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The BEL-GEN Cold Storage Solution is intended for the flushing and the hypothermic 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.

Institut Georges Lopez manufactures the BEL-GEN Cold Storage Solution according to the solution pioneered at the University of Wisconsin by Dr Folkert O. Belzer, 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).

The BEL-GEN Cold Storage Solution is a clear to light yellow single use, sterile and non-pyrogenic solution. BEL-GEN Cold Storage Solution has an osmolality of 320 mOsm/kg, a total sodium concentration of 29 mmol/L, a total potassium concentration of 125 mmol/L and a pH of 7.4 at room temperature. The solution is packaged in 1-liter or 2-liter bags with a shelf life of 2 years.

The BEL-GEN Cold Storage solution is used at hospital by health professionals. The BEL-GEN Cold Storage solution must be cooled to +2°C (36° and 43°F) prior to use The cold solution is used to flush the isolated organ immediately before removal from the donor and/or immediately after removal from the donor. The solution is then left in the organ vasculature during hypothermic storage and transportation to cool the organ and lower its metabolic requirements.

The provided text is a 510(k) Premarket Notification for a medical device called "BEL-GEN Cold Storage Solution." This document focuses on demonstrating that the device is substantially equivalent to existing predicate devices, rather than proving its efficacy through a clinical study with specific acceptance criteria related to a new function or performance benefit.

Therefore, many of the requested details about acceptance criteria, study design for device performance, expert involvement, and ground truth establishment are not directly applicable or present in this type of regulatory submission. The submission is primarily about proving manufacturing quality, safety, and equivalence to a known product.

Here's an analysis based on the provided document, addressing the points where information is available and indicating where it is not:

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

The document does not present "acceptance criteria" in the traditional sense of a clinical trial with performance metrics. Instead, it demonstrates through non-clinical testing that the device meets established safety and quality standards and retains its properties over its shelf life, showing equivalence to predicate devices.

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

This submission describes non-clinical testing (e.g., sterilization validation, biomaterial safety, stability testing) rather than a clinical study involving human or animal subjects for assessing device performance on organs. Therefore, concepts like "test set sample size" for a clinical trial are not applicable here.

• Sample Size: Not specified in terms of clinical cases, but standard testing methodologies for sterilization, biocompatibility, and stability would have defined sample sizes for their respective tests (e.g., number of bags tested for sterility, number of animals for toxicity tests, number of solution samples for stability). These specific numbers are not detailed in the summary.
• Data Provenance: The manufacturer is Institut Georges Lopez (IGL) based in Lissieu, France. The tests were performed to current industry standards (ISO). The testing is prospective for the purpose of this submission (i.e., new tests performed to support the 510(k)).

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)

This is not applicable as there is no "ground truth" established by experts in the context of clinical performance or diagnosis for this type of submission. The tests performed are laboratory-based (e.g., chemical analysis, microbiological testing, in-vitro/in-vivo biocompatibility assays, stability testing). "Ground truth" in this context refers to the defined results of these standardized tests against established parameters (e.g., a solution is sterile if no microbial growth is detected).

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

Not applicable. This is not a study assessing human reader performance or diagnostic accuracy.

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 is a premarket notification for a medical solution, not an AI/CADe/CADx device that assists human readers.

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

Not applicable. This is a cold storage solution, not an algorithm.

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

As mentioned in point 3, the "ground truth" refers to the scientific and regulatory standards met by the physical and chemical properties of the solution and its packaging, and its biological safety. This is based on:

• Chemical composition, pH, osmolality: Verified by analytical chemistry methods to conform to the established formulation (Belzer UW solution).
• Sterility: Absence of microbial contamination, verified by microbiology testing (e.g., sterility tests).
• Non-pyrogenicity: Absence of fever-inducing substances, verified by pyrogen testing.
• Biocompatibility: Absence of toxic or adverse reactions, verified by ISO 10993 compliant in-vitro and in-vivo tests.
• Stability: Maintenance of critical parameters over time, verified by accelerated and real-time aging studies.

These are objective, laboratory-determined "truths" against scientific definitions and regulatory thresholds, not subjective expert consensus.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set. The device is a chemical solution.

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

Not applicable, as there is no training set for this type of device.

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The BEL-GEN® Cold Storage Solution is intended for the flushing and the hypothermic 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.

The BEL-GEN® Cold Storage Solution (BEL-GEN Solution) is clear to light yellow, sterile and pyrogen-free solution. BEL-GEN Solution has an approximate osmolality of 320 mOsm/kg, a sodium concentration of 29 mmol/L, a potassium concentration of 125 mmol/L and a pH of 7.4 at 20°C.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BEL-GEN® Cold Storage Solution:

Important Note: The provided text is a 510(k) summary and FDA clearance letter for a medical device (BEL-GEN® Cold Storage Solution). This type of regulatory document primarily focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device) rather than providing a detailed clinical study report with specific performance metrics and acceptance criteria as one might find for a novel diagnostic AI algorithm. Therefore, many of the requested fields related to AI model performance, expert ground truth, and comprehensive clinical study design are not applicable or not present in this document.

Acceptance Criteria and Reported Device Performance

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance:

   • The document does not describe a "test set" in the context of an AI algorithm or a clinical trial with a defined patient sample size. The substantial equivalence determination is based on the chemical and physical properties of the solution and container, as well as its intended use.
   • Data provenance for specific tests (biocompatibility, stability, chemical identity) is not specified, but these are typically conducted in-house by the manufacturer or by contract labs.

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

   • Not applicable. This is not an AI diagnostic device and does not involve expert-established ground truth for a test set in that sense. The "ground truth" here is the established safety and effectiveness profile of the predicate device and the adherence of the new device to its specified chemical and physical properties.

3. Adjudication method for the test set:

   • Not applicable. No "test set" or adjudication method in the context of AI algorithm evaluation is described.

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 is a cold storage solution for organs, not an AI diagnostic device. No MRMC study was conducted.

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

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

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

   • The "ground truth" for the substantial equivalence claim relies on:
     • The established safety and effectiveness of the predicate device (SPS-1 Static Preservation Solution).
     • Laboratory test results demonstrating the physico-chemical properties (osmolality, pH, concentrations) of the BEL-GEN Solution.
     • Validation of device characteristics such as sterility, pyrogenicity, and biocompatibility, stability, and chemical identity of the dispensing bag.

7. The sample size for the training set:

   • Not applicable. This is a medical solution, not an AI model, so there is no training set.

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

   • Not applicable. No training set is involved.

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