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510(k) Data Aggregation
(279 days)
INVERNESS MEDICAL, INC.
The Clearview Exact II Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasal swab specimens collected from symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. It is recommended that negative test results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.
The Clearview® Exact II Influenza A & B Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A and B nucleoprotein antigens in respiratory swab specimens. These antibodies and a control protein are immobilized onto a membrane support as three distinct lines and are combined with other reagents/pads to construct a Test Strip. Nasal swab samples are added to a Coated Reaction Tube to which an extraction reagent has been added. A Clearview Exact II Influenza A & B Test Strip is then placed in the Coated Reaction Tube holding the extracted liquid sample. Test results are interpreted at 10 minutes based on the presence of pink-to-purple colored Sample Lines. The yellow Control Line tums blue in a valid test.
Here's a breakdown of the acceptance criteria and the study details for the Clearview® Exact II Influenza A & B Test, 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 numerical terms (e.g., "Sensitivity must be > 90%"). Instead, it presents the device's performance against a gold standard (viral culture) as the evidence for substantial equivalence. The predicate device's performance often serves as an implicit benchmark for acceptance.
However, we can infer what constitutes acceptable performance from the presented results, as there's no indication that the results were unacceptable.
| Criterion (Inferred from Performance Data) | Acceptance Criteria (Implicit/Benchmark) | Reported Device Performance |
|---|---|---|
| Influenza Type A Detection | ||
| Sensitivity (vs. Viral Culture) | Likely comparable to predicate device | 94% (95% CI: 83-98%) |
| Specificity (vs. Viral Culture) | Likely comparable to predicate device | 94% (95% CI: 91-96%) |
| Positive Predictive Value (PPV) | Likely comparable to predicate device | 63% (95% CI: 52-74%) |
| Negative Predictive Value (NPV) | Likely comparable to predicate device | 99% (95% CI: 98-100%) |
| Influenza Type B Detection | ||
| Sensitivity (vs. Viral Culture) | Likely comparable to predicate device | 78% (95% CI: 68-86%) |
| Specificity (vs. Viral Culture) | Likely comparable to predicate device | 97% (95% CI: 95-98%) |
| Positive Predictive Value (PPV) | Likely comparable to predicate device | 84% (95% CI = 74-90%) |
| Negative Predictive Value (NPV) | Likely comparable to predicate device | 95% (95% CI = 93-97%) |
| Analytical Sensitivity (LOD 95%) | Likely comparable to predicate device | |
| A/HongKong/8/68 | Not explicitly stated | $2.37 \times 10^4$ TCID50/ml (97% detected) |
| A/PuertoRico/8/34 | Not explicitly stated | $3.16 \times 10^5$ TCID50/ml (88% detected) |
| B/Malaysia/2506/2004 | Not explicitly stated | $3.00 \times 10^6$ TCID50/ml (95% detected) |
| B/Lee/40 | Not explicitly stated | $4.20 \times 10^5$ TCID50/ml (95% detected) |
| Reproducibility | Likely high detection rates for positive samples, very low for negative | |
| Influenza A Moderate Positive | Not explicitly stated | 99.2% |
| Influenza A Low Positive | Not explicitly stated | 94.2% |
| Influenza A High Negative | Not explicitly stated | 9.2% |
| Influenza B Moderate Positive | Not explicitly stated | 99.2% |
| Influenza B Low Positive | Not explicitly stated | 96.7% |
| Influenza B High Negative | Not explicitly stated | 7.5% |
| Negative Samples (Overall) | Not explicitly stated | 100% (118/118) negative results |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 486 prospective specimens
- Data Provenance:
- Country of Origin: U.S. (multi-center, seven trial sites)
- Retrospective or Prospective: Prospective study, conducted during the 2008-2009 respiratory season. Specimens were collected from symptomatic patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number or specific qualifications of experts involved in establishing the ground truth. It relies on viral culture as the ground truth. Viral culture is a laboratory method, not typically performed by "experts" in the sense of clinicians or radiologists, but by trained laboratory personnel.
4. Adjudication Method for the Test Set
The document does not mention an explicit adjudication method (e.g., 2+1, 3+1). The primary comparison is the Clearview® Exact II test result directly against the viral culture result. For discrepant results with Influenza B (19 samples positive by culture, negative by Clearview), an investigational RT-PCR assay was used as a secondary check, showing 10 of these were negative by PCR. This suggests a form of post-hoc investigation for specific discrepancies, rather than a pre-defined adjudication process, but not a consensus reading among multiple human readers.
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. This study is a standalone performance evaluation of a rapid diagnostic test against a gold standard (viral culture), not a study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done for the device. The Clearview® Exact II Influenza A & B Test is itself a rapid immunoassay, a "device-only" test. The "performance vs. viral culture" is the standalone performance of the diagnostic test without human interpretation of complex images or data beyond reading simple color lines.
7. The Type of Ground Truth Used
The ground truth used for the clinical study was Viral Culture. For the 19 discrepant Influenza B samples, an investigational RT-PCR assay was also used as a secondary reference.
8. The Sample Size for the Training Set
The document does not mention a separate "training set" for the clinical performance evaluation. The clinical study described is a prospective validation set. For a device like this, the "training" (development and optimization) would typically involve internal efforts during the assay development process, using laboratory-prepared samples or retrospective samples, but a dedicated "training set" for clinical evaluation is not described for this type of diagnostic device.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" for clinical performance is described, the method for establishing its ground truth is not provided. For analytical studies (e.g., analytical sensitivity, reactivity), the ground truth is typically precisely quantified viral cultures or preparations.
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