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SC+ Machine and SC+ Dialysate Cartridge:

The SC+ Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician's prescription, by a trained person who is competent in the use of the device.

SC+ Blood Tube Set:

The SC+ Blood Tubeset is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The Blood Tubeset is compatible only with the SC+ Hemodialysis System

The SC+ Hemodialysis System is intended for acute and chronic dialysis therapy, with or without ultrafiltration, utilizing Dialysis Water (from standalone Reverse Osmosis (RO) units or a central RO ring main) to produce dialysate. The SC+ Hemodialysis system is for use in patients with arteriovenous (AV) fistula or central venous catheter access.

The system consists of the SC+ Machine, a single use disposable Dialysate Cartridge, and a sterile, single use, disposable Blood Tubeset.

The SC+ Machine consists of a water circuit (heater, de-aeration module, etc) blood leak detector, air in blood detector, a pneumatic interface for the dialysate cartridges, a peristaltic blood pump and various other sensors. The dialysate cartridge contains the following: conductivity monitors, interfaces for pressure and temperature measurement, membrane pumps to perform mixing/proportioning in order to produce dialysis fluid and the controlled removal of fluid from a patient with acute and/or chronic renal failure based on a physician's prescription. The dialysate fluid is manufactured using dialysis water purified externally by reverse osmosis that is heated to approximately 37oC and subsequently de-aerated within the machine before entering the cartridge.

The SC+ Blood Tubeset is a single use, sterile device consisting of an arterial line, a venous line, connections to a standard dialyzer, a saline line, three pressure transducer pods integrated into a single unit, a venous drip chamber, and a line for heparin infusion.

This document is a 510(k) Premarket Notification from the FDA, outlining the substantial equivalence determination for the Quanta SC+ Hemodialysis System. It does not contain the type of acceptance criteria and study data typical for an AI/ML medical device submission, which would include metrics like sensitivity, specificity, AUC, and details on ground truth establishment and expert adjudication.

Therefore, I cannot extract the information required by your prompt regarding acceptance criteria and a study that proves the device meets them, specifically for an AI/ML component. The information provided heavily focuses on the comparison of a hemodialysis machine and its components to predicate devices based on technological characteristics and general performance testing (e.g., dialysate quality, electrical safety, biocompatibility, sterilization, human factors).

To directly address your prompt, using only the provided text, I must state that the document does not contain the requested information about an AI/ML enabled device's acceptance criteria and study as described. It's a regulatory clearance for a traditional medical device, not an AI/ML diagnostic or prognostic tool.

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