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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, Blue, Pink) 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 2011) Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application.

The provided document is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink)" by Ever Light Plastic Products Company, Ltd. It details the safety and effectiveness information for the 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

The acceptance criteria for the device are largely based on the ASTM D5250-06 (Reapproved 2011) Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application and ISO 10993-10 for biocompatibility.

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

The document does not explicitly state the total sample size for the "test set" in a sense that would be typically used for a machine learning model. Instead, it refers to specific sample sizes for particular physical tests:

• Pinhole Test: 125 gloves sampled (for both subject and predicate device performance comparison, and also for the actual testing results).
• Residual Powder: N=5 gloves.
• Other Physical Property Tests (Tensile Strength, Elongation, Dimensions): The inspection level for these tests is S-2, AQL 4.0. While this specifies the sampling plan, the exact number of units sampled for each lot/test is not explicitly given as a single number but is determined by the AQL (Acceptance Quality Limit) table itself.

Data Provenance: The document explicitly states the manufacturer's location as Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000. This indicates the country of origin of the data is China. The studies described are non-clinical (laboratory testing of physical and chemical properties) and appear to be prospective, performed specifically for this 510(k) submission.

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 to this type of device and submission. This is a medical device for which physical characteristics and biocompatibility are tested against established standards (ASTM, ISO). There are no "experts" establishing a "ground truth" in the way one would for diagnostic imaging or a qualitative assessment. The "ground truth" is the objective measurement of the device's properties against predefined quantitative and qualitative standards.

4. Adjudication Method for the Test Set

This information is not applicable. Since the evaluation is against objective, standardized measurements and criteria (e.g., MPa for tensile strength, % for elongation, AQL for pinholes), there's no need for an adjudication method by experts to resolve disagreements. The results are quantitative measurements or qualitative assessments against a defined standard (e.g., "not an irritant").

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 information is not applicable. The device is an examination glove, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.

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

This information is not applicable. The device is an examination glove, not an algorithm or software. Therefore, standalone algorithm performance is irrelevant.

7. The Type of Ground Truth Used

The ground truth used for this device is based on established consensus standards and objective measurements:

• ASTM D5250-06 (Reapproved 2011) for physical properties (tensile strength, elongation, pinholes, dimensions, residual powder).
• ISO 10993-10 for biocompatibility (primary skin irritation and dermal sensitization).

These standards represent a regulatory and scientific consensus on acceptable performance for medical examination gloves.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/ML device that requires a "training set." The device performance is assessed through direct physical and biocompatibility testing against predefined standards.

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

This information is not applicable for the same reason as above. There is no training set for this type of medical device.

Ask a specific question about this device

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 2011) Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application.

Here's a breakdown of the acceptance criteria and the study information for the "Powder Free Vinyl Patient Examination Gloves," based on the provided document:

This document is a 510(k) premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device. The information provided focuses on demonstrating that the new device performs at least as well as the predicate device and meets established standards. It does not describe an AI/ML device, so certain categories related to AI performance, such as multi-reader multi-case studies, effect size, and stand-alone algorithm performance, are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on established ASTM standards and FDA requirements for patient examination gloves. The reported device performance is indicated as "Meets" for all tested characteristics, signifying compliance with these standards.

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

The document does not explicitly state the sample sizes for each specific test (e.g., tensile strength, pinholes, biocompatibility). However, it implies that the tests were conducted according to the methodology outlined in the cited ASTM and ISO standards, which would specify appropriate sample sizes.

• Data Provenance: The tests were conducted by the manufacturer, Ever Light Plastic Products Co., Ltd., based in Donggao Industrial Zone, Zanhuang, Shijiazhuang, Hebei, China. The data would therefore be prospective data generated from their product testing.

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 submission. The "ground truth" for the performance of these examination gloves is established by objective measurements and standardized test methods (e.g., ASTM, ISO standards) rather than expert consensus on diagnostic interpretations. The tests are physical and chemical property assessments.

4. Adjudication method for the test set

Not applicable. As the tests involve objective physical and chemical property measurements against established standards, there is no need for an adjudication method by experts. The results are quantitative and directly assess compliance with the standard's specifications.

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 as the device is a vinyl patient examination glove, not an AI/ML device requiring human reader interaction or interpretation.

