(112 days)
The RPS Adeno Detector is a rapid immunochromatography test for visual, qualitative in-vitro detection of adenoviral antigens (hexon protein) directly from human eye fluid. The test is intended for use as an aid in the rapid differential diagnosis of acute adenoviral conjunctivitis. All negative test results should be confirmed by cell culture.
The RPS Adeno Detector utilizes technology based on lateral flow immunochromatography. Adenoviral antigen, hexon protein, when present in the patient sample is captured between two antigen specific antibodies. One antibody is immobilized in the detection zone of the device. The second antibody is labeled with colloidal gold. The detector is a disposable, rapid test requiring 10 minutes for a result. The patient's lower eyelid is gently retracted to expose the inferior fornix. The eye fluid is collected on the sterile sample collector by gently swabbing the inferior fornix with the sampling pad on the test cover to gain a sample of tears for point of care analysis. The sample collector is reassembled to the immunoassay cassette. Sample transfer happens automatically. Analysis of the sample starts when the absorbant pad of the strip is dipped into a provided buffering solution. After 1-10 minutes, red colored lines in the read out area will appear. One line (control line) only indicates a (Adenoviral) negative result, where as two lines (control line and test line) indicate a (Adenoviral) positive result. It is best used within 7 days of developing a red eye consistent with infectious conjunctivitis.
The provided text describes the RPS Adeno Detector, a rapid immunochromatography test for the visual, qualitative in-vitro detection of adenoviral antigens from human eye fluid, intended as an aid in the rapid differential diagnosis of acute adenoviral conjunctivitis.
Here's an analysis of the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines the acceptance criteria by stating the clinical performance against the "gold standard" of viral cell culture. While explicit targets for sensitivity, specificity, and agreement are not clearly stated as "acceptance criteria," the reported performance metrics are presented as evidence of the device's suitability. For the purpose of this analysis, we will treat the reported performance values as the demonstrated achievement against an unstated but implied satisfactory threshold for market clearance.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sensitivity | Adequate for diagnostic aid | 88% (95% CI: 74.4%-96%) |
| Specificity | Adequate for diagnostic aid | 91% (95% CI: 84.8%-95.2%) |
| Overall Agreement | Adequate for diagnostic aid | 90% (95% CI: 84.9%-94.2%) |
| Positive Predictive Value | Adequate for diagnostic aid | 76% (95% CI: 61.1%-86.7%) |
| Negative Predictive Value | Adequate for diagnostic aid | 96% (95% CI: 91%-98.7%) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: 175 samples
- Data Provenance: The document states, "A total of 175 samples were collected and tested from patients who developed a red eye consistent with infectious conjunctivitis within the last 7 days." This indicates the data is prospective and collected from patients presenting with symptoms. The country of origin is not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The ground truth for the test set was established using viral cell culture as the "gold standard." This is a laboratory-based method. The number of experts involved in interpreting the cell culture results and their specific qualifications are not detailed in the provided text. However, cell culture requires trained laboratory personnel.
4. Adjudication method for the test set:
The document compares the RPS Adeno Detector's results directly against viral cell culture results. There is no mention of an adjudication method involving multiple human readers for the device's test results. It appears the device's output (presence/absence of two lines) was directly compared to the cell culture outcome.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The RPS Adeno Detector is a standalone device producing a visual, qualitative result (lines), not an AI-assisted diagnostic tool for human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone study was done. The clinical performance data presented (sensitivity, specificity, etc.) directly reflects the performance of the RPS Adeno Detector device itself, without human interpretation influencing its diagnostic output. The device produces a visual, qualitative result (one line for negative, two lines for positive) that is read directly.
7. The type of ground truth used:
The type of ground truth used was viral cell culture, which is described as the "gold standard" for identifying adenovirus in conjunctival specimens.
8. The sample size for the training set:
The provided text does not mention a separate training set or its sample size. The "Clinical Studies" section describes a single set of 175 samples used for performance evaluation against the gold standard. For devices utilizing lateral flow immunochromatography (like the RPS Adeno Detector), the "training" typically refers to the development and optimization of the assay components and their interactions, rather than a machine learning training set with labeled data for an algorithm.
9. How the ground truth for the training set was established:
As no specific "training set" in the context of machine learning is indicated, this question is not directly applicable. If "training set" refers to samples used during the development and optimization phases of the immunoassay, the ground truth would have likely been established using viral cell culture or well-characterized adenovirus samples, similar to how the ground truth for the clinical study was established. However, the document does not provide details on this development process.
§ 866.3020 Adenovirus serological reagents.
(a)
Identification. Adenovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to adenovirus in serum. Additionally, some of these reagents consist of adenovirus antisera conjugated with a fluorescent dye and are used to identify adenoviruses directly from clinical specimens. The identification aids in the diagnosis of disease caused by adenoviruses and provides epidemiological information on these diseases. Adenovirus infections may cause pharyngitis (inflammation of the throat), acute respiratory diseases, and certain external diseases of the eye (e.g., conjunctivitis).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.