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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 betweeen patient and examiner.

Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer coating

This document describes the premarket notification (510(k)) for the "Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer coating" by Siam Sempermed Corp., Ltd. The study aims to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for the specific tests (Dimensions, Physical Properties, Freedom from pinholes, Powder Free Residue, Biocompatibility). The tests reference ASTM standards (ASTM D 6319-00-ae³ and ASTM D 6124-2006), which would specify sampling methods and sizes.

The data provenance is from non-clinical performance testing conducted by Siam Sempermed Corp., Ltd., in Thailand (based on the submitter's address). The data is prospective in the sense that it was generated for the purpose of this 510(k) submission to demonstrate the device's adherence to standards.

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

Not applicable. This is a medical device performance study, not a study involving human expert interpretation of data like imaging. The "ground truth" for the device's performance is established by standardized testing methods and their inherent pass/fail criteria or quantitative limits, as defined by ASTM standards and biological testing protocols.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers interpret complex data and their interpretations need to be reconciled (e.g., in radiological studies). For material property testing and biocompatibility assessments, the results are derived directly from the test procedures, eliminating the need for adjudication of human interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is evaluated. This submission is for an examination glove, which does not involve human interpretation in the same way.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. This device is not an algorithm, but a physical product (a medical glove).

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Adherence to recognized industry standards: ASTM D 6319-00-ae³ for dimensions, physical properties, and freedom from pinholes.
• Quantitative measurement against a specified limit: ASTM D 6124-2006 for powder-free residue (≤ 2 mg/glove).
• Biological testing outcomes: "Passed" for Primary Skin Irritation in Rabbits and Guinea Pig Sensitization, indicating non-toxicity/non-sensitization according to established biological evaluation protocols.

8. Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI algorithm that requires a training set. The performance data is based on samples of the manufactured gloves being tested against established standards.

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

Not applicable, as there is no training set for this 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 betweeen patient and examiner.

Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer coating

This is a 510(k) summary for a non-sterile, powder-free nitrile examination glove. It outlines the device's characteristics, intended use, and a comparison to established standards and a predicate device.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes used for testing each characteristic. It only states that the performance tests were conducted. The data provenance is implied to be from the manufacturer's internal testing as part of their 510(k) submission. The country of origin of the data is not explicitly stated for the testing itself, but the manufacturer is based in Thailand. The study is retrospective in the sense that the testing was conducted prior to the submission for regulatory approval.

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

Not applicable to this type of device. The "ground truth" for the performance characteristics of an examination glove is defined by the technical specifications and testing methods described in the referenced ASTM standards (e.g., ASTM D 6319-00-ae3, ASTM D 6124-2001) and biocompatibility test protocols. These standards dictate objective measurements rather than subjective expert interpretation for ground truth establishment.

4. Adjudication Method for the Test Set:

Not applicable. The performance testing of examination gloves involves laboratory measurements against established standards, not a process requiring adjudication among human reviewers.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or other tools where human interpretation plays a significant role and can be enhanced by AI assistance. This device is a disposable medical glove, and its performance is assessed through physical and chemical testing, not through human reader interpretation.

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

Not applicable. This device is a physical product (a glove), not an algorithm or AI system. Its performance is inherent to the product itself, not a function of an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for this device is based on established industry standards and scientifically recognized test methods. Specifically:

• ASTM D 6319-00-ae3: Specifies ground truth for dimensions, physical properties (e.g., tensile strength, elongation), and freedom from pinholes for nitrile examination gloves. These are objective, measurable criteria.
• ASTM D 6124-2001: Specifies the ground truth for powder-free residue, which is a quantitative measurement.
• Biocompatibility (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization): These involve standardized animal testing protocols where "passes" indicates the absence of a defined level of adverse reaction, serving as the ground truth for biological safety.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" for manufacturing such a device would involve process control and quality assurance, not a data-driven training set in the AI sense.

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

Not applicable, as there is no training set in the context of this 510(k) submission for a physical medical device like an examination glove.

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