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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.

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

The provided text describes the acceptance criteria and the study conducted for the Shijiazhuang Hongxiang Plastics Products Co., Ltd. Synthetic (Blue) Vinyl Patient Examination Gloves-Powder Free.

Here's the breakdown of the information requested:

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 a specific numerical sample size for the entire "test set." However, it mentions:

• For Physical and Dimensions Testing: "Inspection Level S-2, AQL 4.0" (AQL refers to Acceptance Quality Limit, a statistical sampling method for quality control, not a fixed sample size).
• For Water Fill Test: "samplings of AQL 2.5, Inspection Level I" (similar to above, a statistical sampling method).
• Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by the manufacturer, Shijiazhuang Hongxiang Plastics Products Co., Ltd. Given the company's location, the data provenance would be from China. The studies are retrospective in the sense that they are conducted on finished products for quality control and regulatory 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 as the device is a medical glove, and its performance is evaluated against engineering and material standards, not by expert interpretation of complex medical data.

4. Adjudication method for the test set
Not applicable for this type of device and testing. Performance is measured against objective 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
Not applicable. This device is a passive medical product (gloves) and does not involve AI or human "readers" in its function or evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device. The "standalone" performance refers to the device's physical and chemical properties as measured in the non-clinical tests.

7. The type of ground truth used
The ground truth used is based on established industry standards and regulatory requirements, specifically:

• ASTM Standard D5250-00E4 (for general glove properties, physical, and dimensions)
• ASTM D-5151-99 (for pinhole detection via water fill test)
• ASTM D6124-01 (for residual powder measurement)
• Biocompatibility standards (for primary skin irritation and sensitization)
• 21 CFR 880.6250 and other applicable 21 CFR references (for regulatory classification and compliance)

8. The sample size for the training set
Not applicable. This is not a machine learning or AI device, so there is no "training set."

9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth to establish for it.

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

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

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

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

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

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

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

8. The sample size for the training set

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

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

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

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

A patient examination glove is disposable device intended for medical a purpose that is worn on the examiner's s een and the circuins in the closed setimal examiner A patient examination glove is disposaolo device institution between patient and examiner.

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

The provided text is a 510(k) summary for a medical device: "Grand Work Plastics Products Co., Ltd. Synthetic (White) Vinyl Patient Examination Gloves—Powder Free." This document describes the device and its compliance with established standards, but it does not involve AI/ML technology or a study proving its performance against a statistical acceptance criteria in the typical sense of AI/ML device evaluations.

Instead, this document details the device's adherence to existing ASTM standards and FDA requirements for patient examination gloves. Therefore, many of the requested elements for an AI/ML device study (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of medical device submission.

However, I can extract the information that is relevant to the acceptance criteria and how the device meets them based on the provided text.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0 (Specific number of gloves not stated, but defined by the AQL standard).
• Sample Size for Water Fill Test: AQL 2.5, Inspection Level I (Specific number of gloves not stated, but defined by the AQL standard).
• Sample Size for Other Tests (Skin Irritation, Sensitization, Residual Powder): Not explicitly stated, but implies sufficient sampling to meet the standard's requirements.
• Data Provenance: The tests were conducted internally by Grand Work Plastics Products Co., Ltd. (implied by "The standards used for Grand Work Plastics Products Co., Ltd. glove production are based on ASTM-D-5250-00E4. All testing meets requirements..."). This is a prospective testing of manufactured product batches. The country of origin of the data would be China, where the manufacturing company is located.

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

• Not Applicable. The "ground truth" for this device is based on objective, standardized physical and chemical tests (e.g., water fill for pinholes, weighing for powder, biological assays for irritation). There are no human "experts" establishing a subjective ground truth in the way a radiologist would interpret an image. The standards themselves define the "truth."

4. Adjudication Method for the Test Set

• Not Applicable. As the tests are objective and quantitative (e.g., pass/fail a water leak, weight measurement), there's no need for adjudication among multiple human reviewers. The test results directly determine compliance with the standard's 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 is a basic medical device (patient examination glove), not an AI/ML diagnostic or assistive tool. MRMC studies are not relevant.

