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

Nitrile Examination Gloves, Dual Color Black-Blue are Class I Patient Examination Gloves. The glove is made dual color by double dipping. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19. The gloves are single use, disposable, and provided non-sterile.

This document describes the non-clinical performance data for the "Nitrile Examination Gloves, Dual Color Black-Blue" (K232550) and compares it to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each specific test in the "Summary of Non-Clinical Performance Data" section. It refers to various ASTM and ISO standards, which typically specify sample sizes for their respective test methodologies. The data provenance is not specified, but it can be inferred that these are laboratory tests performed on samples of the device.

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

Not applicable. These are laboratory-based performance tests for a medical device (examination gloves), not studies requiring expert interpretation of medical images or patient data. The "ground truth" is established by the standardized test methodologies themselves.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring human adjudication. The results are based on objective measurements and observations according to standardized test protocols.

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 imaging devices where human readers interpret medical cases. This document pertains to the performance of examination gloves.

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

Not applicable. This document is for a physical medical device (examination gloves), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance criteria is established by the specifications defined within the referenced ASTM and ISO standards (e.g., minimum length, maximum powder residue, specified AQL for water leak test, biological response classifications).

8. The Sample Size for the Training Set

Not applicable. This document pertains to the performance of a physical medical device (examination gloves) through non-clinical testing, not a machine learning or AI model that requires a training set.

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

Not applicable (as explained in point 8).

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The 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 subject device is a patient examination glove made from nitrile latex compound, powder free and non-sterile (Per 21 CFR 880.6250, class I). They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves.

The provided text is a 510(k) Summary for a medical device: "Powder Free Nitrile Examination Gloves (Black)". This document doesn't describe the kind of acceptance criteria or study that would have the information requested in your prompt (e.g., sample size for training sets, expert qualifications, MRMC studies, effect sizes). The submission is for a Class I general hospital and personal use device, which typically requires a demonstration of substantial equivalence to a predicate device rather than extensive clinical efficacy studies.

Instead, the document focuses on showing that the new device meets established ASTM and ISO standards for examination gloves and is substantially equivalent to another legally marketed glove.

Here's the information that can be extracted relevant to acceptance criteria and performance, as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information (Not applicable or not provided in the document for this type of device and submission):

2. Sample size used for the test set and the data provenance: Not explicitly stated for each test. The tests refer to established standards (e.g., ASTM, ISO), which would define sample sizes within their methodologies. Data provenance is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is defined by compliance with established physical and biocompatibility standards, not expert consensus on diagnostic imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a study requiring human adjudication of results.
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/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/imaging device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth is established by existing, widely recognized industry standards and test methods (ASTM and ISO standards) for physical properties and biocompatibility of examination gloves.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.

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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)

Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.

The provided text describes the acceptance criteria and performance of Powder Free Nitrile Examination Gloves, specifically focusing on their resistance to chemotherapy drugs and Fentanyl Citrate. It does not describe an AI/ML-based medical device. Therefore, many of the requested details about AI/ML specific studies (MRMC, standalone algorithm, training/test set ground truth establishment, expert qualifications, etc.) are not applicable to this document.

However, I can extract information related to the acceptance criteria and "studies" (non-clinical performance tests) conducted for this glove device.

Here's the relevant information based on the provided text:

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

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

• The document refers to "Non-clinical tests" and lists various ASTM and ISO standards used. It does not specify the exact sample sizes used for each test beyond the requirements of these standards (e.g., AQL 2.5 for water leak test implies a specific sampling plan).
• Data Provenance: The document does not explicitly state the country of origin of the data for these non-clinical tests. It refers to Shanxi Hongjin Plastic Technology Co., Ltd. in China, which suggests the tests were likely performed in relation to their manufacturing and quality control processes. The tests are retrospective (i.e., performed on manufactured gloves to confirm compliance).

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

• This is not applicable as this is a physical device (gloves) and the "ground truth" is established by adherence to physical and chemical testing standards (e.g., measuring dimensions, tensile strength, breakthrough detection time for chemicals per ASTM/ISO standards). These are objective measurements, not subjective expert interpretations of images or other data.

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

• Not applicable for physical/chemical testing. The tests have defined methodologies and acceptance 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:

• Not applicable as 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 as this is not an AI/ML device.

7. The type of ground truth used:

• The "ground truth" for these tests is the objective measurement against established physical/chemical standards (e.g., actual dimensions, measured tensile strength, breakthrough time as defined by ASTM D6978-05). It's based on scientific and engineering measurements, not expert consensus, pathology, or outcomes data in a medical context.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device. There is no concept of a "training set" for physical product testing.

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

• Not applicable as this is not an AI/ML device.

