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The probe cover is used as a sanitary barrier between the infra red thermometer and the ear canal. The probe cover is provided non-sterile and for single use only.

The Disposable Ear Thermometer Probe Cover is a disposable plastic cover made of a biocompatible polypropylene material that is dimensionally manufactured to set tolerances so that it can be fitted on the probe tip of the thermometer. The probe cover is used as a sanitary barrier between the infra red thermometer and the ear canal to prevent any ear secretions or particulates from being transferred between different people. The subject device is used as barriers between Braun Thermoscan® PRO3000 series/PRO4000 series/PRO6000 series ear thermometer, and also compatible with Braun Thermoscan® IRT1020/IRT2020/IRT2520/IRT3020/ IRT3520/IRT4020/IRT4520/IRT6020/IRT6520 ear thermometer and users' auditory canal measuring sites to avoid possible contamination and infection during temperature measuring. The probe covers are transparent, colorless and odorless, non-sterile and intended for single use only.

The provided document relates to a 510(k) premarket notification for a Disposable Ear Thermometer Probe Cover. It details the device's characteristics, its intended use, and a comparison to a predicate device. The core of the submission focuses on proving "substantial equivalence" to a previously cleared device.

However, the document does not contain the kind of information requested in the prompt, which is typical for the evaluation of AI/ML-driven medical devices that require robust performance studies to establish accuracy, sensitivity, specificity, or improvement in human reader performance.

Here's why the prompt's questions cannot be answered based on the provided text, followed by an explanation of what the document does provide:

• No AI/ML Component: The "Disposable Ear Thermometer Probe Cover" is a passive, mechanical device (a plastic cover). It does not involve any algorithm, artificial intelligence, machine learning, image analysis, or diagnostic capabilities that would necessitate the types of criteria and studies outlined in the prompt (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts, training set sample sizes).
• Substantial Equivalence, Not Performance Metrics: The FDA's 510(k) process for this type of device (Class II, general hospital, FLL product code) primarily relies on demonstrating "substantial equivalence" to a legally marketed predicate device. This is done by showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise different questions of safety or effectiveness. This is fundamentally different from proving the diagnostic performance of an AI model.

Based on the provided document, here's what can be extracted, and where the requested information is absent:

1. A table of acceptance criteria and the reported device performance

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

• Not Applicable / Not Mentioned: This device did not undergo a "test set" evaluation in the sense of an algorithm performance study. The evaluation was primarily through non-clinical bench testing to confirm compliance with standards and physical properties. No human patient data (retrospective or prospective) was used for performance evaluation.

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

• Not Applicable: There was no "ground truth" to establish for a probe cover's performance in a diagnostic sense. Compliance with standards was assessed through laboratory testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable: No test set requiring expert adjudication was conducted.

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: No MRMC study was conducted as the device is not an AI/ML diagnostic tool and does not involve human readers interpreting data or images.

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

• Not Applicable: The device is a physical, passive accessory. There is no algorithm or standalone performance to evaluate.

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

• Not Applicable: The "ground truth" equivalent for this device is compliance with engineering and material standards (e.g., ASTM E1104, ISO 10993).

8. The sample size for the training set

• Not Applicable: There is no "training set" for this type of device.

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

• Not Applicable: As there is no training set, there's no ground truth establishment process to describe.

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