(84 days)
The EUROIMMUN Anti-Borrelia burgdorferi US Westernblot (IgG) kit is a Western blot assay intended for the qualitative determination of IgG class antibodies against Borrelia burgdorferi in human serum and plasma (K+-EDTA, Li+-heparin, Na+-citrate) samples that have been found positive or equivocal/borderline using an enzyme immunoassay (EIA) or immunofluorescence assay (IFA) test procedure for Borrelia burgdorferi antibodies. Results can be read manually or automated utilizing EUROLineScan. This test is used as an aid in the diagnosis of infections with B. burgdorferi and the associated diseases, in conjunction with other laboratory and clinical findings.
The EUROIMMUN Anti-Borrelia burgdorferi US Westernblot (IgG) kit is a Western blot assay. Results can be read manually or automated utilizing EUROLineScan.
This FDA 510(k) clearance letter and Indications for Use document do not contain the detailed information necessary to fully describe the acceptance criteria and the study that proves the device meets those criteria, as typically found in a clinical study report or a detailed 510(k) summary. The document focuses on the regulatory clearance and general intended use of the device.
However, based on the information provided, here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided document. A 510(k) summary would typically include a detailed comparison to a predicate device, showing performance metrics like sensitivity and specificity. The document only states that the device is "substantially equivalent" to legally marketed predicate devices.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: This information is not available in the provided document.
- Data Provenance: This information is not available in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not available in the provided document.
4. Adjudication method for the test set:
This information is not available in the provided document.
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:
- The device description states: "Results can be read manually or automated utilizing EUROLineScan." This indicates that there's an automated interpretation component. However, the document does not provide any information about an MRMC study or the effect size of human readers improving with AI assistance. This type of study is more common for diagnostic imaging AI devices, whereas this device is a Western blot assay.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The statement "Results can be read manually or automated utilizing EUROLineScan" suggests that the automated utilization of EUROLineScan implies an algorithmic interpretation. However, the document does not provide specific performance data for the algorithm in a standalone manner or comparisons to human-in-the-loop performance.
7. The type of ground truth used:
This information is not explicitly stated in the provided document. For a diagnostic test like this, the ground truth would typically be established by a combination of clinical diagnosis, other laboratory tests (e.g., culture, PCR, or a consensus of multiple reference tests), follow-up on disease progression, or expert clinical judgment.
8. The sample size for the training set:
This information is not available in the provided document.
9. How the ground truth for the training set was established:
This information is not available in the provided document.
Summary of missing information:
The provided documents (FDA 510(k) clearance letter and Indications for Use) serve as regulatory approval but do not contain the detailed study results, acceptance criteria, or specifics of how the device's performance was evaluated against a ground truth dataset, which would typically be found in a more comprehensive technical report or the 510(k) summary document that would have been submitted to the FDA.
§ 866.3830
Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).