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ANNE Pediatric is a wireless vital signs and physiological data monitoring platform indicated for the measurement of heart rate, skin temperature, and body temperature by qualified healthcare professionals in healthcare settings. The device is intended for use on neonatal patients of any gestational age up to infants 2 years of age as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The device is not intended to monitor critically ill patients. The device is not intended to monitor or measure heart rate during motion. The device is not an apnea alarm.

ANNE Pediatric is a wireless vital signs and physiological data monitoring platform that collects electrocardiography (ECG) and temperature biosignals to measure vital signs such as heart rate (HR), skin temperature, and body temperature. The system features two skin-mounted, bio-integrated sensors that pair with the ANNE View application for the display of real-time vital measurements. Data is transmitted wirelessly from the sensors via Bluetooth to the mobile device.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for Heart Rate (HR) measurement are explicitly stated within the text as defined by IEC 60601-2-27. While the general standard is mentioned, the specific performance requirement is a tolerance of ±10% or ±5 bpm, whichever is greater.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set (Clinical Data for HR):
  • Total neonates assessed: n=137
  • Neonates included in the final closed-label round for HR analysis: n=20
  • Neonates included in the overall HR analysis (across multiple rounds): n=70
• Data Provenance: Clinical data was collected in Nairobi, Kenya at Aga Khan University, a tertiary healthcare facility. The study appears to be prospective as it involved assessing the functionality and performance of the ANNE Pediatric system in "n=137 neonates."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not explicitly state the number of experts used or their specific qualifications for establishing ground truth. However, it indicates that the comparison was made against the Masimo Rad-97, which is a widely accepted medical device for physiological monitoring. This implies that the Masimo Rad-97 served as the reference standard, or "ground truth," rather than human expert interpretation of raw data.

4. Adjudication Method for the Test Set

The document mentions "one open label and three closed-label rounds" without detailing specific adjudication methods like 2+1 or 3+1. Given that the ground truth was a reference device (Masimo Rad-97), a traditional adjudication method for human interpretation would not be applicable. The "closed-label" rounds likely refer to blinding the assessors to the ANNE Pediatric output during data collection or analysis against the reference device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The study detailed is a performance assessment of the device against a predicate device for heart rate measurement. There is no mention of human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, the described clinical study for heart rate measurement is a standalone performance assessment of the ANNE Pediatric device. It compares the device's output (presumably from its algorithms) directly against a reference medical device (Masimo Rad-97). There is no mention of human-in-the-loop performance in this specific clinical study.

7. The Type of Ground Truth Used

The ground truth used for heart rate measurement was established by a reference medical device, specifically the Masimo Rad-97.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size used for the training set. The clinical data described is explicitly for performance assessment/testing.

9. How the Ground Truth for the Training Set was Established

Since information regarding the training set and its sample size is not provided, the method for establishing its ground truth is also not available in this document.

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