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The OrganProtex™ HTK Solution is indicated for perfusion and flushing of donor kidneys, liver, pancreas and heart prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation to the patient. OrganProtex™ HTK Solution is not indicated for continuous machine perfusion of donor organs.

OrganProtex™ HTK Solution is a clear, colorless to pale yellow colored solution, sterile, nonpyrogenic electrolyte and amino acid aqueous solution for organ perfusion and preservation. OrganProtex™ HTK Solution is indicated for perfusion and flushing of donor kidneys, liver, pancreas and heart prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation to the patient. OrganProtex™ HTK Solution is not indicated for continuous machine perfusion of donor organs.

Histidine-tryptophan-ketoglutarate or HTK solution is a high-flow, low-potassium preservation solution used for organ transplantation. The solution was initially developed by Hans-Jurgen Bretschneider.

HTK solution is based on the principle of inactivating organ function by withdrawal of extracellular sodium and calcium, together with intensive buffering of the extracellular space by means of histidine hydrochloride, so as to prolong the period during which the organs will tolerate interruption of oxygenated blood. The composition of HTK is similar to that of extracellular fluid. All of the components of HTK, with the exception of mannitol, occur naturally in the body. The solution should be used only by medical healthcare staff, adequately trained according to established operating protocols.

The document describes the OrganProtex™ HTK Solution, which is an organ preservation solution. This device is applying for 510(k) clearance based on substantial equivalence to a predicate device, Custodiol® HTK Solution (K192408).

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a medical solution, the "acceptance criteria" and "reported device performance" are primarily focused on demonstrating equivalence in composition, function, and safety to a legally marketed predicate device, rather than a quantifiable performance metric against a specific clinical outcome.

The main acceptance criterion for a 510(k) is demonstrating substantial equivalence to an existing predicate device. This is achieved by showing that the new device has the same intended use, and either the same technological characteristics or, if different, that these differences do not raise new questions of safety and effectiveness.

The document provides a detailed comparison table (Table 6.0 in the original document, reproduced below as "Comparison of Technological Characteristics") that serves as the reported device performance against the predicate.

Comparison of Technological Characteristics

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

This is a submission for a medical solution, not typically a device that undergoes "test set" evaluation in the same way an AI/software device would. The "test set" here refers to the data and testing used to demonstrate the solution's properties (sterility, pH, osmolality, shelf life, biocompatibility).

• Sample Size for Test Set: The document doesn't specify a numerical "sample size" in terms of how many units of OrganProtex™ HTK Solution were tested for each non-clinical performance category (biocompatibility, sterilization, shelf-life). These are standard laboratory tests typically performed on a statistically relevant batch size for manufacturing quality control and regulatory submission.
• Data Provenance: The manufacturing entity is Rusoma Laboratories Pvt. Ltd. in India. The studies performed (biocompatibility, sterilization, shelf-life) were conducted to demonstrate the properties necessary for substantial equivalence. The document doesn't specify if the underlying data/tests were conducted retrospectively or prospectively, but typically, these are prospectively planned tests to support the submission.

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

This type of information (number of experts, qualifications, and ground truth establishment) is typically relevant for studies involving human interpretation, such as image analysis for diagnosis. For a medical solution like OrganProtex™ HTK Solution, there isn't a "ground truth" established by human experts in the same way. The ground truth for its properties (like sterility, pH, composition) is established through analytical chemistry, microbiology, and physical property testing performed by qualified laboratory personnel following validated methods.

4. Adjudication Method for the Test Set

Not applicable for this type of device. Adjudication methods (e.g., 2+1, 3+1) are common in clinical trials or human performance studies where multiple experts evaluate cases and discrepancies are reconciled. The non-clinical performance data for OrganProtex™ HTK Solution relies on objective laboratory measurements.

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 medical solution (a liquid for organ preservation), not an AI-powered diagnostic or assistive device. Therefore, MRMC studies and the concept of "human readers" or "AI assistance" are not relevant here.

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

Not applicable. This is a medical solution and does not involve any algorithms or software for standalone performance.

