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The BirthNet™ II Perinatal Patient Data Management System is designed for use in the following functions:
a) Collect fetal monitor data for the purpose of central surveillance. Iocal surveillance. review, annotation, and for archiving data for long storage.
b) Report alert conditions generated by the AMS fetal monitors or the AMS computer interface module (CIM).
c) Collect physiological, maternal and fetal data directly from physiological monitors and append such data to the proper patient database table.
d) Feed back selected data items to the AMS fetal monitor for the purpose of printing such data on the fetal monitor strip in real time.
e) Enable manual patient data entry into the system for the purpose of charting.
f) Assemble and display selected data in a summary format of r more efficient review capability by the care giver.
g) Validate data entry when applicable to ensure data integrity.
h) Print pre-formatted reports on individual patients
i) Reproduce fetal monitor records from storage to a printer or an AMS UR10 (stripped down fetal monitor) recorder.
j) Transmit selected items from the database via fax.
k) Enable authorized (password) care giver to access the system remotely.
l) Generate an audit trail for all transactions.
m) Generate statistics reports for quality assurance.
n) Facilitate the generation of a birth certificate by providing pertinent patient data acquired by the system.

The BirthNet TM II Perinatal Patient Data Management System is a comprehensive on-line, real-time information system to collect, display, and store physiological (e.g. fetal heart rate and uterine activity) data and other pertinent patient medical information. Designed specifically for pregnancy, delivery, and early neonatal care, medical personnel can review the status and management of each patient form any hospital based workstation. The primary function of the BirthNet TM II Perinatal Patient Data Management System is to automatically receive and record physiological monitoring data, and correlate this data with health care practitioner supplied data such as medicinal administrations, and recognized physical and physiological conditions. The BirthNet ™ II Perinatal Patient Data Management System is also designed to interface with all AMS fetal monitors and most all fetal and maternal physiological monitors presently available. Patient information can be archived onto optical disks for long-term storage. Aggregate statistical reports can also be generated.

The provided text is a 510(k) summary for the Advanced Medical Systems BirthNet™ II Perinatal Patient Data Management System. It states that the device has undergone "extensive safety testing" and "extensive performance testing prior to release," with "Final testing for the system includes a comprehensive validation of the entire system requirements." However, it does not provide specific details about the acceptance criteria, the study design, or the results that prove the device meets any specific criteria.

Therefore, I cannot populate the requested tables and sections with factual information from the given input. The document focuses on establishing substantial equivalence to predicate devices and describes the device's functions and classification, but it does not detail performance metrics or study specifics like sample sizes, ground truth establishment, or expert qualifications.

Based on the provided text, the following information is NOT available:

• A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are listed.
• Sample size used for the test set and the data provenance: No details on testing sample sizes or data origin are provided.
• 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, and the effect size: Not mentioned.
• 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 (as this is a data management system, not typically an AI/machine learning algorithm with distinct training/test sets in the modern sense).
• How the ground truth for the training set was established: Not mentioned.

The document generally states: "The BirthNet™ II Perinatal Patient Data Management System has been subject to extensive safety testing and will be subject to extensive performance testing prior to release. Final testing for the system includes a comprehensive validation of the entire system requirements." This is a general statement about testing without specifics.

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