(289 days)
PhySoft AMS™ is a web application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of erythropoiesis-stimulating agent (ESA) dosage recommendations to help achieve and maintain target hemoglobin levels in dialysis patients. PhySoft AMS™ is intended to help physicians, nurses, clinicians and anemia managers manage anemia in adult stage 5 chronic kidney disease (CKD) patients.
The PhySoft AMS™ is not a substitute for, but rather intended to assist, clinical judgment. The ESA dosing regimen options calculated by this device are intended to be used by qualified and trained medical personnel to inform the optimization of the dosage of ESAs in accordance with their approved labeling in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the medical professional's clinical judgment. No medical decision should be based solely on the patient Hgb response to dosing regimen options calculated by this device.
PhySoft AMS™ is a software application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of ESA dosage recommendations to help achieve and maintain target Hgb levels in dialysis patients. PhySoft AMS™ is intended to help physicians, nurses, clinicians and anemia managers manage anemia in adult stage 5 CKD patients.
PhySoft AMS™ is intended for use by medical personnel such as clinicians, nurses, and physicians in dialysis clinics or other settings where anemia management for hemodialysis patients is conducted.
Healthcare professionals access PhySoft AMS™ using a web browser communicating with the PhySoft AMS™ web application server. Patient information is obtained by PhySoft AMS™ from healthcare provider information systems. No components of PhySoft AMS™ are required to be installed at end user or healthcare provider locations.
PhySoft AMS™ assesses if there is adequate data to model an individual patient's Hgb response to ESAs. The results of this assessment are reviewed by the physician who, after considering any additional relevant information about the patient's condition, decides if they want to apply the PhySoft AMS™ ESA dose-Hgb response modeling capability to the particular patient's data. If adequate data are available, PhySoft AMS™ enables a physician to model a patient and select from dosing schedule options to achieve target Hgb levels or, at the physician's discretion, override the presented dosing schedule options.
The provided text states that a clinical evaluation was conducted for PhySoft AMS™ to demonstrate its safety and effectiveness. However, it does not provide specific details about the acceptance criteria or the results of the study in a format that allows for the extraction of a table of acceptance criteria and reported device performance, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC study details, standalone performance, type of ground truth, training set sample size, or how ground truth for the training set was established.
The document only generally concludes that "The Performance data demonstrated the safety and effectiveness of PhySoft AMS™ in anemia management for hemodialysis patients." and that it is "substantially equivalent" to its predicate device. This implies that testing was done, but the detailed methodology and results are not included in this summary.
Therefore, I cannot provide the requested information from the given input.
§ 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.