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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, fentanyl citrate, xylazine, gastric acid, fentanyl in gastric acid and xylazine in gastric acid in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical gloves to Permeation by Chemotherapy Drugs.

Warning: do not use with Carmustine and Thiotepa.

The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time:

• Carmustine (BCNU) 3.3 mg/ml 21.5 minutes
• Thiotepa 10.0 mg/ml 13.6 minutes

"Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid" is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of this medical device is to provide single use barrier protection for the wearer and the device meets the specifications for Barrier Protection and tensile properties as defined in ASTM D6319-19, Standard specification for Nitrile Examination Gloves.

The provided document is an FDA 510(k) clearance letter for a medical device: "Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid."

This is a physical medical device (a glove), not a software device or an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML model validation (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of FDA submission.

The document assesses the device's physical properties and its resistance to permeation by various hazardous substances. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to bench testing against established ASTM and CFR standards for medical gloves.

Here's the breakdown of the relevant information from the document, tailored to the nature of this device:

Acceptance Criteria and Device Performance for Disposable Nitrile Examination Gloves

1. Table of Acceptance Criteria and Reported Device Performance

The device (Disposable Powder Free Nitrile Examination Glove, Blue Color) was tested against several physical and chemical permeation standards. The acceptance criteria and results are outlined in the "Assessment of Non-Clinical Performance Data" section (Page 17-19) and the "Indications for Use" section (Page 4-5) and summarized within the "510(k) Summary" (Page 7-11).

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

• Sample Size: The document does not explicitly state numerical sample sizes for each specific test (e.g., how many gloves were tested for a burst, tensile, or permeation). However, it implies that testing was conducted according to the specified ASTM and FDA methodologies, which inherently define minimum sample sizes for material testing (e.g., AQL levels for freedom from holes).
• Data Provenance: The tests are "bench testing" conducted on physical glove samples. The manufacturer is "Ever Global (Vietnam) Enterprise Corporation" from Vietnam, so the testing was likely conducted in accordance with international standards at a facility associated with the manufacturer or a certified testing lab. The data is non-clinical performance data from laboratory experiments, not patient data.

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

• Not Applicable. As this is a physical device subject to material property and permeation testing, "ground truth" is established by adherence to physical measurement standards and chemical analysis protocols (e.g., ASTM D6319-19 for physical properties, ASTM D6978-05 for permeation). No human expert interpretation or consensus is required to establish the "truth" of a chemical breakthrough time or tensile strength value.

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

• Not Applicable. Adjudication methods are relevant in subjective human interpretation tasks (e.g., radiology image reading). For objective bench testing of physical properties, results are determined by instrumentation and adherence to standardized protocols, not human 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. MRMC studies are used for evaluating the impact of AI on human reader performance, typically in medical imaging. This is a physical glove, not an AI-assisted diagnostic tool.

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

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

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

• The "ground truth" is established through objective, standardized laboratory measurement methods as defined by the referenced ASTM (American Society for Testing and Materials) and CFR (Code of Federal Regulations) standards.
  • For physical properties (Dimensions, Tensile Strength, Elongation, Powder Residual, Freedom from Holes), the ground truth is the measured physical values against the defined thresholds in ASTM D6319-19 and 21 CFR 800.20 & ASTM D5151-19.
  • For chemical permeation (Resistance to Hazardous Drugs), the ground truth is the measured breakthrough time determined by chemical analysis according to ASTM D6978-05.
  • For Biocompatibility, the ground truth is the biological response (cytotoxicity, dermal reactions) as measured per AAMI/ANSI/ISO 10993-5 and 10993-10 standards.

8. The sample size for the training set:

• Not Applicable. This is a physical product, not a machine learning model; therefore, there is no "training set." The product's design and manufacturing process are developed through engineering and material science, not data training.

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

• Not Applicable. As there is no training set for this physical device.

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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, fentanyl citrate, and xylazine in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical gloves to Permeation by Chemotherapy Drugs.

"Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate And Xylazine" is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of this medical device is to provide single use barrier protection for the wearer and the device meets the specifications for Barrier Protection and tensile properties as defined in ASTM D6319-19, Standard specification for Nitrile Examination Gloves.

The provided document is a 510(k) Premarket Notification for a Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine.

