(163 days)
The ZEUS ELISA HSV gG-2 IgG Test System is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum. The test is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-2 infection.
The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-2. The test is not intended for donor screening or for self testing.
The performance of this assay has not been established for use in a pediatric population, neonates, or immunocompromised patients.
Not Found
This document describes the FDA's decision to clear the Zeus ELISA HSV gG-2 IgG Test System, not a study report detailing its performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be found in the provided text.
However, I can extract what is implied about the regulatory context and intended use, which informs the type of studies typically required for such devices.
Here's a breakdown of what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided as the document is an FDA clearance letter, not a study report. It does not contain specific acceptance criteria values (e.g., sensitivity, specificity thresholds) or the reported performance data from a clinical study.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not describe the test set size, its provenance, or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Cannot be provided. The document does not describe how ground truth was established, nor the number or qualifications of experts. Given that this is an in-vitro diagnostic device for serological testing, the "ground truth" would likely be established through a combination of other established testing methods rather than expert consensus on images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. The document does not discuss adjudication methods.
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 and cannot be provided. This is an in-vitro diagnostic device (ELISA test) for detecting antibodies, not an imaging device intended for interpretation by human readers, nor does it involve AI assistance for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Implied as 'yes' for the device itself. The device, an ELISA test system, operates as a standalone diagnostic tool to detect antibodies. It's a laboratory test, not an AI algorithm. Its performance is measured directly, not in conjunction with human interpretation for improvement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided explicitly, but typically for serological tests: Ground truth for serological assays like this often involves a composite reference standard, which can include multiple established laboratory tests (e.g., Western Blot, viral culture, PCR, or other highly sensitive and specific serological assays).
8. The sample size for the training set
- Cannot be provided. The document does not mention a training set, as it's an ELISA assay, not a machine learning algorithm that requires supervised training data.
9. How the ground truth for the training set was established
- Cannot be provided. Not applicable as explained above.
Summary based on the provided document:
The provided document is an FDA 510(k) clearance letter for the Zeus ELISA HSV gG-2 IgG Test System. It indicates that the device has been found "substantially equivalent" to legally marketed predicate devices, allowing its commercialization. The letter itself does not contain the detailed clinical study data, including acceptance criteria or performance metrics, that would have been submitted by the manufacturer to the FDA for review.
The primary information available is:
- Device Name: Zeus ELISA HSV gG-2 IgG Test System
- Indications for Use: Qualitative detection of type-specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum for aiding in the presumptive diagnosis of HSV-2 infection in sexually active individuals or pregnant women.
- Limitations: Not intended for donor screening or self-testing. Performance not established for pediatric population, neonates, or immunocompromised patients.
- Regulatory Class: Class II
- Product Code: MYF
- Regulatory Pathway: 510(k) (substantial equivalence)
To obtain the specific acceptance criteria and detailed study data, one would typically need to consult the 510(k) summary submitted by Zeus Scientific, Inc. to the FDA, which is usually publicly available on the FDA's website after clearance, or the device's Instructions For Use (IFU)/package insert. These documents would detail the specific studies performed (e.g., sensitivity, specificity, reproducibility, interference studies) and the results that demonstrated substantial equivalence.
§ 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).