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

The Powder Free Nitrile Examination Gloves (Blue) meets all the requirements of ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application.

The provided document is a 510(k) Pre-market Notification for Powder Free Nitrile Examination Gloves (Blue). This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, primarily focusing on product safety and effectiveness standards rather than complex AI algorithm performance.

Therefore, the requested information pertaining to AI algorithm studies (sample sizes for training/test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) is not applicable to this device.

The study described in this document is a non-clinical performance evaluation to demonstrate adherence to established medical device standards.

Here's the relevant information based on the document's content:

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 the exact sample sizes used for each individual test (e.g., number of gloves tested for dimensions, tensile strength, pinholes, etc.).
• The data provenance is implied to be from tests conducted on the manufacturer's product, Nam Viet Glove Joint Stock Company in Vietnam. The description of tests being performed on "the test article" implies prospective testing.

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

• Not Applicable. For this type of medical device (examination gloves), "ground truth" is established by adherence to physical and chemical standards and test methods outlined by organizations like ASTM and ISO, not human expert consensus on interpretations. The results are objective measurements.

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

• Not Applicable. As mentioned above, the tests involve objective measurements against predefined standards, not subjective interpretations requiring 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 physical product (nitrile gloves), not an AI-powered diagnostic or assistive technology.

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

• Not Applicable. This is a physical product, not an algorithm.

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

• The "ground truth" is defined by the objective specifications and quantifiable limits set by international standards (ASTM D6319-10, ISO 10993-10, ASTM D5151-06, ASTM D6124-06) and FDA regulations (21 CFR 800.20). Performance is measured directly against these specified values.

8. The sample size for the training set:

• Not Applicable. This applies to AI/machine learning models which are not relevant here.

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

• Not Applicable. This applies to AI/machine learning models which are not relevant here.

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

Orange Nitrile Medical Examination gloves powder free, non sterile, as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. They are made nitrile from nitrile latex compound, orange colour, powder free and non sterile.

This document is a 510(k) Pre-market Notification for a medical device: "RS Orange Nitrile Medical Examination Gloves (Powder Free)". This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets acceptance criteria through a full-fledged clinical study in the way a new, high-risk device might.

Therefore, the requested information about clinical study design, sample sizes for test/training sets, experts, adjudication methods, MRMC studies, and standalone algorithm performance does not directly apply to this type of submission. The "study" here refers to non-clinical performance testing and biocompatibility assessments against established standards.

Here's an interpretation of the document in the context of your request:

Acceptance Criteria and Device Performance

The device demonstrates performance against recognized standards, specifically ASTM D6319-10 for physical characteristics and FDA-recommended biocompatibility tests.

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 the exact sample sizes used for the physical and biocompatibility tests. These are typically standard tests performed on batches of gloves according to the relevant ASTM and ISO standards. The data provenance would be from laboratory testing of the manufactured gloves. The document originates from Malaysia (Riverstone Resources Sdn.Bhd.). The testing would be considered prospective in the sense that the tests were performed on the device being submitted.

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. The "ground truth" for glove performance is established by the specified standards (ASTM D 6319-10) and regulatory guidelines for biocompatibility. The results are objective measurements or categorical assessments (e.g., non-irritant, non-sensitizer) from laboratory testing, not subjective expert judgment.

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

Not applicable. Laboratory tests have defined methods for determining outcomes, rather than requiring expert 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 is for a physical medical examination glove, not an AI-assisted diagnostic or imaging device.

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

Not applicable. This is for a physical medical examination glove, not an algorithm.

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

The ground truth for this device is based on:

• Standard Specifications: Meeting the chemical and physical property requirements defined by ASTM D 6319-10.
• Biocompatibility Standards: Results from established laboratory tests (Primary Skin Irritation Test, Dermal Sensitization Assay) based on the Consumer Product Safety Commission guidelines and ISO 10993-10:2010(E).

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model.

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

Not applicable. This is a physical device, not a machine learning model.

Summary of the "Study" (Performance Testing):

The "study" for this device consists of non-clinical performance testing and biocompatibility assessments to demonstrate that the RS Orange Nitrile Medical Examination Gloves (Powder Free) meet the established requirements of ASTM D 6319-10 for physical properties (dimensions, physical properties, freedom from pinholes, powder-free status) and specific biocompatibility standards (Primary Skin Irritation Test and Dermal Sensitization Assay). The results consistently demonstrate that the device "Meets" the ASTM standard and was found to be a "non-irritant" and "non-sensitizer" in the biocompatibility tests. This data forms the basis for the conclusion that the device is substantially equivalent to the predicate devices and performs according to performance standards and FDA requirements.

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