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The Monica Novii Pod is an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii Pod acquires and displays the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Pod also acquires and displays 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 >36 completed weeks, in labor, 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 CTG Fetal monitor. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on 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 Monica Novii Pod Fetal-Maternal Monitor 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 Monica 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 the Bluetooth connection to the Monica Novii CTG Interface device that is a Monica Approved accessory to the Monica Novii Pod.

Here's a breakdown of the acceptance criteria and the studies that prove the Monica Novii Wireless Patch System meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides acceptance criteria for non-clinical tests (Data Transfer Validation and Data Extraction Validation).

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

• Clinical Study (Test Set):
  • Sample Size: 31 patients. The study was conducted in two stages:
    • 24 subjects recruited into three BMI groups.
    • 7 subjects where the Novii Patch was deliberately misplaced.
  • Data Provenance: The document does not explicitly state the country of origin for the clinical study data but implies it was collected in a clinical environment. Given Monica Healthcare is based in the UK, it's probable the study took place there. The study was prospective in nature, comparing the Novii Patch directly against a predicate device in a clinical setting.
• Non-Clinical Data Extraction Validation (Test Set):
  • Sample Size: Ten (10) simulated data files.
  • Data Provenance: The simulated data files were "based on data collected from the maternal abdomen in previous fetal ECG trials" of the predicate Monica AN24 device (K101801). This is retrospective in terms of the original data used to create the simulations, but the testing itself was performed using these pre-existing simulated data sets.

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

• Clinical Study: The document does not specify the number of experts or their qualifications for establishing ground truth in the clinical study. It mentions the study monitored "clinical performance" implicitly against the predicate device's readings, suggesting the predicate device served as the reference rather than independent expert adjudication of the Novii's output alone.
• Non-Clinical Studies: Ground truth for the non-clinical tests (Data Transfer and Data Extraction) was established by comparing the device's output against known input signals or the predicate device's output. No human experts were involved in establishing ground truth for these simulated tests.

4. Adjudication Method for the Test Set

• Clinical Study: The document does not describe a formal adjudication method by experts for the clinical study beyond comparing the Novii Patch's performance directly to that of the predicate device (Monica AN24 with Ambu electrodes).
• Non-Clinical Studies: Adjudication was purely technical/automated, comparing device output to known inputs or predicate device output.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not explicitly mentioned or implied. The studies described focus on the device's performance characteristics and its equivalence to a predicate device, rather than how human readers' diagnostic accuracy or efficiency might improve with or without AI assistance. The Monica Novii Wireless Patch System appears to be a monitoring device that outputs raw data (FHR, MHR, UA tracings) rather than an AI-driven interpretive tool requiring human reader studies.

6. Standalone (Algorithm Only) Performance Study

• Yes, standalone performance was assessed in the non-clinical "Data Extraction Validation." In this test, the Novii Pod's ability to extract FHR, MHR, and UA data from simulated electrophysiological signals was directly compared to the predicate device's output using the same inputs. This assesses the algorithm's performance in isolation from the clinical environment where a human might interpret the data.

7. Type of Ground Truth Used

• Clinical Study: The ground truth was effectively the output of the predicate device (Monica AN24 with Ambu electrodes), as the study aimed to demonstrate substantial equivalence to this legally marketed device. This is a form of comparative ground truth against a recognized standard.
• Non-Clinical Data Transfer Validation: Ground truth was the locally stored extracted data on the Novii Pod's Micro-SD card, compared against the transmitted data. This is a form of internal consistency ground truth.
• Non-Clinical Data Extraction Validation: Ground truth was the output of the predicate Monica AN24 device when fed the same simulated inputs. This is also a form of comparative ground truth against a known standard.

8. Sample Size for the Training Set

• The document does not provide any explicit details about a training set size. The Monica Novii Wireless Patch System's detection technology is explicitly stated to be "identical to the Monica AN24 predicate device in that it use the same electronic components, the same signal processing software." This suggests it reuses the established algorithms from the predicate device, rather than relying on a newly trained (e.g., machine learning) algorithm that would require a distinct training set. The simulated data used in testing was based on "previous fetal ECG trials" of the predicate, which could be considered data from which the original algorithms were developed, but not a "training set" in the context of a new algorithm.

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

• As there's no explicit mention of a new "training set" for a novel algorithm, the document doesn't detail how ground truth for a training set was established. The algorithms are inherited from the predicate device. The simulated data used for non-clinical testing was "based upon data collected in a trial of the predicate Monica AN24 device (K101801)" and "data collected from the maternal abdomen in previous fetal ECG trials" – these historical data sets would have had their own ground truth established via methods relevant to those original trials, likely involving expert review or known physiological parameters.

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