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The Combi Scan 500 is for use with Combi Screen test strips to determine the following parameters from urine: ascorbic acid, bilirubin, blood, glucose, ketones, leucocytes, nitrite, pH, protein, specific gravity, urobilinogen. These measurements are used in the evaluation of diabetes, liver diseases, haemolytic diseases, urogenital and kidney disorders or metabolic abnormalities. For professional use only, not for self testing!

The Combi Scan 500 is a medium automated urine test strip analyser for use with Combi Screen test strips to determine one or more of the following parameters from urine: ascorbic acid, bilirubin, blood, glucose, ketones, leucocytes, nitrite, pH, protein, specific gravity. For professional use only!

The provided text describes the Combi Scan 500, an automated urine analyzer, and its 510(k) submission. However, it does not include detailed information about acceptance criteria, specific study designs, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, or multi-reader multi-case studies. The document primarily focuses on comparisons to a predicate device and regulatory approval.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's the information that can be extracted, with explicit notes for what is not present:

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

The provided document does not explicitly state specific acceptance criteria (e.g., sensitivity, specificity thresholds) or detailed reported device performance in a quantitative or tabular format. It states the device "measures the color of the light that is reflected from the test pads on the strip... These data are converted into meaningful results." However, it does not quantify what constitutes "meaningful results" or provide performance metrics against such criteria.

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 does not provide any information regarding the sample size used for any test set or the data provenance (country of origin, retrospective/prospective).

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)

The document does not provide any information regarding the number or qualifications of experts used to establish ground truth.

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

The document does not describe any adjudication method.

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

A multi-reader multi-case study was not mentioned or described. The device is an automated urine analyzer, intended to replace or assist in manual reading of test strips, but the document does not focus on human reader performance with or without the device.

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

The Combi Scan 500 is an automated urine analyzer. Its operation, as described ("The instrument measures the color of the light that is reflected from the test pads on the strip... These data are converted into meaningful results"), indicates it is a standalone device that performs measurements without direct human-in-the-loop interpretation during the measurement process. However, the document does not present a specific "standalone performance study" with metrics. It primarily establishes substantial equivalence to a predicate device.

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

The document does not explicitly define the type of ground truth used for any validation studies. Given the nature of a urine analyzer, the ground truth would typically be established by established laboratory methods (e.g., quantitative chemical analysis, microscopic examination of urine sediment, or manual expert reading of the dipsticks by trained personnel). However, this is not stated in the provided text.

8. The sample size for the training set

The document does not provide any information regarding the sample size used for a training set. The Combi Scan 500 is a reflectometric device, and the document doesn't explicitly mention machine learning or AI models requiring "training sets" in the modern sense. It refers to a measurement technology that converts reflected light data into results.

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

Since no training set is described, how its ground truth was established is not provided.

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