Powder Free Nitrile Patient Examination Gloves,Blue 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 Nitrile Patient Examination Gloves,Blue Color are disposable device which made of nitrile synthetic rubber , intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 6319 00a (2005)e1.

The provided document describes the acceptance criteria and the study conducted for the "Powder Free Nitrile Patient Examination Gloves, Blue Color." This is a medical device, and the evaluation focuses on its physical and biological properties.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

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

The document does not specify the exact sample sizes used for each of the tests. It states that "The performance test data of the non-clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above," referring to the standards. This implies that the tests were conducted according to the sampling requirements within those ASTM and ISO standards and 21 CFR regulations.

The submitter's address is "JiangSu DongLing Plastic & Rubber Co.,Ltd, DongWu Road, Economic Development Zone, SuQian, JiangSu Province, 223800, China," indicating the data provenance is likely China. The study appears to be prospective for the device being submitted, as it involves testing the specific product for its 510(k) submission.

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 is a physical and biocompatibility testing of a medical glove, not a diagnostic device requiring expert interpretation of images or other data to establish ground truth. Therefore, the concept of "experts" in the context of image or data interpretation to establish ground truth does not apply to this device. The "ground truth" is established by the direct measurement against objective standards (e.g., tensile strength, elongation, water leak test for pinholes, chemical analysis for powder, and animal studies for biocompatibility).

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

Given the nature of the device and testing, an adjudication method for a test set (like for ground truth establishment in diagnostic studies) is not applicable. The tests performed are objective measurements against defined 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation (e.g., radiologists analyzing medical images with and without AI assistance). The device in question is a medical glove, which does not involve human readers interpreting data.

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

No, a standalone study (in the context of an algorithm's performance without human-in-the-loop) was not done. This type of study is relevant for AI/ML-based diagnostic algorithms. The performance of the glove is evaluated through physical, chemical, and biological tests, not through an algorithm.

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

The ground truth for this device is based on objective measurement against established ASTM and ISO standards and FDA regulations. Examples include:

• Physical measurements: Verifying dimensions, tensile strength, and elongation meet the specified ranges.
• Chemical analysis: Measuring powder residual to ensure it's below the threshold.
• Leak testing: (Freedom from pinholes) through water leak tests as per 21 CFR 800.20.
• Biocompatibility testing: Animal studies (rabbits for primary skin irritation, guinea pigs for dermal sensitization) as per ISO 10993-10 standards.

8. The sample size for the training set

Not Applicable. This device is a manufactured product (medical glove), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process is controlled to ensure consistent product quality.

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

Not Applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for a training set does not apply.

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Powder Free Nitrile 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 Nitrile Patient Examination Gloves, White Color are made of synthetic rubber, intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device meets all of the requirements of ASTM standard D 6319 00a (2005)e1.

The acceptance criteria and study proving the device meets these criteria are described below.

1. Acceptance Criteria and Device Performance

The device is "Powder Free Nitrile Patient Examination Gloves, White Color". The acceptance criteria and reported device performance are presented in the table below:

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

The document does not specify the exact sample sizes for the testing of the "Powder Free Nitrile Patient Examination Gloves, White Color." However, it states that the device meets various ASTM standards and CFR regulations, implying specific sample sizes as dictated by those standards.

The data provenance is not explicitly stated in terms of country of origin but is implied to be internal testing conducted by the manufacturer, Jiangsu Dongling Plastic & Rubber Co.,Ltd, located in China. The study appears to be retrospective in nature, as it involves testing the finalized product against established standards.

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

This information is not provided in the document, as the testing involves meeting regulatory and industrial standards (e.g., ASTM, FDA 21 CFR) for product characteristics, rather than diagnostic accuracy requiring expert consensus.

4. Adjudication method for the test set

An adjudication method is not applicable and therefore not described in the document. The testing involves objective measurements against predefined standards for glove characteristics, not subjective interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

An MRMC comparative effectiveness study was not done and is not applicable to this device. This type of study is typically used for diagnostic devices involving image interpretation or other subjective assessments. The "Powder Free Nitrile Patient Examination Gloves, White Color" is a medical device (patient examination glove) whose effectiveness is determined by its physical and chemical properties as per standards, not by human reader interpretation.

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

A standalone performance study is not applicable to this device. This type of study is typically associated with AI/algorithm-based diagnostic tools. The "Powder Free Nitrile Patient Examination Gloves, White Color" is a physical medical device.

7. Type of ground truth used

The ground truth used for evaluating the "Powder Free Nitrile Patient Examination Gloves, White Color" is based on established industry and regulatory standards:

• ASTM standard D 6319 00a (2005)e1: For dimensions and physical properties.
• 21 CFR 800.20: For freedom from pinholes (waterleak test on pinhole AQL).
• ASTM standard D6124-06: For powder residual.
• ISO 10993-10: 2002/Amd. 1: 2006: For biocompatibility (primary skin irritation and dermal sensitization).

These standards define the acceptable performance parameters.

8. Sample size for the training set

This information is not applicable and therefore not provided in the document. The "Powder Free Nitrile Patient Examination Gloves, White Color" is a physical medical device, not an AI/algorithm-based device that requires a training set.

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

This information is not applicable and therefore not provided in the document. As stated above, this device does not utilize a training set in the context of inferential algorithms.

Ask a specific question about this device