(65 days)
SherpaPak Cardiac Transport System: The SherpaPak Cardiac Transport System is intended to be used for the static hypothermic preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart. The intended organ storage time for the SherpaPak Cardiac Transport System is up to 4 hours. Donor hearts exceeding clinically accepted static hypothermic preservation times 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.
SherpaPak Kidney Transport System: The SherpaPak Kidney Transport System is intended to be used for the static hypothermic preservation of kidney organs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with this organ. The SherpaPak Kidney Transport System can maintain the donor organ storage temperature between 4 C and 8 C through 24 hours.
The SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System result from modifications made to the cleared Sherpa Pak Cardiac Transport System and Sherpa Pak Kidney Transport System most recently cleared under K133432 and K133694, respectively. The principle of operation of the modified devices is identical to that of the cleared devices, namely, cold static storage and transportation of donor hearts (Cardiac version) or donor kidneys (Kidney version), using cleared preservation solutions specific to the organ type being transported. Further, the modified designs have the same indications for use and utilize the same technology as the predicate devices.
The subject SherpaPak design (cardiac and kidney) like its predecessor, consists of 1) outer transport shipper which contains within it various non-ice based temperature controlled packaging elements, 2) an inner and outer hard shell assembly (i.e. Sherpa Canister/Sherpa Shell) which provides a double, rigid barrier shipper in which the heart/kidney is immersed and suspended in a cold storage solution cleared for use in storing and transporting donor hearts/kidneys, and 3) a data logger that monitors and displays the temperature of the cold storage solution in which the heart/kidney is stored during transport.
The provided document (K180194 510(k) Summary for SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System) does not pertain to an AI/ML medical device. It describes a medical device designed for the static hypothermic preservation and transport of donor hearts and kidneys.
Therefore, the document does not contain any information regarding:
- Acceptance criteria for an AI/ML device.
- A study proving an AI/ML device meets acceptance criteria.
- Sample sizes for AI/ML test sets or training sets.
- Data provenance for AI/ML models.
- Number of experts or their qualifications for establishing ground truth for AI/ML models.
- Adjudication methods for AI/ML test sets.
- MRMC comparative effectiveness studies for AI/ML.
- Standalone performance of an AI/ML algorithm.
- Types of ground truth for AI/ML models.
- How ground truth for AI/ML training sets was established.
The document focuses on the functional testing performed on the modified SherpaPak systems to demonstrate their equivalence to predicate devices, including:
- Biocompatibility testing of new materials.
- Electrical Safety and EMC testing.
- Transportation testing (ASTM D4169-09).
- Thermal qualification to maintain specified temperature ranges (4°C - 8°C for up to 4 hours for cardiac, and 24 hours for kidney).
- Helium leak testing for seal integrity.
The "acceptance criteria" and "device performance" in this context are related to the physical and functional aspects of the transport system, particularly its ability to maintain organ temperature during transport and ensure sterility, rather than an AI/ML model's diagnostic or predictive performance.
The thermal qualification section implicitly describes a key performance characteristic and implied acceptance criteria:
- Acceptance Criteria (Implied from Thermal Qualification): Maintain donor organ storage temperature between 4°C and 8°C for:
- Cardiac Transport System: up to 4 hours
- Kidney Transport System: up to 24 hours (as stated in the Indications for Use and the predicate device description)
- Reported Device Performance: "This test was performed to demonstrate the system could meet this specification." (This implies successful demonstration, but quantitative results are not explicitly provided in the summary, only the duration the system "can maintain" the temperature in comparison to the predicate). The "Storage Temperature Duration" characteristic in the comparison table states that the Modified SherpaPak Cardiac/Kidney Transport System "Device can maintain 4°C to 8°C through 44 hours," which exceeds the 24-hour requirement for kidneys and 4-hour requirement for hearts, and also exceeds the predicate's 36-hour duration.
Since the request specifically asks for information relevant to an AI/ML device, and this document describes a physical transport system, I cannot fulfill the request as phrased based on 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).