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The Uritek TC-101 urine analyzer is an automated, bench top instrument which is intended for prescription, in vitro diagnostic use only. The instrument is intended to be used together with the Urine Reagent Strips (URS) 10 as a system for the semi-quantitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.

The Uritek TC-101 Urine Analyzer is a portable easy to use instrument which reads Teco Urine Reagent Strips (URS) 10 for testing in the clinical laboratory. The TC-101 can determine the intensity of different colors on the reagent strip test area. It does this by irradiating the test area with light and detecting the reflectance of different wavelengths using an integrated sphere photo-detector. This photo-detector is filtered to measured wavelengths of 525nm, 550nm, 620nm, and 720nm by the integrated sphere. Results are calculated by a reflection rate which is a percentage of the total reflectance of the testing wavelength and are printed automatically.

The Uritek TC-101 reports semi-quantitative assays for 10 urine analytes (glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes). Reagent strip results are automatically displayed on the screen in one minute. A printed hardcopy can also be created either from the results screen or recalled from memory. The analyzer features a display, internal printer, a serial computer interface and an electrical outlet. Communication between the operator and the analyzer is made through the display using the arrows and 'yes' or 'no' buttons on the front of the analyzer.

The Urine Reagent Strips (URS) 10 are urine test strips of which glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocyte reagent pad are affixed onto the firm plastic strips. The reagent pad areas are bibulous material saturated with chemically active substances, then dried and affixed to the plastic strip with double-sided adhesive. URS 10 provide tests for the semi-quantitative determination of glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite and leukocytes in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance, and bacteriuria.

The Uritek TC-101 Urine Analyzer with Urine Reagent Strips (URS) 10 is an automated, bench-top instrument intended for semi-quantitative detection of various analytes in urine. The device's performance was evaluated through clinical studies comparing it to the legally marketed predicate device, Bayer Clinitek Status with Multistix 10 SG.

1. Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical acceptance criteria for each analyte. However, it indicates that "Clinical study results indicate that the intended users were able to obtain comparable testing data when using the Uritek TC-101 with Urine Reagent Strips 10 and the legally marketable Bayer Clinitek Status with Multistix 10 SG." This implies that the device's performance was expected to be equivalent to the predicate device.

The study mentions that "The performance characteristics of the Uritek TC-101 with the Urine Reagent Strips 10 were verified by method comparison, precision, linearity, detection limit, specificity, shelf life, and stress studies. Testing results indicate that the Uritek TC-101 and Urine Reagent Strips 10 perform satisfactorily when used appropriately, as outlined in the package insert."

Therefore, the reported device performance is that it achieved "comparable testing data" and "satisfactory" performance when compared to the predicate device across various performance characteristics.

2. Sample Size and Data Provenance:

The document does not specify the sample size used for the test set.
The clinical studies were performed at "Point-of-Care sites," implying the data was collected in a clinical setting.
The data provenance is prospective, as it describes "clinical studies were performed" using the device against a predicate. The country of origin of the data is not explicitly stated.

3. Number of Experts and Qualifications:

The document does not mention the number of experts used to establish the ground truth or their qualifications.

4. Adjudication Method:

The document does not mention any adjudication method used for the test set. The comparison appears to be direct between the new device and the predicate device's readings.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study compared the device with human-in-the-loop (the intended users operating the device) to a predicate device, but not human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance:

The document describes the system (Uritek TC-101 urine analyzer and Urine Reagent Strips 10) performance, which includes the automated reading by the instrument. This can be considered a form of standalone performance for the specific task of reading the reagent strips. The "intended users were able to obtain comparable testing data," suggesting the automated system's performance.

7. Type of Ground Truth Used:

The ground truth for the clinical studies appears to be based on the results obtained from the predicate device, Bayer Clinitek Status with Multistix 10 SG. The study aimed to show "substantial equivalency on performance" between the two systems. While not explicitly stated as 'ground truth,' the predicate device's results served as the reference for comparison.

8. Sample Size for the Training Set:

The document does not specify the sample size for the training set. It refers to "clinical studies" for evaluation but does not detail a separate training phase or its dataset size. Given the nature of a 510(k) summary for a semi-quantitative analyzer, the training would likely involve calibration and internal validation rather than a distinct "training set" in the machine learning sense.

9. How Ground Truth for Training Set was Established:

The document does not explicitly state how ground truth for a training set was established. However, the methodologies for each analyte (e.g., Glucose: "Based on a double sequential enzyme reaction") describe the chemical principles upon which the device's readings are based. This implies that the device's "training" or calibration would rely on known chemical concentrations and their corresponding color reactions, which form the basis of the semi-quantitative measurements. The "Calibration Method" is stated as "Dark current, white reflectance strip," indicating an internal calibration process.

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