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A patient 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.

These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) 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 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 five sizes: extra-small, small, medium, large, and extra-large.

The provided text describes the regulatory filing (510(k) Premarket Notification) for a "Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)". This document is for a medical device (a glove), not an AI/Software as a Medical Device (SaMD) or an algorithm. Therefore, the questions related to AI/algorithm performance metrics (such as MRMC studies, standalone algorithm performance, AI assistance effect size, training set sample size, expert ground truth establishment for AI data) are not applicable to this submission.

The acceptance criteria and device performance for this physical medical device are related to its material properties, physical dimensions, and resistance to chemotherapy drugs, as outlined by various ASTM and ISO standards.

Here's the information extracted and formatted according to the request, with clarification where the questions are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size used for the test set and the data provenance:

• The reported results for physical and chemical resistance tests seem to be based on representative samples from production, as per the respective ASTM and ISO standards. The specific sample sizes for each test are implicitly defined by these standard test methods (e.g., ASTM D5151 for watertightness mentions testing 125 gloves per batch/size for AQL).
• Data provenance: Not explicitly stated, however, the manufacturer is Inner Mongolia Cureguard Medical Technology Co.,Ltd. (China), suggesting the testing was likely conducted in China or by labs compliant with international standards, possibly in China or elsewhere. The tests are "non-clinical" bench tests, not involving human data or patient populations. The data is retrospective in the sense that it's generated from manufactured product batches for regulatory submission.

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

This question is not applicable as the device is a physical medical glove, and its performance and safety are assessed through objective laboratory tests governed by international standards (ASTM, ISO), not through expert interpretation of medical images or other data that would require a "ground truth" established by experts in a clinical context. The "ground truth" here is the result of standardized material science and chemical permeation testing.

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

Not applicable. This is not a study requiring human adjudication for data interpretation.

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 physical medical device, not an AI/SaMD.

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

Not applicable. This is a physical medical device, not an AI/SaMD.

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

The ground truth for the device's performance is established by the specified international standard test methods (ASTM and ISO standards) for physical properties, chemical resistance, and biocompatibility. For example, for watertightness, the ground truth is the absence of leaks when tested according to ASTM D5151. For chemotherapy drug permeation, the ground truth is the measured breakthrough time and the specific drug concentration in the testing apparatus according to ASTM D6978. For biocompatibility, it's the observed biological response to testing protocols defined in ISO 10993-5 and ISO 10993-10.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/SaMD. There is no "training set" in the context of an algorithm.

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

Not applicable. See point 8.

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The Disposable Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The subject device is powder free nitrile patient examination gloves. The subject device is white color. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The subject device is non-sterile.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Disposable Nitrile Examination Glove

1. Table of Acceptance Criteria and Reported Device Performance

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

The sample sizes for some tests are explicitly mentioned:

• ASTM D5151 (Watertightness Test): 125 gloves per size (XS, S, M, L, XL).
• Other tests (Physical Dimensions, Thickness, Powder Content, Physical Properties Before/After Aging, Cytotoxicity, Irritation, Sensitization): The exact number of samples tested for each of these is not explicitly stated in the provided text, beyond the aggregated "Results" sections.

Data Provenance: The document does not specify the country of origin of the testing data or whether the studies were retrospective or prospective. It only states that the testing was "Non-clinical tests." The submitter is Inner Mongolia Cureguard 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

Not applicable. This device is a medical glove, and the "ground truth" is established by adherence to recognized international and national standards (ISO and ASTM) through laboratory testing, not by expert consensus on diagnostic interpretations.

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

Not applicable. This is a non-clinical device performance study based on standardized laboratory testing, not a diagnostic study requiring expert adjudication of results.

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 medical glove and does not involve AI assistance or human readers.

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

Not applicable. This device is a medical glove and does not involve an algorithm.

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

The ground truth used for this device is based on pre-defined specifications and limits set by international and national standards (ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993-5, ISO 10993-10). These standards define acceptable ranges for physical dimensions, strength, elongation, watertightness, powder content, and biocompatibility.

8. The sample size for the training set

Not applicable. This is a physical medical device (glove) and does not involve a training set as would be used for machine learning.

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

Not applicable. This device does not use a training set.

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The Disposable Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The subject device is powder free nitrile patient examination gloves. The subject device is blue color and has 5 models of XS,S, M, L, XL. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The subject device is non-sterile.

The provided text describes the acceptance criteria and the results of non-clinical testing for a medical device, specifically a "Disposable Nitrile Examination Glove." It does not contain information about studies involving AI, human readers, or clinical trials.

Here's a breakdown of the requested information based on the provided text, focusing on the available non-clinical data:

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

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 Watertightness (ASTM D5151): 125 gloves were tested for each size (XS, S, M, L, XL).
• Other tests (Physical Dimensions, Powder Content, Physical Properties, Biocompatibility): The document does not specify the exact sample sizes for these tests, but it indicates that tests were performed for each glove size (XS, S, M, L, XL).
• Data Provenance: The tests were conducted to demonstrate compliance with international (ISO) and US (ASTM) standards. The manufacturer is based in China. The data's specific origin beyond that is not detailed in the provided text, and it appears to be prospective testing conducted specifically for this 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 section is Not Applicable. The study described is a non-clinical device testing study, relying on standardized test methods (ASTM, ISO) rather than expert interpretation of medical images or patient data.

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

This section is Not Applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not present in this non-clinical testing. The adherence to standard methodologies (e.g., AQL for ASTM D5151) implies a defined pass/fail criterion rather than expert adjudication.

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 section is Not Applicable. The provided document describes non-clinical testing of a physical medical device (examination gloves) and does not involve AI, human readers, or comparative effectiveness studies of that nature.

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

This section is Not Applicable. The device is a physical examination glove, not an algorithm or AI system.

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

The "ground truth" for this device's performance is established by the defined parameters and measurement techniques of the referenced international and national standards (ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993-5, ISO 10993-10). For example, for "Watertightness," the ground truth is a quantitative measurement of leaks based on ASTM D5151 and an AQL of 2.5. For "Cytotoxicity," it's the observed cellular response in an in-vitro test according to ISO 10993-5.

8. The sample size for the training set

This section is Not Applicable. The provided document describes non-clinical performance testing of a manufactured product, not machine learning model development. Therefore, there is no "training set."

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

This section is Not Applicable for the same reason as point 8.

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