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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.

The subject device is disposable medical PVC gloves that made from PVC compound, Clear (non-colored), powder free and nonsterile. The device meets the specifications in ASTM D5250-06(Reapproved 2015) Standard specification for poly (vinyl chloride) gloves for medical application.

This document is a 510(k) Premarket Notification summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". It describes the device, its intended use, and the studies conducted to demonstrate substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes for each non-clinical test (e.g., number of gloves tested for dimensions, physical properties, pinholes). However, the tests are based on recognized standards (ASTM, ISO), which typically specify sample sizes or sampling plans (e.g., AQL levels).

• Data Provenance: The studies are non-clinical (laboratory/bench testing, and animal studies for biocompatibility). The document does not specify the country of origin of the test data but implies it was conducted by or for the manufacturer. All tests are retrospective, meaning they were performed on already manufactured product or materials to demonstrate compliance with standards.

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

This is not applicable to this type of device and study. The "ground truth" for non-clinical performance and biocompatibility relies on objective measurements according to standardized test methods, not expert consensus or clinical interpretation.

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

Not applicable. This is not a study involving human subjective assessment where adjudication would be necessary. The results are objective measurements from laboratory tests.

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 medical glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI assistance are irrelevant.

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

Not applicable. This device is a medical glove and does not involve an algorithm.

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

The "ground truth" for the performance of these gloves is defined by the acceptance criteria specified in internationally recognized standards (ASTM and ISO). These standards establish objective parameters and methods for evaluating physical properties (dimensions, tensile strength, elongation), integrity (pinholes), material properties (powder residual), and biological safety (biocompatibility).

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning algorithm, so there is no concept of a "training set."

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

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

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Powder Free Vinyl Patient Examination Gloves 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 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 D5250-19 Standard Specification for Poly (Vinyl Chloride) Gloves for Medical Application.

The provided document describes the acceptance criteria and performance data for Powder Free Vinyl Patient Examination Gloves (K211177). This is a medical device, and the data provided relates to its physical performance and biocompatibility, not an AI/ML-based diagnostic or imaging device. Therefore, many of the requested fields (such as sample size for test/training sets, data provenance, number of experts, adjudication method, MRMC studies, standalone algorithm performance, and ground truth types related to AI/ML) are not applicable (N/A) for this type of medical device submission.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and 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 Pinhole Test: 125 gloves were sampled.
• Other Physical and Biocompatibility Tests: Sample sizes are not explicitly stated for all tests but are implied by the standards referenced (e.g., "N=5" for residual powder).
• Data Provenance: The manufacturer is Shijiazhuang Hongjun Plastic Manufacture Co., Ltd. located in Shijiazhuang City, Hebei Province, China. The testing was conducted to meet international and US standards (ASTM, ISO, CFR). Specific country of origin for data collection for these non-clinical tests is not detailed beyond the manufacturer's location, but the tests generally follow standardized laboratory protocols rather than clinical data collection. This would be considered prospective testing against established specifications, not retrospective clinical data.

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

• N/A. This is not relevant for the type of device and testing performed. The "ground truth" for these tests is defined by the objective physical and chemical properties measured against recognized industry standards (ASTM, ISO). No expert clinical assessment of "ground truth" is involved.

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

• N/A. Adjudication methods are typically for subjective assessments or discrepancy resolution in clinical studies or expert evaluations, which is not applicable here. The tests are objective measurements based on specified standard methods.

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

• N/A. This is a physical non-diagnostic product (gloves). MRMC studies are for evaluating diagnostic tools involving human interpretation, often in conjunction with AI.

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

• N/A. This device does not have an algorithm or AI component.

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

• The "ground truth" is defined by established engineering and material science standards and specifications (e.g., ASTM D5250-19, ISO 10993-10, ISO 10993-5, ASTM D6124-06, ASTM D5151-19). These standards provide objective, measurable criteria for acceptable performance and biocompatibility.

8. The sample size for the training set

• N/A. This is a physical non-diagnostic product. There is no "training set" in the context of AI/ML.

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

• N/A. This is a physical non-diagnostic product. No AI/ML training set or associated ground truth establishment method is applicable.

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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.

Poly Vinyl Chloride (PVC) films form a barrier to prevent contamination between patient and examiner. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.

