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The Mission® U120 Ultra Urine Analyzer is an urinalysis instrument intended for in vitro diagnostic use. It is intended for professional use only at point-of-care locations. The Mission U120 Ultra Urine Analyzer is intended to read Mission® Urinalysis Reagent strips (Microalbumin/Creatinine) for the semi quantitative measurement of Albumin and Creatinine. These measurements are used to assist diagnosis for kidney function.

The Mission® Liquid Urine Controls and Mission® Liquid Diptube Urine Controls are assayed urine controls, intended for use in validating the precision of analyzer reading of urinalysis for the Creatinine and Albumin analytes.

The Mission® U120 Ultra Urine Analyzer is a reflectance photometer that analyzes the intensity and color of light reflected from the reagent areas of a urinalysis reagent strip.

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) are to be read by the Mission® U120 Ultra Urine Analyzer.

The Mission® Liquid Urine Controls and Mission® Liguid Diptube Urine Controls are assayed urine controls, intended for use in validating the precision of analyzer reading of urinalysis for the Creatinine and Albumin analytes.

Here's an analysis of the acceptance criteria and study information provided for the MISSION® U120 Ultra Urine Analyzer and associated reagent strips and controls:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for the clinical accuracy study in terms of specific percentages for accuracy, sensitivity, and specificity. However, it presents the reported performance values. We can infer that these values were deemed acceptable for substantial equivalence.

Regarding the Precision Study:

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

• Sample Size for Clinical Accuracy: A total of 429 urine specimens were used.
• Data Provenance: The specimens were "randomly collected at three clinical sites from patients." The document does not specify the country of origin, but given the FDA filing, it's typically understood to be within the United States or from sites compliant with US regulations. The data is prospective as it involves new testing of collected specimens.

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

The document states that the clinical study data for accuracy involved comparing the Mission® U120 Ultra Urine Analyzer results against those obtained from a predicate device (Clinitek Microalbumin 2 Reagent Strips read by Clinitek Status Analyzer).

Therefore, the "ground truth" for the clinical accuracy study was established by the predicate device's readings, rather than by human experts directly interpreting raw data. No specific number of experts or their qualifications are mentioned in this context, as the comparison is device-to-device.

4. Adjudication Method for the Test Set

Not applicable. The study compares the new device's readings against a predicate device. There is no mention of an adjudication method involving human experts.

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

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed or reported in this document. This device is an automated analyzer, not an AI-assisted diagnostic tool for human readers.

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

Yes, a standalone performance study was done. The reported accuracy, sensitivity, and specificity for Albumin and Albumin-to-Creatinine Ratio are based on the Mission® U120 Ultra Urine Analyzer's readings without human intervention. The device is described as a "reflectance photometer that analyzes the intensity and color of light reflected from the reagent areas," indicating automated measurement.

7. The Type of Ground Truth Used

The ground truth for the clinical accuracy study was established by comparison with a legally marketed predicate device: "Clinitek Microalbumin 2 Reagent Strips (K972706) read by Clinitek Status Analyzer (K031947)." This is a common method for demonstrating substantial equivalence for in vitro diagnostic (IVD) devices.

For the precision study, control solutions (Level 1, Level 2, Level 3) with defined target concentrations were used as ground truth.

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 models. Given that the device is a reflectance photometer, its "training" would involve calibration and optimization during its development. This document focuses on the validation of the finished product. Therefore, no sample size for an AI/ML training set is provided.

9. How the Ground Truth for the Training Set was Established

As no specific "training set" in the AI/ML sense is mentioned, this question is not directly applicable. For the precision and accuracy studies, the ground truth was established as described in points 3 and 7. The device's internal calibration would have been established by the manufacturer during its development using reference materials and established laboratory methods.

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