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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 between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical purpose 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, Power-Free Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.

This looks like a 510(k) premarket notification for disposable vinyl examination gloves, not an AI/ML medical device. Therefore, the questions about AI/ML specific criteria, study design, and performance metrics (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable.

However, I can extract the acceptance criteria and the "study" (non-clinical tests in this context) that proves the device meets them, based on the provided text.

Here's an interpretation based on the document:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical Tests)

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

• Pinhole Testing (FDA 1000 ml Water Fill Test): "samplings of AQL 2.5, inspection level I". This indicates a specific sampling plan from an Acceptable Quality Level (AQL) standard, but the exact number of gloves tested is not explicitly stated.
• Physical and Dimensional Testing (ASTM-D-5250-00E4): "Inspection level S-2, AOL 4.0". Similar to above, this references an AQL sampling plan, but the exact sample size is not numerically provided.
• Residual Powder Test (ASTM D-6124-06): Not explicitly stated, but implies routine inspection.
• Biocompatibility (Primary Skin Irritation and Skin Sensitization): The exact number of subjects or samples used in these tests is not specified in the document.
• Data Provenance: The device is manufactured by "Super Safe Plastic Products Co., Ltd." in "Shijiazhuang, Hebei, China". The testing was performed by the manufacturer or a contracted lab to demonstrate compliance with US standards. The data is retrospective in the sense that the tests were completed before submission.

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

• This is not applicable as this is a physical medical device (gloves), not an AI/ML diagnostic or interpretive device. The "ground truth" is established through standardized physical, chemical, and biological tests.

4. Adjudication method for the test set:

• Not applicable for this type of device. Compliance is determined by objective measurements against established 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:

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

7. The type of ground truth used:

• The ground truth is based on objective measurements and standardized test methods as defined by ASTM standards (D-5250-00E4, D-6124-06) and FDA test protocols (1000 ml Water Fill Test), as well as biocompatibility testing standards. For example, for the "powder-free" claim, the ground truth is "no more than 2 mg powder per glove" as measured by the ASTM D-6124-06 method.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device. There is no "training set" in the context of manufacturing and quality control for gloves; rather, there are manufacturing processes that are controlled to meet specifications.

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

• Not applicable as this is not an AI/ML device.

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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 between healthcare personnel and the patient's body, fluids, waste or environment.

A patient examination glove is disposable device intended for medical purpose 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, Power-Free Vinyl Patient Examination Gloves, 80 LYZ, and meets all 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 Glove, Yellow:

This document is a 510(k) summary for a medical device (patient examination glove) and focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel efficacy through detailed clinical studies. Therefore, many of the requested points related to advanced AI/ML studies (like MRMC, effect size, training sets, and detailed ground truth establishment for a complex algorithm) are not applicable in this context. The "acceptance criteria" here mainly refer to meeting established physical, chemical, and biocompatibility standards for gloves.

Acceptance Criteria and Reported Device Performance

Study Details (as applicable for this type of device submission)

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

   • Test Set Sample Size:
     • For Physical/Dimensions Testing: Inspection level S-2, AQL 4.0 (specific sample size from a lot is not explicitly stated but is derivable from the AQL tables).
     • For Pinhole (Water Fill) Test: AQL 2.5, inspection level I (specific sample size from a lot is not explicitly stated but is derivable from the AQL tables).
     • For Biocompatibility Testing: Not specified, but standard animal or human patch test panels are typically used for irritation/sensitization.
     • For Residual Powder Test: Not specified, but samples from batches would be tested.
   • Data Provenance: The tests were conducted by the manufacturer, Hong Di Plastic Products Co., Ltd., in China. The data would be prospective from their manufacturing and quality control processes.

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

   • Not Applicable. For this type of device, "ground truth" is established by adherence to recognized industrial standards (ASTM) and FDA test methods. There are no "experts" in the sense of clinical reviewers establishing a diagnostic "ground truth" for the device's performance, but rather qualified lab personnel performing standardized tests.

3. Adjudication method for the test set:

   • Not Applicable. The "adjudication" is essentially the pass/fail criteria defined by the ASTM standards and FDA test methods (e.g., AQL levels for defects, negative results for irritation/sensitization). There's no consensus-based adjudication as would be seen in reading medical images.

4. 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 patient examination glove, not an AI-powered diagnostic or assistive tool.

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

   • Not Applicable. This is a physical medical device (glove), not an algorithm.

6. The type of ground truth used:

   • Standardized Test Results & Compliance to Specifications: The "ground truth" for this device is its performance against established, quantitative specifications outlined in ASTM standards (D-5250-06, D-6124-06) and FDA-mandated tests (1000 mL Water Fill, biocompatibility assays).

7. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device that requires a training set. The "training" for manufacturing involves process control and adherence to quality systems for all produced gloves.

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

   • Not Applicable. As above, no training set in the AI/ML sense. "Ground truth" for manufacturing process quality is established through ongoing quality control and adherence to Good Manufacturing Practices (GMPs) and the specified ASTM standards throughout the production lifecycle.

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