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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, 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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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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Ask a specific question about this device

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.

PVC films form a barrier to body fluids and bloodborne Pathogens. 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. Poly (vinyl chloride) glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.

The provided document describes the acceptance criteria and the study that proves Daxwell, LLC's Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) meet those criteria, primarily through a comparison to a predicate device and adherence to established ASTM and ISO standards.

Here's a breakdown of the requested information:

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 (e.g., how many gloves were tested for pinholes, dimensions, or physical properties). It refers to adherence to standards like ASTM D5250, ASTM D5151, ASTM D6124, 21 CFR 800.20, and ISO 10993-10, which would inherently include specified sampling plans for testing. However, the exact count of items tested via these standards is not provided.

The data provenance is not explicitly stated in terms of country of origin but is based on non-clinical performance data conducted to support a "substantial equivalence" determination. Given the submitter's address (Houston, TX, USA) and the Beijing agent's address (China), and the product's likely manufacturing location, it's probable the testing was conducted in facilities accustomed to these international standards. The data is retrospective, as it's being submitted for premarket notification.

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

This information is typically not applicable to medical devices like examination gloves. The "ground truth" for these devices is established by adherence to recognized national and international standards (e.g., ASTM, ISO), which specify objective measurement methods and pass/fail criteria. There are no human experts "establishing ground truth" in the way one might for diagnostic imaging interpretation.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the assessment relies on objective measurements against predefined standards. There is no subjective human interpretation requiring adjudication.

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

No. An MRMC comparative effectiveness study is designed for evaluating the performance of diagnostic devices, often involving human readers interpreting medical images or data. This is not relevant for examination gloves, which are physical barrier devices.

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

Yes, in a conceptual sense. The "standalone" performance here refers to the device itself meeting the objective physical, chemical, and biological criteria outlined in the standards, without human interaction influencing the test outcome or interpretation beyond standard lab procedures. The device's performance is assessed purely on its intrinsic properties.

7. The Type of Ground Truth Used

The ground truth used is primarily objective performance standards from recognized bodies:

• ASTM (American Society for Testing and Materials) standards: D5250 (Vinyl Patient Examination Gloves), D5151 (Detection of Holes in Medical Gloves), D6124 (Residual Powder on Medical Gloves).
• 21 CFR 800.20: FDA regulation concerning medical gloves.
• ISO 10993-10: Biological evaluation of medical devices - Tests for irritation and skin sensitization.

The "ground truth" is that if the glove meets the specified numerical/qualitative criteria (e.g., tensile strength ≥11MPa), then it performs as expected for its intended use.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its performance is based on manufacturing processes and adherence to quality control measures, which are then verified through testing.

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

Not applicable, for the same reason as point 8.

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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile 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 Gloves, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
-- How the device functions:
PVC films form a barrier to body fluids and bloodborne Pathogens
-- Scientific concepts that form the basis for the device
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.
-- Physical and performance characteristics such as design, materials and physical properties:
PVC gloves are known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.

The document describes the acceptance criteria and performance of the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" manufactured by Better Plastic Co., Ltd. against regulatory standards and a predicate device.

Table of Acceptance Criteria and Reported Device Performance

Study Details:

The document describes a submission for a 510(k) premarket notification, which is a process to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. The study is a comparison of the subject device's performance against established ASTM standards and the predicate device's characteristics rather than a traditional clinical study with patients.

1. Sample sizes used for the test set and the data provenance:

   • The document does not specify a distinct "test set" in the context of a clinical trial or algorithm evaluation. Instead, the "testing" refers to the manufacturing quality control and performance evaluation of the gloves based on established ASTM standards.
   • The data provenance is from non-clinical testing performed by the manufacturer, Better Plastic Co., Ltd. The country of origin for the manufacturing and testing is China, as indicated by the submitter's address. The data is prospective in the sense that it's generated for the submission of this specific device.

2. 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 this type of device and submission. "Ground truth" in the context of diagnostic AI or image analysis typically refers to definitively confirmed diagnoses by expert clinicians, pathology, or long-term outcomes. For patient examination gloves, the "truth" is whether they meet specified physical, chemical, and biological performance standards (e.g., tensile strength, freedom from pinholes, biocompatibility). These are evaluated through standardized laboratory tests, not by human expert consensus on a diagnostic outcome.

