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The glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978.

Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs is a disposable single-use, sterile, natural-colored and powder-free surgical glove made from rubber latex. They are in different sizes - 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0. Gloves meet the specification of ASTM D3577-19 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).

The provided text describes the acceptance criteria and the study that proves a medical device (Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs) meets those criteria.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is primarily assessed against ASTM standards and biocompatibility tests. The table below summarizes these, focusing on the key performance characteristics relevant to general surgical gloves and their resistance to chemotherapy drugs.

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 explicitly state the specific sample sizes for each individual test. However, it indicates that "Non-clinical testing was performed to verify that the subject device meets the acceptance criteria of the performance test and all design specifications." The testing was conducted in accordance with recognized international and national standards (ASTM, ISO, U.S. Pharmacopeia).

• Sample Size: Not explicitly stated for each test, but implied to be sufficient to meet the statistical requirements of the listed ASTM and ISO standards for each test (e.g., AQL 1.5 for freedom from holes implies a certain sample size for inspection).
• Data Provenance: The manufacturer is "Grand Work Plastic Products Co., Ltd." in "Zanhuang, Hebei, 050000 China." The tests would have been performed by or for this company. The document does not specify if the testing was performed in China or by an external laboratory.
• Retrospective or Prospective: The testing described is prospective, as it involves evaluating a new device against predefined standards to support its market clearance.

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 type of information (number and qualifications of experts) is generally relevant for studies involving subjective interpretation, especially in AI/imaging devices. For the physical and chemical testing of surgical gloves, "ground truth" is established by adherence to standardized test methods (e.g., ASTM D3577 for physical properties, ASTM D6978 for chemotherapy permeation, ISO 10993 for biocompatibility). The "experts" in this context would be the technicians and scientists performing and interpreting these standardized tests in a laboratory setting, who are qualified to execute these specific methodologies. Their specific number or individual qualifications are not detailed in this type of regulatory submission but are assumed to meet the requirements of the testing laboratories.

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

Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or expert review processes where there is subjective interpretation involved, especially for ground truth establishment in medical imaging or diagnostic devices. For the non-clinical physical, chemical, and biocompatibility testing of surgical gloves, such adjudication methods are not applicable. The results are obtained through objective measurements and standardized protocols with predetermined pass/fail criteria.

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. An MRMC comparative effectiveness study is not relevant for this device. This is a physical medical device (surgical glove), not an AI-powered diagnostic or assistive technology that involves human readers interpreting cases.

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

No. This concept is not applicable to a physical surgical glove. "Standalone" performance testing for this device refers to its physical and chemical properties and its barrier properties, measured objectively according to specified standards, without any "human-in-the-loop" component in its performance itself (though human labor is involved in its use).

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

The "ground truth" for this device is based on established industry standards and objective physical/chemical measurements. Specifically:

• ASTM D3577-19: Standard Specification for Rubber Surgical Gloves (defines dimensions, physical properties, freedom from holes).
• ASTM D5151-19: Standard Test Method for Detection of Holes in Medical Gloves.
• ASTM D6124-06 (2022): Standard Test Method for Residual Powder on Medical Gloves.
• ASTM D6978-05 (2019): Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs (defines the permeation testing methodology).
• ASTM D5712-15 (2020): Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.
• ISO 10993 series: Biological evaluation of medical devices (for biocompatibility tests like cytotoxicity, sensitization, systemic toxicity, pyrogenicity).
• U.S. Pharmacopeia: Sterility Test.

The pass/fail criteria and metric values within these standards serve as the "ground truth."

8. The sample size for the training set

This is not applicable. The device is a physical product (surgical glove), not a software algorithm that requires a training set.

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

This is not applicable, as there is no training set for this type of device.

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The glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with Chemotherapy drugs and fentanyl citrate in accordance with ASTM D6978.

The subject device is Nitrile Examination Gloves Sterile with Chemotherapy drugs and fentanyl citrate claims. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and sterile. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for permeability to chemotherapy drugs and fentanyl citrate per ASTM D6978-05(2019).

