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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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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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