(263 days)
The ALB Luz Viral Transport Media is intended for the collection and transport of upper respiratory clinical specimens containing Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus from the collection site to the testing laboratory. The Viral Transport Media is a culture-based media that is intended to be used with standard diagnostic/identification techniques that utilize stable recoverable infectious viral particles.
The Viral Transport Medium (VTM) is a non-propagating transport device composed of a culturebased media without swabs. The VTM is designed to preserves upper respiratory samples collected from a patient by placing the sample into the polymer tube containing 3 mL of media. The sample and media are then secured with a leak-proof screwcap for transportation.
The VTM maintains cellular integrity and preservation of viruses when properly stored. Prior to use, vials should be stored at 2℃ to 35℃. After specimen collection, the transport tube containing the specimen can be stored for up to 48 hours at either 2-8°C or 20-25°C, for transportation to the laboratory and storage. The medium has been evaluated for storage of the following respiratory viruses, Influenza A, Respiratory Syncytial Virus (RSV), and Rhinovirus, for viral recovery.
The provided text describes the 510(k) premarket notification for the ALB Luz Viral Transport Media (VTM). This document details the device's characteristics, intended use, and performance testing to demonstrate substantial equivalence to a predicate device.
However, the provided text does not contain the kind of information typically associated with acceptance criteria and clinical study results for an AI-powered medical device, such as:
- Accuracy metrics: Sensitivity, specificity, AUC, F1 score.
- Study design details: Retrospective/prospective, number of patients/cases in the test set.
- Expert ground truth: Number of experts, their qualifications, adjudication methods.
- Comparative effectiveness: MRMC study details, human reader improvement with AI.
- Standalone algorithm performance.
- Training set details: Size, ground truth establishment.
Instead, the document focuses on performance testing relevant to a viral transport medium, specifically:
- Shelf-life studies: Physical stability (appearance, volume) and pH stability over 18 months.
- Sterilization checks: Absence of microbial growth.
- Viral recovery studies: Using plaque forming assays to show the device maintains viral viability for specific viruses (Influenza A, RSV, Rhinovirus) at different temperatures and time points (0, 24, 48 hours).
Therefore, I will interpret the request in the context of the provided document, defining "acceptance criteria" and "device performance" based on the characteristics and tests described for the Viral Transport Media, rather than an AI-powered device.
Acceptance Criteria and Study Proving Device Meets Criteria
The ALB Luz Viral Transport Media (VTM) is a Class I, reserved medical device (Product Code JSM) intended for the collection and transport of upper respiratory clinical specimens containing specific viruses. The study presented in the 510(k) summary (K232454) demonstrates the device's ability to maintain the viability of these viruses over time and under specified storage conditions, thereby proving its suitability for its intended use.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this Viral Transport Media are based on its ability to maintain physical and chemical stability, minimize contamination, and crucially, maintain the viability of specific viruses over a defined transport/storage period. The performance is assessed against these criteria.
| Acceptance Criteria Category | Specific Acceptance Criterion | Reported Device Performance and Confirmation |
|---|---|---|
| Shelf-life (Product) | Physical Stability: No changes in appearance (color, turbidity) or volume over specified shelf life. | Confirmed: Three lots tested at 2°C and 35°C showed no changes in color (remained clear with slight precipitation and orange-pink color) and no changes in liquid media volume over 18 months. |
| pH Stability: pH remains within the acceptable range (7.2 to 7.6) over specified shelf life. | Confirmed: Three lots tested at 2°C and 35°C showed pH measurements within the acceptable range of 7.2 to 7.6 over 18 months. | |
| Contamination Control | Sterility/Low Contamination: No microbial growth after manufacturing process (filtration and aseptic transfer). | Confirmed: Microbial contamination check conducted by incubating tubes for 48 hours at 35°C ± 2°C, followed by transfer to BHI media and incubation for 24 hours at 35°C ± 2°C. "No growth was observed on any of the tested media." (Note: The device is not claimed to be sterile, but this test confirms effective contamination reduction post-filtration processes). |
| Viral Recovery | Maintain Viral Viability: Average viral recovery demonstrates percent changes within ±90% (i.e., 1 log change) compared to 0-hour recovery for tested viruses after 24 and 48 hours of storage. | Confirmed for all tested viruses (Influenza A, RSV, Rhinovirus) at both storage temperatures (2-8°C and 20-25°C): |
| Influenza A: |
- 2-8°C: Percent changes for 24 hours range from 0% to -9%; for 48 hours, -35% to -38%.
- 20-25°C: Percent changes for 24 hours range from -7% to -20%; for 48 hours, -33% to -39%.
Respiratory Syncytial Virus (RSV): - 2-8°C: Percent changes for 24 hours range from -11% to 7%; for 48 hours, -38% to -50%.
- 20-25°C: Percent changes for 24 hours range from -15% to 0%; for 48 hours, -36% to -43%.
Rhinovirus: - 2-8°C: Percent changes for 24 hours range from 0% to 5%; for 48 hours, -33% to -52%.
- 20-25°C: Percent changes for 24 hours range from -21% to -18%; for 48 hours, -29% to -46%.
All reported percent changes are well within the ±90% acceptance criterion. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): For the viral recovery studies, "Three lots of VTM with newly manufactured, mid-range lot and close to expiry lots were used." For each lot, virus stock was serially diluted, transferred into VTM, and stored at two temperatures (2-8°C and 20-25°C) for three time points (0, 24, 48 hours). For each condition, viral samples were serially diluted and "added to the monolayer in triplicate."
- This implies a sample size of 3 lots x 2 temperatures x 3 time points x 3 replicates = 54 measurements per virus strain. Since three virus strains were tested, the total number of primary viral recovery measurements would be 162 (excluding the initial virus stock titrations and cell culture maintenance).
- Data Provenance: The study appears to be an in-vitro laboratory validation study rather than a clinical trial with patient data. The specific origin of the "pooled negative clinical nasal matrix" is not explicitly stated in terms of country, but the sponsor is based in Brazil.
- Retrospective or Prospective: The study design described (testing newly manufactured, mid-range, and close-to-expiry lots, and specific time points) indicates a prospective laboratory validation study for performance characteristics, particularly viral recovery and shelf-life.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This section is not applicable in the context of this device and study. The "ground truth" for Viral Transport Media performance is established through direct laboratory measurements of viral viability (Plaque-Forming Units/mL) and physical/chemical properties (pH, appearance). No human expert interpretation of images or clinical data for diagnosis is involved.
4. Adjudication Method for the Test Set
This section is not applicable for the reasons stated above. There is no human interpretation or diagnostic decision-making that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study is relevant for AI (or other diagnostic) devices where human readers interpret medical images or data. This is a laboratory performance validation for a transport medium.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This section pertains to AI algorithms. The device under review is a physical transport medium, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for the performance evaluation of the Viral Transport Media is based on direct laboratory measurements of viral viability (Plaque-Forming Units/mL) through plaque assays and physical/chemical measurements (pH, visual inspection for appearance/volume). This is an objective, quantitative, and directly observable ground truth.
8. The Sample Size for the Training Set
This section is not applicable. This is not an AI/machine learning device that requires a "training set." The performance evaluation is based on laboratory testing of the manufactured product.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as above.
§ 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).