(250 days)
The FM20 is a Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel LCD(7") Display, recorded on a strip chart recorder and may be transmitted over RS232 port to a remote data receiver. Single/Twin fetal heart rates may be measured by means of Doppler Ultrasound. Uterine Activity is measured with an external TOCO transducer. The FM20 is intended to be used during the antepartum periods on pregnant woman.
FM20 is the fetal monitor that measures uterine contractions and fetal heart rate (FHR) which may be used to predict fetal status. To detect the Doppler frequency signal reflected from the heart of the fetus, FM20 irradiates ultrasound wave to the abdomen of a pregnant woman. FM20 analyzes this signal and displays the heart rate by LCD. Also, FM20 provides the sound from the heart of fetus. FM20 measures the uterine contraction of a pregnant woman by pressure sensors and displays the numerical values. And FM20 prints the heart rate of the fetus and the values of uterine contraction. FM20 records the heart rate of the fetus, the uterine contraction of a pregnant woman. and basic information of the equipment with a provided thermal orinter. FM20 is capable of Twin Monitoring with two pulsed Ultrasound Transducers. FM20 has a free voltage(100 - 240VAC input) power adaptor. FM20 has Fetal movement detection function. To extract fetal movement signal, FM20 uses a circuit and digital filter. FM20 has Event marker function so that the patient can record the time of important events. FM20 has the capability to alert the caregiver in the event a heart rate goes above or below limit for a preset time delay.
The provided text describes a 510(k) submission for the Mediana FM20 Fetal Monitor, focusing on its substantial equivalence to predicate devices. The document highlights the device's technical characteristics, indications for use, and safety testing but does not contain detailed information about specific acceptance criteria or a study proving that the device meets those criteria with quantitative performance metrics. It primarily states that "All test results were satisfactory" for safety, EMC, and performance testing according to standards EN/IEC 60601-1 and EN/IEC 60601-1-2.
Therefore, many of the requested details cannot be extracted directly from the provided text.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that the specifications and performances (FHR monitoring, UC monitoring, Transducer type, ultrasound frequency, FHR range, FHR accuracy, Detection of fetal movement via ultrasound transducer) of Mediana Model FM20 are equivalent to the predicate devices (Bistos Co.,Ltd. Model BT-300, and BiOSYS Co.,Ltd, Model IFM-500). However, it does not explicitly list numerical acceptance criteria or the specific performance values achieved by the FM20.
| Acceptance Criteria (Example) | Reported Device Performance (Example) |
|---|---|
| FHR Accuracy: [Not specified] | Equivalent to predicate devices |
| UC Monitoring: [Not specified] | Equivalent to predicate devices |
| Ultrasound Frequency: [Not specified] | Equivalent to predicate devices |
| FHR Range: [Not specified] | Equivalent to predicate devices |
| Fetal Movement Detection: [Not specified] | Equivalent to predicate devices |
| Electrical Safety: EN/IEC 60601-1 | Satisfactory |
| EMC Testing: EN/IEC 60601-1-2 (2001) | Satisfactory |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify any sample size used for a test set or the data provenance (e.g., country of origin, retrospective or prospective) for a clinical study. The information provided heavily relies on the equivalence to predicate devices and adherence to electrical/EMC standards, rather than new clinical performance data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The document does not describe a study involving expert-established ground truth for a test set.
4. Adjudication Method for the Test Set:
Not applicable. The document does not describe a study with an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study is not mentioned. The submission focuses on substantial equivalence based on technical characteristics and safety standards, not on direct comparison of human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The document describes the device as a "Fetal Monitor," implying it's a standalone monitoring device. However, it doesn't detail performance studies for the algorithm in isolation. Its performance is stated as "equivalent" to predicate devices, which are also standalone fetal monitors. The device does have features like "Fetal movement detection function. To extract fetal movement signal, FM20 uses a circuit and digital filter" and "capability to alert the caregiver in the event a heart rate goes above or below limit for a preset time delay," which represent algorithm-driven functions. However, quantitative standalone performance metrics for these functions are not provided.
7. The Type of Ground Truth Used:
Ground truth, in the context of clinical performance evaluation (e.g., pathology, outcomes data, expert consensus), is not explicitly mentioned or used in this submission. The "ground truth" for the device's acceptable performance appears to be its adherence to established electrical, mechanical, and environmental safety standards (EN/IEC 60601-1, EN/IEC 60601-1-2) and its technical equivalence to previously cleared predicate devices.
8. The Sample Size for the Training Set:
Not applicable. The document does not describe a machine learning algorithm that would require a training set in the conventional sense. The device's "Fetal movement detection function" uses a "circuit and digital filter," suggesting a more traditional signal processing approach rather than a machine learning model requiring a large training dataset.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as a training set for a machine learning algorithm is not described.
§ 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).