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

• Not Applicable. 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, objective ASTM and FDA standards for physical properties (dimensions, tensile strength, freedom from holes) and chemical properties (powder residue) and biological safety (biocompatibility through irritation/sensitization tests). It's based on adherence to these universally accepted and measurable criteria.

8. The Sample Size for the Training Set

• Not Applicable. This device does not involve an AI/ML model, so there is no "training set." The manufacturing process itself is implicitly "trained" through quality control and adherence to standards over time, but not in the machine learning sense.

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

• Not Applicable. As there is no training set for an AI/ML model, 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 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 Patient Examination Glove, 80L YZ, and meets all requirements of ASTM Standard D5250-00E4.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document specifies "samplings of AQL 2.5, Inspection Level I" and "Inspection Level S-2, AQL 4.0" for the physical and pinhole tests. However, it does not explicitly state the exact numerical sample sizes used for these tests or for the biocompatibility tests (skin irritation and sensitization). The data provenance is not mentioned, but it can be inferred that the testing was conducted by or for Grand Work Plastics Products Co., Ltd., likely in China or through contracted labs. The data is presented as retrospective in nature, reflecting completed tests.

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

Not applicable. This device is a patient examination glove, and the "ground truth" for its performance is established through standardized laboratory and biocompatibility tests, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically associated with subjective assessments or diagnostic interpretations by experts, which are not relevant for the type of testing performed on patient examination gloves.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation, which is not the case for patient examination gloves.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a standalone study was performed. The device's performance was evaluated through various non-clinical tests (physical, dimensional, pinhole, biocompatibility, residual powder) without human intervention in its function as a diagnostic aid. The study assesses the inherent properties and protective capabilities of the glove itself.

7. Type of Ground Truth Used

The ground truth used is based on:

• Standardized ASTM specifications: ASTM-D-5250-00E4 for physical and dimensional properties, ASTM D-5151-99 for pinhole, and ASTM D6124-01 for residual powder. These standards define objective, measurable criteria.
• Biocompatibility testing results: Ensuring no primary skin irritation or sensitization reactions, based on established toxicological principles.

8. Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, so there is no concept of a "training set." The testing involved manufacturing samples directly.

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

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

Ask a specific question about this device

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

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 Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document describes the 510(k) submission for Shijiazhuang Great Vision Plastics Products Co., Ltd. Synthetic (White) Vinyl Patient Examination Gloves-Powder Free. As such, the "device" in this context refers to these examination gloves. The studies described are primarily non-clinical, focusing on manufacturing standards and material properties rather than clinical performance (e.g., diagnostic accuracy of an AI algorithm).

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 specific sample sizes for each test performed (e.g., how many gloves were tested for pinholes, or how many subjects for skin irritation). It refers to:

• Physical and Dimensions Testing: "Inspection Level S-2, AQL 4.0" (These are sampling plans from quality control standards, implying a specific number of gloves would be inspected from a lot, but the exact number isn't given).
• FDA 1000 ml. Water Fill Test: "AQL 2.5, Inspection Level I" (Similarly, a sampling plan).
• Primary Skin Irritation and Skin Sensitization: The number of subjects is not specified.
• Residual Powder Test: Not specified.

Data Provenance: Not explicitly stated, but the tests were conducted by or for the manufacturer, Shijiazhuang Great Vision Plastics Products Co., Ltd., based in Hebei Province, P.R. China.

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

Not applicable. This device is a physical product (gloves), not an AI/diagnostic device that relies on expert interpretation for ground truth establishment. The "ground truth" here is defined by physical and chemical properties and patient safety endpoints, measured by established testing methods.

4. Adjudication Method for the Test Set

Not applicable. Since the tests are objective measurements against predefined standards (e.g., water leak, powder content, skin reaction), there is no need for expert adjudication in the way it would be applied to subjective image interpretation or clinical diagnosis.

