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EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is intended for topical cooling of in situ, abdominal donor organs during intraoperative recovery from the donor. It is also intended to maintain organ hypothermia during storage and transport to the transplant recipient. EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is used to establish, and maintain hypothermia of donor organs during recovery, storage, and transport.

It is also indicated for use during open surgical procedures such as cardiovascular, abdominal, and transplant surgeries.

Organ Recovery
Prior to organ recovery, EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is delivered to the open peritoneal cavity of the donor to assist in creating hypothermia by topically cooling external surfaces of organs for recovery. During organ recovery, if ice crystals are no longer visible, the temperature of the saline solution will begin to rise and additional slushed solution may be delivered per established transplant team procedures. (Temperature rise may be assessed with temperature probes, being careful that the probe is measuring the solution and is not in contact with the organ).

Organ Storage/Transport
For organ storage/transport, EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) may be used to topically cool external surfaces of a sterile, sealed, primary organ bag containing chilled preservation solution and the organ. In this application, the slushed solution may be added to a secondary bag or to a tertiary hard container to surround the primary organ bag. Once bagged, the organ can be placed in a bed of non-sterile ice in an insulated transport container, which is then closed. Actual use should follow standard practices of the OPO or hospital for transporting and storing specific types of donor organs using sterile, slush solutions.

Surgical Procedure
During surgical procedures, EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is delivered to assist in creating hypothermia by topically cooling external surfaces of organs. During the procedure, if ice crystals are no longer visible, the temperature of the saline solution will begin to rise and additional slushed solution may be delivered per established surgical team procedures.

EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is a clear, colorless 0.9% Sodium Chloride solution for preparation of slushed solution to provide hypothermia during the recovery, storage, and transport of donor organs for transplantation and to induce regional hypothermia in certain surgical procedures such as open heart and kidney procedures by direct application of slushed solution. The solution is sterile, non-pyrogenic, isotonic and is contained in a 2L sterile, flexible, non- PVC bag.

The provided document, an FDA 510(k) Clearance Letter for EasiSlush® Sodium Chloride Solution, is for a medical device that acts as a sterile slush for topical cooling during surgical procedures and organ transport. It is NOT an AI/ML medical device. Therefore, the information requested in the prompt, which pertains to the acceptance criteria and study proving an AI/ML device's performance (including details like test set sample size, ground truth establishment with experts, MRMC studies, etc.), is not applicable to this document.

The 510(k) discusses the substantial equivalence of the updated EasiSlush® product (K243618) to its previously cleared version (K191006) by detailing changes in its intended use and indications for use, while emphasizing that the core technological characteristics, composition, and safety profile remain unchanged.

To summarize why the specific questions about AI/ML device performance cannot be answered from this document:

• No AI/ML Component: The device is a physical saline solution for cooling. It does not involve any artificial intelligence or machine learning components.
• Substantial Equivalence Study, Not Performance Study: The document describes a "substantial equivalence discussion" showing that the new device (K243618) is equivalent to a predicate device (K191006), primarily by demonstrating that changes to its "Indications for Use" for surgical procedures do not introduce new questions of safety or effectiveness, as the technological characteristics, formulation, and mode of action are unchanged. This is different from a performance study for an AI/ML model.

Therefore, I cannot provide the requested table or information regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device.

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X°Port Lung Preservation System:
The X°Port Lung Preservation System is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient. The X°Port Lung Preservation System is intended to be used with the X°Port Lung Preservation Solution.

The intended organ storage time for the X°Port Lung Preservation System is up to 8 hours.

When clinically accepted static hypothermic preservation times are exceeded, the lungs 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.

X°Port Lung Preservation Solution:
The X°Port Lung Preservation 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.

X°Port Lung Preservation System:
The X°Port Lung Preservation System is an organ preservation system. It is designed to store, preserve, and transport human lungs donated for transplantation at 4°C-10°C.

The X°Port Lung Preservation System consists of an insulated chamber, phase-change cooling packs, a cradle to hold the lung bag, and a temperature probe and logger. The X°Port Lung Preservation System is designed to be mobile, with wheels and a telescopic handle to maneuver the device throughout its travel. The device is designed to protect the lungs during transport and to display and log the internal temperature on an external screen. Additionally, the internal temperature may be monitored via an application running on a mobile device.

X°Port Lung Preservation Solution:
The X°Port Lung Preservation Solution is an organ preservation solution used for flushing, static cold storage, and the perfusion and preservation of lungs intended for transplantation. X°Port Lung Preservation Solution is a clear, sterile, non-pyrogenic, colloid based, lightly buffered extracellular low potassium dextran solution.