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

This is not applicable as the device is a vinyl patient examination glove, not an AI/ML algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on objective, standardized measurements against internationally recognized specifications and test methods. Specifically:

• ASTM D 5250-06 (Reapproved 2011) Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application: This standard defines the acceptable ranges and methods for testing physical properties like tensile strength, elongation, dimensions, freedom from pinholes, and residual powder.
• ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization: This standard defines the methodology for biocompatibility testing related to skin irritation and sensitization.
• 21 CFR 800.20: This FDA regulation pertains to specific requirements for medical devices, which includes aspects like freedom from holes.
• 21 CFR 807.92: This specifies requirements for the 510(k) summary.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML model that requires a training set. The manufacturing process of examination gloves is based on engineering specifications and quality control, not machine learning.

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

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

Ask a specific question about this device

Ask a specific question about this device

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

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

The provided document is a 510(k) premarket notification for "Synthetic Powder Free (Pink) Vinyl Patient Examination Gloves." This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness through extensive clinical trials. Therefore, much of the information requested, such as multi-reader multi-case studies, effect sizes of AI assistance, and detailed ground truth establishment for large training sets, is not applicable to a device of this type (Class I patient examination gloves).

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for this device are compliance with ASTM standard D-5250-06 and FDA requirements for patient examination gloves.

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

• Test Set Sample Size: The document mentions "samplings of AQL 2.5, inspection level I" for the water fill test and "Inspection level S-2, AQL 4.0" for physical and dimension testing. AQL (Acceptable Quality Limit) specifies the maximum proportion of defective units, and inspection levels relate to the sample size relative to the batch size, but the exact number of gloves sampled for each test is not explicitly stated in the provided document.
• Data Provenance: The tests were performed by Ever Light Plastic Products Co., Ltd. for their glove production. The country of origin of the data is China, where the manufacturer is located. The data is prospective in the sense that it was generated as part of the manufacturing and quality control process for these specific gloves to demonstrate compliance.

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

This information is not applicable in the context of this device. The "ground truth" for glove performance is established by the specified ASTM standards and FDA regulations, and the tests are typically performed by trained technicians in a laboratory setting, not by medical experts establishing a "diagnosis."

4. Adjudication Method for the Test Set:

This information is not applicable. The tests for glove performance involve objective measurements against predefined criteria (e.g., pass/fail for pinholes, quantitative measurement of tensile strength, powder content). There is no "adjudication" necessary in the sense of resolving disagreements among multiple experts.

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 information is not applicable. This is a physical medical device (patient examination glove), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or evaluation of AI assistance is irrelevant.

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

This information is not applicable. This is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance is based on established industry standards (ASTM D-5250-06) and regulatory requirements (FDA's 21 CFR and specific test methods like the 1000 ml Water Fill Test). These standards define the acceptable physical properties, barrier integrity, and biocompatibility of examination gloves.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" in the context of a physical device like an examination glove. These devices are manufactured and tested against established specifications, not "trained" like a machine learning model.

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

This information is not applicable. As there is no training set for a physical device, the establishment of ground truth for such a set is not relevant.

Ask a specific question about this device

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

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

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

Here's a breakdown of the acceptance criteria and study information for the Ever Light Powdered (White) Vinyl Patient Examination Gloves, based on the provided text:

Device: Ever Light Plastic Products Co., Ltd. Powdered (White) Vinyl Patient Examination Gloves

Predicate Device: Shijiazhuang Great Eagle Plastic Products Co., Ltd Powdered (White) Vinyl Patient Examination Gloves (K000166)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. (Specific number of units for the sample not provided, but these are statistical sampling plans.)
• Pinhole / Water Leak Test: Sampling AQL 2.5, inspection level I. (Specific number of units for the sample not provided, but these are statistical sampling plans.)
• Primary Skin Irritation and Skin Sensitization: The document does not specify the sample size for the subjects/animals used in the tests.
• Residual Powder Test: "at finished inspection" (specific sample size not provided).

Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of product testing for a 510(k) submission, these would typically be prospective tests conducted by the manufacturer or contracted labs.

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

This type of information is not applicable to this submission. The tests performed are laboratory and material property tests (e.g., physical dimensions, water-fill, chemical analysis, biocompatibility tests), not clinical studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" is established by direct measurement against defined ASTM or FDA standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations in clinical studies. The tests described are objective, pass/fail or quantitative measurements against a standard.

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 used to evaluate the diagnostic performance of a medical device (especially those involving image interpretation or clinical decision support) with and without AI assistance, typically involving human readers. The device in question is a patient examination glove, for which such a study is irrelevant.

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

N/A. This refers to AI algorithm performance. The device is a physical product (gloves) and does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on established industry standards and regulatory requirements:

• ASTM-D-5250-00E4: For physical and dimensions testing.
• FDA 1000 ml. Water Fill Test: For pinhole detection.
• ASTM D-6124-06: For residual powder content.
• Biocompatibility testing guidelines: For primary skin irritation and sensitization.

