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Disposable Vinyl Examination Gloves 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.

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Powder-Free Vinyl Exam Gloves, clear is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The subject device is a powder free vinyl patient examination glove, provided as non-sterile and disposable device. It is provided with clear color. Available in four sizes small, medium, large, and extra - large users can choose the most suitable option.

The provided FDA 510(k) clearance letter and summary describe the regulatory approval process for "Powder-Free Vinyl Exam Gloves, clear." This is a Class I medical device, and the clearance is based on demonstrating substantial equivalence to a predicate device, K220469, "Disposable Vinyl Examination Glove."

The study described is not a clinical study involving human patients or complex AI algorithms necessitating multi-reader, multi-case (MRMC) studies or expert adjudication of medical images. Instead, it's a non-clinical performance study focused on the physical, chemical, and biological properties of the gloves.

Therefore, many of the requested points related to AI performance, human reader improvement, and complex ground truth establishment for medical diagnosis are not applicable to this type of device and study.

Here's the breakdown of the information that is applicable:

Acceptance Criteria and Device Performance for Powder-Free Vinyl Exam Gloves, Clear

The acceptance criteria and device performance are primarily based on non-clinical testing according to recognized industry standards (ASTM and ISO). The goal is to demonstrate that the subject device meets the same performance specifications as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a precise numerical sample size (e.g., number of gloves) for each non-clinical test. However, it indicates that testing was performed according to the specified ASTM and ISO standards, which inherently define the necessary sample sizes and methodologies for ensuring statistical validity within their respective contexts (e.g., AQL for the water leak test).
• Data Provenance: The document does not explicitly state the country of origin for the data. Given the "Basic Medical Technology Inc." is located in Ontario, CA (presumably California, USA) and the predicate device manufacturer is a Chinese company (CHIFENG HUAWEI MEDICAL SCIENCE TECHNOLOGY CO., LTD.), the testing could have been performed either in the US, China, or accredited labs elsewhere.
• Retrospective or Prospective: This testing is inherently prospective as it involves the manufacturing and testing of new device samples to demonstrate compliance with standards.

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

• Not Applicable: For this type of non-clinical device (medical gloves), "ground truth" is not established by medical experts interpreting images or clinical data. Instead, it's established by the physical and chemical properties of the material as measured by standardized laboratory methods. The "experts" would be the accredited laboratory personnel performing the tests according to the ASTM and ISO standards, not medical professionals like radiologists.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert interpretations of complex data (like medical images). This is a physical product testing scenario where results are quantitative measurements against objective criteria, so no adjudication by multiple human observers is required.

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

• Not Applicable: An MRMC study is relevant for evaluating the impact of AI algorithms on human reader performance in tasks like diagnostic imaging. This device is a pair of medical gloves; there is no AI component or human reader interpretation task involved.

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

• Not Applicable: This pertains to AI algorithm performance evaluation. There is no AI algorithm in "Powder-Free Vinyl Exam Gloves, clear." The "standalone" performance here refers to the device's physical and biological properties.

7. Type of Ground Truth Used

• The "ground truth" for this device is based on objective, standardized measurements of its physical properties (e.g., dimensions, tensile strength, elongation, hole detection) and biological compatibility (e.g., cytotoxicity, irritation, sensitization), as defined by internationally recognized ASTM and ISO standards. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. Sample Size for the Training Set

• Not Applicable: This is not an AI/machine learning device. Therefore, there is no "training set" in the context of an algorithm. The manufacturing process of the gloves would have its own quality control and process validation, which might involve data collection analogous to a training set for process refinement, but this is distinct from AI model training.

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

• Not Applicable: As there is no AI training set, this question is irrelevant.

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Disposable Vinyl Examination Gloves 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.

The subject device is a patient examination glove made of Poly (vinyl chloride) compound. It is Non-Sterile, Powder free and is clear in colour. The device is ambidextrous and can be worn on either the left or right hand. (Per 21 CFR 880.6250, class I). The device provides four specifications: S, M, L and XL. The device meets all the specifications in ASTM D5250-19, Standard specification for Vinyl Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-10, ISO 10993-23, ISO 10993-5

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the "Disposable Vinyl Examination Gloves":

This document is a 510(k) summary for a medical device, which seeks to demonstrate substantial equivalence to a legally marketed predicate device. As such, it describes performance testing rather than a study proving the device meets acceptance criteria in the context of clinical AI performance. The device in question is a physical product (gloves), not an AI/software device.

