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Copan Universal Transport Medium (UTM-RT) System is intended for the collection and transport of clinical specimen containing viruses, chlamydiae, mycoplasma or ureaplasma from the to the testing laboratory. UTM-RT can be processed using standard clinical laboratory operating procedures for viral, chlamydial, mycoplasma and ureaplasma culture.

UTM-RT is intended for the stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing respiratory viruses' nucleic acids. UTM-RT is intended for use with compatible molecular assays.

Copan Universal Transport Medium (UTM-RT®) System is composed of a tube with 3mL of UTM-RT® transport medium, which may be supplied in bulk or as a kit with a sterile specimen collection flocked swab. UTM-RT® medium is designed to maintain viability of viruses, chlamydiae, mycoplasma or ureaplasma during transport from the collection site to the testing laboratory for subsequent culture and to maintain the integrity of respiratory viruses' nucleic acids for testing with a compatible molecular assay.

The provided text is for a 510(k) premarket notification for a medical device called "Copan Universal Transport Medium (UTM-RT) System". This type of document describes the device, its intended use, and comparative performance data against a predicate device to demonstrate substantial equivalence, rather than a clinical trial or study in the traditional sense involving human readers or sophisticated AI algorithms.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/machine learning device is not fully applicable here. This document focuses on the stability and preservation of viral nucleic acids in a transport medium.

However, I can extract the relevant "acceptance criteria" and "study" details as they pertain to the chemical and biological stability performance of the transport medium, which is the device in question.

Here's the breakdown of the information as it relates to the device's performance in preserving viral nucleic acids:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Description: The performance and stability study was conducted using specific "sets" of UTM-RT® lots.
  • Lot Ages: Lots within one-to-four months of manufacture ("Freshly produced (new)"), lots approximately a year after manufacture ("Middle-Aged"), and lots aged beyond 18 months ("Old/Expired").
  • Lot Age Ranges: New (0.8–4.2 months), Middle-aged (11.1-13.5 months), Old/Expired (18.7-22.7 months).
  • Test Setup: For each UTM-RT® lot and ATCC strain of representative respiratory viruses (Influenza A, Influenza B, Respiratory Syncytial virus), 5 replicates were tested at each time point.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a premarket notification for a CE-marked device originating from Italy, the studies were likely conducted by the manufacturer. It appears to be a prospective experimental study conducted in a lab setting rather than real-world clinical data.

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

• This information is not applicable to this type of device and study. The "ground truth" for this study is not established by human experts in the sense of image interpretation or diagnostic performance. Instead, it's based on objective molecular assay results (Ct values) indicating viral nucleic acid presence and stability.

4. Adjudication Method for the Test Set

• Not applicable. This is not a study requiring human adjudication. The results are quantitative (Ct values) and objectively measured by the Xpert® Xpress CoV-2/Flu/RSV plus assay.

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

• No. An MRMC study is not relevant for this device, which is a transport medium, not an AI or imaging diagnostic device that human readers interact with.

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

• Not applicable. This device is a transport medium. The "performance" is its ability to preserve nucleic acids, measured by a molecular assay, not an algorithm's standalone diagnostic capability.

7. The Type of Ground Truth Used

• The "ground truth" for the performance and stability study was established by molecular assay results (Ct values) from a reference molecular diagnostic test (Xpert® Xpress CoV-2/Flu/RSV plus assay) on known ATCC strains of viruses. This acts as an objective measure of the integrity and concentration of viral nucleic acids, which is the performance characteristic being evaluated.

8. The Sample Size for the Training Set

• Not applicable. This document describes the validation of a physical transport medium, not an AI/machine learning model that would require a "training set."

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

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

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