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The Mix2vial Transfer Device is intended for transferring and mixing drugs contained in two vials.

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The provided document is a 510(k) premarket notification letter from the FDA for a device called "Mix2vial Transfer Device". This document does not contain information regarding acceptance criteria for a device's performance, nor does it describe a study proving the device meets such criteria in the computational or AI sense.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the FDA granted clearance based on the device being substantially equivalent to a predicate device, rather than requiring performance data from a specific study against predefined acceptance criteria for the new device. The FDA process for 510(k) clearance primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device.

Therefore, I cannot extract the requested information (acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) from the provided text, as it pertains to a different type of regulatory review that doesn't involve these elements in the context of AI/computational device performance validation.

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