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A powder-free 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.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time of less than 30 minutes:

Carmustine (BCNU) (3.3 mg/ml) Thiotepa (10 mg/ml)

These patient examination gloves are formulated using Nitrile. They are a disposable device that is offered powder-free and non-sterile. Gloves are cornflower blue in color. Gloves are not made with natural rubber latex.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cardinal Health Nitrile Cornflower Blue Powder-Free Examination Gloves, structured according to your request.

This document describes a medical device, specifically examination gloves, and presents testing results, rather than an AI/ML powered device. As such, several of your requested points (like "effect size of how much human readers improve with AI vs without AI assistance", training set size, etc.) are not applicable to this type of submission. I will address the relevant points and indicate when information is not applicable.

Acceptance Criteria and Device Performance for Nitrile Cornflower Blue Powder-Free Examination Gloves

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample size (number of gloves or test replicates) used for each individual test (e.g., skin irritation, dimensions, permeation). It states "Gloves meet requirements..." or "Results generated..." indicating that tests were performed to establish compliance.
• Data Provenance: The document does not explicitly state the country of origin for the data or if it was retrospective or prospective. Given it's a 510(k) submission to the FDA, the testing was likely conducted in accordance with recognized international or US standards in accredited laboratories to support the submission.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This is a physical product (gloves) undergoing standardized material and performance testing, not an AI/ML system requiring expert-established ground truth from medical images or clinical observations. The "ground truth" is established by the specifications of the ASTM standards and regulatory requirements.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in human-in-the-loop or expert-driven diagnostic studies, which is not relevant here. The results are based on objective measurements and compliance with specified test methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not Applicable. This type of study assesses the performance of AI systems in a clinical context, often with human readers. This submission is for a physical medical device (gloves) and does not involve AI or human readers for diagnostic purposes.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

• Not Applicable. This is not an algorithm or software device. The "standalone performance" refers to the glove's physical and chemical resistance properties as measured against established standards.

7. Type of Ground Truth Used

• The "ground truth" for this device's performance is defined by established ASTM (American Society for Testing and Materials) standards and FDA regulations.
  • For physical properties and freedom from holes, it's compliance with ASTM D6319 and 21 CFR 800.20.
  • For powder residual, it's compliance with ASTM D6319 using ASTM D6124 methodology.
  • For chemotherapy permeation, it's the breakthrough time as measured according to ASTM D6978-05.
  • For biocompatibility (skin irritation and sensitization), it's the observed biological response as determined by standardized tests.

8. Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary of the Study Proving Device Meets Acceptance Criteria:

The device's performance was proven through a series of standardized laboratory tests detailed in the "Performance Testing" section. These tests were conducted according to recognized ASTM standards (D6319, D6124, D6978-05) and FDA regulations (21 CFR 800.20). The results consistently demonstrate that the Nitrile Cornflower Blue Powder-Free Examination Gloves meet all specified requirements for physical characteristics, freedom from holes, powder residual, primary skin irritation, potential for sensitization, and resistance to permeation by nine specific chemotherapy drugs. The specific "Minimum Breakthrough Detection Time" for each chemotherapy drug was measured to confirm its protective qualities. Based on this comprehensive testing, the manufacturer concluded that the gloves meet the technological characteristics of ASTM D6319 performance standard and are substantially equivalent to their predicate device.

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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. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs.

Nitrile Powder-Free Examination Gloves with coating are formulated using nitrile and offered powder-free.

This document describes the safety and effectiveness summary for Cardinal Health's Nitrile Powder-Free Examination Gloves with Coating, submitted under 510(k) number K032444.

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria for this device are based on meeting safety and performance standards for examination gloves, particularly with added protection against chemotherapy drugs. The reported performance demonstrates compliance with these standards.

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

The document does not specify the exact sample sizes used for each of the tests (e.g., number of gloves tested for tensile strength or barrier defects, number of animals for skin irritation). The data provenance is not explicitly stated as country of origin, but it is implied to be from Cardinal Health's testing procedures, conducted prior to the 510(k) submission date of July 25, 2003, hence, retrospective in relation to the submission.

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

This information is not provided in the summary. The tests performed are standardized material and biological safety tests (ASTM, CFR), which rely on established protocols rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set:

This is not applicable for the types of tests described. The tests are based on objective measurements and established pass/fail criteria from regulatory standards and ASTM methods, not on expert adjudication of interpretations.

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

No, an MRMC comparative effectiveness study was not done. The device is an examination glove, and the testing focuses on its material properties, barrier integrity, and biological safety, not on diagnostic accuracy requiring human reader interpretation.

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

This is not applicable. The device is a physical product (a glove), not an algorithm or AI software. Therefore, there is no concept of "standalone performance" in the context of an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for these tests is based on:

• Established ASTM Standards: For mechanical properties like tensile strength and barrier integrity.
• Regulatory Requirements: As stipulated by 21 CFR for barrier defects.
• Biological Safety Protocols: For primary skin irritation and guinea pig maximization, which determine the absence of irritation or sensitization.
• Standardized Chemotherapy Drug Permeation Testing: Using ASTM F739-99a.

