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A patient examination glove is a disposable intended for medical purposes A patient examiner's hand or finger to prevent contamination between patient and examiner

Sterile, powder-free latex examination gloves with polymer coating and protein claim (50 micrograms or less)

Here's an analysis of the provided 510(k) summary, breaking down acceptance criteria and the study information as requested.

The provided document describes Sterile, powder-free latex examination gloves with polymer coating and protein claim (50 micrograms or less). It is a submission for a 510(k) premarket notification, which is a process to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. This type of submission generally relies on non-clinical performance data and does not typically involve extensive human clinical trials or AI performance evaluations as described for complex AI/ML-based medical devices.

Therefore, many of the requested points related to AI/ML studies (test sets, ground truth establishment, MRMC studies, standalone performance, training sets) are not applicable to this type of device and submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes used for each of the non-clinical tests (Dimensions, Physical Properties, Freedom from pinholes, Powder Free Residue, Protein Level, Biocompatibility). These are typically determined by the referenced ASTM standards.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, given it's a submission from Siam Sempermed Corp., Ltd in Thailand, it's likely the testing was conducted in facilities associated with the manufacturer or certified labs in Thailand, or potentially internationally to meet ASTM standards. The tests are inherently prospective as they are performed on manufactured gloves to demonstrate compliance.

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

• Not Applicable. This device is a physical product (examination glove), and its performance is evaluated against engineering and biological standards using laboratory tests, not human expert interpretation of data or images. "Ground truth" in this context refers to the measured physical or chemical properties of the glove, not expert consensus on an interpretation task.

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

• Not Applicable. As explained above, this submission does not involve interpretation tasks requiring adjudication by multiple experts. Performance is determined by objective measurements against established 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 a physical medical device (examination glove), not an AI/ML-based diagnostic or assistive system.

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

• Not Applicable. This is a physical medical device (examination glove), not an AI/ML-based algorithm.

7. The type of ground truth used

• For Dimensions, Physical Properties, Freedom from pinholes, Powder Free Residue, and Protein Level, the ground truth is established by objective measurements and laboratory testing conforming to the specified ASTM standards.
• For Biocompatibility (Primary Skin Irritation in Rabbits and Guinea Pig Sensitization), the ground truth is established by standardized animal testing protocols to assess biological response.

8. The sample size for the training set

• Not Applicable. This device does not involve a "training set" in the context of AI/ML models. It's a manufactured physical product.

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

• Not Applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply. The performance of the gloves is established through direct testing against defined standards.

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