(457 days)
LifePort™, Kidney Perfusion Transporter (KTR) is intended to be used for the continuous hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient.
Not Found
I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria or a study that proves the device meets specific performance metrics. The document is a 510(k) clearance letter from the FDA for the 'LifePort™ Kidney Perfusion Transporter (KTR)', indicating that the device is substantially equivalent to legally marketed predicate devices.
The letter and the 'Indications for Use Statement' do not contain details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Therefore, I cannot fulfill your request for this specific information using the provided text.
§ 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).