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A powdered Patient Examination Glove is a disposable device made of natural rubber latex or symthetic material that bears powder to facilitate donning and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Patient Examination Glove, Powdered (with protein labeling claims claims 300 micrograms or less)

This device is a Powdered Latex Patient Examination Glove with Protein Label Claims (300 micrograms or less). As such, it is a Class I medical device and its performance is assessed against established physical and chemical specifications, rather than clinical performance metrics typically associated with AI/software devices. Therefore, many of the requested categories are not applicable.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "The data for this examination glove meets all of the current specification listed under ASTM Standard Specification D3578-05." This statement directly confirms that the device meets the established acceptance criteria.

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

• Test Set Sample Size: Not explicitly stated. The specifications provided (e.g., AQL for pinholes, physical properties) are typically derived from a statistically significant sample as defined by the ASTM standard referenced (D3578-05). However, the specific number of gloves tested for each parameter is not included in this summary.
• Data Provenance: Not explicitly stated beyond the manufacturing location (Eufaula, Alabama, U.S.A.). It is assumed that the testing was conducted by the manufacturer or a certified lab on samples produced at this location. It is retrospective in the sense that the data was collected prior to the 510(k) submission.

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

• Not Applicable. This is a medical device (glove) whose performance is evaluated through physical and chemical testing against established standards, not through interpretation by human experts. The "ground truth" is defined by the ASTM standard D3578-05.

4. Adjudication method for the test set

• Not Applicable. As there are no human interpretations involved in determining glove performance against physical specifications, no adjudication method (like 2+1, 3+1 consensus) is needed.

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 not an AI/software device, and its performance is not assessed through human reader studies.

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

• Not Applicable. This is not an AI/software device. Its performance is the standalone performance of the physical glove.

7. The type of ground truth used

• Established Industry Standard (ASTM D3578-05). The ground truth for the device's performance is defined by the quantitative physical and chemical specifications outlined in the ASTM Standard Specification D3578-05 for patient examination gloves.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set."

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

• Not Applicable. As there is no training set, this question is not relevant.

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