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The Ultrasonic Tabletop Doppler is intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices.

The 2 MHz and/or 3 MHz probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability following patient trauma.

Ultrasonic Tabletop Doppler provides the following primary features:

• Basic parameters: FHR
• 240 seconds fetal heart sound record and playback
• Infrared communication (for TD-6000 only)
• Ni-MU1 battery for 20 hours continuous working of main unit
• Li-ion battery for 2.5 hours continuous working of TD-6000 probe
• Charge the TD-6000 probe battery by main unit
• Continuous wave Doppler transducer for FUR detection

The provided 510(k) summary for the TD-5000 & TD-6000 Ultrasonic Tabletop Doppler explicitly states: "Clinical testing is not required" (Page 2).

Therefore, there is no clinical study that proves the device meets specific acceptance criteria based on human performance or diagnostic accuracy. The substantial equivalence determination is based on non-clinical tests and comparison to a predicate device.

Given this, I cannot provide the requested information regarding acceptance criteria and performance based on a clinical study, as such a study was not performed or reported in this submission.

However, I can extract information about the non-clinical tests that were performed:

Non-Clinical Tests Performed:

The following quality assurance measures were applied to the development of the Ultrasonic Doppler (Page 2):

• Software testing
• Hardware testing
• Safety testing
• Environment test
• Risk analysis
• Final validation

The submission states that "Verification and validation testing was done on the TD-5000 & TD-6000 Ultrasonic Tabletop Doppler" (Page 2), and that the device "has similar technology characteristics and has the same intended use, same design principle, same electrical classification, same measurement mode and same accuracy as the predicate device" (Page 2).

Since no clinical study was conducted, the following requested information points cannot be answered:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
• If a standalone performance (algorithm only) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

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