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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 the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state a sample size for the test set. It mentions "Powdered vinyl patient examination gloves, Clear(non-colored) meet requirements per ASTM PRO10002 10 Fowdered - viryl patient channel pro 21 CFR 800.20 and ISO10993-10," implying that these standards' specified testing methodologies (which would include sample sizes) were followed. However, the specific numbers are not provided.

The data provenance is not explicitly mentioned but based on the submitter's address (CHINA) and the general nature of compliance testing for medical devices, it is highly likely the data was generated in China and is prospective (i.e., new testing conducted for the submission).

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

This information is not provided in the document. The standards (ASTM, CFR, ISO) would define the methodology for establishing conformity, which might involve expert assessment, but the document does not elaborate on the expert involvement or their qualifications for the specific tests.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for the test set. The tests appear to be objective measurements against defined standards rather than interpretations requiring adjudication among multiple experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret images or data, and the AI's impact on their performance is being evaluated. This device is a patient examination glove, which does not involve human interpretation in the same way.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, a standalone performance evaluation was done. The device's performance was measured directly against established standards (ASTM, 21 CFR, ISO) for its physical, chemical, and biological properties. This testing does not involve human-in-the-loop interaction for performance evaluation; it's about the inherent qualities of the glove itself.

7. Type of Ground Truth Used:

The ground truth used is primarily objective measurements against established industry and regulatory standards. These standards define acceptable ranges or thresholds for characteristics like dimensions, physical properties, pinholes, and powder amount. For biocompatibility, the ground truth is derived from the results of standardized animal testing (rabbit irritation, guinea pig sensitization).

8. Sample Size for the Training Set:

This information is not applicable to this device and its evaluation methods. Training sets are relevant for machine learning algorithms. The evaluation of a patient examination glove relies on physical, chemical, and biological testing against predefined standards, not on algorithms trained on data.

9. How Ground Truth for the Training Set Was Established:

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

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