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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large.

This is a 510(k) premarket notification for Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs. This document does not describe the acceptance criteria and study for an AI/ML device. Instead, it focuses on the performance characteristics of medical gloves, particularly their resistance to chemotherapy drugs.

Here’s a breakdown of the information provided, re-interpreting some fields for a non-AI/ML medical device where applicable, and highlighting what is missing in the context of your request for an AI/ML device:

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

The document provides several tables detailing the performance of the gloves.

Permeation by Chemotherapy Drugs (Key Performance Claim):

Other Non-Clinical Testing Results (from Table 2 and Table 3):

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 Chemo Permeation: Not explicitly stated as a single number. The testing is done "in accordance with ASTM D6978-05" which specifies test methods. While not clearly itemized in the summary, typical ASTM D6978 testing involves multiple specimens per drug.
• Sample Size for Biocompatibility: Not explicitly stated, but standard ISO 10993 tests involve specific numbers of samples/animals or cell cultures as per the standard.
• Sample Size for Physical Tests (e.g., Holes, Dimensions, Tensile Strength): For "Freedom from Holes," the results show "S:0/125 leaks", "M:0/125 leaks", "L:0/125 leaks", "XL:0/125 leaks," implying a sample size of 125 gloves per size for this test. Other physical tests (dimensions, tensile strength) are usually performed on a representative sample set as per the ASTM standards.
• Data Provenance: Not specified whether the tests were conducted in China (where the manufacturer is located) or another country. The testing methods used are international ASTM and ISO standards. It's a prospective series of tests conducted on the manufactured 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)

This section is Not Applicable to this type of device (medical gloves). The "ground truth" for medical gloves is established through objective physical and chemical testing against recognized national and international standards (ASTM, ISO), not through expert clinical consensus or interpretation of medical images.

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

This is Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving human readers/interpreters to resolve discrepancies, typically for AI/ML diagnostic tools. For physical devices like gloves, performance is measured objectively against predefined criteria.

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. An MRMC study is relevant for AI/ML diagnostic or assistive technologies where human readers are involved in interpretation. This document describes physical, non-AI/ML device performance.

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

This is Not Applicable. This device is not an algorithm or AI.

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

The "ground truth" for this device is established by:

• Objective physical measurements: e.g., length, width, thickness, tensile strength, elongation, powder content.
• Objective chemical permeation testing: measuring breakthrough time of chemotherapy drugs using analytical methods as specified in ASTM D6978-05.
• Biocompatibility assays: in-vitro (cytotoxicity) and in-vivo (irritation, sensitization) tests as per ISO 10993 standards.

These are validated laboratory test methods, not expert consensus or clinical outcomes data in the usual sense for diagnostic devices.

8. The sample size for the training set

This is Not Applicable. This device is not an AI/ML algorithm that requires a training set. The descriptions pertain to physical performance testing of a manufactured product.

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

This is Not Applicable. As it's not an AI/ML device, there is no training set or corresponding ground truth establishment process in the context of your request.

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The Disposable Nitrile Examination Gloves is 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 nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

The provided text describes a 510(k) premarket notification for "Disposable Nitrile Examination Gloves" (K203805) and compares it to a predicate device (K171422). The FDA letter and the 510(k) summary pertain to the substantial equivalence of a medical device, specifically nitrile examination gloves, to pre-existing devices.

Based on the nature of the device (a Class I, non-powered patient examination glove), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating that the new device is as safe and effective as the predicate device, primarily through non-clinical performance and safety testing. This is not a study of an AI/ML medical device, therefore, many of the requested elements for an AI/ML study (e.g., number of experts for ground truth, adjudication methods, MRMC studies, AI/human effect size, training set details) are not applicable.

Here's the breakdown of the information that is applicable and can be extracted from the provided document:

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

The acceptance criteria are derived from recognized standards (ASTM, ISO) and are generally comparative to the predicate device.

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

The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for holes, tensile strength, etc.). The provenance of the data is from the manufacturer, Jiangsu Yanfang Medical Technology Co., Ltd. The study type is non-clinical performance and safety testing, not a retrospective or prospective clinical study on patient data. The country of origin for the data is implicitly China, where the manufacturer is located.

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 or diagnostic imaging device requiring expert interpretation for ground truth. Ground truth for these physical and biocompatibility tests is established through adherence to standardized laboratory test methods (e.g., ASTM D6319 for physical properties, ISO 10993 for biocompatibility).

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

Not applicable. This is not a study involving human reader interpretation or disagreement.

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 a medical glove, not an AI-based diagnostic tool.

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

Not applicable. This describes a physical medical device, not an algorithm.

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

The "ground truth" for the device's performance is established by adherence to recognized international and national standards (ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993-5, ISO 10993-10) for physical properties, barrier integrity, and biocompatibility. Test results are compared against the pass/fail criteria defined within these standards.

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.

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