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The iSWAB-Respiratory Tract Sample Collection Media-Extraction device is intended for the stabilization and inactivation of upper respiratory and saliva human specimens suspected of containing SARS-CoV-2. This device can be used for the collection, transport, and storage of specimens at ambient temperature. Specimens collected in the iSWAB-Respiratory Tract Sample Collection Media-Extraction Less collection device are suitable for use with legally marketed molecular diagnostic tests.

The iSWAB™-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB™ -RC-EL) collection device consists of a collection tube that is pre-filled with 800 µL of the iSWAB™-RC-EL nontoxic, stabilizing buffer and fitted with a proprietary insert. The insert is designed to optimize the release of specimens collected with swabs into the stabilizing buffer, creating a minimal footprint and allowing for swab-free transport of specimens. The iSWAB™-RC-EL collection device eliminates the costly and timeconsuming RNA isolation step from diagnostic workflows.

The provided text describes the Mawi DNA Technologies iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) device, a microbial nucleic acid storage and stabilization device. However, this document does not describe the acceptance criteria of a device or a study that proves the device meets the acceptance criteria in the context of an AI/ML device.

The provided text pertains to a sample collection and stabilization device for SARS-CoV-2, which is a physical diagnostic device, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (e.g., ground truth, MRMC study, training set, human-in-the-loop performance) are not applicable to the information contained in this document.

The document discusses performance data related to:

• Sterilization & Shelf-life Testing: Stability studies for bacterial/fungal growth, appearance, pH, voltage resistance, and density over time.
• Biocompatibility Testing: Not applicable as it's an IVD with no patient contact.
• Electrical safety and electromagnetic compatibility (EMC): Not applicable as it's a passive device.
• Software Verification and Validation Testing: Not applicable as it's a passive device.
• Mechanical and acoustic Testing: Not applicable.
• Animal Study: Not required.
• Human Clinical Performance Testing: Not required.

The performance data that was provided and could be interpreted as "proving the device meets acceptance criteria" for a sample collection device includes:

• Inactivation Study: Demonstrated inactivation of the SARS-CoV-2 virus.
• Limit of Detection (LoD): An analytical sensitivity study to determine the LoD of SARS-CoV-2 collected using the iSWAB-RC-EL in combination with a specific RT-PCR kit.
• Specimen Stability: A study demonstrating stabilization of SARS-CoV-2 at ambient temperature for specified durations (e.g., 28 days for nasal, 33 days for saliva at 15-30°C).
• Precision/Reproducibility: Studies conducted for lot-lot, day-day, and operator-operator reproducibility.
• Compatibility: Demonstrated compatibility with various legally marketed molecular diagnostic tests (e.g., CDC 2019-nCoV RT-PCR Diagnostic Panel, BGI Real-Time Fluorescent RT-PCR Kit).

Since the requested information pertains to an AI/ML device and the provided document is about a physical sample collection device, it is not possible to fully answer the prompt's specific questions.

However, I can extract information relevant to the performance studies conducted for this specific medical device (iSWAB-RC-EL), even though it does not fit the AI/ML context:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" values for each test, but rather describes that the tests were performed and implies successful outcomes for substantial equivalence. I will infer the performance reported based on the study descriptions.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document does not specify the exact sample sizes for the LoD, inactivation, stability, or reproducibility studies. It only mentions "3 lots" for shelf-life testing.
• Data provenance for the performance studies is not explicitly stated (e.g., country of origin, retrospective/prospective). It refers to internal studies conducted by the submitter (Mawi DNA Technologies).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable to this type of device. Ground truth as typically defined for AI/ML models (e.g., expert consensus on image reads, pathology reports) is not relevant for a sample collection and stabilization device. The "truth" here is determined by laboratory assays (e.g., viral load detection, stability measurements, inactivation efficacy assays).

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

• Not applicable to this type of device. Adjudication methods are typically used for reconciling disagreements among human readers/experts in diagnostic evaluations for AI/ML studies.

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

• Not applicable. This is a physical sample collection device, not an AI/ML diagnostic software, and therefore MRMC studies with human readers are not relevant.

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

• Not applicable. This is a physical device, not an algorithm.

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

• The "ground truth" for this device's performance is established by analytical laboratory measurements using reference methods and controls to demonstrate:
  • Viral inactivation efficacy (e.g., cell culture assays, qPCR to confirm no viable virus).
  • Stability of nucleic acids over time (e.g., RT-PCR cycle threshold (Ct) values over incubation periods).
  • Limit of Detection (e.g., serial dilutions of viral RNA analyzed by RT-PCR).
  • Reproducibility of measurements (e.g., statistical analysis of results across different lots, days, operators).

8. The sample size for the training set

• Not applicable. This classification is for AI/ML model development. This device does not involve a training set.

9. How the ground truth for the training set was established

• Not applicable. No training set is involved for this physical device.

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