(251 days)
A 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
Powder Free Latex Examination Gloves meets all the current specifications listed under the ASTM Specification D3578-05, Standard Specification for Rubber Examination Gloves. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
This document is a 510(k) premarket notification for a medical device: "Powder Free Latex Examination Glove." It's not a study proving an AI/computer-aided device meets acceptance criteria, but rather a regulatory submission demonstrating substantial equivalence to a predicate device based on non-clinical performance data for a physical product (a glove).
Therefore, I cannot extract the information required to populate a table for acceptance criteria of an AI device, nor provide details about a study that proves an AI device meets acceptance criteria. The document does not describe:
- AI device performance metrics: The criteria and results are for physical glove characteristics (e.g., tensile strength, freedom of holes, dimensions).
- Sample size for test set or data provenance for an AI algorithm.
- Number of experts and their qualifications for establishing ground truth related to AI.
- Adjudication method for AI ground truth.
- MRMC study or effect size of AI assistance on human readers.
- Standalone AI performance.
- Type of ground truth (e.g., pathology, outcomes data) for medical images.
- Training set size or ground truth establishment for an AI model.
The document states:
- "8.0 Assessment of Clinical Performance Data: Not applicable - Clinical data is not needed." This further indicates the absence of a study similar to what would be done for an AI/CADe device.
- "7.0 Non-Clinical Performance Data: The performance test data of the non-clinical tests is reported in the table above." This refers to the physical and chemical properties of the glove.
In summary, this document is entirely unrelated to the type of AI/CADe device evaluation you're asking about. It's a regulatory submission for a simple Class I physical medical device (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.