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The Dual Mode Up-Grade Forehead/ Underarm Thermometer device is intended for determination of body temperature.
The Dual Mode Up-Grade Forehead/ Underarm Thermometer device is a non-sterile, reusable clinical thermometer intended for the determination of human's body temperature using the forehead and axilla as measurement sites.

The Dual Mode Up-Grade Forehead/ Underarm Thermometer is a clinical electronic thermometer used for determination of body temperature. The over-the-counter Dual Mode Up-Grade Forehead/ Underarm Thermometer is designed to calculate the maximum temperature of a probe in contact with the body site, without waiting for thermal equilibrium to occur, by heat transfer data and mathematical algorithm. The temperature reading range is from 35.0°C to 42.0°C (95.5°F to 107.6°F) and the time of measurement is 6-10 seconds.

The provided text does not contain enough information to fully describe the acceptance criteria and the study that proves the device meets them as per your requested format.

Here's why and what information is missing:

• Acceptance Criteria Detail: The document states "The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the Dual Mode Up-Grade Forehead/ Underarm Thermometer device are substantially equivalent to the predicate devices cited above." This is a general statement of substantial equivalence, not a list of specific performance acceptance criteria (e.g., accuracy +/- X degrees Celsius, precision Y degrees Celsius). While it implies the device must perform similarly to the predicates, it doesn't quantify "performance characteristics."
• Study Details: There is no description of a specific study conducted to demonstrate that the device meets any performance criteria. It mentions "heat transfer data and mathematical algorithm" but doesn't elaborate on any study validating this.

Therefore, I cannot populate the table or answer most of the questions.

Information I can extract/infer from the provided text:

• Device Name: Dual Mode Up-Grade Forehead/ Underarm Thermometer
• Intended Use: Determination of body temperature, non-sterile, reusable clinical thermometer, using forehead and axilla as measurement sites.
• Temperature Reading Range: 35.0°C to 42.0°C (95.5°F to 107.6°F)
• Time of Measurement: 6-10 seconds
• Ground Truth Type (Inferred): For a thermometer, the ground truth would typically be established by a highly accurate reference thermometer or a precise temperature measurement standard. However, the document does not explicitly state how accuracy was verified or what "ground truth" was used in any testing.

Missing Information (and why it's missing from this type of document):

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It typically summarizes findings and often refers to internal company documentation or recognized standards for the detailed study results. The specific performance testing and its criteria, methodology, and results are usually found in the full 510(k) submission, not the publicly available summary.

Therefore, I cannot complete the table or answer most of the questions you've posed based on the provided text.

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