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The BioTeke Sterile Disposable Virus Sampling Kit is intended for the collection and transport of clinical specimens to the laboratory for standard diagnostic / identification techniques. The BioTeke Sterile Disposable Virus Sampling Kit consists of a sterile swab and culture-based media that can be used for respiratory viral diagnostic assays including, Influenza, Respiratory Syncytial Virus (RSV) A and B, Parainfluenza, Adenovirus, and Rhinovirus.

The BioTeke Sterile Disposable Virus Sampling Swab Kit is a specimen collection and transport kit designed to collect a throat or nasal sample from the patient (utilizing the provided Specimen Collection Swab) and subsequently transferring the swab containing the patient's microbial sample into the provide 10mL polymer tube containing 3mL of VTM (Virus Transport Media)for purposes of transferring the swab and associated collected microorganisms into a transport container designed to preserve the sample during transport to the laboratory prior to laboratory analysis. The Specimen Collection Swab is designed with a break point (notched area on the shaft) to allow for the top of the VTM tube to close when the inoculated Specimen Collection Swab is placed into the BioTeke VTM tube.

The Bioteke Sterile Disposable Virus Sampling Swab Kit consists of the following: One (1) Specimen Collection Swab (sterile and individually packaged) One (1) Virus Transport Media (10mLpolymer tube containing 3mL of sterile VTM)

The Specimen Collection Swab measured 150mm with a breakpoint location (from the tip) at 80mm, a head length at 20mm and a head width of 3mm. The width of the Specimen Collection Swab measures 2.5mm. The 10mL polymer tubes are filled with 3mL of Virus Transport Media (VTM) and secured with a leak-proof polymer cap.

The provided text describes the BioTeke Sterile Disposable Virus Sampling Kit and its substantial equivalence to predicate devices, primarily focusing on its intended use, design, and performance testing for virus viability.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Virus recovery testing demonstrated that the BioTeke Sterile Disposable Virus Sampling Swab Kit meets the requirements of CSLI-M40-A2." It also provides a table for "Virus Viability over Time," implying these are the performance criteria and results.

Detailed Virus Viability Results:

Note: The negative log reduction values indicate a decrease in virus concentration, but within the specified threshold of 0.25 log (PFU/mL).

Additionally, Mechanical testing and Biocompatibility studies (per ISO 10993-1) were performed, and the device was deemed substantially equivalent to the predicate for these aspects and safe for its intended use, respectively. However, specific acceptance criteria and detailed performance metrics for these are not explicitly provided in the same granular detail as for virus viability.

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

The document does not explicitly state the sample size used for the virus viability testing (e.g., number of replicates for each virus-time point combination).

Regarding data provenance, the study appears to be non-clinical testing, likely conducted in a laboratory setting. There is no information provided about the country of origin of the data or whether it was retrospective or prospective in the context of human subjects. Given it's a virus transport kit, the "samples" would be aliquots of virus cultures.

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

This information is not applicable and not provided in the document. The device in question is a virus sampling and transport kit, which involves laboratory performance testing (e.g., virus viability) rather than interpretation requiring human experts or ground truth in the context of medical imaging or diagnostic algorithms. The "ground truth" for this testing would be the initial known concentration of the viruses in vitro.

4. Adjudication Method for the Test Set

This is not applicable and not provided. As explained above, this isn't a study involving human interpretation or adjudication.

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

This is not applicable and not provided. This device is a physical medical device (virus sampling kit), not an AI-powered diagnostic tool used by human readers. Therefore, an MRMC comparative effectiveness study is not relevant to this submission.

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

This is not applicable and not provided. This device is a physical medical device. "Standalone" performance in the context of AI algorithms is not relevant here.

7. The Type of Ground Truth Used

The ground truth used for the virus viability testing was the initial known concentration (PFU/mL) of the specific respiratory viruses (Influenza A, RSV A, RSV B, Parainfluenza, Adenovirus, Rhinovirus) at time T=0 in the laboratory setting. This is an in vitro experimental ground truth.

8. The Sample Size for the Training Set

This is not applicable and not provided. Since this is a physical medical device undergoing performance testing, there is no "training set" in the context of machine learning or AI.

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

This is not applicable and not provided for the reasons mentioned above.

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