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Copan UriSponge™ - Urine Collection, Transport, and Preservation System is intended for the collection, transport and preservation of urine specimens from the collection site to the testing laboratory. In the laboratory, UriSponge™ specimens are processed using standard clinical laboratory operating procedures for the cultivation of uropathogenic bacteria and yeasts.

Copan's UriSponge™ - Urine Collection. Transport, and Preservation System UriSponge™ consists of screw cap self-standing plastic tube with conical shaped bottom. Inside the tube, the cap holds a plastic stick with sponges made of hydrophilic polyurethane. The sponges include preservative substances (Sodium Propionate, and Potassium Sorbate). Two sizes of product are available: the regular tube size (100 mm length X 16 mm diameter) plastic tube and the mini tube size (80 mm length x 12 mm diameter) plastic tube.

The provided text describes the 510(k) premarket notification for the UriSponge™ device, a urine collection, transport, and preservation system. It focuses on demonstrating the substantial equivalence of the UriSponge™ to a predicate device (UriSwab™), particularly highlighting the performance data related to the preservation of microorganisms.

Here's an analysis of the acceptance criteria and study as requested, derived from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Microbial Recovery Test Set:

  • For each UriSponge™ lot and ATCC strain of representative urine microorganism, 3 replicates were tested at baseline (T0), 24 hours (T24), and 48 hours (T48) at both cold (2-8°C) and room temperature (19-25°C).
  • The study utilized pooled human negative clinical urine samples, representing the intended use.
  • Testing was performed on three sets of UriSponge™ lots: within one month of manufacture, approximately 5 months after manufacture, and aged beyond 12 months (shelf-life validation).
  • Provenance: Not explicitly stated, but the submission is from Copan Italia S.p.A. in Brescia, Italy. The use of "pooled human negative clinical urine samples" suggests a clinical lab setting, not necessarily a specific country, but likely related to the company's operational region or contracted labs. The data is prospective as it's generated specifically for this pivotal study.

• Fill Volume Flex Study Test Set:

  • Conducted with 3 newly manufactured lots of UriSponge™.
  • Used three specific bacterial strains: E. coli ATCC 25922, P. aeruginosa ATCC 27853, and S. agalactiae ATCC 13813. The number of replicates for this particular study is not specified, but it refers to a "comparative microbial recovery evaluation (as described above)," implying similar methodology for replication.
  • Provenance: Similar to the microbial recovery study, linked to Copan Italia S.p.A. and likely prospective.

• Mechanical/Physical Characteristics Stability Test Set:

  • Conducted with 3 different lots of the mini version of the devices.
  • Tested at multiple timepoints: within 1 month, 5-6 months, 12 months, and 13 months after manufacture.
  • Provenance: Internal testing by the manufacturer, prospective.

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

• This device (Transport Culture Medium) is not an AI/imaging device requiring expert interpretation for ground truth.
• The "ground truth" for the performance studies is objective microbiological measurement (CFU/mL counts) and physical/chemical analyses (e.g., HPLC). These are laboratory measurements, not expert consensus on interpretations. The methodology would be overseen by qualified microbiologists and laboratory personnel. The document does not specify the number or qualifications of these individuals, as it's standard laboratory practice.

4. Adjudication Method for the Test Set

• Not applicable. The "ground truth" is established through direct, quantifiable laboratory measurements (CFU counts) and analytical chemistry (HPLC), not through subjective interpretation requiring adjudication among experts.

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

• No, an MRMC study was not done. This type of study is primarily relevant for diagnostic imaging AI devices where human readers interpret images. This device is a sample collection and transport system, evaluated by its ability to preserve microbial viability, not by how it assists human interpretation of medical images.

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

• Not applicable. This is not an algorithm or AI device. The "performance" refers to the physical and chemical properties of the device in preserving biological samples.

7. The Type of Ground Truth Used

• The ground truth relies on objective laboratory measurements:
  • Colony Forming Units (CFU) counts: To quantify viable microorganisms in the samples over time, representing the gold standard for microbial viability.
  • Physical and Mechanical Testing: To evaluate the integrity of the device components.
  • Chemical Analysis (HPLC): To measure preservative content.
  • Sterility Testing: To confirm SAL.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve machine learning or AI, so there is no "training set." The studies performed are performance and stability validation studies.

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

• Not applicable, as there is no training set for this type of device.

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