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Powdered Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile 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 5250-06e1.

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets those criteria:

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 specific sample sizes used for each test when reporting the device performance (e.g., how many gloves were tested for pinholes, or how many animals were used for biocompatibility).

The data provenance is not explicitly stated as retrospective or prospective, nor are specific countries of origin for the data provided. However, the tests are performed against international and US standards (ASTM, 21 CFR, ISO).

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

This information is not provided in the document. The standards themselves define the test methodologies, but who performed the tests or how many experts validated the "ground truth" (e.g., interpreting if a skin irritation occurred) is not detailed.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1). The tests are performed according to established standards, where the pass/fail criteria are typically objective and defined by the standard itself.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with AI/CAD devices where human readers' performance is compared with and without AI assistance to measure improvement. The device in question is a medical glove, for which such a study would not be applicable.

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

No, a standalone performance evaluation was not done. This concept is relevant for AI/software algorithms. The device is a physical product (medical gloves), and its performance is evaluated through material and biological conformity tests against established standards.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on objective measurements and observations performed according to recognized industry standards and regulatory requirements. For example:

• Physical dimensions are measured.
• Physical properties (e.g., tensile strength, elongation) are measured.
• Freedom from pinholes is determined by a water leak test.
• Powder amount is measured.
• Biocompatibility (skin irritation and sensitization) is determined by in-vivo animal studies with specific observational endpoints defined by the ISO standard.

Essentially, the ground truth is established by strict adherence to the methodologies outlined in the referenced standards (ASTM D 5250-06 e1, 21 CFR 800.20, ASTM D6124-06, AAMI / ANSI / ISO 10993-10).

8. The Sample Size for the Training Set

This device is not an AI/ML algorithm, and therefore, the concept of a "training set" is not applicable. The performance is based on manufacturing and material testing, not machine learning.

9. How the Ground Truth for the Training Set was Established

As stated above, this device is not an AI/ML algorithm, so there is no training set or ground truth established for one.

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