Essentially, the "ground truth" is defined by these measurable standards and the outcome of the tests (e.g., whether a glove leaks, whether it irritates skin, whether it meets dimensional specifications).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for physical examination gloves. This concept applies to machine learning algorithms where data is used to train a model.

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

Not applicable. As there is no training set for this device type.

Ask a specific question about this device

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

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powered Vinyl Patient Examination Gloves, 80 L YZ, and meets all requirements of ASTM standard D-5250-00E4.

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Ever Light Plastic Products Co., Ltd. Powdered (Yellow) Vinyl Patient Examination Gloves.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size for Physical and Dimensions Testing: Not explicitly stated as a fixed number, but refers to "samplings" and an "inspection level S-2" with "AQL 4.0". This implies a statistical sampling plan rather than a fixed sample size.
• Sample Size for Pinholes (Water Fill Test): Refers to "samplings of AQL 2.5, inspection level I". This also implies a statistical sampling plan.
• Sample Size for Primary Skin Irritation and Skin Sensitization: Not explicitly stated.
• Sample Size for Residual Powder Test: Not explicitly stated.
• Data Provenance: The studies were conducted by Ever Light Plastic Products Co., Ltd. for their product. It is a prospective evaluation of their manufactured gloves. The country of origin of the data would be China, where the manufacturer is located.

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 to this type of device and study. The "ground truth" for glove performance is established by standardized testing protocols (e.g., ASTM standards, FDA water fill test) and expert judgment is not typically involved in the same way it would be for diagnostic imaging or clinical outcomes studies. The reported performance is based on direct measurements and observations during these tests.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods are typically used in studies involving subjective interpretations (e.g., by multiple readers) to resolve discrepancies. For objective performance measures of medical gloves, such as physical properties, leak tests, or biocompatibility, direct measurements are taken, and no adjudication by multiple experts is required.

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 information is not applicable. This submission is for a medical device (patient examination gloves) that is not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is irrelevant.

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

This information is not applicable. As mentioned above, this is not an AI algorithm. The performance evaluation is of the physical and biological characteristics of the gloves themselves.

7. The type of ground truth used

The "ground truth" for the performance of these gloves is defined by:

• Performance specifications and testing methods outlined in ASTM-D-5250-00E4.
• FDA requirements for pinholes (1000 ml. Water Fill Test).
• Standardized biocompatibility testing for irritation and sensitization.
• Standardized testing method for residual powder (ASTM D-6124-06).

These standards define the acceptable range or threshold for each property, forming the objective "ground truth" for compliance.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of physical medical devices like examination gloves. The manufacturing process of gloves is not an AI model that requires training data. Instead, there are quality control and acceptance sampling processes during manufacturing.

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

This information is not applicable as there is no "training set" for this device.

Ask a specific question about this device

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

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

Here's an analysis of the provided text regarding the acceptance criteria and study for the Ever Light Plastic Products Co., Ltd. Powder Free (White) Vinyl Patient Examination Gloves:

Device: Ever Light Plastic Products Co., Ltd. Powder Free (White) Vinyl Patient Examination Gloves

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The text does not provide a specific number of gloves, but specifies the AQL (Acceptable Quality Level) and inspection level, which are standard statistical sampling methods for quality control. This is likely a retrospective evaluation of manufacturing batches.
• Pinhole Test (Water Fill Test): AQL 2.5, inspection level I. Similar to the above, a specific number isn't given, but the sampling plan is defined. This is likely a retrospective evaluation of manufacturing batches.
• Primary Skin Irritation and Skin Sensitization: The text states these tests were "conducted" but does not specify the sample size of subjects or the exact provenance of the data (e.g., specific country or demographic). It's broadly a prospective test on human or animal subjects to assess biological response.
• Residual Powder Test: The test is "conducted at finished inspection" to ensure compliance. The sample size or specific provenance isn't detailed, but it's part of standard retrospective quality control during manufacturing.

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

• Not applicable. The tests described are primarily objective, quantitative measurements (e.g., physical dimensions, water-fill, chemical analysis, biocompatibility assessments). They do not rely on expert consensus for "ground truth" in the way a diagnostic imaging study would. The data is generated directly from laboratory testing and quality control processes.

