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The Disposable nitrile gloves are intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The Disposable nitrile gloves are powder free nitrile examination gloves. The Disposable nitrile gloves will be provided in blue. It can be available in four specifications: S,M,L and XL. And it is non-sterile.

This document is a 510(k) submission for disposable nitrile gloves. It is primarily concerned with establishing substantial equivalence to a predicate device, not with a clinical study of AI performance. Therefore, many of the requested elements regarding AI model acceptance criteria and study design are not applicable to this document.

However, I can extract information related to the device's performance acceptance criteria and how they were proven in a non-clinical setting.

Here's the breakdown based on the provided document:

Device: Disposable nitrile gloves (K223280)
Purpose of the document: To demonstrate substantial equivalence to a legally marketed predicate device (K212924) and obtain FDA clearance for marketing.

Acceptance Criteria and Reported Device Performance

The device performance is evaluated against established ASTM and ISO standards for examination gloves.

1. A table of acceptance criteria and the reported device performance

Note: The "Fail" for Cytotoxicity for the subject device is inconsistent with "Same" for Biocompatibility in Table 6A comparing to the predicate and with the overall conclusion of safety and effectiveness. This might be a typo in the table or an acceptable failure within certain thresholds not explicitly stated, or the "Fail" refers to a specific condition that is ultimately deemed not relevant for the overall biocompatibility assessment in comparison to the predicate. Given the "Same" in Table 6A and the overall conclusion, it suggests the cytotoxicity was deemed acceptable in context.

Study Proving the Device Meets Acceptance Criteria

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated for each test, but standard test methods (ASTM, ISO) typically specify sampling plans. This is a non-clinical laboratory testing report, not a human clinical study.
• Data Provenance: The manufacturing entity is HOLIK ASIA GROUP CO.,LTD based in Anhui Province, China. The testing would presumably be conducted by or for the manufacturer. The data is from laboratory testing, not human subjects.
• Retrospective or Prospective: This is prospective testing, as the device was manufactured and then tested against the specified standards.

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

• Not Applicable. This document describes non-clinical performance testing of a physical device against established industry standards. "Ground truth" in the context of expert review for medical imaging or AI is not relevant here. The "ground truth" is defined by the objective measurement criteria of the ASTM and ISO standards.

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

• Not Applicable. See point 3. Testing against physical properties does not involve adjudication by multiple human experts.

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 (gloves), not an AI algorithm. No human reader or AI assistance is involved. The document explicitly states: "Performance Testing - Clinical: Not Applicable." and "Performance Testing - Animal: Not Applicable."

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

• Not Applicable. This is a physical medical device (gloves), not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for these tests is defined by the quantitative and qualitative requirements of the specific ASTM and ISO standards (e.g., tensile strength minimums, AQL levels for holes, maximum powder content, and biological reactivity thresholds). These are objective, standardized measurements.

8. The sample size for the training set

• Not Applicable. There is no AI model or training set for this device.

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

• Not Applicable. There is no AI model or training set for this device.

Summary regarding the nature of the study:

The study described is a non-clinical performance testing study. Its goal is to demonstrate that the physical and biological properties of the disposable nitrile gloves meet recognized consensus standards (ASTM and ISO) and are substantially equivalent to a predicate device. This type of submission (510(k)) for a Class I device (like examination gloves) typically does not require human clinical trials or involve AI.

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