPB3900 Series Patient Monitors. However, it does not contain specific acceptance criteria, detailed study results with performance metrics, or information relevant to AI/algorithm performance, ground truth establishment for a training set, and expert qualifications/adjudication methods as typically found in studies for AI/ML-based devices.

The document outlines the device's features, intended use, and comparison to predicate devices, focusing on regulatory approval based on demonstrating substantial equivalence. The "clinical testing" section describes the types of studies performed but does not provide quantitative results or acceptance criteria in the format requested.

Therefore, many sections of your requested output cannot be filled from the provided text.

Here is an attempt to answer based on the available information, with many points marked as "Not provided in the text."

1. Table of Acceptance Criteria and Reported Device Performance

Measurement	Acceptance Criteria	Reported Device Performance
SpO2 Accuracy	Not explicitly stated (likely defined by a standard, but not specified here)	"Accuracy of the SpO2 measurement was verified in a study on human volunteers." (No specific accuracy metric reported)
NIBP Accuracy	Not explicitly stated (likely according to ANSI/AAMI standard SP-10, but no specific threshold given)	"Clinical testing to validate the accuracy of the NIBP function was conducted according to the ANSI/AAMI standard SP-10." (No specific accuracy metric reported)
Overall Clinical Equivalence	Not explicitly stated (aimed at user perception of equivalence)	"A study was conducted to exercise all the device features in a typical clinical setting, to demonstrate that users perceive the NPB3900 as equivalent to other devices with the same intended use." (No specific metrics or thresholds reported)
Electromagnetic Emissions	EN 55011, Group 1, Class B limits	"All tests passed the stated criteria."
Electrostatic Discharge Susceptibility	IEC 801-2	"All tests passed the stated criteria."
Radio Frequency Interference Susceptibility	IEC 801-3	"All tests passed the stated criteria."
Electric Fast Transient Susceptibility	IEC 801-4	"All tests passed the stated criteria."
Fast Surge Susceptibility	IEC 801-5	"All tests passed the stated criteria."
Line Drop-Out and Variation Susceptibility	FDA Reviewer Guidance for Premarket Notification (Anesthesiology and Respiratory Devices Branch)	"All tests passed the stated criteria."
ECG Performance	ANSI/AAMI EC-13	"All tests passed the stated criteria."
Battery Cycle Testing	Not explicitly stated	"All tests passed the stated criteria."
Operational Temperature Test	Not explicitly stated	"All tests passed the stated criteria."
Altitude Tests	Not explicitly stated	"All tests passed the stated criteria."
Alarm Volume Tests	Not explicitly stated	"All tests passed the stated criteria."
Cleanability Tests	Not explicitly stated	"All tests passed the stated criteria."
Mechanical Shock and Vibration Tests	Not explicitly stated	"All tests passed the stated criteria."
Shipping Container Transportation Test	Not explicitly stated	"All tests passed the stated criteria."
Measure of External Temperature Rise	Not explicitly stated	"All tests passed the stated criteria."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for SpO2 study: "human volunteers" - specific number not provided.
Sample Size for NIBP study: Not provided.
Sample Size for Clinical Equivalence study: Not provided.
Data Provenance: Not provided, but given the context of a US 510(k) submission, it's highly probable the studies were conducted in the US. The studies are described as "clinical testing," implying prospective data collection for the purpose of the submission.

3. 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)

Not applicable/Not provided. The studies described are for physiological measurement accuracy and user perception, not for diagnostic interpretation requiring expert ground truth in the way AI/ML devices often do. For SpO2 and NIBP, ground truth would typically come from reference devices or invasive measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. (See point 3).

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

No. This is a patient monitor, not an AI/ML diagnostic imaging device that would typically involve human readers interpreting cases.

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

The studies relate to the device's measurement accuracy (SpO2, NIBP) and overall clinical use. Performance would inherently be "standalone" in the sense that the device outputs measurements without human interpretation adjusting them in real-time. However, this is not an "algorithm only" study as understood in AI/ML contexts.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

SpO2: Likely comparisons against co-oximetry (gold standard for oxygen saturation) or a highly accurate reference pulse oximeter.
NIBP: Likely comparisons against invasive arterial pressure measurements or a highly accurate reference oscillometric device, as per ANSI/AAMI standard SP-10.
Temperature: Likely comparisons against a highly accurate reference thermometer, potentially invasive Core Body Temperature.
ECG: Comparisons against standard ECG devices.

8. The sample size for the training set

Not applicable/Not provided. The text describes a traditional medical device submitting for 510(k), not an AI/ML device relying on a distinct training set in the modern sense. The "design of the NPB3900 series" is described as being derived from the predicate NPB-4000, implying reuse of validated components and technology rather than training a novel algorithm on a specific dataset. The predictive temperature algorithm is "licensed from Welch Allyn," meaning its development and "training" would have occurred prior to this device's submission and were likely part of Welch Allyn's own validation for their thermometer.

9. How the ground truth for the training set was established

Not applicable/Not provided. (See point 8).

