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ELITech Clinical Systems URINE TOTAL PROTEIN Standard 100 mg/dL is intended for the calibration of quantitative ELITech Clinical Systems URINE TOTAL PROTEIN on ELITech Clinical Systems Selectra Pro Series Analyzers.
ELITech Clinical Systems URINE CONTROL BI-LEVEL is a set of 2 levels of urine controls used for in vitro diagnostic in the quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.

ELITech Clinical Systems URINE TOTAL PROTEIN Standard 100 mg/dL is an aqueous solution ready to use containing bovine albumin at a concentration of 100 mg/dL and sodium azide (

This document describes two devices, a calibrator and a control, for urine total protein measurements. The information provided focuses on demonstrating substantial equivalence to predicate devices rather than independent performance studies with detailed acceptance criteria and expert reviews. Therefore, much of the requested information regarding study design, sample sizes, expert qualifications, and ground truth establishment is not available in these documents.

Here's an attempt to answer based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not explicitly list quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, precision, sensitivity, specificity) with specific numerical targets. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate devices through a comparison of intended use, format, levels, traceability, and stability. The reported "performance" is the equivalence itself.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of a clinical or analytical study with a defined sample size for the purpose of primary performance evaluation. The information provided is a premarket notification (510(k)) which aims to demonstrate substantial equivalence to existing legally marketed devices. This typically involves analytical performance data generated by the manufacturer to support the claims, but the specific details of sample sizes for such internal validation studies are not usually included in the public 510(k) summary.

Thus, there is no explicit mention of:

• Sample size used for a test set.
• Data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This type of information is generally relevant for AI/CADe devices where expert consensus or pathological diagnosis establishes ground truth for image interpretation. For a calibrator and a quality control material like these, "ground truth" refers to the accurately assigned values determined through a rigorous measurement process (e.g., gravimetric methods, certified reference materials, reference methods). This is typically established by the manufacturer's internal processes and is overseen by qualified analytical chemists or scientists, not by "experts" in the clinical interpretation sense.

4. Adjudication method for the test set

Not applicable. As there is no "test set" with expert interpretations being adjudicated, this information is not relevant to the provided documentation.

5. 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. MRMC studies are specific to AI/CADe devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The devices described here (calibrator and control) are in vitro diagnostic reagents and do not involve human interpretation in the same way.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. These are chemical reagents, not algorithms.

7. The type of ground truth used

For the Calibrator: The calibrator is stated to be traceable to SRM 927d (Standard Reference Material 927d). This likely refers to a National Institute of Standards and Technology (NIST) SRM for total protein, which would be the reference method or certified reference material providing the "ground truth" for the calibrator's assigned value.

For the Control: The control is intended for quality control of quantitative methods. The "ground truth" for control materials is typically established by assigned values determined by the manufacturer using validated methods, often relative to reference materials or established laboratory methods. The document also mentions that each urine donation for the control material is "tested individually and found to be negative for HbsAg and antibodies to HCV and HIV-1/HIV-2 according to FDA-approved methods," which contributes to the safety and quality control of the control material itself, rather than establishing a quantitative "ground truth" for a specific analyte measurement.

8. The sample size for the training set

Not applicable. These are not AI/machine learning devices that require a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for these types of devices.

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