(75 days)
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or prevent contamination between patient and finger to examiner.
Nitrile Powder-Free Examination Gloves
Based on the provided text, this document is a 510(k) clearance letter for "Nitrile Powder-Free Examination Gloves." This type of document does not contain information about acceptance criteria or a study proving that an AI/device meets acceptance criteria in the way you've described for medical AI.
This 510(k) clearance signifies that the device is substantially equivalent to a predicate device, meaning it has similar indications for use, technological characteristics, and safety and effectiveness. The FDA's review for such a device typically focuses on performance data (e.g., strength, durability, biocompatibility for gloves) in comparison to a predicate, rather than the complex clinical study designs often associated with AI software.
Therefore, I cannot extract the requested information points because they are not present in this type of regulatory document.
However, if this were a document about a medical AI device, here's what each section of your request generally refers to:
- A table of acceptance criteria and the reported device performance: This would typically list metrics like sensitivity, specificity, AUC, F1-score, accuracy, or other relevant performance indicators, alongside the predefined thresholds the device needed to meet.
- Sample size used for the test set and the data provenance: This would specify the number of cases/patients in the independent test set, and details about where the data originated (e.g., anonymized patient data from multiple hospitals in the US, Europe), and whether it was collected historically (retrospective) or specifically for the study (prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This would detail how many highly qualified specialists (e.g., board-certified radiologists, pathologists) independently reviewed the test cases to determine the true diagnosis or finding.
- Adjudication method for the test set: This explains how discrepancies among expert opinions for ground truth were resolved (e.g., 2+1 means two experts agree, or a third experienced expert acts as tie-breaker).
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: This would assess if human clinical performance improved when using the AI device as an aid compared to reading without it. An effect size (e.g., increase in AUC, sensitivity) would be reported.
- If a standalone performance study was done: This measures the algorithm's performance without any human intervention.
- The type of ground truth used: This specifies the gold standard against which the device's performance was measured (e.g., confirmed by pathology, long-term clinical outcome follow-up, consensus of multiple experts).
- The sample size for the training set: The number of cases/patients used to train the AI model.
- How the ground truth for the training set was established: Similar to the test set, but specifically for the data used to teach the AI.
Again, this type of information is not present in the provided 510(k) clearance letter for examination gloves.
§ 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.