7. The Type of Ground Truth Used

The ground truth for the non-clinical performance data is based on:

• Analytical Chemistry: For composition, pH, osmolality.
• Microbiology Testing: For sterility and pyrogenicity.
• Biocompatibility Testing: In accordance with ISO 10993 standards.
• Stability Studies: To determine shelf life.

8. The Sample Size for the Training Set

Not applicable. This product is a medical solution, not a machine learning model, so there is no "training set."

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

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

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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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Servator M SALF 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, and eventual transportation, and eventual transplantation into a recipient.

The Servator M SALF is a clear, sterile, non-pyrogenic, non-toxic solution for the in-vitro flushing and temporary continuous perfusion preservation of explained kidneys. This solution has an approximate calculated osmolarity of 300 mOsm/kg, a sodium concentration of 100 mEq/L, a potassium concentration of 25 rnEq/L, and a pH of approximately 7.4 at room temperature. The primary containers used for the device are PVC free bags 1000ml, therefore they are free of phthalates. The solution may be used without any point of use filtration. Servator M SALF 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 Servator M SALF Solution is intended for flushing and continuous hypothermic machine perfusion of kidneys, and for the preservation of these organs for eventual transplantation. The device is a clear, sterile, non-pyrogenic, non-toxic solution.

Here's a breakdown of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance relies on demonstrating substantial equivalence to a predicate device (PERF-GENQ® Pulsatile Perfusion Solution, K121736). Therefore, the acceptance criteria are based on matching or providing equivalent performance/characteristics to the predicate.

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

The document does not explicitly mention a "test set" in the context of a clinical trial with a defined sample size for the Servator M SALF Solution itself. Instead, the evaluation focuses on non-clinical performance data and a direct comparison to a predicate device.

• Non-Clinical Performance Data: The reported data includes:
  • Biocompatibility tests (according to ISO 10993 series).
  • Sterilization and Shelf Life validation (according to ISO 17655-1).
  • Chemical comparisons.
  • Leachables performance testing.

The document does not specify the number of samples used for each of these non-clinical tests.

• Data Provenance: The device manufacturer is SALF S.p.A. in Italy, suggesting the non-clinical testing was likely conducted in Italy or by contracted labs. The nature is retrospective in terms of comparing against the established predicate specifications and existing standards.

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

This information is not applicable as the clearance is based on substantial equivalence demonstrated through non-clinical testing and direct comparison to a predicate, rather than a clinical study requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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

This information is not applicable. The device is a medical solution for organ preservation, not an AI-assisted diagnostic or imaging tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.

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

This information is not applicable. The device is a physical solution and not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness profile of the predicate device (PERF-GENQ® Pulsatile Perfusion Solution) and the adherence to relevant international standards (ISO 10993, ISO 17665-1, USP , USP ) for biocompatibility, sterility, and particulate matter. The core of the submission is to demonstrate that the Servator M SALF Solution is chemically identical and performs equivalently to the predicate, meeting these established safety and performance benchmarks.

8. The Sample Size for the Training Set

This information is not applicable. This is not a machine learning or AI device that requires a training set. The "training" in this context refers to the development and manufacturing processes adhering to quality systems (e.g., good manufacturing practice).

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

This information is not applicable. As mentioned above, this device does not utilize a training set in the AI/ML sense.

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CUSTODIOL® HTK solution is indicated for perfusion and flushing of donor kidneys, liver, pancreas and heart prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation to the patient. CUSTODIOL® HTK solution is not indicated for continuous machine perfusion of donor organs.

