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

The Medical Examination Gloves (Nitrile) 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 color, powder free, nitrile ambidextrous gloves are offered in sizes extra-small, small, medium, large, extra-large packed in a paper box. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard.

This request asks to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. However, the provided text is an FDA 510(k) clearance letter for Medical Examination Gloves (Nitrile). This type of device is a low-risk product and its clearance documentation does not involve AI-driven diagnostics, clinical trials, or the detailed study methodologies (like blinding, sample sizes for test/training sets, expert adjudication, MRMC studies) that would be present for a complex medical software device.

The information provided pertains to the physical and chemical properties of examination gloves, focusing on:

• Biocompatibility: Tests for irritation, sensitization, and acute systemic toxicity.
• Performance Testing (Physical): Dimensions, tensile strength, elongation, freedom from holes, and residual powder.

Therefore, many of the requested elements (like "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop performance)," "number of experts used to establish the ground truth," etc.) are not applicable to the documentation for a medical glove.

I will interpret the request based on the actual content related to the medical gloves, explaining the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in that context.

Device: Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)
Product Code: LZA
Regulation Number: 21 CFR 880.6250 - Non-Powdered Patient Examination Glove
Regulatory Class: Class I, reserved

1. Table of Acceptance Criteria and the Reported Device Performance

The "study" in this context refers to non-clinical laboratory testing of the glove's physical, chemical, and biological properties.

Biocompatibility Testing:

Physical Performance Testing (against ASTM D6319-19 and other relevant standards):

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

The proposed device is a powder free medical glove. The device is blue in color. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The proposed gloves are available in five sizes, which are XS, S, M, L, XL, it could be selected by the user depended on size of hand. The difference between each size is just in the dimension. The proposed device is provided non-sterile.

The provided text describes the acceptance criteria and the study conducted for "Medical Examination Gloves" (K213168). However, it does not describe a study involving an AI/Machine Learning device or a multi-reader multi-case (MRMC) comparative effectiveness study, but rather the performance testing for a physical medical device (gloves). Therefore, many of the requested points related to AI/ML device testing will not be applicable and will be marked as "N/A".

Here's the breakdown of the acceptance criteria and study as described in the document:

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)

The document does not specify the exact sample sizes for each physical test. It merely states that "Non clinical tests were conducted to verify that the proposed device met all design specifications and acceptance criteria in the test methodology and the standards." The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated, but given that the manufacturer is in China and the testing is for FDA clearance, it's reasonable to infer the tests were conducted or overseen by the manufacturer. The tests are prospective in nature, as they are performed on the device to prove its compliance.

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 is not applicable as the device is a physical medical glove undergoing performance testing against standardized physical and biocompatibility criteria, not an AI/ML device requiring expert ground truth for image/data interpretation. Ground truth is established by the test methodologies themselves (e.g., measuring dimensions, tensile strength, etc.).

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

Not applicable. Adjudication methods are typically for subjective assessments or disagreements in interpretative tasks, which do not apply to the objective physical and chemical testing of medical 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

No. This study is for a physical medical glove, not an AI/ML device. Therefore, an MRMC comparative effectiveness study was not conducted.

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

Not applicable. This is not an algorithm, but a physical device.

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

The "ground truth" for this device's performance is derived from standardized test methodologies and specifications (e.g., ASTM D6319-19 for dimensions and physical properties, ASTM D5151-19 for holes, ASTM D6124-06 for powder residue, and ISO 10993-10/11 for biocompatibility). These standards define the objective measurements and criteria that the device must meet.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

Not applicable. There is no training set for a physical device.

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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 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 four sizes: small, medium, large, and extra-large. The subject device is non-sterile.

This document, K212506, is a 510(k) premarket notification for Medical Examination Gloves (Tested for Use with Chemotherapy). It details the acceptance criteria and the study proving the device meets these criteria.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and device performance are primarily based on the ASTM D6319 standard for medical examination gloves and ASTM D6978 for chemotherapy drug permeation.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size:
  • Watertightness Test (ASTM D5151): 125 samples (0/125/Pass).
  • Other physical performance tests (Dimensions, Physical properties, Powder Content): Specific sample sizes are not explicitly stated for all tests but are implied by the results provided (e.g., ranges for width/thickness indicate multiple measurements). These tests are typically performed on a statistically relevant sample size according to the respective ASTM standards.
  • Biocompatibility (ISO 10993 series): Sample sizes for the animal studies (toxicity, irritation, sensitization) are not detailed in this summary but would have followed the guidance of the ISO standards.
  • Chemotherapy Permeation (ASTM D6978): The permeation results are presented as single breakthrough times for each drug, implying a specific test protocol dictated by the standard, likely involving multiple replicates to ensure reproducibility, though the exact number isn't given.
• Data Provenance: The data is derived from benchtop performance testing and biocompatibility testing. The manufacturer is based in Guangdong, China, which implies the testing was conducted there or by affiliated labs. The document does not specify if the data is retrospective or prospective; however, given it's a 510(k) submission, it's typically data collected specifically for the regulatory submission (i.e., prospective for this purpose).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This submission is for a Class I medical examination glove, which relies on standardized bench testing rather than interpretation of complex medical images or clinical outcomes that would require expert consensus (e.g., radiologists). Therefore, there were no human experts establishing "ground truth" in the diagnostic sense. The "ground truth" for the performance characteristics (e.g., tensile strength, breakthrough time) is defined by the validated test methods and their quantitative results.

