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EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is intended for topical cooling of in situ, abdominal donor organs during intraoperative recovery from the donor. It is also intended to maintain organ hypothermia during storage and transport to the transplant recipient. EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is used to establish, and maintain hypothermia of donor organs during recovery, storage, and transport.

It is also indicated for use during open surgical procedures such as cardiovascular, abdominal, and transplant surgeries.

Organ Recovery
Prior to organ recovery, EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is delivered to the open peritoneal cavity of the donor to assist in creating hypothermia by topically cooling external surfaces of organs for recovery. During organ recovery, if ice crystals are no longer visible, the temperature of the saline solution will begin to rise and additional slushed solution may be delivered per established transplant team procedures. (Temperature rise may be assessed with temperature probes, being careful that the probe is measuring the solution and is not in contact with the organ).

Organ Storage/Transport
For organ storage/transport, EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) may be used to topically cool external surfaces of a sterile, sealed, primary organ bag containing chilled preservation solution and the organ. In this application, the slushed solution may be added to a secondary bag or to a tertiary hard container to surround the primary organ bag. Once bagged, the organ can be placed in a bed of non-sterile ice in an insulated transport container, which is then closed. Actual use should follow standard practices of the OPO or hospital for transporting and storing specific types of donor organs using sterile, slush solutions.

Surgical Procedure
During surgical procedures, EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is delivered to assist in creating hypothermia by topically cooling external surfaces of organs. During the procedure, if ice crystals are no longer visible, the temperature of the saline solution will begin to rise and additional slushed solution may be delivered per established surgical team procedures.

EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is a clear, colorless 0.9% Sodium Chloride solution for preparation of slushed solution to provide hypothermia during the recovery, storage, and transport of donor organs for transplantation and to induce regional hypothermia in certain surgical procedures such as open heart and kidney procedures by direct application of slushed solution. The solution is sterile, non-pyrogenic, isotonic and is contained in a 2L sterile, flexible, non- PVC bag.

The provided document, an FDA 510(k) Clearance Letter for EasiSlush® Sodium Chloride Solution, is for a medical device that acts as a sterile slush for topical cooling during surgical procedures and organ transport. It is NOT an AI/ML medical device. Therefore, the information requested in the prompt, which pertains to the acceptance criteria and study proving an AI/ML device's performance (including details like test set sample size, ground truth establishment with experts, MRMC studies, etc.), is not applicable to this document.

The 510(k) discusses the substantial equivalence of the updated EasiSlush® product (K243618) to its previously cleared version (K191006) by detailing changes in its intended use and indications for use, while emphasizing that the core technological characteristics, composition, and safety profile remain unchanged.

To summarize why the specific questions about AI/ML device performance cannot be answered from this document:

• No AI/ML Component: The device is a physical saline solution for cooling. It does not involve any artificial intelligence or machine learning components.
• Substantial Equivalence Study, Not Performance Study: The document describes a "substantial equivalence discussion" showing that the new device (K243618) is equivalent to a predicate device (K191006), primarily by demonstrating that changes to its "Indications for Use" for surgical procedures do not introduce new questions of safety or effectiveness, as the technological characteristics, formulation, and mode of action are unchanged. This is different from a performance study for an AI/ML model.

Therefore, I cannot provide the requested table or information regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device.

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EasiSlush™ slushed solution is intended for topical cooling of in-situ, abdominal donor organs during intraoperative recovery from the donor. It is also intended to maintain organ hypothermia during storage and transport to the transplant recipient.

EasiSlush™ slushed solution is used to establish, and maintain hypothermia of donor organs during recovery, storage, and transport.

Organ Recovery

Prior to organ recovery, EasiSlush™ slushed solution is delivered to the open peritoneal cavity of the donor to assist in creating hypothermia by topically cooling external surfaces of organs for recovery.

During organ recovery, if ice crystals are no longer visible, the temperature of the saline solution will begin to rise and additional EasiSlush slushed solution may be delivered per established transplant team procedures. (Temperature rise may be assessed with temperature probes, being careful that the probe is measuring the solution and is not in contact with the organ).

Organ Storage/Transport

For organ storage/transport, EasiSlush™ slushed solution may be used to topically cool external surfaces of a sterile, sealed, primary organ bag containing chilled preservation solution and the organ. In this application, EasiSlush may be added to a secondary bag or to a tertiary hard container to surround the primary organ bag. Once bagged, the organ can be placed in a bed of non-sterile ice in an insulated transport container, which is then closed. Actual use should follow standard practices of the OPO or hospital for transporting and storing specific types of donor organs using sterile, slush solutions.

EasiSlush (Sodium Chloride Solution for Sterile Slush Preparation) is 1.25L sterile 0.9% Sodium Chloride Solution in a 2L bag. It meets the USP 34 monograph for Sodium Chloride Irrigation. It is a sterile, nonpyrogenic, isotonic solution that is chilled for the preparation of slushed solution.

The provided text is a 510(k) summary for EasiSlush™ (Sodium Chloride Solution for Sterile Slush Preparation). It describes the device, its intended use, and a comparison to predicate devices, focusing on the concept of substantial equivalence.

However, the summary does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 of your prompt. The document explicitly states:

• "No clinical testing has been performed on this device." (Page 10)

This means there was no multi-reader multi-case (MRMC) study, no standalone algorithm performance, and no test or training sets with associated ground truth established by experts.

The acceptance criteria and performance data discussed are limited to non-clinical performance testing (biocompatibility, leachables, sterility, and performance bench tests related to temperature and USP standards).

Therefore, I cannot provide a detailed response to your request, as the necessary information regarding clinical study design, acceptance criteria based on clinical outcomes, sample sizes for test/training sets, expert involvement, and ground truth establishment from such studies is absent from this document.

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