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Powdered vinyl 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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00ed

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance Study for Powdered Vinyl Patient Examination Gloves

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: The document does not specify a distinct "test set" sample size for each characteristic. It simply states that the device "Meets" the specified standards. For freedom from pinholes, the "waterleak test on pinhole AQL" implies a statistical sampling method as defined by the AQL (Acceptable Quality Level) in 21 CFR 800.20, but the specific sample size, number of defects allowed, or number of units tested are not provided. Similarly for biocompatibility, it's not explicitly stated how many rabbits or guinea pigs were used.
• Data Provenance: The studies appear to be prospective as they were conducted by the manufacturer (Wuxi Shenzhou Plastic Products Co., LTD) to demonstrate that their device meets the requirements.
• Country of Origin of the Data: The manufacturing company is located in Wuxi City, Jiangsu Province, P.R.China. It is reasonable to infer that the testing was conducted in China, though it's not explicitly stated.

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

This information is not provided in the document. For physical and chemical tests like dimension, physical properties, powder amount, and pinholes, the "ground truth" is typically established by direct measurement against the specified standard (e.g., using calipers, tensile strength testers, or standardized water leak tests). For biocompatibility, the ground truth is established by trained toxicologists or researchers interpreting the biological responses in animal models, but the number and qualifications of these experts are not explicitly mentioned.

4. Adjudication method for the test set:

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used when there are subjective interpretations involved, often in image-based diagnostics where multiple experts might disagree on a finding. The tests for these gloves (dimension, physical properties, pinholes, powder, biocompatibility) are primarily objective measurements against established standards, not requiring human adjudication in the same way.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not the case for patient 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 concept is also not applicable to the device in question (patient examination gloves). The testing performed is to assess the physical, chemical, and biological properties of the glove itself.

7. The type of ground truth used:

• Dimension, Physical Properties, Powder Amount: The ground truth is based on direct measurement and comparison to the specifications outlined in ASTM standard D 5250-00e4.
• Freedom from pinholes: The ground truth is established by a standardized water leak test as per 21 CFR 800.20.
• Biocompatibility: The ground truth is established through animal testing (Primary Skin Irritation in rabbits, Dermal Sensitization in guinea pigs) according to ISO10993-10, with results interpreted as "Passes" or "Not a Primary/Dermal Sensitization."

8. The sample size for the training set:

Not applicable/Not provided. This device is a physical product (gloves), not an AI algorithm, so there is no concept of a "training set" in the context of machine learning. The manufacturer likely had internal quality control and development data, but this is not a training set for an AI model.

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

Not applicable/Not provided for the same reasons as point 8.

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Powder free vinyl 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.

powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-0004

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

The provided document is a 510(k) Premarket Notification summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". It describes the device and its compliance with relevant standards rather than a study for an AI/ML powered device. Therefore, many of the requested fields for AI/ML device studies are not applicable.

Here's the breakdown based on the provided text:

Acceptance Criteria and Device Performance

Study Details (as applicable for a non-AI/ML device)

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

   • Sample Size: Not explicitly stated for each test. For "Powder Residual", a quantity is measured per glove, implying testing on multiple gloves, but the sample size isn't given. For "Freedom from pinholes", it refers to 21 CFR 800.20, which likely specifies an AQL (Acceptable Quality Limit) sampling plan, but the specific sample size used is not provided. For biocompatibility, animal models were used (rabbits for skin irritation, guinea pigs for sensitization), but the number of animals is not specified.
   • Data Provenance: Not explicitly stated, but the tests performed are standard industrial tests for medical devices. The manufacturer is WUXI SHENZHOU PLASTIC PRODUCTS CO.,LTD in P.R.CHINA.

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

   • Not applicable. These are physical and biological material property tests based on standardized methods, not expert interpretation of data.

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

   • Not applicable. Results are quantitative measurements or direct observations against a standard (e.g., "Passes," "Meets," or a specific numerical threshold like "<2mg/glove").

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

   • Not applicable. This is not an AI/ML device.

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

   • Not applicable. This is not an AI/ML device.

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

   • Ground Truth: For physical properties (Dimension, Physical Properties, Freedom from pinholes, Powder Residual), the "ground truth" is defined by the technical specifications and thresholds set in the referenced ASTM standards (D5250-00e4, D6124-01) and regulatory requirements (21 CFR 800.20).
   • For Biocompatibility, the "ground truth" is based on the biological response observed in animal models (rabbits for primary skin irritation, guinea pigs for dermal sensitization) according to the test protocols, confirming the absence of significant irritation or sensitization. The reference ISO10993-10 also points to standardized biological evaluation methods.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, and thus there is no training set in the context of machine learning. The device is manufactured and tested according to established quality control procedures.

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

   • Not applicable. As this is not an AI/ML device, there is no "training set ground truth." The ground truth for device performance is based on adherence to pre-defined industry standards and regulatory requirements.

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