(257 days)
The Merit Cultura™ Collection and Transport System is intended for collection and transport of clinical specimens to the laboratory for standard diagnostic/identification techniques. The Merit Cultura™ Collection and Transport System is a culture-based media that can be used for upper respiratory viral diagnostic assays including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus.
The Merit Cultura™ Collection and Transport System contains a sterile nylon-flocked collection swab with a plastic shaft, a vial with 3.0mL of Viral Transport Medium (VTM) and a sealable biohazard bag. Prior to use, vials should be stored at 2-8°C and 23-25°C. After collection, the transport tube containing the specimen can be stored for up to 120 hours at 2-8°C and 23-25°C.
The provided text describes the 510(k) premarket notification for the Merit Cultura™ Collection and Transport System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional clinical study with defined acceptance criteria and detailed performance of an AI-powered device.
Therefore, many of the requested categories for AI device evaluation (such as multi-reader multi-case studies, number of experts, adjudication methods, and sample sizes for test and training sets for an AI algorithm) are not applicable to this submission, as it is for a medical device (a collection and transport system), not an AI/ML algorithm.
However, I can extract the relevant performance testing data for the physical device based on the provided text.
Here's the breakdown of the information that is available in the document, structured to best match your request, with an explanation for the non-applicable sections:
Acceptance Criteria and Device Performance for Merit Cultura™ Collection and Transport System (Non-AI Device)
The submission demonstrates the ability of the Cultura Collection and Transport System to maintain the viability and detectability of specific viruses over defined periods and temperatures. The acceptance criteria are implicitly defined by the successful recovery and detection of these viruses under testing conditions.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Culture-Based Studies: | Organism Viability: Virus should be viable (present) after specified storage times and temperatures. | RSV: Present at T-0 and T-120 hours at 2-8°C and 23-25°C. |
| Influenza A Virus: Present at T-0 and T-120 hours at 2-8°C and 23-25°C. | ||
| Influenza B Virus: Present at T-0 and T-120 hours at 2-8°C and 23-25°C. | ||
| Rhinovirus: Present at T-0 and T-120 hours at 2-8°C and 23-25°C. | ||
| Amplification-Based Studies (SARS-CoV-2): | Qualitative Concordance: 100% concordance (Ct |
§ 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).