Therefore, many of the requested points, especially those related to AI device performance, sample sizes for test/training sets, ground truth, experts, and MRMC studies, are not applicable to this document.

However, I can extract the acceptance criteria and reported device performance from the provided tables for the physical aspects of the gloves.

Acceptance Criteria and Reported Device Performance

1. Table of acceptance criteria and the reported device performance

Additional Information (As applicable to this type of device)

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

• Physical Performance Testing: For "Freedom from holes," the reported sample size was "80 of 80 passed." Other physical tests (dimensions, physical properties, residual powder) often rely on samples drawn from manufacturing lots according to the specified ASTM standards, but specific sample sizes for each characteristic are not explicitly stated beyond what's implied by the standards.
• Biocompatibility Testing: The standards (ISO 10993 series) define the protocols and sample sizes for these tests, but specific numbers are not provided in this summary.
• Data Provenance: Not explicitly stated, but assumed to be from Anqing Pukang Medical Technology Co., LTD. in China, where the device is manufactured. The tests are prospective, as they are part of the premarket notification process for the new device.

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)

• N/A. For physical and biocompatibility testing of medical gloves, "ground truth" is established by adherence to recognized international standards (e.g., ASTM, ISO) and laboratory protocols, not by expert interpretation in a clinical context. The results are quantitative measurements or observations of biological reactions performed by qualified lab personnel.

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

• N/A. This concept is primarily relevant to studies involving human subjective evaluation or complex diagnostic interpretation where disputes need resolution. Performance testing for gloves involves objective measurements or standardized biological assays.

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

• N/A. This is a physical device, not an AI/software device. No human reader studies are relevant.

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

• N/A. This is a physical device, not an AI/software device.

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

• For physical properties and dimensions: Standards-based objective measurements.
• For freedom from holes: Pass/fail criteria based on water leak test per ASTM standards.
• For residual powder: Quantitative measurement per ASTM standards.
• For biocompatibility: Laboratory assays and observations of biological reactions (e.g., skin irritation, sensitization, cytotoxicity) as defined by ISO 10993 series standards.

8. The sample size for the training set

• N/A. This is a physical device, not an AI/software device. No training set is used.

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

• N/A. This is a physical device, not an AI/software device. No training set or associated ground truth is relevant.

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The vinyl examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The proposed device is a powder free vinyl patient examination glove, provided as nonsterile and disposable device. The proposed device is provided with clear color. There are four sizes: small, medium, large and extra-large as options.

The provided document describes the acceptance criteria and performance data for Vinyl Examination Gloves, a Class I medical device. It does not pertain to an AI/ML-based medical device. Therefore, many of the requested fields regarding AI/ML device testing (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable.

Here's the information extracted from the document, focusing on the device performance and acceptance criteria for these physical 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 specify the exact sample sizes for each test mentioned (e.g., number of gloves tested for physical properties, pinholes, or biocompatibility). The tests are based on established ASTM and ISO standards, which typically specify sampling plans.

• Data Provenance: The tests were conducted internally by the manufacturer, Guangdong Kingfa Sci.& Tech.Co., Ltd., in China. The documentation implies these were prospective tests conducted on the manufactured product 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

Not applicable. This is not an AI/ML device requiring expert interpretation of results. The "ground truth" for the performance of examination gloves is based on objective, quantifiable physical and chemical properties measured according to international standards (ASTM, ISO).

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

Not applicable. This is not an AI/ML device requiring human adjudication of qualitative data.

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" for this device is based on objective measurements against established engineering and biocompatibility standards (ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-11). For example, tensile strength and elongation are measured directly, and biocompatibility is assessed through standardized in-vivo and in-vitro tests with specific endpoints.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no "training set."

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

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

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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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The Disposable Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free non-colored vinyl examination glove. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.

The provided text describes the acceptance criteria and the study that proves a "Disposable Vinyl Examination Glove" meets these criteria. It is important to note that this is a Class I medical device (non-AI/ML).

Here's the 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)

• Sample Size:
  • Watertightness Test (ASTM D5151): The result 0/125 / Pass indicates that out of 125 units tested, 0 failed, suggesting a sample size of 125 for this specific test.
  • For other tests (Physical Dimensions, Powder Content, Physical Properties, Biocompatibility), the document does not explicitly state the number of samples tested for each criterion. It reports ranges for dimensions and physical properties, which usually implies multiple samples were tested, but the exact count is not given.
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. The manufacturer is located in Jiujiang City, Jiangxi, China.

