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The B-D Assure Ear Thermometer is designed for home use to measure body temperature from the tympanic membrane.
The B-D Assure Ear Thermometer is designed for measuring body temperature in a home setting.

The Becton Dickinson Infrared Thermometer is a device that measures patient body temperature by quantifying the infrared emission from the tympanic membrane.
In clinical application the end of the infrared thermometer is placed in the outer portion of the auditory canal, where the sensor can get a good view of the tympanic membrane. Placing the probe is very similar to the maneuver used to visualize the ear drum using an otoscope. There is no risk of eardrum injury because the probe is not long enough or small enough to be inserted too deep into the ear canal.
The most advantageous feature of infrared tympanic thermometry is that it takes very little time. Readings can be taken in a few seconds.

This looks like a 510(k) submission, not a study report. 510(k) submissions demonstrate substantial equivalence to a predicate device rather than explicitly defining and meeting acceptance criteria through a standalone study.

Therefore, many of the requested fields cannot be directly extracted as they would be for a typical clinical or performance study report. The document primarily focuses on demonstrating that the B-D Assure Ear Thermometer has the "same technological characteristics" and functions "in an equivalent manner" to the predicate device, the Thermoscan® Instant Thermometer.

Here's an attempt to answer the questions based on the provided text, flagging where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample size: Not specified. The document only mentions "bench testing."
• Data provenance: Not specified. The nature of "bench testing" suggests it was likely internal testing by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not specified. "Bench testing" typically refers to laboratory or engineering tests, not human expert assessment for ground truth.

4. Adjudication method for the test set

• Not applicable/Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is a medical device (thermometer), not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• The "bench testing" mentioned can be considered a standalone performance evaluation of the device itself. The device is not an algorithm, but a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not explicitly stated, but for bench testing of a thermometer, the "ground truth" would likely be a highly accurate reference thermometer or calibrated temperature source.

8. The sample size for the training set

• Not applicable. This is a traditional medical device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

• Not applicable.

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