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The Doppler FHR Detector (Model BF-500D+ and BF-560) is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound in patients with singleton pregnancies after 12 weeks of gestation. The device is intended to be used by health care professionals in a hospital, clinic, community, and home setting.

The Fetal Doppler is a hand-held device for non-invasive measurement and display of the fetal heart beat utilizing Doppler 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 liquid crystal display(LCD) 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 one frequency.

The difference between BF-500D+ and BF-560 are shown as below:

• BF-500D+ is powered by a 9V rechargeable Ni-MH battery, and adapter is packaged with the unit; BF-560 is powered by three pieces of 1.5V AA alkaline disposable batteries.
• BF-500D+ will display Fetal heart rate, sound volume, and battery indicator; BF-560 will also display the selected working frequency besides in addition to the features of the BF-500D+.
• the two models have different probe shapes.

This 510(k) clearance letter pertains to a Doppler FHR Detector, a device intended to detect fetal heartbeats, display fetal heart rate, and play the fetal heart sound. The document describes non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device.

It's important to note that this document does not describe a study involving human subjects or AI-assisted diagnostic read-outs. Therefore, sections related to multi-reader multi-case studies, expert adjudication for ground truth for test sets, and the impact of AI assistance on human readers are not applicable.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a structured, quantitative table for all performance aspects. Instead, it demonstrates compliance with recognized standards and successful completion of various tests. The tables in the original document ("Table 6-1: Comparison between the predicate device BF-500B and the subject device BF-500D+" and "Table 6-2: Comparison between the predicate device BF-500B and the subject device BF-560") provide a comparison of technical characteristics and indicate "Same" or "Different" for each item, implying that similarity or acceptable differences were the internal criteria for many parameters.

For the performance tests explicitly mentioned in section 7, the reported device performance is that the device "complied with requirements" or "successfully passed all aspects of the testing." I will create a table summarizing the performance parameters that have a quantifiable criterion or a clear pass/fail outcome from the provided text.

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

• Sample Size for Test Set:
  • Biocompatibility: Not explicitly stated, but "Patient contacting materials were subjected to testing."
  • Electrical safety and EMC: Not explicitly stated.
  • Ultrasound and Acoustic Testing: Not explicitly stated.
  • Software Verification and Validation Testing: Not explicitly stated.
  • Use Life Testing: n=3 samples for each device model (BF-500D+ and BF-560).
• Data Provenance: The studies described are non-clinical bench tests. There is no mention of data from human subjects or country of origin for such data.

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

Not applicable. This was a non-clinical performance study. No human ground truth was established by experts for these tests.

4. Adjudication Method for the Test Set

Not applicable. As this was a non-clinical performance study, there was no expert adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not done. This document describes non-clinical performance testing of a medical device, not a study evaluating human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is a Doppler FHR Detector, which is a hardware device for detecting fetal heart rates, displaying them, and playing sounds. While it involves software, it's not an "algorithm-only" or AI-driven diagnostic device in the sense of image analysis or complex pattern recognition. The software is for device control and display of measured physiological parameters. The non-clinical performance testing implicitly evaluates the "standalone" performance of the device's measurement capabilities.

7. The Type of Ground Truth Used

For the non-clinical tests described:

• Biocompatibility, Electrical safety, EMC, Ultrasound and Acoustic Testing: Ground truth is established by the requirements and methodologies of the respective international standards (e.g., ISO 10993-1, IEC 60601-1, IEC 60601-2-37, IEC 62359). These standards define the acceptable limits and procedures.
• Software Verification and Validation: Ground truth is against the software requirements specification and FDA guidance for software in medical devices.
• Use Life Testing: Ground truth is provided by a fetal heart rate simulator for performance evaluation under worst-case operational scenarios, and the expected durability of the physical components (e.g., batteries, buttons).

8. The Sample Size for the Training Set

Not applicable. This is a non-AI, non-machine learning device. There is no concept of a "training set" in the context of these non-clinical performance studies.

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

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

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