The document provided is a 510(k) Premarket Notification from the FDA for "Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate." This document primarily focuses on demonstrating substantial equivalence to a predicate device, specifically by adding a claim for fentanyl citrate permeation. It performs non-clinical testing to support this claim, rather than a study involving AI or human readers for diagnostic purposes.

Therefore, many of the requested details regarding AI device acceptance criteria, human reader studies, and AI-specific ground truth establishment are not applicable to this submission. This is a clearance for a physical medical device (gloves), not a diagnostic AI/ML device.

However, I can extract the relevant information regarding the device's acceptance criteria and the non-clinical study conducted to prove it meets those criteria.

Acceptance Criteria and Study for Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

This medical device is a physical product (examination gloves), not an AI/ML diagnostic tool. The "acceptance criteria" here refer to the physical and chemical performance standards for the gloves, and the "study" refers to non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the re-submitted device (K232039) are based on relevant ASTM and ISO standards, and for chemotherapy and opioid drug permeation, specific minimum breakthrough times (BDT). The reported device performance indicates that the gloves passed all these criteria.

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

The document does not explicitly state the exact sample sizes used for each physical or chemical test. However, for tests like "Freedom from holes," it refers to AQL (Acceptable Quality Level) 2.5, which implies a sampling plan according to ASTM D5151-19. Similarly, other ASTM and ISO standards followed for physical properties and biocompatibility would specify sample sizes.

The data for these tests would be generated prospectively as part of product development and quality control for the submission. The country of origin for the data generation is implied to be China, given the manufacturer's location.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This concept is not applicable here. Ground truth in the context of this submission refers to the established standards and methodologies of the ASTM and ISO tests (e.g., how to measure tensile strength, how to test for permeation). These are standardized laboratory tests, not subjective expert interpretations of images or clinical outcomes. The "experts" are the laboratory personnel who perform these tests according to the published standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers or subjective interpretations requiring adjudication. The tests have predefined, objective measurement protocols.

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-assisted diagnostic tool. No MRMC study was performed.

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

Not applicable. There is no algorithm or AI component in this device. Performance is measured directly through bench testing.

7. The type of ground truth used

The "ground truth" for this device's performance is established by objective, standardized laboratory measurements against predefined performance specifications stated in ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards. Specifically:

• Physical Properties: Measured values (e.g., length, width, thickness, tensile strength, elongation) are compared directly against minimum/maximum thresholds defined in ASTM D6319-19 and ASTM D412-16.
• Freedom from holes: Determined by water leak testing according to ASTM D5151-19, with acceptance based on AQL 2.5.
• Powder Residue: Quantified according to ASTM D6124-06 (2017) against a maximum limit.
• Chemical Permeation: Breakthrough Time (BDT) is measured for specific chemotherapy drugs and fentanyl citrate according to ASTM D6978-05 (2019) and compared against specified minimum times.
• Biocompatibility: Assessed through in-vitro/in-vivo tests for irritation, sensitization (ISO 10993-10:2010), and acute systemic toxicity (ISO 10993-11:2017) to ensure no adverse biological reactions.

8. The Sample Size for the Training Set

Not applicable. As 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 algorithm.

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A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl and oil-based liquid nitrile rubber materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2011) Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application.

The provided document describes the Grand Work Plastic Products Co., Ltd.'s Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color (K142409) and seeks to prove its substantial equivalence to a predicate device (K061562). The study conducted is a non-clinical performance study comparing the subject device against the predicate device based on established standards and FDA requirements.

