Use of the Ami Infant Central ApnealHeart Rate Monitor is indicated for the continuous monitoring of an infant's heart rate and respiration rate in a home, hospital or portable environment. Continuous monitoring is indicated for infants whose physical condition may result or has resulted in an instability in heart rate or respiration which may become detrimental to the infant. Conditions which may require monitoring include (not all inclusive): Prematurity, Respiratory dysfunction, Neurologic dysfunction, Maternal drug abuse, Cardiovascular dysfunction.

Device Description

The Ami Infant Central ApnealHeart Rate Monitor is capable of monitoring an infant's respiratory and heart rates. The device utilizes respiration detection technology for respiratory effort detection and also detects ECG rate through the same two electrodes. The device also incorporates auxiliary inputs for recording stand-alone oximeter output parameters and/or other devices' signal outputs within specified parameters. The device operates off either battery of AC power.

AI/ML Overview

The provided document is a 510(k) summary for the "Ami Infant Central Apnea/Heart Rate Monitor." This document focuses on demonstrating substantial equivalence to a predicate device and does not contain the detailed acceptance criteria, specific study designs, or performance metrics in a format that would allow for a complete response to all aspects of your request.

However, I can extract the information that is present and highlight what is missing.

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the device "was found to meet all of the validation requirements verifying performance to the design specification" and demonstrated "proper functionality, safety and effectiveness and substantial equivalence to the predicate device." However, it does not provide a quantitative table of specific acceptance criteria (e.g., accuracy percentages, sensitivity, specificity for apnea or heart rate detection) or the exact reported performance figures against those criteria.

Acceptance Criteria	Reported Device Performance
Specific performance criteria for apnea/heart rate detection are not detailed in this document.	The device "met all validation requirements" and demonstrated "proper functionality, safety and effectiveness."
Functionality under ESD, EMI, mechanical vibration/shock, high/low temperature/humidity.	The device "fully exercised and evaluate device functionality, performance, safety and effectiveness under conditions such as the presence of electrostatic discharge (ESD), electric and magnetic field interference (EMI), mechanical vibration and shock, high and low temperature and humidity conditions."
User Interface Performance	"The user interface was also tested during this phase." Outcomes not quantified beyond "met validation requirements."
Comparison to predicate device (Aequitron Model 9550) and other reference monitors.	"The results of these studies further demonstrated the proper functionality, safety and effectiveness and substantial equivalence to the predicate device." Specific metrics of comparison are not provided.

2. Sample size used for the test set and the data provenance:

Sample size: Not specified. The document mentions "clinical evaluations were also conducted" but does not give a number of subjects or cases.
Data provenance: Not specified. It's implied that the clinical evaluations would involve infants, but details on country of origin, demographics, or whether the study was retrospective or prospective are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. The document does not describe the process for establishing ground truth in clinical evaluations, nor does it mention the involvement or qualifications of experts for this purpose.

4. Adjudication method for the test set:

Not specified. The document does not detail any adjudication process for the clinical evaluation data.

5. Multi-reader multi-case (MRMC) comparative effectiveness study:

Not mentioned. The document describes clinical evaluations that compared the device to a predicate and "other reference monitors," but it does not specify if this was an MRMC study or involved human readers/interpreters. There is no mention of an effect size for human reader improvement with AI assistance, as AI is not extensively discussed as a separate component of the device's function in this summary beyond its general capabilities.

6. Standalone (algorithm only without human-in-the-loop performance) study:

The device is an "Infant Central Apnea/Heart Rate Monitor" which inherently provides continuous monitoring, implying an algorithmic detection process. The laboratory testing "fully exercised and evaluate device functionality, performance, safety and effectiveness." This seems to include standalone performance without a human in the loop for the primary detection. However, specific standalone performance metrics (e.g., sensitivity, specificity, accuracy of the device's alarms or readings) are not individually broken out or quantified in this document.

7. The type of ground truth used:

For the laboratory testing, the ground truth was established using "physiologic test simulators, test meters, and other sophisticated electronic and mechanical measurement which was maintained under strict calibration control."
For clinical evaluations, the document implies comparison against the "predicate device, Aequitron Model 9550 and other reference monitors." This suggests the ground truth was derived from these established monitoring methods, but the specific type (e.g., expert consensus based on other monitors, clinical diagnosis, or other objective measures) is not explicitly stated.

8. The sample size for the training set:

Not applicable/Not specified. This document does not describe "training" in the context of machine learning or AI. The device's operation is based on "respiration detection technology for respiratory effort detection and also detects ECG rate." It's a medical device, not framed as an AI/ML product developed with training data in the modern sense. Therefore, there is no mention of a training set size.

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

Not applicable/Not specified, for the reasons outlined in point 8.

Summary

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1 4300 250 Ausmin North Minneapolis. Minnesota 55117 800.107.1979 612.557.8200 Fax 612.55, 9200

K961972

APR 1 8 1997

Image /page/0/Picture/3 description: The image shows the logo for Aequitron Medical. The logo is in black and white, with the word "AEQUITRON" in large, bold letters. Below the word "AEQUITRON" is the word "MEDICAL" in smaller letters. The logo is simple and professional, and it is likely used on the company's products and marketing materials.

Contact Individual:

Robert C. Samec Vice President, Quality Assurance/Regulatory Affairs

Robert. Sauer

5-13-96 Date

510(k) SUMMARY

This summary of 510(k) Promarket Notification safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) and 21 CFR 807.92.

Device Name:

The proprietary name of the device to be introduced into interstate commerce by Aequitron Medical, Inc. is the Ami Infant Central AnnealHeart Rate Monitor.

Classification:

The Ami Infant Central Apnea/Heart Rate Monitor is classified as a "Breathing Frequency Monitor" (21 CFR 868.2375).

The device classification is Class II.

Predicate Device(s):

The Ami Infant Central Apnea/Heart Rate Monitor is substantially equivalent to the Aequitron Medical, Inc. Model 9550 Cardiorespiratory Monitor.

Device Description:

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Indications for Use:

Prematurity ●

Respiratory dysfunction ●
Neurologic dysfunction .
Maternal drug abuse ●
Cardiovascular dysfunction .

Description of Laboratory and Clinical Testing:

The Ami Infant Central AonealHeart Rate Monitor was subjected to detailed laboratory testing designed to fully exercise and evaluate device functionality, performance, safety and effectiveness under conditions such as the presence of electrostatic discharge (ESD), electric and magnetic field interference (EMI), mechanical vibration and shock, high and low temperature and humidity conditions.

Performance validation protocols and checklists were derived directly from the device specification to develop the test plan including all monitoring parameters. This laboratory testing utilized physiologic test simulators, test meters and other sophisticated electronic and mechanical measurement which was maintained under strict calibration control.

The user interface was also tested during this phase. The Ami Infant Central ApnealHeart Rate Monitor was found to meet all of the validation requirements verifying performance to the design specification.

Clinical evaluations were also conducted. The design of these studies assessed the performance and functionality of the Ami Infant Central Apnea/Heart Rate Monitor as compared to the predicate device, Aequitron Model 9550 and other reference monitors.

The results of these studies further demonstrated the proper functionality, safety and effectiveness and substantial equivalence to the predicate device.

Thomas J. Callister

(Division Sign-O
Division of Cardiovascular, Respiratory,
*Neurological Devices K961972

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).