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AllTest Viral Transport Medium (VTM) is intended for collection and transport of clinical specimens containing viral agents including Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus from collection site to the testing laboratory. Specimens collected in the AllTest VTM can be processed using standard clinical laboratory operating procedure for viral culture.

The AllTest Viral Transport Medium is also intended for the stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing SARS-CoV-2 nucleic acid. The AllTest VTM is suitable for use with compatible legally marketed molecular diagnostic devices.

The AllTest Viral Transport Medium (VTM) device is comprised of a screw cap polypropylene tube filled with 3 mL VTM. The VTM tube is tightly closed with a polyethylene cap. The AllTest VTM contains Hank's Balanced Buffer solution (HBBS), proteins, sugar, and antimicrobials to provide stability to live viruses. The AllTest VTM also contains a pH indicator (phenol red) to provide a visual check on medium pH. The VTM appears clear and red in color. The packaging also includes a biohazard specimen bag.

The FDA 510(k) clearance letter for "AllTest Viral Transport Medium" describes the acceptance criteria and study that proves the device meets those criteria. Since this is a viral transport medium and not an AI/Software as a Medical Device (SaMD), the typical acceptance criteria for AI models (like sensitivity, specificity, AUC, etc.) and evaluation methods (such as MRMC studies, expert adjudication for ground truth) are not applicable. The device's performance is assessed based on its ability to maintain viral infectivity and nucleic acid stability over time and under different storage conditions.

Here's an analysis of the provided text, focusing on the relevant acceptance criteria and study details for this type of device:

Acceptance Criteria and Reported Device Performance

The core acceptance criteria revolve around the stability and recovery of viral agents within the AllTest VTM.

Study Details

Given the nature of the device (viral transport medium), the typical elements of an AI/SaMD study are not present. However, we can extract analogous information where applicable.

1. Sample sizes used for the test set and the data provenance:

   • Shelf-life study: 15 tubes from each of three lots were tested at each time point for physical appearance and pH. 6 tubes were tested for microbial contamination.
   • Viral Recovery study: Viral recovery was assessed using three lots of media (3-month/new, 8-month/mid, and 12-month/old age lots). Contrived viral samples (pooled negative clinical matrix spiked with known concentration of virus) were used. These were then spiked onto swabs, transferred to VTM, and held at 4°C and 23-25°C for 0 and 48 hours. The specific number of replicates per condition is not explicitly stated beyond "serial 10-fold to a 96-well plate," but the overall methodology suggests controlled laboratory samples. Data provenance is implied to be laboratory-generated (contrived samples) rather than from specific countries or being retrospective/prospective clinical data.
   • Nucleic Acid Stability study:
     • LoD Determination: 20 replicates were tested at the preliminary LoD concentration (10 GCE/reaction) to confirm LoD.
     • Specimen Stability: Both clinical and contrived samples were used. Three lots of media (3-month/new, 8-month/mid, and 12-month/old age lots) were used. 50 µl of each sample was added to nasopharyngeal (NP) swab and transferred into VTM. Samples were stored at 4℃ and 23-25℃ for 0 and 48 hours. The specific number of clinical/contrived samples or replicates per condition is not explicitly stated. Data provenance includes both "clinical and contrived samples," suggesting some real clinical samples might have been used in addition to laboratory-prepared ones. This study appears to be laboratory-based testing.

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

   • Not applicable for this type of device. The "ground truth" for viral recovery and nucleic acid stability is established through quantitative laboratory measurements (TCID50 for viral recovery, Ct values for nucleic acid presence via PCR) against known input concentrations, not through expert consensus or interpretation of images.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. This is a quantitative laboratory performance study, not a
     human-in-the-loop diagnostic accuracy study requiring adjudication.

4. 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 device is a transport medium, not an AI/SaMD for diagnostic interpretation.

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

   • Not applicable. This is not an algorithm. The performance evaluation is for the physical medium itself.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For Viral Recovery: The "ground truth" or reference is the initial known concentration of the spiked virus (T=0 hour log10TCID50) to which the 48-hour recovery is compared. This is a quantitative laboratory reference.
   • For Nucleic Acid Stability: The "ground truth" or reference is the initial Ct value at T=0 hours from the spiked SARS-CoV-2 samples. This is a quantitative laboratory reference.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

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

Summary of the Study Design for AllTest Viral Transport Medium:

The studies conducted for the AllTest Viral Transport Medium are primarily laboratory-based performance studies designed to demonstrate the medium's ability to preserve the integrity of viral samples over specified timeframes and storage conditions. The methodology relies on established virological and molecular diagnostic techniques (viral culture/TCID50, PCR Ct values) using both contrived samples (known concentrations of viruses spiked into a matrix) and, for nucleic acid stability, also mentions the use of clinical samples. The "ground truth" is quantitative and established by the initial measurements of the spiked samples. The focus is on demonstrating stability and recovery rates rather than diagnostic accuracy or human performance.

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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:

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microbiological specimen collection and transport devices are specimen collecting chambers intended for medical purposes to preserve the viability or integrity of micro-organisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

microbiological specimen collection and transport devices are specimen collecting chambers intended for medical purposes to preserve the viability or integrity of micro-organisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory.

This document does not contain the information required to complete the request. The provided text is a "Safety & Effectiveness Summary" for a Viral Transport Medium, which focuses on regulatory classification, safety precautions for handling the product, and general statements about its effectiveness based on published literature and internal quality control.

Here's why the specific questions cannot be answered from the provided text:

• Acceptance Criteria and Reported Device Performance (Table): The document states "Proteins International conducts its own studies on each lot of Viral Transport Medium manufactured, using the following criteria: appearance, sterility, toxicity, and ability of the medium to maintain virus viability over time." However, it does not provide specific numerical acceptance criteria for these attributes (e.g., "maintain virus viability for X hours at Y temperature with Z% recovery") nor does it report the specific performance results against these criteria for any particular study. It only states that "Complete study results for each lot are available on request."
• Sample Size (Test Set), Data Provenance: No details about a specific test set, its sample size, or data provenance (e.g., country, retrospective/prospective) are mentioned.
• Number of Experts, Qualifications: Not applicable as no expert-based ground truth establishment is described.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No mention of a multi-reader, multi-case study comparing human readers with and without AI assistance.
• Standalone Performance: No standalone algorithm performance is described as this is a physical medical device (viral transport medium), not an AI algorithm.
• Type of Ground Truth: The "effectiveness" mentioned refers to maintaining virus viability, which implies laboratory assays rather than expert consensus, pathology, or outcomes data in the context of an AI device.
• Sample Size (Training Set): No training set information is applicable or provided, as this is not an AI/machine learning device.
• Ground Truth (Training Set): Not applicable for the same reason.

In summary, the document describes a viral transport medium and its general safety and effectiveness, but it does not detail a specific study with acceptance criteria and results in a format applicable to evaluating a diagnostic device or AI algorithm's performance. It refers to internal quality control studies for each manufacturing lot, but doesn't provide the specifics of those studies.

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