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The Disposable Thermometer Covers and Sheaths are intended for use as barriers between digital or mercury thermometers and users' rectum or oral cavities to avoid the possible contamination and infection during temperature measuring. These covers and sheaths are non-sterile and intended for single use only.

The Disposable Thermometer Covers and Sheaths, made of PE and EVA, are used for either oral or rectal measurements for digital or mercury thermometers. The products and packaging are non-sterile and are not made with natural rubber latex. The size may vary to accommodate differences in digital and mercury thermometers. The inner packing material is paper, while the outer packing material is carton. Each outer packing contains 100 pieces of covers and sheaths.

The provided text describes a medical device called "Disposable Thermometer Covers and Sheaths" and its 510(k) submission for market clearance. It does not contain information about a study proving the device meets acceptance criteria in the way typically associated with AI/ML-driven devices (e.g., performance metrics like sensitivity, specificity, or AUC against a ground truth dataset). Instead, the "acceptance criteria" and "study" refer to adherence to established standards and bench testing for device safety and effectiveness.

Here's a breakdown based on the information provided:

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 explicitly stated. The document refers to "bench testing" and "safety testing" against standards, which implies samples of the device were tested, but the specific number of units or tests is not provided.
• Data Provenance: The testing was conducted by KANG ZE INDUSTRIAL CO., LTD. or laboratories they commissioned. The raw data and specific locations are not detailed, but it's related to the manufacturing of the device in China. This is not a "clinical data provenance" in the sense of patient data. It's more about laboratory testing of the product itself.

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

This section is Not Applicable to this submission. The "ground truth" for this type of device (thermometer covers) is established by adherence to recognized international and national standards for material safety (biocompatibility, chemical content) and physical performance (e.g., maintaining barrier integrity). Expert consensus for diagnosing a medical condition is not relevant here.

4. Adjudication method for the test set

This section is Not Applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert interpretations of clinical data. This device's evaluation relies on objective laboratory tests against pre-defined thresholds within the specified standards.

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

This section is Not Applicable. This is not an AI/ML-driven device. It's a physical medical device (thermometer covers). Therefore, no MRMC study or AI assistance evaluation was performed.

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

This section is Not Applicable. This is not an algorithm or AI device.

7. The type of ground truth used

The "ground truth" for this device's acceptance is based on validated industry standards and test methodologies for:

• Biocompatibility: Absence of cytotoxicity, irritation, and sensitization as per ISO 10993.
• Physical Performance: Compliance with ASTM E1104 for thermometer probe covers and sheaths.
• Chemical Composition: Levels of regulated substances meeting thresholds defined by IEC 62321 and EPA Method 3546.

8. The sample size for the training set

This section is Not Applicable. This device does not involve a "training set" as it's not an AI/ML model.

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

This section is Not Applicable. No training set was used.

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