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The OCS™ Lung Donor Flush Set is a single-use device indicated for hypothermic flushing and replacement of residual blood in donor lungs with a legally marketed organ preservation solution at the time of organ removal from the donor during the preparation of these organs for transplantation.

The OCS Lung Donor Flush Set is a sterile single-use device indicated for hypothermic flushing and replacement of residual blood in donor lungs with a legally marketed organ preservation solution at the time of organ removal from donor during the preparation of these organs for transplantation. It is comprised of an already 510(k) cleared cannula (K132811, Sarns Soft-Flow Extended Aorta Cannula) along with the donor flush lines subassembly. The donor flush line assembly consists of silicone tubing, clamps and two spike connectors to enable connection between donor lungs and bags of organ preservation solution. The clamps are used to control the gravity flow of solution from bags to the donor organ.

The device is sterilized by ethylene oxide and is provided in a Tyvek pouch packaged in a corrugated box.

The provided FDA 510(k) summary document for the TransMedics, Inc. OCS™ Lung Donor Flush Set focuses on establishing substantial equivalence to a predicate device for medical device clearance, not on providing a study proving a device meets specific clinical performance acceptance criteria in the context of an AI/algorithm-based device.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable as they pertain to the evaluation of AI or algorithmic performance, which is not the subject of this medical device submission.

The document describes a physical medical device used for organ preservation, not an AI or software-driven diagnostic or treatment tool. The "performance data" section refers primarily to bench testing, biocompatibility, sterilization, and shelf-life, which are standard for physical medical devices.

Here's an attempt to answer the questions based only on the provided document, noting where information is not available or not applicable:

Acceptance Criteria and Study for the OCS™ Lung Donor Flush Set

This document describes the 510(k) submission for the OCS™ Lung Donor Flush Set, a physical medical device. The "study" referenced in the document is primarily bench testing to verify product requirements, not a clinical trial or AI performance study.

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Performance testing was done to verify that OCS Lung Donor Flush Set meets all of its product requirements. The testing demonstrated that all acceptance criteria were met and that the OCS Lung Donor Flush Set was acceptable for clinical use."

However, the specific "acceptance criteria" (e.g., tensile strength, flow rate, leak integrity) and the detailed results of "reported device performance" are not explicitly listed in the provided 510(k) summary. These details would typically be found in the full submission, but are summarized as met for the purpose of demonstrating substantial equivalence.

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

Not applicable in the context of an AI/algorithm test set. The "test set" for this physical device was likely a series of units manufactured for bench testing. The document does not specify the number of units tested. The data provenance would be from internal lab testing by TransMedics, Inc.

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

Not applicable. This is not an AI/diagnostic device that requires expert ground truth for image or data interpretation.

4. Adjudication Method for the Test Set

Not applicable. (See #3)

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI systems where human readers interpret cases. The OCS™ Lung Donor Flush Set is a physical device for organ preservation.

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

Not applicable. The device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is its adherence to engineering specifications, material properties, and functional performance (e.g., flow rates, leak integrity, sterility) as verified through design verification and validation testing, often against established standards (e.g., ISO for biocompatibility and sterilization). It does not involve expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. (See #8)

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OCS™ Lung Solution is intended for flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.

The OCS Lung Solution is a colorless, sterile, pyrogen-free solution for cold flushing, storage and transport of donor lungs for transplantation. The OCS Lung Solution is a colloid-based extracellular low potassium solution for cold flushing and storage of donor lungs for transplantation. The OCS Lung Solution is used to flush and store a lung after removal from the donor. Administration of the solution at the recommended temperature will effectively cool the organ to reduce its metabolic requirements.

This document, K211314, is an FDA 510(k) Premarket Notification for the OCS™ Lung Solution. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of studies typically associated with AI/ML evaluations.

Therefore, the information required to answer your prompt about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device is largely not present in this 510(k) summary.

Specifically, the document states:

• "Software Verification and Validation Testing: Not applicable. The device contains no software."
• "Clinical Data: Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device."
• "Animal Testing: Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device."

This indicates that this is a medical solution (a chemical product), not an AI/ML device, and thus the type of performance evaluation typically performed for AI/ML devices (e.g., assessing accuracy, sensitivity, specificity, or human reader improvement with AI assistance) was not conducted.

