(94 days)
The VisiQuant™ Anti-Nuclear Antibody Test System 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.
The proposed VisiQuant™ ANA Test System uses the same VisiQuant™ ANA Test Kit as was previously cleared. Hyperion is now proposing to supply the VisiQuant™ Microscope as an additional reader for use with the VisiQuant™ ANA Test Kit. The reading of the samples remains the same except that the software will now generate the calibration curve and interpolate the titer. The prepared slide is placed onto the stage of the microscope. The microscope focuses on the images of each well and the CCD camera collects the images. The software captures and stores the images. The operator views the images to determine if the sample is positive and identifies the pattern. For the samples determined to be positive by the operator, the software calculates a fluorescence intensity unit (FIU) value. The proposed software will now generate a 4-parameter curve using the FIUs and ANA titers of Calibrators assayed in the same run, from which the VisiQuant titer of the test sample is interpolated. The proposed software now has the capability of generating calibration curve reports and laboratory reports.
VisiQuant™ Anti-Nuclear Antibody Test System - Acceptance Criteria and Study Details
1. Acceptance Criteria and Reported Device Performance
The provided document describes a comparative evaluation of the VisiQuant™ ANA Test System against a previously cleared predicate device, the VisiQuant™ ANA Test Kit using a specially equipped fluorescent microscope. While explicit "acceptance criteria" are not listed as pass/fail thresholds, the study aimed to demonstrate "substantial equivalence." The performance metrics reported are agreement for qualitative results (negative/positive) and pattern agreement.
| Performance Metric | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Agreement for negative results | High agreement with predicate device | 95.2% |
| Agreement for positive results | High agreement with predicate device | 100% |
| Pattern agreement (for positive samples) | High agreement with predicate device | 97.2% |
| Correlation coefficient (ANA titers) | High correlation (e.g., >0.9 accepted in similar contexts) | 0.917 |
2. Sample Size and Data Provenance
- Test Set Sample Size: 113 human serum samples were used for the qualitative comparison. Of these, 71 samples were positive by both methods and were further analyzed for pattern agreement and titer correlation.
- Data Provenance: Not explicitly stated. However, given that the manufacturer is based in Miami, Florida, USA, and the device is intended for in-vitro diagnostic use in human serum samples, it is highly likely the data is from the United States. The study appears to be retrospective, comparing the new system's results to those obtained with a pre-existing predicate device.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly describe the use of experts to establish a "ground truth" for the test set in the traditional sense of independent expert review. The study's design is a method comparison against a predicate device. Therefore, the "ground truth" for the test set is effectively derived from the performance of the predicate device (VisiQuant™ ANA Test Kit using a specially equipped fluorescent microscope), whose accuracy and reliability would have been established in its own clearance process. The agreement percentages and correlation coefficients are then calculated against this predicate.
4. Adjudication Method
Not applicable. This study is a method comparison study between two devices, not an evaluation against a human expert consensus. Discrepancies were noted and analyzed (Table 4), but no formal adjudication process with experts is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed as described in the provided text. The study focuses on comparing the objective measurements and pattern identifications between a new automated system (VisiQuant™ ANA Test System) and a previously cleared manual-microscope-based system (VisiQuant™ ANA Test Kit with a specially equipped fluorescent microscope). The document mentions that the new software will "now generate the calibration curve and interpolate the titer" and that "the operator views the images to determine if the sample is positive and identifies the pattern" with the new system. However, the comparative study itself does not involve human readers evaluating images with and without AI assistance to determine an effect size.
6. Standalone Performance Study
Yes, a standalone study was implicitly performed, though it is framed as a "method comparison." The VisiQuant™ ANA Test System (which includes the VisiQuant™ Microscope and the new software) is evaluated in its entirety without human-in-the-loop performance being a variable in the comparison against the predicate device. The comparison directly assesses the output of the new system, including its software-generated calibration curves and interpolated titers, against the output of the predicate system. The software's role in pattern identification is limited to generating values after an operator identifies the pattern. The core automated function compared here seems to be the quantitative measurement and curve generation.
7. Type of Ground Truth Used
The "ground truth" used in this study is the performance of the predicate device, the VisiQuant™ ANA Test Kit using a specially equipped fluorescent microscope, which was previously cleared under Document Control No. K013213.
8. Sample Size for the Training Set
The document does not provide information regarding a specific training set size or its establishment. This is a 510(k) submission for a modification to an existing cleared device (adding a new reader/software system). The device itself (an ANA test system) does not necessarily involve a machine learning model that requires a "training set" in the typical sense. The software's function is primarily to process images, calculate fluorescence intensity units, and generate a calibration curve.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a training set for a machine learning model is not explicitly mentioned or implied for this device based on the provided text. The device's software appears to perform calculations and curve generation based on established immunoassay principles, not through a learned model requiring a labeled training dataset.
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).