(56 days)
I. Fetal Surveillance
A Corometrics 250 Series Maternal/Fetal Monitoring System is used for noninvasive 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.
II. 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 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 Corometrics 250cx 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 TOCO transducer
- . fetal movement detection
- . maternal non-invasive blood pressure (clinician prompted or automatic)
- . maternal pulse oximetry
- . maternal heart/pulse rate (MECG) and ECG waveform "snapshot"
- . maternal temperature
The provided document is a 510(k) summary for the Corometrics 250cx Series Maternal/Fetal Monitor. This submission is for a design modification of an existing device (Model 250 Series Maternal/Fetal Monitor, K050583) and focuses on changes like the addition of color to the display, an external display, a new serial protocol, an external maternal temperature probe, and additional languages.
The document does not contain acceptance criteria or a study demonstrating that the modified device meets specific performance criteria related to clinical diagnostic accuracy or effectiveness. Instead, it refers to:
- Compliance with voluntary standards: "The Corometrics 250 Series Maternal/Fetal Monitor complies with the voluntary standards as detailed in Tab F of this submission." (Tab F is not provided).
- Verification and validation testing: "The addition of the probe [maternal temperature probe] was included in the verification and validation testing for the modified device."
These statements indicate that the testing performed was primarily for device functionality, safety, and adherence to established industry standards, rather than a clinical study establishing diagnostic performance metrics (like sensitivity, specificity, accuracy) against a ground truth.
Therefore, I cannot populate the requested table or answer most of the questions as the information is not present in the provided text.
Here's a breakdown of what can and cannot be answered based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states compliance with "voluntary standards" and "verification and validation testing" but does not detail specific acceptance criteria or the numerical performance results of a clinical study for diagnostic accuracy.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. There is no mention of a clinical test set size, data provenance, or study design (retrospective/prospective).
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)
- Cannot be provided. Ground truth establishment is not discussed as no clinical study is detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No clinical study, hence no adjudication method.
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
- Cannot be provided. This device is a maternal/fetal monitor, not an AI-assisted diagnostic tool for human readers. No MRMC study or AI assistance is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This refers to algorithm performance; the device is a monitor, not a standalone algorithm in the typical sense of AI-driven diagnostics. The functionality tested was related to hardware and software modifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No clinical ground truth is mentioned in the context of diagnostic performance.
8. The sample size for the training set
- N/A. This device is a monitor and not an AI/machine learning model that typically has a "training set." The development process involved "Risk Analysis," "Requirements specification review," "Design reviews," "Code inspections," "Software and hardware performance testing," "Safety testing," "Environmental testing," and "Final validation" – which are standard engineering/software development practices.
9. How the ground truth for the training set was established
- N/A. See point 8.
In summary, the provided 510(k) document pertains to a design modification of a medical device (maternal/fetal monitor) and focuses on demonstrating that the modified device remains substantially equivalent to its predicate device by confirming functionality, safety, and adherence to standards. It does not include a clinical study establishing diagnostic accuracy metrics against a ground truth in the way one would for a new AI-driven diagnostic 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).