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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

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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

• Width (Small): 85±5mm
• Width (Medium): 95±5mm
• Width (Large): 105±5mm
• Width (Extra-Large): 115±5mm
• Thickness (Finger): ≥ 0.08mm
• Thickness (Palm): ≥ 0.08mm | Pass |
  | ASTM D5250 (Physical Properties - Before Aging) | To determine tensile strength and ultimate elongation before aging | - Tensile Strength: ≥ 11MPa
• Ultimate Elongation: ≥ 300% | Pass |
  | ASTM D5250 (Physical Properties - After Aging) | To determine tensile strength and ultimate elongation after aging | - Tensile Strength: ≥ 11MPa
• Ultimate Elongation: ≥ 300% | Pass |
  | ASTM D5151 | Freedom from pinholes | Meets the ASTM D5151 Test for AQL 2.5 requirements | Pass |
  | ASTM D6124 | Powder Residue | Meets ASTM D6124 requirements:

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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

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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

• Palm - 0.08 mm min.
• Finger - 0.08 mm min.
  Palm Width:
• Small 85 ± 5 mm
• Medium 95 ± 5 mm
• Large 105 ± 5 mm
• X Large 115 ± 5 mm | Pass |
  | Freedom from holes (Water leak) | G-I/AQL 2.5 | Pass |
  | Tensile strength | Before Aging: 11 MPa, min.
  After Aging: 11 MPa, min. | Pass |
  | Elongation | Before Aging: 300% min.
  After Aging: 300% min. | Pass |
  | Powder Residual |

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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

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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

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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

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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

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Vinyl Co-Polymer Powder-free Examination Gloves, Black is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Vinyl Co-Polymer Powder-free Examination Gloves, Black are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl and oil-based liquid nitrile rubber materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-19 Standard Specification for Vinyl Examination Gloves for Medical Application.

The provided text is related to the FDA 510(k) premarket notification for "Vinyl Co-Polymer Powder-free Examination Gloves, Black". This document describes the device's technical specifications and how it compares to a predicate device. It also includes non-clinical performance data to demonstrate that the device meets established standards.

However, the request asks for specific information regarding acceptance criteria and a study proving a medical device meets those criteria, particularly in the context of AI/ML-assisted diagnostic tools (implied by questions about MRMC studies, human readers, ground truth establishment for training/test sets, etc.). The provided document is for examination gloves, which are Class I medical devices and do not involve AI, image analysis, or diagnostic capabilities in the way the questions are framed. Therefore, most of the requested information is not applicable to this submission.

I will fill in the relevant information that is present in the document and explicitly state when the requested information is not applicable due to the nature of the device.

Here's the breakdown based on the provided document:

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

2. Sample sizes used for the test set and the data provenance

The document refers to "non-clinical tests" and "performance test data" but does not specify the exact sample sizes (e.g., number of gloves tested for each individual parameter). The tests conducted are standard physical and biocompatibility tests for examination gloves as per ASTM and ISO standards.

• Sample Size: Not explicitly stated for each test, but implied to be sufficient to meet the specifications of the referenced ASTM and ISO standards.
• Data Provenance: The manufacturing entity is Grand Work Plastic Products Co., Ltd in Donggao Industrial Zone, Zanhuang, Hebei, China. The testing was presumably conducted by or for this manufacturer. The document doesn't specify if the data is retrospective or prospective, but for device development and regulatory submission, it would reflect tests performed on batches of the 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)

Not applicable. This device is an examination glove, not an AI/ML-based diagnostic system that requires expert interpretation for ground truth establishment. The "ground truth" for these tests is based on objective physical, chemical, and biological measurements against established 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 diagnostic system requiring expert adjudication of results. Testing is based on laboratory measurements and adherence to specified tolerances.

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 and does not involve human readers, AI assistance, or diagnostic interpretation.

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

Not applicable. This device is an examination glove and does not involve algorithms or standalone performance testing in the context of AI.

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

The "ground truth" for this device is based on:

• Physical and Mechanical Standards: Measurements of length, palm width, thickness, tensile strength, and elongation against specifications in ASTM D5250-19 and ASTM D412-16.
• Performance Standards: Freedom from holes (ASTM D5151-19, ASTM D65250-19) and powder content (ASTM D6124-06(2017), ASTM D5250-19).
• Biocompatibility Standards: Results from tests for skin irritation, sensitization (ISO 10993-10:2010), in vitro cytotoxicity (ISO 10993-5:2009), and acute systemic toxicity (ISO 10993 Part 11).

8. The sample size for the training set

Not applicable. This device is an examination glove and does not involve AI/ML models that require training sets.

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

Not applicable. As there is no training set for an AI/ML model, no ground truth establishment method for a training set is relevant.

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