The CUSTODIOL® HTK solution is intended for perfusion and flushing donor kidney, liver, heart, and pancreas prior to removal from the donor and for preserving these organs during hypothermic storage and transport to the recipient. CUSTODIOL® HTK solution is based on the principle of inactivating organ function by withdrawal of extracellular sodium and calcium, together with intensive buffering of the extracellular space by means of histidine/histidine HCI, so as to prolong the period for which the organs will tolerate interruption of blood and oxygen supply. Only a small portion of the osmolality of the CUSTODIOL® HTK solution is due to the sodium and potassium. The composition of HTK is similar to that of extracellular fluid. All of the components of the CUSTODIOL® HTK solution occur naturally in the body. The CUSTODIOL® HTK solution is relatively low in potassium concentration so that residual solution in the transplanted organ poses no danger to the recipient. This is particularly important in orqans that take up relatively large amounts of the perfusate, which may find its way into the recipient's circulation. The CUSTODIOL® HTK solution has a low viscosity, even at low temperatures. This characteristic assures rapid flow rates during initial perfusion, allowing the organ to be quickly cooled.

This document is a 510(k) premarket notification for the CUSTODIOL® HTK Solution, an organ preservation solution. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K043461), rather than outlining specific performance criteria and a study to prove they are met in a traditional sense for a new AI/diagnostic device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission. The document primarily focuses on comparing the new device to a predicate based on existing data and prior clearances.

Here's a breakdown of what can be extracted and what cannot:

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

The document does not present "acceptance criteria" and "reported device performance" in the typical format of a diagnostic or AI device where specific metrics (e.g., sensitivity, specificity, AUC) are measured against predefined thresholds. Instead, the "acceptance criterion" for this 510(k) is demonstrating substantial equivalence to the predicate device.

The "reported device performance" is essentially the demonstrated similarity across various characteristics, supported by existing data and non-clinical testing.

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

This information is not provided in this 510(k) submission. The document relies on existing data, standards, and non-clinical testing to demonstrate substantial equivalence, rather than a specific new clinical "test set" with a defined sample size for performance evaluation. The "non-clinical testing" mentioned for packaging differences likely involved laboratory tests, not a patient-based test set.

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 information is not applicable/not provided. This is a device for organ preservation, not an AI/diagnostic device that generates an output requiring expert interpretation or "ground truth" establishment in the context of a diagnostic study.

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

This information is not applicable/not provided. See point 3.

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

This information is not applicable/not provided. This is not an AI-assisted diagnostic device.

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

This information is not applicable/not provided. This is an organ preservation solution, not an algorithm.

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

This information is not applicable/not provided in the context of a new study to establish "ground truth" for a performance evaluation. The "ground truth" here is the established safety and efficacy of the predicate device, and the substantial equivalence of the current device to that predicate based on physico-chemical properties, biological characteristics, and non-clinical testing.

8. The sample size for the training set

This information is not applicable/not provided. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable/not provided. There is no "training set" for this type of device submission.

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The Servator H SALF solution is indicated for perfusion and flushing donor kidneys, liver, pancreas, and heart prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation (not for continuous perfusion) to the recipient.

The Servator H SALF solution is intended for perfusion and flushing donor kidneys, liver, pancreas, and heart prior to removal form the donor or immediately after removal from the donor. The solutions is left in the organ vasculature during hypotermic storage and transportation (not for continuous perfusion) to the recipient. Servator H SALF solution is based on the principle of inactivating organ function by withdrawal of extracellular sodium and calcium, together with intensive duffering of the extrcellular space by means of histidine/histidine HCI, so as to prolong the period for which organs will tolerate interruption of blood and oxygen supply. Only a small portion of the osmolality of the Servator H SALF solution is due to the sodium and potassium. The composition of the Servator H SALF is similar to that of extracellular fluid. All of the components of the Servator H SALF solution occur naturally in the body.

The provided document is a 510(k) summary for the Servator H SALF Solution, which is an organ perfusion and preservation solution. It primarily focuses on demonstrating substantial equivalence to a predicate device (Custodiol HTK) rather than presenting a standalone study with specific acceptance criteria and detailed performance metrics of the device as an AI or diagnostic tool.

Therefore, many of the requested details about acceptance criteria, study design, ground truth establishment, sample sizes for training/test sets, expert involvement, and MRMC studies are not applicable or not explicitly detailed in this type of regulatory submission.

