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The ACON™ Digital Thermometer Probe Covers are intended for use as a barrier that is used as an accessory to oral or rectal measurements for digital thermometers, including the ACON 30 Second Reliable Digital Thermometer. These probe covers are non-sterile and intended for single use only.

The disposable digital thermometer probe covers are plastic coverings used for either oral or rectal measurements for digital thermometers. The product is non-sterile and contains latex.

The provided text is a 510(k) summary for ACONTM Digital Thermometer Probe Covers. It outlines the device's description, intended use, and comparison to a predicate device. The information primarily focuses on substantial equivalence for regulatory approval rather than a detailed performance study with acceptance criteria and results in the format requested.

Here's an analysis based on the provided text, addressing your questions to the best extent possible given the information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for the probe covers. Instead, it relies on demonstrating substantial equivalence to a predicate device and qualitative performance verification through "probe cover leakage test and probe cover validation test."

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

The document does not specify the sample size used for the "probe cover leakage test" or the "probe cover validation test."

The data provenance is not explicitly stated beyond being "laboratory testing results." It is implied to be prospective testing conducted by the manufacturer (ACON Laboratories, Inc.) given it's part of a 510(k) submission for a new device.

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

This information is not applicable to this type of device and study. The testing for a digital thermometer probe cover typically involves objective physical and material tests (e.g., leakage, material compatibility, strength) rather than expert interpretation of data or images.

4. Adjudication method for the test set

This information is not applicable for the reasons stated above.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is more relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is being evaluated.

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

This concept is not applicable as the device is a physical probe cover, not an algorithm or AI system.

7. The type of ground truth used

The concept of "ground truth" in the context of expert consensus, pathology, or outcomes data is not applicable to this device. The "truth" for a probe cover is its ability to physically perform its barrier function and protect against contamination, which is assessed through direct physical testing (leakage, structural integrity, material properties).

8. The sample size for the training set

This information is not applicable as the device is not an AI or machine learning model that requires a training set.

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

This information is not applicable for the same reason as point 8.

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