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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. The device should only be used by a trained medical professional in a clinical setting and is not intended for operated by the patient at home.

The subject device (model FD88) is a hand-held device for non-invasive measurement and display of the fetal heart rate (FHR) utilizing Dopler ultrasound. It includes two major components: main unit and probe. The main unit consists of the main board, power module, battery, speaker, and LCD screen. The main unit is supplied by a rechargeable 3.7V/500mAh Li-ion battery. The wired probe contains two angled semi-circle ultrasonic crystals, one for transmission and the other for reception. The ultrasonic signal is continuously transmitted (at a frequency of 2.5 MHz), received and presented to the user as numerical display. This device is intended to be used after 12 weeks gestation for singleton by a trained health professional in a clinical setting.

The provided text describes the acceptance criteria and the study conducted for the Fetal Doppler, Model FD88 (K182710).

Here's the information broken down as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" for the Fetal Doppler's performance. Instead, it states that the device's "Performance is Same as the predicate device," and then lists the predicate device's performance specifications. Therefore, the predicate device's performance can be inferred as the "acceptance criteria" for substantial equivalence.

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

The document does not specify a separate "test set" for performance evaluation in terms of patient data or clinical trials. The performance data is derived from non-clinical performance testing. The document lists several types of non-clinical tests conducted, such as biocompatibility, cleaning/disinfection validation, software verification/validation, electrical safety, EMC, battery performance, ultrasound testing, acoustic output testing, and use-life testing. These tests evaluate the device's technical specifications and safety rather than its diagnostic accuracy on a patient population.

Therefore:

• Sample size for the test set: Not applicable in the context of patient data for diagnostic accuracy. The "test set" consists of the physical device units undergoing various engineering and safety tests.
• Data provenance: Not explicitly stated as being from a specific country or retrospective/prospective clinical data for a "test set." The studies are non-clinical performance testing conducted in a laboratory setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The provided document details non-clinical performance and safety testing, not diagnostic accuracy requiring expert panel review or ground truth establishment from patient data. The "ground truth" for these engineering tests would be established by reference standards, regulatory requirements (e.g., ISO, IEC), and established engineering principles.

4. Adjudication Method for the Test Set

Not applicable, as this was not a clinical study involving human readers or interpretation of diagnostic output that would require adjudication. The testing involved objective measurements against established standards and design specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. The document describes non-clinical performance testing, not a comparative effectiveness study involving human readers.

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

Yes, in the sense that the device's technical performance (e.g., FHR measurement range, resolution, accuracy, acoustic output) was evaluated in isolation, independent of a human operator, to ensure it met its specifications and safety standards. This is inherent in the "non-clinical performance testing" described. The device's ability to detect and display FHR is presumed to be the "algorithm's" core function.

7. The Type of Ground Truth Used

The ground truth for the non-clinical performance testing was based on:

• Reference standards and regulatory guidelines: e.g., ISO, IEC, FDA guidance documents for biocompatibility, electrical safety, EMC, ultrasound testing, and acoustic output.
• Design specifications: The device's internal design specifications for FHR measurement range, resolution, and accuracy, which were stated as being "Same as the predicate device."
• Functionality validation: Demonstrating that features like battery life, operation time, recharging, and status indicator functions met "all design specifications."

8. The Sample Size for the Training Set

Not applicable. This is not a study involving machine learning or artificial intelligence where a "training set" would be used to develop an algorithm’s performance. The Fetal Doppler is a medical device based on established Doppler ultrasound technology, not a learning-based system.

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

Not applicable, as there is no training set for this device.

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