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

Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium used for rapid cooling, perfusion and storage of lungs in connection with transplantation.

The provided document is a 510(k) summary for a medical device called Perfadex Plus. It describes the device, its intended use, and how it demonstrates substantial equivalence to a predicate device. While it mentions non-clinical testing and clinical data, it does not contain the detailed information needed to fill out all sections of your request regarding acceptance criteria and a specific study proving the device meets those criteria.

Here's an analysis based on the available information:

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

The document broadly states that non-clinical testing and clinical data "have shown the changes to the product do not produce any new safety or effectiveness issues." However, specific numerical acceptance criteria (e.g., pH within a certain range, osmolality within a range) and the corresponding reported performance values are not provided in this summary.

What is mentioned as tested are several parameters for stability studies and mechanical testing for the bag and port system. For example, for pH, Calcium, Osmolarity, Dextran, Glucose, and Particulate analysis, the document only says that these were included in stability studies, not what the criteria or results were. Similarly, for mechanical testing, it only lists the types of tests (e.g., pressure and leakage, resistance to dropping, penetration, tensile strength, flow testing) without detailing the criteria or observed performance.

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

• Clinical Data: "Using a statistically powered sample size with p-values obtained from a federally mandated registry [UNOS] and from a clinical trial, Clinical data on Perfadex® supplemented at point of use with THAM and calcium ions (PTHCa) shows it is substantially equivalent in survival to Perfadex not supplemented with Calcium."
  • Sample Size: Not specified quantitatively. It only states "a statistically powered sample size."
  • Data Provenance: Federally mandated registry [UNOS] (likely United States) and a clinical trial. The type of clinical trial (retrospective/prospective) is not explicitly stated, but registry data often includes both retrospective and prospective elements depending on how it's utilized.

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 as the study mentioned is related to organ survival, not an AI or imaging-based study requiring expert ground truth establishment in that context.

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

This information is not provided as the study mentioned is related to organ survival, not an AI or imaging-based 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:

No, an MRMC comparative effectiveness study was not done. The device is a perfusion solution, not an AI-assisted diagnostic tool.

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

No, a standalone algorithm performance study was not done. The device is a perfusion solution.

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

For the clinical data, the ground truth was outcomes data, specifically "survival" of lung transplants.

8. The sample size for the training set:

This information is not applicable/provided. The document describes a medical solution used in organ transplantation, not a machine learning model that would require a "training set."

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

This information is not applicable/provided. As above, there is no training set for this type of medical device.

Summary of missing information:

The 510(k) summary provides high-level information about non-clinical and clinical testing but lacks the granular detail about acceptance criteria, specific test results, and detailed clinical study design (like exact sample sizes) that would be present in a full study report or a different type of medical device submission. It focuses on demonstrating substantial equivalence based on the safety and effectiveness of the modified perfusion solution compared to its predicate.

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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® and Perfadex® with THAM is a colloid based "extracellular" low potassium electrolyte solution for rapid cooling, perfusion and storage of lungs in connection with transplantation

This document is a Premarket Notification Summary for Perfadex® and Perfadex® with THAM, a solution for lung preservation. It is a 510(k) submission, indicating that the device is seeking clearance based on substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy and safety from scratch.

Therefore, the document does not contain the kind of detailed information typically found in a clinical study report that would establish acceptance criteria and then demonstrate performance against those criteria in a rigorous, quantitative manner. Instead, the focus is on showing that the new device is "substantially equivalent" to existing, cleared devices.

Based on the provided text, here's a breakdown of the requested information, highlighting what is not available in a 510(k) summary of this type:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in this 510(k) summary. For a 510(k) submission, "acceptance criteria" are generally related to demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness profiles, rather than specific performance metrics (like sensitivity, specificity, accuracy) against a predefined benchmark. The "reported device performance" is implicitly that it performs comparably to the predicate devices.

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

This information is not applicable/provided as a separate "test set" and corresponding study demonstrating performance against acceptance criteria in the manner expected for a de novo or PMA submission is not included. The 510(k) relies on comparison to predicate devices, whose performance would have been established previously.

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

This information is not applicable/provided. Ground truth establishment by experts for a specific performance study is not described in this 510(k) summary.

4. Adjudication Method

This information is not applicable/provided. An adjudication method for a test set is not described.

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

No MRMC study is mentioned or referenced. This type of study is more common for diagnostic imaging AI devices, whereas this submission concerns a medical solution for organ preservation.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a solution for organ preservation, not an algorithm.

7. Type of Ground Truth Used

Not applicable. Ground truth for a performance study is not described.

8. Sample Size for the Training Set

No training set is mentioned or referenced. This device is not an AI/ML algorithm that requires training data.

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

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

Summary of What is Available in the Document Regarding "Acceptance Criteria" (Implicit) and "Study" (Substantial Equivalence):

The "acceptance criteria" for a 510(k) submission are implicitly met by demonstrating that the device is "substantially equivalent" to predicate devices. The "study" proving this is presented through a comparison of the new device's characteristics and intended use to those of previously cleared predicate devices.

• Intended Use: The device is intended for "flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient." This matches the intended use of the predicate devices.
• Technological Characteristics:
  • Composition: "Perfadex® and 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."
  • pH: "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; 1 mmol of THAM per liter of Perfadex®."
  • Predicate Device Comparison: The summary explicitly states: "Perfadex® was first 510(k) cleared by the FDA on 8 March 2001 (K000881). Perfadex® with co-packed THAM in a pre-filled syringe was cleared on 27 October 2003 (K022730), and then Perfadex® with co-packed THAM in a 50 ml glass bottle was cleared on 9 October 2008 (K081997)." The current submission (K091989) is for "Perfadex® and Perfadex® with THAM," and the FDA letter confirms substantial equivalence to the predicate devices, implying that the technological characteristics and indications for use are sufficiently similar for clearance.

Essentially, the "study" for this 510(k) is the comparison presented in the "Technological Characteristics" section, which asserts the device is functionally and compositionally similar to already approved versions of Perfadex®. The "acceptance criteria" are met if the FDA agrees that this comparison adequately demonstrates substantial equivalence, meaning the new device is as safe and effective as the predicate devices.

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