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 presenting a study proving a novel device meets specific acceptance criteria in a clinical setting.

Therefore, many of the requested sections are not applicable in this context. However, I can extract information related to the device's technical specifications and the non-clinical tests performed to ensure it meets established safety and performance standards for gloves.

Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally defined by compliance with established ASTM and ISO standards for medical examination gloves. The reported device performance is presented as meeting these standards.

2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual non-clinical test (e.g., how many gloves were tested for pinholes, or how many rabbits for skin irritation). The data provenance is implied to be from the manufacturer (Shandong Shangwei Medical Products Co.,Ltd in China) through in-house testing or contracted labs, as these are non-clinical tests used for product compliance. The data is retrospective in the sense that these tests are performed on manufactured product samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The "ground truth" for these tests are objective measurements against established international and national standards (ASTM, ISO, CFR). There isn't a subjective "expert ground truth" for attributes like glove dimensions or tensile strength.

4. Adjudication method for the test set
Not applicable, as the tests involve objective measurements against predefined standards, not expert adjudication of subjective assessments.

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-powered diagnostic device. It is a medical examination glove.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of the gloves is based on objective measurements performed according to validated test methods defined in recognized international and national standards (e.g., ASTM D5250 for dimensions and physical properties, ASTM D5151 for pinholes, ASTM D6124 for powder residual, ISO 10993 for biocompatibility).

8. The sample size for the training set
Not applicable. This is a manufactured product, not an AI model requiring a training set.

9. How the ground truth for the training set was established
Not applicable.

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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.

Poly Vinyl Chloride (PVC) films form a barrier to prevent contamination between patient and examiner. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.

This document pertains to the 510(k) premarket notification for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored). The information provided heavily focuses on proving substantial equivalence to a predicate device through non-clinical performance data, primarily compliance with established ASTM and ISO standards for medical gloves.

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

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: The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for dimensions, pinholes, tensile strength). It refers to compliance with standards like ASTM D5250. These standards typically define the sampling plans.
• Data Provenance: The tests were conducted by the manufacturer, Shandong Jieshi Medical Products Co.,Ltd, located in China. The data would be considered prospective, as it was generated to support the 510(k) submission for this specific device.

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 document concerns medical device performance testing, not diagnostic AI. Therefore, the concept of "experts establishing ground truth" in the context of clinical interpretation (like radiologists for imaging) is not applicable here. The "ground truth" for these tests is defined by established regulatory standards (ASTM, ISO) and the laboratory methods prescribed within them. The "experts" would be the qualified laboratory personnel performing these physical and chemical tests. Their specific qualification details are not provided in this regulatory summary but are presumed to be in compliance with good laboratory practices.

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

Not applicable. This is not a study involving human interpretation or subjective judgment that would require an adjudication process. The tests are objective measurements against defined physical and chemical 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. This document is for a physical medical device (examination gloves), not an AI diagnostic algorithm. Clinical testing was explicitly stated as "not needed for this device."

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.

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

The "ground truth" here is defined by established consensus standards from organizations like ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization). These standards specify physical properties, test methods, and acceptable limits for medical gloves. This includes:

• ASTM D5250 (Standard specification for poly (vinyl chloride) gloves for medical application)
• ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
• ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
• ISO 10993-5 (Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity)
• ISO 10993-10 (Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization)

8. The sample size for the training set

Not applicable. This is for a physical medical device, not an AI/machine learning model. There is no concept of a "training set" for this type of submission. The manufacturing process itself (Good Manufacturing Practices) would ensure consistent product quality, but there's no data training aspect.

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

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

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The Powder Free Vinyl Patient Examination Glove is a disposable device 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 vinyl patient examination gloves. The subject device is colorless. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.

This document describes the premarket notification for the "Powder Free Vinyl Patient Examination Glove" (K210799). It is a Class I device and the submission focuses on demonstrating substantial equivalence to a predicate device (K163168).

Here's an analysis of the acceptance criteria and study data:

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

The acceptance criteria are implicitly defined by compliance with specific ASTM and ISO standards, and by showing equivalence to the predicate device, particularly regarding physical properties and biocompatibility.

