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510(k) Data Aggregation
(251 days)
The Hyperion VisiQuant™ ANA Test Kit is intended for the visual determination of anti-nuclear antibodies (ANA's) immunofluorescence pattern(s) and the semiquantitative measurement of ANA's in human serum with a single dilution as an aid in the invitro diagnosis of auto-immune and connective tissue diseases such as systemic lupus erythematosus (SLE) and Sjogren Syndrome.
VisiQuant™ ANA is a unique ANA IFA. The test samples are assayed with a single dilution as in the traditional qualitative procedure to determine positive and pattern while obtaining a VisiQuant titer from the same image. The stained slides are read objectively with a digital camera through the FAN microscope to measure the fluorescence intensity of reacted substrate (Hip-2 calls). The Visiguant tive of the test sample is interpolated from a standard curve. VisiQuant ANA uses a unique fluorophore, La Jolla Blue (LJB), which has a longer fluorescence life (photostability) than fluorescent. LJJP has nearinfrared peak excitation and emission wavelengths to minimize autofluoresconce commonly present in biological substances.
The Hyperion VisiQuant™ ANA Test Kit is intended for the visual determination of anti-nuclear antibodies (ANA's) immunofluorescence pattern(s) and the semiquantitative measurement of ANA's in human serum with a single dilution as an aid in the in-vitro diagnosis of auto-immune and connective tissue diseases such as systemic lupus erythematosus (SLE) and Sjogren Syndrome.
1. Table of acceptance criteria and the reported device performance:
Agreement in Test Results (Qualitative)
| Criteria | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Agreement for negative results | High agreement, similar to predicate device | 98.92 % |
| Agreement for positive results | High agreement, similar to predicate device | 94.12 % |
Pattern Agreement (for positive samples)
| Criteria | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Pattern agreement (both positive, VisiQuant pattern matches Bion pattern) | High agreement, similar to predicate device | 94.79 % |
| Pattern agreement (Bion positive, VisiQuant pattern matches Bion pattern) | High agreement, similar to predicate device | 89.21 % |
Quantitative Correlation (VisiQuant Titer vs. Bion IFA Titer)
| Criteria | Acceptance Criteria (Implicit) | Reported Device Performance (R-value) |
|---|---|---|
| Correlation for all positive patterns | Strong positive correlation | 0.731 (N=96, p<0.0001) |
| Correlation for Homogenous pattern only | Very strong positive correlation | 0.909 (N=36, p<0.0001) |
The acceptance criteria are implicitly defined by the sponsor demonstrating "substantial equivalence" to the predicate device (BION Antinuclear Antibody (ANA) Test Kit/Control) through high agreement percentages and strong statistical correlations.
2. Sample size used for the test set and the data provenance:
Test Set Sample Size:
- Qualitative and Pattern Agreement: 195 samples (93 negative, 102 positive by Bion Test)
- Quantitative Correlation (All patterns): 96 serum samples (positive by both VisiQuant ANA and Bion ANA)
- Quantitative Correlation (Homogenous pattern only): 36 serum samples (with homogenous ANA pattern, positive by both tests)
- Titration equivalence: 11 serum samples
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, it is an in-vitro diagnostic product, and the samples are human serum. The study is a comparative evaluation against a legally marketed predicate device, suggesting these were collected samples tested in parallel.
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 the predicate device, the BION Antinuclear Antibody (ANA) Test Kit/Control, which involves visual reading.
For the titration of 11 serum samples (Table 4) using the Bion IFA ANA, the document states: "Average of separate readings by two persons." This indicates that at least two persons were involved in establishing the Bion IFA ANA titers for these specific 11 samples.
The qualifications of these "two persons" are not specified (e.g., "radiologist with 10 years of experience"). For the broader qualitative and pattern assignments by the Bion test, the number of experts or readers and their qualifications are not mentioned. Given it's a visual read, it implies trained laboratory personnel.
4. Adjudication method for the test set:
For the Bion IFA ANA titers in Table 4, the adjudication method was the average of separate readings by two persons.
For the general qualitative and pattern results of the Bion test (predicate device), the adjudication method is not explicitly stated. It's implied that the results from the predicate device serve as the reference.
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 specifically comparing human readers with AI assistance versus without AI assistance was not reported.
This submission describes the performance of the Hyperion VisiQuant™ ANA Test Kit as a standalone system (which includes a digital camera and software for objective reading) in comparison to a predicate manual visual reading method (Bion Test). While the VisiQuant™ uses digital imaging and software for quantitative measurements, the study does not evaluate human readers' improvement with this new technology versus without it in a structured MRMC setting.
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 VisiQuant™ ANA Test Kit. The device is described as reading slides "objectively with a digital camera through the FAN microscope" and then using "VisiQuant software" to calculate fluorescence intensity units (FIUs) and interpolate VisiQuant titers from a standard curve. The reported "Reported Device Performance" values in the table above represent the results achieved by this system.
While the "determination of the absence (negative) or presence (positive) of ANA pattern(s)" is mentioned as being performed "as in the commonly used qualitative (screen) procedure for ANA IFA," for the positive samples, the VisiQuant titer is obtained by saving the image and processing it with the software. This indicates that the VisiQuant system (digital camera + software) operates in a standalone manner to generate the quantitative results.
7. The type of ground truth used:
The ground truth used was the results from the predicate device, the BION Antinuclear Antibody (ANA) Test Kit/Control. This predicate device uses the indirect fluorescent antibody technique (IFA) and involves visual reading to determine the titer and pattern. Therefore, the ground truth is essentially expert visual interpretation (potentially consensus as noted for titration) from a legally marketed device.
8. The sample size for the training set:
The sample size for the training set is not explicitly stated. The document focuses on the comparative evaluation of the VisiQuant™ ANA Test Kit with a predicate device. It is mentioned that "The FIUs and ANA titers of Calibrators assayed in the same run are used to build a standard curve, from which the VisiQuant titer of the test sample is interpolated." This implies a calibration process, but a dedicated "training set" for an AI algorithm is not detailed.
9. How the ground truth for the training set was established:
As no specific "training set" for an AI algorithm is explicitly detailed, the method for establishing its ground truth is also not specified. The document describes the process for generating the "standard curve," which serves as the reference for interpreting VisiQuant FIUs into titers. This standard curve is built using "FIUs and ANA titers of Calibrators assayed in the same run." The ground truth for these calibrators would be their established analytical values, likely determined through a rigorous validation process by the manufacturer, but the specifics are not provided in this 510(k) summary.
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