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510(k) Data Aggregation
(70 days)
A patient examination Vinyl Powder Free Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Vinyl Powder Free Examination Glove
I am sorry, but the provided text from the FDA 510(k) K091429 document for "Vinyl Powder Free Examination Glove" does not contain the specific information required to answer your request about acceptance criteria and a study proving device performance.
The document is a letter from the FDA determining substantial equivalence for the device. It discusses regulatory matters, such as classification, general controls, and compliance with various FDA regulations. It also includes the "Indications for Use" statement for the glove.
However, it does not contain:
- A table of acceptance criteria and reported device performance.
- Details about a study (sample size, data provenance, expert involvement, adjudication, MRMC study, standalone performance).
- Information on ground truth establishment for either test or training sets.
This type of detailed performance data and study design information is typically found in the sponsor's 510(k) submission itself, which is a much more extensive document than the FDA's decision letter provided here.
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(72 days)
A patient examination Vinyl Powder Free Examination Clove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent intended for medical purpose th intended for medical purpose and examiner.
Vinyl Powder Free Examination Glove
The provided document is a 510(k) premarket notification letter for a Vinyl Powder Free Examination Glove. This document pertains to the regulatory approval of a medical device (a glove), not an AI/ML powered device. As such, it does not include information on acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device performance.
Therefore, I cannot provide the requested information based on this document.
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