(76 days)
The Diacap® Polysulfone HiFlo 23 Hemodialyzer is designed for single use in acute and chronic hemodialysis.
The Diacap® Polysulfone HiFlo 23 Hemodialyzer is a high permeability dialyzer intended to be used in acute and chronic hemodialysis. It is composed of polysulfone hollow fiber capillary membranes in a polycarbonate housing with a polyurethane potting resin and a silicone O-ring. The proposed Diacap HiFlo 23 hemodialyzer will be available in one model, the 23, which represents the effective surface area of 2.3m². The dialyzer is intended for single use and is provided sterile.
The provided text is a 510(k) summary for the B. Braun Avitum AG Diacap Polysulfone HiFlo 23 Hemodialyzer. It focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, device performance metrics, or a study that quantitatively proves the device meets those criteria in the way typically expected for AI/ML device evaluations.
Instead, the document states:
"Verification and validation testing for the proposed dialyzer have been completed and all acceptance criteria have been met. The testing demonstrated that there are no differences between the predicate and the proposed device that raise new issues of safety or effectiveness."
This indicates that internal testing was conducted, and the results satisfied predefined acceptance criteria. However, the document does not provide a table of these criteria, the reported device performance, or details about the study design that would allow for a comprehensive answer to your request in the context of an AI/ML device.
Therefore, I cannot provide the requested information regarding sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided document.
The document focuses on the regulatory approval process for a medical device based on substantial equivalence, rather than a detailed scientific study proving performance against specific quantitative metrics for an AI/ML algorithm.
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”