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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 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 (yellow) Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-92.

This is a 510(k) summary for a medical device that is a Shijiazhuang Great Eagle Plastics Products Co., Ltd. Synthetic Powder-Free (Yellow) Vinyl Patient Examination Glove. This submission is for a Class I medical device, which generally means it poses a lower risk to patients and users and often relies on established performance standards rather than extensive clinical studies for approval.

The document describes non-clinical tests performed to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets acceptance criteria in the way one might describe for an AI/ML digital health product or more complex diagnostic device. For this type of glove device, acceptance criteria are tied to manufacturing standards and physical properties.

Here's the breakdown of the information requested, tailored to what's available for this specific medical device submission:

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A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare similar personnel to prevent contamination between and 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 hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General and Plastic Surgery Device Panel 21 CFR 880.6250, Powdered Vinyl Patient Class I, as Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.

The provided text is for a 510(k) summary for medical gloves, which are low-risk devices and do not typically involve the types of studies and acceptance criteria that are relevant to AI/ML-powered medical devices. Therefore, much of the requested information, such as multi-reader multi-case studies, standalone algorithm performance, and expert ground truth establishment, is not applicable.

Here's the information that can be extracted or deduced from the provided document, formatted to best fit the request for an AI/ML device, with explanations where the information is not directly applicable:

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 S-4" for the Water Fill Test and "Inspection Level S-2, AQL 4.0" for Physical and Dimensions Testing. These are statistical sampling plans from ASTM standards, not a fixed sample size in the context of typical AI/ML test sets. The exact number of gloves tested for each lot would depend on the size of the manufacturing lot.

Data Provenance: The document does not specify the country of origin of the data beyond the manufacturer being in China. The data is from non-clinical testing performed by the manufacturer to demonstrate compliance with standards. It is implicitly retrospective in the sense that the tests were performed on manufactured batches.

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

Not applicable. The ground truth for medical gloves is established by objective physical and chemical tests (e.g., water leak tests, measurements of dimensions, chemical assays for irritation). There are no "experts" in the sense of clinical reviewers establishing ground truth for individual cases.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human review of images or data to establish ground truth in diagnostic studies. For glove testing, the results are typically quantitative measurements or pass/fail criteria against established 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 medical glove, not an AI/ML diagnostic tool. Therefore, 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 is a physical product and does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth used is based on objective measurement against established industry and regulatory standards. Specifically:

• Physical and Dimensional Characteristics: Defined by ASTM-D-5250-92.
• Barrier Integrity (Pinhole): Defined by FDA 1000 ml. Water Fill Test (referencing CFR 21 pinhole references) and ASTM-D-5250-92.
• Biocompatibility: Established through Primary Skin Irritation and Skin Sensitization testing, performed to determine the absence of adverse biological reactions.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI/ML model that requires a training set. The "training" for glove manufacturing would involve process control and quality assurance to meet the specified standards across all production.

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

Not applicable. As there is no AI/ML training set, there is no ground truth to be established in this context. The "ground truth" equivalent for manufacturing is the adherence to the ASTM-D-5250-92 standard and internal quality specifications during the production process.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare similar personnel to prevent contamination between and 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 hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General and Plastic Surgery Device Panel Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient as Examination Glove, 80LYZ and meets all requirements of ASTM Standard D5250-92.

The provided document describes the 510(k) summary for the Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powder-Free Vinyl Patient Examination Gloves. It details the device, its intended use, comparison to predicate devices, and non-clinical tests performed to demonstrate substantial equivalence.

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 for each test conducted. It mentions "samplings of AQL 2.5, Inspection Level S-4" for the Water Fill Test and "Inspection Level S-2, AQL 4.0" for Physical and Dimensions Testing, which are statistical sampling plans but don't provide a direct sample count. The tests were performed on gloves produced by Shijiazhuang Great Eagle Plastic Products Co., Ltd. in Shijiazhuang, He Bei Province, P.R. China. The data would be prospective, as it's generated during the production and testing of new devices.

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

This section is Not Applicable. The device is a medical glove, and its performance is evaluated against established technical standards (ASTM, FDA water fill, USP iodine test) and biocompatibility tests. These tests have objective criteria and do not rely on expert interpretation to establish "ground truth" in the way a diagnostic imaging device might.

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

This section is Not Applicable. As explained above, the tests performed on the gloves are objective and rely on direct measurements and observations against predefined pass/fail criteria, not on subjective expert consensus or adjudication.

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 section is Not Applicable. The device is a patient examination glove, not an AI-powered diagnostic tool. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not relevant.

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

This section is Not Applicable. The device is a physical medical glove and does not involve any algorithms or AI for standalone performance evaluation.

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

The "ground truth" for the device, a medical glove, is defined by objective, measurable compliance with established international and regulatory standards and test methods:

• ASTM Standard D5250-92: This standard defines physical properties and dimensions for vinyl examination gloves. The "ground truth" is whether the glove's measured properties (e.g., tensile strength, elongation, dimensions) fall within the specified ranges.
• FDA 1000 ml. Water Fill Test: This test determines the watertight integrity (pinhole defects) of the gloves. The "ground truth" is a pass/fail outcome based on whether water leaks through the glove under specific conditions.
• Primary Skin Irritation and Skin Sensitization Testing: These are biological tests conducted to assess the biocompatibility of the glove material. The "ground truth" is the absence of observed irritation or sensitization reactions in test subjects/models.
• USP Iodine Test for Starch: This test objectively determines the presence or absence of starch, which is critical for a "powder-free" claim. The "ground truth" is a passing result indicating minimal or no starch.

8. The sample size for the training set

This section is Not Applicable. The device is a medical glove, not a machine learning model. Therefore, there is no "training set" in the context of AI. The described tests are for product verification and validation.

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

This section is Not Applicable. As stated above, there is no training set for this type of device.

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