During use, the solution is cooled to 4-8°C and is used to perfuse the isolated organ immediately before its removal from the donor and/or immediately after its removal. The solution is then left in the organ vasculature during hypothermic storage and transportation at 4-10°C.

The solution is slightly acidic (pH 5.4) to permit long shelf life and is adjusted shortly before use to pH 7.4 by the addition of THAM solution. The solution must be supplemented with 0.5 mmol/l Calcium Chloride prior to use.

This is a 510(k) clearance letter for the X°Port Lung Preservation System and Solution, which are devices for preserving donor lungs for transplantation. The provided text does not describe a study involving an AI/Machine Learning component to establish acceptance criteria or device performance in the way the request specifies (e.g., accuracy metrics, human reader improvement with AI assistance, ground truth establishment for AI models).

The document is primarily focused on demonstrating "substantial equivalence" of a medical device (a physical preservation system and solution) to existing predicate devices, as required for 510(k) clearance by the FDA. The performance data presented relates to the physical and biological efficacy of the preservation method (e.g., temperature control, biological safety, and clinical outcomes of lung transplants using the system).

Therefore, it's not possible to fulfill the request as it pertains to AI/ML acceptance criteria and study details based on the provided text. The document does not contain information about:

1. AI acceptance criteria or reported device performance (no AI component).
2. Sample size for test set and data provenance related to AI/ML (no AI component).
3. Number of experts used to establish ground truth for AI/ML test set or their qualifications (no AI component).
4. Adjudication method for AI/ML test set (no AI component).
5. MRMC comparative effectiveness study with AI assistance (no AI component).
6. Standalone (algorithm only) performance (no AI component).
7. Type of ground truth used for AI/ML (no AI component).
8. Sample size for training set for AI/ML (no AI component).
9. How ground truth for training set was established for AI/ML (no AI component).

Instead, the document details:

• Clinical Study Design: Two retrospective, single-arm studies with historical controls conducted outside the United States.
• Study Objective: Evaluate the use of controlled hypothermic lung preservation at 10°C on lung transplant outcomes compared to conventional ice storage methods.
• Patient Population:
  • First study (X°Port Lung Transport Device vs. Conventional Ice): 118 study patients (X°Port group) and 538 control patients.
  • Second study (Temperature-controlled incubator at 10°C vs. Conventional Ice): 138 study patients (Incubator group) and 538 control patients.
• Outcomes Measured: Safety (reduction in (S)AEs), ability to use higher risk organs (longer preservation times, DCD donors), improved long-term Chronic Lung Allograft Free Dysfunction survival, lower infection rates. Comparison to predicate device registry data for grade 3 primary graft dysfunction and 1-year survival.

To reiterate, the provided text describes the regulatory clearance of a physical medical device for organ preservation and does not involve AI or machine learning.

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

The DCX Disposable Cassette, provides a sterile fluid pathway, houses and protects the kidneys during perfusion and it has a gravity flow system which allows circulation of perfusate through the kidneys.

The kidneys are placed in an organ chamber filled with perfusate. The perfusate flows from the organ chamber to the pumphead. Then, it is pumped through the heat exchanger to the bubble trap where it is delivered to the cannulated kidney(s). The perfusate then returns to the organ chamber via the kidney vein to repeat the perfusion cycle.

The cassette can provide circulation of perfusate to one or two kidneys, attached individually or in bloc.

The provided FDA 510(k) clearance letter and summary for the DCX Disposable Cassette (K243998) primarily focuses on demonstrating substantial equivalence to its predicate device through non-clinical testing. It does not detail a clinical study with acceptance criteria often associated with device performance in diagnostic or therapeutic efficacy. Instead, the acceptance criteria are met through various non-clinical tests verifying safety, sterility, biocompatibility, and functional performance.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the DCX Disposable Cassette are primarily focused on safety, sterility, biocompatibility, and functional performance, aligning with regulatory standards and ensuring it operates as intended without posing new risks compared to its predicate.

Table of Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes a non-clinical testing study rather than a clinical trial focused on diagnostic accuracy or therapeutic outcomes in patients.

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

   • The document does not specify a "test set" in the context of patient data or samples. The testing described is primarily for device components and materials (e.g., biomaterial samples for ISO 10993 testing, samples for sterility testing, units for stability testing).
   • The provenance of the data is from Institut Georges Lopez (IGL), based in France, the manufacturer of the device.

2. 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 described study is a non-clinical device performance and safety evaluation (e.g., sterilization validation, biocompatibility testing, stability testing), not a study requiring expert consensus on clinical findings.

3. Adjudication Method for the Test Set:

   • This information is not applicable as the described study is a non-clinical device performance and safety evaluation. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies for interpretation of imaging or clinical outcomes where multiple experts assess the same case.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI-assisted diagnostic tool on human reader performance, which is beyond the scope of this device (a disposable cassette for organ perfusion).

