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The Scanostics UTI Check Application test system consists of the Scanostics UTI Check Application and the URS-2L (UTI) Urine Test Strips. The test system is intended for the qualitative detection of nitrite and leukocytes in urine as an aid in the screening of urinary tract infections (UTI). It is intended for over-the-counter home use only.

The Scanostics UTI Check Application test system consists of the Scanostics UTI Check Application and the URS-2L (UTI) Urine Test Strips. The Scanostics UTI Check Application measures the colour developed in two reaction zones (leukocytes and nitrite pads) on the UTI test strip following application of a urine sample. The developed colors are then compared to calibration colours located on the Scanostics backing material and the result for each pad is determined based on the minimum colour distance between the developed colours and calibration colours.

The URS-2L UTI Test Strip comprises of two reagent pads areas, which are absorbent material saturated with chemically active substances, then dried and affixed to the plastic strip with double-sided adhesive.

The backing card comprises of thirty-two (32) calibration colour blocks and three (3) black and white alignment squares printed onto a rigid card stock and die cut to provide a groove for the strip (preventing strip misalignment). The use of the backing card is primarily to compensate for different lighting environments as it allows the calibration colours and the test strip to be subjected to the same conditions as the reagent pads for comparison - this would not be possible if the calibration colours were stored within the application itself.

The representative platform for the test system is the iPhone 6 with iOS 9. The application has been proven to be compatible on the iPhone 6S (iOS 9) and iPod touch (8th gen with iOS 8 and iOS 9). The application's core technology is based on four (4) patents held by Teco Diagnostics (US 8655009, 8877140, 8911679 and 8506901).

Here's an analysis of the provided text to extract the acceptance criteria and study details for the Scanostics UTI Check Application Test System.

Please note: The provided text is a 510(k) summary, which is a regulatory document. It summarizes the findings rather than presenting the full study report. Therefore, some information like specific statistical metrics for acceptance criteria and the exact number of participants in all study phases might not be explicitly detailed.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria (e.g., sensitivity > X%, specificity > Y%). Instead, it indicates that the device should perform "comparably" to the predicate device in the hands of lay users and "satisfactorily" in non-clinical studies. The ultimate acceptance criterion implicitly relies on the demonstration of substantial equivalence to the legally marketed predicate device, Clinistrip (URS-10).

Study Details

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

   • Test Set Sample Size: Not explicitly stated for specific metrics like sensitivity/specificity studies. The "lay user studies were performed at three sites," suggesting a multicenter approach, but the number of participants or urine samples is not provided in detail.
   • Data Provenance: The document does not specify the country of origin of the data. It seems to be a prospective study, as it describes "lay user studies were performed," implying new data collection rather than retrospective analysis.

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

   • The document implies a comparison against "a trained HCP using the Clinistrip (URS-10)" as a reference for the lay user study. However, it does not specify the number of HCPs, their qualifications, or how a definitive "ground truth" was established for each sample (e.g., if a definitive culture result was also used). Given the nature of a 510(k) submission focusing on substantial equivalence, the "ground truth" for the test set often stems from the established predicate device's performance.

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

   • Not described in the provided text.

4. 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 in the traditional sense was not performed. This device is an AI-powered reader for a diagnostic strip, intended for over-the-counter home use only by lay users. The comparison was between the lay user with the Scanostics app and a "trained HCP using the Clinistrip (URS-10)" (the predicate device). The focus is on enabling accurate interpretation by lay users, not improving expert reader performance.
   • Therefore, an "effect size of how much human readers improve with AI vs without AI assistance" is not applicable in the context of this study design as presented.

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

   • The "Scanostics UTI Check Application test system" inherently involves the app (algorithm) reading the test strip. The "lay user studies" describe the performance when the human (lay user) operates the system. However, the non-clinical studies ("method comparison, precision, detection limit, interference, specificity, shelf life and stress studies as well as several flex studies") would largely assess the standalone performance of the algorithm's ability to read the strips under various controlled conditions, separate from a human's interpretation error. The document states these studies found the device performers "satisfactorily," implying the algorithm itself functions as intended.

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

   • The primary ground truth for comparison in the lay user study appears to be the results obtained by a "trained HCP using the Clinistrip (URS-10)" (the predicate device). For the non-clinical studies, the "ground truth" would likely be established through controlled laboratory testing with known concentrations for precision, detection limit, specificity, etc., but this is not explicitly detailed. It does not mention pathology or outcomes data as direct ground truth for this device's performance.

