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The MindChild Medical Meridian M100 Fetal Heart Rate Monitor is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR). The MindChild Meridian M100 acquires and displays the FHR tracing from abdominal surface electrodes that detect the fetal ECG signal (fECG). FHR tracings are displayed onto a primary fetal monitor. In addition, the M100 synchronizes the TOCO transducer signal which is also displayed to the primary fetal monitor.

The MindChild Meridian M100 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 MindChild Meridian is intended for use by healthcare professionals in a clinical setting.

The Meridian M100 Fetal Heart Rate Monitor is a modification of the cleared M1000 Fetal Heart Rate Monitor (K120018). The modifications are ones that do not affect the intended use or the fundamental scientific technology. The M100 Fetal Heart Rate Monitor is an AC powered fetal heart rate (FHR) monitor. The product consists of a signal processor containing hardware circuitry and software which acquires and processes analog signals using external, abdominal electrode sensors. Software algorithms extract ECG morphology and monitor fetal heart rate.

The M100 connects to existing cleared fetal heart rate monitors with DECG (i.e., primary monitor) using the primary monitor's screen for display of fetal heart rate. The patient data is displayed real time on the primary monitor's display. The Meridian M100 is used as an accessory to a main/primary fetal monitor replacing the Doppler sensor on those monitors. The M100 is for use with the GE Corometrics 120 and the GE Corometrics 250 Fetal Monitors.

This document is a 510(k) summary for the MindChild Meridian M100 Fetal Heart Rate Monitor, which is a modification of a previously cleared device, the M1000. Therefore, the acceptance criteria and study information provided pertain to demonstrating substantial equivalence to the predicate device, rather than a full de novo validation.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of specific thresholds for clinical performance metrics (e.g., sensitivity, specificity, accuracy for FHR detection). Instead, it focuses on demonstrating that the device meets its design specifications and performs as intended, largely by confirming that the modifications from the predicate M1000 do not adversely affect safety and effectiveness.

The "Performance Testing" section (page 11) lists various tests performed and their results:

Additional performance indicators from the "Device Characteristic Comparison" section (pages 6-10) include:

• Intended Use: Identical to predicate.
• Indications for Use: Very similar to predicate, differences don't affect safety or effectiveness.
• Regulation Number: Identical to predicate (884.2740).
• Display: Identical information displayed as predicate; M100 uses primary monitor.
• Controls: Each unit has power on/off; M100 utilizes primary monitor for other controls.
• Printer: Both allow for downloading/transfer of patient data.
• Front/Top Connections: Similar functionality for external electrodes; M100 adds TOCO connection, M1000 had optional fetal scalp electrode connection. These differences do not affect substantial equivalence.
• Rear Connections: M100 has connections to primary monitor; M1000 only power. Functionally identical.
• Side Connections: No impact.
• Input Voltage Range: Identical (120 VAC ±10%).
• Frequency: Identical (60 Hz).
• Method: Algorithm for fECG acquisition and processing is the same as the M1000. M100 adds TOCO signal synchronization.
• Measurement Range: Identical (50 - 240 BPM; abdominal sensor mode).
• Signal Processing: Identical (Analog to digital).
• Safety: Identical patient protection isolation barrier and compliance to FDA recognized standards.
• Software: Microsoft Windows 7 embedded operating system; proprietary MindChild ECG algorithm is the same. M100 has software modification for syncing uterine contraction signal.

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

The document states: "The algorithm used in the M100 to acquire and process fetal ECG signals through externally placed abdominal electrodes is the same as that used and clinically validated in the cleared M1000 device." (page 5) and "The clinical validation of the software responsible for calculating FHR from fECG signals was performed in support of the cleared 510(k) for the M1000. This clinical validation is directly applicable to the modified design as the signal acquisition components (external electrodes) and the signal processing software and algorithm remains the same in the modified M100 device. Therefore further clinical validation was not necessary for the modified device." (page 13).

This implies that no new clinical test set was used for the M100 device itself to validate the FHR algorithm. The previous validation for the M1000 is leveraged. The document does not provide details of the M1000's clinical validation, including sample size or data provenance (e.g., country of origin, retrospective/prospective). New hardware and software modifications were assessed through bench testing and software validation (pages 11-12), but these are not clinical studies with a "test set" in the sense of patient data.

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

As stated above, no new clinical test set was required for the FHR algorithm for the M100 due to its substantial equivalence to the M1000's algorithm. Details about experts used for the M1000's original clinical validation are not provided in this document.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical test set was explicitly detailed for the M100 device's FHR algorithm validation.

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

Not applicable. This device is a Fetal Heart Rate Monitor, not an AI diagnostic imaging tool or a system designed to assist human readers in interpreting complex data like medical images where MRMC studies are common. It calculates and displays FHR, and its core algorithm was previously validated as part of the M1000.

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

The document heavily implies that the FHR algorithm's performance was evaluated independently during the M1000's initial clearance, as it's a "fetal heart rate monitor" that "acquires and processes analog signals using external, abdominal electrode sensors" and "Software algorithms extract ECG morphology and monitor fetal heart rate." (page 4). The consistency of this algorithm between M1000 and M100 suggests a standalone performance evaluation of the algorithm for FHR calculation. However, specific details of this standalone performance, such as metrics (accuracy, precision, recall) or dataset used, are not in this document, as it focuses on demonstrating equivalence.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the M100's FHR calculation algorithm, the ground truth methodology would have been established during the M1000's original clinical validation. This document does not specify the type of ground truth used for that validation (e.g., comparison against an internal uterine pressure catheter for FHR).

8. The Sample Size for the Training Set

The document does not provide information about a training set for the FHR algorithm. This is typical for traditional signal processing algorithms rather than modern deep learning AI models, which explicitly require separate training and testing sets. The algorithm was "clinically validated" for the M1000, suggesting a validation dataset, but not necessarily a "training set" in the current AI sense.

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

Not applicable, as no specific training set or its ground truth establishment is mentioned in this document.

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