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510(k) Data Aggregation
(88 days)
The RAMP RSV Assay is a qualitative immunochromatographic test for the detection of Respiratory Syncytial Virus (RSV) F-protein antigens in nasal wash/aspirate, nasopharyngeal aspirate and nasopharyngeal swab samples. It is an in vitro diagnostic assay that aids in the rapid diagnosis of RSV infections in symptomatic patients 21 years of age and younger. A negative test is presumptive and it is recommended that all negative results be confirmed by cell culture or direct specimen fluorescence assay (DSFA). Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional use.
The RAMP RSV Assay is a qualitative immunochromatographic test for the detection of Respiratory Syncytial Virus (RSV) in nasal wash/aspirate, nasopharyngeal aspirate, and nasopharyngeal swab samples from symptomatic patients 21 years of age and younger. A wash/aspirate or swab sample is mixed with Sample buffer and applied into the sample well of the Test Cartridge. The sample migrates along the strip. Fluorescent-dyed latex (test) particles. coated with anti-RSV antibodies bind to RSV antigens, if present in the sample. As the sample migrates along the strip, RSV-bound particles are captured at the RSV detection zone, and additional particles are captured at the internal standard zone.
This document describes the RAMP® RSV Assay, a qualitative immunochromatographic test for detecting Respiratory Syncytial Virus (RSV). The study presented focuses on its analytical and clinical performance.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Implied/Standard for Assay) | Reported Device Performance |
|---|---|---|
| Analytical Performance | ||
| Analytical Sensitivity (LoD) | Device should detect RSV at low concentrations | Ranged from 3.5x10^2 to >1.7x10^5 TCID50/mL depending on strain and sample matrix. Achieved 90-100% positivity for LoD samples. |
| Precision & Reproducibility | High agreement across sites and operators | 99.2% overall agreement with expected results. RAMP Ratio %CV 13-16%. |
| Interference | No interference from common substances | None of the tested interfering substances (whole blood, mucin, various medications/OTC products) interfered with negative or positive RSV results. |
| Analytical Specificity | No cross-reactivity with common viruses/bacteria | None of the 16 viruses and 17 bacteria tested gave a positive result. |
| Transport Media Compatibility | No interference with common transport media | None of the 7 transport media tested interfered with performance. |
| Swab Material Compatibility | No interference with common swab types | None of the 4 swab materials tested interfered with performance. |
| Clinical Performance | ||
| Overall Sensitivity | Reasonable sensitivity for RSV detection | 87.3% |
| Overall Specificity | High specificity for RSV detection | 95.6% |
| Sensitivity (NP Swab, All Ages) | 88.2% (95% CI: 81.4 - 92.7) | |
| Specificity (NP Swab, All Ages) | 97.4% (95% CI: 94.6 - 98.7) | |
| Sensitivity (NP Swab, Age <6) | 88.5% (95% CI: 81.7 - 93.0) | |
| Specificity (NP Swab, Age <6) | 98.9% (95% CI: 96.2 - 99.7) | |
| Sensitivity (NP Aspirate, All Ages) | 85.3% (95% CI: 79.7 - 89.6) | |
| Specificity (NP Aspirate, All Ages) | 95.1% (95% CI: 92.1 - 97.0) | |
| Sensitivity (NP Aspirate, Age <6) | 85.9% (95% CI: 80.3 - 90.1) | |
| Specificity (NP Aspirate, Age <6) | 96.5% (95% CI: 93.4 - 98.1) | |
| Sensitivity (Nasal Wash/Aspirate, All Ages) | 89.9% (95% CI: 82.8 - 94.3) | |
| Specificity (Nasal Wash/Aspirate, All Ages) | 93.4% (95% CI: 88.0 - 96.5) | |
| Sensitivity (Nasal Wash/Aspirate, Age <6) | 89.7% (95% CI: 82.5 - 94.2) | |
| Specificity (Nasal Wash/Aspirate, Age <6) | 93.6% (95% CI: 87.8 - 96.7) |
2. Sample Size Used for the Test Set and Data Provenance:
- Clinical Test Set Sample Size: 1,279 fresh specimens were collected; valid results were obtained from 1,140 specimens.
- Data Provenance: Prospective study conducted during the 2008-2009 RSV season. Data collected from eight independent centers located in distinct geographical regions across the United States (NY, MO(2), MD, OH(2), MA, AR).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- The document does not specify the number or qualifications of experts used to establish the ground truth. It states that the RAMP RSV Assay's performance was compared to "cell culture and DSFA" (Direct Specimen Fluorescence Assay), which are established methods for viral detection and are considered gold standards or highly reliable reference methods. Staff included "laboratory and non-laboratory personnel" for the RAMP RSV Assay testing, but not for the ground truth establishment itself.
4. Adjudication Method for the Test Set:
- The primary ground truth was established by cell culture and DSFA (Direct Specimen Fluorescence Assay).
- For "samples for which the results of DSFA, culture and RAMP RSV did not all agree," PCR was used as an investigational method for additional analysis. This acts as a form of secondary adjudication or further investigation for discrepant cases, though the PCR results were not formally incorporated into the main sensitivity and specificity tables.
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 is not an MRMC comparative effectiveness study in the context of human readers and AI assistance. The RAMP RSV Assay is a diagnostic device, an immunochromatographic test, not an AI-powered image analysis or diagnostic support system. Therefore, this question is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance presented for the RAMP RSV Assay is its standalone performance. It is a laboratory diagnostic assay where the result (positive/negative) is determined by the reaction in the test cartridge, not by human interpretation of complex data that could be influenced by a human-in-the-loop. The "testing staff included both laboratory and non-laboratory personnel," but their role is in performing the test and reading the direct output, not interpreting intricate images or data.
7. The Type of Ground Truth Used:
- The primary ground truth used for the clinical performance evaluation was expert reference methods: Viral Cell Culture (culture) and Direct Specimen Fluorescence Assay (DSFA).
- For discrepant cases, PCR was used for supplementary analysis.
8. The Sample Size for the Training Set:
- This document describes the validation of a diagnostic immunoassay, not a machine learning or AI model. Therefore, there is no "training set" in the context of AI. The analytical performance evaluations (sensitivity, precision, interference, specificity, transport media, swab compatibility) use laboratory-prepared samples and controls to characterize the device's technical capabilities.
9. How the Ground Truth for the Training Set Was Established:
- As stated above, there is no "training set" in the AI sense for this device. The ground truth for the analytical evaluations was established by preparing samples with known concentrations of RSV or known interfering substances, or by testing against known panels of organisms.
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