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

The Disposable Nitrile Gloves are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue or black color, powder free, nitrile ambidextrous gloves. The gloves are offered in large (L) size, packed in a paper box. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard.

The provided text describes the 510(k) premarket notification for Disposable Nitrile Gloves (ABC-DG01). It outlines the device's characteristics, its intended use, and a comparison to a predicate device (K171422). The submission focuses on demonstrating substantial equivalence through non-clinical testing.

Here's an analysis of the provided information to address your request:

Based on the provided document, the "device" in question is Disposable Nitrile Gloves (ABC-DG01). This is a Class I medical device, meaning it is considered low risk and subject to general controls. The acceptance criteria and "study" described are for physical and chemical performance, not for a diagnostic algorithm or AI.

Therefore, many of the questions regarding AI-specific studies (e.g., sample size for test set, data provenance, expert consensus, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of medical device submission.

The "study" refers to non-clinical performance testing conducted to demonstrate that the Disposable Nitrile Gloves meet established standards for patient examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance

The relevant information is found in "Table 4. Performance Comparison" and "Summary of Non-Clinical Testing" (specifically the table under section G).

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The Disposable nitrile gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Disposable nitrile gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The proposed device is non-sterile.

The provided text is a 510(k) Premarket Notification from the FDA for "Disposable Nitrile Gloves." This document primarily focuses on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device, rather than proving that it meets acceptance criteria for an AI/algorithm-based diagnostic device through a study with human readers.

Therefore, the information requested in the prompt, such as acceptance criteria for AI algorithms, sample sizes for AI test sets, expert adjudication methods, MRMC studies, standalone AI performance, ground truth establishment for training sets, and the number and qualifications of experts for ground truth, is not applicable to this document.

The document describes performance testing for a physical medical device (gloves) against established standards for physical properties and biocompatibility.

Here's an analysis based on the information available in the document, framed to address the prompt's structure where possible, but highlighting the inapplicability of AI-specific criteria.

Analysis of Acceptance Criteria and Device Performance (for Disposable Nitrile Gloves)

The document, K211781, describes the submission for Disposable Nitrile Gloves. The "acceptance criteria" in this context refer to the performance specifications and safety standards for the physical product, not for an AI/algorithm. The study presented is a series of non-clinical bench tests and biocompatibility assessments demonstrating the gloves meet these standards and are substantially equivalent to a predicate device.

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are derived from recognized standards (ASTM and ISO). The reported device performance shows the proposed device meets or exceeds these criteria.

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The Disposable nitrile gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Disposable nitrile gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.

The provided document describes the non-clinical performance testing for "Disposable Nitrile Gloves" (K212009) to demonstrate substantial equivalence to a predicate device (K171422).

Here's the breakdown of the acceptance criteria and the study results:

1. Table of Acceptance Criteria and Reported Device Performance

| No. | Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|-----|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-
| 1 | ISO 10993-10:2010 (Skin Sensitization Test) | Assesses possible contact hazards from chemicals released from medical devices, that may produce skin sensitization. | Grades less than 1, otherwise sensitization. | All grades are 0. All animals survived and no abnormal signs were observed. |
| 2 | ISO 10993-10:2010 (Skin Irritation Test) | Assesses possible contact hazards from chemicals released from medical devices, that may produce skin irritation. | Primary irritation index of 0-0.4 for negligence. | Primary irritation index is 0. The response of the proposed device was categorized as negligible. |
| 3 | ISO 10993-5:2009 (Cytotoxicity) | Assesses the in vitro cytotoxicity of medical devices. | Viability percentage (Viab.%) of the 100% extract of the test article is the final result. If viability is reduced to

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The Disposable Nitrile Gloves are 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 document is a 510(k) Premarket Notification summary for Disposable Nitrile Gloves (K210276). It is not for an AI/ML medical device, but rather for a physical medical device (gloves). Therefore, the information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) is not applicable to this document.

The document discusses the substantial equivalence of the Disposable Nitrile Gloves to a predicate device (K171422) based on performance testing and adherence to recognized standards.

Here's an attempt to interpret the provided content in the context of your request, while acknowledging that it doesn't fit the typical AI/ML device evaluation structure:

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

The document outlines comparisons between the subject device (K210276) and the predicate device (K171422), effectively serving as the acceptance criteria for substantial equivalence. The reported device performance is demonstrated by its compliance with the listed standards.

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

• Sample Size: The document does not specify exact sample sizes for each test conducted (e.g., number of gloves tested for tensile strength, holes, etc.). It only states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The standards themselves (e.g., ASTM D6319, ASTM D5151) would define the required sample sizes for their respective tests, but these details are not present in this summary.
• Data Provenance: The tests were non-clinical performance tests, usually performed in a lab setting by the manufacturer or a contracted lab. The manufacturer is Fujian Ercon Medical Management Co., Ltd. in China. The provenance is internal testing, not patient data.

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 a study requiring expert readers or ground truth establishment in the context of interpreting medical images or data. The "ground truth" for these tests is defined by the technical specifications and standards (e.g., a hole is present or absent according to ASTM D5151 criteria).

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

• Not Applicable. As this is not an interpretive/diagnostic study, no adjudication method for human readers is relevant. The tests are laboratory measurements.

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 (gloves), not an AI/ML diagnostic aid. There were no human readers or AI assistance involved.

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 algorithm.

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

• The "ground truth" for this device's performance is objective measurements and compliance with industry standards (e.g., ASTM D6319-19 for glove specifications, ASTM D5151-19 for holes, ISO 10993 for biocompatibility). It is based on pre-defined engineering specifications and test protocols.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device; there is no training set.

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

• Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.

In summary, the provided document details the regulatory submission for a physical medical device, not an AI/ML diagnostic tool. Therefore, many of the questions related to AI/ML study design are not applicable. The device's acceptance is based on non-clinical performance testing confirming its compliance with recognized standards and substantial equivalence to a legally marketed predicate device.

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