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SPS-1TM 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.

SPS-1 TM is a clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs. The solution has an approximate calculated osmolality of 320 mOsm, a sodium concentration of 29 mEq/L, a potassium concentration of 125 mEq/L, and a pH of approximately 7.4 at 20°C.

The provided document (K091656) does not contain information about a study proving the device meets acceptance criteria. Instead, it is a 510(k) summary for a "Static Preservation Solution" that establishes substantial equivalence to predicate devices based on shared manufacturing processes, chemical composition, and intended use.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment are not available in this document.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a study. The "functional and safety testing" mentions verifying device design met its requirements through biocompatibility, sterility, chemical identification, and particle enumeration in accordance with standards. However, the specific acceptance criteria (e.g., maximum allowable particle count, sterility pass/fail definition) and the results against these are not detailed.
   • Reported Device Performance: Not provided in terms of outcome statistics from a study (e.g., organ viability rates, post-transplant function). The document states the primary evidence for equivalence is that the device and predicate devices "are manufactured by the same process, with exactly the same chemical composition and have the same intended use." This implies performance is assumed to be equivalent due to these factors, rather than directly measured in a comparative study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size: Not applicable. No clinical or comparative study data is presented. The "testing" mentioned refers to laboratory tests (biocompatibility, sterility, etc.), not a test set of patient or organ data.
   • Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. No test set requiring adjudication is described.

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:

   • Not applicable. This device is a static preservation solution, not an AI-assisted diagnostic tool or system that involves human readers.

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

   • Not applicable. This device is a medical solution, not a software algorithm.

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

   • Not applicable in the context of a performance study. For the laboratory testing (biocompatibility, sterility, chemical ID, particle enumeration), the "ground truth" would be the established industry standards and validated test methods for these specific properties.

8. The sample size for the training set:

   • Not applicable. This device is a medical solution, not a machine learning model requiring a training set.

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

   • Not applicable.

Summary of Device Acceptance Rationale from the Document:

The acceptance of the SPS-1™ Static Preservation Solution (K091656) by the FDA is based on demonstrating substantial equivalence to existing legally marketed predicate devices (CoStorSol® K083453, K073693, and ViaSpan® K944866).

The key arguments for substantial equivalence are:

• The SPS-1™ is manufactured by the same process as the predicate devices.
• It has exactly the same chemical composition as the predicate devices.
• It has the same intended use (flushing and cold storage of kidney, liver, and pancreas organs for transplantation).

Functional and safety testing mentioned includes biocompatibility, sterility, chemical identification, and particle enumeration, all performed "in accordance with applicable industry standards and/or FDA guidance documents." However, specific results or acceptance criteria for these tests are not detailed in this summary. The primary evidence presented for equivalence relies on the identical nature of the product to already approved devices.

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CoStorSol® 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.

Preservation Solutions, Inc. manufacturers CoStorSol® according to a "recipe" pioneered at the University of Wisconsin by Folkert O. Belzer, MD and James H. Southard, PhD. Indeed, the cold storage solution is often referred to as "Belzer UW" solution. 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).

CoStorSol® is a clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs. The solution is packaged in 1-liter bags, which must be chilled to between 2° and 6° C prior to use. The solution may be used without any point of use filtration.

The provided text describes a 510(k) premarket notification for a medical device called CoStorSol®, an organ storage solution. The submission aims to demonstrate substantial equivalence to a previously cleared version of CoStorSol® (K083453 and K073693) but without the need for a microfilter at the time of use.

The document heavily focuses on demonstrating substantial equivalence by showing that the unfiltered CoStorSol® is equivalent to the filtered CoStorSol®. It does not describe a study to prove a device meets specific acceptance criteria for performance in a traditional sense (e.g., diagnostic accuracy, sensitivity, specificity). Instead, it describes a study proving an attribute of the device (lack of need for filtration) does not negatively impact its performance or safety compared to the predicate device.

Below is an attempt to respond to your request based on the available information, noting where specific details are not provided in the text.

Acceptance Criteria and Device Performance for CoStorSol® (K091245)

The acceptance criteria for K091245 focused on demonstrating that CoStorSol® without instructions for final filtration is substantially equivalent to the predicate CoStorSol® with filtration instructions, particularly regarding safety and biological compatibility. The key performance attributes evaluated were related to particulate matter and sterility/pyrogenicity without the final filtration step.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not specify the sample size for the tests conducted (biocompatibility, particulate matter, sterility validation).
• The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). However, given that it's a 510(k) submission to the US FDA, the tests would typically be conducted under GLP (Good Laboratory Practice) guidelines. The phrase "Preservation Solutions, Inc. has compiled data" suggests internal company testing.

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

• This information is not applicable in the context of this device and submission. This is a medical device for organ preservation, not a diagnostic or AI-driven device requiring expert adjudication of images or clinical outcomes for ground truth. The "ground truth" here is established by adherence to recognized scientific and regulatory standards (USP, ISO, biocompatibility testing).

4. Adjudication Method for the Test Set:

• This information is not applicable to this type of device submission. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical studies, particularly for diagnostic accuracy, which is not the focus here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic imaging devices or AI tools, often involving human readers. CoStorSol® is a chemical solution for organ preservation.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• This question is not applicable as CoStorSol® is not an algorithm or AI-driven device. The "standalone" performance here refers to the chemical and physical properties of the solution itself, which were evaluated through various bench tests and validations (biocompatibility, particulate matter, sterility).

7. The Type of Ground Truth Used:

• The "ground truth" for this device's acceptance criteria primarily relies on established scientific and regulatory standards, including:
  • Pharmacopoeia standards: USP Section for particulate matter, USP Section for sterilization.
  • International standards: ISO 10993 series for biocompatibility, ISO 17665 for sterilization.
• The fundamental "ground truth" being demonstrated is that the absence of a final filtration step does not compromise the safety or equivalence of the product compared to its predicate.

8. The Sample Size for the Training Set:

• This question is not applicable as CoStorSol® is not an AI/machine learning device that requires a training set. The "training" in manufacturing comes from validating processes against established standards.

9. How the Ground Truth for the Training Set Was Established:

• This question is not applicable for the same reason as point 8.

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