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The Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution is intended for the collection, inactivation, preservation/stabilization, and transport of unprocessed upper respiratory clinical specimens from individuals suspected of influenza A infection by their healthcare provider. Specimens collected with the Sample Preservation Solution can be stored and transported at 4 °C or at room temperature (20-25°C) for preservation of microbial nucleic acid until the sample is processed and used with compatible molecular diagnostic assays.

The Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution consists of a plastic, polypropylene screw-cap collection tube filled with non-sterile sample preservation medium. The tubes are pre-filled with either 2 mL (suitable for swabs with flocking length of 20-24 mm) or 3 mL (suitable for swabs with flocking length of 24-30 mm) of solution. The device is nonsterile, for single use. Swabs are not included.

The provided document is a 510(k) summary for the Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution, which is a microbial nucleic acid storage and stabilization device. It details the device's intended use, description, principles of operation, and a comparison to a predicate device. Crucially, it includes performance data related to shelf-life stability, limit of detection (LoD), nucleic acid stability, and viral inactivation.

However, the document does not describe acceptance criteria in the format of a table with specific thresholds and reported performance against those thresholds, nor does it detail a study proving the device meets acceptance criteria per se in the context of an AI/human-in-the-loop diagnostic system. This document is a regulatory submission demonstrating substantial equivalence for a medical device (a sample preservation solution), not for an AI algorithm or a diagnostic test involving human readers.

Therefore, many of the requested points are not applicable to the provided text. I will address the relevant points based on the information available in the document.

Acceptance Criteria and Device Performance (as inferred from the context of a sample preservation solution):

Since this is not an AI diagnostic device, the "acceptance criteria" here refer to the performance benchmarks demonstrated for the sample preservation solution itself, such as stability of the nucleic acid, effective viral inactivation, and physical/chemical stability over time.

Table of Acceptance Criteria and Reported Device Performance (Inferred):

• 3 Day: -0.43 ΔCt
• 6 Day: -2.76 ΔCt
  Room Temperature (20-25°C) Storage:
• 3 Day: 0.57 ΔCt
• 6 Day: 0.44 ΔCt
  All values met the +/- 3.0 Ct pre-defined acceptance criteria. Stability claimed for up to 6 days at both 4°C and room temperature. |
  | Viral Inactivation | Inactivation leading to >4.0 log reduction in concentration (predicate's performance indicated) or a specific log reduction as determined to be effective. The document states "meeting the pre-defined acceptance criteria" for nucleic acid stability, implying a pre-defined target. | >6.2 log reduction in Influenza A concentration at 5 minutes (equivalent to >99.99% inactivation for all lots at 5 and 10 minutes). For Lot#1 and Lot#2, inactivation was already >6.97 log reduction at 0 minutes. For Lot#3, it was 3.28 log reduction at 0 minutes, but increased to >6.20 at 5 and 10 minutes. The conclusion states "inactivates Influenza A virus when incubated for at least 5 minutes." |

Regarding the specific points for AI/diagnostic studies:

1. Sample sized used for the test set and the data provenance:

• Test Set Description: The document describes performance testing for a sample preservation solution, not an AI model.
  • LoD Study: 4 replicates for preliminary LoD determination at each of 5 concentrations; 20 replicates for LoD confirmation.
  • Nucleic Acid Stability: Triplicate samples of 3 lots (total 9 samples per time point/temperature combination).
  • Viral Inactivation: Triplicate samples of 3 lots (total 9 samples per time point/exposure time combination) for cytotoxicity; triplicate samples of 3 lots for Test, Positive, and Negative Control groups (total 27 samples per exposure time for viral inactivation).
• Data Provenance: Not explicitly stated beyond "upper respiratory matrix." It's not clinical patient data but rather spiked laboratory samples. No country of origin is mentioned for the data itself, only for the manufacturer (China). The study design is laboratory-based (spiking known quantities of virus).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth for these studies (LoD, nucleic acid stability, viral inactivation) is established by the known concentration of spiked virus and quantitative molecular assays (RT-PCR) or cell culture-based infectivity assays (TCID50), rather than expert human interpretation.

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

• Not applicable. This is not a study requiring human adjudication of images or clinical cases.

4. 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 performance study for a sample preservation solution, not a diagnostic device involving human readers or AI assistance.

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

• Not applicable. There is no algorithm being tested in this context. The "device" is a physical solution.

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

• Quantitative Laboratory Measurements: Ground truth is established by:
  • Known concentrations of spiked Influenza A virus.
  • RT-PCR Ct values: Quantitative measure of nucleic acid presence.
  • TCID50 (Tissue Culture Infectious Dose 50%): Quantitative measure of live virus infectivity.

7. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning model.

8. How the ground truth for the training set was established:

• Not applicable. See point 7.

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