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The F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring are intended for continuous wireless fetal monitoring indicated for pregnant women from about 22 weeks gestation through delivery: to be used during antepartum and intrapartum monitoring. This device is singleton pregnancies only. It is not intended for home use.

The Ultrasound Transducer detects and evaluates the fetal heart rate during uterine contractions, and the Toco Transducer detects uterine contractions. The Transducers are to provide a means of sensing and function for signals to pass through from the patient to the monitoring or recording system. No other usage is intended for the transducers.

The system should only be used by, or under the direct supervision of, a licensed physician or other health care practitioner who is trained in the use of fetal heart rate monitors and in the interpretation of fetal heart race traces.

The F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring is a perinatal monitoring accessory that integrates with GE Corometrics series monitors. The accessory's intended use is for antepartum and intrapartum wireless measurement and recording of fetal heart rate and maternal contractions. The intended use environment is a clinical setting, in the labor and delivery room of a hospital. The F1 is equipped with 1 Ultrasound (US) transducer, 1 Tocodynamometer (TOCO) transducer, and 1 Base Station. The Base Station transmits data wirelessly between the US/TOCO transducers (respectively) and a separate FDA-cleared fetal monitor ("monitor"), and is connected directly to the monitor via wired connection. The monitor must be used with the F1 accessory for display and recording of signals.

The Ultrasound and TOCO Transducers are water-resistant and may be used in the shower and tub during the first stage of labor, but not during the second stage of labor (underwater delivery), and should not be submerged or operated underwater. The Transducers may be used in the shower and tub in the same manner as when used away from water.

The provided text describes specific performance testing for the F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring, but it does not provide a clear table of acceptance criteria with corresponding reported device performance metrics. Instead, it lists various non-clinical and clinical tests performed.

Therefore, I cannot create the requested table of acceptance criteria and reported device performance from the given information.

However, I can extract information related to the other points you've asked for, based on the provided text, and will indicate where information is not present.

Here's a summary of what's available and what's missing:

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

• Not provided: The document lists the types of tests performed (e.g., EMC, electrical safety, wireless range, acoustic output, accuracy) but does not present a table with specific numerical acceptance criteria (e.g., "Accuracy must be ±X%") or the precise, quantified reported performance against those criteria. It states that tests were performed to "verify performance and safety" and "verify efficacy" or "verify operation." For US accuracy, it mentions "accuracy was measured using a fetal heart rate simulator" but doesn't state the measured accuracy value. For TOCO, it notes the ability to "measure pressure over a clinically-relevant range...in a monotonic fashion."

2. Sample sized used for the test set and the data provenance

• Test Set Sample Size: "pilot clinical testing on pregnant women (n=5)."
• Data Provenance: The study was a "pilot clinical testing on pregnant women" which implies prospective data collection, specifically "in a simulated antepartum and intrapartum environment." The country of origin is not explicitly stated, but the submission is to the U.S. FDA by Farus, LLC, based in Vista, CA, USA, suggesting a U.S.-based study is likely, though not confirmed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not provided: The document mentions that the system "should only be used by, or under the direct supervision of, a licensed physician or other health care practitioner who is trained in the use of fetal heart rate monitors and in the interpretation of the fetal heart rate traces." However, it does not specify how ground truth was established for the clinical test, nor does it list the number or qualifications of any experts involved in defining or adjudicating ground truth.

4. Adjudication method for the test set

• Not provided: The document does not describe any adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth in the clinical test.

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 / Not done: This device is a medical accessory for monitoring fetal heart rate and uterine contractions, not an AI or diagnostic imaging device that would typically involve human readers interpreting results with or without AI assistance. The clinical test compared the wireless EFM accessory's performance to "standard, wired EFM" in terms of "efficacy in the measurement."

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

• Yes, for certain functional aspects: The device itself performs sensing and data transmission. Several non-clinical bench tests (e.g., Wireless Range Test, Wireless Coexistence Test, Acoustic Output Test, Code Compilation Summary Test, Data Transmission Test, Pairing Verification Test, Charging Verification Test, System Performance Verification Test, TOCO Strain Performance Test, US Performance Test, TOCO Base Station Operations Test, US Base Station Operations Test, Interoperability Test) assessed the device's standalone performance and its proper functioning. The "Clinical Measurement Accuracy Test" on a fetal heart rate simulator also represents a standalone assessment of the transducers' accuracy.

7. The type of ground truth used

• For clinical measurement accuracy: A "fetal heart rate simulator" that provides "discrete simulated fetal heart rates" was used as ground truth for the US transducer. For the TOCO transducer, the ground truth was "clinically-relevant range of pressures (simulating uterine contractions)."
• For pilot clinical testing: The performance was compared to "standard, wired EFM" which served as the reference or ground truth in that specific context to demonstrate "substantial equivalence."

8. The sample size for the training set

• Not applicable / Not provided: The device described is a hardware accessory (transducers and base station) for monitoring, not a machine learning or AI algorithm that would typically require a "training set" in the conventional sense. The document does not mention any training data for the device.

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

• Not applicable / Not provided: As no training set is mentioned for an AI/ML algorithm, this question is not relevant to the information provided.

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