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WaterCleck™ CP Reagent Strip is intended to be used in detecting residual chlorine or peroxide in dialysis water. It also is used for detection of effective high level of chlorine in the disinfecting solution.

WaterCleck™ CP Reagent Strip is a paper based dry chemistry reagent strip. It consists of a single reagent pad, 0.2x0.2 inch square, adhered to one end of a 0.2x2.5 inch plastic handle with a double sided adhesive. The chemistry of the regent strip allows the same single reagent pad to react with either chlorine or peroxide. It is self-contained and is ready to use as a dip-and-read reagent strip without other additional reagent.

The provided text describes a medical device called "WaterCheck™ CP Reagent Strip for Chlorine and Peroxide." It focuses on its intended use, technological comparison to existing products, and a statement of substantial equivalence. However, the document does not contain the detailed acceptance criteria and study information typically found in a comprehensive medical device submission that would allow for a complete answer to your request.

Specifically, the document lacks:

• A table of acceptance criteria with reported device performance values.
• Details on sample sizes for test sets, data provenance, or information about training sets.
• Information on experts used to establish ground truth, adjudication methods, or MRMC studies.
• Data regarding standalone algorithm performance or the type of ground truth used in a formal study.

Therefore, I cannot fully answer your request with the provided information.

However, based on the limited information about performance claims, I can infer what might be considered acceptance criteria based on its comparison to predicate devices, but this is a reconstruction and not explicitly stated in the document.

Inferred Potential Acceptance Criteria and Reported Device Performance (Based on Substantial Equivalence Claims):

Missing Information (Cannot be extracted from the provided text):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not available.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable (this is not an AI device or an imaging study requiring human reader performance).
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (this is a chemical reagent strip, not an algorithm).
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated, but for chemical detection, the "ground truth" would typically be established by laboratory methods using known concentrations of chlorine or peroxide.
7. The sample size for the training set: Not applicable (this is a chemical reagent strip, not a machine learning model requiring a training set).
8. How the ground truth for the training set was established: Not applicable.

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