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A disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

The proposed devices are powder-free nitrile examination gloves, provided as non-sterile and disposable devices. The proposed devices are mainly made from nitrile and there are four sizes, includes small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is NBR BLUE 7214 (which composed of Phthalocyanine blue (CAS No.147-14-8) and Propylene glycol (CAS No.57-55-6). The examination glove is smooth surface with textured fingertips and a rolled rim atthe cuff edge.

The examination gloves meet the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

This document is a 510(k) Pre-Market Notification for "Nitrile Gloves (Model: NE01)". It does not describe an AI medical device. Therefore, many of the requested fields are not applicable.

Here's the information extracted from the provided text, focusing on the device's acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

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The Nitrile 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 examination gloves. The subject device is blue. The subject device is non-sterile.

The provided document is a 510(k) Premarket Notification for a Nitrile Glove, which is a Class I medical device. Therefore, the "device" in this context is a physical product (a medical glove), not a software or AI-driven diagnostic tool. The questions you've asked are highly relevant to the evaluation of AI/ML-based medical devices, specifically regarding their performance on test sets, ground truth establishment, and clinical studies.

Since the document describes a physical medical device (nitrile glove) and not an AI or software device, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context relate to physical properties, performance standards, and biocompatibility rather than diagnostic accuracy, reader studies, or training sets for AI models.

Therefore, I cannot extract the information requested in your prompt because it pertains to a different type of medical device (AI/ML) than what is described in the provided text.

However, I can extract the acceptance criteria and performance data relevant to this specific device (Nitrile Glove) as described in the document.

Acceptance Criteria and Device Performance for a Nitrile Glove

The document details performance testing for the Nitrile Glove based on established ASTM and ISO standards for examination gloves.

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

• S: ≥220
• M/L/XL: ≥230
  Width (mm):
• S: 80±10
• M: 95±10
• L: 110±10
• XL: 120±10
  Thickness (mm):
• Finger: ≥0.05
• Palm: ≥0.05 | Length:
• S: >220/Pass
• M/L/XL: >230/Pass
  Width:
• S: 81-85 /Pass
• M: 91-96/ Pass
• L: 102-106/ Pass
• XL: 114-116/Pass
  Thickness:
• Finger: 0.06-0.08/Pass
• Palm: 0.07-0.08/Pass |
  | ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 leaks / Pass |
  | ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124

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

The proposed device is powder free, non-sterile nitrile examination gloves. Following FDA Code LZA, a "nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants."

This document is a 510(k) Premarket Notification for a medical device: Nitrile Glove Powder Free Blue. It seeks to demonstrate substantial equivalence to a predicate device.

The provided text describes the regulatory process, device information, and a comparison of the proposed device with a predicate device, focusing on non-clinical performance testing. It does not contain information about an AI/ML device, nor does it describe a study involving human readers or comparative effectiveness for an AI model.

Therefore, I cannot provide the detailed information requested regarding acceptance criteria and a study proving an AI/ML device meets those criteria, specifically concerning:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample sizes, data provenance, and ground truth establishment for AI/ML test and training sets.
• Details on expert involvement (number, qualifications, adjudication) for an AI/ML ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness studies for AI assistance.
• Stand-alone AI algorithm performance.

The document is entirely focused on the physical and chemical properties and safety of a medical glove, not an AI/ML system.

However, I can extract the acceptance criteria and performance data for the Nitrile Glove Powder Free Blue from the provided document, which pertains to its non-clinical testing.

Here's a breakdown of the acceptance criteria and results for the medical glove as presented in the document:

1. A table of acceptance criteria and the reported device performance (for the physical glove)

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

The document does not specify the exact sample sizes (number of gloves) used for each non-clinical test. It only states the tests were conducted. The data provenance is implied to be from the manufacturer's internal testing or accredited labs in China (Changzhou Universal Medical Equipment Co. Ltd. is located in Changzhou, Jiangsu Province, China). The tests are retrospective in the sense that they were performed on finished products.

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

Not applicable to this type of non-clinical testing for a medical glove. The "ground truth" for these tests is established by standardized laboratory methods (e.g., measuring dimensions, performing leak tests, chemical assays for cytotoxicity) according to the specified ISO, ASTM, and EN standards. These are objective measures, not requiring expert consensus or interpretation in the same way an AI model's output would.

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

Not applicable. As noted above, these are objective physical and biological tests, not requiring adjudication of human performance or AI output.

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 document is for a medical glove, not an AI/ML device. No human reader studies were conducted or relevant.

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

Not applicable. This is not an AI algorithm. The 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 the glove's performance is based on the results of standardized laboratory engineering and biological tests as defined by ISO, ASTM, and EN standards (e.g., presence/absence of leaks, specific measurements (length, width, thickness), tensile strength, elongation, cytotoxicity, irritation, sensitization).

8. The sample size for the training set:

Not applicable. There is no training set for a physically manufactured medical glove in the context of an AI/ML model.

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

Not applicable. There is no training set as this is not an AI/ML device.

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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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