(352 days)
FC-1400 detects and displays twin Fetal Heart Rate (FHR), Fetal Movement (FM) and Uterine Activity (UA) in a real time on the color LCD viewer, and also provides the fetal heart beat sound with internal speaker. Twelve hours of tracing may be stored and later retrieved for printing. It intended to be used by trained healthcare personnel. It is not intended for home use.
FC-1400 is a fetal monitor, providing continuous monitoring, displaying, printing and recording of twin Fetal Heart Rate (FHR), Fetal Movement (FM) and Uterine Activity (UA) for antepartum testing and monitoring. FC-1400 irradiates the ultrasound from the external abdomen, and detects the Doppler effect signal reflected from the heart of the fetus. FC-1400 detects the Doppler effect signal reflected from the heart of the fetus and provides the fetal heart beat sound with internal speaker. FC-1400 measures the UA of a pregnant woman using TOCO sensor. FC-1400 displays FHR, UA and FM with waveforms and numbers in a real time on the color LCD viewer, and also stores them in internal flash memory and prints a part of them with high speed to review in details. It provides the most accurate and continuous obstetrical measurements enduring and rigorous hospital environment. FC-1400 detects and displays twin Fetal Heart Rate (FHR), Fetal Movement (FM) and Uterine Activity (UA) in a real time on the color LCD viewer, and also provides the fetal heart beat sound with internal speaker. Twelve hours of tracing may be stored and later retrieved for printing. It is not intended for home use.
The provided 510(k) summary for the BioNet FC-1400 Perinatal Monitor does not include information about specific acceptance criteria or performance studies comparing the device against such criteria.
The document focuses on demonstrating substantial equivalence to predicate devices (FETALGARD Lite and Philips Avalon CTS Cordless Fetal Transducer System) by comparing technological characteristics and adherence to safety and electromagnetic compatibility standards.
Here's an breakdown of the requested information based on the provided text, highlighting what is not available:
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A table of acceptance criteria and the reported device performance
- Not Available. The document does not specify quantitative acceptance criteria for parameters like FHR accuracy, FM detection sensitivity, or UA measurement accuracy. It generally states the device provides "accurate and continuous obstetrical measurements" but does not provide specific performance metrics against defined targets.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. The document mentions "NONCLINICAL TESTS" for electrical safety, EMC, and biocompatibility, but these are not performance studies related to the clinical function of FHR, FM, or UA monitoring. No details about clinical test sets, sample sizes, or data provenance (country, retrospective/prospective) are provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Available. As no clinical performance study involving a test set and ground truth is described, this information is absent.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available. No clinical test set or adjudication method is described.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is a perinatal monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to AI assistance for human readers would not be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device performs functions (detecting and displaying FHR, FM, UA). However, the document does not describe a standalone performance study (algorithm only) with quantitative results against specific criteria. The focus is on demonstrating equivalence to predicate devices through design characteristics and safety standards, rather than direct, standalone clinical performance measurement.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available. As no clinical performance study involving a test set and ground truth is described, this information is absent.
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The sample size for the training set
- Not Applicable. This type of device (a monitor) typically does not involve a "training set" in the context of machine learning or AI algorithms as diagnostic tools would. Its performance is based on sensor technology, signal processing, and display, not on being "trained" on data.
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How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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).