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The Fetal Doppler is intended to detect fetal heart beats, display fetal heart rate and play the fetal heart sound from early gestation thru delivery for singleton pregnancies. The Fetal Doppler is intended for use by trained healthcare professionals only in a clinical setting.

The Fetal 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 provided document is a 510(k) summary for a Fetal Doppler device (Models AOJ-50A and AOJ-50B). It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

Here's the information about acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The core performance acceptance criteria for the Fetal Doppler relate to its ability to measure Fetal Heart Rate (FHR) accurately. The performance reported is in comparison to the predicate device, which inherently sets the acceptance criteria through substantial equivalence.

Note: The document states that the "subject and predicate device have similar technological characteristics" and that the "differences in technological characteristics between the subject and predicate device do not raise different questions of safety or effectiveness." This implies that the acceptance criteria for the subject device are met if its performance matches or falls within acceptable limits established by the predicate device for these parameters.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly mention specific sample sizes for clinical test sets or data provenance (country of origin, retrospective/prospective clinical studies). The submission relies on non-clinical performance testing and comparison to a legally marketed predicate device.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document does not mention the use of human experts to establish ground truth for a test set. This type of device (Fetal Doppler) typically relies on direct measurement accuracy against established standards or instruments rather than expert interpretation of complex medical imagery or data requiring consensus.

4. Adjudication Method for the Test Set

Since no expert panel or clinical test set requiring subjective interpretation is described, an adjudication method is not applicable and therefore not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed or reported as this device is a diagnostic tool primarily for objective measurement (FHR detection and display) and not one that relies on human interpretation of complex data that could be augmented by AI. The document does not describe AI assistance for human readers.

6. Standalone Performance Study (Algorithm Only)

The document focuses on the performance of the device as a whole system. It does not detail a standalone algorithm-only performance study in the context of AI or advanced algorithms. The core function is based on established Doppler ultrasound principles.

7. Type of Ground Truth Used

The ground truth for the performance parameters (like FHR measurement) would typically be established by:

• Bench testing against calibrated instruments: For accuracy, range, resolution, and acoustic output parameters, precise measurements from calibrated test equipment serve as the ground truth.
• Compliance with recognized standards: Adherence to standards like IEC 60601-1, IEC 60601-2-37, and NEMA UD2 ensures performance meets established safety and effectiveness benchmarks.

The document implicitly refers to these as the methods for establishing ground truth through "Non-Clinical Performance Testing" which includes "Ultrasound and Acoustic Testing."

8. Sample Size for the Training Set

The document does not describe or refer to a training set in the context of machine learning or AI models. This device is an ultrasonic monitor that relies on physical principles of Doppler shift, not on data-driven learning models with training sets.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set for machine learning, the question of how its ground truth was established is not applicable.

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