(135 days)
X°Port Lung Preservation System:
The X°Port Lung Preservation System is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient. The X°Port Lung Preservation System is intended to be used with the X°Port Lung Preservation Solution.
The intended organ storage time for the X°Port Lung Preservation System is up to 8 hours.
When clinically accepted static hypothermic preservation times are exceeded, the lungs should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.
X°Port Lung Preservation Solution:
The X°Port Lung Preservation Solution is indicated for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.
X°Port Lung Preservation System:
The X°Port Lung Preservation System is an organ preservation system. It is designed to store, preserve, and transport human lungs donated for transplantation at 4°C-10°C.
The X°Port Lung Preservation System consists of an insulated chamber, phase-change cooling packs, a cradle to hold the lung bag, and a temperature probe and logger. The X°Port Lung Preservation System is designed to be mobile, with wheels and a telescopic handle to maneuver the device throughout its travel. The device is designed to protect the lungs during transport and to display and log the internal temperature on an external screen. Additionally, the internal temperature may be monitored via an application running on a mobile device.
X°Port Lung Preservation Solution:
The X°Port Lung Preservation Solution is an organ preservation solution used for flushing, static cold storage, and the perfusion and preservation of lungs intended for transplantation. X°Port Lung Preservation Solution is a clear, sterile, non-pyrogenic, colloid based, lightly buffered extracellular low potassium dextran solution.
During use, the solution is cooled to 4-8°C and is used to perfuse the isolated organ immediately before its removal from the donor and/or immediately after its removal. The solution is then left in the organ vasculature during hypothermic storage and transportation at 4-10°C.
The solution is slightly acidic (pH 5.4) to permit long shelf life and is adjusted shortly before use to pH 7.4 by the addition of THAM solution. The solution must be supplemented with 0.5 mmol/l Calcium Chloride prior to use.
This is a 510(k) clearance letter for the X°Port Lung Preservation System and Solution, which are devices for preserving donor lungs for transplantation. The provided text does not describe a study involving an AI/Machine Learning component to establish acceptance criteria or device performance in the way the request specifies (e.g., accuracy metrics, human reader improvement with AI assistance, ground truth establishment for AI models).
The document is primarily focused on demonstrating "substantial equivalence" of a medical device (a physical preservation system and solution) to existing predicate devices, as required for 510(k) clearance by the FDA. The performance data presented relates to the physical and biological efficacy of the preservation method (e.g., temperature control, biological safety, and clinical outcomes of lung transplants using the system).
Therefore, it's not possible to fulfill the request as it pertains to AI/ML acceptance criteria and study details based on the provided text. The document does not contain information about:
- AI acceptance criteria or reported device performance (no AI component).
- Sample size for test set and data provenance related to AI/ML (no AI component).
- Number of experts used to establish ground truth for AI/ML test set or their qualifications (no AI component).
- Adjudication method for AI/ML test set (no AI component).
- MRMC comparative effectiveness study with AI assistance (no AI component).
- Standalone (algorithm only) performance (no AI component).
- Type of ground truth used for AI/ML (no AI component).
- Sample size for training set for AI/ML (no AI component).
- How ground truth for training set was established for AI/ML (no AI component).
Instead, the document details:
- Clinical Study Design: Two retrospective, single-arm studies with historical controls conducted outside the United States.
- Study Objective: Evaluate the use of controlled hypothermic lung preservation at 10°C on lung transplant outcomes compared to conventional ice storage methods.
- Patient Population:
- First study (X°Port Lung Transport Device vs. Conventional Ice): 118 study patients (X°Port group) and 538 control patients.
- Second study (Temperature-controlled incubator at 10°C vs. Conventional Ice): 138 study patients (Incubator group) and 538 control patients.
- Outcomes Measured: Safety (reduction in (S)AEs), ability to use higher risk organs (longer preservation times, DCD donors), improved long-term Chronic Lung Allograft Free Dysfunction survival, lower infection rates. Comparison to predicate device registry data for grade 3 primary graft dysfunction and 1-year survival.
To reiterate, the provided text describes the regulatory clearance of a physical medical device for organ preservation and does not involve AI or machine learning.
§ 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).