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CHEMVIEW-10™ is a visual qualitative and semi-quantitative test for the determination of urobilinogen, glucose, ketones, bilirubin, protein, nitrite, pH, blood, specific gravity and leukocytes in urine. These metabolites are useful in the evaluation of renal, urinary and metabolic disorder.

CHEMVIEW-10™ is a visual qualitative and semi-quantitative test for the determination of urobilinogen, glucose, ketones, bilirubin, protein, nitrite, pH, blood, specific gravity and leukocytes in urine.

Here's an analysis of the provided text regarding the CHEMVIEW-10™ Urinalysis Test Strips, structured according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided text. Instead, the study aims to demonstrate "substantial equivalence" to the predicate device (Roche Chemstrip®) through high agreement percentages. The reported device performance is presented as the agreement with the predicate.

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

• Sample Size for Test Set: A total of 188 specimens were tested.
• Data Provenance: The comparison studies were conducted at three reference laboratories. The specimens included "Fresh Urine specimens submitted to the laboratories for urinalysis as well as spiked urine specimens." This indicates a mix of naturally occurring clinical samples and possibly artificially altered samples, and the study is prospective in nature, as specimens were tested simultaneously with both devices. The country of origin is not explicitly stated, but the company is in Morganville, NJ, USA, and the FDA review is for the US market, suggesting data是从美国收集的.

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

The text does not specify the number of experts used to establish the ground truth or their qualifications. The comparison is made against the Roche Chemstrip® urinalysis reagent test strips, which itself serves as a reference, rather than an independent expert reading of a gold standard.

4. Adjudication Method for the Test Set

The text does not describe an adjudication method. The performance is reported as a direct agreement between the "CHEMVIEW-10™" and the "Roche Chemstrip®" results. There's no mention of multiple readers or steps to resolve discrepancies.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is for a visual, qualitative, and semi-quantitative test strip, not an AI-assisted diagnostic device where human readers interact with AI. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

This question is not applicable as the CHEMVIEW-10™ is a visual test strip designed for human interpretation, not an algorithm. Therefore, "algorithm only without human-in-the-loop performance" doesn't fit the context of this device. The performance data is essentially the "standalone" performance of the test strip when read by a human.

7. The Type of Ground Truth Used

The "ground truth" for this study is the results obtained from the predicate device, Roche Chemstrip® urinalysis reagent test strips. The study establishes substantial equivalence by comparing results from the CHEMVIEW-10™ to those from the legally marketed predicate device.

8. The Sample Size for the Training Set

The text does not mention a separate training set. This is a traditional device comparison study and not an AI/machine learning study that typically involves training sets. The 188 specimens appear to be the only dataset described for performance evaluation.

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

As no training set is mentioned or applicable in this context, the method for establishing its ground truth is not provided.

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