However, I can extract information regarding the "device" as described in this 510(k) submission, even if it doesn't align with an AI/ML context:

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

Since this is a solution and not an AI/ML device, typical "performance" metrics like accuracy, sensitivity, or specificity are not applicable. The closest aspects to "acceptance criteria" for a solution would be its chemical composition, sterility, and shelf life. The document focuses on demonstrating substantial equivalence to an existing predicate device (Perfadex®) rather than meeting defined performance criteria through a study.

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

This information is not applicable as no "test set" in the context of an AI/ML algorithm was used. The evaluation for this device focused on bench testing (chemical analyses) and demonstrating similarity to a predicate device.

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. No ground truth for an AI/ML test set was established. The "ground truth" for this product type is its chemical composition, sterility, and demonstrated biocompatibility, which are verified through standard laboratory testing methods and comparison to an established predicate.

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

This information is not applicable. No test set or expert adjudication was performed in the context of an AI/ML device.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a solution, not an AI-assisted diagnostic tool.

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

This information is not applicable. There is no algorithm, so no standalone performance testing was conducted.

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

Since this is a medical solution and not a diagnostic AI/ML device, the concept of "ground truth" as typically defined for AI/ML is not directly applicable. For this product, "ground truth" would relate to:

• Chemical Analysis: Verifying the exact composition of the solution.
• Sterility Testing: Verifying the absence of microorganisms.
• Biocompatibility Testing: Verifying that the materials do not elicit adverse biological responses.
• Bench Testing: Comparison to established standards for solutions for organ preservation.

8. The sample size for the training set

This information is not applicable. There is no AI/ML model, and therefore no training set.

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

This information is not applicable. There is no AI/ML model or training set.

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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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The SherpaPak Cardiac Transport System is intended to be used for the station of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart. The intended organ storage time for the SherpaPak Cardiac Transport System is up to 4 hours. Donor hearts exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the SherpaPak Cardiac Transport System. It indicates that the device has been found substantially equivalent to predicate devices for its intended use. However, the document does not contain any information about acceptance criteria for device performance, nor does it describe any study demonstrating that the device meets such criteria.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance using the provided input. The document focuses on regulatory clearance based on substantial equivalence, not on detailed performance metrics or clinical trial results.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (which may be part of a 510(k) submission but is not included in this clearance letter), a clinical study report, or a descriptive document of the device's validation.

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SherpaPak Cardiac Transport System: The SherpaPak Cardiac Transport System is intended to be used for the static hypothermic preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart. The intended organ storage time for the SherpaPak Cardiac Transport System is up to 4 hours. Donor hearts exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.

SherpaPak Kidney Transport System: The SherpaPak Kidney Transport System is intended to be used for the static hypothermic preservation of kidney organs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with this organ. The SherpaPak Kidney Transport System can maintain the donor organ storage temperature between 4 C and 8 C through 24 hours.

The SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System result from modifications made to the cleared Sherpa Pak Cardiac Transport System and Sherpa Pak Kidney Transport System most recently cleared under K133432 and K133694, respectively. The principle of operation of the modified devices is identical to that of the cleared devices, namely, cold static storage and transportation of donor hearts (Cardiac version) or donor kidneys (Kidney version), using cleared preservation solutions specific to the organ type being transported. Further, the modified designs have the same indications for use and utilize the same technology as the predicate devices.

The subject SherpaPak design (cardiac and kidney) like its predecessor, consists of 1) outer transport shipper which contains within it various non-ice based temperature controlled packaging elements, 2) an inner and outer hard shell assembly (i.e. Sherpa Canister/Sherpa Shell) which provides a double, rigid barrier shipper in which the heart/kidney is immersed and suspended in a cold storage solution cleared for use in storing and transporting donor hearts/kidneys, and 3) a data logger that monitors and displays the temperature of the cold storage solution in which the heart/kidney is stored during transport.

The provided document (K180194 510(k) Summary for SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System) does not pertain to an AI/ML medical device. It describes a medical device designed for the static hypothermic preservation and transport of donor hearts and kidneys.

