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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, 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.

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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.

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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