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Powder free vinyl patient examination glove is a disposable non-sterile 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 5250-06.

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 is a 510(k) summary for a Class I medical device (patient examination gloves). As such, the "studies" primarily involve non-clinical testing against established standards and physical property requirements, rather than clinical trials or AI/software performance studies. The questions provided are more applicable to AI-enabled devices or those requiring clinical effectiveness studies. Therefore, many sections will indicate "Not Applicable" or reframe the answer in the context of a Class I glove device.

Acceptance Criteria and Device Performance Study Summary

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated for each test (e.g., how many gloves were tested for pinholes, or how many animals for biocompatibility). The document indicates testing was performed "per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10," implying adherence to the sampling plans specified in these standards.
• Data Provenance: Not explicitly stated, but given the submitter's address (CHINA), it's highly probable the testing was conducted in China. The data is retrospective relative to the submission date.

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

• Not Applicable. For a Class I patient examination glove, "ground truth" is established by adherence to recognized consensus standards and regulatory requirements, not by expert consensus on clinical findings. The "experts" would be the personnel conducting the lab tests according to the specified standards.

4. Adjudication method for the test set:

• Not Applicable. As the tests are based on objective physical/chemical properties and standardized biological responses, there is no need for a human adjudication method in the context of this device. Results are determined by test methodologies.

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:

• Not Applicable. This is a physical medical device (gloves), not an AI-enabled diagnostic or interpretive system. Therefore, no MRMC study, human reader comparison, or AI component is involved.

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

• Not Applicable. This is a physical medical device, not an algorithm or software. "Standalone performance" in this context would refer to the device's intrinsic physical and chemical properties as measured by the standards, which is what was performed.

7. The type of ground truth used:

• Given the nature of the device, the "ground truth" is defined by:
  • Consensus Standards: ASTM D 5250-06, ASTM D6124-06.
  • Regulatory Requirements: 21 CFR 800.20 (Freedom from pinholes).
  • Biocompatibility Standards: ISO10993-10.
  • The device's physical dimensions, material integrity (pinholes), chemical residue (powder), and biological reactions are objectively measured against predefined thresholds in these standards.

8. The sample size for the training set:

• Not Applicable. This type of device does not involve a "training set" in the machine learning sense. The manufacturing process is designed to consistently produce gloves that meet the specified characteristics.

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

• Not Applicable. As there is no "training set" in the AI/machine learning sense, no ground truth needed to be established for it. The "ground truth" for the device's performance is established by the referenced standards and regulations as described in point 7.

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