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

   • No, this refers to an algorithm's performance, which is not applicable to a disposable cassette.

6. The Type of Ground Truth Used:

   • The "ground truth" for this device's evaluation is based on established regulatory standards and engineering specifications. For example:
     • Sterility: Achieved by verifying results against ISO 11135 and ISO 10993-7.
     • Biocompatibility: Achieved by verifying results against ISO 10993 (cytotoxicity, sensitization, irritation, hemolysis, acute systemic toxicity).
     • Stability: Achieved by verifying that product specifications remain within acceptable limits after aging tests for the specified shelf life.
     • Functional Performance: Achieved by demonstrating that the device "performs as expected and meets the requirements set for the device" when used with compatible components (RM4 Control Unit and perfusion accessories).

7. The Sample Size for the Training Set:

   • This information is not applicable. The DCX Disposable Cassette is a physical medical device, not a machine learning algorithm that requires a training set.

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

   • This information is not applicable for the same reason as point 7.

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Belzer UW® Cold Storage Solution (BTLBUW-001) is indicated 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. Belzer UW® Cold Storage Solution (BTLBUW-001) is not indicated for continuous machine perfusion.

Belzer UW® Cold Storage Solution (BTLBUW-001) is a clear to light yellow, sterile, nonpyrogenic solution for hypothermic flushing and storage of organs. The solution has an approximate calculated osmolarity of 320 mosmol/kg, 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 solution should be used only by medical healthcare staff, adequately trained according to established operating protocols.

The Belzer UW® Cold Storage Solution (BTLBUW-001) is supplied in non-PVC bags: 500 mL bags, shelf carton of 6; 1000 mL in 1-liter bags, shelf carton of 10; and 2000 mL in 2-liter bags, shelf carton of 5. The solution is sterile and is intended for one single use.

The solution should be stored indoors at temperatures controlled between 2° and 25°C (36° and 77°F) until use. Excessive heat and freezing should be avoided. Belzer UW® Cold Storage Solution (BTLBUW-001) should not be used if discolored or if obvious particulate matter, precipitates, or contamination are evident in the solution.

The provided text is an FDA 510(k) Premarket Notification summary for a medical device called "Belzer UW® Cold Storage Solution (BTLBUW-001)". This document is for a cold storage solution used for organ preservation, not for an AI-powered diagnostic device.

Therefore, the document does not contain information related to:

• Acceptance criteria for an AI device's performance metrics (e.g., sensitivity, specificity, AUC).
• Sample sizes for test sets and training sets for an AI model.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods for test sets.
• MRMC comparative effectiveness studies or effect sizes of human reader improvement with AI assistance.
• Standalone algorithm performance.
• Type of ground truth used for AI models (e.g., pathology, outcomes data).

The document focuses on demonstrating substantial equivalence of the new cold storage solution (Belzer UW®) to a legally marketed predicate device (CoStorSol® Solution). The "study" proving the device meets acceptance criteria is primarily a non-clinical comparison of product characteristics and safety/performance testing (biocompatibility, sterility, shelf life).

Here's a breakdown of the relevant information provided in the document:

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

The document doesn't present "acceptance criteria" in the typical sense of quantitative thresholds for an AI/diagnostic device's performance (e.g., "Sensitivity > X%"). Instead, it compares the proposed device's characteristics to those of its predicate device to establish substantial equivalence.

2. Sample sized used for the test set and the data provenance:
Not applicable for this type of device. The "test set" here refers to specific non-clinical tests (biocompatibility, sterility, shelf life stability). The provenance of organs or patient data is not relevant or mentioned. These tests are laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth for a cold storage solution is established through laboratory analyses and well-defined chemical and biological testing standards, not by expert interpretation of images or patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication is relevant for studies involving human interpretation (e.g., radiology reads), not for direct measurements of solution properties or standard in-vitro biological 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 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 diagnostic device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance would be established through:

• Chemical analysis to verify composition, osmolarity, and pH.
• Microbiological testing to verify sterility and non-pyrogenicity.
• Biocompatibility testing (in vitro and potentially in vivo animal studies, referenced as ISO 10993 standards) to ensure the material does not cause adverse biological reactions.
• Stability studies to confirm shelf life and maintain properties over time.
• Functional performance testing (e.g., in animal models or ex-vivo organ models, although not explicitly detailed in this summary, would typically be part of the full submission for a device of this nature) to show the solution preserves organs effectively.

8. The sample size for the training set:
Not applicable. This is not an AI diagnostic device.

9. How the ground truth for the training set was established:
Not applicable. This is not an AI diagnostic device.

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Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is indicated for the in vitro flushing and continuous hypothermic machine perfusion of explanted abdominal organs.

Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is a clear to straw-colored, sterile, non-pyrogenic solution for the in-vitro flushing and continuous perfusion of explanted abdominal organs. The Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) has the same composition and indication for use as MaPerSol® Organ Preservation Solution.

The solution is consistent with an extracellular solution, based on its sodium/potassium ratio and has a calculated potassium concentration of 25 mEq/L, a sodium concentration of 100 mEq/L, an osmolarity of 300 mosmol/kg, and a pH of approximately 7.4 at 20°C.

The Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is supplied in single use 1000mL solution bags, made from flexible PVC free material (e.g., laminated EVA film) with at least two integrated ports including ports for delivery and component addition. Each individual bag is enclosed in a protective outer overwrap bag. The solution is sterile and is intended for one single use.

The provided text describes a 510(k) premarket notification for a medical device called Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001). This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (MaPerSol® Solution, K080432), rather than providing detailed acceptance criteria and performance study data typically associated with de novo clearances or PMAs for novel devices or software.

Therefore, much of the requested information regarding "acceptance criteria" and "the study that proves the device meets the acceptance criteria" in terms of algorithm performance for an AI/ML device is not applicable in this specific document. The "acceptance criteria" in this context are for demonstrating substantial equivalence of a solution composition and function, not algorithmic performance.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

• Acceptance Criteria (for Substantial Equivalence to Predicate): The core acceptance criterion is that Belzer MPS® (BMPS-001) is "substantially equivalent in composition, safety and efficacy" to the predicate device, MaPerSol® Solution. This is primarily demonstrated by:
  • Same Indications for Use: Flushing and continuous hypothermic machine perfusion of explanted abdominal organs.
  • Same Composition: The exact chemical composition (components and g/L) is identical to the predicate.
  • Same Technological Characteristics: pH, Osmolality, Product State (liquid), Single Use, Storage Temperature, Pre-cooling requirements, Internal cooling mechanism, Product Bag materials, Pyrogenicity, Sterility methods, Biocompatibility (as per ISO standards), Fluid Volume.
• Reported Device Performance: The document states that the device is "safe and effective as predicate and reference devices" and that "The non-clinical data supports and demonstrates the safety of the device." No specific quantitative performance metrics (e.g., organ viability rates, post-transplant outcomes) are provided for the Belzer MPS® itself, as its equivalence is established based on its identical composition and intended use to a proven predicate. The "performance" is implicitly deemed equivalent to that of the predicate.

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

• This document does not describe a clinical study in the form typically seen for AI device validation with test sets of patient data. The "test set" here refers to the parameters/characteristics of the solution itself and its manufacturing process, not patient data.
• Data Provenance: Not applicable in the context of patient data. The data provenance relates to the chemical composition, physical properties, manufacturing processes, sterilization, and biocompatibility studies conducted on the solution and its packaging materials. These are typically generated through laboratory testing of the product itself.

3. 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/ML device that generates diagnoses or interpretations requiring expert ground truth in the radiological sense. The "ground truth" for this device relates to its chemical and physical properties meeting specified standards, and its safety/efficacy being equivalent to a known predicate. This is established through standard laboratory testing, chemical analysis, and biocompatibility assessments by qualified personnel in those fields, not expert radiologists creating consensus labels.

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

• Not applicable. This methodology is for clinical image interpretation or similar tasks requiring human consensus or adjudication, which is not relevant to a medical solution like Belzer MPS®.

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-assisted interpretation device. No MRMC study was conducted or is applicable.

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

• Not applicable. This is not an algorithm. Therefore, no standalone performance study was done.

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

• The "ground truth" for this device is based on analytical chemistry, physical property measurements, biocompatibility testing (in vitro and in vivo animal models often), and sterility testing to confirm the product's specifications and safety. The ultimate "ground truth" for "substantial equivalence" rests on the established safety and efficacy of the predicate device, MaPerSol® Solution, which presumably underwent its own validation studies years prior (K080432).

8. The sample size for the training set:

• Not applicable. This is a chemical solution, not an AI/ML model that requires training data.

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

• Not applicable. As above, no training set or ground truth in the AI/ML context.

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LungProtect 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.

LungProtect is an organ preservation solution used for flushing, static cold storage, and the perfusion and preservation of lungs intended for transplantation. LungProtect is a clear, sterile, non-pyrogenic, colloid based, lightly buffered extracellular low potassium dextran solution. During use, the solution is cooled to 4-8°C and is used to perfuse the isolated organ immediately before its removal from the donor and/ or immediately after its removal. The solution is then left in the organ vasculature during storage and transportation. The solution is slightly acidic (pH 5.4) to permit long shelf life and is adjusted shortly before use to pH 7.4 by the addition of THAM solution. The solution is packaged in one-liter (1000 ml) or two-liter (2000 ml) EVA bags, permanently and integrally connected to one (for 1L) or two (for 2L) PVC bags each containing 25 ml (1 mmol) THAM.

