(106 days)
The Corometrics 250 Series Maternal/Fetal Monitoring System is intended for monitoring fetal and maternal vital signs: fetal heart rate; optional fetal movement detection, FHR and UA alarms; maternal uterine activity; heart/pulse rate, blood pressure and %SpO2.
Fetal Surveillance: A Corometrics 250 Series Maternal/Fetal Monitoring System is used for non-invasive and invasive monitoring of the fetus during the antepartum as well as throughout labor and delivery (i.e. fetal heart rate and uterine activity and movement detection and poor signal quality alarms) are available.
Maternal Monitoring: A Corometrics 250 Series Maternal/Fetal Monitoring System is intended for monitoring maternal vital signs to help assess maternal well-being. The vital signs available in various configurations are summarized as follows: Blood Pressure: The monitor is intended for use in the non-invasive monitoring of blood pressure. It is not intended for use in the neonatal or pediatric blood pressure monitoring. Pulse Oximetry: The monitor is intended for use in the non-invasive monitoring of arterial hemoglobin (MSpO2). Heart/Pulse Rate: The monitor is intended for use in the non-invasive monitoring of heart/pulse rate. Optionally, an MECG waveform "snapshot" may be displayed and printed.
The Corometrics 250 Series Maternal/Fetal Monitoring System consists of the following features/options that can be available in multiple configurations: fetal heart rate (via Doppler Ultrasound of FECG); maternal uterine activity (via intrauterine pressure catheter or tocotransducer); fetal movement detection; maternal non-invasive blood pressure (clinician prompted or automatic); maternal pulse oximetry; maternal heart/pulse rate (MECG) and ECG waveform "snapshot".
The provided text is a 510(k) summary for the Corometrics 250 Series Maternal/Fetal Monitor. It describes the device, its intended use, and states that it complies with voluntary standards and the predicate device. However, it does not contain specific acceptance criteria, detailed study results, or the other requested information such as sample sizes, ground truth establishment, or expert qualifications.
The document indicates that the device was deemed "substantially equivalent" to predicate devices, implying that its performance is considered comparable. The "Test Summary" simply lists development and testing activities (requirements review, code inspections, software/hardware testing, safety testing, environmental testing, final validation) and concludes that "The results of these measurements demonstrated that the Corometrics...Monitor is as safe and effective, and as the predicate device."
Therefore, based solely on the provided text, the following information cannot be extracted:
- A table of acceptance criteria and the reported device performance: This information is not present. The document only states that the device "complies with the Test Summary...as detailed in Section 9 of this submission" and that "The results of these measurements demonstrated that the Corometrics...Monitor is as safe and effective, and as the predicate device." No specific performance metrics or acceptance criteria are listed.
- Sample sized used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- 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 mentioned. This device is a maternal/fetal monitor, not an AI-assisted diagnostic imaging device, so an MRMC study with human readers assisting AI is unlikely to be relevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
In summary, the provided document does not contain the detailed performance study information requested. It is a regulatory submission summary primarily focused on substantial equivalence to predicate devices and general software/hardware development practices rather than detailed clinical performance metrics and their validation studies.
§ 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).