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The AUTION HYBRID™ AU-4050 Fully Automated Integrated Urine Analyzer System contains a test strip chemistry urine analyzer and a flow cytometry urine particle analyzer together in a single integrated device. The test strip chemistry module (CHM) is an automated urine analyzer intended for the in vitro measurement of the following parameters: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The chemistry module is intended for use with the Uriflet™ S 9HA multi-parameter urine chemistry test strips. The flow cytometry module (FCM) is an automated urine particle analyzer intended to analyze the following parameters in urine samples: Red Blood Cells, White Blood Cells, Epithelial Cells, Casts, and Bacteria and flags the presence of the following: Pathologic Casts, Crystals, Sperm, Small Round Cells, Yeast Like Cells, and Mucus. The AUTION HYBRID AU-4050 is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

Uriflet™ S 9HA is a urinalysis test strip with reagent pads for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, and Leukocytes. Uriflet S 9HA is for use with the AUTION HYBRID AU-4050 only.

The AUTION Control Solution is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry module.

The AUTION HYBRID AU-4050 is a fully automated urine analysis system. The AU-4050 contains a test strip chemistry urine analyzer also called the chemistry module (CHM) and a flow cytometry urine particle analyzer also called the flow cytometry module (FCM) together in a single integrated device. The CHM module analyzes the following parameters in urine: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The FCM module measures the following parameters in urine utilizing flow cytometry technology: Red Blood Cells. White Blood Cells. Epithelial Cells, Casts, and Bacteria. The FCM module flags for the presence of the following: Pathologic Casts, Crystals, Sperm, Small Round Cells. Yeast Like Cells and Mucus.

The provided document is a 510(k) summary for the ARKRAY AUTION HYBRID AU-4050 Fully Automated Integrated Urine Analyzer System, Uriflet™ S 9HA Urine Test Strips, and AUTION Control Solution. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics in the way a novel device might.

Therefore, the information typically requested in your prompt regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not explicitly detailed in this 510(k) summary. The document emphasizes comparison to predicate devices and states that "Clinical and bench testing was used to verify the performance characteristics of this device. This testing showed acceptable device performance that is substantially equivalent to the performance of the predicate devices."

However, I can extract the available information and also highlight what is not present in the document.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or specific reported device performance metrics in a table format for the new device against predefined thresholds. Instead, it relies on demonstrating substantial equivalence to existing predicate devices (AUTION MAX AX-4030 Urinalysis System (K093098), SYSMEX UF1000i Automated Urine Particle Analyzer with Urinalysis WAM software (K080887), and Sysmex UF-II Control (K070910)).

The "performance" demonstration is primarily through comparison of technological characteristics, intended use, operating principles, and design features to the predicate devices. The assumption is that since the predicate devices are already cleared, demonstrating equivalence implies acceptable performance.

Here's a summary of the comparisons provided, which implicitly serve as performance benchmarks by virtue of their equivalence:

Note: Changes in operational characteristics like "Processing Speed," "Sample Volume," "Display," "Built-in Printer," "Dimensions," and "Weight" are noted but are not considered performance criteria in the context of substantial equivalence for accuracy or clinical efficacy. The critical aspect for this type of submission is that these changes do not raise new questions of safety or effectiveness.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "Clinical and bench testing was used to verify the performance characteristics of this device." However, it does not provide details on:

• The specific sample sizes used for any test sets.
• The provenance of the data (e.g., country of origin, retrospective or prospective nature of the studies).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the 510(k) summary. For in-vitro diagnostic devices like this, expert review for ground truth might involve clinical pathologists or laboratory professionals, but the document does not elaborate.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the 510(k) summary.

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

The device is an automated urine analyzer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance is not applicable and was not performed or referenced. The device performs the analysis automatically.

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

Yes, the device is inherently a standalone (algorithm only) device as it is a fully automated integrated urine analyzer system performing in vitro measurements. Its performance would be evaluated based on the accuracy and precision of its automated measurements against a reference method or predicate device, independent of direct real-time human interpretation assistance during the analysis. The "comparison to predicate devices" and "clinical and bench testing" mentioned constitute this standalone performance evaluation relative to known performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the specific type of ground truth used. For IVD devices, "clinical and bench testing" typically refers to studies where:

• Bench testing might involve spiked samples, controls, or samples with known concentrations/particle counts verified by confirmatory lab methods.
• Clinical testing would involve patient samples, likely compared against a reference method (e.g., manual microscopy for urine sediment, or established clinical chemistry methods for parameters like glucose, protein) which would effectively serve as the ground truth. Since the application is for "in vitro diagnostic use in screening patient populations," the ground truth would likely be established by clinical laboratory standards and reference methods.

8. The sample size for the training set

This information is not provided in the 510(k) summary. The document describes a traditional automated analyzer, not a machine learning/AI device that typically employs distinct "training" datasets in the computational sense. Performance verification for this device involved "clinical and bench testing."

9. How the ground truth for the training set was established

As the document does not describe a "training set" in the context of machine learning, this information is not applicable/provided. For traditional IVD analyzers, ground truth for sample data used in method comparison or verification studies (analogous to validation) would be established by reference laboratory methods, sometimes using spiked samples or certified reference materials for precision and accuracy assessments.

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