7. The sample size for the training set:

   • The document does not provide information about the sample size used for the training set of the Scanostics UTI Check Application's algorithm.

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

   • This information is not provided in the 510(k) summary. Training set ground truth would typically be established through expertly-read images of a large number of test strips, potentially correlated with laboratory-confirmed analyte concentrations, but these details are absent.

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Creatinine Enzymatic Reagent Kit is a device which is intended for measurement of creatinine level in human serum, in vitro diagnostic use only. Test results may provide information regarding the status of kidney function and the diagnosis of renal diseases, and also serve as a component of several calculations for determination of creatinine clearance or glomerular filtration rate (GFR).

Creatinine Enzymatic Reagent Kit is a dual reagent one contains Good's buffer, creatine amidinohydrolase, sarcosine oxidase and ESPMT (3-(N-Ethyl-3methylanilino) propanesulfonic acid sodium salt). Reagent two contains Good's buffer, creatinine amidohydrolase, Peroxidase and 4-aminoantipyrine.

The provided text describes the performance characteristics and acceptance criteria for the Teco Creatinine Enzymatic Reagent Kit, but it does not detail a study involving human readers or AI assistance. The device is a diagnostic test kit, not an AI-powered diagnostic system requiring human interpretation.

Therefore, questions related to human reader performance, AI assistance, multi-reader multi-case studies, and human interpretation of ground truth are not applicable to this document. The information provided focuses solely on the analytical performance of the diagnostic reagent kit.

Here's the breakdown of the information that is applicable from your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list acceptance criteria in a dedicated table, but it presents performance data against established guidelines (CLSI standards) and compares it to a predicate device. The "acceptance criteria" are implied by meeting CLSI standards and demonstrating comparable performance to the predicate.

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Teco Carbon Dioxide Reagent Set is a device which is intended for measurement of Carbon Dioxide level in human serum, in vitro diagnostic use only. Test results may provide information regarding the status in the assessment of acid-base balance of metabolic alkalosis or respiratory acidosis.

Teco Carbon Dioxide Reagent Set is a single reagent kit. Reagent contains Good's buffer, phosphoenolpyruvate (PEP), phosphoenolpyruvate carboxylase (PEPC), malate dehydrogenase (MDH), magnesium ions, NADH analog, nonreactive stabilizer, preservative, and Buffer. Approximately 90% of carbon dioxide present in serum is in the form of bicarbonate. The measurement of bicarbonate is useful in the assessment of disturbances of acid-base balance resulting from metabolic or respiratory causes.

Here's a breakdown of the acceptance criteria and study information for the Teco Carbon Dioxide Reagent Set, based on the provided document:

Acceptance Criteria and Device Performance

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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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The TC-Thunderbolt Automated Urine Analyzer System is an in vitto diagnostic device used to automate the urine chemistry analysis using TC-Thunderbolt URS-10 strips. It produces semi-quantitative results of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity and leukocytes in urine. TC-Thunderbolt URS-10 strips are intended for use only with TC-Thunderbolt Automated Urine Analyzer System, they are not intended for manual visual reading. This device is for clinical laboratory use only. This device is not for Point of Care Use. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function.

The proposed device is an automated urine chemistry analyzer system intended for use only with TC-Thunderbolt URS-10 strips for the measurement of ten urine chemistry analytes from the chemistry strip. The system consists of the TC-Thunderbolt Automated Urine Analyzer and the TC-Thunderbolt URS-10 strips.

This document describes the performance of the TC-Thunderbolt Automated Urine Analyzer System, an in vitro diagnostic device for semi-quantitative analysis of urine chemistry. The studies presented focus on the analytical performance of the device and its associated test strips (TC-Thunderbolt URS-10 strips) rather than human-in-the-loop performance with an AI. Therefore, sections related to human reader improvement with AI assistance (MRMC studies) and expert consensus in the typical sense for AI model ground truth are not directly applicable to this type of device submission.

Here's a breakdown of the requested information based on the provided text, focusing on the device's analytical performance:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implied by the results of the precision and method comparison studies, generally aiming for high agreement with either the expected control values or a predicate device. The tables below summarize the reported device performance for selected analytes from the precision (within-run and run-to-run) and method comparison studies.

