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The disposable vaginal speculum is a non-sterile product and is to be used by a medical professional to visualize the interior of the vagina and cervix during obstetrical and gynecological examination.

The disposable vaginal speculum consists of up-foliage, under-foliage and handle with the specification of large, medium and small, which is used by medical department for examining female patients.

This is a 510(k) summary for a Disposable Vaginal Speculum, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, sample sizes, and expert qualifications for AI/ML performance is not applicable.

The document describes a traditional medical device and its substantial equivalence to a predicate device based on material, intended use, and mechanical/biocompatibility safety testing.

Here's a breakdown of the relevant information provided for this device:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable. This is a physical medical device, and the evaluation relies on compliance with established consensus standards for mechanical properties and biocompatibility, rather than a "test set" of data in the context of AI/ML.
• The document implies that the tests were performed by, or on behalf of, Kunshan Deyi Plastic Co., Ltd., which is a manufacturer in China.

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

• Not applicable. Ground truth in the AI/ML sense is not relevant for this type of device submission. The "ground truth" here is compliance with material, design, and performance standards as determined through laboratory testing.

4. Adjudication method for the test set:

• Not applicable. There is no "adjudication method" described as would be for an AI/ML system's output. Compliance is determined by the results of the specified tests against the criteria in the 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:

• Not applicable. This is not an AI-assisted device.

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

• Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

• For mechanical and environmental safety: Compliance with the specified performance requirements within the standard YY0336-2002 (Disposable Vaginal Speculum).
• For biocompatibility: Absence of cytotoxicity, irritation, or delayed type hypersensitivity reactions as determined by the methods and criteria in ISO 10993-5 and ISO 10993-10.

8. The sample size for the training set:

• Not applicable. There is no training set for a physical, non-AI medical device.

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

• Not applicable.

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