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

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: The sample sizes for each test are indicated by the "Inspection Level and AQL" or "N" values.
  • For physical dimensions (Overall Length, Width, Palm Thickness, Finger Thickness), Tensile Strength, and Ultimate Elongation: S-2, AQL4.0.
  • For Pinhole: G-I, AQL1.5.
  • For Residual Powder: N=5 (5 gloves tested).
  • For Biocompatibility (Primary Skin Irritation, Dermal Sensitization): The specific number of samples (e.g., animals, human subjects, in-vitro replicates) is not explicitly stated, but the tests were performed "Under conditions of the study".
• Data Provenance: The study was conducted by Grand Work Plastic Products Co., Ltd., which is located in Zanhuang, Hebei, China. The data originates from this manufacturer. It is a prospective study as the tests were performed on the subject device to demonstrate 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 study is a physical and chemical performance test of a medical device (examination gloves), not an AI/clinical diagnostic device. Therefore, it does not involve experts establishing "ground truth" in the clinical sense (e.g., radiologists, pathologists). The "ground truth" is established by the pre-defined technical standards (e.g., ASTM D5250-06(2011), ISO 10993-10) and FDA requirements. The tests are performed by technicians in a laboratory setting according to specified protocols.

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

Not applicable. This is not a study involving human readers or clinical adjudication. The results are quantitative measurements or qualitative observations against a set standard.

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 performance study for a physical device (examination gloves), not a comparative effectiveness study involving human readers or AI assistance.

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

Not applicable. This is a performance study for a physical device (examination gloves), not an algorithm or AI system.

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

The "ground truth" for this study is based on established industry standards and regulatory requirements. Specifically:

• ASTM D5250-06 (Reapproved 2011) Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application.
• ISO 10993-10 for biocompatibility (Primary Skin Irritation and Dermal Sensitization).
• FDA requirements (e.g., for pinhole AQL).

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI study; there is no training set involved.

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

Not applicable. There is no training set.

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A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.

This is not a medical device that utilizes AI/ML. The provided text is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves," which is a Class I medical device. Therefore, information related to AI/ML specific criteria such as multi-reader multi-case studies, effect size of human readers with AI assistance, standalone algorithm performance, or training set details is not applicable and cannot be extracted from this document.

However, I can provide the acceptance criteria and the studies that prove the device meets these criteria based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical and Dimensions Testing: "Inspection level S-2, AQL 4.0." (Specific numerical sample size not provided, but AQL and inspection level are specified which determine the sample size. The data provenance is internal testing by the manufacturer.)
• FDA 1000 ml. Water Fill Test: "samplings of AQL 2.5, inspection level I." (Specific numerical sample size not provided, but AQL and inspection level are specified. The data provenance is internal testing by the manufacturer.)
• Primary Skin Irritation and Skin Sensitization: The document does not specify the sample size for human or animal subjects used in these tests. The testing was conducted, implying it's a prospective study for the purpose of this submission.
• Residual Powder Test: The document does not specify the sample size. The data provenance is internal testing by the manufacturer.

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

Not applicable. This device is a physical product (examination gloves), and the "ground truth" is established through standardized physical, chemical, and biological testing rather than expert-based interpretations.

4. Adjudication method for the test set

Not applicable. The testing methods for physical properties, pinholes, and biocompatibility are objective measurements against established standards, not subjective interpretations requiring adjudication.

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 not an AI/ML powered device.

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

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

The "ground truth" for the device's performance is based on objective measurements against established national and international standards for medical gloves:

• ASTM D-5250-06e1 (Standard Specification for Vinyl Patient Examination Gloves) for physical and dimensional properties.
• FDA 1000 ml. Water Fill Test for barrier integrity (pinholes).
• Primary Skin Irritation and Skin Sensitization testing for biocompatibility.
• ASTM D-6124-06 for Residual Powder.

8. The sample size for the training set

Not applicable. There is no AI/ML algorithm or training set for this type of device. The "training" for manufacturing would involve adherence to quality control processes and standards.

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

Not applicable. As there is no AI/ML algorithm or training set, this question is not relevant.

Ask a specific question about this device

A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 CFR §880.6250 Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.

The provided text describes the 510(k) submission for Grand Work Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves. This information focuses on demonstrating substantial equivalence to a predicate device rather than a study proving the device meets acceptance criteria in the context of an AI/ML algorithm.

Therefore, many of the requested categories for AI/ML study details are not applicable to this submission. However, I can extract the relevant information regarding acceptance criteria and non-clinical testing performed.