4. Adjudication Method for the Test Set:

• Not applicable. As the tests are objective measurements, there is no need for expert adjudication in the traditional sense (e.g., comparing expert reads to an algorithm's output). The results are determined by adherence to pre-defined numerical or qualitative standards (e.g., "no primary skin irritant reactions," "meets requirements," "no more than 2 mg powder per glove").

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

• No. This type of study is typically performed for diagnostic devices (e.g., AI in radiology) where human readers interpret data, and the AI's impact on their performance is evaluated. This device is a patient examination glove, and the tests relate to its physical properties, barrier function, and biological compatibility, not its interpretation performance.

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

• No. This device is a physical product, not an algorithm. Therefore, "standalone algorithm performance" is not relevant. The performance described is the inherent performance of the physical glove itself.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's performance is established by:
  • External Standards: Adherence to established industry standards like ASTM-D-5250-00E4 for physical properties and dimensions, and ASTM D6124-06 for residual powder.
  • Regulatory Requirements: Meeting FDA's 1000 ml. Water Fill Test requirements for barrier integrity and general 21 CFR references for biocompatibility.
  • Direct Laboratory Measurements/Observations: Results from primary skin irritation and sensitization tests (direct observation of biological response).
  • Predicate Device Equivalence: The ultimate "ground truth" for market clearance is demonstrating substantial equivalence to a legally marketed predicate device (K000071) where those benchmarks established its safety and effectiveness.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical product, not an AI or machine learning model that requires a "training set." The testing described relates to product quality control and performance validation, not algorithm development.

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

• Not applicable. As there is no training set for an algorithm, this question is not relevant to the described device and studies.

Ask a specific question about this device

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

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder Free Vinyl Synthetic Examination Gloves with Aloe Vert Creen Color, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.

The provided text describes a 510(k) summary for "Ever Light Plastic Products Co., Ltd. Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color." This document is focused on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a study in the way one would for diagnostic or therapeutic devices.

Therefore, many of the typical acceptance criteria and study details requested (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable in this context. This is a Class I medical device (patient examination glove), which typically requires demonstrating adherence to recognized standards and biocompatibility, not clinical performance studies with specific statistical metrics like sensitivity or specificity.

Here's a breakdown of the information that is available based on your request, highlighting where information is not applicable or not provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size:
  • For ASTM-D-5250-00E4 (Physical & Dimensions): Inspection level S-2, AQL 4.0. (Specific number of gloves not stated, but defined by the inspection level and AQL for lot acceptance).
  • For FDA 1000 ml. Water Fill Test: Sampling AQL 2.5, inspection level I. (Specific number of gloves not stated, but defined by the inspection level and AQL for lot acceptance).
  • For Primary Skin Irritation and Skin Sensitization: Not specified (usually involves a number of human subjects or animal models, but specific count not provided).
  • For Residual Powder Test: Not specified (usually involves a number of gloves from a batch, but specific count not provided).
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective clinical data). Given it's a device manufactured in China (Ever Light Products Co., Ltd. is based in Hebei, China), the testing would likely have been conducted by the manufacturer or a contracted lab to meet international and US standards. The studies described are non-clinical, related to product quality and safety characteristics, not clinical performance in a patient population.

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

• This is not applicable. The ground truth for these types of tests (physical properties, barrier integrity, biocompatibility) is established by the specifications of the ASTM standards and FDA test methods, not by expert consensus on clinical findings. For example, a pinhole is a physical hole, not an interpretation.

4. Adjudication Method for the Test Set

• This is not applicable. Adjudication methods like 2+1 or 3+1 are used for interpreting ambiguous clinical cases, often in diagnostic imaging. The tests described here have objective pass/fail criteria based on measured physical or chemical properties.

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

• No. An MRMC study is relevant for diagnostic devices where human readers interpret data (e.g., medical images). This document describes examination gloves, which do not involve human interpretation in this manner.

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

• No. This question is also not applicable as it pertains to AI/algorithm performance. The device is a physical product (gloves).

7. The Type of Ground Truth Used

• The ground truth used is based on objective standards and test methods:
  • ASTM Standard D-5250-00E4: Defines acceptable physical dimensions and properties.
  • FDA 1000 ml. Water Fill Test: Defines acceptable barrier integrity (absence of pinholes).
  • Primary Skin Irritation and Skin Sensitization testing protocols: Define methods and criteria for evaluating biocompatibility.
  • ASTM D-6124-01: Defines acceptable levels of residual powder.
  • Biocompatibility principles: Informed by scientific understanding of material interaction with the body.

8. The Sample Size for the Training Set

• This is not applicable. The device is not an AI/ML algorithm or diagnostic tool that requires a "training set." The testing described relates to quality control and meeting product standards.

