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The Novii+ Pod is an antepartum and intrapartum Maternal/Fetal Monitor that non-invasively measures fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii+ Pod acquires the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Pod also acquires the UA tracing from the uterine electromyography (EMG) signal and the MHR tracing from the maternal ECG signal (mECG). The Pod is indicated for use on women who are at 34 weeks and 0/7 days and greater with singleton pregnancies, using surface electrodes on the maternal abdomen.

The Novii Patch is an accessory to the Novii+ Pod that connects directly to the Novii+ Pod and contains the surface electrodes that attach to the abdomen.

The Novii+ Interface is an accessory to the Novii+ Pod which provides a means of interfacing the wireless output of the Novii+ Pod to the transducer inputs of a Maternal/Fetal Monitor. The Novii+ Interface enables signals collected by the Novii+ Pod to be printed and displayed on a Maternal/Fetal Monitor and sent to a central network, if connected.

The Novii+ Pod Maternal/Fetal Monitor and its accessories are intended for use by healthcare professionals in a clinical setting.

The Novii+ Wireless Patch System (Novii+ system) is a battery-powered maternal-fetal monitoring system that measures abdominal fetal heart rate (FHR), abdominal uterine activity (UA), and abdominal maternal heart rate (MHR). The Novii+ Wireless Patch system is designed as an ambulatory device for the monitoring of a pregnant mother. The monitor enables the abdominal electrophysiological signal to be picked up from three different positions on the maternal abdomen using the 5 electrodes on the Novii Patch. The monitor filters the abdominal signals, converts the abdominal electrophysiological data into a digital format and then processes it in real time to extract the fetal heart rate, maternal heart rate and uterine activity. The result of the processing is transmitted via a Bluetooth connection to the Novii+ Interface device which is an accessory to the Novii+ Pod.

The Novii+ Pod (proposed device) is indicated for use on women who are at 34 weeks and 0/7 days and greater with singleton pregnancies with cephalic fetal presentation.

Here's a breakdown of the acceptance criteria and study details for the Novii+ Wireless Patch System, based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

Note:

• PA: Percent Agreement
• RI: Relative Interpretability
• PPA: Positive Percent Agreement
• RMSE: Root Mean Square Error
• MAE: Mean Absolute Error
• GS: Gold Standard

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

• Sample Size for Clinical Study: 30 subjects
  • 14 subjects with threatened pre-term labor (non-laboring)
  • 16 subjects with pre-term labor and delivery
• Data Provenance: The document does not explicitly state the country of origin. Given that GE HealthCare is the submitter and their address is in Wauwatosa, WI, USA, it is likely the study was conducted in the United States. The study type is prospective clinical study.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical study. Instead, the ground truth was established by comparator devices:

• FHR ground truth: Doppler Fetal Heart Rate device
• MHR ground truth: SpO2 Maternal Heart Rate device and 12-lead ECG data (Gold Standard)
• UA ground truth: TOCO Uterine Activity device

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1). The primary comparison was against established medical devices (Doppler, SpO2, TOCO, 12-lead ECG) which inherently serve as the reference/ground truth.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study's focus was on the Novii+ Wireless Patch System's equivalence to existing, established monitoring devices (Doppler, SpO2, TOCO, ECG) for capturing physiological data, not on how human readers' interpretations improve with AI assistance.

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

The study implicitly evaluated the standalone performance of the Novii+ Wireless Patch System. It directly compared the measurements generated by the Novii+ algorithms (FHR, UA, MHR) against the measurements from the comparator devices. There is no mention of human-in-the-loop performance evaluation in this specific context.

7. The Type of Ground Truth Used

• Fetal Heart Rate (FHR): Doppler Fetal Heart Rate device
• Maternal Heart Rate (MHR): SpO2 Maternal Heart Rate device, and a 12-lead ECG data (referred to as "MECG Gold Standard (GS)")
• Uterine Activity (UA): TOCO Uterine Activity device

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. This particular document focuses on the performance evaluation of the device in a clinical study for premarket notification, not the development or training of its underlying algorithms.

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

The document does not provide information on how the ground truth for the training set was established, as details about the training process are not included in this 510(k) summary.

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