Here's the information derived from the provided text, adapted to your requested format where possible:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test. For physical and dimensions testing, "Inspection level S-2, AQL 4.0" is mentioned. For the FDA Water Fill Test, "AQL 2.5, inspection level I" is mentioned. These are statistical sampling plans, but not a direct number of samples.
• Data Provenance: Not specified (e.g., country of origin). The tests were performed by "Grand Work Plastic Products Co., Ltd.'s glove production," implying the testing was done by the manufacturer. The text does not indicate if the data is retrospective or prospective.

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

• Not Applicable. This submission details non-clinical laboratory and performance testing of physical characteristics and biocompatibility, not expert-adjudicated ground truth for AI/ML.

4. Adjudication method for the test set

• Not Applicable. See point 3.

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 not an AI/ML device.

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

• Not Applicable. This is not an AI/ML device.

7. The type of ground truth used

• The "ground truth" for the tests performed were established by adherence to ASTM standards, FDA testing procedures (e.g., Water Fill Test), and laboratory assays for biocompatibility (Primary Skin Irritation and Skin Sensitization) and residual powder. These are objective measurements against defined criteria.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there's no training set in that context. The devices are manufactured according to a process that undergoes quality control and testing.

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

• Not Applicable. See point 8.

Ask a specific question about this device

A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4

The device described is the Grand Work Plastic Products Co., Ltd.'s Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color. The submission is a 510(k) for substantial equivalence to a predicate device. This type of submission generally relies on non-clinical performance data rather than extensive clinical studies.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The specific number of items sampled is not explicitly stated but is determined by the AQL and inspection level. Data provenance is not specified but would typically be from the manufacturer's internal testing.
• Pinhole Detection (Water Fill Test): AQL 2.5, Inspection Level G-1. The specific number of items sampled is not explicitly stated. Data provenance is not specified.
• Primary Skin Irritation and Skin Sensitization: The sample size for these biological tests is not specified in the provided document. These tests are typically conducted in vitro or in vivo on animal models or human volunteers according to standard protocols. Data provenance is not specified.
• Residual Powder Test: The sample size is not specified. Data provenance is not specified.

All testing would be considered retrospective in the context of this submission, as they were performed prior to the submission for FDA clearance. The country of origin of the data is implied to be from the manufacturer's testing facilities, likely in China, given the submitter's location.

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

Not applicable for this type of device and submission. The "ground truth" for the performance tests (e.g., tensile strength, pinholes) is established by the objective physical and chemical testing methods and their predefined acceptance criteria, not by expert consensus on interpretations of complex data like medical images.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements against predetermined standards, not subjective assessments requiring adjudication among experts.

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 relevant for diagnostic devices where human readers interpret medical data (e.g., images), and the AI's impact on reader performance is evaluated. Examination gloves do not involve such human interpretation.

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

No, a standalone algorithm performance study was not done. The device is a physical product (gloves), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective measurements and predefined standards.

• For physical properties and dimensions, the ground truth is derived from the ASTM D-5250-00E4 standard specifications.
• For pinhole detection, the ground truth is determined by the FDA 1000 ml. Water Fill Test based on ASTM D-5151-99.
• For biocompatibility (skin irritation and sensitization), the ground truth is established by the results of standardized biological assays that demonstrate no adverse reactions.
• For residual powder, the ground truth is based on the ASTM D-6124-06 standard for starch content.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance is based on the manufacturing process and material characteristics, assessed through quality control and testing.

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

Not applicable, as there is no training set for this device.

Ask a specific question about this device

A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
The Vinyl Plastic Co-Polymer Powder-Free Examination Gloves (Blue Color) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Vinyl Patient Examination Glove, 80 LZA, and meets all requirements of ASTM standard D-6319-00a1 and ASTM D-5250.

The provided document describes the safety and effectiveness information for the "Grand Work Plastic Products Co., Ltd. Vinyl Nitrile Co-Polymer Powder Free Exam Gloves (Blue Color)".