4. Adjudication Method for the Test Set

Not applicable. As described above, this involves quantitative bench testing and not subjective expert interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This device is a physical glove, and its performance is evaluated through laboratory bench tests.

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

This question is not applicable to this device. This is a physical non-diagnostic medical device. There is no algorithm or AI component involved, hence no "standalone" algorithm performance to evaluate. The device's performance is inherently "standalone" in that it performs its function (e.g., barrier to chemicals, physical strength) intrinsically.

7. The Type of Ground Truth Used

The ground truth used for this device's performance testing is based on:

• Standardized Test Methods (Benchtop Data): Adherence to specific ASTM and ISO standards (e.g., ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, ASTM D6978, ISO 10993-10, ISO 10993-11). The results obtained from these tests are considered the objective ground truth for the glove's physical and chemical resistance properties.
• Chemical Permeation Data: Direct quantitative measurement of breakthrough times for specific chemotherapy drugs, as determined by ASTM D6978-05.
• Biocompatibility Data: Results from in vivo (for toxicity, irritation, sensitization) studies following ISO 10993 guidelines, which define the biological response to the material.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI/ML algorithm. Therefore, 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 this type of device.

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The Medical Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The proposed device is Powder Free Medical Examination 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.

Here's a breakdown of the acceptance criteria and study information for the Medical Examination Gloves, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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The Medical Examination 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 Medical Examination 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 is a 510(k) summary for Medical Examination Gloves. It details the device's characteristics and compares them to a predicate device to demonstrate substantial equivalence. Since this is an application for a Class I medical device (Medical Examination Gloves), the acceptance criteria and supporting studies are focused on demonstrating that the device performs as intended and is as safe and effective as a legally marketed predicate device, rather than a detailed AI-driven diagnostic or treatment device study. Therefore, many of the requested categories for AI/human reader studies are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria (from recognized standards) and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The device's compliance is proven through a series of non-clinical (bench) tests against recognized international and national standards. The document explicitly states:

• "The following tests were performed to evaluate the biocompatibility of the proposed device, the tests' results to show substantial equivalence to the predicate device:"
  • ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
  • ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
  • ISO 10993-11 Third edition 2017-09, Biological evaluation of medical devices -Part 11: Tests for systemic toxicity.
• "In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:"
  • ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
  • ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
  • ASTM D6319-19, Standard Specification For Medical Examination Gloves For Medical Application.
  • ASTM D7160-16, Standard Practice for Determination of Expiration Dating for Medical Gloves

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the exact sample sizes for each non-clinical test (e.g., number of gloves tested for holes, number of samples for biocompatibility). These are typically determined by the testing standards themselves.

The data provenance is from testing conducted by the manufacturer (Guangdong Gymda Medical Technology Co., Ltd) or their designated testing facilities in China, as indicated by the company's address and the origin of the submission. These are prospective tests conducted during the device development and submission process.

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

Not applicable. For this type of device (medical examination gloves), the "ground truth" for performance is established by the specified standards (ASTM, ISO) and laboratory testing methodologies, not by expert human interpretation of results in the way a diagnostic AI system would require. The tests yield objective, measurable outcomes (e.g., tensile strength, presence of holes, cytotoxicity levels).

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in human interpretation of data, typically for clinical studies or image-based diagnostic systems. The non-clinical tests performed here produce direct, quantifiable results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No. This is not an AI-assisted diagnostic device, so an MRMC comparative effectiveness study is not applicable. The device is a physical barrier (glove).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Not applicable. The device is not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth is based on objective measurements against established performance specifications and biocompatibility endpoints defined by international and national standards (ASTM and ISO), measured through laboratory testing.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/machine learning system that requires a training set. The "training" for such devices involves adherence to manufacturing quality systems and design controls to consistently produce devices meeting specifications.

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

Not applicable. As above, there is no "training set" in the context of an AI model for this device.

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