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

The document does not specify the exact sample sizes used for each test (e.g., number of gloves tested for tensile strength, pinholes, etc.). It only references compliance with the standards, which typically define sampling plans. The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). However, given the manufacturer's location in China, it is highly probable that the testing was conducted in China.

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

This information is not applicable. The device is a medical glove, and its performance is evaluated against engineering and biological standards, not through expert human interpretation of medical data (like radiology images).

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in expert-dependent diagnostic studies, not for the physical and biological testing of medical devices like 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic tools, not for medical gloves. The device is not an AI-assisted tool.

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

A standalone performance study was not applicable/conducted in the context of an algorithm or AI. The performance studies conducted were on the physical and biological properties of the glove itself.

7. The type of ground truth used

The "ground truth" for this device's performance is established by compliance with recognized industry standards and regulatory requirements. This includes:

• Engineering Standards: ASTM D5250 (Standard Specification for Poly (vinyl chloride) Gloves for Medical Application), ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves), ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves).
• Biocompatibility Standards: ISO 10993-10 (Tests For Irritation And Skin Sensitization), ISO 10993-5 (Tests For In Vitro Cytotoxicity).
• Predicate Device Equivalence: Demonstrating that the subject device performs similarly or better than a legally marketed predicate device (K163168) in key functional and safety attributes.

8. The sample size for the training set

This information is not applicable. The device is a physical product (medical glove), not an AI algorithm requiring a training set.

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

This information is not applicable. As explained above, there is no AI algorithm or training set for this device.

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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.

The proposed device is Powder Free Examination Gloves. The proposed device is Clear (non-colored). The proposed device is non-sterile.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what's available and noting what's not:

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, but quantities like "Checked on 5pcs sub-samples (N=5)" are mentioned for "Residual Powder." "Inspection Level I AQL2.5" is an AQL (Acceptance Quality Limit) sampling plan, implying a specific sample size based on the lot size, but the exact number of units tested is not provided.
• Data Provenance: The studies were non-clinical tests performed by Anhui Powerguard Technology Co.,Ltd, likely in China (country of origin of the manufacturer). The studies are retrospective in the sense that they were conducted specifically for this 510(k) submission, not ongoing clinical trials.

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 device is a medical glove undergoing non-clinical performance testing. The "ground truth" is established by adherence to recognized international standards (e.g., ASTM, ISO). Therefore, "experts" in the context of clinical interpretation or diagnosis are not relevant here. The "experts" would be the scientists and engineers conducting the tests according to the standard protocols. Their qualifications are not detailed.

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

• Not applicable. This is not a study involving human interpretation or adjudication of results in the way described (e.g., radiologists reviewing images). Performance is measured against physical and chemical 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 study was not done. This device is a medical glove, not an AI or diagnostic imaging device.

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

• Not applicable. This is not an algorithmic device.

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

• The "ground truth" for the device's performance is defined by the acceptance criteria of recognized international standards (ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-5, ISO 10993-10). These standards specify the test methods and the acceptable range of performance for each characteristic (e.g., tensile strength, elongation, freedom from pinholes).

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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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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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Powder free vinyl patient examination glove, colored (yellow) is a non-sterile, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder free vinyl patient examination glove, colored (yellow) are patient examination gloves available in S, M, L, XL. They are provided non-sterile and meet the entire requirement of ASTM standard D5250-06(reapproved), except for sterility requirements.

This document describes the 510(k) premarket notification for the "Powder free vinyl patient examination glove, colored (yellow)" (K160675). The submission aims to demonstrate substantial equivalence to a predicate device, the "White vinyl patient examination glove" (K143277) from Life safety products (Hui Zhou) Co., Ltd.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" for the subject device are generally presented as meeting relevant ASTM and ISO standards, with specific values reported for the subject device's performance which are then compared to the predicate device's reported performance.

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

The document does not explicitly state a test set from a clinical study for the device, as this is a device clearance based on substantial equivalence to a predicate, heavily relying on non-clinical performance data and conformity to recognized standards.

• For Freedom from pinholes, the subject device reported 0/200, implying a sample size of 200 gloves tested for pinholes. The predicate device reported 10/500, implying a sample size of 500 gloves.
• For Powder residual, the measurement is "0.5mg per glove," which would typically be an average or maximum over a sampled number of gloves, but the specific sample size for this test is not provided.
• Biocompatibility testing (Cytotoxicity, Sensitization, Irritation) involved testing samples of the subject device. The specific number of samples tested for these biocompatibility evaluations is not mentioned in the provided text.

