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The Disposable Nitrile Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The Disposable Nitrile Gloves are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue or black color, powder free, nitrile ambidextrous gloves. The gloves are offered in large (L) size, packed in a paper box. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard.

The provided text describes the 510(k) premarket notification for Disposable Nitrile Gloves (ABC-DG01). It outlines the device's characteristics, its intended use, and a comparison to a predicate device (K171422). The submission focuses on demonstrating substantial equivalence through non-clinical testing.

Here's an analysis of the provided information to address your request:

Based on the provided document, the "device" in question is Disposable Nitrile Gloves (ABC-DG01). This is a Class I medical device, meaning it is considered low risk and subject to general controls. The acceptance criteria and "study" described are for physical and chemical performance, not for a diagnostic algorithm or AI.

Therefore, many of the questions regarding AI-specific studies (e.g., sample size for test set, data provenance, expert consensus, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of medical device submission.

The "study" refers to non-clinical performance testing conducted to demonstrate that the Disposable Nitrile Gloves meet established standards for patient examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance

The relevant information is found in "Table 4. Performance Comparison" and "Summary of Non-Clinical Testing" (specifically the table under section G).

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

The document provides some direct sample sizes for specific tests:

• Freedom from holes: "125 of 125 passed of each color" (meaning 125 blue gloves and 125 black gloves were tested).
• For other tests like Dimensions, Physical properties, and Residual Powder, specific sample sizes are not explicitly stated in the provided text, but the results indicate that a sample was tested according to the ASTM standards.
• Data provenance: Not explicitly stated, but given the company location (Huizhou, China), the testing was likely conducted in China, often by accredited labs specializing in material testing. The data is retrospective in the sense that it was collected as part of product verification before submission.

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

Not Applicable. This is a physical product (gloves), not a diagnostic algorithm where expert consensus establishes "ground truth." The "ground truth" for these tests are the objective measurements against the specified ASTM standards.

4. Adjudication method for the test set

Not Applicable. There is no "adjudication" in the sense of reconciling expert opinions for a diagnostic outcome. The tests are objective measurements (e.g., measuring thickness, tensile strength, liquid leakage, residual powder mass). The results pass or fail based on the numerical comparison to the acceptance criteria.

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 for a physical medical product (gloves), not an AI/Software as a Medical Device (SaMD). No "human readers" or "AI assistance" are involved in the performance testing of gloves.

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

Not Applicable. This is for a physical medical product (gloves), not an AI/SaMD. There is no algorithm.

7. The type of ground truth used

The "ground truth" for these physical and chemical tests is defined by the objective measurement against established engineering standards (ASTM D6319-19, ASTM D5151-19, ASTM D6124-06). For example, for "freedom from holes," the ground truth is simply whether liquid leaks or not according to the specified test method. Similarly, for "tensile strength," the ground truth is the measured force required to break the glove.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device. No "training set" is used.

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

Not Applicable. As above, no training set or AI model is involved.

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