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Gambro FH 22H Fiber Hemofilter
This document is a 510(k) clearance letter from the FDA for a medical device (Gambro FH 22H Fiber Hemofilter). It primarily states that the device has been found substantially equivalent to a predicate device and can be marketed.
However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria, nor any of the specific details requested in your prompt (e.g., sample size, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth, training set information).
This type of FDA letter confirms regulatory clearance based on substantial equivalence, but it typically summarizes the outcome of the review process, not the detailed performance data or study specifics submitted by the manufacturer. The detailed studies and data would be part of the original 510(k) submission, which is not included here.
§ 876.5880 Isolated kidney perfusion and transport system and accessories.
(a)
Identification. An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.(b)
Classification. Class II (performance standards).