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This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.

Non-sterile surgical face mask, white, yellow, pink, blue and green.

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

Acceptance Criteria and Device Performance

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A finger cot is a disposable device intended for medical purposes that is worn on the examiner's finger to prevent contamination between patient and examiner.

Latex Finger Cot, Powder-Free, with Protein Labeling

This 510(k) submission (K980827) describes a Latex Finger Cot, Powder-Free, with Protein Content Labeling Claim (50 Micrograms or Less). This device is a Class I medical device (Product Code: LZB) and is substantially equivalent to predicate devices already on the market.

1. Table of Acceptance Criteria and Reported Device Performance

The provided documentation does not include specific quantitative acceptance criteria or detailed device performance results beyond the protein labeling claim. The submission focuses on substantial equivalence to existing devices.

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

The provided 510(k) summary and FDA letter do not describe a specific clinical or performance study with a test set. The submission relies on demonstrating substantial equivalence to predicate devices already on the market. Therefore, information on sample size and data provenance for a test set is not applicable here as no such study is detailed.

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

As no specific study with a test set is detailed in the provided documents, there is no mention of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

As no specific study with a test set is detailed, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study is described in the provided documents. The submission focuses on substantial equivalence of the device itself, not on its impact on human reader performance.

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

This device is a physical medical device (latex finger cot), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance is not applicable.

7. The Type of Ground Truth Used

Given that this is a physical device and the submission focuses on substantial equivalence based on its physical characteristics and intended use, the "ground truth" would primarily refer to objective measurements of the device's properties (e.g., latex protein content, physical integrity, barrier properties) and comparison to established standards for similar devices. However, the provided documents do not detail these specific measurements or the type of ground truth used beyond the protein claim.

8. The Sample Size for the Training Set

No training set is mentioned or applicable as this is a physical medical device, not a machine learning model.

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

Not applicable, as there is no training set for this type of device.

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A patient examination glove 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.

Nitrile Exam Gloves, Powder-Free, Blue

This document is a 510(k) summary for a Nitrile Exam Glove, Powder-Free, Blue. It is a medical device submission, and the content provided does not relate to an AI/ML powered device or a study demonstrating its performance. Therefore, I cannot fulfill your request for detailed information about acceptance criteria, study design, and AI-specific metrics like MRMC studies or human reader improvement, as these concepts are not applicable to the provided document.

The document discusses the substantial equivalence of the Nitrile Exam Glove to already marketed devices based on physical characteristics and intended use. The "Test Results" section (K980802 on page 34 of 34) lists the standards and tests that the device has met or exceeded, which serve as the acceptance criteria for the glove's performance.

Here's a breakdown of the information that can be extracted relevant to your request, adapted for a non-AI medical device submission:

1. Table of Acceptance Criteria and the Reported Device Performance:

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

• Sample Size: The document does not specify the exact sample sizes used for each test. For medical devices like gloves, testing is typically done on representative batches according to the specified ASTM standards.
• Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted on the manufacturer's product (Sinochem Ningbo Latex Gloves Factory). The document does not specify country of origin for the data itself, but the device is manufactured by Sinochem Ningbo Latex Gloves Factory, implying the testing was done on their product. It is a retrospective evaluation of the product's compliance with established standards.

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

• This concept is not directly applicable to the testing of examination gloves. The "ground truth" here is adherence to objective, standardized test methodology and performance thresholds defined by organizations like ASTM and the FDA. The experts involved would be the certified laboratory technicians and engineers performing these specific tests, adhering to the standard protocols. Their qualifications would be in laboratory practices and materials testing, not medical diagnosis or interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. Performance testing for medical gloves involves objective measurements against predefined standards, not subjective interpretations 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 is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

• The "ground truth" is defined by the objective performance criteria specified in the referenced ASTM standards and FDA guidelines (e.g., specific tensile strength, elongation, water leak rate, biocompatibility thresholds).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device. There is no concept of a "training set" in the context of standard physical and biocompatibility testing for medical gloves.

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

• Not applicable.

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This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.

FACE MASK, SURGICAL

The provided text is a letter from the FDA regarding a 510(k) premarket notification for a "Face Mask, Surgical Mask, Non-Sterile." This document does not describe an AI/ML device or its performance criteria.

Therefore, I cannot provide the requested information, as the input document does not contain details about:

• Acceptance criteria for an AI/ML device
• A study demonstrating performance against such criteria
• Sample sizes for test or training sets
• Data provenance
• Ground truth establishment or type
• Expert qualifications or adjudication methods
• MRMC studies or standalone algorithm performance.

The document essentially states that the surgical face mask is substantially equivalent to legally marketed predicate devices and can proceed to market.

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