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The DNA/RNA Shield™ SafeCollection Kit is intended for the collection, inactivation, stabilization, and transportation, of unprocessed saliva specimens suspected of containing SARS-CoV-2. The DNA/RNA Shield™ SafeCollect Saliva Collection Kit is intended to transport and store saliva specimens at ambient temperature (20-25°C) from the collection site to the laboratory. Specimens collected and preserved in a DNA/RNA Shield™ Saliva Collection kit sample collection tube are suitable for use with legally marketed molecular diagnostic devices.

The DNA/RNA Shield SafeCollect Saliva Tube consists of a tube pre-filled with DNA/RNA Shield transport media. DNA/RNA Shield is a transport media that ensures stability of SARS-CoV-2 RNA during sample transport/storage at ambient temperatures (20-25 ℃) and is intended to inactivate SARS-CoV-2, effectively lyses cells from collected saliva specimens. The DNA/RNA Shield SafeCollect Saliva Tube contains a foil seal barrier that sequesters the DNA/RNA Shield transport media inside of the tube, until the cap, with a Safe Puncture tip is used to seal the DNA/RNA Shield SafeCollect Saliva tube. When the foil seal barrier is broken by the Safe Puncture Tip, the specimen is then, and only then mixed with the DNA/RNA Shield™ transport media. The DNA/RNA Shield SafeCollect Saliva Collection Kit consists of a DNA/RNA Shield SafeCollect Saliva Tube, a funnel designed for the collection of human saliva samples, and a cap with a Safe Puncture tip. Sample collection is conducted under the supervision of a healthcare provider. 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 Safe Puncture tip cap, the DNA/RNA Shield is released into the tube and mixes with the saliva.

The provided text describes the performance data for the DNA/RNA Shield SafeCollect Saliva Collection Kit, specifically for its ability to detect and stabilize SARS-CoV-2 in saliva specimens, and to inactivate the virus. This information is typically presented as part of a 510(k) submission to the FDA to demonstrate substantial equivalence to a predicate device.

However, the document is NOT an AI/ML medical device submission. It describes a physical medical device (a saliva collection kit) and its performance, using laboratory-based analytical studies, not an AI algorithm. Therefore, many of the requested criteria in the prompt, such as those related to AI/ML specific studies (e.g., MRMC studies, standalone algorithm performance, AI assistance effect size, training set details, expert ground truth establishment for AI/ML) are not applicable to this device.

The acceptance criteria and performance data provided are for the analytical validity of a diagnostic aid, specifically:

• Detection Limit (LoD): The lowest concentration of SARS-CoV-2 that the device (in combination with a specified RT-PCR kit) can reliably detect.
• Stability: How long SARS-CoV-2 RNA remains stable in the collected saliva at a specific temperature within the device.
• Inactivation: The device's ability to inactivate SARS-CoV-2.

Here's an attempt to extract and present the relevant information based on the provided text, while acknowledging that many AI/ML specific criteria are not present.

Acceptance Criteria and Device Performance (Based on Analytical Studies)

Given that this document describes a physical sample collection device and not an AI/ML algorithm, the nature of "acceptance criteria" and "study" are focused on analytical performance rather than clinical or AI/ML-specific validation.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Detection Limit (LoD) Study:
  • Preliminary LoD Determination: 5 replicates per concentration level.
  • Confirmatory LoD Study: 20 replicates per concentration level (at and around the preliminary LoD).
  • Data Provenance: Not explicitly stated, but implies laboratory-controlled spiking experiments (inactivated SARS-CoV-2 spiked into negative saliva). The data is analytical/experimental, not from patient samples.
• Stability Study: 3 replicates per time point (Day 0, 1, 2, 3, 4, 5, 6, 7, 14, and 21).
• Inactivation Study: Replication not explicitly stated for individual samples, but the study was "replicated three independent times" in a BSL-3 facility.

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

• N/A. This is an analytical/laboratory study, not a clinical study involving human judgment or interpretation of medical images/data by experts. Ground truth is established by quantitative laboratory measurements (e.g., viral concentration, presence/absence of signal from RT-PCR, plaque formation).

4. Adjudication Method for the Test Set

• N/A. As this is a laboratory-based analytical study, there is no human adjudication process involved in establishing ground truth. The results are based on objective assay readings (Ct values for PCR, plaque counts for infectivity).

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

• N/A. This device is a sample collection kit, not an AI/ML algorithm that assists human readers.

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

• N/A. This is a physical device, not an algorithm. Its "standalone" performance refers to its direct analytical capabilities (e.g., stabilizing RNA, inactivating virus) as measured by laboratory assays.

