(94 days)
The Nitrile Powder Free Examination Glove (Blue) is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner
Nitrile Powder Free Examination Glove (Blue)
The provided document is a 510(k) premarket notification for a medical device: "Nitrile Powder Free Examination Glove (Blue)". This type of document is a regulatory approval, not a scientific study report describing acceptance criteria and device performance in the way a clinical trial or algorithm validation study would.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, and comparative effectiveness is not available in this document.
The document primarily focuses on:
- Confirming that the device is substantially equivalent to legally marketed predicate devices.
- Stating its intended use (Indications for Use).
- Outlining the regulatory requirements the manufacturer must comply with.
Here's what can be extracted from the document based on your request, along with explanations for what cannot be provided:
1. A table of acceptance criteria and the reported device performance
- Not Available in this document. For a medical examination glove, acceptance criteria would typically relate to physical properties (tensile strength, elongation, force at break), barrier integrity (AQL for pinholes), and biocompatibility. Performance data would show how the glove met these specific criteria. This document states substantial equivalence to predicate devices, implying these criteria were met, but does not list them or the specific performance results.
2. 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. This document does not detail the testing methodology or sample sizes used to demonstrate compliance with performance standards.
3. 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 is a physical device (glove) approval, not a diagnostic algorithm or image analysis tool. There is no "ground truth" established by human experts in the context of diagnostic accuracy for this device. Ground truth for a glove would relate to its physical properties and barrier integrity, which are measured objectively.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, this concept doesn't apply to the regulatory approval of an examination glove.
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 is not a diagnostic device or AI algorithm for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. As explained, the concept of "ground truth" in the diagnostic sense is not relevant for an examination glove. The "truth" would be objective measurements against product standards (e.g., ASTM standards for medical gloves) and biocompatibility testing. The document implies these were met to establish substantial equivalence.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set or ground truth in this context.
§ 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.