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The Nitrile Glove Powder Free White is a disposable device intended purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is white. The proposed device is non-sterile.

The provided document is a 510(k) summary for the "Nitrile Glove Powder Free White." This type of document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a predicate device already on the market. It primarily focuses on comparing the new device's characteristics and performance to the predicate device and relevant standards, rather than describing a traditional clinical study with human subjects, AI involvement, or ground truth establishment as might be found for more complex diagnostic devices.

Therefore, many of the requested categories are not directly applicable or are not detailed in this document.

Here's an analysis based on the provided text:

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

The acceptance criteria are established by various ASTM and ISO standards, and the reported device performance indicates compliance with these standards.

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

The document does not specify the exact sample sizes used for each individual test (e.g., number of gloves tested for tensile strength or holes). It refers to compliance with standards like ASTM D5151 and D6319, which would typically define such sample sizes. The data provenance is implied to be from laboratory testing performed by "Haining Medical Products Co., Ltd." or their designated testing facilities in China (as per the submitter's address). The tests are non-clinical tests, not studies with human subjects.

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

This information is not applicable to this type of device and submission. The "ground truth" for medical gloves is established by objective physical and chemical testing against recognized international and national standards (e.g., ASTM, ISO) for properties like tensile strength, elongation, freedom from holes, powder content, and biocompatibility. There are no human "experts" establishing a "ground truth" in the clinical sense for this product's performance.

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 studies, particularly for diagnostic devices where subjective interpretation of images or other data by multiple readers is involved. For medical glove testing, objective measurements against pre-defined thresholds from standards are used.

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. This document concerns a physical medical device (nitrile gloves), not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned or relevant.

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

This is not applicable. This document concerns a physical medical device (nitrile gloves), 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 objective measurements and laboratory tests against the specific requirements and methodologies outlined in the referenced standards (ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-5). For example, "freedom from holes" is determined by a specific test method in ASTM D5151, not by expert consensus or pathology. Biocompatibility is assessed through standardized in-vitro and in-vivo tests as per ISO 10993.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms.

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

This is not applicable as there is no training set mentioned or relevant to this device's submission.

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The Nitrile Glove Powder Free Black is a disposable device intended purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is black. The proposed device is non-sterile.

This document is a 510(k) summary for a Nitrile Glove Powder Free Black, classifying it as a Class I medical device. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K171422).

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria & Reported Device Performance:

The document presents a "Technological Characteristic Comparison Table" (Table 1), "Device Dimensions Comparison" (Table 2), "Performance Comparison" (Table 3), and "Safety Comparison" (Table 4) where the proposed device's performance is compared against the predicate device and relevant standards. This serves as the primary method to demonstrate that the proposed device meets the acceptance criteria (substantial equivalence to the predicate and compliance with recognized standards).

2. Sample Sizes and Data Provenance (for test set, if applicable):

The document states, "Non-clinical tests were conducted to verify that the proposed device met all design specifications." However, it does not specify the sample sizes used for these non-clinical tests (e.g., how many gloves were tested for Freedom from Holes, Tensile Strength, etc.).

The data provenance is not explicitly stated as retrospective or prospective, nor does it mention a country of origin for the data, other than the submitting company being located in China. Given the nature of these tests (bench testing for physical and chemical properties), they would typically be prospective tests performed on samples of the manufactured device.

3. Number of Experts and Qualifications (for ground truth of test set):

This information is not applicable to this submission type. Ground truth in this context typically refers to clinical diagnosis or pathology readouts. For a Class I medical device like a glove, the "ground truth" is adherence to physical/chemical standards and biocompatibility tests, not expert clinical interpretation. The "experts" would be the personnel in the testing laboratories conducting the ASTM and ISO standard tests. Their qualifications are inherent in their ability to perform these accredited tests.

4. Adjudication Method (for test set):

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for diagnostic accuracy, where multiple human readers interpret data, and a consensus mechanism is employed to establish ground truth or resolve discrepancies. For physical and biocompatibility testing of a medical glove, objective laboratory test results are obtained, and no such adjudication is necessary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study was not done and is not relevant for this type of device. MRMC studies are typically performed for diagnostic imaging devices to assess the impact of AI on reader performance.

