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The ELVIS®HSV ID and D3 Typing Test System provides Cells, Replacement Medium and Test Reagents for the culture, qualitative identification and typing of Herpes simplex virus (HSV) from cutaneous or mucocutaneous specimens collected from patients with clinical suspicion of HSV infection. The performance characteristics of this assay have not been established for antiviral therapy, prenatal monitoring or CSF specimens.

The ELVIS®HSV ID and D3 Typing Test System provides Cells, Replacement Medium and Test Reagents for the culture, qualitative identification and typing of herpes simplex virus (HSV) from cutaneous or mucocutaneous specimens as an aid in the diagnosis of HSV type 1 (HSV-1) and HSV type 2 (HSV-2) infections. The performance characteristics of this assay have not been established for antiviral therapy, prenatal monitoring or use with cerebral spinal fluid specimens.

ELVIS HSV Cells are genetically engineered Baby Hamster Kidney (BHK) cells, which, when infected with either HSV-1 or HSV-2, are induced to generate and accumulate an endogenous, intracellular bacterial enzyme, ßgalactosidase. Other related viruses (e.g., Varicella zoster) are not capable of inducing the formation of this enzyme. HSV infection of the ELVIS®HSV Cells also results in the formation of HSV-type-specific proteins. The presence of these proteins can be detected microscopically when fluorescent labeled HSV-type-specific antibodies are used. The two Type 1 monoclonal antibodies used in ELVIS® are directed against specific to epitopes on the HSV-1 protein. The three Type 2 monoclonal antibodies are directed against the HSV-2 glycoproteins C, G and a recombinant glycoprotein G that occur in the cytoplasm of infected cells.

The ELVIS®HSV ID and D2 Typing Test System consists of:

1. ELVIS®HSV Cells: The ELVIS®HSV Cells have a routine use period of 7 days from customer receipt while all other components have a shelflife of months (see expiration date on label of each component). ELVIS® HSV Cells are provided as 75% to 95% confluent monolavers in shell-vials with or without coverslips, or in multi-well plates with or without coverslips, and up to 24 monolayers per plate. Each monolayer is covered by at least 0.75-mL of Eagle's Minimum Essential Medium (EMEM) with fetal bovine serum (FBS), penicillin, and streptomycin. Cells are characterized by isoenzyme analysis and have been tested and found free of Mycoplasma spp. and other adventitious organisms.
2. ELVIS HSV Replacement Medium: Sterile EMEM containing FBS, Penicillin, Streptomycin and Amphotericin B. ELVIS®HSV Replacement Medium is for use with ELVIS®HSV Shell-Vials and Multi-well Plates.
3. ELVIS® HSV Solution 1 (Cell Fixative): an aqueous acetone solution.
4. ELVIS® HSV Solution 2T (Staining Buffer): A diluted solution of X-Gal (5-Bromo-4-Chloro-3-Indolyl-B-D-Galactopyranoside), N.N-Dimethylformamide, iron, sodium and magnesium salts, fluorescein-labeled HSV-2-specific murine MAbs (directed against HSV-2 glycoproteins C, G, and a recombinant glycoprotein G) and nonlabeled HSV-1-specific murine MAbs (specific to epitopes on the HSV-1 protein UL42), penicillin, streptomycin, bovine serum albumin and Evans Blue in an aqueous, buffered solution.
5. ELVIS®HSV Solution 3: An aqueous, stabilized, buffered solution containing fluorescein-labeled, affinity purified goat-anti-mouse IgG antibody and Evans Blue with sodium azide as preservative.
6. ELVIS®HSV Mounting Fluid (Buffered Glycerol): Aqueous, stabilized, buffered glycerol (pH 7.3 +/- 0.5), containing sodium azide as preservative.
7. 40X PBS Concentrate. 25-mL: One bottle of a 40X PBS concentrate consisting of 0.4% sodium azide (0.1% sodium azide after dilution to 1X using de-mineralized water).

Here's a breakdown of the acceptance criteria and the study details for the ELVIS®HSV ID & D3 Typing Test System, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Study Details

This device is not an AI/ML device, so certain categories below (like multi-reader multi-case studies, human-in-the-loop performance, and training set details) are not applicable.

1. Sample size used for the test set and the data provenance:

   • Clinical Test Set: 735 specimens initially, with 719 specimens included in the final analysis after exclusions (16 were excluded due to toxicity to cell culture or contamination).
   • Data Provenance: The origin of the data (country) is not explicitly stated. The study was conducted at "three locations" and specimens were "submitted, April through May, 2009, for HSV culture." This indicates a prospective collection of clinical samples during that period.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • For the clinical performance study, the ground truth was established by comparing the subject device's results against the legally marketed predicate device (ELVIS®HSV ID/Typing Test System), which itself is an in vitro diagnostic (IVD) device. Therefore, it relies on the established performance of that predicate device as the reference standard, rather than a panel of human experts establishing ground truth for each case. No specific number or qualifications of human experts establishing ground truth are mentioned for the clinical study.

3. Adjudication method for the test set:

   • Not applicable as the comparison was made against a predicate device, not through expert adjudication of images.

4. 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, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) test system for virus identification and typing, not an AI or imaging device involving human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • This is an IVD test system, which inherently operates without a human-in-the-loop for result generation, but requires human interpretation of microscopic staining. The performance described (e.g., PPA, NPA) represents the standalone performance of the device itself (cells + reagents + staining procedure + microscopic observation) compared to the predicate device. It's not an "algorithm" in the AI sense.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the clinical study, the ground truth was the results obtained from the legally marketed predicate device (ELVIS®HSV ID/Typing Test System).
   • For the analytical and reproducibility studies, the ground truth was based on known virus strains and concentrations (TCID50) and confirmed uninfected samples.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. This is not an AI/ML device that requires a training set.

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