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 this device is a physical examination glove, not an AI/ML device requiring expert interpretation for ground truth. The "ground truth" is established by direct measurement and standardized test methods (e.g., ASTM and ISO standards) and their inherent acceptance criteria.

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

This information is not applicable as this device is a physical examination glove. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., medical imaging) where there might be disagreement among reviewers, needing a tie-breaker. The tests for this device involve objective measurements against established 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 information is not applicable as this device is a physical examination glove and not an AI-assisted diagnostic tool.

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

This information is not applicable as this device is a physical examination glove and does not involve any algorithms.

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

The "ground truth" for this device is based on objective measurements against established industry standards, specifically ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-5, and ISO 10993-10. These standards define acceptable physical properties, freedom from holes, powder content, and biocompatibility, which are directly measured and compared.

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI/ML device that requires a "training set."

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

This information is not applicable as this is a physical medical device, not an AI/ML device that requires a "training set" or ground truth for such a set.

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The DISPOSABLE VINYL EXAMINATION GLOVE (Pink, Black, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl examination glove. The subject device's color is pink, black and blue. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.

The provided document is a 510(k) Premarket Notification for Disposable Vinyl Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device based on bench testing (non-clinical testing) rather than clinical studies involving human patients or complex AI algorithms.

Therefore, many of the requested points related to AI, MRMC studies, expert ground truth adjudication, and clinical trial specifics are not applicable to this submission.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document explicitly mentions "0/125 / Pass" for the ASTM D5151 Watertightness Test, indicating a sample size of 125 for this test. For other "Pass" results, the exact sample sizes are not explicitly stated, but the tests are typically performed on a statistically relevant number of samples to demonstrate compliance with the ASTM/ISO standards.
• Data Provenance: The tests are non-clinical (bench testing) performed by the manufacturer. The company is Anhui Bytech Medical Supplies Co., Ltd., located in Anhui Province, China. The data is from the manufacturer's internal testing as part of their premarket notification. The document indicates these are "non-clinical tests."

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

• Not Applicable. This is a medical device 510(k) submission for examination gloves, which are low-risk devices. The "ground truth" for proving the device meets acceptance criteria comes from standardized laboratory bench testing (e.g., measuring physical properties, mechanical strength, and biocompatibility), not from expert interpretation of medical images or clinical outcomes. Therefore, no medical experts were involved in establishing "ground truth" for the performance tests.

4. Adjudication Method for the Test Set

• Not Applicable. As the "ground truth" is established via objective physical and chemical measurements (bench testing) according to international standards (ASTM, ISO), there is no need for expert adjudication. The results are quantitative and directly compared to pre-defined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

• Not Applicable. This device is an examination glove, not an AI-powered diagnostic or assistive tool. MRMC studies are relevant for evaluating the impact of AI on human readers' performance in tasks like image interpretation, which is not pertinent to this device.

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

• Not Applicable. There is no AI algorithm involved with this device; it is a physical product (gloves).

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on objective, quantitative measurements from standardized laboratory tests according to recognized international consensus standards (ASTM and ISO). Examples include:
  • Direct measurement of dimensions (length, width, thickness).
  • Quantification of tensile strength and ultimate elongation.
  • Detection of holes using a water integrity test.
  • Measurement of residual powder content.
  • Biological performance testing (cytotoxicity, irritation, sensitization) in vitro, which involves observing cellular responses under controlled lab conditions.

8. The Sample Size for the Training Set

• Not Applicable. This submission is for a physical medical device (gloves), not an AI/machine learning model. Therefore, there is no "training set" in the context of machine learning. The manufacturing process itself involves quality control and process validation, which might involve sample testing, but this is distinct from "training data" for an algorithm.

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

• Not Applicable. As there is no training set for an AI model, this question is not relevant to the provided document.

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The Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl examination gloves. The subject device's color is yellow. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

This document describes the regulatory approval for "Disposable, vinyl examination gloves, Yellow" and focuses on non-clinical testing for equivalence. Therefore, it does not contain the information requested for a study proving device performance against acceptance criteria in the context of an AI/medical imaging device.

The provided text pertains to a Class I medical device (disposable vinyl examination gloves) and its 510(k) submission for substantial equivalence to a predicate device. The information requested (acceptance criteria and study details for an AI-powered device or diagnostic tool) is not applicable to this submission.

However, I can extract the acceptance criteria and reported device performance from the "Summary of Non-clinical Testing" section (Table 2) in the document, which are related to the physical and biocompatibility properties of the gloves.