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

Not done. This is not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

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

7. Type of Ground Truth Used

The "ground truth" for the performance claims of these gloves is based on:

• Standardized Physical Measurements: Adherence to ASTM-D-5250-00 for physical properties and dimensions, and ASTM D6124-01 for residual powder.
• Biocompatibility Testing: Results from primary skin irritation and sensitization tests.
• FDA Pinhole Requirements: Passing the FDA's 1000 ml Water Fill Test.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set. The "training" for glove manufacturing would involve process control and quality assurance, not data training in a computational sense.

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

Not applicable. As there is no training set in the context of an AI device, no ground truth needs to be established for it.

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.

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

The provided text describes the 510(k) summary for Shijiazhuang Eversharp Plastics Products Co., Ltd.'s Synthetic (White) Vinyl Patient Examination Gloves-Powder Free.

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 this medical device are based on demonstrating substantial equivalence to a predicate device and adherence to established industry standards.

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

The document does not explicitly state the exact sample sizes used for each specific test (e.g., number of gloves for physical testing, number of subjects for biocompatibility). However, it mentions:

• Physical and Dimensions Testing: The inspection level and AQL (Acceptable Quality Level) values are provided: "Inspection Level S-2, AQL 4.0." These are statistical sampling plans where a certain number of units are inspected from a lot, and the lot is accepted or rejected based on the number of defects found. While not an explicit sample size, they define the statistical rigor of the sampling.
• FDA 1000 ml. Water Fill Test: "AQL 2.5, Inspection Level I." Similar to the above, this indicates a statistical sampling plan.
• Biocompatibility Testing (Primary Skin Irritation and Skin Sensitization): The specific number of subjects or samples is not provided, but the tests were "conducted with results showing no primary skin irritant or sensitization reactions."

Data Provenance: The document implies the data was generated internally by Shijiazhuang Eversharp Plastics Products Co., Ltd. for their product. There is no mention of country of origin of the data beyond the manufacturer's location (China). The studies are inherently prospective as they are tests performed on the device to prove its compliance with standards and claims for premarket notification.

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

The document does not provide information regarding the number or qualifications of experts used to establish the ground truth for the test set. The tests performed (physical, water fill, biocompatibility, residual powder) are typically standardized laboratory tests, where "ground truth" is established by adherence to the specified test methodology and objective measurements, rather than expert consensus on subjective findings.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective laboratory measurements (e.g., physical dimensions, water leakage, chemical residues, biological responses in animal models or in-vitro tests for irritation/sensitization). There is no "adjudication" in the sense of multiple human readers or experts reviewing the same data and reaching a consensus. The results are quantitative or qualitative assessments based on predefined criteria in the standards.

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

Not applicable. This is a medical device for patient examination gloves. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret images or data, and the study assesses the impact of AI assistance on their diagnostic performance. This device is not an imaging or diagnostic AI product, so an MRMC study is not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical product (gloves), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not relevant. The performance metrics are related to the physical and chemical properties of the gloves themselves.

7. Type of Ground Truth Used

The "ground truth" used for these tests is based on:

• Industry Standards: Specifically ASTM Standard D5250-00, which defines the expected physical properties and performance characteristics of synthetic vinyl patient examination gloves.
• Regulatory Requirements: FDA requirements for pinhole/barrier integrity (Water Fill Test) and biocompatibility.
• Manufacturer's Claims: The claim of "powder-free" is verified against a specific standard (ASTM D6124-01).

These are objective, quantitative, or qualitatively verifiable standards and protocols.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device (gloves), not an AI/ML algorithm. There is no "training set" in the context of machine learning. The manufacturing process is controlled to produce gloves that consistently meet the required specifications.

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

Not applicable, for the same reasons as #8.

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A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste, or environment.

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

Glove, Disposable, Non-sterile, Patient Examination, Vinyl (Powder Free)

The provided text describes the acceptance criteria and performance of the EVERGREEN MEDICAL PRODUCTS Vinyl Patient Examination Gloves - Powder Free. However, it does not contain information about a study proving the device meets the acceptance criteria in the manner of a multi-reader, multi-case (MRMC) comparative effectiveness study, or a standalone (algorithm only) performance study as typically seen for AI/ML medical devices. The document is a 510(k) summary for a medical device (examination gloves), which follows a different set of regulatory requirements focused on demonstrating substantial equivalence to a predicate device.

