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NEST ITM is an enclosed system intended for the collection, inactivation stabilization and transportation of pharyngeal and nasal swabs suspected of containing adenovirus, influenza A virus or parainfluenza virus 2 from the collection site to the testing laboratory. The specimen transported in NEST ITM can be used for molecular detection in the laboratory.

The NEST ITM is a medical-grade Polypropylene preservation tube (5 mL and 10 mL) filled with 2.5 mL ITM Inactivated Transport Media for 5 mL tube or 3 mL Inactive Transport Media for 10 mL tube, with or without the sterile swabs. NEST ITM is composed of Guanidine isothiocyanate, TCEP, sodium acetate, PEG-6000, Tris, Hcl, purified water in order to inactivate infectious unprocessed oropharyngeal and nasopharyngeal samples which are suspected of containing adenovirus, influenza A virus or parainfluenza virus 2 from human samples. For both oropharyngeal and nasopharyngeal swabs, the swab head is made of flocked nylon fiber, and the rod is made of ABS (acrylonitrile butadiene styrene).

The provided text describes the non-clinical performance data for the "Disposable Sampler Inactivated Transport Media (NEST ITM)". This device is a microbial nucleic acid storage and stabilization device, not an AI/ML-based device. Therefore, many of the requested criteria related to AI/ML device performance (e.g., human-in-the-loop, MRMC studies, ground truth establishment for deep learning models) are not applicable.

However, I can extract information related to the device's functional performance, which serves as its "acceptance criteria" for demonstrating substantial equivalence to a predicate device.

Here's the relevant information:

Device: Disposable Sampler Inactivated Transport Media (NEST ITM)
Purpose: Collection, inactivation, stabilization, and transportation of pharyngeal and nasal swabs suspected of containing adenovirus, influenza A virus, or parainfluenza virus 2 for molecular detection.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are its ability to:

1. Inactivate target viruses rapidly.
2. Preserve the nucleic acids of the target viruses over a specified period and temperatures (stability).
3. Detect the target viruses at a low concentration (Limit of Detection - LoD).

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

1. Sample Size Used for Test Set and Data Provenance:

   • LoD Test Set:
     • Preliminary LoD: 5 replicates per concentration for each of the 3 viruses (Adenovirus, Influenza A, Parainfluenza 2 virus) at multiple concentrations (1.0x10^4, 1.0x10^3, 5.0x10^2, 1.0x10^2 copies/mL).
     • Confirmatory LoD: 20 replicates per virus (Adenovirus, Influenza A, Parainfluenza 2 virus) at 5.0x10^2 copies/mL.
   • Viral Stability Test Set: At least 20 replicates for each virus (Adenovirus, Influenza A, Parainfluenza 2 virus) per time point (Day 0, 9, 15) and storage condition (4°C, 25°C). This means a total of 20 x 3 x 2 = 120 samples per virus for stability, across 3 lots.
   • Inactivation Test Set: Not explicitly stated as a number of replicates, but the method suggests controlled laboratory experiments comparing virus only, virus + NEST ITM, and NEST ITM only.
   • Data Provenance: The studies were conducted by Wuxi Nest Biotechnology Co., Ltd. The data is based on laboratory testing of synthetic viral material (spiked into contrived matrix) rather than patient samples. No mention of country of origin of data beyond the manufacturer's location (China). These are non-clinical, prospective studies designed to evaluate product performance.

2. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications of those Experts:

   • Not applicable. This is a non-clinical, in-vitro diagnostic device component. The "ground truth" for these tests is the known concentration of spiked virus or the measured reduction in viral titer / preservation of nucleic acids using validated laboratory assays (e.g., PCR, TCID50). There's no human expert adjudication of images or clinical outcomes in these studies.

3. Adjudication Method for the Test Set:

   • Not applicable. As described above, these are lab-based quantitative measurements using predefined assay thresholds and controls.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No. This type of study is typically performed for AI/ML diagnostic aids for image interpretation or similar tasks that directly assist human readers. This device is a sample transport media.

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" is the physical and chemical properties of the transport media.

6. Type of Ground Truth Used:

   • For LoD and Viral Stability: The "ground truth" is the known concentration of spiked virus (e.g., 5.0x10^2 copies/mL) and subsequent detection/quantification using validated molecular methods (PCR, measured in Ct values).
   • For Inactivation: The "ground truth" is the initial viral titer (TCID50) and the measured reduction in viable virus after exposure to the transport media, assessed by absence of cytopathic effect (CPE) in cell culture.

7. Sample Size for the Training Set:

   • Not applicable. This is not an AI/ML device that requires a training set. The device formulation and manufacturing processes are developed through R&D and quality control, not machine learning.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable.

In summary, the document details the rigorous non-clinical laboratory testing performed to demonstrate that the NEST ITM meets its functional performance requirements for viral inactivation, nucleic acid stabilization, and detection limit, thereby supporting its substantial equivalence to the predicate device. The acceptance criteria and the proof align with the nature of a microbial nucleic acid storage and stabilization device.

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