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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 ACON UTI Urinary Tract Infection Test Strips is for the qualitative detection of Leukocyte and Nitrite in urine as an aid in the screening of urinary tract infection (UTI). It is intended for over-the-counter home use only.

The ACON UTI Urinary Tract Infection Test Strips for Leukocytes and Nitrite are urine test strips of which Nitrite and Leukocyte reagent pads are affixed onto the plastic strips. The reagent pads react with the urine and provide a visible color reaction. Results are obtained by direct comparison of the test strip with the color blocks printed on the bottle label. The product is packaged with a drying agent in a plastic bottle. The entire reagent strip is disposable when the disposal directions are followed exactly. Laboratory instrumentation is not required. These tests are intended for over-the-counter home use with human urine.

Here's an analysis of the acceptance criteria and study information based on the provided text for the ACON UTI Urinary Tract Infection Test Strips:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or detailed reported device performance metrics (e.g., sensitivity, specificity, accuracy percentages) for the ACON UTI Urinary Tract Infection Test Strips. Instead, it focuses on demonstrating "substantial equivalence" to a predicate device.

The "reported device performance" is broadly stated as:

• "The performance characteristics of the ACON UTI Urinary Tract Infection Test Strips were verified by sensitivity study, reproducibility study, interference studies, temperature flex study, read time flex study, and stability studies."
• "Testing results indicate that the ACON UTI Urinary Tract Infection Test Strips are robust and can perform satisfactorily when used according to the 'Directions for Use' statement specified in the package insert."
• "The laboratory testing results and clinical studies demonstrated a substantial equivalency on performance between the ACON UTI Urinary Tract Infection Test Strips and a legally marketed product, Bayer Multistix 10 SG Reagent Strips for Urinalysis (K905396), with similar product features and intended use."

Since specific numerical acceptance criteria are not provided, a table with quantitative metrics cannot be fully constructed. The primary "acceptance" was demonstrating substantial equivalence to the predicate device.

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

• Sample Size: The document does not specify the exact sample size (number of patients or urine samples) used for the clinical tests. It only states "clinical studies were conducted at Beta sites."
• Data Provenance: The data was collected from "Beta sites," indicating real-world clinical settings. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, and the submitter is based in San Diego, California, suggesting the studies were likely conducted in the USA (or at least within a regulatory framework acceptable to the FDA for a US market device). The studies were retrospective or prospective is not specified and cannot be determined from the provided text.

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

• The document states that "inexperienced lay users were able to obtain comparable testing data compared to those obtained by the professionals." This implies that "professionals" were involved in establishing a comparative benchmark.
• Number of Experts: Not specified.
• Qualifications of Experts: The experts are referred to as "professionals," but their specific qualifications (e.g., "radiologist with 10 years of experience" or medical technologists, lab technicians) are not detailed.

4. Adjudication Method for the Test Set

• The adjudication method is not explicitly described. The comparison involved "inexperienced lay users" versus "professionals" (presumably interpreting the test strips as well), but the process for resolving disagreements or establishing a definitive ground truth from these interpretations is not detailed.

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. This device is a manual urine test strip for home use, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving 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

• No. This device is a test strip that requires human visual interpretation. It is not an algorithm, and it does not operate in a standalone-algorithm-only manner.

7. The Type of Ground Truth Used

• The ground truth for the comparison was established by "professionals" using the "legally marketed Bayer Multistix 10 SG Reagent Strips for Urinalysis (K905396)." This implies a comparative ground truth against an established, legally marketed predicate device, rather than an independent gold standard like pathology or advanced imaging, given the nature of the test. For a UTI test strip, the "professional" interpretation of the predicate device's results would serve as the reference.

8. The Sample Size for the Training Set

• This information is not provided. The document discusses "clinical studies" and "laboratory testing results" but does not differentiate between "training" and "test" sets in the context of machine learning. As this is not an AI/ML device, a traditional "training set" as understood in that domain is likely not applicable. The "sensitivity study, reproducibility study, interference studies, temperature flex study, read time flex study, and stability studies" would involve various samples used for product development and validation, but these are not explicitly termed "training set."

