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A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste, or environment.

A patient examination glove is a disposable device intended for medical purpose worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Glove, Disposable, Non-sterile, Patient Examination, Vinyl (Powder Free)

The provided text describes the acceptance criteria and performance of the EVERGREEN MEDICAL PRODUCTS Vinyl Patient Examination Gloves - Powder Free. However, it does not contain information about a study proving the device meets the acceptance criteria in the manner of a multi-reader, multi-case (MRMC) comparative effectiveness study, or a standalone (algorithm only) performance study as typically seen for AI/ML medical devices. The document is a 510(k) summary for a medical device (examination gloves), which follows a different set of regulatory requirements focused on demonstrating substantial equivalence to a predicate device.

Instead, the "study" described in this document is essentially a series of quality characteristic tests performed against established ASTM and FDA standards for patient examination gloves.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify a distinct "test set" sample size in terms of number of gloves tested for each characteristic. It refers to established standards and tests (e.g., JIS-S-2045.509, JIS-S-2045.5.2, FDA Glove 1000ml Water Leak Test, Primary Dermal Irritation in Rabbits, Guinea Pig Sensitization). These standards imply specific sampling plans.
• Data Provenance: The tests for biocompatibility were "Issued by Consumer Products Testing Co." The document states the manufacturer is located in Shijiazhuang City, Hebei, China. Thus, the provenance of the testing data is likely China. The study is retrospective in the sense that the data presented reflects the results of quality control and testing performed on manufactured batches to demonstrate compliance with standards.

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

• This concept is not applicable here as this is a physical medical device (gloves) and not an AI/ML diagnostic or image analysis device that requires expert consensus for "ground truth." The "ground truth" for the performance characteristics are the established ASTM and FDA standards themselves. The assessment is against these objective measurements.

4. Adjudication method for the test set:

• This concept is not applicable. Performance against physical and chemical specifications does not involve "adjudication" by experts in the context of diagnostic interpretation. The methods are standardized physical and chemical tests (e.g., measuring length, tensile strength, pinhole rate via water leak test, biological irritation tests).

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:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic systems, not for examination gloves.

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

• No, a standalone (algorithm only) performance study was not done. This type of study is relevant for AI/ML diagnostic systems, not for examination gloves.

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

• The "ground truth" for this device's performance is adherence to established, objective material and physical specifications and testing standards (e.g., ASTM Specification D 5250-99 for physical properties, FDA Glove 1000ml Water Leak Test for pinholes, and standard biocompatibility tests).

8. The sample size for the training set:

• This concept is not applicable. This device is not an AI/ML algorithm that requires a "training set." The manufacturing process itself (described in Section 10.0) is continuously refined and controlled, but there isn't a "training set" in the sense of data used to train a model.

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

• This concept is not applicable, as there is no "training set." The standards for glove manufacturing and performance are established by regulatory bodies and industrial organizations (e.g., ASTM, FDA) based on extensive research and consensus within the medical and materials science communities to ensure safety and effectiveness for their intended use.

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