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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)

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 describes a 510(k) premarket notification for a medical device -- Powder Free Vinyl Patient Examination Gloves, Clear (non-colored). The studies conducted are non-clinical, primarily focused on meeting established material and performance standards for patient examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not explicitly state the specific sample sizes for each test (e.g., number of gloves tested for pinholes, dimension, physical properties, or the number of animals for biocompatibility tests). It relies on adherence to the referenced ASTM and CFR standards, which would prescribe appropriate sample sizes within those methodologies.
• Data Provenance: The testing was conducted by or on behalf of YONGSHENG PLASTIC CO., LTD in China. The data would be retrospective in the sense that the tests were performed to demonstrate compliance after the gloves were manufactured, rather than as part of a prospective clinical trial.

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

This type of non-clinical testing does not typically involve "experts" in the sense of clinical specialists establishing a "ground truth." The ground truth for these tests is defined by the objective, quantitative criteria outlined in the referenced industrial and regulatory standards (ASTM D 5250-06, D6124-06, 21 CFR 800.20, ISO10993-10). Testing laboratories with appropriate accreditation and expertise in materials science, mechanical testing, and biocompatibility testing would perform these evaluations. The qualifications of the personnel performing these tests are implied to meet the requirements of the respective standards and regulatory bodies.

4. Adjudication Method for the Test Set

No adjudication method (like 2+1, 3+1 consensus) is described or applicable here. The evaluation of the device's performance against the acceptance criteria is based on objective measurement and observation as per the specified standards. The results either "Meet" or "Pass" the predefined numerical and qualitative thresholds.

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 relevant for diagnostic imaging devices where human readers interpret results, and the impact of AI assistance on their performance is measured. For a simple medical device like an examination glove, such a study is not applicable.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone (algorithm only) study was not done. This device is a physical product (a glove), not an algorithm or AI software. Therefore, the concept of "algorithm only" performance is not applicable. The studies performed directly assess the physical properties and biological safety of the glove itself.

7. The Type of Ground Truth Used

The ground truth used for this device is based on established industry standards and regulatory requirements. This includes:

• Measurement Standards: ASTM standard D 5250-06 for dimensions and physical properties.
• Regulatory Limits: 21 CFR 800.20 for freedom from pinholes, and D6124-06/D5250-06 for powder residual (quantified as <2mg/glove).
• Biocompatibility Standards: ISO10993-10 for primary skin irritation and dermal sensitization, which define "passes" based on specific tissue reactions in animal models.

8. The Sample Size for the Training Set

This device does not utilize a "training set" in the context of machine learning or AI. Therefore, there is no sample size for a training set. The device is a manufactured physical product whose performance relies on its material composition and manufacturing process, not on a learned algorithm.

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

As there is no training set for this product, the question of how its ground truth was established is not applicable.

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