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510(k) Data Aggregation
(89 days)
AVANTI POLAR LIPIDS, INC.
Avanti's VDRL antigen and Buffered Saline are intended for use in the Venereal Disease Research Laboratory (VDRL) slide test for syphilis. The VDRL slide test is a non-treponemal, micro-flocculation test, that provides both qualitative and semi-quantitative results. The test is for the detection of IgM and IgG anticardiolipin antibodies in serum specimens.
The Venereal Disease Research Laboratory slide test is a test for the detection of syphilis. The test employs an antigen containing cardiolipin, phosphatidylcholine (lecithin), and cholesterol dissolved in ethanol. The antigen is suspended in a buffered saline solution, which flocculates when combined with serum containing IgM and IgG anti-cardiolipin antibodies. The IgM and IgG antibodies are produced in response to infection by Treponema pallidum the causitive agent of syphilis. The flocculation forms a three-dimensional lattice structure that can be seen at low magnification (10x oculars and 10x objective) with a light microscope.
Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:
Device: Avanti Polar Lipids VDRL Antigen Slide Test Kit
Intended Use: For use in the Venereal Disease Research Laboratory (VDRL) slide test for syphilis, a non-treponemal, micro-flocculation test that provides both qualitative and semi-quantitative results to detect IgM and IgG anticardiolipin antibodies in serum.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria (Implied / Comparator Performance) | Reported Device Performance (Avanti Polar Lipids VDRL Antigen Slide Test Kit) |
|---|---|---|
| Specificity | Not explicitly stated as a numerical acceptance criterion, but the claim of "substantial equivalence" implies that the specificity should be comparable to legally marketed VDRL Antigen Slide Test Kits. The predicate devices are listed as: Becton Dickinson's VDRL Antigen For Syphilis Serology, Cenogenics ADRL/STS Test, Lee Laboratories VDRL Antigen, and Centers for Disease Control and Prevention VDRL Antigen. Performance of these predicates is not given in the document, but it can be inferred that 100% specificity is a very high, desirable performance characteristic. | 100% |
| Sensitivity | Not explicitly stated as a numerical acceptance criterion, but the claim of "substantial equivalence" implies that the sensitivity should be comparable to legally marketed VDRL Antigen Slide Test Kits (as listed above). Performance of these predicates is not given in the document. | 86.5% |
| Reproducibility | Inter-day and intra-day testing should demonstrate consistency. A "maximum inter-day and intra-day difference of one doubling dilution" when tested by the same clinician, and "an end point within two doubling dilutions of the true end point when tested by different clinicians" are the criteria for acceptable reproducibility. This implies that the device should yield consistent qualitative and semi-quantitative results across different testing sessions and operators. | Demonstrated. Maximum inter-day and intra-day difference of one doubling dilution (same clinician). All reactive specimens gave an end point within two doubling dilutions of the true end point (different clinicians). |
| Technological Characteristics (Antigen Composition) | The composition of the Avanti VDRL Antigen (Cardiolipin, Cholesterol, Lecithin dissolved in ethanol) should be comparable to predicate devices. Specific concentrations of Cardiolipin, Cholesterol, and Lecithin (for standard reactivity) are provided for comparison, implying these concentrations define the acceptable range for a VDRL antigen. | Cardiolipin: 0.1 g/L, Cholesterol: 9.0 g/L, Lecithin: sufficient for standard reactivity (1-1.9 g/L) – Comparable to Becton Dickinson, with slight variation in Cardiolipin and Lecithin ranges. |
| Technological Characteristics (Buffered Saline Composition) | The composition of the Avanti Balanced Saline solution (Formaldehyde, Sodium Chloride, Disodium phosphate, Monopotassium phosphate dissolved in deionized water) should be comparable to predicate devices. Specific concentrations for each component are provided. | Formaldehyde: 0.5 mL/L, NaCl: 10.0 g/L, Disodium phosphate: 0.037 g/L, Monopotassium phosphate: 0.170 g/L – Identical to Becton Dickinson. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Specificity and Sensitivity (Performance Data): 100 documented cases of syphilis.
- Sample Size for Reproducibility Data: Not explicitly stated, but “specimens from a blind, coded panel” were used. The number of specimens in this panel is not provided.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "documented cases of syphilis," implying these were existing patient samples with established diagnoses.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The ground truth is referred to as "documented cases of syphilis," which implies a clinical diagnosis, but the method or personnel establishing this documentation are not detailed. For reproducibility, "different clinicians" were involved, but their qualifications are not given.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing the ground truth of the "documented cases of syphilis." The ground truth appears to be based on pre-existing diagnostic records. For reproducibility, results from different clinicians were compared, but no formal adjudication process between them is outlined beyond comparing an end point within two doubling dilutions of the "true end point."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The study focuses on the performance of the Avanti Polar Lipids VDRL Antigen Slide Test Kit itself, not on how human readers' performance might improve with or without AI assistance. This device is an antigen for a manual slide test, not an AI-assisted diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, a standalone performance assessment was conducted. The sensitivity and specificity reported are those of the "Avanti Polar Lipids, Inc. VDRL Antigen Slide Test Kit" itself, meaning the kit's ability to react correctly with samples. While a human is involved in observing the flocculation under a microscope, the performance metrics are attributed to the device's ability to yield the correct reaction, forming the basis for a diagnosis. It's a test kit, not an algorithm, so algorithm-specific standalone performance isn't applicable in the modern AI sense. However, the data presented pertains to the device's inherent performance.
7. The Type of Ground Truth Used
The ground truth used for sensitivity and specificity was based on "documented cases of syphilis." This broadly refers to clinical diagnosis or confirmed cases (likely by other established methods for syphilis diagnosis). For reproducibility, a "true end point" was mentioned, which would presumably be a previously established titer for the control specimens in the blind panel.
8. The Sample Size for the Training Set
The document does not mention a training set or any machine learning/AI components. This device is a traditional in vitro diagnostic (IVD) test kit, not an AI/ML-based device.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned (since it's not an AI/ML device), this information is not applicable.
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