(22 days)
The Starswab Multitrans Collection and Transport System (Cat. No. S160) is intended for the collection and transportation of Chlamydia, Mycoplasmas and viruses obtained from clinical specimens.
Starswab Multitrans Collection and Transport System provides a safe and convenient way to collect and transport clinical specimens without leakage under optimum storage conditions. The osmotically balanced buffered medium will maintain the viability of viral, chlamydia and mycoplasma specimens during transportation to the laboratory. Antibiotics are incorporated into the medium to inhibit growth of competing bacteria and yeast. The addition of serum albumin provides a stabilizing effect. The high concentration of sucrose aids in the preservation of viruses and chlamydia if the specimens are frozen (-70℃) for prolonged storage.
The provided text describes a 510(k) premarket notification for the Starswab Multitrans Collection and Transport System, focusing on a change in the recommended storage condition. It does not contain information about a study proving the device meets specific performance criteria with detailed metrics like sensitivity, specificity, or reader performance.
However, based on the information provided, we can infer some details related to the "study" mentioned for the change in storage conditions.
Here's a breakdown of what can be extracted and what is not available in the given text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Maintain viability of viral, chlamydia, and mycoplasma specimens during transportation and storage under new conditions (2-25°C). | "Performance characteristics of the product held under new storage conditions is not compromised." |
| Inhibition of competing bacteria and yeast by incorporated antibiotics. | Not explicitly stated but implied to be maintained if performance is "not compromised." |
| Preservation of viruses and chlamydia during prolonged frozen storage (-70°C) with sucrose. | Not explicitly stated but implied to be maintained if performance is "not compromised." |
Explanation: The document does not provide specific quantitative acceptance criteria (e.g., "X% viability of viral load"). Instead, the "acceptance criterion" is implicitly that the device's performance under the new storage conditions (2-25°C) should be equivalent to its performance under the old conditions (2-8°C). The reported performance is a qualitative statement that this was met.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: The "Clinical evaluation has been carried out by the Ontario Provincial Public Health Laboratory." This suggests the data is likely from Canada. The document does not explicitly state if it was retrospective or prospective, but clinical evaluation often implies prospective testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The Ontario Provincial Public Health Laboratory would imply trained laboratory professionals, but specific qualifications (e.g., virologists, microbiologists, years of experience) are not detailed.
4. Adjudication Method for the Test Set
- Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study is not indicated or described. The evaluation focuses on the device's performance rather than human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone algorithm performance study is not indicated. This device is a physical transport system, not an AI algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: The context suggests that the ground truth would have been based on established laboratory methods for detecting and quantifying viable viruses, chlamydia, and mycoplasmas in clinical specimens. This would likely involve viability assays, culture methods, and potentially molecular diagnostics to confirm the presence and viability of the target organisms after transport and storage.
8. Sample Size for the Training Set
- Not applicable. This device is a physical transport system, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for an AI algorithm.
Summary of Device Performance Study (as described for the storage condition change):
- Study Goal: To ensure the performance characteristics of the Starswab Multitrans Collection and Transport System are not compromised when the recommended storage condition prior to use is changed from 2-8°C to 2-25°C.
- Study Conducted By: Ontario Provincial Public Health Laboratory.
- Outcome: "Clinical evaluation has been carried out... to ensure performance characteristics of the product held under new storage conditions is not compromised." This is a qualitative statement indicating that the device met its implied performance criteria under the extended storage temperature range. Specific quantitative data, sample sizes, and detailed methodology are not provided in this 510(k) summary.
§ 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).