(211 days)
Optiflux Dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
The Optiflux dialyzers are part of the FMCRTG family of single use dialyzers, which allow for the transfer of water and solutes between blood and the dialysate through a semi-permeable membrane. The Optiflux dialyzers are available in four (4) sizes. The sizes are differentiated by membrane surface area.
The proposed Optiflux dialyzers are single use dialyzers manufactured from Advanced Fresenius Polysulfone, polycarbonate, silicone and polyurethane. The dialyzers are provided with the blood pathway sterile and non-pyrogenic. The dialyzers are sterilized using e-beam radiation.
The principle of hemodialysis involves the diffusion of solutes across a semi-permeable membrane. Dialyzers use a counter-current flow, where the dialysate is flowing in the opposite direction to the blood flow in the extracorporeal circuit. Counter-current flow maintains the concentration gradient across the membrane for waste removal (diffusion) and fluid removal (ultrafiltration).
The provided document is a 510(k) premarket notification for a medical device (Optiflux Dialyzers). It details the device's characteristics, intended use, and comparison to a predicate device, along with the performance data demonstrating substantial equivalence. However, this document does not contain information about a study proving that the device meets acceptance criteria related to an AI/Software as a Medical Device (SaMD) context.
The document is for a physical medical device (dialyzer) and the performance data presented (e.g., urea clearance, structural integrity, biocompatibility) are relevant to the dialyzer's function in hemodialysis. There is no mention of an algorithm, AI, or software as a core component of the device being evaluated against specific performance metrics for diagnostic or therapeutic applications typically associated with AI/SaMD.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI/SaMD device meets those criteria from this text. The questions posed in your prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are highly specific to the validation of AI/SaMD products, which is not the subject of this 510(k) submission.
To directly address your request, based on the provided text, the answer is that the document does not contain the information required to fulfill the prompt.
§ 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.”