3. Adjudication method for the test set:

   • Not applicable. The "adjudication" for this product involves laboratory testing against defined standards. There is no human observer consensus or adjudication required beyond verifying that the test results meet the specified criteria.

4. 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 (patient examination gloves), not an AI diagnostic imaging tool or a system that involves human "readers" or AI assistance.

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

   • Not applicable. This device is not an algorithm or AI system. Its performance is evaluated through physical and chemical testing.

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

   • The "ground truth" for this device's performance is defined by adherence to established international and national standards for patient examination gloves, specifically:
     • ASTM D5250-06 (Reaffirmation 2011): Standard Specification for Poly(Vinyl Chloride) Gloves for Medical Application.
     • ASTM D5151-06 (Reapproved 2011): Standard Test Method for Detection of Holes in Medical Gloves.
     • ASTM D6124-06 (Reaffirmation 2011): Standard Test Method for Residual Powder on Medical Gloves.
     • 21 CFR 800.20: General requirements for medical devices.
     • ISO 10993-10 Third Edition 2010-08-01: Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization.
   • The testing also focuses on demonstrating substantial equivalence to a legally marketed predicate device (K120968) which presumably met these same standards.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of this device. The manufacturing process is controlled, and samples are taken for quality assurance testing against the standards. This is not an AI/ML product that learns from a training dataset.

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

   • Not applicable, as there is no training set for this type of device. The performance standards are established by consensus national and international bodies (e.g., ASTM, ISO, FDA regulations) for medical devices of this type.

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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile 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 Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011). PVC films form a barrier to body fluids and bloodborne Pathogens. 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. PVC gloves are known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.

This document describes the FDA's decision regarding the substantial equivalence of Dahoon Plastic Company Limited's Powder Free Vinyl Patient Examination Gloves. It details the device, its intended use, and a comparison to a predicate device, focusing on non-clinical performance standards.

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

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

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

The document does not explicitly state the specific sample sizes used for each test (e.g., for width, thickness, tensile strength, pinholes, residual powder, or biocompatibility). Instead, it states that the device "meets requirements per ASTM D5250-06," "per ASTM D6124-06," "per 21 CFR 800.20," and "ISO 10993-10: 2002/Amd. 1:2006(E)." These ASTM and ISO standards define the testing methodologies, including sampling plans (e.g., AQL for pinholes).

The data provenance is not explicitly stated in terms of country of origin for the tests themselves, but the submitting company (Dahoon Plastic Co., Ltd.) is from China. The studies are described as non-clinical performance evaluations, which are typically retrospective in the sense that they are conducted on finished products or samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the "ground truth" for this medical device is based on standardized physical and chemical performance tests as defined by ASTM and ISO standards, rather than expert interpretation of complex data (like medical images). The "experts" in this context would be the technicians and engineers performing and interpreting the results of these standardized tests according to the specified protocols.

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 clinical studies or studies involving human readers/interpreters where there's subjectivity and potential for disagreement. For the specified physical and chemical tests of gloves, the results are quantitative and objective, determined by adherence to standardized test methods rather than expert consensus on subjective findings.

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. MRMC studies, especially those involving AI, are relevant for diagnostic imaging or other interpretation tasks where human readers make subjective judgments. This submission is for patient examination gloves, which are assessed through objective physical and chemical testing.

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

This is not applicable. The device is a physical product (gloves), not an algorithm or software. Its performance is evaluated through direct measurement against established material and performance standards.

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

The "ground truth" for this device's performance is established by international and national consensus standards for medical gloves, specifically:

• ASTM D5250-06 (Reaffirmation 2011): Standard Specification for Poly(Vinyl Chloride) Patient Examination Gloves. This standard specifies dimensions, physical properties (tensile strength, elongation), and freedom from holes.
• ASTM D5151-06 (Reaffirmation 2011): Standard Test Method for Detection of Holes in Medical Gloves. This standard defines the water leak test and Acceptable Quality Limits (AQL) for pinholes.
• ASTM D6124-06 (Reaffirmation 2011): Standard Test Method for Residual Powder on Medical Gloves.
• 21 CFR 800.20: FDA regulation regarding the water leak test for medical gloves.
• ISO 10993-10: 2002/Amd. 1:2006(E): Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.

The "ground truth" is therefore objective, measurable, and defined by these widely accepted technical specifications and test methods.

8. The sample size for the training set

This is not applicable. The device is not an AI algorithm or a diagnostic tool that requires a "training set." It is a manufactured physical product.

