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The PERF-GEN Pulsatile Perfusion is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.

Institut Georges Lopez manufactures the PERF-GEN Pulsatile Perfusion Solution according to the solution pioneered at the University of Wisconsin by Dr Folkert O. Belzer, often referred to as "Belzer-MPS solution" used as kidney flushing and perfusion storage solution. The formulation includes soluble colloids, buffers, sodium and potassium salts, redox stabilizers, and compounds to aid tissue viability by enabling regeneration of adenosine triphosphate (ATP). The PERF-GEN Pulsatile Perfusion Solution is a clear to light yellow, sterile, non-pyrogenic solution for the in-vitro flushing and temporary continuous perfusion of explanted kidneys. PERF-GEN Pulsatile Perfusion Solution has an osmolality of 300 mOsm/kg, a total sodium concentration of 100 mmol/L, a total potassium concentration of 25 mmol/L and a pH of 7.4 at room temperature. The solution is packaged in 1-liter bags with a shelf life of 18 months. The PERF-GEN Pulsatile Perfusion Solution is used at hospital by health professionals. The PERF-GEN Pulsatile Perfusion Solution must be cooled to +2°C and +8°C (35.6-46.5°F) prior to use. The colution is used for the in-vitro flushing and temporary continuous perfusion of explanted kidneys.

The provided text describes the 510(k) summary for the PERF-GEN Pulsatile Perfusion Solution. This document is a premarket notification for a medical device and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study demonstrating device performance against specific acceptance criteria for AI/diagnostic devices.

Therefore, many of the requested categories related to AI/diagnostic device performance, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this submission.

The "acceptance criteria" in this context refer to the successful completion of non-clinical tests to demonstrate that the expanded shelf life and storage conditions do not raise new questions of safety or effectiveness compared to the predicate.

Here's the information that could be extracted from the provided text:

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

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

• Not Applicable. This submission details non-clinical testing (sterility, biocompatibility, stability) on the perfusion solution itself, not a diagnostic or AI device tested on patient data. There isn't a "test set" in the context of patient data.

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. Ground truth for clinical data is not relevant to this type of device submission. The 'ground truth' for non-clinical tests would be defined by validated laboratory methods and standards.

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

• Not Applicable. Adjudication methods are for clinical data interpretation, not for objective non-clinical laboratory tests.

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 not an AI or diagnostic device.

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

• Not Applicable. This is not an AI or diagnostic device.

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

• Not Applicable (in the clinical sense). For the non-clinical tests, the "ground truth" would be established by the adherence to ISO standards (e.g., ISO 13408 for sterility, ISO 10993 for biocompatibility) and accepted laboratory methodologies for stability testing.

8. The sample size for the training set

• Not Applicable. There is no AI model or "training set" for this device.

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

• Not Applicable. There is no AI model or "training set" for this device.

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The PERF-GEN® Pulsatile Perfusion Solution is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.

The PERF-GEN® Pulsatile Perfusion (PERF-GEN Solution) is a clear, sterile, non-pyrogenic, non-toxic solution for the in-vitro flushing and temporary continuous perfusion of explanted kidneys. This solution has an approximate calculated osmolarity of 300 mOsm/kg, a sodium concentration of 100 mEq/L, a potassium concentration of 25 mEq/L, and a pH of approximately 7.4 at room temperature.

The PERF-GEN® Pulsatile Perfusion Solution is a medical device that received a 510(k) clearance based on substantial equivalence to a predicate device, the BELZER-MPS™ UW Machine Perfusion Solution. This regulatory pathway typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical trials to establish new efficacy. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the demonstration of substantial equivalence through comparative testing and analysis against the predicate, rather than performance against pre-defined, quantitative clinical metrics of efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable in the traditional sense of a clinical test set for performance, as this was a substantial equivalence submission relying primarily on bench testing and comparison.
• Data Provenance: The studies performed were primarily bench testing (biocompatibility, stability, chemical comparisons) conducted by the manufacturer, Waters Medical Systems, LLC. The "data provenance" refers to the results generated from these in-house or contract laboratory tests. There is no mention of country of origin for clinical data as no clinical trials were presented for this 510(k).

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

• Not applicable. Ground truth in the context of this 510(k) submission was established through scientific and engineering principles applied to the comparative testing and analysis against the predicate device's known characteristics, rather than expert consensus on clinical outcomes. The FDA's review division (Division of Reproductive, Gastro-Renal, and Urological Devices) evaluated the submitted evidence.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set requiring adjudication in the context of expert review was conducted or reported. Adjudication in this context would refer to the FDA's regulatory review process, where they adjudicate the substantial equivalence claim based on the submitted evidence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs without AI Assistance

• Not applicable. This device is a pulsatile perfusion solution, a chemical and delivery system for organ preservation, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI-driven performance improvements are irrelevant to this submission.

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

• Not applicable. This device is a solution used in organ preservation, not an algorithm or software. Its performance is evaluated through its physical and chemical properties, and its biological interaction with organs, not through a standalone algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this 510(k) submission was demonstrably equivalent to the predicate device regarding:
  • Predicate Device Characteristics: The known, legally marketed, and accepted properties, composition, and performance of the BELZER-MPS UW Machine Perfusion Solution.
  • ISO 10993 Standards: Biocompatibility testing followed established international standards, where "ground truth" is defined by the passing criteria of these validated tests.
  • Chemical Equivalence: Established through analytical chemistry techniques (infrared, chromatography, conductivity), where "ground truth" is the scientific validation of similar molecular and ionic profiles.
  • Stability Standards: Industry-accepted methods for shelf-life determination.

8. The Sample Size for the Training Set

• Not applicable. This medical device is not an AI/ML algorithm that requires a training set. The "training" for this product would conceptually involve its development and formulation, and the testing involved was to validate its properties against established standards and the predicate.

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

• Not applicable. As the device is not an AI/ML algorithm, a "training set" and associated "ground truth" for training are not relevant concepts in this submission.

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