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The intended use of the WatchChild™ Obstetrical Patient Data Management System is a complete obstetrical information system which has the ability to record, store, and display data from fetal monitors and maternal vital signs monitors, and manages patient information from the initial fetal stress tests through post delivery discharge. The WatchChild™ System organizes clinical data, which would normally be provided on paper records or other clinical systems and devices. This system serves as a decision support tool as well as an electronic medical record. This device is intended for use in a hospital/clinical environment.

The WatchChild™ Obstetrical Patient Data Management System (The WatchChild™ System) is a complete Obstetrical Information Management System that has the capability to record, store, and display fetal and maternal data from initial fetal stress tests through labor, delivery and discharge. Specifically, data from fetal monitoring and maternal vital signs monitoring equipment can be recorded, stored, and displayed on The WatchChild™ System via automation of the following areas:

• Admission/Discharge/Transfer (ADT) .
• Labor and Delivery notes .
• Nursing notes ●
• . Physician's notes
• Fetal Strip faxing .
• Obstetrical statistical trend reports, e.g., patient enrollments and discharges over ● time
  The WatchChild™ System has the ability to simultaneously display graphic and text data on the same screen permitting the clinician to view a patient's fetal strip along with her medical data. Interaction with The WatchChild™ System is accomplished through a graphical user interface (GUI). The user activates buttons on the screen utilizing either a light pen or a mouse. The WatchChild™ System is offered with an optional optical disk archiving system (WORM technology) that replaces conventional paper storage. In addition, an optional physician's remote access is also available. Using a personal computer, a physician can call from outside the hospital and display real time and/or trended data for any patient connected to the system, as well as perform annotations to the patient's fetal strip.
  The WatchChild™ System can be installed as a stand-alone system or connected to the Hospital's Information System.

The provided text is a 510(k) summary for the WatchChild™ Obstetrical Patient Data Management System. It explicitly states that clinical testing is not applicable for this device. As such, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in a clinical context.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's a breakdown of what can be extracted:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not applicable/not provided for clinical performance as clinical testing was deemed unnecessary. The submission focuses on substantial equivalence to a predicate device and software verification/validation.
• Reported Device Performance: Not applicable for clinical performance. The device's performance is described in terms of its features and capabilities (recording, storing, displaying data, organizing clinical information, decision support, EMR functionality).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable as no clinical test set was used.

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 no clinical test set was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable as no clinical test set was used.

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. The device is an information management system, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable for clinical performance. The "standalone" mentioned refers to its ability to be installed as a standalone system or integrated with hospital information systems, not its performance as an algorithm without human interaction for clinical decision-making.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable for clinical performance. The "ground truth" for this device would relate to the accuracy of data acquisition, storage, and display, which would be verified through software testing and functional validation, not clinical ground truth like pathology.

8. The sample size for the training set

• Not applicable as no machine learning/AI training set is mentioned for this device.

9. How the ground truth for the training set was established

• Not applicable as no machine learning/AI training set is mentioned for this device.

Summary of what is present:

• Nonclinical Testing: "Testing was conducted to verify and validate the software." This is the only type of "testing" mentioned.
• Predicate Device: The system is compared to "The WatchChild™ System Obstetrical Patient Data Management System cleared for marketing by FDA in 510(k) K014094 on January 11, 2002." The submission claims substantial equivalence based on having "the same capabilities to record, display, and archive data collected from fetal and maternal monitors, nurse's and doctor's notes and annotations."
• Conclusion: The manufacturer concluded that the device is "as safe, as effective, and performs as well as or better than the legally marketed predicate device."

In essence, this is a re-submission or update of an existing device, and the regulatory pathway chosen (510(k)) and the nature of the device (data management system) meant that clinical effectiveness studies were not required to demonstrate substantial equivalence. The focus was on software validation and functional equivalence to the predicate device.

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