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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 text:

Acceptance Criteria and Device Performance

Study Information

Here's the detailed breakdown of the study components based on the provided text:

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 exact sample size for any test set or the data provenance (country of origin, retrospective/prospective). It refers to meeting ASTM and CFR standards, which imply specific testing protocols but don't explicitly state the sample size used in this specific submission's 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 information is not provided in the document. The document describes testing against established standards (ASTM, CFR), not expert-derived ground truth in the context of a clinical or image-based study.

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

   • Adjudication methods are not applicable here as it's not a study involving human interpretation or subjective assessments that would require adjudication. The testing is based on objective measurements against established standards.

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

   • A multi-reader, multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this type of device (patient examination gloves). This device does not involve AI or human interpretation in its function.

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

   • A standalone performance study of an algorithm was not performed, nor is it applicable. This device is a physical medical glove, not a software algorithm.

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

   • The "ground truth" for this device's performance is based on established industry standards and regulatory requirements. This includes:
     • ASTM standard D 5250-06 (for dimensions, physical properties, powder amount)
     • ASTM standard D6124-06 (for powder amount)
     • 21 CFR 800.20 (for freedom from pinholes)
     • FDA recognition number 2-87 for AQL (related to pinholes)
     • ANSI / ISO 10993-10:2002 (for biocompatibility - primary skin irritation and dermal sensitization).

7. The sample size for the training set

   • There is no training set mentioned or implied, as this is a physical product and not an AI/machine learning model.

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

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

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