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Powder Free Nitrile Examination Gloves, Orange is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Nitrile Examination Gloves, Orange are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of nitrile latex and are powder free. They are ambidextrous. The physical and performance characteristics of the devices meet all requirements of ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

This document is a 510(k) summary for the Powder Free Nitrile Examination Gloves, Orange, and it describes a non-clinical study to demonstrate substantial equivalence to a predicate device, not a study to prove the device meets acceptance criteria for a new medical device technology. Therefore, many of the requested elements for a study proving device performance (e.g., sample size for test set, ground truth, MRMC study, training set information) are not applicable or not provided in the context of this regulatory submission.

However, I can extract the acceptance criteria and reported performance for the non-clinical tests conducted to support the device's substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Tests):

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

• Test Set Sample Size: The document does not specify the exact sample sizes (number of gloves or tests) for each non-clinical test conducted. It only reports the ranges of performance achieved.
• Data Provenance: The data is from non-clinical tests performed by Shanxi Hongjin Plastic Technology Co., Ltd. for their device Powder Free Nitrile Examination Gloves, Orange. The type of data is laboratory test results. No country of origin for the data is explicitly stated beyond the manufacturing company's location in China. The tests are prospective in the sense that they were conducted for this specific device to meet regulatory requirements.

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):

• Not applicable. These are non-clinical material and performance tests, not clinical studies requiring expert ground truth for interpretation of medical data. The "ground truth" is defined by the technical specifications and standards (e.g., ASTM, ISO).

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

• Not applicable. This is not a clinical study involving human readers or adjudicators for diagnosis. The tests are objective measurements against defined 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:

• Not applicable. This is not an AI-assisted device, nor a comparative effectiveness study involving human readers.

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 (expert consensus, pathology, outcomes data, etc):

• The "ground truth" for these tests is based on established industry standards (ASTM D6319-19, ASTM D412-16, ASTM D5151-19, ASTM D6124-06(2017)) and international biocompatibility standards (ISO 10993-10:2010, ISO 10993-5:2009, ISO 10993-11:2017). These standards specify the test methods and the acceptable ranges for the physical, chemical, and biological properties of examination gloves.

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Not applicable. As above, this does not involve a training set for an algorithm.

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Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978 and will be labeled with a statement of compliance and a summary of the testing results.

Powder Free Nitrile Examination Gloves(Blue), Tested for Use with Chemotherapy Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes-Extra Small, Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).

The provided document describes the acceptance criteria and performance data for "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs." This is a Class I medical device, and the testing focuses on its physical properties, biocompatibility, and resistance to chemotherapy drug permeation. It is crucial to note that this document pertains to a physical medical device (gloves) and not an AI/Software as a Medical Device (SaMD). Therefore, questions related to AI/SaMD specific aspects like expert data labeling, MRMC studies, training set data, etc., are not applicable to this submission. The information provided aligns with typical performance testing for physical devices.

Here's the breakdown of the acceptance criteria and reported performance, tailored to the available information:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and the Reported Device Performance

Regarding the AI/SaMD specific questions, the following points are not applicable as this document describes performance testing for a physical medical glove.

2. Sample sized 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 (e.g., how many gloves were tested for tensile strength, or how many samples for biocompatibility). Standard test methods (ASTM, ISO) typically define minimum sample sizes. The data provenance is implied to be from testing labs in relation to the manufacturer (Shanxi Hongjin Plastic Technology Co., Ltd. in China) and their US representative. This is a prospective testing of the manufactured product.

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)

• Not applicable. Ground truth for physical device performance is established by standardized laboratory testing methods (ASTM, ISO) rather than expert human interpretation.

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

• Not applicable. Adjudication methods are typically relevant for human-in-the-loop assessments or expert consensus in image interpretation, not for physical material 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 not an AI/SaMD.

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

• Not applicable. This is not an AI/SaMD. The "standalone" performance here refers to the physical properties of the glove itself.

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

• The 'ground truth' for this device is based on objective measurements derived from standardized testing protocols (ASTM and ISO standards) measuring physical properties (like length, thickness, tensile strength, freedom from holes, powder content) and chemical resistance (breakthrough time for chemotherapy drugs), as well as biological responses (irritation, sensitization, cytotoxicity, systemic toxicity).

8. The sample size for the training set

• Not applicable. This is not an AI/SaMD, so 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 physical device testing, there is no ground truth establishment method for it.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical performance tests conducted in accordance with recognized international (ISO) and national (ASTM) standards. These tests assess the physical, chemical, and biological properties of the nitrile examination gloves.

The "Non-Clinical Performance Data" section (Page 9 of the document) explicitly lists the test methods used, their purpose, the acceptance criteria, and the results, confirming that the proposed device complies with these standards. For example, ASTM D6319-19 was used for dimensions and tensile properties, ASTM D5151-19 for freedom from holes, ASTM D6124-06 for powder content, and ASTM D6978-05 (Reapproved 2019) for chemotherapy drug permeation. Biocompatibility was assessed using ISO 10993 series standards (Parts 5, 10, and 11) for cytotoxicity, irritation, sensitization, and systemic toxicity.

The conclusion states, "The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device." This indicates that the results met the established benchmarks (which are often derived from the requirements of the standards themselves or comparison to a predicate device).

