(287 days)
The HANNAH Wireless Vital Signs Monitor is indicated for the continuous monitoring of an infant's heart rate, respiration rate, and occurrences of central apnea in home, hospital and other environments.
The HANNAH system is an infant apnea monitor, which is substantially equivalent to legally marketed devices. The HANNAH system includes features incorporated in legally marketed devices. Like most legally marketed infant apnea monitors, the HANNAH incorporates sensors and alarms for monitoring both breath and heart rate. Like most legally marketed infant apnea monitors, the HANNAH system monitors heart rate using a 3-lead ECG measurement. The HANNAH system has the same technological characteristics as legally marketed devices. Because lead wires connected to the infant present a documented risk for strangulation and electrocution, and because lead wires are the source of a substantial majority of the false alarms associated with wired monitors, the decision was made to use radio frequencies to transmit the monitoring information from infant-placed sensors to the central unit. Further, since the more common method of monitoring, impedance pneumography, is highly susceptible to false readings due to interference with cardiac signals and motion artifacts, respiration is monitored using a pressure sensor instead.
The provided text describes the 510(k) summary for the HANNAH Wireless Vital Signs Monitor, which is an infant apnea monitor. It explicitly states that a clinical study was conducted for "clinical performance relative to a legally marketed predicate device." However, the document does not contain specific acceptance criteria, reported device performance metrics against those criteria, or the detailed methodology of the study.
Therefore, for the requested information, much of it is not available in the provided text.
Here's an overview of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the provided text.
- Reported Device Performance: Not specified in the provided text. The text only mentions "a clinical study of the device was conducted by an independent contract research organization in order to evaluate the HANNAH monitor's clinical performance relative to a legally marketed predicate device." No specific performance metrics or comparative results are given.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (country of origin, retrospective/prospective). The study was conducted by "an independent contract research organization."
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 specified in the provided text. The nature of "ground truth" for an infant apnea monitor would likely involve direct observation or a highly accurate reference device, but the specifics are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified in the provided text.
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
- The device is an infant apnea monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study with human readers would not be applicable in this context. The study mentioned was to evaluate the monitor's clinical performance relative to a predicate device, implying a comparison of device performance itself, not human interpretation improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The described device is a "monitor," suggesting it operates as a standalone system to detect vital signs and apnea. The clinical study evaluated the HANNAH monitor's performance "relative to a legally marketed predicate device," which typically implies testing the device's output (measurements, alarms) against a reference. This aligns with a standalone performance evaluation of the device's sensing and processing capabilities. However, specific performance metrics or details of the standalone evaluation are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated. For a vital signs monitor, ground truth would typically be established by a gold-standard measurement device or direct clinical observation by healthcare professionals.
8. The sample size for the training set
- Not applicable as this is a medical device (monitor) primarily relying on sensor technology and signal processing, not a machine learning model that requires a distinct "training set" in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable for the same reason as above.
§ 868.2377 Apnea monitor.
(a)
Identification. An apnea monitor is a complete system intended to alarm primarily upon the cessation of breathing timed from the last detected breath. The apnea monitor also includes indirect methods of apnea detection such as monitoring of heart rate and other physiological parameters linked to the presence or absence of adequate respiration.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA.”