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

This is not applicable for the reasons stated above.

Ask a specific question about this device

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile 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 Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
-- How the device functions:
PVC films form a barrier to body fluids and bloodborne Pathogens
-- Scientific concepts that form the basis for the device
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.
-- Physical and performance characteristics such as design, materials and physical properties: PVC gloves are known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.

I am sorry, but the provided text describes a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This product is a medical device, but it is not an AI/ML-powered device for which the requested information about acceptance criteria, study details, expert involvement, and training/test set specifics would typically apply.

The document focuses on demonstrating substantial equivalence to a predicate device based on standard performance tests for gloves (e.g., ASTM D5250, ASTM D5151, ASTM D6124) and biocompatibility (ISO 10993-10). It does not involve any AI/ML components or the kind of study design that would address the detailed questions you've asked.

Therefore, I cannot provide the requested information from the given input.

Ask a specific question about this device

Powder Free Vinyl Patient Examination Gloved) is a non-sterile 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 Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

The provided document is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This type of medical device submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and material characteristics, rather than clinical studies with human subjects or AI-driven performance metrics. Therefore, many of your requested points regarding acceptance criteria, study design, and AI performance are not applicable to this document.

However, I can extract the relevant information regarding the acceptance criteria and the methods used to prove the device meets these criteria.

Acceptance Criteria and Device Performance Study for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

This summary is based on the provided 510(k) submission, K130751. The device in question is a Class I medical device (patient examination glove), and its clearance relied on demonstrating substantial equivalence to a predicate device by meeting established ASTM standards and other regulatory requirements. Clinical studies and AI performance metrics are not applicable to this type of device and submission.

1. Table of Acceptance Criteria and Reported Device Performance

The device meets the requirements of ASTM standard D 5250-06 (Reaffirmation 2011), ASTM D5151-06 (Reapproved 2011), ASTM D6124-06 (Reapproved 2011), 21 CFR 800.20, and ISO 10993-10: 2002/Amd. 1:2006(E).

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

The document does not specify a distinct "test set" sample size in the context of clinical trials or AI validation. Instead, the performance data is generated from testing batches of gloves to ensure compliance with the AQL (Acceptance Quality Limit) for pinholes and other physical property tests as per the mentioned ASTM standards. These tests are internal to the manufacturing process and documented for regulatory submission. The data provenance is from the manufacturer's own testing in China, as the applicant is Cabin Plastic Co., Ltd. from China. The studies are not prospective or retrospective clinical studies but rather product testing and characterization.

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

Not applicable. For this device, ground truth is established by objective measurements against quantitative performance standards (e.g., tensile strength, dimensions, pinhole AQL) as defined by ASTM and ISO standards, and regulatory requirements (e.g., 21 CFR 800.20). No human experts are used to "establish ground truth" in the clinical sense for this type of device.

4. Adjudication Method for the Test Set

Not applicable. Measurements against established technical standards do not typically involve adjudication panels in the way clinical studies or image-based AI studies do.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC study was done. This type of study is not relevant for a patient examination glove. The device's performance is assessed based on its physical and chemical properties, not diagnostic accuracy requiring human reader interpretation with or without AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Not applicable. There is no algorithm or AI component in this device. Performance is inherently "standalone" in the sense of the physical glove performing its intended function (barrier protection) based on its material properties and manufacturing quality.

7. The Type of Ground Truth Used

The ground truth used for demonstrating substantial equivalence is established by objective technical standards and regulatory requirements. This includes:

• ASTM Standard D5250-06 (Reaffirmation 2011): Specification for Vinyl Patient Examination Gloves.
• ASTM Standard D5151-06 (Reapproved 2011): Standard Test Method for Detection of Pinholes in Medical Gloves.
• ASTM Standard D6124-06 (Reapproved 2011): Standard Test Method for Residual Powder on Medical Gloves.
• 21 CFR 800.20: Regulations regarding medical device requirements.
• ISO 10993-10:2002/Amd.1:2006(E): Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (for biocompatibility).

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in the computational sense. The "training" in manufacturing refers to adherence to good manufacturing practices and quality control processes to consistently produce gloves meeting the established standards.

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

Not applicable. See point 8. The manufacturing process is designed to meet the aforementioned ASTM, ISO, and CFR standards, which serve as the "ground truth" for quality and performance.

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