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. The document is an FDA 510(k) clearance letter and a 510(k) Summary for the LungProtect device. It discusses the device's indications for use, technological characteristics, and non-clinical tests performed to demonstrate substantial equivalence to a predicate device, PERFADEX AND PERFADEX WITH THAM.

Specifically, the document states:

• Non-Clinical and/or Clinical Tests Summary & Conclusions: "Non clinical tests submitted to demonstrate biological safety are: 1) Cytotoxicity, 2) Sensitization, 3) Intracutaneous Irritation, 4) Acute Systemic & Pyrogenicity, 5) Hemolysis. Packaging validation tests submitted demonstrates that the packaging of solution is safe. The following tests were performed on realtime aged samples: 1) Shipping and Distribution tests, 2) Environmental conditioning, 3) Compression testing. Compositional analysis and microbiological testing (sterility and endotoxin) were performed to verify the stability of the solution over the defined shelf life. The physical and chemical analysis of the LungProtect solution was completed to demonstrate that the LungProtect is substantially equivalent to its predicate. Nor-clinical testing was sufficient to demonstrate substantial equivalence to the non-clinical data supports the safety and effectiveness of the LungProtect."

However, it does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set, data provenance, or details about retrospective/prospective studies.
3. Information on experts used to establish ground truth or their qualifications.
4. Adjudication methods.
5. Details on a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
6. Information on standalone (algorithm-only) performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for a training set.
9. How ground truth for a training set was established.

The document focuses on non-clinical testing to demonstrate biological safety, packaging integrity, and compositional equivalence to a predicate device, as required for 510(k) clearance for this type of medical device (an organ preservation solution). It does not describe a clinical performance study with defined acceptance criteria for a diagnostic or AI-driven device.

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The Paragonix KIDNEYvault Portable Renal Perfusion System is intended to be used for the pulsatile hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with this organ.

The Paragonix KIDNEYvault Portable Renal Perfusion System can maintain the donor organ storage temperature between 4°C and 8°C through 24 hours.

Donor kidneys exceeding clinically accepted 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 KIDNEYvault Portable Renal Perfusion System (KIDNEYvault) device is designed to provide pulsatile perfusion of pre-chilled machine preservation solution through the kidney by means of a mechanical pump and closed fluid circuit integrated within the device and attached to the kidney. Its intended use and principle of operation are the same as the predicate device, LifePort Kidney Perfusion Transporter (K021362), while the differences in the technological characteristics from the predicate are supported by the literature, testing, and the following reference devices: SherpaPak KTS and KIDNEY Assist. To maintain the chilled temperature of the machine preservation solution, the subject KIDNEYvault utilizes the same technology as the first reference device, SherpaPak KTS; whereas certain specifications for the subject device are based on the second reference device, KIDNEY Assist-transport.

The subject KIDNEYvault device consists of the following components:

1. KIDNEYvault SherpaCool Pouch and Ribbons Phase Change Material (PCM) (identical to the first reference device) to maintain temperature of the cold machine preservation solution and kidney throughout transportation. The KIDNEYvault device maintains the temperature between 4°C to 8°C throughout preservation and transportation.
2. KIDNEYvault Canister Assembly Proprietary hard shell, polycarbonate nested canister set for the packaging of the donor kidney within cold machine preservation solution and circulation of preservation solution through kidney vasculature.
   The Canister Assembly incorporates a closed fluid pathway and connections to the donor kidney that draws cold machine preservation solution from the Inner Canister and circulates it through the renal artery of the kidney and exits through the renal vein or ureter back into the Inner Canister.
3. KIDNEYvault Shipper Outer transport shipper which comprises a protective and insulative package. The KIDNEYvault Shipper is a rigid, molded expanded polystyrene (EPS) insulative container into which the KIDNEYvault SherpaCool and KIDNEYvault Canister Assembly are placed. The maintenance of temperature of the donor kidney between 4°C to 8°C is assisted by the EPS insulation of the Shipper, providing insulation from the exterior environment to the interior components and KIDNEYvault SherpaCool.
   The KIDNEYvault Shipper incorporates a peristaltic pump used to circulate the machine preservation solution through the kidney vascular system. The pump is a peristaltic pump that circulates chilled machine preservation solution (drawn from the Inner Canister) into the renal artery, through the kidney vasculature, and exiting back into the Inner Canister through the renal vein or ureter.
   The KIDNEYvault Shipper includes a datalogger (connected to a temperature probe and pressure sensor) which records and displays the temperature of the machine preservation solution surrounding the donor kidney and the perfusion pressure within the fluid pathway.
4. KIDNEYvault Cannula The cannula connects to the renal artery of the kidney and the fluid circuit of the KIDNEYvault. There are multiple sizes of round cannulas and oval cannulas for different kidney anatomies.

