(112 days)
The Biogel Eclipse Indicator Underglove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
The Biogel Eclipse Indicator Underglove is a sterile powder free, polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram.
The provided text describes a 510(k) submission for a surgical glove (Biogel Eclipse Indicator Underglove). This document does not contain information about an AI-powered medical device or any study that would typically include the requested details about acceptance criteria for AI performance, sample sizes, expert adjudication, or MRMC studies.
The "performance data" section in the K071414 510(k) summary refers to the device meeting physical and chemical characteristics of a surgical glove as per ASTM standards, not the performance of an AI algorithm. The device is a physical product (a glove), not a software or AI diagnostic tool.
Therefore, I cannot fulfill your request as the input document is not about an AI-powered device or a study of its performance. The fields you've requested (such as sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are irrelevant to this particular device and its review process.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).