(63 days)
The RPS Adeno Detector Plus is a rapid immunoassay test for the visual, qualitative in vitro detection of Adenoviral antigens (hexon protein) directly from human eye fluid. The test is intended for professional use as an aid in the rapid differential diagnosis of acute conjunctivitis.
Negative results do not preclude Adenovirus infection nor are thev intended to rule out other microbial-caused infections of the conjunctiva. and should not be used as the sole basis for treatment or other management decisions.
The RPS Adeno Detector Plus™ consists of three (3) parts: a Sample Collector, an immunoassay test strip in a plastic Test Cassette housing, and a Buffer. The Sample Collector is used to take a sample of ocular fluid. The separately packaged and sterile Sample Collector has a contoured end with a Dacron fleece to collect the samples. The plastic housing of the Test Cassette body protects the strip from unintended physical influence. Additionally the housing guarantees correct sample transfer onto the lateral flow assay strip. The Buffer is a buffered salt solution containing proteins, detergents and preservatives. The Buffer functions as the solution that initiates the test, extracts the Adenoviral proteins, filters unwanted cellular debris, and transports the immune complex and the control conjugate to the Test and Control Lines on the test strip membrane.
Mechanism of action - RPS Adeno Detector Plus™ is based on the principle of lateral flow immunoassays using Direct Sampling Micro-filtration technology. Viral particles or virus antigens are captured by an antigen specific antibody. A single monoclonal antibody highly specific to the Adenoviral hexon protein is labeled with colloidal gold and also is immobilized as the Test Line.
Here's a summary of the acceptance criteria and study details for the RPS Adeno Detector Plus™, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of target sensitivity, specificity, etc. However, the reported performance from the clinical trial is provided. We can infer that the reported values met the unstated acceptance criteria for the FDA to issue a substantial equivalence determination.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance | 95% Confidence Interval |
|---|---|---|---|
| Sensitivity | Sufficient for clinical aid | 90% (28/31) | [74.2-98.0] |
| Specificity | Sufficient for clinical aid | 96% (93/97) | [89.8-98.9] |
| Negative Predictive Value | Sufficient for clinical aid | 97% (93/96) | [91.1-99.3] |
| Positive Predictive Value | Sufficient for clinical aid | 88% (28/32) | [71.0-96.5] |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: N = 128 (Total number of patients in the clinical trial).
- Data Provenance: The study design was a prospective, sequential, masked, clinical trial with eight (8) Clinical Trial Sites. The country of origin is not explicitly stated, but the sponsor is based in Sarasota, FL, USA, suggesting the clinical trial was likely conducted in the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The ground truth was established by Cell Culture. This is a laboratory diagnostic method and does not involve human experts establishing a subjective ground truth for the test set.
4. Adjudication Method for the Test Set
- Not applicable, as the ground truth was established by Cell Culture, which is an objective laboratory method. There was no mention of human adjudication for the Cell Culture results themselves.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study solely evaluated the performance of the device against a gold standard (Cell Culture) and did not involve human readers comparing performance with and without AI assistance.
6. Standalone Performance Study
- Yes, a standalone performance study was done. The clinical trial directly assessed the RPS Adeno Detector Plus™ performance (sensitivity, specificity, etc.) against Cell Culture, without any human interaction influencing the device's reading or interpretation for the purpose of the study's primary endpoint. The device itself is a rapid immunoassay test designed for "visual, qualitative in vitro detection," implying human visual interpretation, but the reported performance metrics are for the device's ability to accurately detect Adenovirus compared to culture.
7. Type of Ground Truth Used
- The ground truth used was Cell Culture, which is a laboratory-based gold standard for detecting the presence of Adenovirus.
8. Sample Size for the Training Set
- The document does not specify a separate training set or its sample size. This device is a rapid immunoassay test, not a machine learning or AI-based algorithm that typically requires a distinct training phase with a dedicated dataset. Its development would involve analytical testing and validation rather than "training" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Given that a training set is not mentioned and the device is an immunoassay, the concept of establishing ground truth for a training set in the context of an algorithm's learning is not applicable. The immunoassay operates based on biochemical reactions with a fixed design. Its "training" would be more akin to optimizing reagents and manufacturing processes through bench testing.
§ 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.