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The ACON™ U120 Urine Analyzer is intended for use in conjunction with the ACON Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic Acid), Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection of Nitrite. The ACON Urinalysis Reagent Strips are available in different combinations of the aforementioned analytes. The instrument is intended for professional, in vitro diagnostic use only. The measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract.

The U120 Urine Analyzer is a reflectance photometer that analyzes the intensity and color of light reflected from the reagent areas of a urinalysis reagent strip. Without a urine analyzer, operators must visually compare the reagent areas of the strip to a color chart using the naked eye. Obviously, visual determination for urinalysis is a time consuming task and is prone to inaccuracy due to human misinterpretation and variable light sources. To minimize the variability associated with visual testing, the ACON U120 Urine Analyzer is specifically designed for improved accuracy and efficiency of urinalysis featuring data management and report generation capabilities.

The provided text describes the ACON™ U120 Urine Analyzer and its substantial equivalence to a predicate device. However, it does not include specific acceptance criteria or a detailed study proving the device meets particular numerical performance targets. The document focuses on demonstrating substantial equivalence to a predicate device (Bayer Clinitek Status Urine Chemistry Analyzer) through various tests, rather than establishing and meeting predefined performance metrics.

Therefore, many of the requested sections (Table of acceptance criteria and reported device performance, sample size for test set, number of experts, adjudication method, MRMC study, sample size for training set, training ground truth establishment) cannot be extracted from the given text.

Here's an analysis based on the information available:

Acceptance Criteria and Study Overview for ACON™ U120 Urine Analyzer

The provided document describes the ACON™ U120 Urine Analyzer and its comparison to a predicate device, the Bayer Clinitek Status Urine Chemistry Analyzer (K031947). The primary goal of the studies mentioned was to demonstrate "substantial equivalence" to the predicate device, rather than meeting a specific set of numerical acceptance criteria publicly disclosed in this summary.

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided in the document.
The submission focuses on demonstrating substantial equivalence without detailing specific numerical performance acceptance criteria for each analyte. The "Discussion of Non-Clinical Tests Performed" and "Discussion of Clinical Tests Performed" sections indicate that various studies were conducted to show the device's performance is comparable to the predicate.

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

The document states: "Studies were conducted in-house and in clinical setting..." and "Clinical studies were conducted using the ACON U120 Urine Analyzer." However, specific sample sizes for clinical or test sets are not provided. The provenance of the data (country of origin, retrospective/prospective) is also not specified.

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

Not explicitly provided. The document mentions "inexperienced intended users" in the context of obtaining comparable testing results, but does not detail how ground truth for the test set was established or the number/qualifications of any experts involved.

4. Adjudication Method for the Test Set

Not described in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The study compared the ACON U120 Urine Analyzer against the predicate device, with a focus on whether "inexperienced intended users were able to obtain comparable testing results." This suggests a device-to-device comparison rather than an AI-assisted human vs. human-alone study.

6. Standalone Performance Study

The clinical study described compares the ACON U120 Urine Analyzer directly with the Bayer Clinitek Status Urine Chemistry Analyzer. This implies a standalone performance comparison of the device against the predicate. The document states: "Study results indicate that the inexperienced intended users were able to obtain comparable testing results when using the ACON U120 Urine Analyzer and a legally marketed Bayer Clinitek Status Urine Chemistry Analyzer (K031947)."

7. Type of Ground Truth Used

The document implies that the predicate device's results (Bayer Clinitek Status Urine Chemistry Analyzer) served as the de facto "ground truth" or reference for establishing substantial equivalence. The goal was to show "comparable testing results." No mention of pathology, expert consensus (beyond the predicate), or outcomes data as "ground truth" is made.

8. Sample Size for the Training Set

Not applicable/Not provided. This device is a reflectance photometer, which measures the intensity and color of light reflecting from reagent areas on urinalysis strips. It is not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning.

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

Not applicable/Not provided as this is not an AI/ML algorithm that uses a training set.

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