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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 the data provenance

The document does not specify the exact sample size used for the test set for each characteristic. It broadly states that the device "meets" the requirements, implying testing was performed to the standards. The data provenance is not explicitly stated in terms of country of origin but is implicitly from the manufacturer's testing, specifically Suzhou Shengyuda Plastic Products Co.,Ltd. The studies were nonclinical.

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

This information is not applicable as this device (patient examination gloves) does not involve human interpretation or subjective assessment by experts. The ground truth is established by objective physical and chemical testing against established industry standards and regulations.

4. Adjudication method for the test set

This information is not applicable as there is no subjective assessment or multiple interpretations requiring adjudication. Performance is determined by objective measurements against defined pass/fail criteria in the 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

This information is not applicable. The device is a medical glove, not an AI-powered diagnostic tool. Therefore, MRMC studies and the concept of human readers improving with AI are irrelevant.

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

This information is not applicable. The device is a medical glove, not an algorithm or AI system.

7. The type of ground truth used

The ground truth used for this device's performance assessment is based on established industry standards and regulations. These include:

• ASTM standard D 5250-06 e1 (for dimensions and physical properties)
• 21 CFR 800.20 (for freedom from pinholes)
• ASTM D6124-06 (for powder amount)
• AAMI / ANSI / ISO 10993-10:2002 (for biocompatibility regarding primary skin irritation and dermal sensitization)

These standards define objective and measurable criteria for product performance.

8. The sample size for the training set

This information is not applicable. The device is a physical product (medical gloves), not a machine learning model. Therefore, there is no "training set" in the context of an algorithm.

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

This information is not applicable for the same reason as point 8.

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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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