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The Safecare Urinary Tract Infection Test is for the qualitative detection of Leukocytes (LEU,white blood cells) and nitrite (NIT) in urine as an aid in the screening of a Urinary Tract infection (UTI). It is intended for over-the-counter home use.

Urinary Tract Infection Test is in vitro diagnostic test device for qualitative detection of leukocyte and nitrite in urine. The device is composed of two-color pads aligned on a strip. One pad is employed for testing leukocyte and the other for nitrite by visually reading the color change of the pad and comparing with the corresponding blocks on a color chart. The Safecare Urinary Tract Infection Test are for the qualitative detection of Leukocytes (white blood cells) and nitrite in urine as an aid in the screening of a Urinary Tract infection (UTI). It is intended for over-the-counter home use only.

This document, particularly the "510(k) Summary" section, details the performance characteristics of the Safecare Urinary Tract Infection Test. While it doesn't present a formal "acceptance criteria" table in the typical sense of a pre-defined set of numerical thresholds for device performance, the data provided in the "Lay user Study" serves as the proof that the device meets the necessary performance for its intended use, especially for over-the-counter home use, by demonstrating high agreement with a predicate device.

Here's a breakdown of the requested information based on the provided text:

Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the agreement rates deemed acceptable for an over-the-counter device intended for screening, where high agreement with a physician-used predicate device signifies adequate performance for lay users. The study aimed to demonstrate that lay users could achieve results comparable to healthcare professionals using a predicate device.

Note: For the Leukocytes, "Agreement (+/- Color Block)" was 100% for all grades, indicating excellent performance when allowing for slight variations in visual interpretation around the color block, which is common in visual assays.

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

• Sample Size: 154 lay users with UTI symptoms.
• Data Provenance: The document does not explicitly state the country of origin for the lay user study data. It was conducted at "Three (3) sites." Given the applicant is Safecare Biotech (Hangzhou) Co., Ltd. in China, it is plausible the study was conducted in China, though this is not confirmed. The study was prospective, as it involved recruiting participants to test their own urine samples in real-time.

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

• Number of Experts: The ground truth was established by "healthcare professionals" using the predicate device. The exact number of individual healthcare professionals is not specified, but it implies a standard clinical practice setting where trained personnel perform the testing.
• Qualifications of Experts: They are referred to as "healthcare professionals." Their specific qualifications (e.g., medical technologists, nurses, physicians) and years of experience are not detailed in this summary.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The ground truth was established by "healthcare professionals using the predicate device." It appears to be a direct comparison between the lay user's result on the Safecare device and the healthcare professional's result on the predicate device, implying the predicate device's result, as performed by a healthcare professional, was taken as the reference.

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

• Not Applicable. This document describes a diagnostic test strip for visual interpretation (Urinary Tract Infection Test). It does not involve AI assistance or a comparison of human reader performance with and without AI. It focuses on the ability of lay users to correctly interpret the visual results compared to healthcare professionals using a predicate device.

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

• Not Applicable. This device is a visual test strip intended for human (lay user) interpretation. There is no automated algorithm or standalone performance without human input.

7. The Type of Ground Truth Used

The ground truth for the lay user study was established by comparison to a legally marketed predicate device (Healgen URS Test Strips, K231045) as interpreted by healthcare professionals. This serves as a clinical reference standard for diagnostic performance in the context of this 510(k) submission.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of a machine learning model, as this is a traditional in-vitro diagnostic test strip. However, if "training set" refers to the data used for internal development, optimization, or early analytical studies, the following information is provided:

• Precision and Reproducibility Study: "A total of forty-five (45) assays results on each of eight levels of control were obtained." This involved three (3) clinical sites, two (2) operators per site, three (3) replicate assays over five (5) days.
• Analytical Specificity Interference: "Potentially interfering substances were added to negative urine with different leukocyte and nitrite concentrations. These samples were tested with three lots of the Safecare Urinary Tract by three different operators (one operator per lot)."
• Assay Cut-off/Sensitivity Study: "Urine samples were spiked to known concentrations of each analyte. These samples were then diluted to the lowest positive concentrations...Each sample was tested in 30 replicates with three (3) different operators."

These analytical studies use controlled samples and protocols to define the device's inherent performance characteristics, prior to the lay user study which demonstrates real-world applicability.

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

For the analytical studies (which might be considered analogous to a "training/development" phase for traditional IVDs):

• Precision and Reproducibility: Ground truth involved preparing "eight levels of control" which are presumably well-characterized, spiked samples with known concentrations.
• Analytical Specificity Interference: Ground truth involved "negative urine with different leukocyte and nitrite concentrations" and then spiking them with "potentially interfering substances" at known concentrations.
• Assay Cut-off/Sensitivity: Ground truth involved "Urine samples...spiked to known concentrations of each analyte." This means the true concentration of the analytes was known by design. Readings were taken by multiple operators and likely compared against these known concentrations to define the lower limits of detection and appropriate cut-offs.

In summary, the "ground truth" for the analytical and development phases was established through controlled laboratory experiments using precisely prepared and characterized samples with known analyte concentrations.

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