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Systems are intended for use with a hemodialysis system to remove organic and inorganic substances resulting in contaminants from water used to dilute dialysis concentrate to form dialysate, reprocessing of hemodialyzers, equipment rinse and disinfection.

The Acute PEDI System consists of a sediment filter, carbon filtration, mixed bed deionizers, and system monitoring with remote alarm functions. It is intended for use in a location with a portable dialysis machine for the dialysis of a single patient.

The Central PEDI System consists of a booster pump / pressure tank assembly, sediment filter, carbon filtration, mixed bed deionizers, resin trap filter, endotoxin filter and system monitoring with flow isolation/divert and remote alarm functions. It is intended for use in a central location for the dialysis of multiple patients.

The Back-up PEDI System consists of mixed bed deionizers, intermediate water quality (QC) indicator (light) and connection hoses. It is intended for use to provide a "back-up" for reverse osmosis filtration and system monitoring with flow isolation / divert and remote alarm functions are provided when required to meet ANSI/AAMI RD62:2001 requirements.

The PEDI systems are primary or temporary devices to provide water for hemodialysis applications per the requirements of ANSI/AAMI RD62:2001.

The systems consist of a booster pump / pressure tank assembly, sediment filter, carbon filtration, mixed bed deionizers, resin trap filter, endotoxin filter and system monitoring with flow isolation/divert and remote alarm functions. Refer to Operating Manuals for flow diagrams.

The booster pump / pressure tank assembly (central system only) consists of a multistage pump, and pressure tank. The multistage pump construction has minimum 304 SST wetted parts with no copper or iron wetted parts. The pressure (bladder) tank construction is an airtight shell inside of coil rolled steel with a 1 27 approved butyl rubber diaphragm to separate water from tank inside. The assembly requires 115V/1P/60Hz power to operate a multistage pump to raise pressure up to 80 psig.

The sediment filter consists of a polypropylene housing with pressure relief valve and a replaceable filter cartridge. The filter cartridge consists of spun polypropylene fiber wound on a polypropylene core and with a filtration rating of 10 microns. (Back-up system uses existing sediment filtration).

The carbon filtration consists of ABS lined fiberglass pressure tank containing granular activated carbon and PVC distributors. The size and number of tanks is dependent on flowrate required with carbon and PVC distributors listed in Appendix C. Back-up system uses facilities existing carbon filters if available, Acute system single tank.

The mixed bed deionizers consist of ABS lined fiberglass pressure tank with PVC distributors containing mixed bed ion exchange resin. The size and number of tanks is dependent on flowrate required and inlet water conductivity maximum values listed in Operating Manual.

The resin trap filter consists of a polypropylene housing with pressure relief valve and a replaceable filter cartridge. The filter cartridge consists of spun polypropylene fiber wound on a polypropylene core and has a filtration rating of 5 microns. (Not used on acute systems).

The endotoxin filter consists of a polypropylene housing with a replaceable filter cartridge. The filter cartridge consists of an element with 222 o-ring/closed type seals and has a reduction factor of 10' for bacteria and 10 for endotoxins.

System monitoring consists of pressure gauges, quality control indicator and resistivity monitor. Pressure gauges prior to deionization minimum brass body with phosphorous bellows, gauge after deionization 304 SST stem with SST bellows. The resistivity monitor has a digital readout, indicators for above and below water quality, push buttons for alarm setpoint indication and alarm function test. Connections to the monitor provide under low water quality: remote alarm (horn), isolation of flow to use (valve) and diversion of flow to drain (valve). Inline sensor construction stainless element with polypropylene body. Divert to drain not supplied for acute systems located in patient room. Monitor and divert to drain not supplied for back-up systems with existing monitor/alarm/divert. Refer to Operating Manuals for Control Diagram.

This 510(k) summary (K042018) does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria. It focuses on establishing substantial equivalence with a predicate device and describing the device's components and indications for use.

Therefore, I cannot provide the requested information from the provided text. The document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or their data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for test sets.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes.
6. Details on a standalone algorithm performance study.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document is a regulatory submission for a water purification system for hemodialysis, which typically involves performance testing against industry standards (e.g., ANSI/AAMI RD62:2001 for water quality parameters) rather than clinical studies with expert readers or ground truth establishment in the way AI/imaging devices might. The "performance" in this context would likely refer to water quality parameters (e.g., conductivity, removal of specific contaminants) which are not detailed as specific acceptance criteria or study results here beyond general compliance with RD62:2001.

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