The provided document is a 510(k) summary for the Paragonix KIDNEYvault Portable Renal Perfusion System (K234060). It describes the device, its intended use, and its comparison to predicate and reference devices, as well as a summary of bench testing. However, it does not contain specific acceptance criteria, reported device performance metrics in relation to those criteria, or details of a study explicitly proving the device meets acceptance criteria in a quantifiable manner (e.g., sensitivity, specificity, accuracy for a diagnostic device).

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (LifePort Perfusion Kidney Transporter, K021362) and reference devices (SherpaPak Kidney Transport System, K180194; KIDNEY ASSIST-transport, K211333) through a comparison of technological characteristics and a summary of bench testing. The bench testing verifies that the device meets specifications, but these specifications are not explicitly laid out as acceptance criteria with numerical performance targets in the context of a clinical study or performance evaluation in the provided text.

Therefore, many of the requested details cannot be extracted from this document.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format requested. It discusses "specifications" met by various components during verification and validation, but these are not framed as quantifiable acceptance criteria with numerical results in a performance table.

The key performance claims related to the intended use are:

• Temperature Maintenance: "The Paragonix KIDNEYvault Portable Renal Perfusion System can maintain the donor organ storage temperature between 4°C and 8°C through 24 hours."
• Pulsatile Perfusion: The device provides "pulsatile hypothermic machine perfusion of kidneys."

The bench testing "demonstrates the ability of the KIDNEYvault device to maintain hypothermic preservation and pulsatile perfusion under varying environmental and transportation conditions of the donor kidney beyond the intended organ storage time of 24 hours." This is a general statement of meeting specifications rather than reporting specific performance metrics against defined acceptance criteria.

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

Not applicable. The document summarizes bench testing, not clinical studies with "test sets" in the context of diagnostic or interventional effectiveness. The provenance mentioned in the "Summary of Literature" is "relevant publications" from a "literature search" and does not refer to data provenance for a specific test set used in the device evaluation.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This information is typically relevant for diagnostic AI/ML device evaluations where expert consensus is used to establish ground truth for image interpretation or disease classification. This document describes a medical device for organ preservation and transport, which does not involve such a process.

4. Adjudication Method

Not applicable for the same reasons as point 3.

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

Not applicable. This type of study is relevant for diagnostic devices involving human readers. The KIDNEYvault is an organ preservation and transport system.

6. Standalone (Algorithm Only) Performance

Not applicable. The device is a mechanical system with integrated datalogger and pump, not a standalone algorithm.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI/ML or diagnostic devices (e.g., pathology, outcomes data) is not directly relevant here. The evaluation focuses on the mechanical and thermodynamic performance of the system. The "ground truth" for verifying its function would be measured physical parameters (temperature, pressure, flow) under controlled conditions and comparison against engineering specifications. The conclusion section mentions "verification/validated" and "supported by the reference devices," suggesting that physical and operational characteristics were assessed against predetermined engineering and functional requirements derived from predicate devices and standards.

8. Sample Size for the Training Set

Not applicable. The device is not an AI/ML or diagnostic algorithm that undergoes a "training set."

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

Not applicable for the same reasons as point 8.

In summary, the provided FDA 510(k) document is a summary for a mechanical device used in organ preservation and transportation. It focuses on demonstrating substantial equivalence through a comparison of technological characteristics and basic bench testing (biocompatibility, electrical safety, mechanical verification of components, and performance validation). It does not detail specific acceptance criteria or performance metrics in the way a diagnostic or AI/ML device submission would, nor does it refer to clinical studies with test sets, expert-driven ground truth, or MRMC studies.

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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 <788> 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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BAROguard™ is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs.

The intended organ storage time for BAROguard™ is up to 8 hours.

Donor lungs 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.

Note: Partial lungs can be transported via BAROguard™ by packaging lungs per institutional protocol and UNOS guidelines.

