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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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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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The WAVES is intended to be used for the pulsatile hypothermic machine perfusion of kidneys for preservation, transportation, and eventual transplantation into a recipient.

The WAVES is a transportable, self-contained renal preservation system, designed to support static monitoring and transportation of kidneys. The WAVES system provides controlled pulsatile kidney perfusion using oxygenated hypothermic physiologic solutions, and monitors, displays, trends, and saves important perfusion parameters, including: perfusate flow, temperature, pressure, and renal resistance. The WA VES system can be configured to signal an audio and visual alarm for user-selected limits.

The WAVES is a two-part system comprising a 'control unit' for perfusion and monitoring of a single kidney, and a sterile, single-use, disposable 'cassette module' used to contain, refrigerate, and circulate perfusate to and through the kidney.

The provided document describes a medical device called WAVES, a renal preservation system, and discusses its substantial equivalence to predicate devices for 510(k) premarket notification. However, it does not contain information about acceptance criteria, device performance metrics, or study details in the format requested, such as test set size, data provenance, expert-established ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

The document focuses on demonstrating substantial equivalence through a comparison of intended use, principle of operation, and specific control aspects (perfusion and hypothermic) with predicate devices. It mentions that certain aspects like pump performance, cooling system performance, and software validation were evaluated. Sterilization and biomaterial testing were also conducted.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.

The document primarily asserts substantial equivalence based on:

• Intended Use: All systems perform pulsatile hypothermic machine perfusion of kidneys for preservation, transportation, and eventual transplantation.
• Principle of Operation: Similar design and function for maintaining kidneys.
• Perfusion Control: WAVES perfusion control (perfusate parameters, pressure, automated features, cassette priming) is "substantially equivalent" and "evaluated through a pump performance testing and a software validation testing."
• Hypothermic Control: WAVES hypothermic control (cassette mounting, cooling method/duration/temperature, heat exchanger) is "substantially equivalent" and "evaluated through a cooling system performance testing and a software validation testing."
• Disposable Cassette Module: Sterilization validated per ISO 11135-1, and shelf life supported by accelerated aging testing.
• Biomaterials: ISO 10993 compliant testing for new biomaterials.
• User Interface: Software validation testing showed user interface operates as expected.

The FDA's letter explicitly states that they "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination means a comparative effectiveness study in the sense of AI performance metrics (like sensitivity, specificity, AUC) against human readers or a pathology-confirmed ground truth is not typically required or performed for such a device, as it's a renal preservation system, not a diagnostic imaging AI.

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