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The Spectrum Solutions Saliva Collection Device is designed for use in the non-invasive collection, and stabilization of viral nucleic acids for in vitro diagnostic testing of saliva samples. The device is intended to inactivate and stabilize human clinical saliva samples from the collection site to the laboratory at room temperature. The saliva sample is stabilized and suitable for use with legally marketed molecular diagnostic device is intended to be used by a health care provider for samples suspected of containing SARS-CoV-2.

The Spectrum Solutions Saliva Collection device consists of a plastic tube designed for the collection of human saliva samples, a funnel, a cap with a stem flare, and a fluid chamber containing Spectrum's inactivating media. Sample collection is conducted under the supervision of a Health care provide. The user deposits their saliva into the collection tube with the aid of the attached funnel, the user removes the funnel and replaces it with the cap. Upon twisting and closing the cap, the stabilizing solution is released into the tube and mixed with the saliva.

The Spectrum Solutions Saliva Collection Device is a microbial nucleic acid storage and stabilization device designed for the non-invasive collection, inactivation, and stabilization of viral nucleic acids for in vitro diagnostic testing of saliva samples, specifically for SARS-CoV-2.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Limit of Detection (LoD):

  • Preliminary LoD: 5 samples per concentration (total of 7 concentrations tested: 0, 10, 20, 50, 100, 250, 500 GEC/reaction).
  • Confirmatory LoD: 20 replicate samples for each of 15 GEC/reaction and 20 GEC/reaction concentrations (total of 40 samples).

• Sample Stability: 4 contrived samples (from two different device lots, each collecting two samples).

• Viral Inactivation: Not explicitly stated as a "test set" in the context of clinical samples, but the experiment involved 3 different lots of devices, with each test performed in two replicates per device, and plating of each replicate performed four times. The analysis appears to be based on laboratory-contrived samples.

• Data Provenance: The studies appear to be laboratory-based performance studies using contrived samples. The data provenance is not specified regarding country of origin or whether it's retrospective or prospective, but given the nature of the tests (LoD, stability, inactivation), they are typically prospective, controlled laboratory studies. The "clinically negative matrix (saliva)" and "single negative donor" indicate the use of human biological material, but the primary focus is on the device's interaction with spiked viral loads.

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

• The ground truth for these performance studies (LoD, stability, inactivation) is established by the known concentration of spiked SARS-CoV-2 (for LoD and stability) and the measured viral reduction (for inactivation). This is an objective measurement based on laboratory methods (RT-PCR and TCID50 assays), not clinical expert consensus. Therefore, the concept of "experts used to establish the ground truth" in the diagnostic interpretation sense does not apply here. The protocols and interpretation of results would be overseen by qualified laboratory personnel and study directors.

4. Adjudication Method for the Test Set:

• Adjudication methods like 2+1, 3+1 are typically used in clinical studies where human readers or diagnosticians interpret images or clinical data. In these laboratory performance studies, the results are objectively measured (e.g., Ct values, log reduction) against pre-defined quantitative acceptance criteria. Discrepancies would likely be resolved through re-testing or investigation of methods, rather than clinical 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:

• No, an MRMC comparative effectiveness study was not done. This device is a saliva collection and stabilization device, not an AI-powered diagnostic imaging tool or a device requiring human interpretation in the context of an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• The concept of "standalone performance" typically refers to the algorithmic performance of an AI-driven device. This is not applicable to the Spectrum Saliva Collection Device, as it is a physical medical device for sample collection and stabilization, not an algorithm. The performance evaluated here is the device's ability to maintain the integrity and detectability of viral nucleic acids.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

• The ground truth used in these studies is primarily known contrived samples with specific concentrations of SARS-CoV-2 (molecular ground truth).
  • For LoD and stability, the ground truth is the intentionally spiked SARS-CoV-2 GEC/reaction.
  • For inactivation, the ground truth is the initial known concentration of live virus and the subsequent measured reduction in viral infectivity.

8. The Sample Size for the Training Set:

• This device is not an AI/machine learning model, so there is no "training set" in the conventional sense. The studies described are performance validation studies for a physical product.

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

• As there is no training set for an AI/machine learning model, this question is not applicable. The establishment of ground truth for the performance studies involved meticulous laboratory preparation of known viral concentrations in a saliva matrix.

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