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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 Probe Cover is a disposable plastic cover made of a biocompatible clarified 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 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 text is a 510(k) summary for Probe Covers (YF-001, YF-002). The acceptance criteria for this device are based on its equivalence to a predicate device and compliance with established standards, primarily ASTM E1104-98 for Clinical Thermometer Probe Covers and Sheaths.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

A non-clinical study was conducted to verify that the subject devices met all design specifications and were substantially equivalent to the predicate device. The study involved testing against the mentioned standards.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size for the test set used for the non-clinical tests. The tests were likely conducted on a representative sample of the manufactured probe covers.

Data Provenance: Not explicitly stated, however, the manufacturer is Shenzhen Yi Fang Blister Packaging Co., Ltd. in China, implying the testing was likely conducted in China or by organizations partnered with the manufacturer. The tests are non-clinical (laboratory-based).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The "ground truth" for the performance of this device (probe covers) is established through adherence to technical standards (e.g., ASTM E1104, ISO 10993 series) and direct physical/chemical testing, not through expert human assessment of diagnostic output.

4. Adjudication Method for the Test Set

Not applicable as the testing involves objective measurement against engineering and biocompatibility standards, not interpretive human assessment.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a passive medical device (probe cover), not an AI-assisted diagnostic tool or an imaging device that would typically involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device does not involve an algorithm. The testing is for the physical and biological characteristics of a disposable product.

7. Type of Ground Truth Used

The ground truth used for this type of device is compliance with established international and national standards (e.g., ASTM E1104 for physical properties, ISO 10993 for biocompatibility). This involves objective measurements and scientific testing against predefined criteria, rather than expert consensus, pathology, or outcomes data, which are more relevant for diagnostic or therapeutic devices.

8. Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve AI or machine learning, which would require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable as there is no training set for this device.

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