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Powdered Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.

The provided text is a 510(k) summary for Powdered Vinyl Patient Examination Gloves. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence.

Based on the content provided, the device in question is a medical glove, not an AI/ML-driven medical device. Therefore, the questions related to AI/ML device performance (such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, and effect sizes of human reader improvement with AI assistance) are not applicable to this document. The provided text does not contain information about an AI/ML device or its performance study.

However, I can extract the acceptance criteria and reported device performance from the provided text for the medical glove.

Acceptance Criteria and Reported Device Performance (for Medical Glove):

Study Details (based on provided text for Medical Glove):

• Sample sizes used for the test set and the data provenance: Not explicitly stated as a "test set" in the context of AI/ML, but the device was tested against the specified ASTM and CFR standards. No specific sample sizes for these tests are detailed in the summary. Data provenance is not specified beyond the device being manufactured by PPP Medical and Safety Products Company Limited in China. The study is implicitly a nonclinical study, as stated: "A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence."
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for medical glove testing typically relies on standardized laboratory procedures and measurements, not expert consensus in the way it's used for AI/ML image interpretation.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of device and testing.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the glove, the "ground truth" is adherence to established industry standards and regulations for physical properties, chemical composition (powder amount), freedom from defects (pinholes), and biocompatibility. This is determined through laboratory testing and measurements based on the specified ASTM and CFR standards, rather than clinical outcomes, pathology, or expert consensus on interpretations.
• The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) submission for a non-AI/ML medical device (patient examination gloves). The "acceptance criteria" relate to meeting established engineering and biocompatibility standards, and the "study" proving this involves nonclinical laboratory testing as per those standards. The concept of "ground truth" here refers to the measured physical and biological properties of the glove conforming to the standard specifications.

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