(267 days)
The EON Portable Reverse Osmosis Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment. EON can be connected to hemodialysis equipment used in hospitals, clinics and in home environments, in conjunction with the appropriate pre and post treatment units, as part of a water treatment system designed to meet current AAMI and Federal (U.S.) standards.
EON has optional heat disinfection cycles intended to disinfect the reverse osmosis (RO) machine and product loop, and connection tubing to the hemodialysis machine. EON's heat disinfection cycle to disinfect the connection tubing (heat forward cycle) is intended to be used only with hemodialysis machines which contain their own heat disinfection cycles and hence are able to tolerate high temperatures. EON is not intended to heat disinfect the hemodialysis machine.
The device is a portable water purification system which uses reverse osmosis to remove contaminants from water that is used to dilute dialysis concentrate to form dialysate for use in hemodialysis equipment. Feed water enters the unit and is directed through a pump into a RO membrane. The pump applies a high hydrostatic pressure that forces water from the concentrated (feed) side to the dilute (product) side of the RO membrane. As water flows across the membrane purified water is produced. Both devices are designed to maintain low microbiological levels in the flow pathway by using optional cycles which perform heat disinfection on the entire RO machine and loop. The subject device also has an optional Heat Forward cycle which is intended to heat disinfect the connection tubing to the hemodialysis machine.
The provided text describes the 510(k) premarket notification for the "EON Portable Reverse Osmosis Water Purification System." This document is a regulatory submission for a medical device and not a study that proves the device meets specific acceptance criteria in the context of an AI/ML algorithm or diagnostic test.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Millenium HX) for a water purification system used in hemodialysis. The "acceptance criteria" and "study" described are related to the device's physical functions (water purification, heat disinfection) and regulatory compliance (electrical safety, biocompatibility), rather than performance characteristics of an AI/ML system.
Therefore, I cannot extract the information required by your prompt, such as:
- A table of acceptance criteria and reported device performance for an AI/ML model.
- Sample sizes for AI/ML test sets.
- Number of experts and their qualifications for AI/ML ground truth.
- Adjudication methods for AI/ML ground truth.
- MRMC comparative effectiveness studies for AI assistance.
- Standalone AI algorithm performance.
- Type of ground truth used for AI/ML.
- Sample size and ground truth establishment for an AI/ML training set.
The document is about a water purification system, not an AI/ML diagnostic or predictive device.
§ 876.5665 Water purification system for hemodialysis.
(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.