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The Merit Cultura™ Collection and Transport System is intended for collection and transport of clinical specimens to the laboratory for standard diagnostic/identification techniques. The Merit Cultura™ Collection and Transport System is a culture-based media that can be used for upper respiratory viral diagnostic assays including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus.

The Merit Cultura™ Collection and Transport System contains a sterile nylon-flocked collection swab with a plastic shaft, a vial with 3.0mL of Viral Transport Medium (VTM) and a sealable biohazard bag. Prior to use, vials should be stored at 2-8°C and 23-25°C. After collection, the transport tube containing the specimen can be stored for up to 120 hours at 2-8°C and 23-25°C.

The provided text describes the 510(k) premarket notification for the Merit Cultura™ Collection and Transport System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional clinical study with defined acceptance criteria and detailed performance of an AI-powered device.

Therefore, many of the requested categories for AI device evaluation (such as multi-reader multi-case studies, number of experts, adjudication methods, and sample sizes for test and training sets for an AI algorithm) are not applicable to this submission, as it is for a medical device (a collection and transport system), not an AI/ML algorithm.

However, I can extract the relevant performance testing data for the physical device based on the provided text.

Here's the breakdown of the information that is available in the document, structured to best match your request, with an explanation for the non-applicable sections:

Acceptance Criteria and Device Performance for Merit Cultura™ Collection and Transport System (Non-AI Device)

The submission demonstrates the ability of the Cultura Collection and Transport System to maintain the viability and detectability of specific viruses over defined periods and temperatures. The acceptance criteria are implicitly defined by the successful recovery and detection of these viruses under testing conditions.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Culture-Based Studies:
  • Sample Size: Unspecified number of organism suspensions (Influenza A, Influenza B, RSV, and Rhinovirus) were inoculated into the Cultura VTM in quadruplicate for each condition (0, 48, 72, 120 hours at 2-8°C and 23-25°C). The initial viral titers (TCID50) are provided.
  • Data Provenance: Commercial strains (ATCC# provided) were used. This indicates laboratory-controlled experiments rather than clinical patient data. This is a prospective lab study.
• Amplification-Based Studies (SARS-CoV-2):
  • Sample Size: 12 unique SARS-CoV-2 positive clinical specimens. Each was tested in triplicate.
  • Data Provenance: "12 unique, SARS-CoV-2 positive clinical specimens." This suggests human clinical samples, though the country of origin is not specified. The study design described (testing at T=0, 72, 120, 240 hours) is prospective for evaluating the device's performance.

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

• Not applicable for this device. This device is a specimen collection and transport system, not an AI diagnostic algorithm. The "ground truth" for the performance studies was based on laboratory assays (viral culture for viability, RT-PCR for nucleic acid detection/quantification). There were no human readers/experts evaluating the "results" as they would for an AI output.

4. Adjudication Method for the Test Set

• Not applicable for this device. As explained above, no human expert adjudication was required for the performance testing of this physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a specimen collection and transport system.

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

• No. This entire submission is for a physical medical device (collection and transport system), not an AI algorithm. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

• Culture-Based Studies:
  • Ground Truth: Organism viability determined by the Reed-Muench method calculation of TCID50 (50% Tissue Culture Infectious Dose) and confirmed by standard laboratory culture techniques. This is a direct measure of viral infectivity/presence.
• Amplification-Based Studies (SARS-CoV-2):
  • Ground Truth: Detection of SARS-CoV-2 nucleic acid (RNA) using the CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel, with Ct values used as quantitative markers. The qualitative ground truth was a positive rRT-PCR result (Ct < 40).

8. The Sample Size for the Training Set

• Not applicable. This submission is for a physical device, not an AI/ML algorithm that would require a training set.

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

• Not applicable. (See point 8).

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