However, based on the non-clinical performance data section, we can infer some "acceptance criteria" through the tests conducted.

Here's a breakdown of the information that can be extracted or inferred:

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

Since this is a substantial equivalence claim for a physical solution and not an AI/diagnostic device, acceptance criteria are generally related to safety, sterility, biocompatibility, and chemical composition matching the predicate.

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

This information is not provided in the document. The document refers to "performance data" and "test standards" but does not detail sample sizes for any specific tests or the provenance of the data beyond the manufacturer being S.A.L.F. S.p.A. (Italy).

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 information is not applicable as the device is a chemical solution for organ preservation, not a diagnostic device requiring expert interpretation for ground truth.

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

This information is not applicable for the same reason as above.

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

This information is not applicable as the device is not an AI-assisted diagnostic tool or an imaging device.

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

This information is not applicable as the device is a chemical solution, not an algorithm.

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

For this type of device (organ preservation solution), "ground truth" is established through:

• Chemical composition analysis: Comparing the exact chemical constituents and their concentrations to the predicate device.
• Biocompatibility testing: Standardized in-vitro and in-vivo tests to assess toxicity, irritation, etc.
• Sterility testing: Confirmation of absence of microbial contamination.
• Stability testing: Confirmation that the solution maintains its properties over its shelf life.

The document states that a "direct comparison between the subject and predicate device" was completed for performance testing including chemical analysis, and that "performance reports are included in the submission." This implies that the ground truth for chemical and physical properties was the established characteristics of the predicate device.

8. The sample size for the training set

This information is not applicable as the device is a chemical solution, not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the same reason as above.

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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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SPS-1TM 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.

SPS-1 TM is a clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs. The solution has an approximate calculated osmolality of 320 mOsm, a sodium concentration of 29 mEq/L, a potassium concentration of 125 mEq/L, and a pH of approximately 7.4 at 20°C.

The provided document (K091656) does not contain information about a study proving the device meets acceptance criteria. Instead, it is a 510(k) summary for a "Static Preservation Solution" that establishes substantial equivalence to predicate devices based on shared manufacturing processes, chemical composition, and intended use.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment are not available in this document.

Here's a breakdown of what can be extracted and what is missing:

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

   • Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a study. The "functional and safety testing" mentions verifying device design met its requirements through biocompatibility, sterility, chemical identification, and particle enumeration in accordance with standards. However, the specific acceptance criteria (e.g., maximum allowable particle count, sterility pass/fail definition) and the results against these are not detailed.
   • Reported Device Performance: Not provided in terms of outcome statistics from a study (e.g., organ viability rates, post-transplant function). The document states the primary evidence for equivalence is that the device and predicate devices "are manufactured by the same process, with exactly the same chemical composition and have the same intended use." This implies performance is assumed to be equivalent due to these factors, rather than directly measured in a comparative study.

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

   • Sample Size: Not applicable. No clinical or comparative study data is presented. The "testing" mentioned refers to laboratory tests (biocompatibility, sterility, etc.), not a test set of patient or organ data.
   • Data Provenance: Not applicable.

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. No ground truth establishment for a test set is described.

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

   • Not applicable. No test set requiring adjudication is described.

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 device is a static preservation solution, not an AI-assisted diagnostic tool or system that involves human readers.

6. 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.

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

   • Not applicable in the context of a performance study. For the laboratory testing (biocompatibility, sterility, chemical ID, particle enumeration), the "ground truth" would be the established industry standards and validated test methods for these specific properties.

8. The sample size for the training set:

   • Not applicable. This device is a medical solution, not a machine learning model requiring a training set.

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

   • Not applicable.

Summary of Device Acceptance Rationale from the Document:

The acceptance of the SPS-1™ Static Preservation Solution (K091656) by the FDA is based on demonstrating substantial equivalence to existing legally marketed predicate devices (CoStorSol® K083453, K073693, and ViaSpan® K944866).

The key arguments for substantial equivalence are:

• The SPS-1™ is manufactured by the same process as the predicate devices.
• It has exactly the same chemical composition as the predicate devices.
• It has the same intended use (flushing and cold storage of kidney, liver, and pancreas organs for transplantation).

