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The MagXtract Collection Tube is intended for the stabilization, transportation, and direct lysis of infectious unprocessed nasopharyngeal samples suspected of containing SARS-COV-2 virus RNA. These devices can be used for collection transport and storage of specimens at refrigerated (2-8℃) or ambient temperatures (20-25℃). Specimens collected and stored in a MagXtract collection tube are suitable for use with legally marketed molecular diagnostic devices.

The MagXtract collection tube is intended for the collection, transportation, direct lysis, and stabilization of RNA from unprocessed nasopharyngeal swab samples suspected of containing SARS-COV-2. The MagXtract collection tube stores and transports specimens in a closed tube. Proper specimen collection and transport are essential in molecular testing and obtaining accurate test results. MagXtract collection tube allows for the stabilization and transportation of nasopharyngeal swab samples at ambient temperature from the collection site to the processing laboratory. The MagXtract collection tube consists of a sterile plastic, 5 ml cryogenic collection tube pre-filled with 1.2 mL of proprietary stabilization/lysis buffer (MagBio CTL Medium). MagBio CTL Medium is intended to disrupt/lyse cells and stabilize SARS-COV-2. The preserved and stabilized RNA maintains its integrity for downstream molecular based detection/analysis. MagXtract collection tube may be used in conjunction with a swab or as a tube alone.

The information provided does not describe an AI medical device. The document is a 510(k) premarket notification for a medical device called the "MagXtract Collection Tube," which is intended for the stabilization, transportation, and direct lysis of infectious unprocessed nasopharyngeal samples suspected of containing SARS-CoV-2 virus RNA.

Therefore, the requested information about acceptance criteria for an AI device, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document as it pertains to a different type of medical device.

However, I can extract the acceptance criteria and study information that is present in the document for the MagXtract Collection Tube:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Limit of Detection Study: The document states that "The viral culture lysate of SARS-COV-2 was spiked into MagXtract collection tube containing Magbio CTL Medium with nasopharyngeal swab matrix." No specific number of samples (test set size) is provided. The data provenance is not explicitly stated as 'country of origin' or 'retro/prospective', but implies laboratory-based spiked samples.
• Specimen Stability Study: "The stability study used nasopharyngeal matrix in transport media and SARS-CoV-2 viral lysate spiked at the limit of detection." No specific number of samples (test set size) is provided. The data provenance implies laboratory-based spiked samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the studies described are analytical performance studies (LoD, stability) involving viral lysates and molecular detection, not clinical studies requiring expert ground truth for interpretation of medical images or other clinical data. The "ground truth" here is the known concentration of spiked virus.

4. Adjudication method for the test set:

Not applicable for analytical performance studies involving known spiked concentrations.

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 is not an AI medical device.

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

Not applicable. This is not an AI medical device.

7. The type of ground truth used:

• Limit of Detection Study: Known concentration of SARS-CoV-2 viral culture lysate spiked into the collection tubes.
• Specimen Stability Study: Known concentration of SARS-CoV-2 viral lysate spiked at the limit of detection.

8. The sample size for the training set:

Not applicable. This is not an AI medical device, and the described studies are analytical performance validation, not machine learning model training.

9. How the ground truth for the training set was established:

Not applicable.

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