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The Medline Disposable Electronic Thermometer Probe Covers are intended for use as barriers between any SureTemp and SureTemp Plus digital thermometer probe and users' oral, rectal, or axillary measuring sites to avoid possible contamination and infection during temperature measuring. The probe covers are non-sterile and intended for single use only.

The proposed device is a disposable, single use, non-sterile shell-like device used to cover electronic thermometer probes of temperature taking devices. The Medline Disposable Electronic Thermometer Probe Cover is compatible with the intended use of all SureTemp and SureTemp Plus reusable digital thermometers probes, which require the use of probe covers for oral, axillary, or rectal temperature measurements.

The provided text describes a 510(k) premarket notification for the Medline Disposable Electronic Thermometer Probe Cover (K173113) and compares it to a predicate device, the Welch Allyn SureTemp Plus Thermometer (K030580). This document focuses on demonstrating substantial equivalence, not conducting a study to prove a device meets acceptance criteria as would be typical for a novel AI device.

Therefore, many of the requested elements are not applicable to this type of regulatory submission for a simple medical accessory. However, I can extract the information that is present regarding the non-clinical testing performed.

Here's the breakdown of the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified for any of the tests.
• Data Provenance: The tests are "Non-clinical verification" and "Performance Testing (Bench)", implying laboratory data. The country of origin is not specified, but the applicant (Medline Industries, Inc.) is based in Northfield, Illinois, USA. The data is prospective in the sense that these tests were conducted for this specific submission to demonstrate equivalence.

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

• Not applicable. These are standard engineering and biocompatibility tests conducted according to established procedures, not requiring expert consensus for ground truth on a 'test set' in the context of an AI device.

4. Adjudication method for the test set

• Not applicable. As above, these are standard engineering and biocompatibility tests.

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

• Not applicable. This device is a thermometer probe cover, not an AI device.

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

• Not applicable. This device is a thermometer probe cover, not an AI device.

7. The type of ground truth used

• For Performance Testing (ASTM E1104-98): The ground truth would be defined by the specified technical parameters and tolerances within the ASTM standard. This standard typically covers accuracy and response time of clinical electronic thermometers, and the probe cover's performance is evaluated against how it affects these parameters.
• For Biocompatibility Testing (ISO 10993 series): The ground truth is established by the specified biological responses (e.g., absence of cytotoxicity, irritation, or sensitization) as defined by the ISO standards and their acceptance criteria.

8. The sample size for the training set

• Not applicable. This device is a thermometer probe cover, not an AI device that requires a training set.

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

• Not applicable. This device is a thermometer probe cover, not an AI device that requires a training set and ground truth establishment in that context.

Summary of the Study:

The "study" described here is a series of non-clinical (bench and biocompatibility) tests conducted to demonstrate that the Medline Disposable Electronic Thermometer Probe Cover meets recognized standards and performs similarly to its predicate device's component. The primary standard referenced is ASTM E1104-98 (2016) for performance, and ISO 10993 series for biocompatibility. The results "demonstrated the overall performance of the proposed device and ultimately support a substantial equivalence determination." The tests confirm that the probe covers do not significantly impede the thermometer's performance according to the ASTM standard and are biologically safe according to ISO standards.

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