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Servator P Plus SALF Solution is indicated for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.

Servator P Plus SALF Solution is an extracellular electrolyte solution containing Dextran 40. The solution is pre-buffered with 2 mM THAM and pre-supplemented with 0.5 mM CaCl2. Servator P Plus is used for rapid cooling, perfusion, and cold static storage of lungs in connection with transplantation. Administration of the solution at the recommended temperatures will effectively cool the lung to reduce its metabolic requirements. The colloid component, Dextran 40 counteracts tissue oedema and protects the microvasculature against post-ischemic reperfusion injury. Calcium is important to maintain endothelial and epithelial cell integrity and endothelial contractility. The device is buffered with THAM to achieve a physiological ph. that enables safe preservation of lungs for up to 12 hours depending on status of the lung during retrieval. The intended patient population is adult patients in need of a lung transplantation.

The provided text describes a 510(k) submission for the Servator P Plus SALF Solution, an organ perfusion and preservation solution. The submission aims to demonstrate substantial equivalence to a predicate device, Perfadex Plus (K170826).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of acceptance criteria and the reported device performance:

The document primarily focuses on demonstrating substantial equivalence by comparing the subject device (Servator P Plus SALF Solution) to a predicate device (Perfadex Plus). The acceptance criteria are implicitly aligned with the characteristics of the predicate device and relevant industry standards.

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

The document does not specify a separate "test set" in the context of clinical or image-based studies. The performance data provided is primarily non-clinical, comparing the physical, chemical, and manufacturing characteristics of the subject device to the predicate device and relevant standards.

• Test Set Sample Size: Not applicable in the context of clinical/image data. The "test" here refers to non-clinical laboratory testing (e.g., biocompatibility, sterility, chemical analysis). The sample sizes for these lab tests would be determined by the specific ISO standards followed (e.g., number of units tested for sterility validation).
• Data Provenance: The studies are non-clinical, related to the manufacturing and composition of the solution. The provenance would be the manufacturing facility in Italy (S.A.L.F. spa) and the laboratories where the testing was conducted, following international standards (ISO, USP). The studies appear to be prospective, as they are conducted to validate the new device.

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

This information is not applicable. The device is a medical solution for organ preservation, not an AI/imaging device requiring expert interpretation for ground truth establishment. The "ground truth" for this device relates to its chemical composition, sterility, biocompatibility, and physical properties, which are established through laboratory testing against predefined scientific and regulatory standards.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or reader studies where human interpretation of data (e.g., images) needs to be reconciled to establish a consensus ground truth. This is not relevant for the non-clinical laboratory testing performed for a medical solution.

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 is not applicable. The Servator P Plus SALF Solution is an organ preservation solution, not an AI-based diagnostic or imaging device. Therefore, MRMC studies and AI assistance are not relevant to its evaluation.

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

This is not applicable. As mentioned, the device is a medical solution, not an algorithm or AI system.

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

For this device, the "ground truth" is established by:

• Chemical Analysis: Direct measurement of the qualitative and quantitative composition of the solution, compared against the known composition of the predicate device and formulation targets.
• Physical Property Measurements: Laboratory tests to determine pH, osmolarity, and appearance.
• Biocompatibility Standards: Adherence to ISO 10993 series standards, which define acceptable biological responses to medical devices.
• Sterilization Validation: Demonstrated sterility according to ISO 17665-1.
• Particulate Matter Limits: Conformance to USP limits.
• Shelf Life Data: Stability studies demonstrating the maintenance of product specifications over time.

These are objective, measurable criteria established by scientific and regulatory bodies, rather than subjective expert consensus or pathology in a clinical sense.

8. The sample size for the training set:

This is not applicable. There is no concept of a "training set" for an organ preservation solution. The development of the solution is based on established biochemical principles and extensive prior knowledge from the predicate device and organ preservation research.

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

This is not applicable. As there is no training set for this type of device, there is no ground truth establishment for a training set. The development and validation largely rely on established scientific knowledge, comparison to the predicate, and adherence to performance standards.

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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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Servator P SALF Solution with THAM is indicated for flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.

Servator P SALF Solution with THAM is a clear to light yellow, single use only, sterile (by steam sterilization) is indicated for the flushing, static cold storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into recipient. The solution is used for organ perfusion and hypothermic preservation. It is an ideal solution for the preservation of lungs.