The subject BAROguard device results from modifications made to the cleared LUNGguard (previously named, SherpaPak Lung Preservation System) cleared under K192869. The subject BAROguard device consists of the following components:

1. BAROguard SherpaCool Pouches Phase Change Material (PCM) pouches (identical to the predicate) to maintain temperature of the cold preservation solution and lung throughout transportation. The BAROguard device maintains the temperature between 4°C to 8°C identical to the predicate with the use SherpaCool pouches throughout preservation and transportation.
2. BAROguard Lung Containment Assembly Nested lung containment bags for the packaging of donor lungs and preservation solution. BAROquard Lung Containment Assembly includes pneumatic connections to the donor lung in the inner-most bag, a pneumatic connection to the BAROguard Shipper Airway Pressure Management System, endotracheal connectors to connect the trachea of the donor lungs to the BAROguard Lung Containment Assembly, and tools for the secure attachment of the endotracheal connectors and closure of the BAROguard nested lung containment bags.
3. BAROquard Shipper- Outer transport shipper which comprises a protective and insulative package. The BAROguard Shipper is a rigid, molded expanded polystyrene (EPS) insulative container and into which the SherpaCool pouches and donor lung within the BAROguard Lung Containment Assembly are placed. The maintenance of temperature of the donor lung between 4°C to 8°C is assisted by the EPS insulation of the BAROguard Shipper, providing insulation from the exterior environment to the interior components and BAROguard SherpaCool.

The BAROguard Shipper incorporates an Airway Pressure Management System. The Airway Pressure Management System maintains the donor lung airway pressure when connected to the BAROguard Lung Containment Assembly.

The BAROquard Shipper includes an off-the-shelf datalogger (connected to a temperature probe and airway pressure sensor) which monitors and displays the temperature of the solution surrounding the donor lungs and the airway pressure of the donor lungs.

Although the BAROguard is based on the predicate LUNGguard design, it also includes two new design elements:
. Incorporation of a sterile Lung Containment Assembly instead of use of offthe-shelf bags in K192869.
. Incorporation of an Airway Pressure Management System to maintain donor lung airway pressure during preservation and transportation.

The provided text describes the BAROguard device, intended for static hypothermic preservation of lungs during transportation for transplantation. The acceptance criteria and supporting studies are detailed, particularly in comparison to a predicate device (Paragonix LUNGguard, K192869) and a reference device (Auto CPAP System, K211155).

Here's a breakdown of the requested information:

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)

The document describes various bench testing and validation studies for the device's components and overall function (biocompatibility, electrical safety, thermal/airway pressure, shipper durability, component verification, sterile packaging, filter validation).

• Sample sizes for these tests are not explicitly stated in the provided text. For example, while it mentions "Validation demonstrates the ability of the BAROguard device," it doesn't quantify how many devices or trials were part of that validation.
• Data provenance: The studies are described as functional testing and verification/validation studies, implying laboratory or engineering testing. There is no mention of human clinical data, animal studies, country of origin of data, or whether it was retrospective or prospective. The testing focuses on the physical and functional characteristics of the device itself.

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 provided in the document. The studies are described as engineering-focused verification and validation, not clinical trials requiring expert consensus on ground truth.

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

This information is not provided in the document. As the testing focuses on objective functional performance rather than subjective interpretation, an adjudication method, as typically used in clinical studies with human assessors, would not apply here.

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

There is no mention of an MRMC comparative effectiveness study in the provided text. The device is for organ preservation and transport, not for interpretation or diagnosis by human "readers" or involving AI assistance in that context.

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

This question is not applicable to the BAROguard device, as it is a medical device for organ preservation and transport, not an algorithm, or AI diagnostic tool.

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

The "ground truth" for the performance criteria appears to be based on established engineering specifications, recognized international standards (e.g., ISO, IEC), and clinical guidelines related to organ preservation (e.g., maintaining specific temperature and pressure ranges, sterility, biocompatibility). For example, temperature maintenance is verified against the 4°C to 8°C range; airway pressure is verified against 12-15 cmH2O. These are objective, measurable parameters rather than subjective interpretations or clinical outcomes in the traditional sense of a diagnostic device.

8. The sample size for the training set

This question is not applicable. The BAROguard device is a physical medical device, not a machine learning model, so there is no "training set."

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

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

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The KIDNEY ASSIST-transport is intended to be used for the pulsatile hypothermic oxygenated machine perfusion of kidneys for the preservation, transport and eventual transplantation into a recipient.

The KIDNEY ASSIST-transport system of Organ Assist Products B.V. is a portable pump system that continuously allows hypothermic pulsatile perfusion of donor kidneys with oxygenated preservation solution during transport from donor to recipient in transplantation procedures. The system consists of the reusable KIDNEY ASSISTtransport device and a disposable KIDNEY ASSIST-transport perfusion set. The characteristics of the KIDNEY ASSIST-transport are:

• Pulsatile oxygenated hypothermic machine perfusion of donor kidneys ●
• Transportable hypothermic machine perfusion technique
• Hypothermic preservation and reconditioning device
• Improved preservation compared to cold storage in DBD, ECD and DCD
• Easy to install disposable perfusion set