This device is a Class I medical device (non-powered patient examination glove). For devices in this class, the FDA typically does not require a clinical performance study with human subjects. Instead, evidence of substantial equivalence to a predicate device is primarily demonstrated through non-clinical performance data (bench testing).

Therefore, the requested information regarding AI device acceptance criteria, MRMC studies, ground truth establishment, training sets, and expert adjudication are not applicable to this particular device submission. This document describes the performance of a physical examination glove, not an AI or imaging device.

However, I can extract the acceptance criteria and reported device performance from the non-clinical testing:

Acceptance Criteria and Reported Device Performance

The study aims to demonstrate that the subject device (Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine) meets the acceptance criteria for various physical and chemical resistance properties, establishing its substantial equivalence to a predicate device (K193555).

Here is a table summarizing the acceptance criteria and the device's reported performance:

Regarding the specific questions about AI/imaging studies:

• 2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical tests on glove samples.
• 3. Number of experts used to establish the ground truth... and their qualifications: Not applicable. Ground truth for physical properties is established by standardized testing methods.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Results are quantitative measurements from lab tests.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. This is not an AI or imaging device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is established through adherence to recognized international/national standards for medical glove testing (e.g., ASTM D6319-19, ASTM D5151-19, ASTM D6978-05, AAMI/ANSI/ISO 10993-5, AAMI/ANSI/ISO 10993-10). These standards define the test methods and performance requirements.
• 8. The sample size for the training set: Not applicable. This is a manufactured product, not an AI model.
• 9. How the ground truth for the training set was established: Not applicable. Manufacturing controls and quality assurance ensure consistency, not a "training set" in the context of AI.

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A non-powdered 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.

A Disposable Powder Free Vinyl Examination Gloves (with color Beige or Clear) is a patient examination glove made from poly (vinvl chloride), non-sterile (as per 21 CFR 880.6250, Class I). The operation principle of this medical device is to provide single use barrier protection for the wearer and the device meets all the requirement specifications for barrier protection, tensile properties as defined in ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.

The document provides information about the non-clinical performance evaluation of "Disposable Powder Free Vinyl Examination Gloves, Beige/Clear" to demonstrate its substantial equivalence to a predicate device.

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

1. A table of acceptance criteria and the 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)

The document does not explicitly state the sample sizes used for each specific test. For instance, for "Freedom from holes," it mentions "G-I/AQL 2.5," which implies a sampling plan, but the exact number of units tested is not provided. The data provenance is not specified beyond being "nonclinical bench testing" conducted by the manufacturer. It does not mention countries of origin for the data or whether it was retrospective or prospective, as these are typically not applicable to bench testing of this nature.

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)

This section is not applicable as the study involves non-clinical bench testing of physical and chemical properties of gloves, not medical image analysis or diagnostic performance requiring expert interpretation. The "ground truth" is established by adherence to recognized international standards (ASTM, ISO) for material properties.

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

This is not applicable as the tests are objective, quantitative measurements against predefined criteria as per ASTM and ISO standards, not subjective assessments requiring adjudication by multiple readers.

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

This is not applicable as the device is a medical glove, a physical product, and does not involve AI assistance or human reader interpretation.

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

This is not applicable as the device is a medical glove, not an algorithm or AI system.

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

The ground truth for this device is based on established international standards and specifications for medical gloves, specifically:

• ASTM D3767 (Dimensions)
• 21 CFR 800.20 & ASTM D5151-19 (Freedom from holes)
• ASTM D412-16 & ASTM D573-04 (Tensile strength and Elongation)
• ASTM D6124-06 (Powder Residual)
• ISO 10993-10:2010 (Skin Irritation and Sensitization)
• ISO 10993-5:2009 (Cytotoxicity)

These standards define the acceptable physical properties and biocompatibility.

8. The sample size for the training set

This is not applicable as this study is a non-clinical performance evaluation of a medical device (glove) against established standards, not a machine learning or AI algorithm that requires a training set.

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

This is not applicable for the same reason as point 8.

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A non-powdered 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.

A Disposable Powder Free Vinyl Exam Glove (with color Black, Blue, or Purple) is a patient examination glove made from poly (vinyl chloride), non-sterile (as per 21 CFR 880.6250, Class I). This device is available in size S, M, L, and XL. The operation principle of this medical device is to provide single use barrier protection for the wearer and the device meets all the requirement specifications for barrier protection, tensile properties as defined in ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.

