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The Ultrasonic Fetal Doppler (Model M520, M521, M523) is intended to detect and display fetal heart rate, and used by health care professionals in a hospital, clinic, community, and home setting for singleton pregnancies after 16 weeks gestation.

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The provided text is a 510(k) clearance letter from the FDA for an "Ultrasonic Fetal Doppler." This document primarily focuses on regulatory approval and does not contain specific information about the acceptance criteria, study details, or performance metrics of the device as typically found in clinical validation studies.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size
• Standalone performance details
• Type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

The document states the device's intended use: "to detect and display fetal heart rate, and used by health care professionals in a hospital, clinic, community, and home setting for singleton pregnancies after 16 weeks gestation." However, it does not provide the technical validation data that would be used to establish equivalence and meet performance criteria.

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