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A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

White Nitrile Powder-Free Patient Examination Glove, Non-Sterile is manufactured from nitrile rubber. Innersurface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.

The provided document describes the acceptance criteria and performance data for the "White Nitrile Powder-Free Patient Examination Glove, Non Sterile" (K222713). This medical device is a patient examination glove and the testing performed aligns with engineering and material specifications, rather than AI/software performance. Therefore, many of the requested fields related to AI/ML device studies (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, and training set information) are not applicable to this submission.

Here's the relevant information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

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A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner

Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile is manufactured from nitrile rubber. Innersurface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.

Based on the provided document, the device in question is a Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile. This is not a medical imaging AI device or a diagnostic AI device. The document is a 510(k) Premarket Notification summary for a medical glove, which is a physical device, and the testing conducted is for physical and chemical properties, not algorithmic performance.

Therefore, the requested information, which pertains to the acceptance criteria and study designs for AI/ML device performance (e.g., sample size for test set, expert ground truth, MRMC studies, standalone performance, training set details), is not applicable to this document.

The document describes non-clinical testing for the glove, focusing on properties like tensile strength, elongation, dimensions, watertight integrity, residual powder, and biocompatibility.

However, I can extract and present the acceptance criteria and performance data as per the document's content, formatted as a table, making it clear that this applies to a physical device and not an AI/ML system.

Acceptance Criteria and Device Performance for Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile (K222720)

The following table summarizes the non-clinical acceptance criteria and the reported performance of the device. It's crucial to understand that this concerns the physical and chemical properties of a medical glove, not the performance of an AI/ML algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

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A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner

Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile is manufactured from nitrile rubber. Innersurface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.

The provided document describes the non-clinical performance testing for a medical device: "Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile." This submission is a 510(k) premarket notification to the FDA, demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes and Data Provenance:

• Test Set (Current Device):
  • Physical Properties (Tensile Strength, Ultimate Elongation): Not explicitly stated, but tests were performed for different glove sizes (XS, S, M, L, XL). ASTM D412 and D6319 typically specify sample sizes.
  • Dimensions (Length, Width, Thickness): Not explicitly stated, but performed for all glove sizes (XS, S, M, L, XL). ASTM D3767 specifies measurement practices.
  • Watertight: 315 pieces (for a batch size of 150,001 to 500,000).
  • Residual Powder: 5 pieces.
  • Biocompatibility (Primary Skin Irritation, Dermal Sensitization, Acute Systemic Toxicity): Not explicitly stated for each test, but typically involves animal subjects (e.g., guinea pigs for sensitization, Swiss albino mice for systemic toxicity).
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given it's a 510(k) submission for a new device, the testing would be prospective for this specific device.

3. Number of Experts and Qualifications for Ground Truth for the Test Set:

This document describes non-clinical performance testing of a physical medical device (gloves). The ground truth for this type of device is established through standardized laboratory tests according to recognized ASTM and ISO standards, not via expert consensus or clinical evaluation in the same way as, for example, an AI diagnostic tool. Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth in this context doesn't directly apply as it would for a clinical study or AI performance evaluation. The "experts" are implicitly the technicians and scientists performing the tests according to the defined standards.

4. Adjudication Method for the Test Set:

Not applicable. The tests are objective measurements and evaluations against specified pass/fail criteria from recognized standards (ASTM, ISO). There is no "adjudication" between multiple human readers or interpretations.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specifically relevant for AI-powered diagnostic devices or imaging tools where human readers are involved in interpreting results. This submission is for a physical medical device (gloves) and focuses on non-clinical performance characteristics.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is a physical medical device, not an algorithm or AI.

7. Type of Ground Truth Used:

The ground truth used is based on:

• Standardized Test Methods: Adherence to established and recognized ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards.
• Quantitative Measurements: Direct measurements of physical properties (tensile strength, elongation, dimensions, powder content).
• Qualitative Assessments: Outcomes of biocompatibility tests (irritation, sensitization, toxicity) as defined by ISO standards on animal models.
• Statistical Sampling: For watertightness, an Acceptance Quality Limit (AQL) statistical sampling plan (ISO 2859) is used.

8. Sample Size for the Training Set:

Not applicable. There is no concept of a "training set" for this type of medical device which undergoes standardized physical and chemical testing. This is not an AI or machine learning model.

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

Not applicable, as there is no training set. The device's performance is evaluated directly against pre-established, widely accepted industry standards and regulatory requirements for medical examination gloves.

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A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner

Violet Nitrile Powder-Free Patient Examination Glove, Non-Sterile meets all requirements of ASTM D6319 standard and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from nitrile rubber. Innersurface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.

The provided text describes the acceptance criteria and performance data for a medical device: "Violet Nitrile Powder Free Patient Examination Glove, Non Sterile" (K222721). This is a physical product, not an AI/ML powered medical device. Therefore, the questions related to AI/ML specific criteria, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," or "sample size for the training set," are not applicable.

Here's the relevant information based on the provided text, primarily derived from the "Summary of Non-Clinical Testing" (Section 7.0) and "Comparison of the Technological Characteristics of the Device" (Table 1):

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

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