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The CSAM CKHEMO rev 1.0 software computer program is a stand-alone product used to calculate total urea clearance (Kt/V), total urea clearance (Kt/V) delivered using the natural log formula, residual renal urea clearance (KrU), normalized protein catabolic rate (NPCR), actual blood flow, urea reduction ratio, body water volume calculated by urea kinetic modeling, total body water volume calculated using Watson's formula, actual weight loss after treatment, percent deviation (%Dev), and treatment time. These values are calculated using the test results of blood drawn immediately prior to and upon completion of kidney hemodialysis treatment based on the existing scientific formulas for single pool urea kinetic modeling. The device software is not meant to serve as the sole tool for determining effectiveness of treatment but as an adjunct to assist the physician in making the determination.

The CSAM CKHEMO rev 1.0 software computer program is a stand-alone product used to calculate various parameters related to kidney hemodialysis treatment based on test results of blood drawn before and after treatment and existing scientific formulas for single pool urea kinetic modeling.

This document is a 510(k) clearance letter from the FDA for a device called "CKHEMO Version 1.0" by CSAM, Inc. It describes the device's indications for use. However, it does not contain any information regarding acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is essentially a regulatory approval letter, not a scientific study report.

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