7. The Type of Ground Truth Used

• Analytical Ground Truth:
  • Detection Limit & Stability: Defined by spiking known concentrations of inactivated SARS-CoV-2 (measured in GEC/mL) into negative saliva and then performing a legally marketed molecular diagnostic test (Quick SARS-CoV-2 rRT-PCR Kit). The RT-PCR results (Ct values, positive/negative calls) serve as the ground truth against the known spiked viral load.
  • Inactivation Study: Defined by the quantifiable reduction in infectious virus (plaque-forming units, PFU/mL) using a plaque assay after exposure to the collection medium, compared to an untreated control.

8. The Sample Size for the Training Set

• N/A. This is not an AI/ML device that requires training data. The studies are analytical performance validation studies for a physical product.

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

• N/A. No training set exists for this type of device.

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The DNA/RNA Shield™ collection tube is intended for the stabilization and inactivation of upper and lower respiratory human specimens suspected of containing SARS-CoV-2. These devices can be used for collection transport and storage of specimens at ambient temperatures (20-25°C). Specimens collected and stored in a DNA/RNA Shield™ collection tube are suitable for use with legally marketed molecular diagnostic devices.

The DNA/RNA Shield™ collection tube and reagent consist of a tube pre-filled with DNA/RNA Shield™ transport media. DNA/RNA Shield™ is a transport media that ensures stability of SARS-CoV-2 RNA during sample transport/storage at ambient temperatures and is intended to inactivate SARS-CoV-2, effectively lyses cells from collected upper and lower respiratory biological specimens. The DNA/RNA Shield™ transport media may be kitted with a swab, sputum collection kit or as a tube alone.

The provided text describes the DNA/RNA Shield Collection Tube's performance data, which supports its substantial equivalence to a predicate device. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• Equivalent performance to PrimeStore MTM for inactivation. | > 2.0 log reduction in viral titer after 30 min exposure. |
  | Limit of Detection (LoD) | - Determine SARS-CoV-2 LoD in combination with a legally marketed rRT-PCR Kit. | 250 GEC/mL (15 GEC/reaction) for sputum and oral swab. |
  | Specimen Stability | - SARS-CoV-2 RNA from sputum and oral swab preserved and stabilized.
• Acceptance criteria of +/- 3.0 Ct after 4 weeks storage at 20-25°C.
• Equivalent performance to the legally marketed predicate device. | RNA stabilized in DNA/RNA Shield met the acceptance criteria of +/- 3.0 Ct after 4 weeks storage at 20-25°C. |

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

The document does not explicitly state the sample size for the test set in each study. However, it indicates:

• Inactivation Study: High concentrations of SARS-CoV-2 virus (9x10^6 PFU) were inoculated.
• Limit of Detection Study: "Samples" were extracted and amplified.
• Specimen Stability Study: "Contrived specimens with sample matrices and SARS-CoV-2 RNA spiked into DNA/RNA Shield" were used.

The data provenance is retrospective in the sense that the studies were conducted to gather performance data on the device. The specific country of origin of the data is not mentioned, but the submitting company is Zymo Research in Irvine, California, USA, suggesting the studies were likely conducted in the US.

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

This information is not provided in the document. The studies described are laboratory-based performance evaluations (inactivation, LoD, stability) and do not involve human interpretation or expert consensus for establishing ground truth in the typical clinical sense.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are laboratory-based performance evaluations, not 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 information is not applicable. The device is a "DNA/RNA Shield Collection Tube," a sample collection and stabilization device, not an AI-powered diagnostic or imaging tool that would typically involve human readers or AI assistance.

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

This information is not applicable. The device is a sample collection and stabilization tube, not an algorithm, so the concept of "standalone performance" in this context is irrelevant. The performance evaluated is the physical and chemical properties of the shield media itself.

7. The Type of Ground Truth Used

• Inactivation Study: The ground truth for inactivation was established by measuring the viability of the virus (cytopathic effect, CPE) after exposure to the DNA/RNA Shield medium. This is a direct biological measure.
• Limit of Detection Study: The ground truth for LoD was established by spiking known concentrations of SARS-CoV-2 RNA (measured in GEC/mL) into the medium and performing rRT-PCR. This is an analytical measurement based on a known standard.
• Specimen Stability Study: The ground truth for stability was established by spiking SARS-CoV-2 RNA into contrived specimens and then measuring the Ct values from rRT-PCR over time, comparing them to a baseline. This also relies on analytical measurements against a known standard.

In all cases, the ground truth is based on pre-defined analytical standards and direct biological or molecular measurements, not expert consensus, pathology, or outcomes data in a clinical setting.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product (collection tube and media), not a machine learning model, so there is no concept of a "training set."

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

This information is not applicable as there is no training set for this type of device.

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