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Fudakang Bluetooth Digital thermometer (Model: BT-A41CN-BT) is intended for the measurement and monitoring of oral, axillary, and rectal temperature of adults via a thermistor. The device is for use of a doctor or lay consumers in the hospital or home. The result of measurement can be transmitted to smart mobile device (cell phone, iPad) while displayed on the LCD.

Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)

The provided text from the FDA 510(k) clearance letter and Indications for Use document contains information about the Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT). However, it does not provide specific details about the acceptance criteria and the study conducted to prove the device meets these criteria.

This type of FDA document primarily focuses on documenting substantial equivalence to a predicate device and specifying the intended use, regulatory classification, and general compliance requirements. It typically does not include the detailed technical study information that would define acceptance criteria, sample sizes, ground truth establishment, or specific performance metrics from validation studies. These details are usually found in the full 510(k) submission, which is not publicly available in this format.

Therefore, I cannot provide a table of acceptance criteria, reported performance, or details about the study design (sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC, or standalone performance) based solely on the provided text.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This statement is key – it indicates that the device was cleared because it was demonstrated to be equivalent to an already approved device, rather than necessarily undergoing a new comprehensive clinical trial with explicit acceptance criteria detailed in this public brief.

To obtain the information requested, one would typically need to refer to the full 510(k) submission's performance data section, which is proprietary to the manufacturer and not generally disclosed in the public clearance letter.

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