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The BT-200T is a Fetal Monitor for measuring Fetal Heart Rate, Data is displayed on a front panel LCD display, Fetal heart may be measured by means of Doppler ultrasound.
BT-200T is pocket size Fetal Monitor for measuring Fetal Heart rate, Pulse Doppler and uterine contraction of pregnant women. It is intended to aid a comprehensive check for the well being of single fetus.

Bistos' BT-200T is a pocket size Fetal Monitor that measures the fetal heart rate and out puts the fetal sound through built-in speaker. By measuring fetal heart rate (FHR), they are able to predict fetal well-being. BT-200T irradiates ultrasound wave to the abdomen of a pregnant women to detect. The Doppler Frequency signal and analyze, displays the heart rate in LCD screen. The device also provides the heart sound from the heart of fetus.

This 510(k) submission for the Bistos BT-200T Fetal Monitor is primarily based on substantial equivalence to a predicate device (Bistos BT-200, K052190). As such, the information provided focuses on demonstrating equivalence rather than detailed de novo efficacy studies with specific acceptance criteria and performance metrics typically found in submissions for novel devices.

However, Section 9 describes a "Voluntary performed Clinical safety test result attached (E) - *HR Accuracy Measuring Report (E-1)". This is the most relevant section for performance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document refers to an "HR Accuracy Measuring Report (E-1)" but does not present the specific acceptance criteria or the reported performance data within the text. For a full understanding, this report would need to be reviewed.

Based on the typical requirements for Fetal Heart Rate (FHR) monitors, the acceptance criteria would likely be related to accuracy and precision of FHR measurement compared to a gold standard. Without the actual report, the detailed criteria cannot be specified.

Hypothetical table (based on common FHR monitor standards and lack of specific data in the document):

Note: The above table uses hypothetical metrics and limits as the actual "HR Accuracy Measuring Report (E-1)" is not provided in the extracted text. The submission states the device's substantial equivalence to the predicate "in every angles" including "Performing," implying that its HR accuracy would meet similar standards to the cleared predicate.

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

The document does not specify the sample size used for the "HR Accuracy Measuring Report (E-1)" or the data provenance (e.g., country of origin, retrospective/prospective nature).

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

This information is not provided in the document. For FHR accuracy, the "ground truth" would typically come from a highly reliable, simultaneously recorded FHR signal (e.g., direct fetal ECG in specific clinical settings, or a validated simulator). Clinical expert review is less common for establishing the ground truth of a numerical FHR value itself, though experts would interpret the overall fetal well-being.

4. Adjudication Method for the Test Set

Not applicable/not specified in the provided document. As ground truth for FHR would likely be a direct physiological measurement or simulation, an adjudication method amongst experts would not typically be required for the FHR value itself.

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

No MRMC study is mentioned. This type of study is typically related to diagnostic image interpretation where multiple readers assess cases with and without AI assistance. The BT-200T is a Fetal Monitor, which primarily measures and displays FHR, rather than an interpretative diagnostic imaging device.

6. Standalone (Algorithm Only) Performance Study

The "HR Accuracy Measuring Report (E-1)" represents a standalone performance evaluation of the device's ability to measure FHR. While the report itself is not included, its reference indicates a test of the device's intrinsic function.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the "HR Accuracy Measuring Report (E-1)". For FHR devices, the ground truth is typically established by:

• Simulated FHR signals: Using a phantom or simulator that can generate known FHR patterns.
• Simultaneous direct FHR measurement: In some clinical scenarios, direct fetal ECG (such as during labor via a scalp electrode) can be used as a gold standard.
• Simultaneous and independently validated ultrasound reference: Another highly accurate ultrasound system or a reference system known for its precise FHR measurement.

Given it's an "HR Accuracy Measuring Report," it strongly implies a comparison against a reliable, independent measurement of fetal heart rate.

8. Sample Size for the Training Set

The document does not mention a training set. Fetal monitors like the BT-200T are typically engineered using established signal processing algorithms to detect and calculate FHR from Doppler signals. While these algorithms are developed and refined, the concept of a "training set" as understood in modern machine learning is not explicitly discussed in this 2010 submission. The device's performance is demonstrated through its "HR Accuracy Measuring Report."

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

Not applicable, as a distinct training set for an AI/ML algorithm is not explicitly described or implied in the provided document for this type of device. The FHR measurement principles are based on well-established Doppler physics and signal processing.

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