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The Uritek TC-201 Urine Chemistry Test System consists of the Uritek TC-201 Urine Chemistry Analyzer and the Teco Diagnostics Urine Reagent (URS-10) Strips. The Uritek TC-201 urine analyzer is an automated, bench top instrument which is intended for point-of-care, in vitro diagnostic use only and is intended to be used together with the Teco Diagnostics Urine Reagent (URS-10) Strips as a system for semi-quantitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in urine. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function.

The Uritek TC-201 Urine Analyzer (TC-201) is a portable easy to use instrument which reads Teco Diagnostics' Urine Reagent (URS-10) Strips for testing in the clinical laboratory. The analyzer 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 photodiode. 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-201 Urine Analyzer reports semi-quantitative assays for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in urine. 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 user interface touch screen on the front surface of the instrument. 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 Urine Reagent Strips (URS-10) for Urinalysis are firm plastic strips to which ten different reagent pads are affixed. The reagent pad areas are bibulous material saturated with chemically active substances, then dried and affixed to the plastic strip with double-sided adhesive. The Teco Urine Reagent (URS-10) Strips provide tests for the semi-quantitative determination of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, and Leukocytes in urine.

Here's a breakdown of the acceptance criteria and the study results for the Uritek TC-201 Urine Chemistry Test System, based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criterion for most analytes in the precision studies (both in-house and Point-of-Care) was 100% agreement within ±1 color block. For the comparative studies, the acceptance criteria were also based on agreement within and outside of specified color blocks. For Specific Gravity, the acceptance criteria was +/- 0.005.

Here's a summary table combining the reported performance from various studies:

Note: "L1", "L2", "L3" refer to Level I (High), Level II (Low), and Level III (Negative/Trace) control solutions, respectively. "N" indicates the number of tests performed.

Additional Information:

2. Sample size used for the test set and the data provenance:

• Precision Studies (In-house):
  • Within-Run: 180 strips per control level (20 strips x 3 strip lots x 1 day x 3operators/analyzers).
  • Run-to-Run: 120 strips per control level (3 strips x 2 runs x 10 days x 2 operators/analyzers/strip lots).
  • Data Provenance: In-house studies using commercially available urine control solutions. The country of origin of the data is not explicitly stated but implied to be from the manufacturer's facility.
• Precision Studies (Point-of-Care):
  • Sample Size: 40 tests per sample (duplicates per run, two runs per day for 10 days). Combined across 3 POC sites, the total for each control level (L1, L2, L3) was 120 (40 tests x 3 sites).
  • Data Provenance: Prospective, from three Point-of-Care (POC) sites: Clinica Medica Del Sagrado Corazon (Anaheim, CA), Clinica Medica San Miquel (Santa Ana, CA), and Artritis & Osteoporosis Center (Edinburg, TX). This data is from the USA.
• Method Comparison Study:
  • Sample Size: A total of 509 urine specimens. This comprised:
    • At least 115 unaltered patient samples per site from 3 POC sites (total > 345).
    • Additional contrived samples (10% of total samples).
    • 91 clinical samples from POC Site I and Site II.
    • A separate study at Site I with 26 patient urine samples prescreened at pH ≥ 8.0.
  • Data Provenance: Prospective, from three Point-of-Care (POC) sites in the USA. Samples were a mix of unaltered patient samples and contrived samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Precision Studies: Ground truth was established by the expected ranges of commercially available urine control solutions (HYCOR Biomedical), which have known target analyte concentrations confirmed by their package inserts and certificates of analysis. No external human experts are explicitly mentioned for these studies beyond the internal operators.
• Method Comparison Study: The ground truth for the method comparison study was established by the predicate device, the Siemens Clinitek Status+ Urine Analyzer (using Clinitek Multistix 10 SG Strips). This is a comparison between two devices, not a comparison against a clinical expert consensus or pathology.
• Linearity/Assay Reportable Range: For pH, a pH meter was used to confirm results. For specific gravity, a clinical, handheld refractometer was used. These serve as the "ground truth" or reference methods for these specific parameters. Three operators performed these measurements.

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

• Adjudication Method: Not explicitly described in the provided text for most studies. The precision studies rely on the expected values of control solutions. The method comparison study compares the Uritek TC-201 directly against the predicate device; discrepancies are noted but a formal multi-expert adjudication process is not detailed. For the precision studies, results were considered "within the expected results +/- one color block"; however, the process for resolving disagreements or establishing a definitive ground truth in cases of initial disagreement is not specified beyond relying on the control solution's stated values.

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 document describes a clinical chemistry test system for urine analysis, which is an automated instrument reading reagent strips. It is not an AI-assisted diagnostic imaging or human-in-the-loop system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

• The Uritek TC-201 Urine Analyzer is described as an automated, bench top instrument that "reads Teco Diagnostics' Urine Reagent (URS-10) Strips". It operates by "irradiating the test area with light and detecting the reflectance of different wavelengths using photodiode" and "Results are calculated by a reflection rate... and are printed automatically." This indicates that the device operates in a standalone (algorithm only) manner for interpreting the reagent strips. Human involvement is primarily in sample preparation and loading, and interpreting the printed results.

