(358 days)
The NxStage Therapy System is indicated for treatment of renal failure or fluid overload using hemofiltration and/or ultrafiltration. The NxStage Cartridge Express is part of the NxStage Therapy System and is intended for use with the NxStage Cycler.
The NxStage Cartridge Express is an extracorporeal blood tubing set with preconnected high flux (permeability) hollow-fiber filter.
The provided text describes the NxStage Cartridge Express, a medical device, and its regulatory clearance. However, it does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically seen for AI/ML-based devices.
Here's why the requested information cannot be extracted from the provided text:
- Device Type: The NxStage Cartridge Express is described as an "extracorporeal blood tubing set with preconnected high flux (permeability) hollow-fiber filter," which is a physical medical device, not an AI/ML algorithm or system.
- Study Details: The document explicitly states "Clinical Data: Not applicable" and refers to "in vitro testing" to characterize performance and establish substantial equivalence to predicate devices. This type of testing for a physical device focuses on performance characteristics (e.g., filtration rates, biocompatibility), not on metrics like sensitivity, specificity, or reader improvement seen in AI/ML studies.
- Acceptance Criteria for AI/ML: The concepts of "acceptance criteria," "test set," "ground truth," "expert consensus," "MRMC studies," "standalone performance," and "training set" are primarily relevant to the validation of AI/ML algorithms, not to the in vitro testing of a physical hemifilter.
Therefore, I cannot provide the requested information in the format specified because it is not present in the provided document, as the device is not an AI/ML product.
The summary states:
- Summary of Non-clinical Test: "In vitro testing was conducted to characterize performance of the NxStage Hemofilter to provide a basis of comparison to the predicate devices. Results of in vitro studies have documented that the NxStage Cartridge Express is substantially equivalent to the predicate devices and is suitable for the intended use specified."
- Clinical Data: "Not applicable"
This indicates that the clearance was based on non-clinical, in-vitro testing demonstrating substantial equivalence to predicate devices, rather than a clinical study with detailed performance metrics against specific acceptance criteria for AI algorithms.
§ 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.”