(89 days)
I. Fetal Surveillance
The Corometrics® Model 173 Series Monitor is used for monitoring of the fetus throughout labor and delivery (i.e. fetal heart rate via US Transducer, fetal ECG via Spiral Electrode and uterine activity monitoring via TOCO Transducer or IUPC). The device also has an optional monitoring mode to detect fetal body movements.
II. Maternal NBP Recording
Blood Pressure. The monitor has an interface to select external NBP monitors. The Monitor does not process any NBP data but only prints the NBP data , from the external monitor, to its chart recorder.
The Model 173 Series Fetal Monitor is intended for monitoring fetal and maternal vital signs: fetal heart rate, fetal ECG, maternal uterine activity, optional fetal movement detection, and an interface for select maternal NIBP monitors. The device is intended for use in a hospital/clinical environment.
The provided text does not contain specific information about the acceptance criteria or a detailed study proving the device meets these criteria in the way a modern AI/ML device submission would. Instead, it is a 510(k) summary for a Fetal Monitor, focusing on substantial equivalence to predicate devices and general regulatory information.
Therefore, many of the requested fields cannot be answered based on the provided text.
However, I can extract what is available and acknowledge what is missing:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or detailed performance metrics are provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices (Corometrics Model 151 and Models 171/172 Fetal Monitors). The device "has been extensively tested to meet its requirements and design," but these requirements and designs are not detailed, nor are the specific performance outcomes of these tests.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not mentioned in the document.
3. 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 applicable, as this is a hardware medical device submission rather than an AI/ML algorithm requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. 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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated in terms of a "ground truth" for an algorithm. The device's performance would be validated against established medical standards for fetal heart rate, uterine activity, and NBP monitoring, likely using reference instruments or clinical observation, but the details of this validation are not provided.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
§ 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).