(1318 days)
The Azer Scientific Universal Transport Medium is for the collection and transport of upper respiratory clinical specimens. containing respiratory viruses from the to the testing laboratory. The Azer Scientific Universal Transport Medium is a culture-based media that can be processed usincal laboratory operating procedures for the isolation and detection of upper respiratory viruses including Influenza A, Respiratory Syncytial Virus (RSV) and Adenovirus.
The Azer Scientific Universal Transport Medium includes a plastic screw-cap tube with conical bottom containing 3 mL of transport medium and three, 3 mm size glass beads. Azer Scientific Universal Transport Medium tubes can be supplied alone or in a kit format with one of three different collection swab options in a sterile peel pouch.
The provided document is a 510(k) Premarket Notification for the Azer Scientific Universal Transport Medium. It does not describe an AI/ML powered device, but rather a universal transport medium for the collection and transport of respiratory clinical specimens containing viruses. Therefore, many of the requested sections related to AI/ML device performance and testing (e.g., human reader studies, AI effect size, training set details, expert qualifications for ground truth) are not applicable.
However, I can provide the available information regarding the acceptance criteria and the study proving the device meets these criteria, focusing on the device's intended function: viral recovery and stability.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Internal) | Reported Device Performance (Azer Scientific Universal Transport Medium) |
|---|---|
| Shelf-life Stability: | |
| 12 months from manufacture when stored at 2-25°C. | Met: The shelf-life was determined to be 12 months from the date of manufacture when stored at 2-25°C. Studies covered 0, 3, 6, 9, and 12-month time points. |
| Appearance: No significant color change (pink, transparent), precipitate, particulates, or cloudy appearance. | Met: All lots tested at each time point passed the criteria for appearance when held at 2-8°C and 20-25°C. |
| pH Stability: pH within the targeted range of 7.3 ± 0.2. | Met: For all tubes at each time point and each lot, the pH was within the targeted range of 7.3 ± 0.2 when held at 2-8°C and 20-25°C. |
| Microbial Contamination: No growth contaminants after overnight incubation at 37±2°C. | Met: All lots tested at each time point and each temperature passed the criteria for no contamination (no growth) when held at 2-8°C and 20-25°C. |
| Viral Recovery: Change of virus titer within one log (+/-90%) from the baseline (time point 0) considered acceptable for H1N1, Adenovirus, and RSV. | Met: The Azer Scientific Universal Transport Medium demonstrated the recovery of H1N1 Influenza BEI NR-29027, Adenovirus 10 JJ, and Human Respiratory Syncytial Virus (HRSV) in all replicates at tested incubation times (24 and 48 hours) and storage conditions (2-8°C and 20-25°C) met the acceptance criteria. For example, for Influenza A, the average percent change at 48 hours was 77% at 2-8°C and 41% at 20-25°C, well within the 90% threshold. One instance for Influenza A at 24 hours at 2-8°C showed a 133% increase but was considered acceptable as the subsequent 48hr time point showed ≤ 90% increase, demonstrating stability. Other viral strains also showed results within the acceptance criteria. |
| Sterility for Swabs: Individually packaged and sterile. | Met: The swabs provided with the Azer Scientific Universal Transport Medium are individually packaged and are sold as sterile. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Description: The performance testing for viral recovery involved "three (3) lots of test kits." Each viral strain (Influenza A, Adenovirus, RSV) was spiked into "pooled, human nasopharyngeal swab sample matrix tested as negative using an FDA cleared RT-PCR assay." Serial dilutions (10⁻¹, 10⁻², 10⁻³, and 10⁻⁴) of each virus were used, and samples were tested "in triplicate."
- Sample Size Calculation (Implied): While an explicit sample size calculation is not provided, the "in triplicate" testing for each dilution, across 3 lots, for 3 viruses, at 2 temperatures, and 3 time points (0, 24, 48 hours) suggests a robust experimental design.
- Data Provenance: The origin of the "pooled, human nasopharyngeal swab sample matrix" is not explicitly stated (e.g., country of origin). The study appears to be a prospective laboratory study designed to evaluate the viral transport medium's performance under controlled conditions.
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. This is not an AI/ML device relying on expert-reviewed imagery or clinical interpretation. The ground truth for viral recovery studies is established by laboratory methods, specifically:
- Inoculation of known viral strains at specific concentrations.
- Measurement of viral titers (TCID50/mL) using established cell culture techniques.
- Observation of cytopathic effect (CPE) under a microscope, which is a standard laboratory endpoint.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device where human interpretation or consensus is required for establishing ground truth from complex data. The evaluation relies on quantitative laboratory measurements of viral titers and qualitative observations of cell culture effects.
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device. The device itself is the transport medium, and its performance is evaluated in a standalone manner without human-in-the-loop assistance for its primary function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the performance study (viral recovery) was established by:
- Known Viral Stocks: Using well-characterized and quantified viral strains (Influenza A, Adenovirus, HRSV).
- Laboratory Assays: Measuring viral viability and infectivity through cell culture techniques (cytopathic effect - CPE) and calculating viral titers (TCID50/mL) using the Reed-Muench method. This is a scientific, quantitative ground truth.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device requiring a training set.
§ 866.2390 Transport culture medium.
(a)
Identification. A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.(b)
Classification. Class I (general controls).