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The Uritest-50 and Uritest-500B urine analyzers are semi-automated, bench top instruments which are intended for prescription, in vitro diagnostic use only. The instruments perform semi-quantitative detection of the following analytes in urine: leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood, pH and ascorbic acid. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acidbase balance and bacteriuria. The instruments use the accompanying check strip for daily calibration.

Untest 10G urine reagent strips provide semi-quantitative tests for leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood and pH in urine. The Uritest 10G urine reagent strips are for use with the Uritest-50 urine analyzer and are for prescription, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.

Untest 11G urine reagent strips provide semi-quantitative tests for leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood, pH and ascorbic acid in urine. The Untest 11G urine reagent strips are for use with Untest-500B urine analyzer and are for prescription, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.

The Uritest-50 and Uritest-500B Urine Analyzers are reflectance spectorphotometers that instrumentally measure the reflectance of a reacted Uritest 10G or Uritest 11G urine reagent strip for urinalysis. The Uritest-50 and Uritest-500B Urine Analyzers display and print urinalysis results and can be connected to a laboratory computer for data management.

The provided text is a 510(k) summary for the Uritest-50 and Uritest-500B Urine Analyzers and accompanying reagent strips. It states that "Studies were conducted in-house and in clinical settings to demonstrate that the performance of the Uritest-50 and Uritest-500B Urine Analyzers and Uritest 10G or Uritest 11G urine reagent strips are equivalent to the predicate devices." and thus "demonstrate that the device is equivalent in performance to the predicate devices and suitable for its intended use."

However, this document does not include any specific acceptance criteria or detailed results from the performance studies. It generally claims equivalence to predicate devices but does not provide data or methodology to support this claim in the given text.

Therefore, for most of your requested information, I cannot provide an answer based only on the provided text.

Here's what I can provide and what is missing:

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

• Acceptance Criteria: Not specified in the provided text.
• Reported Device Performance: Not detailed in the provided text. The document only makes a general statement about equivalence to predicate devices.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: "in-house and in clinical settings." The country of origin is not explicitly stated for the clinical settings, but the submitter is in China. Whether it was retrospective or prospective is not mentioned.

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)

• Not specified or mentioned in the provided text. The nature of the ground truth (e.g., comparison to predicate devices, or a specific reference method) is implied to be relative to predicate devices, but the process of establishing ground truth for the test set based on expert input is not described.

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

• Not specified or mentioned in the provided text.

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

• This device is a urine analyzer and reagent strips, which performs semi-quantitative detection automatically. It is not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or results with and without AI assistance. Therefore, an MRMC study in the context of human reader improvement with AI is not applicable to this type of device based on its description.

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

• The device, as described, is a standalone instrument (Uritest-50 and Uritest-500B Urine Analyzers) that performs semi-quantitative detection on reagent strips. The user manually dips the strip and places it in the analyzer, which then measures and displays results. This effectively performs as an "algorithm only" device in terms of its measurement and result generation.

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

• The document implies that the ground truth for comparison was the performance of predicate devices (Bayer Clinitek 500 Urine Chemistry Analyzer, Bayer Multistix 10-SG Reagent Strips for Urinalysis, Dirui URISTK H-11 Reagent Strips and Dirui H-500 Urine Analyzer). The specific type of ground truth data (e.g., what independent reference method these predicate devices themselves were compared against) is not detailed.

8. The sample size for the training set

• Not specified in the provided text.

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

• Not specified in the provided text, and given the nature of the device (semi-quantitative chemical analysis), a "training set" in the context of supervised machine learning might not be directly applicable in the same way it would be for an AI-based image analysis device. However, system calibration and validation would involve known samples. This detail is not provided.

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