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CoStorSol® plus G is intended for the flushing and cold storage of liver, kidney, 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® plus G according to a "recipe" pioneered at the University of Wisconsin by Folkert O. Belzer, MD and James H. Southard, PhD. Indeed, this 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.

CoStorSol® plus G 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, to which 0.922 g of sterile glutathione may be added just prior to use. The solution must be chilled to between 2° and 6° C prior to use.

The provided text describes a 510(k) premarket notification for a medical device called "CoStorSol® plus G," a solution for organ preservation. The document primarily focuses on establishing substantial equivalence to a predicate device, CoStorSol®, rather than presenting a detailed study with specific acceptance criteria and performance data in the typical sense of a diagnostic or interventional device.

The "device performance" and "acceptance criteria" here relate to demonstrating that the new device, CoStorSol® plus G, is as safe and effective as the predicate device by showing that the added component (glutathione) does not change its fundamental function or properties.

Here's an attempt to extract and organize the information according to your request, with the caveat that a traditional "study" proving performance against acceptance criteria for a new AI or diagnostic device isn't present in this regulatory document.

Acceptance Criteria and Device Performance for CoStorSol® plus G

The acceptance criteria for CoStorSol® plus G are primarily focused on demonstrating substantial equivalence to its predicate device, CoStorSol®, particularly in chemical composition, intended use, preparation for use, sterility, storage, actions and functions, particulate matter, biocompatibility, and interaction with other medical technology. The key "performance" here is that the modified device remains functionally equivalent to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not detail a "test set" in the context of clinical or AI performance evaluation. Instead, testing was conducted on the device itself (CoStorSol® plus G solution and its packaging) to confirm its physical, chemical, and biological properties are equivalent to the predicate.

• Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients." Testing was performed on batches of the CoStorSol® plus G solution and its components (e.g., bags, glutathione vials).
• Data Provenance: The testing appears to be internal validation by Preservation Solutions, Inc. and conducted according to relevant international standards (e.g., ISO, USP). The location of these tests (e.g., country of origin) is not specified, but the company is U.S.-based (Elkhorn, Wisconsin). The nature of the tests (biocompatibility, particulate matter, chemical identity, general appearance, weight loss, package integrity, shelf life) indicates a prospective series of laboratory and bench tests on the manufactured device.

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

N/A. This is not applicable as the "ground truth" here is based on established scientific and regulatory standards (e.g., chemical purity, pH, osmolality, sterility, biocompatibility standards like ISO 10993, and USP for particulate matter) rather than clinical expert consensus on complex medical diagnoses. The company's Quality Assurance Director (William Wagner) is the contact person, implying oversight, but no panel of experts for "ground truth" establishment is mentioned.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like 2+1 or 3+1 are typically used for clinical ground truth establishment in studies involving human interpretation or subjective assessments. Here, the "truth" is determined by objective laboratory measurements against defined specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

N/A. This document is a 510(k) submission for a non-diagnostic, non-AI medical device (organ preservation solution). An MRMC study is not relevant to its type of evaluation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

N/A. This product is a chemical solution, not an algorithm or AI. Standalone performance is not applicable.

7. Type of Ground Truth Used

The "ground truth" for evaluating CoStorSol® plus G is based on defined scientific, chemical, and biological specifications and standards. These include:

• Chemical identity and purity of components.
• Physical properties (pH, osmolality, particulate matter count).
• Sterility (absence of microorganisms).
• Biocompatibility (based on ISO 10993 series of tests).
• Stability and shelf life (demonstrating consistency over time).
• Functional equivalence in vitro/ex vivo (implied by chemical similarity and predicate equivalence, but no specific organ performance studies are detailed in this document for the new device).

8. Sample Size for the Training Set

N/A. A "training set" is relevant for AI/machine learning models. This document describes a chemical solution.

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

N/A. Not applicable for this type of device.

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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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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" proneered at the University of Wisconsin by Dr Folkert O Belzer Indeed, the cold storage solution is often referred to as "Belzer UW" solution The formulation includes soluble collords, buffers, sodium and potassium salts, redox stabilizers, and phosphoric compounds to and tissue vrability 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

Here's an analysis of the provided 510(k) summary, structured to address your specific questions. It's important to note that this document is a summary for regulatory clearance, not a detailed scientific paper, so some requested information may not be explicitly present.

Device Name: CoStorSol® (Organ Storage Solution)

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k), the primary "acceptance criterion" is
substantial equivalence to the predicate device. The performance data presented focuses on demonstrating that the proposed device, stored at ambient temperature, is identical to the predicate device stored under refrigeration, particularly regarding its chemical composition and biocompatibility.

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

The document does not specify a "test set" in the context of clinical performance data involving organs or patients, as this submission focuses on demonstrating equivalence through chemical and biocompatibility testing.