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

• Precision Studies: Ground truth was established by the expected ranges of commercially available urine control solutions with confirmed analyte concentrations.
• Linearity/Assay Reportable Range Study: For pH, a pH meter was the ground truth. For Specific Gravity, a clinical, handheld refractometer was the ground truth.
• Method Comparison Study: The ground truth was the predicate device's measurements (Siemens Clinitek Status+ Urine Analyzer).

8. The sample size for the training set:

• The document describes performance testing for a diagnostic device, not the development or training of a machine learning model. Therefore, a "training set" in the context of AI/ML is not applicable here. The studies described are for verification and validation of the device's analytical performance against established standards and a predicate device.

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

• As mentioned above, there is no "training set" in the context of AI/ML for this device. The ground truth for the various performance studies (precision, linearity, method comparison) was established using commercially available control solutions with known values, reference instruments (pH meter, refractometer), and comparison to a legally marketed predicate device.

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Uritek TC-201 Urine Chemistry Test System consists of Urine Analyzer and Urine Microalbumin Creatinine Strips. The Uritek TC-201 Urine Analyzer is an automated, bench top instrument which is intended for prescription, in vitro diagnostic use only. It is intended for use only at Point-of-Care (POC) sites by professionals. The device is intended to be used together with the Urine Microalbumin Creatinine (UAC) Strips as a system for the semiquantitative detection of Microalbumin and Creatinine and determination of the albumin to creatinine ratio in urine. Test results may be used in screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage.

Uritek TC-201 Urine Chemistry Test System consists of Uritek TC-201 Urine Analyzer and Urine Microalbumin Creatinine Strips. The Uritek TC-201 Urine Analyzer (TC-201) is a portable easy to use instrument which reads Teco Diagnostics' Urine Microalbumin Creatinine (UAC) Strips for testing in the clinical laboratory. The analyzer 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 photodiode. 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-201 Urine Analyzer reports semi-quantitative assays for microalbumin and creatinine. 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 user interface touch screen on the front surface of the instrument.

The Urine Microalbumin Creatinine (UAC) Strips are urine test strips of which microalbumin and creatinine 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. UAC strips provide tests for the semi-quantitative detection of Microalbumin (low concentration of Albumin) and Creatinine and determination of the Albumin to Creatinine ratio (A : C) in urine.

The document describes the Uritek TC-201 Urine Chemistry Test System and its performance evaluation to establish substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document provides the following comparison study results for the Uritek TC-201 Urine Chemistry Test System against a predicate device:

Note: The acceptance criteria are not explicitly stated in numerical form. The conclusion states that "product specifications are met" and that the data "supports the substantial equivalence to the predicate device." Therefore, the reported performance metrics are implicitly presented as meeting the unstated acceptance criteria for substantial equivalence.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: A total of 518 urine specimens were analyzed in the comparison study.
• Data Provenance: The document does not explicitly state the country of origin. It indicates the study was conducted at "three Point-of-Care sites," implying real-world clinical samples. While not explicitly stated as retrospective or prospective, the nature of a comparison study using collected specimens for analysis often points to a prospective collection for the study's purpose, though it cannot be definitively confirmed from the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide information on the number of experts used or their qualifications to establish the ground truth for the test set. The comparison study was conducted against a "predicate device" (Clinitek Status Plus Analyzer and Siemens Reagent Strips for Urinalysis), which would have its own established accuracy and is used as the reference standard in this context.

4. Adjudication method for the test set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set. The comparison was primarily made against the results from the predicate device.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
• Effect Size of Human Readers with/without AI: Not applicable, as this device is an automated urinalysis system for chemical analysis, not an AI-assisted diagnostic imaging or interpretation system that involves human readers improving with AI.

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

Yes, the analytical performance and comparison studies described appear to be evaluations of the "algorithm only" or the device's automated performance (Urine Analyzer and Urine Microalbumin Creatinine Strips as a system). The Uritek TC-201 Urine Analyzer is an "automated, bench top instrument." The comparison study evaluates the system's performance in generating results compared to the predicate device.

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

The ground truth for the comparison study was established by the predicate device (Clinitek Status Plus Analyzer and Siemens Reagent Strips for Urinalysis). The study compares the results from the Uritek TC-201 system to those obtained from the predicate device on the same urine specimens.

8. The sample size for the training set

The document does not explicitly state the sample size used for a training set. The provided information pertains to verification, validation, and a comparison study for the device's analytical performance. As a medical device for chemical analysis, training sets in the typical machine learning sense might not be directly applicable in the same way as for AI/ML-based diagnostic algorithms. Device calibration and internal validation would involve specific samples, but these are not termed "training sets" in this context.

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

Since no specific "training set" is described for an AI/ML context, the method for establishing its ground truth is not applicable or provided. For the device itself, the "self-calibration with the white area located at the back of the test strip bed" is mentioned, which serves a calibration function.

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