6. Standalone (Algorithm Only) Performance Study:

A standalone performance study was not done and is not applicable. This is a physical product (a glove), not an algorithm or AI-powered device.

7. Type of Ground Truth Used:

The "ground truth" for the device's performance is established through:

• Compliance with recognized international and national standards: ISO 10993-10, ISO 10993-5, ASTM D6124-06, ASTM D5151-06, and ASTM D6319-10. These standards define the acceptable performance characteristics for medical gloves.
• Comparison to a legally marketed predicate device (K171422): Demonstrating that the proposed device's characteristics (dimensions, physical properties, material, biocompatibility) are substantially equivalent to a device already cleared by the FDA.

8. Sample Size for the Training Set:

This information is not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.

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

This information is not applicable as there is no training set for this device.

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Nitrile Powder Free 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.

Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

The provided document describes a 510(k) premarket notification for "Nitrile Powder Free Patient Examination Gloves, Blue Color," which is a Class I medical device. The document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than describing a study to prove performance against acceptance criteria for an AI/ML powered device.

Therefore, many of the requested fields are not applicable to this document. I will extract the available information and indicate where information is not present or not relevant to an AI/ML context.

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 a distinct "test set" in the context of an AI/ML algorithm. The performance data presented (e.g., dimensions, physical properties, biocompatibility) are based on testing a sample of the manufactured gloves to ensure they meet the established standards. The size of these samples is not explicitly stated in the provided text. The data provenance is implied to be from the manufacturer's testing, Haining Medical Products Co., Ltd., which is located in China. The testing is assumed to be prospective relative to the 510(k) submission.

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

This information is not applicable. The device is a patient examination glove, not an AI/ML diagnostic tool requiring expert ground truth for interpretation. Performance is assessed against international standards and regulations (e.g., ASTM, ISO, CFR).

4. Adjudication method for the test set

This information is not applicable. There is no expert review or adjudication process described for the performance testing of these gloves.

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. The device is a physical medical glove and does not involve AI/ML or human readers.

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

This information is not applicable. The device is a physical medical glove and does not involve an algorithm.

7. The type of ground truth used

The "ground truth" for the glove's performance is based on established international standards and regulatory requirements for medical gloves, such as ASTM D6319-10, ASTM D6124-06, ASTM D5151-06, 21 CFR 800.20, and ISO 10993-10. These standards define the acceptable physical, mechanical, and biological properties.

8. The sample size for the training set

This information is not applicable. The device is a physical medical glove and does not involve an AI/ML training set.

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

This information is not applicable. The device is a physical medical glove and does not involve an AI/ML training set or its associated ground truth establishment.

Summary of the Study Proving Device Meets Acceptance Criteria:

The document describes non-clinical performance testing conducted by Haining Medical Products Co., Ltd. (the manufacturer) to demonstrate that the "Nitrile Powder Free Patient Examination Gloves, Blue Color" meet the requirements outlined in various ASTM standards (D6319-10, D6124-06, D5151-06), 21 CFR 800.20, and ISO 10993-10 (for biocompatibility). These standards set the acceptance criteria for properties like dimensions, physical strength (tensile strength, elongation), freedom from pinholes (waterleak test), powder residue, and biocompatibility (skin irritation and sensitization).

The study involved testing samples of the manufactured gloves against these specified standards. For instance, dimensions (length, width, thickness), physical properties (elongation, tensile strength), and powder residue were measured and found to "Meet" or exceed the requirements of the ASTM standards. Freedom from pinholes was assessed against 21 CFR 800.20 and ASTM D5151-06 with an Acceptable Quality Level (AQL) of 2.5% for holes. Biocompatibility testing (Primary Skin Irritation in rabbits and Dermal Sensitization in guinea pigs) was performed according to ISO 10993-10, and the gloves "Passed," demonstrating they were not irritants or sensitizers.

The results of these tests, as summarized in the table and the "6.0 Summary of the Technological Characteristics of the Device" and "7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data" sections, directly demonstrate that the device performs according to the established acceptance criteria. No clinical data was deemed necessary for this type of device according to the document. The overall conclusion is that the device is "as safe, as effective, and performs as well as the predicate device," thereby establishing substantial equivalence.

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