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Powder Free Vinyl Patient Examination Gloves,White Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Vinyl Patient Examination Gloves,White Color are disposable devices which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.

The provided text describes a medical device called "Powder Free Vinyl Patient Examination Gloves, White Color" and its substantial equivalence to a predicate device. This is a Class I device and the submission focuses on non-clinical performance criteria based on established standards.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for pinholes, physical properties, etc.). However, it refers to compliance with established standards (ASTM D 5250-06 e1, ASTM D6124-06, 21 CFR 800.20, and ISO 10993-10). These standards would define the required sample sizes for testing.

The data provenance is from non-clinical testing conducted by the manufacturer, Suqian Ruijiang Medical Supplies Co., Ltd. The document does not specify the country of origin of the raw data, but the manufacturer is based in Suqian, Jiangsu, China. The testing described is retrospective in the sense that the results were generated prior to the 510(k) submission to demonstrate compliance with existing standards.

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

This information is not applicable to this submission. The "ground truth" for this Class I medical device (patient examination gloves) is established by adherence to recognized regulatory standards and specifications, rather than expert consensus on complex diagnostic interpretations. The standards themselves define the acceptable parameters for glove performance.

4. Adjudication Method for the Test Set

This information is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or other subjective assessments. For this device, the "judgement" is determined by whether the test results meet the objective, quantitative criteria outlined in the referenced ASTM standards and FDA regulations.

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. This submission is for a basic medical device (examination gloves) and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study is not relevant.

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

This information is not applicable. This device is a physical product (gloves) and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth used is based on established regulatory standards and objective test methods. Specifically:

• ASTM D 5250-06 e1: Standard for Vinyl Patient Examination Gloves. This standard specifies requirements for dimensions, physical properties (tensile strength, elongation), and other performance characteristics.
• ASTM D6124-06: Standard Test Method for Residual Powder on Medical Gloves. This standard dictates the acceptable levels of powder residue.
• 21 CFR 800.20: This FDA regulation pertains to the freedom from pinholes (water leak test).
• ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization. This standard sets the criteria for biocompatibility testing.

The "ground truth" is that the device must meet the specifications and pass the tests outlined in these standards.

8. The Sample Size for the Training Set

This information is not applicable. This submission is for a physical medical device. The concept of a "training set" is relevant to machine learning algorithms, which are not involved here.

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

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

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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.

Here's a breakdown of the acceptance criteria and the study information for the device, based on the provided text:

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 sample size used for the test set for any of the characteristics. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. The testing refers to "current standards" (ASTM, ISO, CFR) which implies testing was conducted according to these standards.

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

Not applicable. This device is a Class I medical device (patient examination gloves) where performance is assessed through physical, chemical, and biocompatibility testing against established standards, not through expert interpretation of medical images or other data requiring clinical "ground truth" from experts.

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

Not applicable. See point 3.

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/software device.

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

Not applicable. This is not an AI/software device. The "device performance" described is the standalone performance of the physical glove.

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

The "ground truth" for this device's performance is defined by the objective metrics and acceptance criteria outlined in the referenced standards: ASTM D 5250-06 e1, 21 CFR 800.20, ASTM D6124-06, and ISO 10993-10. These standards set measurable thresholds for properties like dimensions, physical strength, absence of pinholes, powder residue, and biological reactions.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/machine learning algorithm that requires a training set.

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

Not applicable. See point 8.

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Powder Free Vinyl Patient Examination Gloves, Yellow Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Vinyl Patient Examination Gloves, Yellow Color are disposable devices which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.

The provided text describes the acceptance criteria and performance of "Powder Free Vinyl Patient Examination Gloves, Yellow Color" but does not describe a study involving a device that uses AI or requires a human-in-the-loop for its operation.

Therefore, most of the requested information (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types for AI/ML models) is not applicable to this medical glove.

Here's the relevant information that can be extracted:

Acceptance Criteria and Device Performance

Additional Information based on the provided text:

1. Sample sizes used for the test set and the data provenance: Not applicable. Performance is based on compliance with ASTM and FDA standards for medical gloves.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Performance is assessed against established technical standards, not expert consensus on medical imaging or diagnoses.
3. Adjudication method for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical glove, not an AI-powered diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" here is compliance with defined ASTM standards (D 5250-06 e1, D6124-06) and FDA regulations (21 CFR 800.20, ISO 10993-10) for medical gloves.
7. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

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Powdered Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Vinyl Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material, intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the device, organized according to your requested information:

Description of Acceptance Criteria and Proving Study

This submission describes the acceptance criteria and performance for "Powdered Vinyl Patient Examination Gloves, Clear (non-colored)". The device's performance is demonstrated through nonclinical testing against established ASTM standards and FDA regulations, as clinical data is explicitly stated as not being needed for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

The subsequent points (2-9) are not applicable to this device submission, as it concerns a Class I medical device (patient examination gloves) that relies on nonclinical testing against established standards rather than clinical studies with human participants, expert ground truth, or AI algorithms.

However, I will address each point and explain why it's not applicable in this context.

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

Not applicable. The "test set" here refers to physical gloves undergoing nonclinical laboratory tests according to standards like ASTM. While a sample size would have been used for tests like pinhole detection or physical properties, the document does not specify these individual sample sizes. The data provenance is from laboratory testing performed to meet specified standards.

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 expert consensus, is not relevant for this device. The "ground truth" for glove performance is defined by the objective metrics and thresholds established within the referenced ASTM standards and FDA regulations (e.g., specific tensile strength values, acceptable pinhole rates, bio-reactivity tests).

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers in clinical studies. This is not pertinent to the nonclinical testing of gloves against predefined physical and chemical 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

Not applicable. This device is a physical medical glove and does not involve AI, human readers, or image interpretation. Therefore, an MRMC comparative effectiveness study is not relevant.

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 and does not involve any algorithm or AI performance.

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

The ground truth used for this device is based on established industry standards and regulatory requirements.

• For physical properties and dimensions: ASTM standard D 5250-06 e1 dictates the acceptable ranges and performance.
• For freedom from pinholes: 21 CFR 800.20 sets the standard.
• For powder residual: ASTM standard D 5250-06 e1 and D6124-06 set the acceptable limit.
• For biocompatibility: ISO 10993-10 outlines the testing methodology and acceptable outcomes (e.g., "Not a Primary Skin Irritation," "Not a Dermal Sensitization").

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set."

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

Not applicable. As there is no training set for a machine learning algorithm, the concept of establishing ground truth for it does not apply.

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