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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.

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.

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.

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.

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