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The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The system consists of a smartphone application, proprietary Color-Board and an ACR Reagent Strip. The system is available for prescription-use only and is intended for people at risk of kidney disease. Results are intended to be used in conjunction with clinical evaluation as an aid in the assessment of kidney health.

The Minuteful - kidney test is comprised of a kit and a smartphone application. It is intended for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The Minuteful - kidney test is intended for prescription-use only, as a home-use device to aid in the assessment of kidney health. The results can be used together with clinical evaluation to guide patient care. The device is provided as a kit that comprises a urine receptacle, an ACR Reagent Strip, an absorbing (i.e. "blotting") pad, a proprietary Color-Board and a user manual. The device also consists of an easy-to-use smartphone application, image recognition algorithms, and a physician compendium. The software component of the Minuteful - kidney test consists of both an application (app) and a backend server. Both components encompass different computer vision and machine learning algorithmic components, performing the image analysis activities. The app instructs the user how to accurately administer the test. The Image Validation Transfer System (IVTS) component of the Minuteful - kidney test enables its usage across a wide range of smartphone types and operating systems, essentially making the test platform agnostic.

Here's a breakdown of the acceptance criteria and study information for the Healthy.io Minuteful - kidney test (K210069), based on the provided document:

Acceptance Criteria and Device Performance for Minuteful - kidney test (K210069)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implies acceptance criteria by reporting performance results against the predicate device that demonstrate substantial equivalence.

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

• Sample Size: More than 450 subjects were recruited for the clinical trials.
• Data Provenance: The document does not explicitly state the country of origin. The study was a prospective clinical trial, as subjects were "recruited" and tasks were "completed" within the context of the study.

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

The ground truth was established by comparing the Minuteful - kidney test results to those obtained from a professional user performing the test on the URISCAN Optima Urine Analyzer (predicate device).

• Number of Experts: Not explicitly stated as a count of individual professionals, but referred to as "a professional user." It's implied that this
  professional operated the predicate device.
• Qualifications: "Professional user" suggests trained laboratory or healthcare personnel familiar with operating the URISCAN Optima Urine Analyzer and interpreting its results. Specific credentials (e.g., medical technologist, clinical laboratory scientist, years of experience) are not provided.

4. Adjudication Method for the Test Set

The adjudication method involved a 2-part comparison:

1. A lay user (subject in the clinical trial) performed the test using the Minuteful - kidney test app.
2. A professional user (operating the predicate device, URISCAN Optima Urine Analyzer) then performed the test on the same urine sample.

The professional user was blinded to the results of the lay user until after they had completed their test. This can be considered a form of adjudication where the predicate device's result, as read by a professional, serves as the comparison benchmark. There was no explicit multi-expert consensus or 2+1/3+1 method described for establishing a single "ground truth" independent of the comparison devices; rather, the predicate device's output was the reference.

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

No, an MRMC comparative effectiveness study was not explicitly done in the sense of comparing multiple human readers with and without AI assistance on the same cases. The study compared a lay user with the AI-powered device to a professional user with a predicate device. It was a method comparison study to show substantial equivalence, not a study evaluating human reader improvement with AI assistance.

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

The clinical performance study involved a lay user interacting with the smartphone application and performing the test steps guided by the app. While the app uses "image recognition algorithms" and "machine learning algorithmic components," it is not a purely standalone algorithm-only performance assessment in the sense of a laboratory-based algorithm evaluation without human interaction for image capture and strip preparation. However, the analytical performance testing (Precision, Interference, Limit of Detection, Linearity, Stability) would represent the closest to "standalone" algorithm performance testing, as these evaluate the device's technical capabilities in a controlled environment. The linearity study, showing 100% exact match for every level of albumin, creatinine, and ACR, is a strong indicator of the core algorithm's accuracy at different concentrations.

7. The Type of Ground Truth Used

The ground truth was established by comparison to a legally marketed predicate device (URISCAN Optima Urine Analyzer) operated by a professional user. This is a form of reference standard comparison where the predicate device's output serves as the truth.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size for the training set used for the device's algorithms.

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

The document does not provide information on how the ground truth was established for the training set of the device's algorithms. It only describes the ground truth for the clinical performance (test set) comparison.

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