(189 days)
This test system is designed for the manual or automated, qualitative detection of IgG antibodies to HSV-2 in human serum. The test system is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV. Due to cross reactivity of shared antigens, the HSV-1 IgG ELISA test should be performed in conjunction with this test system to fully evaluate the patient serum. The test is for in vitro diagnostic use.
Not Found
The provided text is related to a 510(k) clearance for an in-vitro diagnostic device, the "Aptus (automated) Application of the HSV-2 IgG ELISA Test." However, it does not contain the detailed study information, acceptance criteria, or performance data that would allow for a comprehensive answer to your request.
The document is a clearance letter from the FDA, stating that the device is substantially equivalent to a predicate device. It briefly mentions "indications for use" but does not delve into the specifics of a validation study as outlined in your prompt.
Therefore, I cannot provide the requested information from the given text. To answer your questions, I would need access to the actual 510(k) summary, clinical study reports, or performance data submitted by Zeus Scientific, Inc. for K984120.
Here's what I can tell you based on the provided text, and what is missing:
1. A table of acceptance criteria and the reported device performance
- Missing: The document does not specify any acceptance criteria (e.g., sensitivity, specificity thresholds) or report actual performance data (e.g., observed sensitivity, specificity, accuracy) for the Aptus HSV-2 IgG ELISA Test.
2. Sample size used for the test set and the data provenance
- Missing: The document does not mention the sample size used in any test set or the provenance of the data (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Missing: The document does not describe the establishment of ground truth for any test set, nor does it mention experts or their qualifications.
4. Adjudication method for the test set
- Missing: No adjudication method is described.
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
- Not Applicable / Missing: This device is an automated ELISA test, not an imaging AI system that would typically involve human readers. Therefore, an MRMC study or AI-assisted human reader improvement metrics are not relevant to this type of device and are not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Missing: As an automated ELISA, the "algorithm only" performance would be its standard performance, as it's designed to be used without continuous human intervention during the assay run. The document does not provide this performance.
7. The type of ground truth used
- Missing: The document does not specify the method for establishing ground truth (e.g., expert consensus, pathology, outcomes data). For an HSV-2 IgG ELISA, ground truth would typically involve a "gold standard" confirmatory test for HSV-2 infection, often a Western Blot, or clinical diagnosis combined with other serological markers.
8. The sample size for the training set
- Missing: The document does not refer to a training set or its size. This concept is more applicable to machine learning algorithms, whereas an ELISA is a chemical assay.
9. How the ground truth for the training set was established
- Missing: As above, the concept of a training set ground truth, as typically understood in AI/ML contexts, is not directly applicable here and is not mentioned.
In summary, the provided FDA clearance letter confirms the device's market approval based on substantial equivalence but does not offer the detailed technical and clinical study data requested.
§ 866.3305 Herpes simplex virus serological assays.
(a)
Identification. Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.(b)
Classification. Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).