(459 days)
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.
§ 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).