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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 Viny/Nitrile Blend Exam 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/nitrile blend examination gloves. The subject device is blue. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.

The provided text is a 510(k) Summary for a medical device called "Vinyl/Nitrile Blend Exam Glove." This type of document is for demonstrating substantial equivalence to a predicate device, not typically for reporting studies validating an AI/ML driven medical device's performance against detailed acceptance criteria for diagnostic or prognostic tasks.

Therefore, many of the requested elements (e.g., number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of medical glove submission. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biocompatibility tests for manufacturing quality and safety, not for diagnostic performance evaluation of an AI model.

However, I can extract the relevant information from the provided document regarding its physical and biological performance acceptance criteria and results.

Here's the breakdown based on the provided text, focusing on the device itself (medical glove) and its physical/biocompatibility characteristics, not an AI system.

Acceptance Criteria and Device Performance for Vinyl/Nitrile Blend Exam Glove

This document describes the non-clinical testing performed to demonstrate that the Vinyl/Nitrile Blend Exam Glove meets established safety and performance standards for patient examination gloves. It is important to note that this is not an AI/ML device, and thus most AI/ML-specific study design criteria (e.g., ground truth, reader studies, AI performance metrics) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Sizes:
  • Watertightness Test (ASTM D5151): 125 samples (Implied from "0/125/Pass").
  • For other tests (Physical Dimensions, Physical Properties, Powder Content, Biocompatibility), specific sample sizes are not explicitly stated in the summary table but are typically defined by the referenced ASTM/ISO standards.
• Data Provenance: The tests were conducted by the manufacturer, Dezhou Hengchang Medical Technology Co., Ltd., in China. The data would be specific to their manufactured device. The studies were non-clinical (laboratory testing), not involving human subjects for retrospective or prospective data collection.

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

• Not Applicable. This is a physical device (glove) and the "ground truth" is established by adherence to engineering performance standards (e.g., tensile strength, dimensions) and biological safety standards (e.g., cytotoxicity, irritation). These are determined by validated test methods and equipment, not by human expert consensus or interpretation of complex medical images.

4. Adjudication Method for the Test Set:

• Not Applicable. As the tests are objective laboratory measurements against predefined physical and chemical specifications, there is no need for expert adjudication.

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

• No. This type of study is relevant for diagnostic imaging AI tools where human reader performance is being evaluated with and without AI assistance. This device is a medical glove.

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

• Not Applicable. This is not an algorithm or AI device. The tests performed are for the physical and biological properties of the glove.

7. The Type of Ground Truth Used:

• Quantitative Material and Biocompatibility Standards: The "ground truth" is based on the quantitative requirements set forth in recognized international and national standards (e.g., ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993 series). These standards define acceptable ranges or thresholds for physical properties (dimensions, strength, elongation, hole detection) and biological responses (cytotoxicity, irritation, sensitization, systemic toxicity).

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. No training set for an AI model.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets its acceptance criteria involved a series of non-clinical, laboratory-based tests. These tests measured physical properties (dimensions, tensile strength, ultimate elongation, watertightness, powder content) according to ASTM standards (D5250, D5151, D6124, D412) and assessed biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity) according to ISO 10993 standards (10993-5, 10993-10, 10993-11). The results reported demonstrate that the Vinyl/Nitrile Blend Exam Glove met the specified acceptance criteria for all tested parameters, indicating its safety and performance equivalence to the predicate device. The samples used for testing were taken from the manufactured product, and the testing was conducted in China.

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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 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 that proves the device meets the acceptance criteria for Vinyl Examination Gloves. This is a medical device focused on physical properties and biocompatibility, not an AI/imaging device. Therefore, many of the requested criteria regarding AI model evaluation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone algorithm performance, and ground truth establishment methods) are not applicable to this document.

However, I can extract the relevant information regarding the device's performance against its acceptance criteria based on the provided non-clinical testing summary.

Here's the breakdown:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Non-Applicable / Not Provided Information (for this type of device submission)

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: For specific tests, sample sizes are sometimes implicitly mentioned (e.g., "0/125" for watertightness), but a general "test set" sample size for overall performance evaluation as would be described for an AI model is not applicable or provided. The testing is per standard procedures for each physical/chemical property.
   • Data Provenance: Not applicable in the same sense as for clinical data. The tests are laboratory-based conformance tests. The manufacturer is Dezhou Hengchang Medical Technology Co., Ltd. from 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):

   • Not applicable. Ground truth for these physical and biocompatibility tests is established by objective measurements and standardized laboratory procedures/protocols, not expert consensus.

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

   • Not applicable. This concept is relevant for subjective evaluations or diagnostic tasks, not for objective material properties testing.

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 for AI-assisted diagnostic devices.

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

   • Not applicable. This is for AI algorithms.

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

   • The ground truth for this device's performance is based on objective measurements and chemical/biological assays conducted according to internationally recognized standards (ASTM, ISO). For example, a "hole" is objectively defined by the ASTM D5151 test, and tensile strength is measured quantitatively.

8. The sample size for the training set:

   • Not applicable (no AI/machine learning training involved).

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

   • Not applicable (no AI/machine learning training involved).

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical performance tests conducted in accordance with recognized international standards. These tests evaluate the physical properties (dimensions, watertightness, powder content, tensile strength, ultimate elongation) and biocompatibility (cytotoxicity, systemic toxicity, irritation, sensitization) of the Vinyl Examination Gloves. The results demonstrate that the device complies with all specified acceptance criteria derived from these standards (ASTM D5250, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993-5, ISO 10993-10, ISO 10993-11). The conclusion is that the device is "as safe, as effective, and performs as well as or better than the legally marketed predicated device K180861" based on these non-clinical tests. Clinical testing was deemed "not needed for this device."

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