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The exact sample size is not explicitly stated but is determined by the AQL and inspection level standards.
• Pinhole (Water Fill Test): Inspection level G-1, AQL 2.5. The exact sample size is not explicitly stated but is determined by the AQL and inspection level standards.
• Primary Skin Irritation and Skin Sensitization: Sample size not specified.
• Residual Powder Test: Sample size not specified.
• Data Provenance: Not explicitly stated, however, the submitter is based in China, suggesting the testing likely occurred in China or at an approved testing facility. The data is reported as part of a premarket notification (510(k)), representing retrospective data collected for regulatory submission.

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

• Not applicable. The tests performed are objective, laboratory-based tests (e.g., physical measurements, chemical analysis, biocompatibility assays) that do not require human expert interpretation to establish ground truth in the way medical imaging or clinical diagnoses would. The "ground truth" is established by the results of the standardized tests themselves against predefined criteria.

4. Adjudication method for the test set

• Not applicable. As noted above, the tests are objective and do not involve human interpretation that would necessitate adjudication. The results are compared directly to the specified ASTM standards and thresholds.

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 medical device (examination glove) and not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not relevant.

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

• Not applicable. This is a medical device (examination glove) and not an algorithm or AI system.

7. The type of ground truth used

• Objective measurements against established standards: The ground truth for this device is based on objective laboratory measurements and tests conforming to recognized industry standards (ASTM D-6319-00a1, ASTM D-5250, ASTM D-5151-99, ASTM D-6124-01) and regulatory requirements (FDA 1000 ml. Water Fill Test, biocompatibility guidelines for primary skin irritation and sensitization). The "ground truth" is whether the physical, chemical, and biological properties of the gloves meet these predefined quantitative criteria.

8. The sample size for the training set

• Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set."

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

• Not applicable. There is no training set for this device.

Ask a specific question about this device

A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00€4.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Grand Work Plastics Products Co., Ltd. Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document specifies the following for the non-clinical tests:

• ASTM D5250-00€4 (Physical and Dimensions Testing): Inspection Level S-2, AQL 4.0. The exact sample size is not explicitly stated but is implicitly defined by the AQL (Acceptable Quality Level) and inspection level, which are statistical sampling plans.
• FDA 1000 ml. Water Fill Test based on ASTM D-5151-99: AQL 2.5, Inspection Level I. Again, the exact sample size is not explicitly stated but is defined by the AQL and inspection level.
• Primary Skin Irritation and Skin Sensitization Testing: The sample size for these biocompatibility tests is not provided in the document.
• Residual Powder Test: The sample size for this test is not provided.

Data Provenance: The tests were conducted by Grand Work Plastics Products Co., Ltd. in China. The data's provenance is therefore retrospective (tests conducted on manufactured products) and originates from China.

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

This information is not applicable as the device is a physical medical glove, and the "ground truth" for its performance is established through objective, standardized physical and chemical tests, not through expert human interpretation of data for diagnostic purposes.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as #3. The tests have predefined pass/fail criteria based on accepted standards.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI devices where human readers interpret medical images or data. The device in question is a physical glove, not an AI-powered diagnostic tool.

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

No, a standalone study (in the context of an algorithm) was not done. This device is not an algorithm or AI product. Its performance is measured through direct laboratory testing.

7. The Type of Ground Truth Used

The ground truth used for this device is based on:

• Objective, Pre-defined Standards and Specifications: Specifically, ASTM D5250-00€4, ASTM D-5151-99, and ASTM D6124-01. These standards define the acceptable physical properties, barrier integrity (pinhole), and powder content.
• Biocompatibility Testing Protocols: Which assess the biological response to the material.

8. The Sample Size for the Training Set

This refers to the sample size of data used to train a machine learning model. Since the device is a physical product and not an AI/ML algorithm, a "training set" in this context is not applicable. The manufacturing process for the gloves would involve quality control and process validation, but this is distinct from an AI training set.

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

As there is no training set for an AI/ML algorithm associated with this device, this question is not applicable.

Ask a specific question about this device

A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirements of ASTM Standard D5250-00e4.