Precision Study Acceptance Criteria & Performance (Within-Run & Run-to-Run for Urine Controls):

The acceptance criteria for precision studies are generally for high exact match agreement and 100% agreement within +/- one color block.

Method Comparison Study Acceptance Criteria & Performance (vs. Predicate Device):

The acceptance criteria for method comparison studies are generally for high overall agreement, with a specific note for SG.

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

Precision Study (Test Set):
For Within Run precision: 60 strips per control level (20 replicates x 1 day x 3 operators/strip lots) were tested. There were 3 control levels (I, II, III).
For Run to Run precision: 60 strips per control level (2 replicates x 2 runs x 5 days x 3 operators/strip lots) were tested. There were 3 control levels (I, II, III).
Data Provenance: Not explicitly stated for all samples, but the "Method Comparison Study Summary" states: "This comparison study testing was performed at Teco Diagnostics, Anaheim CA in United States." It also mentions "The urine samples for analysis in these method comparison studies were provided by external clinical sites." This implies a prospective data collection for the method comparison, and likely also for the precision studies, as real-time control solutions were used.

Method Comparison Study (Test Set):
A total of 487 urine samples were used for the method comparison study.
Data Provenance: The study was performed at Teco Diagnostics, Anaheim, CA, United States. Samples were collected from external clinical sites. These could be considered a mix of retrospective and prospective, as some samples might have been collected specifically for the study (prospective), and others could have been existing samples (retrospective), but the description implies a prospective approach to sample collection and testing for the study. Spiked samples were also prepared.

Sensitivity/Cutoff Point Determination Study & Linearity Study (Test Set):
For Sensitivity: 21 data points for each level (7 strips x 3 operators/strip lots). This study used spiked urine samples.
For Linearity: 21 measurements for every sample tested (7 strips x 3 operators/strip lots). This study used negative urine and spiked negative urine.
Data Provenance: Performed at Teco Diagnostics, Anaheim, CA, United States. Samples were negative urine, with many spiked to achieve various concentrations.

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

For this type of in vitro diagnostic device, "ground truth" is typically established by:

• Reference materials/control solutions: For precision studies, commercially available urine control solutions with confirmed target analyte concentrations were used.
• Comparative method (Predicate Device or Reference Method): For method comparison, the predicate device (Uritek-720+ Urine Analyzer) served as the comparative method against which the new device's performance was evaluated.
• Known concentrations: For sensitivity and linearity studies, samples were prepared by spiking known concentrations of analytes into negative urine. For pH, a pH meter confirmed results, and for Specific Gravity, a clinical, handheld refractometer confirmed values.

Therefore, the ground truth is established by analytical reference methods and known chemical concentrations, rather than human expert reads of images. There is no mention of human experts establishing ground truth in the context of image interpretation or reading. The studies mentioned involve operators performing tests, but their role is to execute the protocol and collect data, not to adjudicate ground truth. The number of operators (3) is mentioned for precision and sensitivity/linearity studies, indicating consistency checks across different users of the device.

4. Adjudication Method for the Test Set

Adjudication as typically understood in the context of human reader disagreement for AI models is not directly applicable here. The "ground truth" for these analytical tests is based on the known concentrations of controls, the results from a predicate device, or measurements by reference instruments (pH meter, refractometer). Discrepancies in device readings are analyzed as agreement percentages (exact match and +/- color block) against these pre-established analytical references, rather than being arbitrated by human experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. This submission is for an automated in vitro diagnostic device (urine analyzer) that produces semi-quantitative results by measuring chemical reactions on test strips. It is not an AI-assisted diagnostic imaging device that involves human readers interpreting images. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this submission.

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

Yes, the studies are essentially standalone performance evaluations of the automated device (TC-Thunderbolt Automated Urine Analyzer System). While operators conduct the tests, the output is generated by the instrument's sensing and processing of the chemical reactions on the strips. The tables presented show the performance of the device itself (e.g., % agreement with controls or predicate device), representing its standalone analytical capability.

