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The device is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home.

The 510(k) covers four series of Fetal Doppler devices, including FD-200, FD-231, FD-591, and FD-640. Each series contains two models, and four series consists of a total of eight individual models (FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D). The subject devices are used for non-invasive measurement and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. All models have two hand-held components, a main unit and a probe. The main unit consists of the main board, power module, battery, speaker, and LED screen. The probe consists of the ultrasonic transducers for transmission and one for signal reception. The ultrasonic signal is continuously transmitted at a frequency of 2.0. 2.5, or 3.0 MHz, depending on the probe selected. The reflected continuous signal is received, and detected Doppler shift is presented to the user. These devices are intended for use at or after 12 weeks' gestation.

The provided text is a 510(k) summary for a Fetal Doppler device. It describes the device, its intended use, and substantial equivalence to a predicate device, but it does not contain a detailed study proving the device meets specific acceptance criteria based on clinical performance with a test set, ground truth, or expert involvement.

The summary focuses on non-clinical performance testing and substantial equivalence.

Here's a breakdown of the requested information based on the provided document, highlighting what is not available:

1. Table of acceptance criteria and the reported device performance

Note: The document states that the FHR measuring range of the subject device is 50-210 bpm, while the predicate device is 50-230 bpm. This is a difference, but the document concludes it "does not raise different questions of safety and effectiveness."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not available. The document describes non-clinical performance testing, not a clinical study involving a test set of patient data to evaluate algorithmic performance. The "Use-life testing" involved evaluating "pressing-key performance and FHR measurement accuracy" under "simulated repeated use conditions," but this is not a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not available. No clinical test set with expert-established ground truth is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not available. No clinical test set with adjudication is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable / Not available. This device is a Fetal Doppler, which directly measures FHR. It is not an AI-assisted diagnostic tool that would typically involve human readers interpreting AI output.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable / Not available. This is a hardware device for FHR detection. The "Performance" section lists device specifications for FHR measuring range, resolution, and accuracy, which are standalone device performance metrics. However, these are not the result of an "algorithm only" study in the context of AI/ML, but rather the intrinsic performance of the sensing and processing hardware.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For the FHR accuracy claim (±2 bpm), the ground truth would typically be established by a highly accurate reference standard for heart rate measurement. The document implies this was evaluated during "Use-life testing" under "simulated repeated use conditions," but does not explicitly state the ground truth methodology. It would likely involve a calibrated signal generator or a highly precise alternative FHR measurement system. It does not involve expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• Not applicable. This device is a Fetal Doppler, not an AI/ML device that requires a "training set" for an algorithm.

9. How the ground truth for the training set was established

• Not applicable. As above, there is no mention of a training set as this is not an AI/ML device.

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