(271 days)
ARX Viral Transport Media Collection & Transport System (ARX-VTM) is intended for the collection and transport of clinical specimens containing viruses from the collection site to the testing laboratory. The ARX-VTM is a culture-based media that is intended to be used in the laboratory to perform viral culture or diagnostic assays for viruses including, Influenza A, Parainfluenza type 3, Coronavirus OC43, Respiratory Syncytial Virus (RSV) A, Herpes Simplex virus 1 & 2, Echovirus, and Cytomegalovirus.
ARX Viral Transport Media Collection and Transport System (ARX-VTM) is a specialized systems for collecting and transporting viruses at 2-8 ºC or 20-25 ºC. The ARX-VTM is for use in laboratories to aid in the diagnosis of infections, especially when there is a delay between specimen collection and processing for up to 72 hrs. ARX Viral Transport Media Collection & Transport System (ARX-VTM) is intended for the collection and transport of clinical specimens containing viruses from the collection site to the testing laboratory. The ARX-VTM is a culturebased media that is intended to be used in the laboratory to perform viral culture or diagnostic assays for viruses including, Influenza A, Parainfluenza type 3, Coronavirus OC43, Respiratory Syncytial Virus (RSV) A, Herpes Simplex virus 1 & 2, Echovirus, and Cytomegalovirus.
Device Specifications: The ARX-VTM contains a non-propagating media supplied in a polypropylene (PP) tube individually with 1 or 3 mL of transport medium and as a kit. The kit contains a PP tube with 1 or 3 mL of transport medium and a sterile peel pouch containing a nylon flocked swab applicator for collecting specimens. Nylon flocked swabs are available in various score points and configurations to facilitate specimen collection from various anatomical sites.
The provided document describes the ARX Viral Transport Media Collection and Transport System (ARX-VTM) and its performance characteristics for viral recovery.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Viral Recovery | Any change of virus titer within one log (+/- 90%) from the baseline (time point 0) was considered acceptable. This applies to recovery at both 2-8°C and 25-30°C for multiple viruses. |
| Storage Temperature: 2-8°C (72 hours) | |
| Cytomegalovirus | -29.91% (within +/-90%) |
| Coronavirus OC43 | -20.29% (within +/-90%) |
| Echovirus Type 30 | -13.54% (within +/-90%) |
| Herpes Simplex Virus Type 1 | -29.74% (within +/-90%) |
| Herpes Simplex Virus Type 2 | -29.78% (within +/-90%) |
| Influenza A H3N2 | 26.89% (within +/-90%) |
| Parainfluenza Type 3 | -36.19% (within +/-90%) |
| Respiratory Syncytial Type A | -41.66% (within +/-90%) |
| Storage Temperature: 25-30°C (72 hours) | |
| Cytomegalovirus | -34.58% (within +/-90%) |
| Coronavirus OC43 | -27.68% (within +/-90%) |
| Echovirus Type 30 | -19.81% (within +/-90%) |
| Herpes Simplex Virus Type 1 | -36.23% (within +/-90%) |
| Herpes Simplex Virus Type 2 | -33.85% (within +/-90%) |
| Influenza A H3N2 | 8.63% (within +/-90%) |
| Parainfluenza Type 3 | -46.93% (within +/-90%) |
| Respiratory Syncytial Type A | 23.07% (within +/-90%) |
| Shelf-Life | |
| Visual Inspection (turbidity, color) at 20 months | Clear, no cloudy, no precipitation, pink color maintained. |
| pH (acceptable range: 7.4 ± 0.4) at 20 months | All results acceptable. |
| Osmolarity (acceptable range: 290 ± 30 mOsm/Kg) at 20 months | All results acceptable. |
2. Sample size used for the test set and the data provenance
- Sample Size for Viral Recovery: For each virus and each temperature condition (2-8°C and 25-30°C), tests were conducted with swabs in triplicate at time points 0, 24, 48, and 72 hours. While the exact number of swabs per time point isn't explicitly stated beyond "in triplicate," this would mean at least 3 swabs per virus per time point per temperature. The total 'n' would be 8 viruses * 2 temperatures * 4 time points * 3 replicates = 192 samples (excluding additional replicates for baseline).
- Sample Size for Shelf-Life: Three lots of ARX-VTM samples were tested, with duplicate samples from each lot for visual inspection, pH, and osmolarity.
- Data Provenance: The document does not specify the country of origin of the data. The study appears to be a prospective laboratory study, where the performance of the ARX-VTM was measured under controlled conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The ground truth for viral recovery was established via visual enumeration of fluorescent foci units (FFU) by researchers. The document does not specify the number or qualifications of experts involved in this enumeration. It appears to be a standard laboratory method rather than expert consensus on clinical cases.
4. Adjudication method for the test set
The document does not describe an adjudication method for the test set, as the ground truth was established through quantitative laboratory measurements (FFU counts). Adjudication methods like "2+1" typically apply to subjective assessments requiring multiple readers, which is not the case here.
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
No, an MRMC comparative effectiveness study was not done. The device is a viral transport medium, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a viral transport medium, not an algorithm or software. The performance assessment focused on the medium's ability to maintain viral viability.
7. The type of ground truth used
The type of ground truth used for viral recovery studies was quantitative laboratory measurement of viral viability, specifically the visual enumeration of fluorescent foci units (FFU) after inoculation into monolayer cells and immunostaining. For shelf-life, the ground truth involved quantitative measurements of pH and osmolarity, and qualitative visual inspection.
8. The sample size for the training set
This is not applicable. The ARX-VTM is a physical medical device (transport medium) and not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above; there is no training set for this type of device.
§ 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).