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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 study information for the "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)" based on the provided 510(k) summary:

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 the sample sizes used for testing each characteristic. However, it indicates compliance with recognized standards (ASTM D 5250-06, 21 CFR 800.20, ASTM D6124-01, and 15010993-10). These standards would specify the required sample sizes for each test.

The data provenance is from the manufacturer, Langfang Huilong Plastic Product Co., Ltd. in China. The data appears to be prospective testing conducted by the manufacturer to demonstrate compliance with the referenced standards for their specific device.

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

This information is not provided in the document. For device testing that relies on recognized standards, the "ground truth" is typically established by the criteria outlined within those standards and evaluated by trained technicians or laboratories following the standard's methodologies. There isn't an explicit mention of "experts" in the context of establishing a ground truth for individual test sets, as one might find in clinical image analysis studies.

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 in clinical studies, particularly those involving human readers or subjective interpretations of data, to resolve discrepancies or establish a consensus diagnosis. For compliance testing of medical devices like gloves, results are typically objective measurements against defined pass/fail criteria per the relevant standards.

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, an MRMC comparative effectiveness study was not done. This type of study is entirely irrelevant for a medical device like patient examination gloves, which are consumables and do not involve AI assistance, human readers, or image interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No, a standalone algorithm performance study was not done. This is also not applicable to patient examination gloves.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The ground truth used for performance evaluation is defined by established consensus standards and regulatory requirements.

• For Dimension, Physical Properties, and Powder Amount, the ground truth is defined by the specific parameters and tolerance limits outlined in ASTM standard D 5250-06.
• For Freedom from pinholes, the ground truth is defined by the visual inspection criteria and Acceptable Quality Limits (AQL) specified in 21 CFR 800.20.
• For Biocompatibility, the ground truth is established by the responses observed in animal models (rabbits for skin irritation, guinea pigs for dermal sensitization) according to the methodologies referenced (e.g., 15010993-10 or equivalent, although the specific standard is not fully detailed in the biocompatibility section, it's mentioned in (b)(1)). "Passing" these tests signifies that the material does not induce a significant adverse biological reaction as defined by the test protocols.

8. The Sample Size for the Training Set:

Not applicable/Not provided. This device is a physical product (gloves) and does not involve machine learning algorithms that require a "training set."

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

Not applicable/Not provided. As there is no training set, there is no ground truth to establish for it.

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