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The BODYTRONIC 200 is a photoelectric plethysmograph intended for the measurement of the leg vein function.

The BODYTRONIC 200 is based on light reflection rheography. A small quantity of infrared light is radiated into the legs just above the ankles, and the reflected light is measured. On the basis of the quantity of reflected light over a defined period, conclusions can be drawn about the flow of blood in the veins.

The provided text describes the 510(k) Premarket Notification for the Bauerfeind BODYTRONIC 200, a photoelectric plethysmograph. However, it does not contain any information about acceptance criteria, device performance metrics, or experimental studies performed to prove the device meets specific acceptance criteria.

The document focuses on establishing substantial equivalence to a predicate device (Elcat vasoquant VQ1000 D-PPG) based on intended use and technological characteristics, and compliance with various international standards related to electrical safety, EMC, usability, software life-cycle, risk management, biocompatibility, and photobiological safety.

Therefore, I cannot provide the requested information from the given text. The text primarily details:

• Device Description: The BODYTRONIC 200 uses light reflection rheography to measure blood flow in leg veins.
• Intended Use: Measurement of leg vein function.
• Predicate Device: Elcat vasoquant VQ1000 D-PPG (K944395).
• Regulatory Information: Classification as Class II, Product Code JOM, under 21 CFR 870.2780.
• Standards Compliance: Listing of various IEC and ISO standards the device complies with.
• FDA Premarket Notification Outcome: FDA's determination of substantial equivalence.

Without a study report or performance data, I cannot fill out the requested table or answer the specific questions about acceptance criteria, sample sizes, ground truth establishment, expert involvement, or comparative effectiveness studies.

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