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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 5250-06.

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

Acceptance Criteria and Device Performance

Study Proving Device Meets Acceptance Criteria:

The device's performance against the acceptance criteria is demonstrated through a series of non-clinical tests. The summary explicitly states: "Powdered vinyl patient examination gloves, Clear(non-colored) meet requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10." The table above details how the device meets each characteristic's standard.

Detailed Study Information:

1. 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 specify the direct sample sizes for each test (e.g., how many gloves were tested for pinholes, or how many animals were used for biocompatibility). It references standards (ASTM D5250-06, 21 CFR 800.20, ISO10993-10) which would typically define such sample sizes.
   • Data Provenance: The manufacturing company, SHIJIAZHUANG ELEGANCE PLASTIC PRODUCTS CO., LTD., is located in China. Therefore, it's highly probable the testing was conducted in China or by labs accredited to perform these tests for a Chinese manufacturer. The document does not explicitly state the country of origin of the data itself, only the submitter's address. The data is retrospective, as it refers to completed tests.

2. 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 question is not applicable to this type of device (patient examination gloves). The "ground truth" for these tests (e.g., whether a glove has pinholes, its tensile strength, or if it causes irritation) is determined by standardized laboratory methods and measurements, not by expert consensus or interpretation in the way medical image analysis might be.

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

   • Not applicable. Adjudication methods are typically associated with subjective assessments or classifications (e.g., in clinical trials or diagnostic studies), which is not the case for the objective physical and biocompatibility tests performed on these gloves.

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 device is a physical product (gloves), not an AI diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant.

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

   • Not applicable. This device is a physical product, not an algorithm.

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

   • The "ground truth" for this device type is established through objective, standardized laboratory measurements and compliance with industry and regulatory standards. For example:
     • Dimension, Physical Properties, Powder Amount: Measured against the specifications outlined in ASTM D 5250-06.
     • Freedom from pinholes: Determined by standardized water leak tests as per 21 CFR 800.20 (and often specified within ASTM standards as well).
     • Biocompatibility: Determined by standardized animal testing protocols (Primary Skin Irritation in rabbits, Dermal Sensitization in guinea pigs) as per ISO 10993-10.

7. The sample size for the training set

   • Not applicable. This device is not an AI algorithm requiring a training set. The manufacturing process of physical products involves quality control, but not "training sets" in the AI sense.

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

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

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