(99 days)
Brightway™ Brand Colored Nitrile Examination Glove (Powdered) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Brightway™ Brand Colored Nitrile Examination Glove (Powdered)
This is a 510(k) clearance letter for "Brightway™ Brand Blue Nitrile Examination Gloves (Powdered)". As such, it does not contain the detailed study results, acceptance criteria, and performance data typically found in a clinical study report or a pre-market approval (PMA) application.
510(k) clearances are based on a showing of substantial equivalence to a predicate device, rather than a demonstration of clinical efficacy and safety through extensive clinical trials. Therefore, the document will not provide answers to most of your specific questions regarding acceptance criteria, performance metrics, sample sizes, ground truth establishment, or multi-reader studies.
Here's what can be inferred or stated based on the provided document and the nature of 510(k) submissions for this type of device:
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A table of acceptance criteria and the reported device performance:
- Not available in this document. For examination gloves, acceptance criteria typically relate to physical properties (e.g., tensile strength, elongation, freedom from holes) and biocompatibility. The performance would be tested against recognized standards (e.g., ASTM standards for medical gloves). This document only states that the device is "substantially equivalent."
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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 available in this document. Such details would be in the 510(k) summary or full submission, not the clearance letter.
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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 question pertains to diagnostic or analytical devices where expert interpretation of results is crucial for ground truth. For examination gloves, "ground truth" relates to the physical and chemical properties of the material and their performance against established standards, not expert interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 3.
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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-assisted diagnostic tool. Therefore, MRMC studies are not relevant.
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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):
- For examination gloves, the "ground truth" for showing substantial equivalence would typically be:
- Standardized laboratory testing: Against recognized consensus standards (e.g., ASTM D6319 for Nitrile Examination Gloves) for attributes like freedom from holes (water leak test), tensile strength, elongation, and dimensions.
- Biocompatibility testing: According to ISO 10993 series (e.g., cytotoxicity, irritation, sensitization).
- The document itself does not specify these, only implies that the device met the requirements for substantial equivalence.
- For examination gloves, the "ground truth" for showing substantial equivalence would typically be:
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The sample size for the training set:
- Not applicable and not available. This is not an AI/machine learning device. The concept of a "training set" in this context is irrelevant. For manufacturing quality control, there would be sampling plans, but not a "training set" in the AI sense.
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How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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.