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510(k) Data Aggregation
(389 days)
The NEST Disposable Sampler (Viral Transport Medium) is intended for the collection and transport of upper respiratory clinical specimens to the laboratory for standard diagnostic or identification techniques. The Viral Transport Medium can be used in the laboratory to perform culture, isolation and detection of upper respiratory viruses including Influenza A, Rhinovirus, and Respiratory Syncytial Virus (RSV).
The Disposable Sampler Viral Transport Media is composed of preservation tubes filled with VTM (Viral Transport Media), kitted with or without swabs, depending on the product type. The Disposable Sampler Viral Transport Media is composed of Sodium chloride, Disodium hydrogen phosphate dodecahydrate, Potassium chloride, Potassium dihydrogen phosphate, Magnesium sulfate heptahydrate, Glucose, HEPES, Sodium bicarbonate, Fluconazole, Gentamicin sulfate, Griseofulvin, Polymyxin sulfate, Phenol red (optional), Sodium hydroxide, Calcium chloride, Bovine serum albumin and L-Cysteine. The preservation tube is made of medical-grade polypropylene materials. 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 document describes a 510(k) premarket notification for the "Disposable Sampler Viral Transport Media" by Wuxi NEST Biotechnology Co., Ltd. The study conducted is a non-clinical performance test focusing on culture-based viral recovery.
Here's an analysis of the provided information according to your requested components:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter / Acceptance Criteria | Reported Device Performance |
|---|---|
| Viral Recovery (Implicit) | The NEST Disposable Samplers "preserved the samples of all the viruses tested for up to 48 hours at both room temperature and when refrigerated." The results "confirm that the media stabilizes the target viruses meeting the performance specifications for the subject device." No specific quantitative threshold (e.g., maximum attenuation rate) is explicitly stated as an "acceptance criterion" but the performance data (Table 2) shows varying attenuation rates for different viruses, temperatures, and timepoints, all of which are presented as acceptable evidence of performance. |
Note: The document states the device "meets the performance specifications," but does not explicitly list what those specifications are in a quantitative manner (e.g., "attenuation rate must be <X%"). The reported data (Table 2) implicitly serves as the performance demonstration against an unstated or assumed acceptance level for viral viability.
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Description: The test set comprised commercial strains of three viruses: Influenza A virus A/PR/8/34 H1N1, Rhinovirus Type 16, and Respiratory syncytial virus Type A.
- Sample Size for each virus: For each virus, three different lots of the preservation solution (080921ES1, 040121PS, 101020E01) were tested. For each lot, an initial virus titer was established at 0 hours. Then, at two different temperatures (23-25 ℃ and 2-8 ℃) and two different time points (24 and 48 hours), the viral recovery was assessed. Each time point was assessed in triplicate.
- Calculation: 3 viruses * 3 lots * (1 initial + 2 temperatures * 2 timepoints) * 3 replicates = 3 * 3 * (1 + 4) * 3 = 135 samples (or measurements) per lot, for a total of 405 samples/measurements across all lots and viruses.
- Data Provenance: The data appears to be prospective, generated specifically for this premarket notification. The clinical matrix (negative clinical nasopharyngeal matrix) was collected from healthy subjects. The country of origin of the data is not explicitly stated, but the company is Wuxi NEST Biotechnology Co., Ltd., which is based in Wuxi, China.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This study does not involve human readers or experts establishing ground truth in the traditional sense for diagnostic performance. Ground truth for viral recovery is based on laboratory measurements of viral activity (plaque-forming units) after exposure to the transport media.
4. Adjudication Method for the Test Set
Not applicable. This is a non-clinical, laboratory-based viral recovery study, not a study involving human interpretation or adjudication of diagnostic images/results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is a non-clinical laboratory study of a viral transport medium, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No. This device is a viral transport medium, not an algorithm or AI device. The study evaluates the standalone performance of the transport medium in preserving viral viability.
7. The Type of Ground Truth Used
The ground truth used is laboratory culture results, specifically the measurement of Mean Virus Titer (x10^4 PFU/mL - Plaque-Forming Units per Milliliter). This directly quantifies the viable viral particles recovered.
8. The Sample Size for the Training Set
No training set is mentioned or applicable. This is a non-clinical performance evaluation of a medical device, not an AI/machine learning model that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device and study.
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