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FM-200 Doppler Fetal Heart Rate Detector is a hand-held, battery powered Doppler devices used for detecting fetal heart beats.

Doppler fetal heart rate detector is a portable equipment to detect the heart rate of fetus in Obstetrics & Gynecology and delivery room. It can also be used at home or in public place for prenatal diagnosis on pregnant women. Doppler fetal heart rate detector is composed of the parts used for ultrasonic signal emitting and receiving, simulating signal processing, fetal heart rate calculation and display control.

The provided document is a 510(k) summary for the Shenzhen Biocare Electronics Co., Ltd's Doppler Fetal Heart Rate Detector (Model FM-200). It focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or an analytical study with performance metrics in the way a clinical or standalone study report would.

Based on the provided text, the device's performance was validated through laboratory testing to ensure it met "all design specifications, including electrical safety, EMC, specification." However, it does not explicitly state quantitative acceptance criteria for fetal heart rate detection accuracy or sensitivity/specificity, nor does it provide a detailed study with specific performance metrics against such criteria.

Here's an attempt to extract and synthesize the requested information, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present quantitative acceptance criteria or detailed performance metrics for the FM-200 Doppler Fetal Heart Rate Detector in the typical sense of a clinical performance study (e.g., accuracy against a gold standard, sensitivity, specificity).

Instead, it states:

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document mentions "laboratory testing" but does not detail the number of subjects or data points used to validate the device's core function of detecting fetal heart beats.
• Data Provenance: Not specified. The testing described is "laboratory testing," which typically means controlled environments. It does not provide information on whether human subjects were involved, their country of origin, or if the data was retrospective or prospective.

3. Number of Experts and their Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

The document refers to "design specifications" and "consensus standards" as the basis for evaluation, implying a compliance-based assessment rather than an expert-driven ground truth establishment for a diagnostic performance study.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the nature of the testing described (compliance to electrical safety, EMC, and design specifications), a traditional adjudication method for diagnostic performance would likely not be relevant or documented in this type of submission summary.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not performed or reported in this submission summary. The device is a "Doppler Fetal Heart Rate Detector," which is typically used by a single operator to detect heartbeats. Its primary function is direct measurement/detection, not interpretation by multiple readers of complex images or signals requiring AI-assisted analysis.

6. Standalone Performance Study

• Standalone Performance Study: The "laboratory testing" described is a form of standalone testing, as it evaluates the device's ability to meet its design specifications and comply with standards. However, it is not a standalone diagnostic performance study (e.g., yielding sensitivity, specificity, accuracy against a clinical gold standard) that you might find for an AI algorithm. The document emphasizes technical compliance rather than diagnostic efficacy quantified in typical clinical metrics for standalone performance.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the "laboratory testing" appears to be defined by adherence to design specifications (e.g., measuring heart rate within a certain range, performing specific functions) and consensus standards (e.g., electrical safety, EMC limits). It does not mention clinical outcomes data, pathology, or expert consensus on fetal heart rate diagnosis. The device "detects fetal heart beats," implying its 'ground truth' is the actual presence and rate of the fetal heart beat during testing, likely validated using reference measurement equipment.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not specified. This device is a traditional hardware-based Doppler fetal heart rate detector, not an AI/ML algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable. As it's not an AI/ML device, there is no training set or associated ground truth establishment process.

Summary Limitations:

It is crucial to understand that the provided text is a 510(k) Summary, which is designed to demonstrate substantial equivalence to a predicate device based on technical specifications and safety standards. It is not a detailed clinical study report and therefore does not contain the in-depth performance metrics, study designs, and ground truth methodologies typically found in submissions for AI/ML-driven devices or those requiring extensive clinical efficacy trials. The "Test Conclusion" confirms technical compliance rather than diagnostic accuracy against a clinical gold standard.

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