Therefore, the document does not contain any information regarding:

• Acceptance criteria for an AI/ML device.
• A study proving an AI/ML device meets acceptance criteria.
• Sample sizes for AI/ML test sets or training sets.
• Data provenance for AI/ML models.
• Number of experts or their qualifications for establishing ground truth for AI/ML models.
• Adjudication methods for AI/ML test sets.
• MRMC comparative effectiveness studies for AI/ML.
• Standalone performance of an AI/ML algorithm.
• Types of ground truth for AI/ML models.
• How ground truth for AI/ML training sets was established.

The document focuses on the functional testing performed on the modified SherpaPak systems to demonstrate their equivalence to predicate devices, including:

• Biocompatibility testing of new materials.
• Electrical Safety and EMC testing.
• Transportation testing (ASTM D4169-09).
• Thermal qualification to maintain specified temperature ranges (4°C - 8°C for up to 4 hours for cardiac, and 24 hours for kidney).
• Helium leak testing for seal integrity.

The "acceptance criteria" and "device performance" in this context are related to the physical and functional aspects of the transport system, particularly its ability to maintain organ temperature during transport and ensure sterility, rather than an AI/ML model's diagnostic or predictive performance.

The thermal qualification section implicitly describes a key performance characteristic and implied acceptance criteria:

• Acceptance Criteria (Implied from Thermal Qualification): Maintain donor organ storage temperature between 4°C and 8°C for:
  • Cardiac Transport System: up to 4 hours
  • Kidney Transport System: up to 24 hours (as stated in the Indications for Use and the predicate device description)
• Reported Device Performance: "This test was performed to demonstrate the system could meet this specification." (This implies successful demonstration, but quantitative results are not explicitly provided in the summary, only the duration the system "can maintain" the temperature in comparison to the predicate). The "Storage Temperature Duration" characteristic in the comparison table states that the Modified SherpaPak Cardiac/Kidney Transport System "Device can maintain 4°C to 8°C through 44 hours," which exceeds the 24-hour requirement for kidneys and 4-hour requirement for hearts, and also exceeds the predicate's 36-hour duration.

Since the request specifically asks for information relevant to an AI/ML device, and this document describes a physical transport system, I cannot fulfill the request as phrased based on the provided text.

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The Sherpa Pak Cardiac Transport System is intended to be used for the static hypothermic preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart.

The intended organ storage time for the Sherpa Pak Cardiac Transport System is up to 4 hours.

Donor hearts exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.

The Paragonix Sherpa Pak Cardiac Transport System is a device intended to provide a safe, consistent method for cold ischemic storage and transport of donor hearts to recipients for transplantation. The Sherpa Pak System consists of 1) an outer shipper which contains various non-ice based temperature controlled packaging elements, 2) an inner and outer hard shell container (i.e. Sherpa Pak/Sherpa Pak Shell) which provides a double, rigid barrier container in which the heart is immersed and suspended in a Cold Storage Fluid cleared for use in storing and transporting donor organs and 3) a temperature display and timer to monitor temperature and elapsed time of transport, respectively. The device is identical to the cleared Sherpa Pak Cardiac Transport System in all respects.

Here's an analysis of the provided text regarding the Paragonix Sherpa Pak Cardiac Transport System, focusing on acceptance criteria and the supporting study information:

It's important to note that this document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for a novel device with specific acceptance criteria in the same way a PMA (Premarket Approval) submission would.

Key takeaway from the document: The applicant is seeking to distribute the existing Sherpa Pak Cardiac Transport System (K133432) as a "Convenience Kit" with any FDA-cleared, commercially-available preservation solution. The core device itself (the transport system) has no design changes. Therefore, the document largely refers to the prior clearance (K133432) for performance data.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a Special 510(k) for a "Convenience Kit" that involves no design changes to the core device, the acceptance criteria are not presented in a classic statistical hypothesis testing format for a performance study. Instead, the "acceptance criteria" are implied by the demonstration that the modified device (the kit) performs identically to the predicate device in terms of temperature maintenance and organ protection, and that the combination with other cleared solutions is safe and effective.

