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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 5250-06.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)":

This document is a 510(k) Premarket Notification Summary for a Class I medical device, specifically patient examination gloves. As such, the "study" described is a demonstration of substantial equivalence to a predicate device, primarily through meeting established performance standards rather than a typical clinical trial.

Acceptance Criteria and Reported Device Performance

Study Information

This document does not describe a "study" in the traditional sense of a clinical trial or a deep learning model evaluation. Instead, it details the non-clinical testing performed to demonstrate that the device meets established consensus standards and regulatory requirements for substantial equivalence.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size: The document does not specify the exact sample sizes used for each test (e.g., how many gloves were tested for pinholes, or how many animals were used for biocompatibility testing). It simply states that the device "meets" the standards.
   • Data Provenance: The testing was conducted by TANGSHAN ZHONGPU PLASTIC PRODUCTS CO.,LTD., which is located in Tangshan City, Hebei Province, China. The data would be considered prospective internal testing.

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. For a Class I device like examination gloves demonstrating compliance with ASTM standards and regulatory requirements, "ground truth" is not established by expert consensus on clinical findings. Instead, it's determined by the results of standardized physical, chemical, and biological tests following established protocols. The experts involved would be laboratory technicians and engineers qualified to perform these specific tests.

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

   • This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or subjective clinical endpoints. For the objective performance criteria of gloves, test results are directly compared to the specified standard thresholds.

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

   • This is not applicable. This device is a physical medical product (examination gloves), not an AI/software as a medical device (SaMD) that would involve human readers or AI assistance.

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

   • This is not applicable, as this is not an AI/SaMD product.

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

   • The "ground truth" for the performance characteristics of these gloves is defined by:
     • Standardized Test Methods and Thresholds: For dimensions, physical properties, powder residual, and freedom from pinholes, the "ground truth" is adherence to the specified quantitative and qualitative criteria within ASTM D5250-06 and 21 CFR 800.20.
     • Biocompatibility Standard Interpretations: For primary skin irritation and dermal sensitization, the "ground truth" is the interpretation of animal study results according to ISO10993-10, demonstrating a "Pass" (i.e., not a primary skin irritant or dermal sensitizer).

7. The sample size for the training set

   • This is not applicable, as this device does not involve a "training set" in the context of machine learning or AI models. The testing described is for product validation against established standards.

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

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

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