Summary

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K980411

AUG 20 1998

510(k) Summary for Analogic Corporation NPB3900 Series Patient Monitors

DATE THIS SUMMARY WAS PREPARED: JANUARY 30, 1998

SUBMITTER'S NAME AND ADDRESS:

Analogic Corporation 8 Centennial Drive Peabody, MA 01960

CONTACT PERSON:

Steven Clarke, Regulatory Specialist
Telephone:	(978) 977-3000	Extension 3316
Facsimile:	(978) 977-6808

DEVICE NAME:

Proprietary Name:	NPB3900 Series Patient Monitors
Common Name:	Multi-Function Patient Monitor
Classification Name:	Physiological Patient Monitoring System and Accessories

PREDICATE DEVICES

The legally marketed devices to which equivalence is being claimed are:

NPB-4000 patient monitor, manufactured by Analogic Corporation ● (K962424).
SureTemp Thermometer Model 679, manufactured by Welch Allyn, Inc. ● (K943695 and K964643)

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DEVICE DESCRIPTION:

The NPB3900 Series Patient Monitors is a compact, lightweight monitor for measuring, processing, storing, and displaying information derived from four physiological measurements:

Electrocardiogram (ECG). A three lead ECG is acquired and a . waveform can be displayed real-time on the LCD screen or permanently recorded on the optional strip chart recorder. The design of the ECG function is derived directly from the predicate device, the NPB-4000.
Pulse Oximetry (SpO2). Functional Oxygen Saturation is calculated . from the ratio of light transmissivity through the capillary bed at two wavelengths. The SpO2 subsystem uses the same printed wiring board, including microprocessor and imbedded firmware that is used in the predicate device, the NPB-4000.
The temperature is measured using thermistor probes and a . "predictive" algorithm to enable temperature measurements to be completed more quickly. The temperature subsystem uses technology licensed from the manufacturer of the Welch Allyn SureTemp® Portable Thermometer, which was cleared for marketing under premarket notification K943695 and K964643.
Blood pressure is measured noninvasively (NIBP) by the oscillometric . method. The design of the NIBP subsystem is an enhanced version of the NIBP subsystem used in the predicate device, the NPB-4000.
An optional thermal printer records waveforms, digital vital signs, and . tabular trends on a 50-mm wide strip chart.

The NPB3900 series monitors are powered by internal sealed lead-acid batteries. A fully charged battery will power the monitor for four hours.

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INTENDED USE:

The NPB3900 Series Patient Monitors are multi-parameter patient monitors that is used to monitor ECG waveforms, heart rate, noninvasive blood pressure, (systolic, diastolic, and mean arterial pressure), functional arterial oxygen saturation, and temperature for adult and pediatric patients in all hospital areas and hospital type facilities and for patient transport in the hospital and in ambulances.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

The design of the NPB3900 Patient Monitors is derived from the design of the NPB-4000 Patient Monitor. The NPB3900 series consists of four models; the NPB3910 which monitors NIBP and SPO2; the NPB3920 which monitors NIBP, SPO2: and temperature, the NPB3930 which monitors NIBP, SPO2; and ECG; and the NPB3940 which monitors NIBP, SPO2; temperature, and ECG.

The NPB3900 series monitors are smaller and lighter than their predicate, and they feature a predictive temperature algorithm, licensed from Welch Allyn, Inc.

The NBP3900 series does not include the respiration monitoring function which is present in the NPB-4000.

NONCLINICAL TEST USED IN DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

The design of the NPB3900 Series Patient Monitors has been thoroughly validated at the unit and system level and meets all elements of its Requirements Specification. This included the following nonclinical tests:

Electromagnetic Emissions Tests to determine if it was in compliance with the . EN 55011, Group 1, Class B emissions limits.
Electrostatic Discharge Susceptibility was tested according to IEC 801-2.
. Radio Frequency Interference Susceptibility was tested according to IEC 801-3.
. Electric Fast Transient Susceptibility was tested according to IEC 801-4.
. Fast Surge Susceptibility was tested according to IEC 801-5.

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Line Drop-Out and Variation Susceptibility was tested according to the FDA . Reviewer Guidance for Premarket Notification Submissions, November 1993 (Anesthesiology and Respiratory Devices Branch).
ECG Performance Testing According to ANSI/AAMI EC-13 .
Battery Cycle Testing .
Operational Temperature Test .
Altitude Tests ●
Alarm Volume Tests ●
Cleanability Tests .
Mechanical Shock and Vibration Tests ●
Shipping Container Transportation Test ●
Measure of External Temperature Rise ●

All tests passed the stated criteria.

CLINICAL TESTING

The following clinical testing was conducted:

Accuracy of the SpO2 measurement was verified in a study on human . volunteers.
. Clinical testing to validate the accuracy of the NIBP function was conducted according to the ANSI/AAMI standard SP-10.
A study was conducted to exercise all the device features in a typical clinical . setting, to demonstrate that users perceive the NPB3900 as equivalent to other devices with the same intended use.

CONCLUSIONS FROM NONCLINICAL AND CLINICAL TESTING

The testing of the NPB3900 Series Patient Monitors demonstrates that the performance is substantially equivalent to the predicate devices cited above.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 20 1998

Mr. Steven A. Clarke Regulatory Affairs Specialist Analogic Corporation 8 Centennial Drive Peabody, MA 01960

Re : K980411 NPB3900 Series Patient Monitor Regulatory Class: II (two) Product Code: MXH Dated: June 29, 1998 Received: July 2, 1998

Dear Mr. Clarke:

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 leqally 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 Requlations, 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any

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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 notification² (21CFR 807.97). Other qeneral 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. Callahon

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): _ K980 Ytl

Device Name: NPB3900 Series Patient Monitors

Indications For Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
(Per 21 CFR 801.109)
	OR
	Over-The-Counter Use

	8-20-98
	(Division Sign-Off)
	Division of Cardiovascular, Respiratory,
	and Neurological Devices

510(k) Number __

×980411

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.