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This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Nitrile Examination Gloves (Blue), non-sterile.

Here's an analysis of the provided information regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Regarding the study proving the device meets the acceptance criteria, the provided document is a 510(k) summary for a medical device (Powder-Free Nitrile Examination Gloves). As such, it focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study report for an AI/imaging device. Therefore, many of the requested points below (sample size, experts, adjudication, MRMC, standalone performance, ground truth establishment) are not applicable in the context of this type of submission for examination gloves.

However, based on the information provided, we can infer the following about the testing and evidence:

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

• Sample Size: Not explicitly stated. For physical property testing of gloves, sample sizes are typically defined by the specific ASTM standards (e.g., a certain number of gloves per batch for dimension, tensile strength, and freedom from holes testing).
• Data Provenance: Not explicitly stated, but based on the nature of manufacturing and testing for medical devices, it would be retrospective data collected during the production and quality control processes of the manufacturer (THAI HUA HOLDING COMPANY LIMITED). The country of origin of the data would likely be Thailand, where the manufacturer is located, or potentially the location of the testing laboratories.

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

• Not Applicable. For physical and biocompatibility testing of gloves, "experts" in the sense of clinician reviewers establishing ground truth for disease detection are not relevant. The "ground truth" is objective measurement against specified standards. Testing would be performed by lab technicians or engineers trained in the relevant ASTM and ISO standards.

4. Adjudication Method for the Test Set:

• Not Applicable. As the "ground truth" relies on objective measurements against standards, an adjudication method for different human interpretations is not needed. Test results either meet the numerical criteria or they don't.

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 an examination glove, not an AI or imaging device that would involve human readers or AI assistance.

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

• Not Applicable. See point 5.

7. The type of ground truth used:

• Objective Measurements/Standards: The ground truth for this device's performance is established by the specified ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards, and Consumer Product Safety Commission regulations. For example:
  • Dimensions and Physical Properties: Direct measurements of glove size, tensile strength, elongation, etc., compared against the numerical ranges defined in ASTM D 6319-00a(2005).
  • Freedom from Holes: Water leak testing as per ASTM D 5151-06, yielding a quantified Acceptable Quality Level (AQL).
  • Powder Free Residual: Measurement of residual powder, compared against the limit in ASTM 6124-06.
  • Biocompatibility: Results from standardized animal (rabbit, guinea pig) tests for irritation and sensitization, evaluated against established toxicology protocols.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/machine learning device that requires a "training set." The testing methods are based on established engineering and materials science principles.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. See point 8.

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This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder-Free Polymer Coated Latex Examination Gloves with Protein Labeling (50microgram or less of total water extractable proteins per square decimeter of gloves), non-sterile.

The provided text describes the acceptance criteria and performance of Powder-Free Polymer Coated Latex Examination Gloves.

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 explicitly state the specific sample sizes used for each test (e.g., freedom from holes, protein content, biocompatibility). It references ASTM and ISO standards, which would typically specify sampling plans.

The data provenance is not explicitly stated in terms of country of origin but is presented as nonclinical test results performed on the device. Given the applicant is THAI HUA HOLDING CO., LTD. based in Bangkok, Thailand, it is reasonable to infer the tests were conducted in facilities related to their operations or authorized testing laboratories. The data appears to be retrospective as it's presented to demonstrate that the manufactured device meets established standards.

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

This information is not provided in the document. The "ground truth" for the device's performance is established by its adherence to specified ASTM and ISO standards, which are themselves expert-developed and widely accepted.

4. Adjudication method for the test set:

This information is not provided. The assessment method relies on the device meeting numerical or qualitative criteria defined by the referenced standards, rather than expert adjudication of subjective outcomes.

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 device is a medical glove, not an AI-assisted diagnostic or imaging tool. Therefore, the concept of "human readers improve with AI" is not applicable here.

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

No, a standalone algorithm performance study was not done. This device is a physical product (medical glove) and does not involve any algorithms or AI for its function.

7. The type of ground truth used:

The ground truth used is based on established national and international standards for medical gloves. Specifically:

• ASTM D 3578-05 Standard Specification for Rubber Examination Gloves for dimensions, physical properties, and freedom from holes.
• ASTM D 5151-06 for freedom from holes.
• ASTM D 5712-99 for protein content.
• ASTM D 6124-06 for powder-free residue.
• Consumer Product Safety Commissions Title 16, Chapter II. Part 1500.41& 1500:3(c)(4) for primary skin irritation.
• ISO 10993-10: 2002(E) for guinea pig sensitization.

These standards provide objective, measurable criteria which serve as the "ground truth" for the device's acceptable performance.

8. The sample size for the training set:

This concept is not applicable as the device is a physical product and does not involve machine learning or a "training set."

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

This concept is not applicable for the reasons stated in point 8.

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This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powdered Latex Examination Gloves. non-sterile.

The provided text describes a 510(k) premarket notification for "Powdered Latex Examination Gloves" by THAI HUA HOLDING CO. LTD. It outlines the device's characteristics, intended use, and conformance to standards.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The "DEVICE PERFORMANCE" column indicates that the gloves meet or pass the specified criteria, demonstrating compliance with the referenced ASTM, CPSC, and ISO standards.

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

The document does not specify the sample size used for the test set (e.g., how many gloves were tested for dimensions, holes, etc.).

It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective). The testing appears to be conducted by the manufacturer to demonstrate compliance with international standards.

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

This information is not applicable and therefore not provided in the document. The "ground truth" for this type of device (examination gloves) is established by adherence to predefined objective physical and chemical standards (e.g., ASTM, ISO), not by expert opinion or interpretation in a medical imaging or diagnostic context.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation (e.g., medical image reading) where disagreements between experts need to be resolved. For objective physical and chemical tests, the results are quantifiable and do not require adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the impact of an AI algorithm on their performance is being evaluated. For medical gloves, the performance is assessed against objective technical standards, not through human reader interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical product (examination gloves), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective, verifiable physical and chemical standards as defined by:

• ASTM D 3578-05: Standard Specification for Rubber Examination Gloves (for dimensions, physical properties, freedom from holes).
• ASTM D 5151-06: Standard Test Method for Detection of Holes in Medical Gloves.
• ASTM 6124-06: Standard Test Method for Residual Powder on Medical Gloves.
• ASTM D 5712-99: Standard Test Method for the Measurement of Latex Allergens in Natural Rubber and Latex Products.
• CPSC Title 16, Chapter II, Part 1500:41: For Primary Skin Irritation in Rabbits.
• ISO 10993-10: 2002(E): Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (specifically for Guinea Pig Sensitizations).

These standards provide the definitive criteria against which the device's performance is measured.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an AI/ML model that requires a training set. The manufacturing process of gloves does not involve machine learning training sets.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this type of physical device.

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