(260 days)
The MindChild Medical Meridian Fetal Heart Rate Monitor is an intrapartum fetal monitor that externally or internally measures and displays fetal heart rate (FHR). The MindChild Meridian acquires and displays the FHR tracing from abdominal surface electrodes that detect the fetal ECG signal (fECG). The MindChild Meridian may also be used to measure and display fetal heart rate using direct ECG (DECG) with a fetal scalp electrode. The MindChild Meridian is indicated for use on women who are at term (> 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 MindChild Medical Meridian 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. Data is stored locally for retrieval in an off-line mode. The patient data is displayed real time on a touch screen LCD display monitor. Data may be printed out offline for permanent hard copy records. The system also possesses the ability to acquire and analyze signals from a fetal scalp electrode using the device's direct ECG (DECG) capability. The entire system is housed within a medical grade roll-up cart. The device is intended to be used in a hospital environment by trained medical staff.
The MindChild Medical Meridian Fetal Heart Rate Monitor is an intrapartum fetal monitor that externally or internally measures and displays fetal heart rate (FHR). The MindChild Meridian acquires and displays the FHR tracing from abdominal surface electrodes that detect the fetal ECG signal (fECG). The MindChild Meridian may also be used to measure and display fetal heart rate using direct ECG (DECG) with a fetal scalp electrode.
Here's an analysis of the provided text regarding the MindChild Medical Meridian Monitor, structured to answer your questions about acceptance criteria and the supporting study:
The document (K120018) describes the MindChild Medical Meridian Fetal Heart Rate (FHR) Monitor, an intrapartum fetal monitor. The primary study mentioned is a clinical validation of the Meridian algorithm for calculating FHR from fECG signals.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" with numerical targets in a formal table. However, based on the clinical validation section, we can infer the primary performance metric and its outcome. The comparator device, the HP M1350A Fetal Monitor/FSE, serves as the "Gold Standard" or reference for evaluating performance.
| Acceptance Criteria (Inferred from study goals) | Reported Device Performance |
|---|---|
| FHR accuracy within a clinically acceptable number of beats per minute (BPM) compared to Gold Standard. | Mean RMS error of 5 BPM for the Meridian algorithm (similar to other FDA cleared FHR monitors). |
| Percent successful recordings (i.e., # comparator signals / # of Meridian signals x 100) | At least 94% successful signal reading for all signals recorded with the comparator FSE device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the total number of patients or recordings used in the clinical validation study. It mentions a "single Bland Altman (BA) difference plot was generated... for each patient," which implies multiple patients were included, but the exact count is not given.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). However, the study involved acquiring and recording fetal ECG signals simultaneously using the Meridian Monitor and the HP M1350A Fetal Monitor/FSE, suggesting it was a prospective data collection in a clinical setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for the test set. Instead, the HP M1350A Fetal Monitor/FSE itself was considered the "comparator" or "Gold Standard" for FHR measurements.
4. Adjudication Method for the Test Set
No adjudication method is described. The comparison was directly between the Meridian algorithm's FHR calculations and those from the HP M1350A Fetal Monitor/FSE.
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 MRMC comparative effectiveness study was done or mentioned. This study focuses on the standalone algorithm's performance against a reference device, not human reader performance or improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone (algorithm-only) performance study was conducted. The clinical validation directly compared the fetal heart rates calculated by the Meridian algorithm to the fetal heart rates calculated by the HP M1350A Fetal Monitor/FSE. There is no mention of human interpretation being part of this primary performance evaluation.
7. The Type of Ground Truth Used
The ground truth for the clinical validation was derived from the HP M1350A Fetal Monitor/FSE, which served as the "Gold Standard device" or comparator for calculating fetal heart rate. This is a form of reference device comparison or device-derived ground truth.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. The clinical validation solely describes the testing of the Meridian algorithm.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, there is no information on how its ground truth was established.
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).