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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.

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This Doppler can be used for the detection of average fetal heartbeat rate.

Doppler fetal heartbeat rate detector uses Doppler principle of ultrasound signal to detect the fetal heart rate. Doppler fetal heartbeat rate detector uses a split D piezoelectric transducer. A high frequency oscillator supplies a continuous high frequency voltage to one half of the split D transmitter transducer. The high frequency voltage is converted to an ultrasound acoustic wave by the transducer and is transmitted to biophysical objects through an applied coupling water based medium and moves through biophysical objects. The acoustic ultrasound is reflected by body and moving objects such as the fetal heart. The reflected ultrasound is received by the second split D receiver transducer and is converted via the piezoelectric effect into a high frequency electronic signal. The received electronic signal is amplified and detected. The result is a base band audio Doppler shifted signal which is filtered and converted to audio via a loudspeaker. At the same time the fetal heart rate is displayed on a liquid crystal arithmometer display.

The provided text details a 510(k) summary for a Doppler fetal heartbeat rate detector (K090570) manufactured by Shenzhen Bestman Instrument Co., Ltd. However, it does not contain specific acceptance criteria or an explicit study that quantitatively proves the device meets such criteria.

The document primarily focuses on establishing "substantial equivalence" to a predicate device (K040480 SONOTRAX) rather than providing detailed performance metrics for the new device. The evaluation process in such submissions often relies on demonstrating that the new device performs "as well as" or "similarly to" the predicate, implying that if the predicate met certain performance standards, the new device will as well.

Here's an analysis of the provided information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, there are no explicitly stated quantitative acceptance criteria or detailed reported device performance metrics that can be presented in a table. The document broadly states:

• "Doppler fetal heartbeat rate detector has been subjected to extensive safety, performance test and validations before release."
• "Final test of the Doppler fetal heartbeat rate detector includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications."
• "The conclusions drawn from the test of the Doppler fetal heartbeat rate detector demonstrates that the device is substantially equivalent to the predicate device."

This level of detail is typical for a 510(k) summary, which often summarizes testing without providing raw data or specific performance tables.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It simply states that "various performance tests" were conducted.

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

The document does not provide any information about the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method used for establishing ground truth for a test set.

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

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. There is no mention of human readers or AI assistance, nor any effect size regarding improvement with AI. This is a standalone device without AI functionality for interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

The device is described as a "Doppler fetal heartbeat rate detector" and an "Ultrasonic Fetal Monitor." Its function is to detect and display the average fetal heartbeat rate. The testing described (general performance and safety tests) would inherently be a standalone performance evaluation of the device itself, as it's a diagnostic tool that directly outputs a reading. While not explicitly termed "standalone performance" in the context of an AI algorithm, the device's function is standalone data acquisition and display.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used. Given the nature of a fetal heartbeat detector, the ground truth would typically be:

• Physiological measurement from a reference standard: Comparison against a known, accurate method of measuring fetal heart rate. This could involve using a precise simulator or a direct physiological measurement from a live subject (animal or human) with a validated alternative method.
• Clinical observation/expert consensus: In a clinical validation, comparison against the fetal heart rate determined by experienced clinicians using established methods.

However, the text does not explicitly state which method was used.

8. Sample Size for the Training Set

The device described is a hardware-based Doppler fetal monitor. It does not appear to be an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training set" concept is not applicable here as there is no learning algorithm involved.

9. How Ground Truth for the Training Set Was Established

As the device does not employ an AI/machine learning algorithm with a "training set," this question is not applicable.

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