The solution cooled to 4° to 8° C (39° to 46° F) is used to spray the organ isolated immediately after removal from the donor. The colloidal component Dextran 40 protects in particular microvessels from a possible damage caused by the post-ischemic reperfusion, since it prevents pathological leukocyte-endothelial interactions. In addition, Dextran 40 prevents edema and the formation of thrombi.

The primary containers used for the device are:

• 1. PVC free bags 1000ml, therefore they are free of phthalates. The solution may be used without any point of use filtration.
• 2. Clear glass bottles 25ml, therefore they are free of phthalates. The solution may be used without any point of use filtration.

The provided FDA 510(k) summary for "Servator P SALF Solution with THAM" does not describe an AI/ML-based medical device. Instead, it details a solution used for organ preservation (specifically lungs) during transplantation.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, MRMC studies, standalone performance, and ground truth establishment for an AI/ML device is not applicable to this submission.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Perfadex® with THAM) based on:

• Identical Indications for Use and Intended Use.
• Identical Chemical Composition: This is explicitly stated multiple times ("The composition list is identical for the subject and predicate device composition and therefore, the subject and predicate devices are identical in chemical composition.").
• Similar Technological Characteristics: Such as mode of operation (cold storage), container type, and sterilization method (steam).
• Non-Clinical Performance Data:
  • Biocompatibility: Tests performed according to ISO 10993 series. The subject device passed all biocompatibility test standards.
  • Sterilization and Shelf Life Validation: Sterility validated according to ISO 17655-1. Shelf life is 24 months, identical to the predicate.
  • Performance Testing: Chemical comparisons and leachable performance testing were conducted to demonstrate substantial equivalence to the predicate.

In summary, this 510(k) submission establishes substantial equivalence through direct comparison of the product's attributes and non-clinical testing, rather than through a study proving an AI/ML device meets specific performance criteria.

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Servator C SALF Solution is intended for flushing and cold storage of hearts at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.

Servator C SALF Solution is a clear to light yellow, single use only, sterile (by steam sterilization) and non-pyrogenic for hypothermic cardiac flushing and storage in preparation for transportation and eventual transplantation of the recipient. The solution is slightly alkaline (pH 7.3 ± 0.2 at 20°C), slightly hypertonic (approximate calculated osmolarity 242-368 mOsmol/L) with low viscosity (1.15 cSt), and has a high buffering capacity (acidic approximately 11 mmol, alkaline approximately 7 mmol). After removal from refrigerated storage (2°-8°C or 36°-46°F), the cold solution is used to flush the heart immediately before removal from the donor and/or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation. The primary containers used for the device are PVC free bags in 1000ml, therefore they are free of phthalates. The containers are in accordance with the reference European Pharmacopoeia and USP Pharmacopeia.

This document describes the Servator C SALF Solution, an organ perfusion and preservation solution, and its substantial equivalence to a predicate device (Celsior Cold Flush, Storage and Transport Solution for Hearts). The information provided focuses on non-clinical performance data to support this equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Servator C SALF Solution are not explicitly stated as numerical targets in the same way one might see for an AI algorithm's sensitivity or specificity. Instead, the acceptance criteria are demonstrated by proving substantial equivalence to the predicate device across various technological characteristics and performance tests. The "reported device performance" is essentially that the Servator C SALF Solution matches or passes the same standards as the predicate or relevant ISO standards.

The overall acceptance criterion is based on demonstrating that the Servator C SALF Solution is substantially equivalent to the predicate device (Celsior Cold Flush, Storage and Transport Solution for Hearts) in terms of safety and effectiveness, despite a minor difference in sterilization method.

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

The document does not explicitly mention a "test set" in the context of clinical trials with human subjects for efficacy. The studies performed are primarily non-clinical performance data focusing on chemical, physical, and biological properties of the solution and its packaging materials.

• Sample Size: Not specified in terms of number of organs or human subjects. The tests mentioned (e.g., biocompatibility guidance per ISO standards, particulate count per USP ) involve samples of the device components/solution itself. For instance, biocompatibility testing would involve a certain number of test specimens of the device material in contact with various biological environments.
• Data Provenance: The document does not specify country of origin for the non-clinical test data, but the manufacturer is SALF S.p.A., Italy. The studies are by nature prospective in the sense that they are designed and conducted specifically to test the new device's compliance with standards.

