(264 days)
Hemodialysis with these dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It may also be indicated in the treatment of patients intoxicated with poisons or drugs. This dialyzer is indicated for single use or reuse. If the dialyzer is reused on the same patient, the reuse procedure and disinfectant specified in the Direction Insert must be followed. No other reuse procedure or disinfectant has been evaluated for clinical acceptability.
Models CA-90, CA-110, CA-130, and CA-150 Hemodialyzers
The provided text describes a 510(k) summary for the CA® Cellulose Acetate Hollow Fiber Dialyzer. The information focuses on the device's equivalence to a predicate device and its compliance with various standards and regulations. However, it does not contain the specific details required to answer your questions about acceptance criteria, device performance from a test set, ground truth establishment, or studies showing performance metrics as typically expected for AI/ML device evaluations.
This document is for a medical device (hemodialyzer) from 1997, which predates many of the standardized evaluation methodologies common for AI/ML-driven devices. Therefore, the information you're requesting regarding "acceptance criteria and reported device performance" (with specific metrics like sensitivity, specificity), "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication methods," "MRMC studies," "standalone performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established" is not present in the provided text.
The closest analogue to "acceptance criteria" and "device performance" in this document refers to how the device meets biological requirements, sterilization levels, residue limits, pyrogen testing, particle limits, and functional testing against manufacturing specifications, rather than performance in detecting a condition or making a diagnosis. The study mentioned, "Clinical data was collected according to the FDA Guidance for Hemodialyzer Reuse Labeling," is focused on the reuse aspect, not on a diagnostic or AI-driven performance metric.
Given the nature and age of the document, it's not possible to extract the information you've requested in the format applicable to modern AI/ML device evaluations.
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.