(90 days)
A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, Trade Name : Arsoft OR other client's trade name.
The provided document is an FDA 510(k) clearance letter for Nitrile Examination Gloves and does not contain information about acceptance criteria or a study proving device performance as typically expected for complex medical devices with performance claims (e.g., diagnostic AI tools).
The document is a regulatory approval notice, indicating that the device is substantially equivalent to a legally marketed predicate device. This type of clearance generally relies on demonstrating equivalence in terms of intended use, technological characteristics, and safety and effectiveness, rather than a detailed performance study against specific acceptance criteria.
Therefore, almost all of the requested information cannot be extracted from this document, as it is not a performance study report.
Here's what can be inferred or explicitly stated based on the document's nature:
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A table of acceptance criteria and the reported device performance: Not applicable. The document is an FDA clearance letter, not a performance study report. There are no acceptance criteria or reported device performance metrics in this context. The clearance is based on substantial equivalence.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This document does not describe a performance study with a test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. This document does not describe a performance study with a test set.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This document does not describe a performance study with a test set.
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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 an examination glove, not an AI or diagnostic device that would involve human readers or MRMC studies.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an examination glove, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a medical glove in the context of substantial equivalence primarily relates to its material properties, physical dimensions, leak resistance, and biocompatibility, which are typically assessed through standardized tests and comparisons to predicate devices, not expert consensus on diagnostic images or pathology.
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The sample size for the training set: Not applicable. This document does not describe a performance study involving a training set for an algorithm.
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How the ground truth for the training set was established: Not applicable. This document does not describe a performance study involving a training set for an algorithm.
In summary: The provided document is an FDA 510(k) clearance letter for medical gloves, indicating substantial equivalence to a predicate device. It does not contain the type of detailed performance study information with acceptance criteria, sample sizes, and expert adjudication that would be requested for an AI/diagnostic device.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.