7. The Type of Ground Truth Used

The types of ground truth used are:

• Defined Control Solutions/Reference Materials: For precision studies, commercially available urine control solutions with certified analyte concentrations were used.
• Predicate Device Gold Standard: For method comparison, the Uritek-720+ Urine Analyzer (the predicate device) served as the reference against which the new device was compared.
• Known Chemical Concentrations: For sensitivity/cutoff point determination and linearity studies, samples were prepared by spiking urine with precise, known concentrations of analytes.
• Reference Instruments: For pH, a pH meter was used as the ground truth. For specific gravity, a clinical, handheld refractometer was used as the ground truth.

8. The Sample Size for the Training Set

This document only describes analytical performance studies for a medical device submitted for 510(k) clearance, which demonstrates substantial equivalence to a predicate device. It does not provide information about a "training set" in the context of machine learning. The device's operation is based on established chemical principles and optical measurement, not on a machine learning model that requires a "training set."

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

Since there is no mention of a machine learning model or a "training set" in the context of AI development, this question is not applicable. The device relies on chemical reactions and optical measurement, for which the underlying scientific principles and performance are validated through the analytical studies described.

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The URS-2GP (Glucose Protein) Urine Strips are visually read, semi-quantitative tests for the detection of glucose and protein in urine and are intended for prescription home use. Test results may provide information regarding the status of carbohydrate metabolism and kidney function.

This device consists of glucose and protein reagent pads that are affixed onto firm plastic strips. The reagent pad areas are made of absorbent material saturated with chemically active substance, then dried and affixed to the plastic strip with double-sided adhesive. Each strip is carefully packaged individually along with a desiccant in a sealed, foiled pouch. A packaged along with the foil pouches into a box. The package insert contains all the necessary product information. Results of each test is based on the color produced from the reaction of each reagent pad area once the reagent strip comes into contact with a urine sample. Each parameter is color coded accordingly as described in the color chart. Results can be obtained in clinically meaningful units directly, by comparison with the color chart on the foil pouch. The color blocks represent different concentrations of urine glucose and urine protein. The entire reagent strip is disposable following federal and local regulations. Laboratory instrumentation is not required.

The provided text describes the URS-2GP (Glucose Protein) Urine Strips and their performance based on studies conducted for 510(k) clearance. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate, pre-defined set of thresholds. Instead, it presents the study results as demonstrating substantial equivalence to the predicate device. The key performance metrics reported are agreement rates. Based on the "Summary of Clinical Tests Performed" and "Precision" sections, the implied performance targets (or observed performance that supports equivalence) are high agreement rates.

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

• Sample Size (Clinical Study): 162 lay users.
• Data Provenance: The document states, "A comparison study was performed at three clinical sites..." implying prospective data collection. The country of origin is not explicitly stated, but the submission is to the FDA in the USA, so it's likely the studies were conducted within the US or under US regulatory standards.

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

For the clinical comparison study, the ground truth was established by "healthcare professionals testing the sample using a comparator device (URS-3, Teco Diagnostics)." The number of professionals is not specified, nor are their specific qualifications (e.g., radiologist with 10 years of experience). However, "healthcare professionals" implies trained medical personnel who would be competent in performing and interpreting such tests.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The "ground truth" (or reference) for the clinical study was established by healthcare professionals using the predicate device, against which the lay users' results with the new device were compared. This implies a direct comparison rather than a consensus-based adjudication process for the test set interpretations.

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, an MRMC comparative effectiveness study involving AI assistance for human readers was not done. This device is a visually-read urine strip, and the comparison was between lay users with the new device and healthcare professionals with a predicate device. There is no AI component mentioned.

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

No, a standalone algorithm study was not done. The device is a visually-read reagent strip that requires human interpretation of color changes against a color chart.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Clinical Study: The ground truth for the clinical comparison study was based on the results obtained by "healthcare professionals testing the sample using a comparator device (URS-3, Teco Diagnostics)." This can be considered a form of expert interpretation using a legally marketed device as a reference standard.
• Laboratory Studies (Precision, Sensitivity, Specificity, Interference): For these studies, the ground truth would have been established using controlled urine samples with known concentrations of analytes and interfering substances, likely prepared and verified in a laboratory setting.

8. The Sample Size for the Training Set

The document does not mention "training sets" in the context of machine learning or AI. This is a traditional diagnostic device where performance is evaluated through clinical and laboratory studies, not by training an algorithm. Therefore, this question is not applicable.

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

As there is no mention of a "training set" in the context of an AI/ML algorithm, this question is not applicable. The device's formulation and performance characteristics were developed and validated through laboratory and clinical testing, as described above.