Functional and safety testing mentioned includes biocompatibility, sterility, chemical identification, and particle enumeration, all performed "in accordance with applicable industry standards and/or FDA guidance documents." However, specific results or acceptance criteria for these tests are not detailed in this summary. The primary evidence presented for equivalence relies on the identical nature of the product to already approved devices.

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Custodiol HTK Solution is indicated for perfusion and flushing donor kidneys, liver, pancreas, and heart prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation (not for continuous perfusion) to the recipient.

The HTK solution is intended for perfusion and flushing donor kidney, liver, heart, and pancreas prior to removal from the donor and for preserving these organs during hypothermic storage and transport to the recipient. HTK solution is based on the principle of inactivating organ function by withdrawal of extracellular sodium and calcium, together with intensive buffering of the extracellular space by means of histidine/histidine HCI, so as to prolong the period for which the organs will tolerate interruption of blood and oxygen supply. Only a small portion of the osmolality of the HTK solution is due to the sodium and potassium. The composition of HTK is similar to that of extracellular fluid. All of the components of the HTK solution occur naturally in the body. The HTK solution is relatively low in potassium concentration so that residual solution in the transplanted organ poses no danger to the recipient. This is particularly important in organs that take up relatively large amounts of the perfusate, which may find its way into the recipient's circulation. The HTK solution has a low viscosity, even at low temperatures. This allows the organ to be quickly cooled.

Here's a breakdown of the acceptance criteria and study information for the Custodiol® HTK Solution, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than defining specific performance acceptance criteria like often seen for novel AI/medical imaging devices. For drug or solution products like Custodiol HTK Solution, "performance" is typically measured by clinical outcomes related to organ preservation effectiveness.

Therefore, the "acceptance criteria" here are implicitly tied to the performance of the legally marketed predicate devices, and the "reported device performance" is the demonstration that Custodiol HTK Solution performs similarly.

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

• Test Set Sample Size: The document states that "a small number of independent clinical studies" were used to demonstrate equivalence. It does not specify the exact sample sizes for these studies.
• Data Provenance: The studies are described as "independent clinical studies," suggesting real-world data, likely prospective or retrospective clinical trials comparing outcomes. The country of origin is not specified.

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

This type of information (number and qualifications of experts) is typically relevant for studies involving subjective assessment (e.g., image interpretation). For a solution like Custodiol HTK, the "ground truth" for its effectiveness is generally established by objective clinical outcomes (e.g., organ survival rates, transplant success) rather than expert consensus on a subjective measure. Therefore, this question is not applicable in the traditional sense for this device.

4. Adjudication Method for the Test Set

As the "ground truth" is based on objective clinical outcomes, an adjudication method for subjective assessments is not applicable. Clinical studies generally have established protocols for data collection and outcome assessment, but not a "2+1" or "3+1" adjudication model for interpreting performance.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating diagnostic devices or AI algorithms that assist human readers in interpreting images or data.
• The Custodiol HTK Solution is an organ preservation solution, not an AI-powered diagnostic tool. Therefore, this question is not applicable.

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

• No, a standalone (algorithm-only) performance study was not done.
• The Custodiol HTK Solution is a medical product (chemical solution), not an algorithm or AI. Therefore, this question is not applicable.

7. The Type of Ground Truth Used

The ground truth used was primarily clinical outcomes data, specifically:

• "Survival rates"
• "Other outcome measures" (likely related to organ function post-transplant, rejection rates, etc.)

8. The Sample Size for the Training Set

• Not applicable. As this is a medical solution and not a machine learning algorithm, there is no "training set" in the context of AI development. The "training" or development of the solution would involve pharmaceutical research and chemical formulation, not data-driven model training.

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

• Not applicable. There is no "training set" or corresponding "ground truth" as defined for AI/ML devices. The "ground truth" for the overall effectiveness of the solution is established through clinical studies (as mentioned in point 7).

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