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The Ultrasonic Doppler uses continuous-wave Doppler to detect fetal heart rate and play the fetal heart sound from early gestation thru delivery for singleton pregnancies. The Ultrasonic Doppler is intended for use by trained healthcare professionals only in a clinical setting.

The Ultrasonic Doppler is a hand-held device for non-invasive measurement and display of the fetal heart beat utilizing the principle of Doppler shift of an ultrasound. The device consists of two main components, the main unit and probe. The main unit consists of the main board, power module, battery, speaker, and organic light-emitting diode screen. The wired probe consists of the transducer and includes two angled semi-circle ultrasonic crystals, one for transmission and one for reception. The ultrasonic signal is continuously transmitted at a frequency of 2 MHz. The reflected continuous wave signal is received by one of the crystals and then any detected Doppler shift is presented to the user.

The main unit is powered by two 1.5V AA alkaline batteries.

The provided S510(k) summary for the Ultrasonic Doppler (Model YM-2T8) does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-based diagnostic device.

The document describes a fetal ultrasonic monitor and accessories which uses continuous-wave Doppler technology to detect fetal heart rate. This is not an AI/algorithm-based diagnostic device in the sense of image interpretation or complex pattern recognition. Instead, it's a hardware device that measures a physiological parameter.

Therefore, the requested information, which is highly relevant for AI/algorithm-based medical devices (like those in radiology or pathology where performance metrics, ground truth establishment, and human reader studies are crucial), is not found in this submission.

This S510(k) focuses on:

• Substantial Equivalence: Demonstrating that the device is as safe and effective as a legally marketed predicate device (K153475 - SD5 Ultrasonic Tabletop Doppler).
• Performance Testing: Primarily non-clinical testing related to:
  • Biocompatibility (ISO 10993-1, 5, 10)
  • Electrical safety and electromagnetic compatibility (EMC) (IEC 60601-1, 1-2, 1-11)
  • Ultrasound and Acoustic Testing (IEC 60601-2-37, NEMA UD2)
  • Software Verification and Validation (adhering to FDA guidance for moderate software level of concern)

The document explicitly states "8. Clinical Performance Testing: Not Applicable" (page 6), further indicating that the type of study you're asking for, which involves human readers, AI assistance comparison, or complex ground truth establishment on a test set, was not performed or deemed necessary for this specific device.

If this were an AI medical device, the information would likely be found under "Clinical Performance Testing" or a similar section dedicated to the algorithm's diagnostic accuracy.

In summary, none of the requested information (acceptance criteria table, sample size, expert number/qualifications, adjudication, MRMC, standalone performance, ground truth type, training set details) is present because this is a hardware device for physiological measurement, not an AI diagnostic algorithm.

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