(262 days)
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:
| Characteristic/Criterion (Implicit) | KIDNEY ASSIST-transport Performance / Compliance |
|---|---|
| Intended Use | Pulsatile hypothermic oxygenated machine perfusion of kidneys for preservation, transport, and eventual transplantation into a recipient. |
| Perfusion Parameters | Pressure: 0-50 mmHg; Flow: 0-250 mL/min; Temp: 2°C -10°C. |
| Duration of Perfusion | Up to 24 hours. |
| Oxygenation | Medical oxygen, 100 mL/min gas flow, Hollow fiber oxygenator. |
| Electrical Safety & EMC | Complies with IEC 60601-1:2012 Ed 3.1, ANSI/AAMI ES60601-1:2005/(R)2012 for safety and IEC 60601-1-2:2007 + AC:2010 for EMC. |
| Software Compliance | Complies with IEC 62304:2006 (Class B software, "major" level of concern). |
| Biocompatibility | Complies with ISO 10993-1. |
| Human Factors & Usability | Complies with IEC 62366:2008 and ANSI/AAMI HE75. |
| Sterility | Perfusion set complies with ISO 11135:2014 (SAL 10⁻⁶) and ISO 10993-7:2008. |
| Packaging & Shelf Life | Packaging complies with ISO 11607:2019; Shelf life complies with ASTM F 1980-16:2016. |
| Clinical Performance (Oxygenated HMP vs. Non-oxygenated HMP) | Improved outcomes: Significantly reduces severe post-operative complications and leads to 44% fewer rejections of the kidney after transplantation, along with improved kidney function and graft survival at 1 year. (Note: These are clinical outcomes using the device, not direct device performance metrics like accuracy). |
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.
§ 876.5880 Isolated kidney perfusion and transport system and accessories.
(a)
Identification. An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.(b)
Classification. Class II (performance standards).