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The BT-300 is an Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel 7-segment LED Display, recorded on a strip chart recorder and may be transmitted over telephone lines to a remote data receiver. Single/Twin fetal heart rates may be measured by means of Doppler Ultrasound. Uterine Activity is measured with an external TOCO transducer.

The BT200 is a Fetal Monitor for measuring fetal heart rate. Data is displayed on a front panel LCD Display. Fetal heart rate may be measured by means of Doppler Ultrasound.

BT-300 is the fetal monitor that measures the fetal heart rate(FHR) which may be evaluated to predict fetal status and uterine contraction. BT-300 irradiates ultrasound wave to the abdomen of a pregnant woman, and detects the Doppler frequency signal reflected from the heart of the fetus. BT-300 analyzes this signal and displays the heart rate by LED. Also, BT-300 provides the sound from the heart of fetus.

BT-300 measures the uterine contraction of a pregnant woman by pressure sensors and displays the numerical values.

And BT-300 prints the heart rate of the fetus and the values of uterine contraction.

BT-300 records the heart rate of the fetus, the uterine contraction of a pregnant woman, and basic information of the equipment with a provided thermal printer.
BT-300 is capable of Twin Monitoring with two pulsed Ultrasound Transducers.
BT-300 has a free voltage(100 240VAC input) power adaptor.
BT-200 is a pocket-size fetal Monitor that measures the fetal heat rate and outputs the fetal heart sound through built-in speaker. By measuring fetal heart rate(FHR), you are able to predict fetal well-being. BT-200 irradiates fetal wave to the abdomen of a pregnant woman to detect the Doppler frequency signal and analyze, and displays the heart rate on LCD screen. The device also provides the heart sound from the heart of fetus.

This 510(k) summary for the Bistos BT-300 and BT-200 Fetal Monitors does not contain the detailed information typically found in a clinical study report or performance evaluation that would address acceptance criteria and how a device meets them. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on safety, EMC, and general performance standards.

Therefore, many of the requested sections (1-9) cannot be fully populated from the provided text. The document primarily highlights adherence to electrical, mechanical, and environmental safety standards, and EMC testing.

Here's a breakdown of what can and cannot be extracted:

Based on the provided 510(k) summary for the Bistos BT-300 and BT-200 Fetal Monitors, the following information regarding acceptance criteria and performance studies can be reported:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary does not specify quantitative acceptance criteria or detailed device performance metrics (e.g., accuracy, sensitivity, specificity) for measuring FHR or uterine contractions. Instead, it indicates compliance with general safety and electromagnetic compatibility (EMC) standards.

2. Sample Size for the Test Set and Data Provenance

The provided 510(k) summary does not contain any information regarding a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for evaluating the Fetal Monitor's performance in measuring FHR or uterine contractions. The document only references compliance with general safety and EMC standards.

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

The provided 510(k) summary does not contain any information about experts used to establish a ground truth.

4. Adjudication Method for the Test Set

The provided 510(k) summary does not contain any information about an adjudication method.

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

The provided 510(k) summary does not contain any information regarding an MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is a fetal monitor, not an AI-assisted diagnostic tool in the sense of image interpretation.

6. Standalone Performance Study (Algorithm Only)

Given the nature of the device as a Fetal Monitor that measures and displays physiological data, rather than being an AI algorithm for interpretation, the concept of "standalone performance" is not directly applicable in the way it would be for an AI diagnostic device. The performance evaluation described is related to the device's adherence to safety and EMC standards, and its ability to physically measure and display FHR and uterine contractions, which is inherent to its function, not an "algorithm-only" performance study.

7. Type of Ground Truth Used

The provided 510(k) summary does not explicitly state the type of ground truth used for evaluating the primary functions of FHR and uterine contraction measurement. The clinical performance is implicitly validated through substantial equivalence to predicate devices and adherence to relevant performance standards, but no specific ground truth methodology (e.g., expert consensus, pathology, outcomes data) is described.

8. Sample Size for the Training Set

The provided 510(k) summary does not contain any information about a training set size. This device is not described as being based on machine learning or AI models that require training data.

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

The provided 510(k) summary does not contain any information about how ground truth for a training set was established, as it does not describe an AI/machine learning-based device requiring a training set.

Summary of Limitations:

The provided document is a 510(k) summary, which aims to demonstrate "substantial equivalence" to legally marketed predicate devices, primarily through compliance with recognized standards for safety and performance (e.g., electrical, mechanical, EMC). It is not a detailed clinical study report and therefore lacks the specific clinical performance metrics, study designs, sample sizes, and ground truth methodologies that would typically be found in a performance evaluation for a more complex diagnostic or AI-driven device. The "satisfactory" results for safety and EMC are the main reported performance outcomes in this context.

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