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510(k) Data Aggregation
(884 days)
Ensol Biosciences Inc.
The Ensol EnTM Collection and Transport System is intended for the collection of clinical samples containing upper respiratory viruses including Influenza A, Human Coronavirus 229E, and Respiratory Syncytial Virus (RSV) from the collection site to the testing laboratory to be used with standard diagnostic identification techniques that utilize stable recoverable infectious viral particles.
The EnTM Collection and Transport System medium consists of a polypropylene conical tube filled with 2 ml of the transport medium (pale brown to red color medium solution), affixed with a polyethylene screw cap. The bottom part of the tube has a self-standing shape. Tubes are provided in a paper rack. The media tubes can be provided with one or two kinds of sterile specimen collection swabs, one for oropharyngeal (OP) oral use and the other nasopharyngeal (NP) for nasal use. The swab shaft is polystyrene with a breaking point, and the swab tip is flocked nylon fibers. The media is provided in two different configurations with and without the sterile peel pouch containing swabs.
The provided text describes the Ensol EnTM Specimen Collection and Transport System, a viral transport medium, and its non-clinical performance evaluation. It does not contain information about an AI/ML powered device, therefore, many of the requested categories are not applicable.
Here's an analysis of the provided information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical Stability | |
| Appearance | Acceptable (red and clear solution) |
| UV Spectrum Analysis (250-800 nm) | Similar results for all lots at all storage times |
| Absorbance at 290 nm | No changes, similar results for all lots at all storage times |
| pH Measurement | Within 7.4 ± 1 for all lots at all storage times |
| Sterility | No bacterial or fungal proliferation detected |
| Culture-Based Viral Recovery | |
| Average viral titer percent change within ±90% (1 log change) for Influenza A, Human Coronavirus 229E, and Respiratory Syncytial Virus (RSV) at 4°C storage for 0, 24, and 48 hours. | All tested viral strains (Influenza A, Human Coronavirus 229E, and RSV) maintained viral viability at 4°C storage for up to 48 hours, with percent changes within the ±90% (1 log change) acceptance criteria. Refer to Table 1 in the original text for specific values. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Physical Stability and Sterility: The study used three lots of the Ensol EnTM Collection and Transport System. The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated.
- Culture-Based Viral Recovery Study:
- Sample Size: Three lots of VTM (ENTM-2001, ENTM-22003, and ENTM-23001) were used. For each lot and each virus (Influenza A, Human Coronavirus 229E, and Respiratory Syncytial Virus), aliquots were stored at 4°C for 0, 24, and 48 hours. The number of replicates for each viral sample is not specified beyond "aliquots of each replicate".
- Data Provenance: The study was conducted in a laboratory setting using specific viral strains and host cells. The country of origin of the data and whether it was retrospective or prospective is not explicitly stated, but it implicitly describes a prospective study designed to evaluate the device's performance.
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)
This information is not applicable as the device is a viral transport medium, not an AI/ML powered diagnostic device that requires expert ground truth establishment for image or data interpretation. The "ground truth" in this context refers to the controlled viral titers and their expected viability, which are established through standard laboratory techniques and biological assays.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies involving multiple readers or assessors to resolve discrepancies in subjective interpretations, which is not relevant for the objective measurements performed on a viral transport medium.
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
This information is not applicable. The device is a viral transport medium, not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a viral transport medium and does not involve any algorithm or AI for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the viral recovery study was based on laboratory-established viral titers (TCID50). This involves:
- Using established, characterized viral strains (Influenza A, Human Coronavirus 229E, and RSV).
- Determining the initial viral concentration at 0 hours using standard cell culture infectivity assays (Reed-Muench method calculation of TCID50).
- Comparing the viral titers at 24 and 48 hours to the initial titers to assess changes in viability.
8. The sample size for the training set
This information is not applicable. The device is a physical medical device (viral transport medium), not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of device.
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