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

Non-sterile, Powder-free Nitrile Examination Glove with Polymer coating, Aloe and Vitamin E. Blue.

The provided text describes a 510(k) summary for a Nitrile Examination Glove, not a medical imaging AI device. Therefore, it does not contain information related to acceptance criteria, study methodologies (like sample size, ground truth establishment, expert adjudication, MRMC studies, or standalone performance) typically associated with the development and validation of AI models for medical imaging.

The document focuses on demonstrating substantial equivalence of a new glove product to existing predicate devices based on material, intended use, physical properties, and biocompatibility.

Therefore, I cannot extract the requested information as it is not present in the provided text.

If you have a document describing an AI device for medical imaging, please provide that, and I will be happy to extract the relevant details.

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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 Nitrile Examination Glove, Blue.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified in the provided text. The document states "The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above," referring to the table of characteristics, but does not detail the sample sizes used for each test.
• Data Provenance: Not explicitly stated as retrospective or prospective, or country of origin for the data collection itself. However, the tests cited are ASTM standards, which are internationally recognized. The manufacturer is Siam Sempermed Corp., Ltd from Thailand.

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

• Not Applicable. This device is a nitrile examination glove. The "ground truth" for its performance is established through standardized physical and biocompatibility testing (e.g., tensile strength, freedom from holes, skin irritation), not through expert interpretation of medical images or clinical outcomes that would require adjudicators.

4. Adjudication method for the test set:

• Not Applicable. As mentioned above, the evaluation of this device relies on standardized physical and chemical tests against ASTM standards, not on subjective assessment or consensus among experts.

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 patient examination glove and does not involve AI or human "readers" in its intended use or evaluation.

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

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

7. The type of ground truth used:

• The "ground truth" is based on objective measurements and observations according to established industry standards (ASTM D 6319-10) for physical properties (dimensions, tensile strength, elongation, freedom from holes, powder residue) and standardized biological assays for biocompatibility (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization).

8. The sample size for the training set:

• Not Applicable. This device concerns a physical product tested against standards, not a machine learning model requiring a training set.

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

• Not Applicable. 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 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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