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Bloomlife MFM-Pro is indicated for monitoring of maternal heart rate (MHR) and fetal heart rate (FHR) during the antepartum period for singleton pregnancies 32 weeks gestation or later.

It is to be used by healthcare professionals, clinics, physicians' offices, antepartum rooms, and in the patient's home on the order of a physician.

Bloomlife MFM-Pro is not intended for use in critical care situations or those patients hospitalized for or suspected to have preterm labor.

Bloomlife MFM-Pro is not intended to be used for antepartum monitoring (e.g., non- stress testing).

Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate (FHR) and maternal heart rate (MHR) during the antepartum period on pregnant women with a singleton pregnancy at 32 weeks gestation or later. The healthcare professional applies the device to the patient and uses Bloomlife MFM-Pro to generate the Bloomlife MFM-Pro report that provides 5 minutes of fetal heart rate (FHR) and maternal heart rate (MHR) monitoring to the clinic. A typical Bloomlife MFM-Pro session is expected to take 12 minutes; approximately 7 minutes to perform system quality checks and 5 minutes to record data. Signal quality checks continue during recording to ensure data quality.

Bloomlife MFM-Pro consists of three main components: the Bloomlife Sensor, the Bloomlife App, and the Bloomlife Cloud.

The Bloomlife Sensor measures biopotential signals picked up on the abdominal surface using electrodes and transfers the data to the Bloomlife App via Bluetooth Low Energy.

The Bloomlife App is used by a healthcare professional to enter patient information, start'stop recording sessions, and get feedback on data quality and recording status during a recording. The App does not process or visualize data; it acts as a gateway for the raw data measured by the sensor.

The Bloomlife Cloud receives the data from the app, stores and processes the data into a Report, which is provided to the clinic via electronic fax. The Cloud Algorithm extracts the maternal heart rate from 50 bpm to 240 bpm within ±7 beats per minute, and fetal heart rate from 50 bpm to 240 bpm within ±10 beats per minute at a sample rate of 4 samples per second.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the reported performance values were "within the pre-defined acceptable range of LoA for this pivotal study." However, the exact numerical thresholds for the acceptance criteria were not explicitly provided in the text. I've inferred that the reported values met these unstated criteria.

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

• Sample Size (for analysis): 56 participants
• Sample Size (enrolled): 61 participants
• Data Provenance: Prospective, collected from two clinical sites in the USA.

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

The document does not explicitly state the number of experts or their qualifications used to establish the ground truth. It mentions that the Philips Avalon FM30 was used as a "standard of cardiotocograph (CTG) monitoring device comparator." This implies that the ground truth was established by comparing the Bloomlife MFM-Pro's readings against the output of this established medical device, rather than through expert consensus on the raw data.

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method (like 2+1 or 3+1). The ground truth was established by comparison to a "standard of cardiotocograph (CTG) monitoring device comparator" (Philips Avalon FM30).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study focused on the performance of the Bloomlife MFM-Pro device itself in comparison to a reference device (Philips Avalon FM30) for heart rate measurements, not on the improvement of human readers with AI assistance.

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

Yes, the study appears to be a standalone performance evaluation of the Bloomlife MFM-Pro device. The "Bloomlife Cloud Algorithm" processes the data, and the report is generated from the device's output. While healthcare professionals apply the device and enter information, the core performance assessment is on the device's ability to accurately measure FHR and MHR. The algorithm's performance is implicit in the "Bloomlife MFM-Pro 5-minute Report data" used for analysis.

7. The Type of Ground Truth Used

The ground truth used was comparison to a legally marketed predicate device (Philips Avalon FM30 CTG monitor), which is described as a "standard of cardiotocograph (CTG) monitoring device comparator."

8. The Sample Size for the Training Set

The document does not specify the sample size for the training set. The clinical study described is for validation/performance testing, not for training.

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 it focuses on the performance of the device in a pivotal study.

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