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The BT-200V Vascular Doppler ( Brand Hi-dop ) detects arterial and venous Hood flow in extremities as well as fetal heart sounds. and displays velocity waveform, numerical data and fetal heart rate with heart beat indicator. The BT-200V selection is 2, 4, 5 and 8 MHz.

Bistos' BT-200V is a pocket size Ultrasound Doppler System, 2 MHz Ultrasound Doppler Probe that measure the fetal heart rate and outputs the Fetal Heart sound through built-in Speaker, By measuring fetal heart rate (FHR), they are able to predict fetal well-being, BT-200V irradiates fetal 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.

4,5.8 MHz Ultrasound Doppler probe that measures the vascular pulse rate and outputs the blood flow sound through built-in speaker. By measuring pulse rate (PR) they are able to check vascular blood flow status.

BT-200V irradiates vascular wave to the patient skin to detect the Doppler frequency signal and analyze to displays the pulse rate on LCD screen. The device also provides the blood flow sound from the patient.

The following probes may be utilized with the BT-200V Vascular doppler:

2 MHz for fetal heart rate

4 MHz detections of arterial and venous blood flow velocity

5 MHz detections of arterial and venous blood flow velocity

8 MHz detections of arterial and venous blood flow velocity

The provided text is a 510(k) summary for the Bistos BT-200V Vascular Doppler and does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way typically required for AI/ML-based diagnostic devices.

The document discusses:

• Substantial Equivalence: The primary assertion is that the BT-200V is substantially equivalent to a predicate device (Smartdop 45 Vascular Doppler Koven Technology Corp. model K050601) in terms of intended use, design, function, performance, operation principle, etc.
• Device Description: It describes the BT-200V as a pocket-sized ultrasound Doppler system that measures fetal heart rate (FHR) using a 2 MHz probe and vascular pulse rate (PR) using 4, 5, and 8 MHz probes.
• Indications for Use: Detects arterial and venous blood flow in extremities and fetal heart sounds, displaying velocity waveform, numerical data, and FHR with a heart beat indicator.
• Safety and Performance Testing: It vaguely states that the device "done various Performing, Safety test voluntary and accordance with the guidance for Industry and FDA Staff - Information for Manufacturers seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers. All test report attached." However, no specific details of these tests, acceptance criteria, or results are provided in this summary.
• Biocompatibility: Mentions using the same material as a previously cleared device (Bistos BT-200T under K100885 Fetal Doppler) and compliance with ISO 10993.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving their fulfillment. The 510(k) summary relies on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance study results against predefined acceptance criteria.

The requested fields would typically be found in a more detailed clinical validation or performance study report, which is not part of this 510(k) summary.

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