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The Mission Urinalysis Reagent strips (Microalbumin/Creatinine) are intended for the semi quantitative measurement of albumin and creatinine in urine samples using the Mission U120 Urine Analyzer. These measurements are used to assist diagnosis for kidney function. It is intended for professional use only at point-of-care locations.

The Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) are firm plastic strips that contain two reagent areas to test for Microalbumin (low concentration of albumin) and creatinine in urine. Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) can be read by the Mission® U120 Urine Analyzer.

The provided document describes the clinical performance and acceptance criteria for the Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) device. This device is intended for the semi-quantitative measurement of albumin and creatinine in urine samples using the Mission U120 Urine Analyzer, to assist in diagnosing kidney function.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document compares the new device against a predicate device (CLINITEK Microalbumin Reagent Strips) to establish substantial equivalence. The primary performance metric presented is agreement in classifying Albumin-to-Creatinine (A:C) ratios.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: 390 urine specimens.
• Data Provenance: Retrospective, collected randomly at three clinical sites from patients. The country of origin is not explicitly stated, but the submission is to the U.S. FDA by a company based in San Diego, CA, suggesting U.S. clinical sites.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The "ground truth" for the test set was established by comparing the results of the new device (Mission® Urinalysis Reagent Strips read by Mission U120 Urine Analyzer) to the predicate device (CLINITEK Microalbumin Reagent Strips read by Clinitek Status Analyzer). No independent human experts were stated to have established a separate ground truth for the clinical accuracy study. The predicate device itself acts as the reference for comparison.

4. Adjudication Method for the Test Set:

No explicit adjudication method (like 2+1 or 3+1) is mentioned. The study directly compares the results of the new device against the predicate device for each specimen.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. This device is an in-vitro diagnostic (IVD) test strip read by an analyzer, not an AI-assisted diagnostic imaging or interpretation tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Yes, the performance study is a standalone evaluation of the device system (reagent strips + analyzer). The device itself performs the semi-quantitative measurement. While human operators are involved in dipping the strips and initiating the reading, the "performance" described is that of the automated analytical system in interpreting the strip's reaction.

7. The Type of Ground Truth Used:

The ground truth for the clinical accuracy study was the results obtained from a legally marketed predicate device (CLINITEK Microalbumin Reagent Strips read by Clinitek Status Analyzer). This is a common approach for demonstrating substantial equivalence for new IVD devices.

8. The Sample Size for the Training Set:

The document does not explicitly mention a "training set" in the context of machine learning or AI. For a traditional IVD device like this, the development and calibration of the reagent strips and analyzer would involve extensive internal testing and optimization, but it's not typically referred to as a "training set" in the same way as for AI algorithms. The clinical accuracy study used 390 specimens.

9. How the Ground Truth for the Training Set Was Established:

As there's no explicitly defined "training set" in the AI sense for this type of IVD device, the method for establishing its ground truth isn't applicable. The performance is based on the chemical reactions of the strips and the optical reading capabilities of the analyzer, which would have been rigorously developed and validated against known concentrations of analytes and reference methods during the product development phase.

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