(30 days)
-
- Fetal Surveillance
A Corometrics 120 Maternal/Fetal Monitoring System is used for non-invasive and invasive monitoring of the fetus during the antepartum period as well as throughout labor and delivery (i.e. fetal heart rate and uterine activity monitoring). Fetal movement detection and fetal heart rate alarm options (user selectable high/low and poor signal quality alarms) are available.
- Fetal Surveillance
ll Maternal Monitoring
A Corometrics 120 Maternal/Fetal Monitoring System is intended for monitoring maternal vital signs to help assess maternal well-being. The vital signs which can be measured with these monitor configurations are summarized as follows:
NOTE: Maternal vital signs provided by the monitor should only be used as an adjunct in patient assessment in conjunction with clinical signs and symptoms.
Blood Pressure: The monitor is intended for use in the non-invasive monitoring of maternal blood pressure (NBP). This monitor 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 maternal functional oxygen saturation of arterial hemoglobin (MSpO2).
Heart/Pulse Rate. The monitor is intended for use in the non-invasive monitoring of the maternal heart/pulse rate. Additionally, an MECG waveform "snapshot" may be displayed and printed.
NOTE: Only the maximum configuration provides both maternal heart rate and pulse rate data.
The 120 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 of Safety and Effectiveness for the Corometrics Model 120 Maternal/Fetal Monitor. It details the device, its intended use, and states that it employs the same fundamental scientific technology as predicate devices. However, it does not contain specific acceptance criteria or a detailed study proving the device meets those criteria.
The "Test Summary" section lists general quality assurance measures applied to the development, such as:
- Requirements specification review
- Code inspections
- Software and hardware testing
- Safety testing
- Environmental testing
- Final validation
The "Conclusion" states that "The results of these measurements demonstrated that the Model 120 Maternal/Fetal Monitor (with Masimo SET Pulse Oximetry) is as safe, as effective, and performs as well as the predicate device."
Without further documentation, it is not possible to complete the requested table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies. The 510(k) summary typically references a more detailed technical file that would contain this information.
Therefore, based solely on the provided text, I cannot describe the acceptance criteria or a detailed study that proves the device meets specific performance metrics.
However, I can extract the information that is present:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Explicitly stated) | Reported Device Performance (Explicitly stated) |
|---|---|
| Not explicitly stated in terms of metrics | The device "is as safe, as effective, and performs as well as the predicate device" (K991739 Corometrics Model 120 Maternal/Fetal Monitor and K992238 Masimo SET® Radical Pulse Oximeter and LNOP® series of sensors and cables). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. The document mentions "Software and hardware testing," "Safety testing," "Environmental testing," and "Final validation" but does not detail the datasets used for these tests.
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 specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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:
- This device is a physical monitor, not an AI diagnostic tool. Therefore, an MRMC study related to human readers improving with AI assistance is not applicable. The comparison is against predicate devices, not human performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is a physical monitor, not a standalone algorithm. Performance demonstrated was likely the integrated system's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not specified. For a maternal/fetal monitor, ground truth would typically refer to the accuracy of physiological measurements (e.g., actual fetal heart rate, uterine pressure, maternal SpO2 measured by a gold standard), but the document does not detail this.
8. The sample size for the training set:
- Not applicable as this is not an AI/machine learning device that requires a training set in the conventional sense. The "development" process included reviews and various forms of testing.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/machine learning 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).