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

• This is not applicable for the reasons stated in point 8.

Ask a specific question about this device

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

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

The provided text describes the regulatory submission for the "Ever Light Plastic Products Co., Ltd. Synthetic (Yellow) Vinyl Patient Examination Gloves-Powder Free." This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive clinical study.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria in the context of, for example, an AI/ML medical device, is largely not applicable to this submission. The device is a patient examination glove, and its evaluation relies on established standards for physical properties and biocompatibility, not on AI-driven performance metrics.

Below, I've addressed the relevant sections based on the available information and indicated where the requested details are not applicable.

Table of Acceptance Criteria and Reported Device Performance

Additional Requested Information:

This section will address the remaining points, noting their applicability to a medical glove submission.

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 Physical & Dimensions testing: "Inspection level S-2, AQL 4.0." (ASTM D-5250-00E4)
     • For Water Fill Test: "samplings of AQL 2.5, inspection level I."
     • For Primary Skin Irritation and Skin Sensitization: Not specified, but implied to be sufficient for a "no primary skin irritant or sensitization reactions" conclusion.
     • For Residual Powder Test: Not specified, but implied to be sufficient to "insure that our gloves meet our 'powder-free' claims."
   • Data Provenance: Not explicitly stated beyond the tests being conducted for the submitter, Ever Light Plastic Products Co., Ltd., which is based in Hebei, China. The tests are assumed to be prospective, carried out on samples from the manufacturing process.

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. For medical gloves, "ground truth" is established by adherence to recognized industrial standards (ASTM) and regulatory requirements (FDA water fill test, biocompatibility). These criteria are objective measurements, not subjective interpretations by medical experts in fields like radiology.

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 subjective interpretations (e.g., image review by radiologists). For the objective tests performed on gloves (e.g., tensile strength, dimensions, pinhole detection, chemical residue), no such adjudication is necessary. The results are quantitative and directly compared against the specified limits in the 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 device is a patient examination glove and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study is irrelevant.

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

   • Not Applicable. This device is a physical medical product (gloves), not an algorithm or AI system.

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

   • The "ground truth" for this device's performance is based on objective measurements against established engineering and safety standards (e.g., ASTM D-5250-00E4 for physical properties, ASTM D-6124-01 for residual powder, FDA's water fill test for barrier integrity, and biocompatibility testing for skin irritation/sensitization). There is no "expert consensus" or "pathology" in the sense of diagnostic interpretation for a glove.

8. The sample size for the training set

   • Not Applicable. This device is a physical product, not a machine learning model; therefore, there is no "training set."

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

   • Not Applicable. As there is no training set for a physical device like a glove, this question is not relevant.

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

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

The document is a 510(k) Pre-market Notification for a medical device: Ever Light Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves-Powdered. It focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating AI performance. Therefore, many of the requested categories related to AI studies, multi-reader multi-case studies, and ground truth for AI training and testing are not applicable.

Here's the information that can be extracted from the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • For ASTM D-5250-00E4 compliance and FDA Water Fill Test, inspection levels, and AQL (Acceptable Quality Level) are mentioned:
     • ASTM testing: Inspection level S-2, AQL 4.0
     • Water Fill Test: AQL 2.5, inspection level I
   • Specific raw sample sizes (number of gloves) are not explicitly stated, but these AQL and inspection levels define the sampling plan used.
   • Data Provenance: The device is manufactured by Ever Light Products Co., Ltd. in Hebei, China. The testing was performed by them or on their behalf. The data is retrospective in the sense that it's performed on manufactured batches of gloves.

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

   • Not applicable. This is a physical device testing, not an AI evaluation requiring human expert ground truth.

3. Adjudication method for the test set:

   • Not applicable. Results are based on objective physical and chemical tests against defined standards.

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 document describes a physical medical device (gloves), not an AI-powered diagnostic or assistive technology.

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

   • Not applicable. This document describes a physical medical device (gloves), not an AI algorithm.

6. The type of ground truth used:

   • Objective physical and chemical standards: The "ground truth" for the performance of the gloves is established by predefined standardized tests and limits (e.g., ASTM D-5250-00E4, FDA 1000 ml. Water Fill Test requirements, ASTM D-6124-01 for residual powder, and biocompatibility standards measured by irritation/sensitization tests).

7. The sample size for the training set:

   • Not applicable. This is not an AI study requiring a training set. The "training" in a manufacturing context would refer to process parameters and quality control, not data used to train an algorithm.

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

   • Not applicable. See point 7.

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