Instead, the "study" described in this document is essentially a series of quality characteristic tests performed against established ASTM and FDA standards for patient examination gloves.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify a distinct "test set" sample size in terms of number of gloves tested for each characteristic. It refers to established standards and tests (e.g., JIS-S-2045.509, JIS-S-2045.5.2, FDA Glove 1000ml Water Leak Test, Primary Dermal Irritation in Rabbits, Guinea Pig Sensitization). These standards imply specific sampling plans.
• Data Provenance: The tests for biocompatibility were "Issued by Consumer Products Testing Co." The document states the manufacturer is located in Shijiazhuang City, Hebei, China. Thus, the provenance of the testing data is likely China. The study is retrospective in the sense that the data presented reflects the results of quality control and testing performed on manufactured batches 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 concept is not applicable here as this is a physical medical device (gloves) and not an AI/ML diagnostic or image analysis device that requires expert consensus for "ground truth." The "ground truth" for the performance characteristics are the established ASTM and FDA standards themselves. The assessment is against these objective measurements.

4. Adjudication method for the test set:

• This concept is not applicable. Performance against physical and chemical specifications does not involve "adjudication" by experts in the context of diagnostic interpretation. The methods are standardized physical and chemical tests (e.g., measuring length, tensile strength, pinhole rate via water leak test, biological irritation 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:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic systems, not for examination gloves.

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

• No, a standalone (algorithm only) performance study was not done. This type of study is relevant for AI/ML diagnostic systems, not for examination gloves.

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

• The "ground truth" for this device's performance is adherence to established, objective material and physical specifications and testing standards (e.g., ASTM Specification D 5250-99 for physical properties, FDA Glove 1000ml Water Leak Test for pinholes, and standard biocompatibility tests).

8. The sample size for the training set:

• This concept is not applicable. This device is not an AI/ML algorithm that requires a "training set." The manufacturing process itself (described in Section 10.0) is continuously refined and controlled, but there isn't a "training set" in the sense of data used to train a model.

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

• This concept is not applicable, as there is no "training set." The standards for glove manufacturing and performance are established by regulatory bodies and industrial organizations (e.g., ASTM, FDA) based on extensive research and consensus within the medical and materials science communities to ensure safety and effectiveness for their intended use.

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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.

Classified by FDA 's General and Plastic Surgery Device Panel as Class I, 21CFR 880.6250
Viryl Patient Examination Glove, Power Free, 80LYZ
conform to all requirements of ASTM Standard D5250-92 and FDA water leak test.

This document describes the performance of the Vinyl Patient Examination Gloves, Powder Free, manufactured by Everrise Glove Products Co., Ltd.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance was evaluated against ASTM Standard D5250-92 and FDA water leak test requirements.

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

The document does not explicitly state the sample sizes used for the physical property tests (length, width, thickness, tensile strength, ultimate elongation) or the FDA water leak test. The data provenance is Taiwan, R.O.C., where the manufacturer is located. The studies are non-clinical performance studies conducted on the applicant's device. No information on whether they were retrospective or prospective is provided, but standard test methods like ASTM D5250-92 are typically conducted prospectively on a sample set.

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

Not applicable. This device is a physical product (gloves), and performance is assessed against established engineering and safety standards (ASTM D5250-92 and FDA water leak test), which do not involve expert interpretation or ground truth establishment in the way an AI diagnostic algorithm would.

4. Adjudication method for the test set:

Not applicable. Performance is measured against quantitative standards, not through adjudication of 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 (examination gloves), not an AI-powered diagnostic tool engaging 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.

7. The type of ground truth used:

The "ground truth" for this device's performance is defined by the objective, measurable criteria specified in ASTM Standard D5250-92 and the FDA 1000ml water leak test. These are engineering and quality control standards.

8. The sample size for the training set:

Not applicable. There is no training set as this is a physical product evaluated against standards, not a machine learning algorithm.

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

Not applicable.

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