8. The Sample Size for the Training Set:

This is not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set. The manufacturing process itself is expected to produce consistent products that adhere to the established quality and performance standards.

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

This is not applicable as there is no "training set" in the context of developing this medical device. The "ground truth" for ensuring quality during manufacturing would be established through ongoing quality control processes that verify the product meets the specifications outlined by the ASTM and CFR standards, as detailed in point 7.

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Nitrile Powder-free Examination Glove, ProBlue is a disposable device made of synthetic materials intended for medical purposes that are worn on the examiner's hand or finger(s) to prevent contamination of potentially infectious materials between patient and examiner.

Nitrile Powder-Free Examination Gloves, ProBlue, #7235 & #7735

The provided text is a 510(k) premarket notification letter from the FDA regarding "Nitrile Powder-Free Examination Gloves, ProBlue, #7235 & #7735." This document outlines the FDA's determination of substantial equivalence for a medical device and does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria for an AI/ML product.

The letter is for a physical medical glove and discusses regulatory compliance for manufacturing and marketing, not the performance metrics of a software or AI device. Therefore, I cannot generate the requested table and study information based on this document.

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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. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs.

Nitrile Powder-Free Examination Gloves are formulated using nitrile and offered powder-free.

This document describes the safety and effectiveness of "Nitrile Powder-Free Examination Gloves" and does not relate to artificial intelligence or machine learning devices. Therefore, most of the requested information (e.g., sample sizes for test and training sets, expert qualifications, MRMC studies, standalone algorithm performance, adjudication methods, details about AI-related ground truth) is not applicable to this submission.

However, I can extract and present the information that is relevant to the acceptance criteria and the summary of testing for these medical gloves.

Acceptance Criteria and Device Performance for Nitrile Powder-Free Examination Gloves

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: Not specified in the provided document for any of the tests.
• Data Provenance: Not specified. Standard practice for these tests is typically prospective testing of manufactured batches.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable as this is not an AI/ML device requiring expert ground truth for interpretation of complex data. The "ground truth" for glove performance tests is determined by standardized physical and biological testing methodologies.

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

• Not applicable. These are laboratory tests with objective outcomes based on established 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 is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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

• The "ground truth" is established by the specified standards and regulations:
  • Primary Skin Irritation & Guinea Pig Maximization: Biological tests to assess skin reactions, interpreted by trained personnel following toxicological guidelines (implied).
  • Tensile Strength: Objective measurement against specifications defined in ASTM D6319-00a.
  • Barrier Defects: Objective measurement against specifications defined in 21 CFR§800.20 (Pinholes in Medical Gloves) and ASTM D6319-00a.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

Summary of Safety and Effectiveness Explanation (Based on Provided Text):

The "Nitrile Powder-Free Examination Gloves" were determined to be substantially equivalent to the predicate device (Flexam Nitrile T Ambi Examination Gloves, Allegiance Healthcare Corp.) based on shared characteristics and testing results. The device's safety and effectiveness were demonstrated by laboratory testing confirming:

• No primary skin irritation.
• No potential for irritation in a guinea pig maximization test.
• Conformity to or exceeding the tensile strength requirements of ASTM D6319-00a.
• Conformity to or exceeding the barrier defect requirements of 21 CFR§800.20 and ASTM D6319-00a.

These tests ensure the gloves perform their intended function of preventing contamination and protecting the wearer, without causing adverse biological reactions, and meet the mechanical and barrier integrity standards for medical examination gloves.

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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.

Nitrile Powder-Free Examination Gloves are formulated using nitrile and offered powder-free.

The provided text describes a 510(k) premarket notification for "Nitrile Powder-Free Examination Gloves" by Allegiance Healthcare Corporation. It is a submission for a medical device that does not involve AI or algorithms, and therefore, many of the requested categories are not applicable.

Here's the information based on the provided text, indicating "N/A" (Not Applicable) for categories that pertain to AI/algorithm-based devices:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not specified, as this is a physical device rather than an AI/data-driven one. The tests are for physical properties and biocompatibility.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties and biocompatibility tests would be established through standardized testing protocols executed by designated laboratory personnel, not clinical experts for ground truth in the AI sense.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. The tests involve objective measurements and observations against established standards, not interpretation requiring adjudication.

4. 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, as this is not an AI-assisted device.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is based on established industry standards and regulatory requirements. For example:

   • Biocompatibility tests (Skin Irritation, Guinea Pig Maximization): "No irritation" or "no potential for irritation" as determined by standardized biological evaluation methods.
   • Tensile Strength: Measurements meeting specified values in ASTM D6319-00a.
   • Barrier Defects: Compliance with defect limits set in 21 CFR §800.20 and ASTM D6319-00a.

7. The sample size for the training set: Not applicable, as there is no training set for a physical device like examination gloves.

8. How the ground truth for the training set was established: Not applicable.

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