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

This is not applicable as the studies are non-clinical, comparing the device's characteristics against established standards and a predicate device, rather than against a ground truth established by medical experts for a diagnostic or AI performance study. Compliance with standards like ISO 10993 and USP is determined by accredited laboratories and their qualified technical staff.

4. Adjudication Method for the Test Set

Not applicable. The performance is assessed against predefined scientific standards and direct comparison with the predicate device's known characteristics, rather than through adjudication of medical decisions.

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 an organ preservation solution, not an AI-assisted diagnostic or imaging system. Therefore, MRMC studies involving human readers and AI are irrelevant to this submission.

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

Not applicable, as this is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is established by:

• Established scientific and regulatory standards: Such as ISO 10993 series for biocompatibility, ISO 17665-1 for sterilization, and USP for particulate matter.
• The chemical and physical properties of the legally marketed predicate device: The Servator C SALF Solution's composition, pH, osmolarity, etc., are directly compared to the Celsior solution, aiming for identical or equivalent characteristics.

8. The Sample Size for the Training Set

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

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

Not applicable. As there is no training set for an AI algorithm.

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Servator B SALF Solution 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.

Servator B SALF Solution is a clear to light yellow, single use only, sterile (by steam sterilization) and non-pyrogenic for hypothermic flushing and preservation of organs.

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 primary containers used for the device are PVC free bags 1000ml and 2000ml; therefore, they are free of phthalates. The bags must be chilled to between 2° and 6° C (36° to 43° F) prior to use. The solution may be used without any point of use filtration.

The Servator B SALF Solution is intended for perfusion and flushing donor kidneys, liver and pancreas immediately before or immediately after removal from a dead donor or immediately after removal from a living donor. The solution remains in the organ vessels during hypothermic storage and transportation. Servator B SALF Solution is meant for the cold storage of the organ and is not indicated for hypothermic preservation with continuous mechanical perfusion.

The provided text describes the "Servator B SALF Solution," an organ preservation solution, and its substantial equivalence to a predicate device, CoStorSol® (Belzer UW). The document is a 510(k) summary for FDA clearance.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not present a formal table of "acceptance criteria" in the typical sense of numerical thresholds for clinical performance metrics (e.g., sensitivity, specificity for a diagnostic device). Instead, the acceptance criteria are implicitly the demonstration of substantial equivalence to the predicate device, CoStorSol®, across various technological characteristics and non-clinical performance aspects. The "reported device performance" is the result of tests confirming this equivalence.

Here's a table based on the provided "Table of Comparison" and "Non-Clinical Performance Data" section, framed as a comparison to achieve substantial equivalence:

2. Sample size used for the test set and the data provenance

The document explicitly states: "Performance Testing...was completed as a direct comparison between the subject and predicate device. The chemical comparisons and leachables performance testing demonstrated the substantial equivalence of this device to the predicate."

However, it does not specify the sample size for these tests (e.g., how many batches were tested for chemical composition, how many samples for leachables) nor the data provenance (e.g., country of origin, retrospective or prospective). Given the nature of the device (a solution), the "test set" would refer to specific batches or formulations tested in a laboratory setting, not patient data.

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

This information is not provided in the document. For a 510(k) submission concerning a medical solution, ground truth is typically established through analytical chemical testing and standardized biological assays, not human expert consensus on interpretations of complex data like medical images.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers interpreting data, especially in diagnostic imaging. For a chemical solution, the assessment relies on objective measurements and established scientific protocols.

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 MRMC study was done or is relevant for this device. This is a medical solution for organ preservation, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is a solution, not an algorithm.

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

The ground truth for demonstrating substantial equivalence for this device relies on:

• Analytical Chemistry and Physicochemical Properties: Direct measurement of concentrations (Na+, K+), pH, osmolality, and confirmation of chemical composition.
• Sterility Testing: Conformance to ISO and ASTM standards.
• Biocompatibility Testing: Conformance to ISO 10993 series standards.
• Leachables Testing: To ensure no harmful substances migrate from the packaging into the solution.
• Functional Equivalence: Implicitly, the solution's performance in preserving organs is assumed to be equivalent to the predicate due to identical composition and physical properties.

8. The sample size for the training set

Not applicable. This device is a medical solution, not based on an AI algorithm that requires a training set.

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

Not applicable. There is no training set for this type of device.

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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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