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

• Sample Size: The document does not specify a sample size for a new test set in this Special 510(k). The functional testing described ("Thermal qualification" and "robustness") refers to tests performed for the original K133432 clearance. The details of those tests, including sample sizes, are not provided in this summary.
• Data Provenance: Not explicitly stated as retrospective or prospective, nor does it mention a country of origin. This type of engineering bench testing is typically prospective, conducted in a lab setting.

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

Not applicable in the context of this device. The "ground truth" for this device's performance relates to physical parameters like temperature maintenance and structural integrity, which are established through engineering tests, not expert interpretation of medical images or clinical outcomes. Clinical efficacy would be evaluated in PAI (Premarket Approval Inspection) rather then 510K.

4. Adjudication Method for the Test Set

Not applicable. This device's performance is measured objectively against engineering specifications (e.g., temperature range, structural robustness), not requiring expert adjudication in the way medical image analysis or clinical endpoint determination might.

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 medical device for organ transport, not an AI-powered diagnostic or assistive technology involving human readers.

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

Not applicable. This device does not involve an algorithm.

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

The "ground truth" for the performance of the Sherpa Pak Cardiac Transport System is based on engineering specifications and physical measurements. This includes:

• Temperature measurements in controlled environments (thermal qualification).
• Mechanical testing (implied by "robustness" testing).
• Biocompatibility testing against established standards.
• Sterilization validation.

8. The sample size for the training set

Not applicable. This device does not utilize machine learning or AI, 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, there is no ground truth for it.

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The Sherpa Pak Cardiac Transport System is intended to be used for the static hypothermic preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart.

The intended organ storage time for the Sherpa Pak Cardiac Transport System is up to 4 hours.

Donor hearts exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.

The Paragonix Sherpa Pak Cardiac Transport System is a device intended to provide a safe, consistent method for cold ischemic storage and transport of donor hearts to recipients for transplantation. The Sherpa Pak System consists of 1) an outer shipper which contains various non-ice based temperature controlled packaging elements. 2) an inner and outer hard shell container (i.e. Sherpa Pak/Sherpa Pak Shell) which provides a double, rigid barrier container in which the heart is immersed and suspended in a Cold Storage Fluid cleared for use in storing and transporting donor hearts and 3) a temperature display and timer to monitor temperature and elapsed time of transport. respectively. The changes made to the currently cleared device are labeling changes only. The device subject to this notification is identical to that cleared under K123326.

The provided document is a 510(k) premarket notification for a medical device called the "Paragonix Sherpa Pak Cardiac Transport System." It describes a device intended for the cold ischemic storage and transport of donor hearts.

The key finding from the document is that the submission is for a labeling change only. The device itself has not changed and is identical to a previously cleared device (K123326). Therefore, the substantial equivalence determination is based on the prior clearance and the fact that the labeling change does not alter the device's intended use or technological characteristics.

This means the current document does not contain a new study proving the device meets new acceptance criteria, as the device itself hasn't changed. The original device's performance data and acceptance criteria would be in the K123326 submission, which is not provided here.

Based on the provided text, here's what can be extracted and inferred:

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

Since this is a labeling change and the device is identical to the cleared predicate (K123326), no new acceptance criteria or performance data are presented in this document. The document states:

• "The device subject to this notification is identical to that cleared under K123326." {1}
• "The testing performed in support of the original 510(k) continues to be supportive of the modified device." {1}
• "The design, intended use, principles of operation, and technological characteristics of the Sherpa Pak Cardiac Transport System are substantially equivalent to the previously cleared Sherpa Pak Cardiac Transport System. The labeling change does not alter the device's intended use. There were no changes to the device itself and it is identical to the device cleared under K123326." {1}

The stated "Intended Use" and "Indications for Use" from the document are:

• Static hypothermic preservation of hearts during transportation and eventual transplantation.
• Use with cold storage solutions indicated for the heart.
• Intended organ storage time: up to 4 hours.
• Donor hearts exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon. | Met by substantial equivalence to K123326. The device did not change, only the labeling. The original testing for K123326 supports these indications. |

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 for this submission. This 510(k) is for a labeling change, not a new performance study. The document explicitly states: "Functional Testing: The premarket notification was submitted for a labeling change to the device. The device did not change in any respect otherwise. The testing performed in support of the original 510(k) continues to be supportive of the modified device." {1}

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. As noted above, no new performance study was conducted for this 510(k) submission.

