(242 days)
A powder-free 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. Gloves are available with finger textured surface in four sizes; Small, Medium, Large and X-large.
Not Found
The provided text is a 510(k) premarket notification for "Midas Touch™ Nitrile Examination Gloves - Powder-Free, Orange." This document is a regulatory submission for a medical device and does not contain information about a study proving the device meets acceptance criteria in the format typically found for AI/ML-based medical devices.
Instead, this document focuses on establishing substantial equivalence to a predicate device, which is a regulatory pathway for lower-risk medical devices like gloves. It confirms that the device is intended for medical purposes, to be worn on the hand or finger to prevent contamination between patient and examiner.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details as they would apply to an AI/ML device, as this document pertains to a physical medical device (gloves).
Here's why the requested information categories are not applicable to the provided document:
- A table of acceptance criteria and the reported device performance: This document doesn't provide performance metrics in the way an AI/ML study would (e.g., sensitivity, specificity, AUC). For gloves, performance criteria would typically involve barrier integrity (e.g., AQL for pinholes), tensile strength, elongation, etc., which are not detailed here beyond the general claim of being "powder-free" and available in sizes.
- Sample size used for the test set and the data provenance: Not applicable. There's no "test set" of data in the context of an AI/ML algorithm.
- Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth, in the AI/ML sense, is not established for gloves.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This is for evaluating changes in human reader performance with AI assistance, which doesn't apply to examination gloves.
- Standalone (i.e. algorithm only without human-in-the loop performance): Not applicable. This device is not an algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable. There's no AI model to train.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory approval for examination gloves and does not contain the kind of study data requested for AI/ML device performance.
§ 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.