FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

THE INTENDED USE OF THESE DEVICES IS ALLOW THE HEMODIALYSIS FACILITY TO MIX SODIUM BICARBONATE POWDER WITH PRUIFIED WATER THAT MEETS AAMI STANDARDS FOR HEMODIALYSIS TREATMENT, AND ALLOW THE MIXED SOLUTION TO BE AUTOMATICALLY DELIVERED TO THE DIALYSIS MACHINES.

Device Description

Not Found

AI/ML Overview

The provided documents are a 510(k) clearance letter from the FDA and an Indication for Use statement for Sodium Bicarbonate Mixers/Delivery Systems. These documents declare substantial equivalence for the device based on its intended use, but they do not contain any information regarding performance metrics, acceptance criteria, or a study demonstrating that the device meets such criteria.

Therefore, I cannot extract the requested information. The concepts of "acceptance criteria," "reported device performance," "sample size for test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "effect size," "standalone performance," "ground truth type," "sample size for training set," or "how ground truth for training set was established" are not addressed in these regulatory documents.

Ask a Question

Ask a specific question about this device

K Number

K944493

Device Name

REVERSE OSMOSIS SYSTEM

Manufacturer

G.E.M. WATER SYSTEMS

Date Cleared

1996-02-20

(525 days)

Product Code