The provided text describes the acceptance criteria and the results of non-clinical performance testing for a medical device, specifically Disposable Powder Free Vinyl Exam Gloves.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the 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)

The document does not explicitly state the sample size used for each specific test or the data provenance. It only states "Pass" for each criterion, indicating that the tests were conducted.

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)

This information is not applicable as the acceptance criteria are based on standardized test methods and physical/chemical properties, not on expert interpretation of medical images or patient data.

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

This information is not applicable as the assessment involves standardized laboratory tests with objective measurements, not expert adjudication of subjective findings.

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

This information is not applicable. The device is a physical product (examination gloves), not an AI-assisted diagnostic tool. Therefore, an MRMC study is irrelevant.

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, not a standalone algorithm.

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

The "ground truth" for the performance evaluation of these gloves is based on established international and national standards for physical, chemical, and biological properties of medical gloves. Specifically, the tests reference:

• ASTM D3767 (for Dimension)
• 21 CFR 800.20 & ASTM D5151-19 (for Freedom from holes)
• ASTM D412-16 & ASTM D573-04 (for Tensile strength & Elongation)
• ASTM D6124-06 (for Powder Residual)
• ISO 10993-10:2010 and ISO 10993-23:2021 (for Biocompatibility - Skin Irritation and Sensitization)
• ISO 10993-5:2009 (for Biocompatibility - Cytotoxicity)

These standards define the acceptable range or condition for each characteristic.

8. The sample size for the training set

This information is not applicable. The described study is a non-clinical performance evaluation against predetermined standards, not a machine learning model requiring a training set.

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

This information is not applicable for the same reasons as point 8.

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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers 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.

Disposable Powder Free Nitrile Examination Glove, White/Blue Color, Tested For Use With Chemotherapy Drugs is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

The provided text is a 510(k) summary for Disposable Powder Free Nitrile Examination Gloves, white and blue colors, tested for use with chemotherapy drugs. It focuses on the safety and effectiveness of the device through non-clinical testing and comparison to a predicate device.

Here's an analysis to extract the requested information, noting that much of it pertains to AI/software device studies and is not applicable to this type of medical glove submission:

1. A table of acceptance criteria and the reported device performance

Note: The document distinguishes between white and blue gloves for chemotherapy drug permeation times. For other characteristics, it states "White/Blue Color" and indicates compliance with the same standards, implying similar performance unless specified.

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

The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for permeation, pinholes, etc.). It refers to compliance with ASTM standards, which would define appropriate sample sizes for those tests.

• Data Provenance: The tests described are "bench testing" performed presumably by the manufacturer (Ever Global (Vietnam) Enterprise Corporation) or a contracted lab. The manufacturer's address is Vietnam. The testing standards are international (ASTM, ISO) and US federal regulations (21 CFR).

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)

This question is not applicable as this submission is for medical gloves and not a software/AI device that requires expert ground truth for interpretation. The "ground truth" for the performance criteria is defined by the objective measurements outlined in the referenced ASTM and ISO standards for physical properties, chemical resistance, and biocompatibility.

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

This question is not applicable as this is not a study involving subjective human interpretation requiring adjudication. Performance is measured against objective standards.

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

This question is not applicable. This is a submission for a physical medical device (gloves), not an AI/software device.

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

This question is not applicable. This is a submission for a physical medical device (gloves), not an AI/software device.

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

The "ground truth" for the device's performance is established by objective measurements against recognized international and national standards:

• ASTM D6978-05: For chemotherapy drug permeation breakthrough times.
• ASTM D6319-10: For dimensions, physical properties (tensile strength, elongation), and freedom from pinholes (water leak test).
• 21 CFR 800.20: For freedom from pinholes.
• ASTM D5151-06 (Reapproved 2015) and D6124-06 (Reaffirmation 2011): For powder residual tests.
• ISO 10993-10: Third Edition 2010-08-01 and ISO 10993-5: For biocompatibility tests (primary skin irritation, dermal sensitization, MEM Elution).

8. The sample size for the training set

This question is not applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI.

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

This question is not applicable. There is no "training set" or need for "ground truth" establishment in the AI/ML sense for this device. The standards provide the criteria against which the device's physical and chemical properties are measured.

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