• Sample Size:
  • For chemical analysis: "both fresh reference samples naturally aged at 25° ± 2°C". The exact number of samples is not stated but implies a comparison between newly manufactured product and product aged under the new storage conditions.
  • For biocompatibility: Tests were conducted on CoStorSol® itself and the flexible solution administration pouches. The sample sizes for these specific ISO 10993 tests are not provided but would have been defined by the standards.
• Data Provenance: The data appears to be from bench testing and laboratory analysis, rather than human clinical trials. The country of origin of the data is not explicitly stated but is implied to be from the manufacturer or contracted testing labs. It is retrospective in the sense that the studies were performed on existing product formulations to support a change in storage conditions.

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

Not applicable. This submission relies on scientific and engineering testing (chemical analysis, biocompatibility, sterility validation) rather than expert consensus on diagnostic interpretations or clinical outcomes. There is no "ground truth" established by human experts in the context of a test set for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. There's no "test set" requiring adjudication by multiple readers/experts in this type of submission. The evaluation is based on objective laboratory measurements and adherence to standards.

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

No. An MRMC study is typically for evaluating the diagnostic performance of a medical imaging device or software. This device is an organ preservation solution, and its evaluation focuses on chemical integrity, safety (biocompatibility, sterility), and stability under new storage conditions.

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

Not applicable. This device is not an algorithm or AI system. Its performance is inherent in its chemical properties and physical stability.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Chemical Analysis: Demonstrating the chemical composition of the proposed device (stored ambient) is identical to the predicate device (stored refrigerated). The "truth" is the established chemical formula and stability profile.
• Biocompatibility Standards: Adhering to the requirements of ISO 10993 series, where the "truth" is that the materials are deemed safe for biological contact.
• Sterility Validation Standards: Adherence to ISO 17665 or USP Section , establishing "truth" through validated sterilization processes.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this device is not a predictive model or AI system.

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

Not applicable. As explained in point 8, there's no training set for this type of device.

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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 Dr. Folkert O. Belzer. The cold storage solution is still referred to as "Belzer UW" solution, even though it has been marketed under the trade name ViaSpan®. The formulation includes soluble colloids, buffers, sodium and postassium 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.

Here's an analysis of the provided 510(k) summary regarding the CoStorSol® device, focusing on acceptance criteria and supporting studies:

Summary of Acceptance Criteria and Device Performance for CoStorSol®

The provided 510(k) summary for CoStorSol® establishes substantial equivalence by demonstrating that the device is identical in composition, intended use, and performance to a legally marketed predicate device, ViaSpan® (Belzer - UW) Organ Solution (K944866). Therefore, the "acceptance criteria" are implicitly met by demonstrating this identity and confirming essential safety and functional characteristics.

Study Details:

The 510(k) submission for CoStorSol® primarily relies on demonstrating substantial equivalence to a predicate device rather than conducting a de novo clinical study with specific performance endpoints. The "study" here refers to the testing and analysis performed to prove this equivalence.

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

   • No specific "test set" in the sense of a patient cohort or a dataset with ground truth labels is described for this type of device. The samples used were samples of the CoStorSol® product itself for various chemical, biological, and physical tests.
   • The provenance of these test samples (e.g., manufacturing location, specific batch numbers) is not detailed. The tests performed are laboratory-based.
   • This is not a retrospective or prospective human clinical study. The data is generated from laboratory testing of the solution and its packaging materials.

2. 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):

   • This is not applicable. The "ground truth" for this type of device is established through validated laboratory methods for chemical composition, sterility, biocompatibility, and physical characteristics, rather than expert interpretation of medical images or clinical outcomes. The experts involved would be laboratory scientists, chemists, and microbiologists adhering to established standards (e.g., ISO, USP).

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

   • Not applicable. Adjudication methods are typically employed in studies where human interpretation or consensus is required (e.g., pathology review, clinical endpoints). Here, objective laboratory measurements are the basis of evaluation.

4. 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 an organ preservation solution, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant in this context.

5. 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.

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

   • The "ground truth" here is the established scientific and regulatory standards for chemical identity, sterility, biocompatibility, and stability, as demonstrated through objective laboratory testing. The predicate device's established efficacy and safety, based on its identical formulation, serves as the ultimate benchmark.

7. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not a machine learning model.

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

   • Not applicable, as there is no training set.

Conclusion from the 510(k) Summary:

The 510(k) submission for CoStorSol® demonstrates substantial equivalence to the predicate device, ViaSpan® (K944866), by showing that it is an identical solution with the same intended use and chemical composition. Supporting evidence includes:

• Biocompatibility testing against ISO 10993.
• Validation of sterilization processes against ISO 17665 or USP .
• Chemical analyses and Fourier transformed infrared scans confirming identity and stability to the predicate.

This approach is common for devices that are direct copies or minor modifications of existing, legally marketed products, where the safety and effectiveness profile is already well-established by the predicate. Therefore, the "study" demonstrating the device meets acceptance criteria is primarily a series of laboratory tests and analyses confirming identity and adherence to relevant standards.

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