(345 days)
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.
§ 864.7675 Leukocyte peroxidase test.
(a)
Identification. A leukocyte peroxidase test is a device used to distinguish certain myeloid cells derived from the bone marrow, i.e., neutrophils, eosinophils, and monocytes, from lymphoid cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their peroxidase activity as evidenced by staining. The results of this test are used in the differential diagnosis of the leukemias.(b)
Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.