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Servator B SALF Solution is intended for the flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient.

Servator B SALF Solution is a clear to light yellow, single use only, sterile (by steam sterilization) and non-pyrogenic for hypothermic flushing and preservation of organs.

The formulation includes soluble colloids, buffers, sodium and potassium salts, redox stabilizers, and phosphoric compounds to aid tissue viability by enabling regeneration of adenosine triphosphate (ATP).

The primary containers used for the device are PVC free bags 1000ml and 2000ml; therefore, they are free of phthalates. The bags must be chilled to between 2° and 6° C (36° to 43° F) prior to use. The solution may be used without any point of use filtration.

The Servator B SALF Solution is intended for perfusion and flushing donor kidneys, liver and pancreas immediately before or immediately after removal from a dead donor or immediately after removal from a living donor. The solution remains in the organ vessels during hypothermic storage and transportation. Servator B SALF Solution is meant for the cold storage of the organ and is not indicated for hypothermic preservation with continuous mechanical perfusion.

The provided text describes the "Servator B SALF Solution," an organ preservation solution, and its substantial equivalence to a predicate device, CoStorSol® (Belzer UW). The document is a 510(k) summary for FDA clearance.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not present a formal table of "acceptance criteria" in the typical sense of numerical thresholds for clinical performance metrics (e.g., sensitivity, specificity for a diagnostic device). Instead, the acceptance criteria are implicitly the demonstration of substantial equivalence to the predicate device, CoStorSol®, across various technological characteristics and non-clinical performance aspects. The "reported device performance" is the result of tests confirming this equivalence.

Here's a table based on the provided "Table of Comparison" and "Non-Clinical Performance Data" section, framed as a comparison to achieve substantial equivalence:

2. Sample size used for the test set and the data provenance

The document explicitly states: "Performance Testing...was completed as a direct comparison between the subject and predicate device. The chemical comparisons and leachables performance testing demonstrated the substantial equivalence of this device to the predicate."

However, it does not specify the sample size for these tests (e.g., how many batches were tested for chemical composition, how many samples for leachables) nor the data provenance (e.g., country of origin, retrospective or prospective). Given the nature of the device (a solution), the "test set" would refer to specific batches or formulations tested in a laboratory setting, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For a 510(k) submission concerning a medical solution, ground truth is typically established through analytical chemical testing and standardized biological assays, not human expert consensus on interpretations of complex data like medical images.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers interpreting data, especially in diagnostic imaging. For a chemical solution, the assessment relies on objective measurements and established scientific protocols.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done or is relevant for this device. This is a medical solution for organ preservation, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a solution, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for demonstrating substantial equivalence for this device relies on:

• Analytical Chemistry and Physicochemical Properties: Direct measurement of concentrations (Na+, K+), pH, osmolality, and confirmation of chemical composition.
• Sterility Testing: Conformance to ISO and ASTM standards.
• Biocompatibility Testing: Conformance to ISO 10993 series standards.
• Leachables Testing: To ensure no harmful substances migrate from the packaging into the solution.
• Functional Equivalence: Implicitly, the solution's performance in preserving organs is assumed to be equivalent to the predicate due to identical composition and physical properties.

8. The sample size for the training set

Not applicable. This device is a medical solution, not based on an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this type of device.

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The Sherpa Pak 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 Sherpa Pak Kidney Transport System can maintain the donor organ storage temperature between 4°C and 8°C through 24 hours.

The Paragonix Sherpa Pak Kidney Transport System is a device intended to provide a safe, consistent method for cold ischemic storage and transport of donor kidney organs to recipients for transplantation. The Sherpa Pak Kidney Transport System consists of 1) an outer shipper which contains various non-ice based temperature controlled packaging elements, 2) an inner and outer hard shell container (i.e. Sherpa Pak/Sherpa Pak Shell) which provides a double, rigid barrier container in which the donor kidney is immersed and suspended in a Cold Storage Fluid cleared for use in storing and transporting donor organs and 3) a temperature display and timer to monitor temperature and elapsed time of transport, respectively. The device is identical to the cleared Sherpa Pak Cardiac Transport System with the exception of the indications for use specific to donor organs, and removal of a connector in the canister component.

Acceptance Criteria and Device Performance for Paragonix Sherpa Pak Kidney Transport System

Here's a breakdown of the acceptance criteria and the study details for the Paragonix Sherpa Pak Kidney Transport System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a sample size for a "test set" in the context of clinical data for algorithmic performance. The testing described is laboratory bench testing and refers to a "descriptive information and laboratory bench testing" approach to demonstrate the device meets design specifications and perform as intended.

There is no mention of data provenance (e.g., country of origin, retrospective/prospective) for a test set, as clinical data for performance assessment (e.g., organ viability post-transport) is not described as being part of the submission for determining substantial equivalence regarding its temperature maintenance capabilities. The focus is on the physical and functional characteristics of the transport system itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This device is a medical device for organ transport, not an AI/diagnostic software. No "ground truth" established by experts in the context of diagnostic accuracy is mentioned.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication method for a test set, as the testing described focuses on bench-top performance of the device's physical functions.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

Not applicable. This is not a comparative effectiveness study involving human readers or AI assistance. It describes a medical device for organ transport.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device for organ transport, not an algorithm.

7. The type of ground truth used

The "ground truth" can be inferred from the stated performance goals:

• Temperature Maintenance: The ability to consistently maintain the temperature of a simulated/actual organ (or the internal environment of the device) between 4°C and 8°C for 24 hours. The ground truth would be the actual measured temperature by calibrated sensors.
• Physical Protection/Robustness: The ability to protect the donor organ during transport. The ground truth would be the structural integrity of the device and its contents after simulated transport conditions.
• Biocompatibility: The materials being non-toxic and compatible with the organ. The ground truth would rely on established biocompatibility testing standards and results from a predicate device.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is a medical device, not an AI model.

Summary of the Study that Proves Acceptance Criteria:

The key study information provided is:

• Type of Study: Descriptive information and laboratory bench testing.
• Purpose: To demonstrate that the device meets its design specifications, performs as intended, and is safe for its intended use.
• Specific Tests: Testing was conducted to demonstrate the system's robustness to protect the donor organ during transport and its ability to maintain the specified temperature range (4°C to 8°C) for the duration of transport (24 hours).
• Biocompatibility: No new biocompatibility testing was deemed necessary because there were no material changes from the previously cleared Sherpa Pak Cardiac Transport System (K123326), implying the previous device's biocompatibility data was leveraged.
• Basis for Equivalence: Substantial equivalence was based on these descriptive characteristics and testing, comparing the Sherpa Pak Kidney Transport System to its predicate, the Sherpa Pak Cardiac Transport System (K123326), as well as other predicate devices for context (Avid Medical Custom Procedure Tray and CoStorSol Cold Storage Solution).

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