This 510(k) summary describes a patient examination glove and its performance testing. It focuses on demonstrating substantial equivalence to a predicate device rather than a study proving performance against specific acceptance criteria in the context of an AI/software device. Therefore, many of the requested fields are not applicable to this document.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size:
  • Physical and Dimensions Testing: Not explicitly stated, but performed with "Inspection Level S-2, AQL 4.0".
  • Pinhole (Water Fill Test): Not explicitly stated, but performed with "samplings of AQL 2.5, Inspection Level I".
  • Primary Skin Irritation and Skin Sensitization: Not explicitly stated.
  • Residual Powder Test: Not explicitly stated, but performed at "finished inspection".
• Data Provenance: Not specified, but likely from internal manufacturing and testing processes of Grand Work Plastics Products Co., Ltd.

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

Not applicable. This is for a physical medical device (gloves), not an AI/software device where ground truth is established by experts. The performance is measured against physical and chemical standards.

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

Not applicable. No expert adjudication method is described for this type of device testing.

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 for a physical medical device (gloves), not an AI-assisted diagnostic tool.

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

Not applicable. This is for a physical medical device (gloves), there is no algorithm involved.

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

The "ground truth" for this device's performance is established by conformance to established industry standards (ASTM D5250-00E4, ASTM D-5151-99, ASTM D6124-01) and biocompatibility testing (Primary Skin Irritation and Skin Sensitization).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. The "training" for a manufacturing process would be the ongoing quality control and process validation, which is not detailed in terms of sample size for this summary.

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

Not applicable. There is no training set in the context of AI/ML for this device. The manufacturing process implicitly aims to produce gloves that meet the defined standards.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

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

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powdered Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00E4.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Grand Work Plastics Products Co., Ltd. Synthetic (Yellow) Vinyl Patient Examination Gloves—Powdered:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly mentions sample sizes and inspection levels where applicable:

• Physical and Dimensions Testing (ASTM-D-5250-00E4): Inspection Level S-2. AQL 4.0.
• FDA 1000 ml. Water Fill Test (ASTM D-5151-99): Samplings of AQL 2.5, Inspection Level I.

Provenance: The tests were conducted by the manufacturer, Grand Work Plastics Products Co., Ltd., in China, as part of their production and quality control processes to ensure compliance with ASTM standards. The data is retrospective, as it relates to the evaluation of the device against established standards.

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

Not applicable. The ground truth for these tests is established by published, internationally recognized consensus standards (ASTM and FDA test methods), not by individual expert interpretation of complex clinical cases or images. The "experts" would be the technical committees that develop and validate these standards.

4. Adjudication Method for the Test Set

Not applicable. As the tests involve objective measurements against predefined acceptance criteria from standards (e.g., AQL levels for physical properties and water fill tests, quantitative limits for residual powder, and observable skin reactions for biocompatibility), there is no need for a subjective adjudication method like 2+1 or 3+1. The results are compared directly to the specified benchmarks.

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 used for diagnostic or screening devices where the performance involves human interpretation of results, often with AI assistance. For patient examination gloves, the performance evaluation is based on objective physical, chemical, and biological tests, not reader-dependent assessments.

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

Yes, in a way, the entire testing regimen described can be considered "standalone" as it evaluates the inherent properties of the gloves themselves without human interaction during the functional assessment. The tests are designed to measure the intrinsic characteristics and performance of the glove material and construction. There is no "algorithm" in the context of AI, but the manufacturing and testing processes are designed to produce a standalone product meeting specifications.

7. The Type of Ground Truth Used

The ground truth used is primarily based on:

• Consensus Standards: Specifically, ASTM Standard D5250-00E4 for physical properties and dimensions, ASTM D-5151-99 for water leak testing, and ASTM D6124-01 for residual powder content.
• Regulatory Requirements: FDA requirements for pinhole integrity and general biocompatibility.
• Observation/Measurement: Direct observation for skin irritation and sensitization.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product (patient examination gloves), not a machine learning or AI algorithm that requires a training set of data.

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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