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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.

Subject device: Powder Free Clear Vinyl Patient Examination Glove Color: Clear Overall Length: 230mm min Width: 94mm min Palm Thickness: 0.09 mm min Fingertip Thickness: 0.086 mm min

The provided document describes the acceptance criteria and performance of the Powder-Free Clear Vinyl Patient Examination Gloves by Zibo Yue Fan Medical Products Co., Ltd. against a predicate device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are defined by compliance with ASTM standards and key physical properties. The "reported device performance" reflects the measured values for the subject device and the predicate device.

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

• Test Set Sample Size:
  • For Pinhole Results: 125 pieces of gloves.
  • For other physical and performance characteristics, the document states "Inspection Level S-2, AOL 2.5," which refers to sampling plans defined in standards like ASTM D-5250-06 or ISO 2859-1. The exact number of samples tested for each characteristic is not explicitly stated as a single number but is determined by the AQL (Acceptance Quality Limit) and inspection level.
• Data Provenance: Not explicitly stated, but based on the manufacturer's location (Zibo, Shandong, China) and the testing standards used (ASTM), the testing would likely have been conducted in China or by a laboratory accredited to perform these tests for a Chinese manufacturer. The data appears to be prospective as it is generated for the purpose of a 510(k) submission.

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

This information is not applicable to this type of device. The "ground truth" for patient examination gloves is established through objective, standardized physical and chemical tests (e.g., tensile strength, elongation, pinhole detection, residual powder) according to recognized ASTM standards, rather than through expert consensus on qualitative assessments.

4. Adjudication method for the test set

Not applicable. As noted above, the "truth" is determined by objective measurement against established physical and chemical standards, not by human interpretation or adjudication.

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 device is a patient examination glove and does not involve AI or human "readers" in its function or evaluation.

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

Not applicable. This device is a physical medical product, not an algorithm or software.

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

The ground truth used for this device is based on objective, quantitative measurements obtained through standardized physical and chemical testing methods, as defined by ASTM (American Society for Testing and Materials) standards. This includes:

• ASTM D-5250-06 for physical and dimensional testing (e.g., length, width, thickness, tensile strength, elongation).
• ASTM D-6124-06 for residual powder content.
• ASTM D-5151-06 for pinhole detection.
• Biocompatibility tests (primary skin irritation and dermal sensitization) performed under controlled conditions.

8. The sample size for the training set

Not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI models.

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

Not applicable. As there is no training set for this type of device, no ground truth was established for it.

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