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Hardy Diagnostics' Viral Transport Medium (VTM) is intended for the collection and transport of clinical specimens for the preservation of viral agents influenza A, Influenza B, Adenovirus, and Echovirus from the collection site to the testing laboratory. Hardy Diagnostics' VTM is a culture-based media that is intended to be used in standard laboratory procedures for virus culture and diagnostic assays that utilize stable recoverable infectious viral particles.

Hardy Diagnostics' Viral Transport Medium (VTM) is a non-propagating culture-based transport media used for the collection and transport of specimens suspected of containing viruses including Influenza A, Influenza B, Adenovirus, and Echovirus for downstream laboratory test methods. The VTM includes a screw-cap polypropylene tube with skirted conical bottom containing 3mL of transport medium. VTM tubes can be supplied alone, or in a kit format with a mini-tip flocked swab in a sterile peel-pouch. Hardy Diagnostics' VTM is not claimed to be sterile nor is it intended to be sterilized by the end user. Hardy Diagnostics' VTM vials are single use devices.

The product is supplied in multiple configurations described in more detail in table 1 below: tubes alone, or in a kit format with a swab.

The provided text is a 510(k) Premarket Notification summary for a Viral Transport Medium (VTM), a Class I device. It describes the design, intended use, and studies conducted to demonstrate its substantial equivalence to a predicate device.

It's important to note that this document is not for an AI/ML-based medical device. Therefore, many of the requested elements for describing the acceptance criteria and study that proves an AI device meets acceptance criteria (such as MRMC studies, ground truth establishment by experts, and training set details) are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding the device's performance studies and acceptance criteria as provided for this specific product, which focuses on viral recovery performance and shelf-life stability.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance for Viral Transport Medium (VTM)

The studies presented focus on demonstrating the VTM's ability to preserve viral agents over time and under various storage conditions.

1. Table of Acceptance Criteria and Reported Device Performance

For Viral Recovery Performance:

*The note states that -92.24% for Influenza A at 24 hours (20-25°C) was "Considered acceptable because subsequent timepoints, i.e., 48 h time point showed < 90% increase." This implies a tolerance for transient excursions if the overall trend at later, crucial time points remains within the acceptance range.

For Shelf-life Stability:

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

• Viral Recovery Study: "A minimum of three lots of Viral Transport Medium" were inoculated with known virus concentrations. Aliquots of each lot were pulled at 0, 24, and 48 hours, serially diluted, and inoculated in triplicate into susceptible host cell lines.
• Shelf-life Stability Study: "Three lots of VTM were assessed qualitatively at each time point."
• Data Provenance: The studies appear to be prospective laboratory studies conducted by Hardy Diagnostics. The document does not specify the country of origin of the data beyond being part of a US FDA submission. The "pooled negative clinical matrix" suggests human-derived samples were used as the base, but the testing itself was laboratory-controlled.

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

• Not applicable in the context of an AI/ML device. For this VTM, the "ground truth" (or reference standard) for viral recovery was established by laboratory measurements of viral titer (TCID50/mL) using the Reed-Muench method, which is a quantitative, objective measure. There's no indication of human expert consensus building for the "ground truth" in this type of product.

4. Adjudication Method for the Test Set

• Not applicable. This is not an AI/ML device requiring human adjudication of performance. The performance was determined by quantitative laboratory assays.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• Not applicable. This is not an AI/ML device, and no human reader studies (MRMC or otherwise) would be relevant for evaluating its performance.

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

• Not applicable. This is a physical transport medium, not an algorithm. Its performance is inherent in its chemical composition and ability to preserve viral viability.

7. The Type of Ground Truth Used

• For Viral Recovery Performance: The ground truth was laboratory-derived viral titers (TCID50/mL) determined at baseline (T=0 hours) using the Reed-Muench method, which serves as the reference for percentage change calculations.
• For Shelf-life Stability: The ground truth for functional and physical characteristics included quantitative measurements (pH, fill volume) and qualitative assessments (appearance, growth/no growth for contamination) against predetermined specifications.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires 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, a ground truth for it was not established.

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