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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Powdered Synthetic Vinyl Patient Examination Gloves, White

This document is a 510(k) premarket notification letter from the FDA regarding "Powdered Synthetic Vinyl Patient Examination Gloves, White." This type of submission is for medical devices that are substantially equivalent to already legally marketed devices and does not typically involve the detailed performance studies or AI validation often seen with more novel devices or software as a medical device (SaMD).

Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study proving device performance as typically expected for an AI/ML-based medical device.

The document is purely an administrative notification of "substantial equivalence" for a physical medical glove. It confirms that the gloves meet the general controls provisions of the Act but does not delve into specific performance metrics or studies in the way an AI-driven device would.

To directly answer your numbered points based only on the provided text, most items are not applicable or cannot be found:

1. A table of acceptance criteria and the reported device performance: Not present. This document is about regulatory approval for substantial equivalence, not a performance study report.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method for the test set: Not present.
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 device).
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable (this is not an AI device).
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

In summary, the provided document is a regulatory clearance letter for a non-AI physical medical device (gloves) and therefore does not contain the kind of technical performance study details you are asking for, which are typically relevant for AI/ML medical devices.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination 10 ween healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powdered Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-00.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document describes a 510(k) submission for patient examination gloves, which are low-risk devices. Therefore, the "study" described is primarily a series of non-clinical bench tests and biocompatibility assessments demonstrating equivalence to a predicate device, rather than a clinical trial involving human patients or complex AI algorithms.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical and Dimensions Testing: "Inspection Level S-2, AQL 4.0" (The exact sample size isn't explicitly stated but is determined by the AQL and inspection level from ASTM-D-5250-00, which are standard statistical sampling plans.)
• Pinhole Test (FDA 1000 ml. Water Fill Test): "AQL 2.5, Inspection Level I" (Similar to above, sample size is determined by AQL and inspection level from standard testing protocols.)
• Primary Skin Irritation and Skin Sensitization: Not explicitly stated, but these are typically performed on a limited number of animal or human subjects/patches under controlled lab conditions.
• Data Provenance: The tests were conducted by the manufacturer, Shijiazhuang Eversharp Plastics Products Co., Ltd., in Hebei Province, P.R. China. The data would be prospective as it was generated specifically for this 510(k) submission.

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

Not applicable for this type of device. The "ground truth" for glove performance is established by standardized test methods (ASTM standards, FDA water fill test) and the results are analytical measurements, not subjective interpretations by experts.

4. Adjudication Method for the Test Set

Not applicable. The tests involve objective measurements against predefined thresholds, not subjective assessments requiring adjudication.

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 device is a physical medical product (gloves) and does not involve AI or human readers for diagnostic interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is not an algorithm or software.

7. The Type of Ground Truth Used

The ground truth used for these tests were:

• Standardized Thresholds: Defined by ASTM-D-5250-00 for physical properties and dimensions, and by FDA requirements for the pinhole test.
• Biocompatibility Standards: Established limits and criteria for irritation and sensitization reactions based on recognized testing protocols.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI or machine learning model that requires a "training set."

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

Not applicable. This device is not an AI or machine learning model.

Ask a specific question about this device

Ask a specific question about this device