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

Not applicable. No new performance study was conducted.

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 physical transport system, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical transport system, not an algorithm.

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

Not applicable. No new performance study was conducted. Performance for the device would likely be assessed through engineering testing (e.g., temperature stability, integrity) and potentially clinical outcomes data from the original K123326 submission, but this information is not in the provided document.

8. The sample size for the training set

Not applicable. This device is a physical transport system and does not involve AI or machine learning that would require a training set.

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

Not applicable. As above, no training set is relevant for this type of device.

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The Sherpa Pak Cardiac Transport System is intended to be used for the static hypothermic preservation of hearts, up to 4 hours, during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with the heart.

The Paragonix Sherpa Pak Cardiac Transport System is a device intended to provide a safe, consistent method for cold ischemic storage and transport of donor hearts to recipients for transplantation. The Sherpa Pak System consists of 1) an outer shipper which contains various non-ice based temperature controlled packaging elements, 2) an inner and outer hard shell container (i.e. Sherpa Pak/Sherpa Pak Shell) which provides a double, rigid barrier container in which the heart is immersed and suspended in a Cold Storage Fluid cleared for use in storing and transporting donor hearts and 3) a temperature display and timer to monitor temperature and elapsed time of transport, respectively.

Here's a breakdown of the acceptance criteria and study information for the Paragonix Sherpa Pak Cardiac Transport System based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative "acceptance criteria" for the device's performance in a table format. Instead, it describes general design specifications and functional testing outcomes.

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

The document states: "Descriptive information, laboratory bench testing, and biocompatibility testing were provided to demonstrate the device meets its design specifications, performs as intended, and is safe for its intended use."

• Sample Size: The document does not specify any sample sizes for the functional or biocompatibility testing conducted. It refers to "testing" generically.
• Data Provenance: The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned. The testing described appears to be internal lab testing rather than clinical study data.

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

• Number of Experts: This information is not provided. The "ground truth" for this device's performance primarily relates to objective physical parameters (temperature stability, structural integrity, biocompatibility) rather than expert interpretation of images or clinical outcomes.
• Qualifications of Experts: This information is not provided.

4. Adjudication Method for the Test Set:

• Adjudication Method: This information is not provided. Given the nature of the tests (bench testing, biocompatibility), there is no indication of an adjudication process typically associated with subjective assessments or clinical outcomes.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

• No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done or mentioned. This type of study is typically relevant for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This device is a transport system, not a diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

• Yes, a standalone performance study was done in the sense that the "Functional Testing" described ("testing to demonstrate that the Sherpa Pak System provided a transport system robust enough to protect the heart during transport and maintained temperature throughout the duration of transport") and "biocompatibility testing" were evaluations of the device itself, independent of human interaction during the test. There is no "algorithm" in the conventional AI sense for this device.

7. Type of Ground Truth Used:

The ground truth used was based on objective measurements and laboratory standards:

• Functional Testing: Measuring whether the device maintained temperature, its structural integrity under stress (robustness), and protection of the "heart" (simulated or actual, not specified but likely simulated for bench testing).
• Biocompatibility Testing: Adherence to established standards for cytotoxicity, systemic toxicity, genotoxicity, sensitization, and intracutaneous reactivity.
• UNOS Policy 5: Assessed against a defined policy standard.

8. Sample Size for the Training Set:

This device is a physical medical device, not an AI/machine learning algorithm that requires a "training set" in the computational sense. Therefore, the concept of a training set sample size is not applicable.

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

As there is no AI/machine learning algorithm with a training set for this device, how ground truth for a training set was established is not applicable.

