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This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
CAUTION: Safe use of this glove by on or latex sensitized individuals has not been established. CAUTION: This product contains natural rubber latex which may cause allergic reactions.

Non-Sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, or ground truth for a medical device that would involve AI, human readers, or specific performance metrics like sensitivity or specificity.

The document is a 510(k) clearance letter from the FDA for Non-sterile, Powder-Free Latex Examination Gloves. This type of device does not typically involve complex performance studies with AI, human interpretation, or ground truth establishment in the way described in your request. The clearance is based on substantial equivalence to legally marketed predicate devices, and the "Indications for Use" section simply describes the intended use of the gloves for preventing contamination.

Therefore, I cannot provide the requested information as it is not present in the given text.

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

This glove contains 50 micrograms or less of total water extractable protein per gram.

CAUTION: Safe use of this glove by or on latex sensitized individuals has not been established. CAUTION: This product contains natural rubber latex which may cause allergic reactions

Non-sterile, Powder-Free Latex Examination Glove

This document is a 510(k) premarket notification decision letter from the FDA for a Non-sterile, Powder-Free Latex Examination Glove. It is not for a medical device that utilizes AI or algorithmic performance, therefore, the requested information regarding acceptance criteria, study details, ground truth establishment, and expert involvement is not applicable to this document.

The document discusses substantial equivalence to predicate devices for a physical product (gloves) and outlines regulatory requirements for such products, not performance metrics for an AI/algorithm-based 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 to prevent contamination between patient and examiner.

Non-sterile, powder-free latex examination gloves with polymer coating, vitamin E, and protein claim (50 micrograms or less).

The provided document is a 510(k) summary for non-sterile, powder-free latex examination gloves. It does not describe an AI/ML powered medical device, nor does it contain information about a study with acceptance criteria, sample sizes, expert ground truth, or adjudication methods for an AI/ML device.

Instead, this document is concerned with demonstrating substantial equivalence to a predicate device (Siam Sempermed Latex Patient Examination Glove, Powder free, 510(k) #K970794) for regulatory purposes. The comparison table confirms that the new device has "Identical" or "Similar" characteristics to the predicate device across various technological aspects.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML device meets them, as this document is not about such a 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 to prevent contamination between patient and examiner.

Non-sterile, powder-free latex examination gloves with polymer coating, aloe, vitamin E, and protein claim (50 micrograms or less).

The provided 510(k) summary for the "Non-sterile, powder-free latex examination gloves with polymer coating, aloe, vitamin E and protein claim (50 micrograms or less)" does not contain a study to prove the device meets specific acceptance criteria in the manner of a typical clinical performance study for an AI/ML device or diagnostic tool. Instead, this submission is an Abbreviated 510(k) based on substantial equivalence to a predicate device (Siam Sempermed Latex Patient Examination Glove, Powder free, 510(k) #K970794).

The acceptance criteria here are primarily regulatory and performance characteristics being compared to the predicate device, demonstrating that the new device is as safe and effective as the previously cleared one.

However, I can extract the information requested based on the context of a 510(k) submission for a medical glove.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating "substantial equivalence" to a predicate device. This involves comparing technological characteristics and showing that the new device is as safe and effective. The reported device performance is implicitly that it meets or is comparable to the predicate device across various parameters.

Study Details (as applicable for a 510(k) of a medical glove)

Given that this is a 510(k) for a medical glove based on substantial equivalence, the "study" referred to generally involves a comparison of technical characteristics and performance testing rather than a clinical trial with experts establishing ground truth in the way of an AI/ML diagnostic.

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

   • The provided summary does not detail specific sample sizes for performance tests (e.g., tensile strength, puncture resistance, protein content). Such data would typically be found in the "additional technical comparative table" mentioned but not included in this extract.
   • Provenance: Not explicitly stated, but typically these tests are conducted internally by the manufacturer (Siam Sempermed Corp., Ltd.) during product development and quality control.

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

   • Not applicable in the sense of clinical ground truth. For a medical glove, "ground truth" relates to objective physical, chemical, and biological properties (e.g., dimensions, barrier integrity, protein content, biocompatibility). These are established through standardized testing procedures, not by human expert interpretation.
   • The experts involved would be quality engineers, chemists, and microbiologists conducting the tests, often overseen by qualified staff (e.g., Dr. Poonsuk Cherdkiatgumchai, Chief Quality Officer).

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert consensus in interpreting complex clinical data (e.g., radiology reads). For a physical device like a glove, test results are typically objective measurements against engineering specifications or established standards (e.g., ASTM).

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 medical glove, not an AI/ML diagnostic tool. There are no "human readers" to assist in interpretation.

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

   • Not applicable. This device is a medical glove, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for a medical glove refers to its objective, measurable physical, chemical, and biological properties as defined by relevant standards (e.g., ASTM D3577 for examination gloves, ISO 10993 for biocompatibility) and regulatory requirements (e.g., protein content limits).

7. The sample size for the training set:

   • Not applicable. This device is a physical product, not an AI/ML model that requires a "training set."

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

   • Not applicable. No training set is used for this type of device.

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