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

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D-6139 and ASTM D-5250.

The provided text describes the 510(k) submission for Anhui Intco Medical Products Co. Ltd.'s Powder-Free Vinyl Patient Examination Gloves, Yellow Color (K191092). This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the performance of an AI-powered medical device through a clinical study.

Therefore, most of the requested information regarding AI device acceptance criteria and study details (such as MRMC studies, standalone algorithm performance, AI training/test set ground truth, and expert qualifications for ground truth establishment) is not applicable to this document.

However, I can extract information related to the performance characteristics that were tested for these medical gloves to demonstrate substantial equivalence.

Here's the information that is applicable based on the provided document:

1. Table of acceptance criteria and the reported device performance:

The document compares the subject device (K191092) to a predicate device (K022091) across various physical and biocompatibility characteristics. The "acceptance criteria" here are essentially the performance levels of the predicate device or established standards (like ASTM).

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

The Vinyl Examination Gloves are single use only, disposable gloves intended for medical purposes to be worn on the hands or fingers of examiners. The gloves are powder-free, clear and are made of poly vinyl chloride. The gloves are offered non-sterile and are available in small, medium, large and extra-large sizes.

The provided document is a 510(k) Premarket Notification for Powder-Free Clear Vinyl Patient Examination Gloves (K190095). This document is a submission to the FDA (Food and Drug Administration) for a Class I medical device. For such devices, the primary demonstration of meeting acceptance criteria relies on adhering to recognized performance standards and biocompatibility tests.

The document does not describe an AI medical device or a study involving human readers and AI assistance. Therefore, information related to AI-specific criteria (e.g., sample size for training set, number of experts for ground truth, MRMC studies, standalone algorithm performance, effect size of human improvement with AI) is not applicable and is not present in the document.

Instead, the acceptance criteria and performance data pertain to the physical and biological properties of the examination gloves.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance for Powder-Free Clear Vinyl Patient Examination Gloves (K190095)

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• ASTM D5151-06 (Pinhole/Water Leak Test): 125 gloves were tested for the AQL (Acceptable Quality Level) 2.5 sampling.
• Other standards (e.g., ASTM 5250-06 for physical properties, ASTM D6124-06 for residual powder, ISO 10993 series for biocompatibility): Specific sample sizes for these tests are not explicitly stated within the provided text, but industry standards dictate typical sample sizes for such evaluations.
• Data Provenance: The manufacturer is Anhui Intco Medical Products Co., Ltd., located in Anhui Province, China. The testing was conducted by the manufacturer to demonstrate compliance with international standards. The data is retrospective, generated for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not Applicable. This document pertains to the physical and biological testing of a medical device (examination gloves), not an AI algorithm that requires expert annotation for ground truth. The "ground truth" here is established by the validated methodologies of the ASTM and ISO standards themselves.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is a submission for a Class I medical device based on performance standards and biocompatibility, there is no "adjudication" in the sense of expert consensus on image interpretation. The results are quantitative and objective measurements against established standard criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This is not relevant for the type of device (examination gloves) and the nature of the 510(k) submission.

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

• Not Applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

• The ground truth is based on validated methodologies and acceptance criteria defined by international standards such as ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization). These standards outline the methods for objectively measuring physical properties (e.g., tensile strength, elongation, dimensions, powder residue, pinholes) and biological responses (e.g., irritation, sensitization, cytotoxicity).

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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