The KIDNEY ASSIST-transport device is a thermo isolated enclosure wherein the kidneys are cooled passively by ice and a separate compartment holding the electronics, batteries and a dedicated medical oxygen cylinder. The device has sufficient battery power, holds enough oxygen and ice for an application period of 24 hours of hypothermic oxygenated perfusion. Pulsatile perfusion is generated by a rotary pump driven by an electromotor and is pressure controlled. User-friendly firmware allows the user to change perfusion parameters. Settings and results of the perfusion measurements are numerically displayed on the top of the enclosure. The single-use disposable KIDNEY ASSIST-transport perfusion set contains an easy to install preassembled perfusion cartridge for use in combination with the KIDNEY ASSIST-transport device. The purpose of the KIDNEY ASSIST-transport Perfusion Set is to perfuse human organs to be transplanted with an approved pump perfusion solution. Its set contains a reservoir, kidney holder, cannula, oxygenator, pump head, pressure sensor and compatible tubing. Pulsatile perfusion is maintained by the centrifugal pump head, pulsating the perfusion solution from the reservoir through the oxygenator to the kidney holder in the reservoir. Oxygenation is performed by the hollow fiber membrane oxygenator which facilitates the gas exchange with the perfusion solution. All kidneys will be perfused with University of Wisconsin Machine Perfusion Solution (UW-MP).

KIDNEY ASSIST-transport allows transportable machine perfusion to bridge the timespan between procurement and transplantation of kidneys.

The information provided describes a medical device, the KIDNEY ASSIST-transport, and its substantial equivalence to a predicate device. However, it does not explicitly state "acceptance criteria" for the device's technical performance in a table, nor does it detail a study designed to "prove the device meets the acceptance criteria" in terms of specific performance metrics (like sensitivity, specificity, accuracy, etc.) you would typically find for diagnostic or AI-driven devices.

Instead, the document focuses on demonstrating substantial equivalence through various types of testing and an investigator-initiated clinical study primarily comparing oxygenated HMP (Hypothermic Machine Perfusion) with non-oxygenated HMP, where the KIDNEY ASSIST-transport was used in the oxygenated arm.

However, I can extract information related to the device's characteristics and performance to construct a response that aligns with your request as much as possible given the provided text.

Here's an attempt to answer your questions based on the provided document:

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

The document doesn't provide a formal "acceptance criteria" table for specific performance metrics in the way one might see for an AI algorithm. Instead, it compares the KIDNEY ASSIST-transport to a predicate device based on various characteristics and reports the findings of a clinical study that used the device.

Based on the "Substantial equivalence summary" table (page 5) and "Performance Data" section (page 6-7), here's a synthesis:

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

The relevant study is an "Investigator Initiated Clinical Data" study.

• Sample Size: Kidney pairs from donors were randomized. There were 106 recipients in each study arm (oxygenated HMP and non-oxygenated HMP), totaling 212 recipients. Kidney pairs imply 2 kidneys per donor, so likely 106 donor kidneys per arm = 212 donor kidneys total.
• Data Provenance: The document does not specify the country of origin.
• Study Design: It was an "investigator-initiated clinical study" described as a "paired design" where kidney pairs were randomly assigned. This indicates a prospective study design.

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 section is not applicable to the provided document. The device is a kidney perfusion and transport system, not a diagnostic device that requires expert ground truth annotation for images or other data. The "ground truth" for the clinical study would be objective clinical outcomes (e.g., rejection rates, kidney function, graft survival, complications) observed in patients after transplantation. These are physiological endpoints, not expert interpretations.

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

This is not applicable. The clinical study described involves objective clinical outcomes (rejection rates, complications, graft survival, kidney function) in humans. Adjudication methods like "2+1" are typically used for establishing ground truth in image interpretation studies where expert consensus is needed. Clinical outcomes are typically measured directly or through established medical criteria, not by expert adjudication of subjective assessments. The study itself is an effectiveness comparison for a device used in treatment.

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 device is a medical apparatus for organ preservation, not an AI-based diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

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

This is not applicable. The KIDNEY ASSIST-transport is a physical device that performs machine perfusion; it is not an algorithm, and its operation inherently involves human interaction for setup, monitoring, and clinical decisions.

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

For the "Investigator Initiated Clinical Data" study, the ground truth was based on clinical outcomes data after transplantation. This includes metrics such as:

• Kidney function (not detailed how measured, but implied clinical performance)
• Graft survival at 1 year
• Number of severe post-operative complications (including (S)AE – serious adverse events)
• Rejections of the kidney after transplantation

8. The sample size for the training set

This is not applicable. The document describes a physical medical device and a clinical study validating its use. It is not an AI/ML model for which a "training set" would be used. The "Investigator Initiated Clinical Data" study is an evaluation of the device's clinical performance, not a dataset for training an algorithm.

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

This is not applicable for the same reasons as point 8. No "training set" for an algorithm is described.

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