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

• As a traditional diagnostic device (not AI/ML), the concept of a "training set" with ground truth in the AI sense is not directly applicable. If one considers the development and validation efforts as "training," then the establishment of ground truth for these internal studies would involve standard laboratory methods, reference materials, and controlled experimental conditions to determine the expected reactions and establish performance characteristics. However, these specific methods are not detailed in the provided summary.

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The ACON Urinalysis Reagent Strips (Urine) are for qualitative and semi-quantitative detection of one or more of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes and Ascorbic Acid.

The ACON Urinalysis Reagent Strips (Urine) are for single use in professional nearpatient (point-of-care) and centralized laboratory locations. The strips are intended for use in screening at-risk patients to assist diagnosis in the following areas:

• Kidney function .
• Urinary track infections .
• Carbohydrate metabolism (e.g. diabetes mellitus) .
• Liver function .
• Acid-base balance .
• Urine concentration ●

The results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The test is to be read visually. It is intended for professional use only.

The ACON Urinalysis Reagent Strips are urine test strips of which Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocyte reagent pads are affixed onto the plastic strips. The reagent pads react with the urine and provide a visible color reaction. Results are obtained by direct comparison of the test strip with the color blocks printed on the bottle label. The product is packaged with a drying agent in a plastic bottle. The entire reagent strip is disposable when the disposal directions are followed exactly. Laboratory instrumentation is not required. These tests are intended for professional use with human urine.

The provided text describes the ACON Urinalysis Reagent Strips, their intended use, and a comparison to predicate devices, but it does not contain specific acceptance criteria, detailed study results, or information about sample sizes for training/test sets, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, for aspects related to specific numerical acceptance criteria, detailed performance data, sample sizes, expert involvement, and comparative effectiveness studies, the information is not available in the provided document.

Here's an analysis of what information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The document states that "performance characteristics... were verified by sensitivity study, reproducibility study, interference studies, temperature flex study, and stability studies," but it does not specify the quantitative acceptance criteria for these studies or present the detailed reported performance values against such criteria.

The submission focuses on establishing substantial equivalence based on intended use, target population, specimen type, materials, storage, test time, and methodologies used, which are listed as "Same" as the predicate devices.

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

Not available in the provided document. The document mentions "clinical studies were conducted at Beta sites" but does not specify the sample size for these studies or the country of origin. It also does not explicitly state whether the data was retrospective or prospective.

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

Not available in the provided document. The document states the "test is to be read visually" and "intended for professional use only," implying human interpretation. However, it does not detail how ground truth was established for the clinical studies, nor if experts were involved, their number, or their qualifications.

4. Adjudication Method for the Test Set

Not available in the provided document. There is no mention of any adjudication method (e.g., 2+1, 3+1) used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described. The document discusses "clinical accuracy of results" and "comparable testing data" between the ACON strips and predicate devices, which suggests an equivalence study rather than a comparative effectiveness study involving human readers with and without AI assistance (which is not relevant for this type of manual test).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Partially applicable, but not in the context of an algorithm. The device is a manual urinalysis reagent strip intended for visual reading by a professional. Therefore, the concept of an "algorithm only" or "standalone" performance study in the context of AI is not applicable. The device is the standalone test, and its performance is inherently tied to human interpretation of the visual reaction. The document does state that the test is "to be read visually" and "intended for professional use only."

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not explicitly stated for clinical studies. While the document describes the chemical reactions for each analyte (e.g., glucose, bilirubin, ketone, etc.), forming the basis of the test, it does not specify how the "ground truth" was established for the clinical studies used to compare the ACON strips to the predicate devices. For urinalysis, ground truth often involves laboratory reference methods, but this is not detailed here.

8. The Sample Size for the Training Set

Not applicable. The ACON Urinalysis Reagent Strips are a chemical test, not an AI/machine learning algorithm. Therefore, there is no "training set" in the computational sense. The product development would involve chemical optimization and validation, not model training.

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

Not applicable. As stated above, this is not an AI/machine learning device, so the concept of a training set and its ground truth establishment is not relevant.

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