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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 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 RM4 control unit, as part of the RM4 Kidney Perfusion System is intended to be used for the pulsatile hypothermic machine perfusion of kidneys for preservation and eventual transplantation into a recipient only in healthcare professional environment.

The RM4 Control Unit controls kidney perfusion of hypothermic physiologic solutions and monitors, displays, trends, and saves the perfusion parameters. The RM4 Control Unit is part of the RM4 Kidney Perfusion System (RM4), which is a lightweight and compact renal perfusion system intended to provide controlled perfusion of a hypothermic physiologic solution for the preservation of donor kidney organs before transplantation into the recipient. The RM4 Control Unit is used with a sterile, disposable, singleuse, organ cassette intended to receive one or two kidneys from the same donor. The system is provided with a power cord and a USB flash drive that contains the instructions for use, and is intended to be used with an organ cassette and accessories including an insulation cover, and various cannulas/clamps for arterial cannulation of the kidneys to the perfusate circuit into the cassette.

The provided document is a 510(k) premarket notification for the RM4 control unit, an accessory to an isolated kidney perfusion and transport system. This device is intended for the pulsatile hypothermic machine perfusion of kidneys for preservation prior to transplantation.

The document focuses on demonstrating substantial equivalence to a predicate device (RM3 Renal Preservation System - Control Unit) through non-clinical testing. It does not present a study with specific acceptance criteria and performance data for an AI-powered device or a medical imaging system. Therefore, it is impossible to provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or ground truth types, as this information is not contained within the provided text.

The document highlights the following verification and validation activities for the RM4 control unit:

• Software Verification and Validation: Adherence to IEC 62304 and ISO 14971.
• Electrical Safety and Electromagnetic Compatibility: Compliance with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 62133, and IEC 60601-1-8.
• Performance Testing: Included sensors performance testing, pulsatile pump testing, cooling system testing, operational testing, bubble priming testing, power management testing, and accessories compatibility verification testing.

The conclusion states that these tests demonstrated that the RM4 Control Unit does not raise new issues of safety and effectiveness compared to the predicate device. However, no specific quantitative acceptance criteria or detailed performance results from these tests are provided in a format that would allow filling out the requested table or answering the specific questions about AI/imaging study design.

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