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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.

Powder Free Vinyl Patient Examination Gloves are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2015) Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application.

This document is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves," a Class I medical device. The information provided pertains to the substantial equivalence of the subject device to a predicate device, focusing on non-clinical performance characteristics to demonstrate safety and effectiveness.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The acceptance criteria are generally established by the ASTM D 5250-06 (Reapproved 2015) Standard Specification for Poly(Vinyl Chloride) Gloves For Medical Application. The predicate device and the subject device both aim to meet these requirements.

2. Sample sized 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 numerical sample sizes for each test. Instead, it refers to "Inspection Level and AQL" (Acceptable Quality Level) from the ASTM standards for some tests (e.g., S-2, AQL 4.0 for dimensions and tensile strength; G-I, AQL 2.5 for pinhole). These AQLs imply a sampling plan rather than a fixed sample size.

• Pinhole: Inspection Level G-I, AQL 2.5.
• Dimensions, Tensile Strength, Ultimate Elongation: Inspection Level S-2, AQL 4.0.
• Residual Powder: N=5 (5 gloves were tested).
• Biocompatibility Tests (Primary Skin Irritation, Dermal Sensitization, Cytotoxicity Test): No sample sizes are specified for these in the table; the results are qualitative ("not an irritant," "not a cytotoxic potential").

The data provenance is from Shanxi Hongjin Plastic Technology Co., Ltd in China, as indicated by their address on the document. The studies are non-clinical lab tests conducted to support the 510(k) submission, implying a prospective data generation process for the purpose of regulatory approval.

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 section is not applicable as the device is a medical glove, and the "ground truth" is based on objective physical, chemical, and biological performance characteristics measured by laboratory tests and adherence to industry standards (ASTM D5250-06), not expert medical interpretation of images or clinical outcomes.

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 typically used in studies involving subjective human interpretation (e.g., radiologists reading medical images) to establish consensus ground truth. The tests for these gloves are objective 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

This is not applicable. This type of study relates to AI-assisted diagnostic devices and human reader performance, not physical medical devices like examination gloves.

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

This is not applicable. This concept applies to AI/software as a medical device, where the algorithm performs a task independently. The tests performed here are direct measurements of a physical product's attributes.

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

The "ground truth" for this device's performance is established by objective measurements against pre-defined specifications and compliance with recognized industry standards, specifically ASTM D 5250-06 (Reapproved 2015). For biocompatibility, it's based on standard biological evaluation tests determining if the material is an irritant or cytotoxic.

8. The sample size for the training set

This is not applicable. The concept of a "training set" refers to data used to train machine learning models. This document describes the testing and performance of a physical product according to established standards, not an AI/ML device.

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

This is not applicable for the same reasons as point 8.

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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.

Powder Free Vinyl Patient Examination Gloves (Yellow, White) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2015) Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application.

This document is a 510(k) Pre-Market Notification for Powder Free Vinyl Patient Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria through clinical studies in the typical sense of AI/software devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" here refer to compliance with recognized standards and performance thresholds for examination gloves.

Here's a breakdown of the requested information based on the provided text, interpreted in the context of a medical glove submission:

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)

• Sample Size for Test Set: The sample sizes are indicated by the "Inspection Level and AQL" (Acceptable Quality Limit) for most physical and performance tests, such as S-2, AQL4.0, and G-I, AQL2.5. For Residual Powder, the sample size was N=5. These AQL levels refer to sampling plans (e.g., ISO 2859-1 or ANSI/ASQ Z1.4), where a specific number of units are inspected from a lot, and the lot is accepted or rejected based on the number of defects found. The exact number of units tested isn't explicitly stated but would be determined by the AQL tables for the lot size.
• Data Provenance: The manufacturing entity is Shanxi Hongjin Plastic Technology Co., LTD, located in China. The testing would have been conducted by or on behalf of this company. The data is prospective in the sense that it's generated for the purpose of demonstrating compliance for this submission.

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 product is a medical device (patient examination gloves) tested against recognized physical, chemical, and biological standards. "Ground truth" in this context is established by the accepted scientific methodologies and criteria outlined in the ASTM and ISO standards, rather than expert human interpretation in the way it applies to diagnostic AI. Therefore, there are no "experts" in the sense of clinicians establishing ground truth for individual cases. The ground truth is the objective measurement against the specified standard requirements.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in medical image reading). For device performance testing against quantitative standards, the measurements are objective.

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 device is a physical product (medical glove), not an AI or software algorithm. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for the performance tests in this submission is the objective measurement against scientifically established and recognized standards (e.g., ASTM D5250-06 for physical properties, specific thresholds for residual powder, and standard biocompatibility tests for irritation and sensitization). It is not pathology, outcomes data, or expert consensus on a diagnostic interpretation.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, so there is no training set in that context. Statistical sampling is used for quality control during manufacturing and for conformity testing.

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

Not applicable. As there is no training set for a machine learning model, this question is not relevant.

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