Here's a breakdown of the available information based on your request, with the understanding that it will not completely align with the format for AI/diagnostic studies:

1. Table of Acceptance Criteria and the Reported Device Performance

Regarding the other requested information for a study proving device meets acceptance criteria (for an AI/diagnostic device):

The provided document is for disposable examination gloves and does not involve AI, image analysis, or complex diagnostic studies. Therefore, most of the following points are not applicable to this specific submission.

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

• Sample Size:
  • For the ASTM D5151 Watertightness Test, a sample size of 125 was used (0/125/Pass).
  • Specific sample sizes for other tests (e.g., physical dimensions, tensile strength, biocompatibility) are not explicitly stated as individual counts for each test in this summary section, though they would have been part of the full test reports.
• Data Provenance: Not specified in this summary. These are laboratory non-clinical tests performed in a controlled environment as per international standards, not patient data.
• Retrospective/Prospective: Not applicable, as these are product performance tests, not clinical studies.

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. Ground truth in the context of medical gloves refers to objective measurements and adherence to specified standards (e.g., ASTM, ISO standards) performed by laboratory technicians, not expert clinical interpretation.

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

• Not applicable. Adjudication methods are relevant for subjective interpretations, like radiology reads. These tests involve objective physical and chemical measurements.

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 not an AI-powered diagnostic tool.

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

• Not applicable. This device is a physical medical glove.

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

• Objective Measurements/Standard Specifications: The "ground truth" for these non-clinical tests is adherence to predefined physical, chemical, and biological properties outlined in the cited ASTM and ISO standards (e.g., minimum tensile strength, maximum powder content, specific dimensions, non-toxicity, non-irritation). These are objective, measurable criteria.

8. The sample size for the training set

• Not applicable. This is not an AI device that requires a training set.

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

• Not applicable. As above, no training set is relevant for this type of device.

In summary: The provided document is for the 510(k) clearance of disposable examination gloves, focusing on non-clinical performance and biocompatibility testing to demonstrate substantial equivalence to a predicate device. The nature of this device means that many of the questions asked (which are typically relevant for AI-powered diagnostic tools) are not applicable.

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The DISPOSABLE VINYL EXAMINATION GLOVE is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl examination gloves. The subject device's color is clear. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

The provided text describes the acceptance criteria and the study conducted for a Disposable Vinyl Examination Glove (K220469).

Here's a breakdown of the requested information:

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 full sample size for all tests. However, for the Watertightness Test (ASTM D5151), a sample size of 125 was used (0/125/Pass).

The data provenance is not explicitly mentioned as "country of origin" or "retrospective/prospective" studies. However, the tests are non-clinical, meaning they are laboratory-based and not derived from patient data. The submitter is CHIFENG HUAWEI MEDICAL SCIENCE & TECHNOLOGY CO.,LTD. (China), suggesting the non-clinical testing likely took place in China or a contracted lab.

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

This information is not applicable as the described tests are non-clinical (material and performance testing of a physical product) and do not involve expert interpretation or ground truth establishment in a clinical sense. The "ground truth" for these tests are the established standards (e.g., ASTM, ISO) and their defined acceptance criteria.

4. Adjudication method for the test set

This information is not applicable for these non-clinical, objective tests. Adjudication methods are typically used in studies involving subjective interpretation, often in clinical imaging or diagnostic contexts, where multiple experts might disagree on an assessment.

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

An MRMC comparative effectiveness study was not performed. This type of study is relevant for AI-powered diagnostic tools or imaging analysis where human readers are involved. The device in question is a disposable vinyl examination glove, which does not involve human reader interpretation or AI assistance in its core function.

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

A standalone performance study in the context of an algorithm or AI was not done. The tests performed are for the physical and biological properties of the glove itself, not for an algorithm.

7. The type of ground truth used

The "ground truth" for these tests is based on established standard specifications and analytical measurements. For example:

• Physical dimensions are measured against defined ranges.
• Tensile strength and ultimate elongation are measured against minimum values.
• Powder content is measured against a maximum value.
• Biocompatibility (cytotoxicity, irritation, sensitization) is assessed by laboratory tests based on ISO standards to determine if the device elicits a specific biological response.

8. The sample size for the training set

This information is not applicable. The tests described are for a physical product, a disposable glove. There is no AI algorithm being "trained" in this context, so there is no training set in the conventional machine learning sense.

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

This information is not applicable as there is no training set mentioned for this medical device.

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