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The Teco Saliva Alcohol Test is a semi-quantitative screening test for measuring alcohol in human saliva. This strip specifies the relative Blood Alcohol Concentration (BAC) at 0.0%, 0.02%, 0.04%, 0.08%, and 0.30% cut-off levels. Results can be used for the indication of alcohol intoxication. For in vitro diagnostic use only.
The Teco Saliva Alcohol Test is a screening test for the semi-quantitative detection of the presence of ethyl alcohol in human saliva. The test strip indicates relative Blood Alcohol Concentrations (BAC) at 0.0%, 0.02%, 0.04%, 0.08%, and 0.30% cut-off levels. Results are used for the diagnosis of alcohol intoxication. The test is intended for both prescription and over-the-counter in vitro diagnostic use. The assay is a disposable test for one-time use.

The Teco Saliva Alcohol Test is used to detect the amount of alcohol in the saliva after consumption. This is a semi-quantitative test that is read visually. The test strip determines the relative Blood Alcohol Concentration at 5 cut-off levels (negative, 0.02%, 0.04%, 0.08% and 0.3%). The device consists of a test strip (1 test strip per foil pouch). The resultant color on the test strip is compared to the color blocks printed on the pouch.
The Teco Saliva Alcohol Test is a plastic strip tipped with a reactive pad containing tetramethylbenzidine, alcohol oxidase, and peroxidase. The test is utilizes two coupled enzymatic reactions to create the visual changes in the presence of varying amounts of saliva alcohol. The first reaction consists of an oxidation reaction where the ethanol in the saliva is converted to aldehyde by the alcohol oxidase. The second reaction is the oxidation of TMB, the color indicator substrate, and is catalyzed by the enzyme peroxidase. The color change of the pad corresponds to the amount of present alcohol in the sample. The results are read by comparing the colored pad to the color chart found on the strip package

This document describes the Teco Saliva Alcohol Test, a semi-quantitative screening test for measuring alcohol in human saliva. The device aims to determine relative Blood Alcohol Concentration (BAC) at specific cut-off levels.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format for performance metrics like sensitivity, specificity, or accuracy. It primarily focuses on demonstrating substantial equivalence to a predicate device (ACON Mission Saliva Alcohol Test).

However, it implicitly indicates that the device's performance is acceptable if it can achieve "comparable testing data" to the predicate device and "perform satisfactorily" in conjunction with various studies.

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

The document states "Clinical study results indicate that the intended users were able to obtain comparable testing data." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature) for the clinical study.

3. Number of Experts and Qualifications for Ground Truth Establishment

The document does not provide information on the number of experts used to establish ground truth for the test set or their qualifications. The primary ground truth for comparison appears to be the results obtained from the predicate device.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. It mentions comparison with a predicate device, suggesting a direct comparison rather than an expert consensus/adjudication process for the Teco Saliva Alcohol Test's results themselves.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The evaluation focuses on the device's performance compared to a predicate, not on how human readers' performance improves with or without the device's assistance.

6. Standalone (Algorithm Only) Performance Study

The Teco Saliva Alcohol Test is described as a "visually read color change" device with the resultant color compared to color blocks printed on the pouch. This intrinsically involves human interpretation. Therefore, a standalone (algorithm only without human-in-the-loop performance) study is not applicable and not mentioned.

7. Type of Ground Truth Used

The primary "ground truth" used for evaluating the Teco Saliva Alcohol Test is the performance of a legally marketed predicate device (ACON Mission Saliva Alcohol Test). The clinical study aimed to show "comparable testing data" between the two devices. The predicate device itself would have had its own established ground truth (likely laboratory confirmation of BAC levels).

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. This device is a chromogenic assay; it is not a machine learning or AI-based algorithm that typically requires explicit training datasets.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set in the context of this device, the question of how its ground truth was established is not applicable.

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The Teco Diagnostics UTI Test Strips are intended for the qualitative detection of Nitrite and Leukocytes in urine as an aid in the screening of urinary tract infection (UTI). It is intended for over-the-counter home use only.