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Perfadex® with THAM is intended for flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient
Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal from the donor, in preparation for eventual transplantation into a recipient

Perfadex® with THAM is a colloid based "extracellular" low potassium electrolyte solution for rapid cooling, perfusion and storage of lungs in connection with transplantation
Perfadex® with THAM contains THAM at strength of 3.3 mmol in a sterile 50 ml glass bottle, while the predicate device (K022730) contains THAM at strength of 1.0 mmol in a 1.0 or 2.8 ml pre-filled syringe with THAM.
Perfadex® with THAM is a clear, sterile, non-pyrogenic, colloid based, lightly buffered so called "extracellular" low potassium dextran solution primarily for rapid cooling, perfusion and storage of lungs in connection with transplantation. The solution is slightly acidic (pH 5.5) to permit long shelf life, and is adjusted shortly before use to pH 7.4 by the addition of THAM solution from the co-packed bottle, 1 mmol of THAM per liter of Perfadex®.

This document is a 510(k) Premarket Notification for a medical device called "Perfadex® with THAM." The device is a solution for lung preservation.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text does not contain explicit acceptance criteria or a study demonstrating device performance in terms of clinical outcomes or specific metrics (e.g., survival rates, organ viability post-transplant). This 510(k) submission focuses on demonstrating substantial equivalence to a predicate device, not on proving new clinical effectiveness through performance criteria.

The "acceptance criteria" here implicitly revolve around demonstrating that the modified device (Perfadex® with THAM containing 3.3 mmol THAM in a 50 ml bottle) is as safe and effective as the predicate device (Perfadex® with THAM containing 1.0 mmol THAM in a 1.0 or 2.8 ml pre-filled syringe), and thus does not raise different questions of safety and effectiveness.

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

The document does not describe any "test set" in the context of clinical performance data. The submission is focused on the device's technical characteristics and comparison to a predicate, not a clinical study with a test set of patients or data.

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 there is no "test set" and corresponding ground truth establishment described for a clinical performance study.

4. Adjudication Method for the Test Set:

This information is not applicable as there is no "test set" or clinical study with adjudication 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:

This information is not applicable. The device is a solution for lung preservation, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI-related effect size are irrelevant.

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 medical solution, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc):

This information is not applicable in the context of a clinical performance study or diagnostic accuracy. For a 510(k), the "ground truth" for substantial equivalence is primarily established by comparison to the legally marketed predicate device's established safety and effectiveness. The submission aims to show that the new device's technological characteristics (specifically the different THAM concentration and packaging) do not alter its fundamental nature or intended use from the predicate, and thus its "ground truth" performance is assumed to be equivalent to the predicate.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" as this is not an AI/machine learning device or a clinical trial with a training phase described in this document.

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

This information is not applicable for the reasons stated in point 8.

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Custodiol HTK Solution is indicated for perfusion and flushing donor kidneys, livers, and hearts 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 hearts prior to removal from the donor and for preserving the heart 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 characteristic assures rapid flow rates during initial perfusion, allowing the organ to be quickly cooled.

The provided text is a 510(k) summary for the Custodiol HTK Solution, which is a medical device for organ preservation. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the generalized sense of a diagnostic, imaging, or AI-powered device. Instead, it describes clinical studies comparing the performance of the Custodiol HTK Solution with predicate devices to demonstrate its substantial equivalence for organ preservation.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) summary does not define explicit "acceptance criteria" in a quantitative sense as might be seen for a diagnostic or imaging device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices in terms of performance and safety for organ preservation. The reported device performance is related to survival rates and other outcome measures of transplanted organs.

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

• Test Set Sample Size: "a small randomized clinical study" and "extensive experience of the largest heart transplant center in the world." Specific numbers are not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin), but reference to "the largest heart transplant center in the world" suggests a clinical setting. The studies are clinical in nature. The term "retrospective or prospective" is not used, but "clinical studies have been reported" implies real-world data collection.

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

Not applicable. The "ground truth" here would relate to organ viability and patient outcomes, which are objective clinical measures rather than expert interpretations of data (like radiology reads).

4. Adjudication method for the test set:

Not applicable for this type of device and study.

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 imaging device that involves human readers.

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

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

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

The "ground truth" largely refers to clinical outcomes data, specifically "survival rates and other outcome measures" of transplanted organs.

8. The sample size for the training set:

Not applicable. This is not a machine learning device with a training set. The clinical studies mentioned serve as the basis for demonstrating equivalence.

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

Not applicable.

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