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These transducers are intended to be used as replacement accessories for Hewlett Packard and Corometrics fetal monitors. These transducers measure fetal heart rate or uterine contractions in the gravid patient.

Tenacore Holdings, Inc. Transducers for Fetal Ultrasound and Tokodynamometer Monitoring are direct replacements for similar transducers manufactured by GE Marquette Medical Systems and Epic Medical Equipment Services. A Transducer employing ultrasound Doppler Shift Technology is used for the detection of Fetal Heart Rate during labor and a Tokodynamometer Transducer, which actually is a strain gauge, is used to evaluate and measure the duration, frequency, and relative pressure of uterine contractions during labor.

I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary and FDA clearance letter for a medical device (transducers for fetal monitoring), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria.

The document mentions:

• Intended Use: As direct replacement accessories for appropriate Perinatal Monitoring Systems that display the graphical relationship between labor and fetal heart rate.
• Performance Standards: "Tenacore Holdings, Inc has declared to conform to consensus performance standards concerning Electrical Electromagnetic Compatibility / Mechanical / Efficacy / Safety and Biocompatibility aspects of the product."

However, it does not provide:

• A table of specific acceptance criteria and reported device performance.
• Details about a specific study (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC study, standalone performance).
• Information on training set sample size or how its ground truth was established.

Therefore, I cannot generate the requested table and answer the study-related questions based on the provided text.

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