Teco Diagnostics UTI Test Strips provides tests for the qualitative determination of leukocytes and nitrite in urine. The product is a firm plastic strip to which is affixed two separate dry reagent pad areas that is used for urinalysis. The reagent pad areas are bibulous material saturated with chemically active substances. All UTI Test Strips are carefully packaged along with a desiccant in a sealed, foil pouch. The color chart for reading the strips is on the outside of the foil pouch. A package insert is packaged along with the foil pouch into a box. The package insert contains all the necessary product information. Results of each test are based on the color produced from the reaction of each reagent pad area once the Urine Reagent Strip comes into contact with a urine sample. Each parameter is color coded accordingly as described in the color chart. Results with Teco Diagnostics UTI Test Strips can be obtained in clinically meaningful units directly by comparison with the color chart. The color blocks represent nominal values will vary around the nominal values.

The Teco Diagnostics UTI Test Strips are intended for the qualitative detection of Nitrite and Leukocytes in urine as an aid in the screening of urinary tract infection (UTI). It is intended for over-the-counter home use only.

The device's performance was proven through a combination of laboratory and clinical studies demonstrating its substantial equivalence to the predicate device, Bayer Multistix 10 SG Reagent Strips for Urinalysis (K905396).

Here's a breakdown of the requested information:

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

The provided document does not explicitly state numerical acceptance criteria (e.g., specific sensitivity or specificity thresholds) or quantitative device performance metrics (e.g., exact percentages for accuracy, sensitivity, or specificity). Instead, the studies aim to demonstrate that the Teco Diagnostics UTI Test Strips "run well and met all required performance characteristics" and that lay users could "obtain comparable testing data compared to those obtained by the professionals" and to the predicate device.

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

The document does not explicitly state the sample size for the clinical test set or the laboratory test set.

• Data Provenance: The clinical studies were conducted at "Point of Care sites" and "with lay persons," implying the data was collected from human urine samples. The document does not specify the country of origin, but given the submitter is based in Anaheim, CA, USA, and the predicate device is from Elkhart, IN, USA, it's highly probable the data is from the US. The studies are prospective in nature, as they involve testing the device on samples collected for the purpose of the study.

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

The document states that clinical studies compared results from "inexperienced lay users" to "professionals." It does not specify the exact number of professionals or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, given the context of urinalysis, these professionals would likely be trained medical technicians, nurses, or other healthcare providers familiar with performing and interpreting urine reagent strip tests in a clinical setting.

4. Adjudication method for the test set

The document does not mention a specific adjudication method like "2+1" or "3+1." It implies a direct comparison, stating "inexperienced lay users were able to obtain comparable testing data compared to those obtained by the professionals." This suggests that the professionals' readings or a more definitive lab result for the same sample served as the benchmark against which lay users' readings were compared.

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: A type of comparative effectiveness study was done comparing the performance of lay users and professionals using the Teco Diagnostics UTI Test Strips, and against the predicate device. This aligns with the spirit of an MRMC study in that it assesses different "readers" (lay vs. professional) on the same "cases" (urine samples).
• Effect Size/AI Assistance: This study does not involve AI assistance. The comparison is between human readers (lay vs. professional) and between two different manual test strips. Therefore, there is no effect size related to AI improvement.

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

No, a standalone (algorithm only) performance study was not done. This device is a manual urine reagent strip, requiring human-in-the-loop performance (visual interpretation of color changes).

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

The ground truth for the clinical study was based on the results obtained by "professionals" using either the Teco Diagnostics UTI Test Strips or the legally marketed Bayer Multistix 10 SG Reagent Strips for Urinalysis. This can be considered a form of expert reference or standard device comparison, where the predicate device's results and professional interpretation of the test strips serve as the benchmark. It is not explicitly stated if further confirmatory tests (e.g., urine culture for UTI) were used as the ultimate ground truth, but the focus is on the performance of the test strips themselves in aiding screening.

8. The sample size for the training set

The document does not specify a separate "training set" or its sample size. For medical devices, particularly those without complex algorithms that "learn," the concept of a distinct training set (as in machine learning) may not directly apply in the same way. The development and optimization of the test strip's chemical reagents and color chart would be an iterative process, but not typically referred to as "training" in the context of sample sizes in regulatory submissions like this.

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

As there's no explicitly defined "training set" in the machine learning sense, the concept of establishing ground truth for it is not applicable here. The development of the test strip's performance (e.g., sensitivity, reproducibility, stability) would have been established through internal laboratory studies where known concentrations of analytes and controlled conditions were used to assess and optimize the reagents' performance. This would involve established analytical methods as a form of reference.

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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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