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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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) 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 supporting study for the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)":

This is a 510(k) summary for medical gloves, which are low-risk devices. As such, the "study" demonstrating the device meets acceptance criteria is primarily based on non-clinical performance testing against established standards, rather than a complex clinical trial.

Acceptance Criteria and Device Performance

Study Details

The "study" in this context refers to a series of non-clinical tests performed to demonstrate compliance with recognized standards.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated in the provided summary. For these types of tests, sample sizes are typically defined by the specific ASTM and ISO standards (e.g., a certain number of gloves per batch for tensile strength, or a specific number of animals for biocompatibility tests).
• Data Provenance: The tests were conducted according to recognized international and US standards (ASTM, 21 CFR, AAMI / ANSI / ISO 10993-10). The location where the actual testing was performed is not specified, but it would have been in a certified laboratory. The nature of these tests is always prospective for the device being submitted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not applicable in the traditional sense of clinical studies. The "ground truth" for these tests is defined by the specifications and methodologies outlined in the referenced standards (ASTM, 21 CFR, ISO).
• Qualifications of Experts: The "experts" are the technical committees and bodies responsible for developing and maintaining these international and national standards. The actual testing would be performed by qualified laboratory technicians and scientists following the standard operating procedures defined by the standards. For biocompatibility, qualified toxicologists/pathologists would interpret results.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. The "adjudication" is inherent in the pass/fail criteria defined by the respective standards. There is no subjective interpretation requiring multiple experts to reach a consensus. The results are quantitative and compared directly to predefined thresholds.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human interpretation is involved and needs to be compared with or without AI assistance. For patient examination gloves, such a study would not be appropriate or necessary.

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

• Standalone Performance: Not applicable. This device is a physical medical device (gloves), not an algorithm or AI system.

7. The type of ground truth used:

• Type of Ground Truth: The ground truth is established by international and national standards and regulations (ASTM standard D 5250-06 e1, ASTM D6124-06, 21 CFR 800.20, AAMI / ANSI / ISO 10993-10). These standards define the acceptable physical properties, safety parameters, and test methods for patient examination gloves.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that requires a training set. The device is evaluated directly against pre-defined performance standards.

9. How the ground truth for the training set was established:

• Ground Truth for Training Set: Not applicable, as there is no training set for this device type.

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