Data Provenance: The document does not specify the country of origin for the testing data, but the manufacturer is based in China. The data would be retrospective relative to the 510(k) submission, as it represents tests already conducted to support the filing.

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

This information is not applicable as the device is a medical glove, and the evaluation relies on objective physical and chemical testing against established standards, not on expert interpretation of results like in diagnostic imaging. Ground truth for these types of devices is based on laboratory measurements and adherence to specified performance metrics.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the evaluation is based on objective laboratory testing against performance standards, which does not involve subjective adjudication or consensus methods typically seen in clinical studies with human readers.

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

No MRMC study was done. This device is a patient examination glove, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is irrelevant and not part of the submission for this type of device.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This is a physical medical device (glove), not an algorithm or software. Therefore, a standalone performance study in the context of AI algorithms is not relevant.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Standardized laboratory measurements: Adherence to physical properties (length, width, thickness, tensile strength, elongation), freedom from pinholes, and powder residual, as defined by ASTM standards (D5250-06, D5151-06, D6124-06).
• Biocompatibility testing results: Based on ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization and Irritation), assessing the biological response of the device material.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI development.

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

Not applicable. As there is no training set for an AI model, the concept of establishing ground truth for it does not apply here.

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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.

Powder Free Vinyl Patient Examination Glove (Non-Sterile) is a patient examination glove available in S, M, L, XL. The glove is provided non-sterile and meets the entire requirement of ASTM standard D 5250-06.

The provided text is a 510(k) premarket notification for a medical device: "Powder Free Vinyl Patient Examination Glove (Non-Sterile)". The document outlines the device description, intended use, and a comparison to a predicate device.

However, the information requested in the prompt, specifically regarding acceptance criteria and the study that proves the device meets the acceptance criteria, is presented in a different context than typically found in AI/ML performance studies. This document pertains to the regulatory clearance of a physical medical device (examination gloves), not an algorithmic or AI-powered one.

Therefore, many of the requested fields are not applicable in this context. I will extract the relevant information regarding performance criteria and how the device meets them from the provided text.

Here's the breakdown of the acceptance criteria and the supporting information:

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

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

• Sample Size for Test Set:
  • For "Freedom from pinholes," the sample size is explicitly stated as 32.
  • For other physical and material properties (dimension, tensile strength, elongation, powder residual), the sample sizes are not specified in the provided text, but it's implied that testing was conducted according to the respective ASTM standards.
  • For biocompatibility tests, the sample sizes for animal tests (rabbits, guinea pigs) are not specified.
• Data Provenance: The testing was conducted by or for LPL (HUI ZHOU) GLOVE CO., LTD in China, as stated by their address in the submitter information. The text does not specify whether the data is retrospective or prospective, but testing for regulatory submission typically involves prospective testing of manufacturing lots.

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

This question is not applicable to the evaluation of a physical medical device like examination gloves. "Ground truth" and "experts" in this context don't align with the AI/ML paradigm. The acceptance criteria are based on established international standards (ASTM, ISO) for physical and material properties and biological safety. Compliance is measured quantitatively.

4. Adjudication method for the test set

Not applicable. The evaluation is against objective, quantitative standards (e.g., specific dimensions, tensile strength values, AQL levels). There's no human "adjudication" in the sense of reconciling differing expert opinions.

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, not an AI or imaging diagnostic tool that would involve human readers.

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

The "ground truth" for this device's performance is defined by:

• International Standards: Specifically, ASTM D5250-06 (Standard Specification for Vinyl Patient Examination Gloves for Medical Application), ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves), and ASTM 5151-06 (likely D5151, Standard Test Method for Detection of Holes in Medical Gloves).
• Biocompatibility Standards: ISO 10993-5: 2009 (Cytotoxicity), ISO 10993-10: 2010 (Irritation and Skin Sensitization), and the general framework of ISO 10993-1.

These standards provide the quantitative and qualitative benchmarks against which the device's performance is measured.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI 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 this type of device.

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