(73 days)
A medical giove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
NITRILON CORRECT-TOUCH POWDERED NITRILE Examination Glove
Here's an analysis of the provided text regarding acceptance criteria and study details for the Nitrilon™ Correct-Touch® Powdered Nitrile Examination Gloves:
Important Note: The provided document is a 510(k) clearance letter from the FDA for medical gloves. This type of document declares substantial equivalence to a previously marketed device, rather than providing a detailed study report with specific performance metrics and acceptance criteria as would be found for a novel AI device or a more complex medical device requiring clinical trial data.
Therefore, many of the requested sections (e.g., sample size for training/test sets, expert qualifications, MRMC studies, standalone algorithm performance) are not applicable or not explicitly detailed in this document, as the regulatory pathway for examination gloves relies on demonstrating equivalence rather than establishing de novo performance characteristics through such studies.
However, I will extract what can be inferred or stated as "not applicable" based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
For examination gloves, the "acceptance criteria" are generally based on recognized standards for physical properties and biocompatibility to ensure they are safe and effective for their intended use and equivalent to existing predicate devices. The document does not explicitly list a table of acceptance criteria or performance metrics specific to the Nitrilon™ Correct-Touch® gloves. Instead, the FDA's clearance implies that the device meets the general controls and equivalence requirements.
Therefore, for this document, a direct table of acceptance criteria and reported performance cannot be generated. The "performance" being assessed here is predominantly the device's substantial equivalence to a predicate device in terms of materials, intended use, and manufacturing processes, rather than a quantifiable performance metric like sensitivity or specificity.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This document does not describe a "test set" in the context of evaluating an AI algorithm's performance. The review is for a physical medical device (gloves) and relies on substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in the context of AI algorithm evaluation is irrelevant here. The FDA's review involves regulatory experts, but they are assessing compliance and equivalence, not establishing a "ground truth" for a dataset.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the context of AI algorithm evaluation described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Not applicable. MRMC studies are used for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This document pertains to examination gloves.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is not an algorithm.
7. The Type of Ground Truth Used
Not applicable. "Ground truth" is a concept for evaluating algorithms. For medical gloves, the "truth" is established by adherence to recognized standards for materials, manufacturing, and performance (e.g., tensile strength, barrier integrity, biocompatibility), which are demonstrated through testing that is not detailed in this FDA clearance letter.
8. The Sample Size for the Training Set
Not applicable. This document is not about an AI algorithm, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set mentioned in this document.
Summary based on the provided document:
The provided FDA 510(k) clearance letter for Nitrilon™ Correct-Touch® Powdered Nitrile Examination Gloves is for a physical medical device, not an AI algorithm. The regulatory pathway for such devices focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than on proving performance through studies typically associated with AI or novel diagnostic/therapeutic devices (e.g., clinical trials, AI performance metrics, expert adjudication). Therefore, most of the requested information regarding acceptance criteria, study design parameters (sample sizes, experts, ground truth, MRMC studies, standalone performance) is not available or applicable in this specific regulatory document. The FDA's letter confirms that the device meets the general controls provisions of the Federal Food, Drug, and Cosmetic Act and is substantially equivalent to a predicate 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.