Search Results

FX CorAL HD dialyzers are intended for hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration in patients, including pediatric patients, with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.

Consider body and dialyzer surface area, blood flow, body weight and extracorporeal blood volume when selecting dialyzers for use with pediatric patients.

The FX CorAL dialyzers are high-flux, single-use, steam-sterilized hemodialyzers. The dialyzers are provided blood pathway sterile and non-pyrogenic. The dialyzers allow for the transfer of water and solutes between blood and dialysate using semipermeable, hollow fiber membranes.

The FX CorAL dialyzers are high-flux, sterile devices designed for single-use acute and chronic hemodialysis. The dialyzers are configured to connect to a bloodline set which connects to a patient's vascular access system when used with a hemodialysis machine equipped with ultrafiltration control. During hemodialysis, blood is pumped from the patient's body through an extracorporeal circuit, one component of which is the dialyzers contain semipermeable membranes that allow for diffusion and/or ultrafiltration to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate compartment. Dialyzers utilize a counter-current flow in which dialysate and blood flow in opposite directions in the dialyzer. The counter-current flow maintains the concentration gradient across the membrane for waste and fluid removal.

The document describes the FX CorAL 40 and FX CorAL 50 dialyzers and their substantial equivalence to predicate devices, focusing on performance, materials, and intended use. There is no information provided in the document regarding acceptance criteria or performance of an AI/ML device.

The provided text describes a medical device clearance (K242053) for FX CorAL 40 and FX CorAL 50 dialyzers, which are high permeability hemodialysis systems. While the request asks about acceptance criteria and study details for an AI/ML device, the document focuses on the performance data of these physical medical devices. Therefore, much of the requested information regarding AI/ML specifics (like effect size of AI assistance, standalone algorithm performance, training set details, expert qualifications for ground truth) is not applicable to this submission.

However, I can extract the relevant information pertaining to the tests conducted for these dialyzers, which function as "acceptance criteria" for a physical device.

Here's a breakdown based on the provided document:

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

The document lists performance tests conducted and states that "All testing met predetermined acceptance criteria." It does not explicitly list numerical acceptance criteria values for each test but provides typical performance results for urea clearance.

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

• Performance Testing (in vitro): Sample size for each specific in vitro test (e.g., clearance, integrity) is not explicitly stated, but it's implied that multiple samples were tested to generate the "typical" values and ensure criteria were met.
• Clinical Studies (retrospective):
  • Sample Size: Fourteen (14) pediatric ESRD patients
  • Data Provenance: Retrospective clinical data analysis. The country of origin is not specified.

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

This is not applicable as the document describes a physical medical device (dialyzer), not an AI/ML diagnostic tool requiring expert interpretation for ground truth establishment. The "ground truth" for the dialyzer's performance is established through well-defined physical and chemical measurements following international standards (e.g., ISO 8637-1).

4. Adjudication method for the test set:

Not applicable. For physical device performance, the results are typically quantitative measurements against defined specifications, not subjective interpretations requiring adjudication.

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, as this is not an AI-assisted diagnostic device.

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

Not applicable, as this is not an AI/ML device.

7. The type of ground truth used:

• In vitro Performance Tests: Ground truth is based on established physical and chemical measurement standards (e.g., ISO 8637-1 First Edition 2017-11) and direct laboratory measurements of parameters like clearances, sieving coefficients, ultrafiltration rates, and pressure drops.
• Biocompatibility Testing: Ground truth is established through standardized biological evaluation tests as per FDA guidance and ISO 10993-1.
• Clinical Studies: "Adequate clearance" (demonstrated by spKt/V values) and patient tolerance serve as clinical outcomes demonstrating the device's effectiveness in a real-world setting.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device and thus does not have a "training set" in that context.

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

Not applicable.

Ask a specific question about this device