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The Cadence Fetal Monitor , model 2001 for singletons and model 2002 for twins, is a fetal monitor for monitoring fetal well being during the antepartum period. It performs what is commonly called the non stress test.

The Cadence Fetal Monitor 2001/2002 is to be used by trained medical personnel in hospitals clinics, physicians offices, and in the patients home by prescription or doctors orders.

The Cadence Fetal monitor is a perinatal monitoring system for non-invasively measuring, displaying and printing out in graphic form on a strip chart recorder maternal abdominal contractions and fetal heart rate for either a singleton fetus or twin fetuses during the last trimester. A manual hand held pushbutton marker for patient identification of contractions is also part of the monitor. The Cadence Fetal monitor uses one or two ultrasound transducers for monitoring the fetal heart rate (FHR) depending on whether there is a singleton or twin pregnancy. The multi crystal , broad band ultrasound transducer operates at a frequency of 2 mHz. The ultrasound transducer or transducers are placed on the maternal abdomen by means of one or two belts and transmits the ultrasound signal to the fetal heart(s). The transducer(s) also receive the echo from the fetal heart(s) and processes the echoes determining the fetal heart rate(s) The TOCO transducer is also placed on the maternal abdomen with a belt and it detects the forward displacement of the maternal abdominal muscles during a contraction. The TOCO transducer is a tocotonometer which operates on the strain gauge principle to measure displacement. The central section of the TOCO transducer is depressed by the forward displacement of the abdominal muscles during a contraction. It is used for assessing frequency and duration of uterine contractions. It gives an indication of contractions pressure.

The fetal heart rate(s) and TOCO percent contractions pressure are displayed on numerical readouts and printed out on a strip chart recorder in graphic form.

A fetal event marker pushbutton is also available for the patient to identify contractions manually by pushing the button on the fetal event marker.

The Cadence Fetal Monitor device was deemed substantially equivalent to predicate devices (Sonicaid 820 and Corometrics 171/172) based on

• principles of operation
• specifications
• performance

This means that the device meets the same acceptance criteria as the predicate devices. The submission indicates that "Extensive safety, performance testing, and validation" were performed to ensure the device met "all of its functional requirements and performance specifications" and complied with safety standards. However, specific acceptance criteria and detailed performance results from this testing are not explicitly reported in the provided text.

Based on the information provided, here's a summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the performance tests. It generically mentions "Extensive safety, performance testing, and validation" but provides no details on these aspects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not provided in the document. The Cadence Fetal Monitor is a hardware device for monitoring, not an AI-assisted diagnostic tool, so an MRMC study with AI assistance would not be applicable in this context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not explicitly stated. The device itself is designed for continuous monitoring and provides numerical and graphical readouts to be used by trained medical personnel. Its "standalone" performance would refer to its ability to accurately detect FHR and TOCO measurements, which is implied by the performance testing mentioned, but no specific standalone study details are given.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not explicitly describe the type of ground truth used for validating the device's measurements. For a fetal monitor, ground truth would typically involve comparing the device's FHR and TOCO readings against established medical standards or other validated monitoring equipment, but the details of this comparison are not provided.

8. The Sample Size for the Training Set

This information is not provided in the document. As this is a hardware device based on established principles of operation (Pulsed Doppler with auto-correlation and strain gauge for TOCO), it would likely not involve a "training set" in the sense of machine learning algorithms. Its design and calibration would be based on engineering principles and preclinical testing.

9. How the Ground Truth for the Training Set Was Established

As noted above, this information is not applicable in the context of a "training set" for a traditional hardware medical device like a fetal monitor.

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