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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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The Light Diagnostics™ HSV 1/2 Typing DFA Kit is an in vitro diagnostic test for the qualitative detection and identification of herpes simplex virus type 1 and/or type 2 in direct specimens from patients with vesicular lesions and symptoms consistent with herpes infection and for culture confirmation by immunofluorescence. Negative results do not preclude an infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Specimens found negative on direct specimen detection should be confirmed by culture.

For In Vitro Diagnostic Use.

Light Diagnostics™ HSV 1/2 Typing DFA Kit is a qualitative test that uses specific typing reagents and FITC filter fluorescence microscope to detect and differentiate herpes simplex viruses 1 and 2 in direct specimens from symptomatic patients with lesions and in specimens amplified by cell culture. The kit consists of HSV-1 Typing Reagent vial, HSV-2 Typing Reagent vial, two HSV Control Slides, Phosphate-Buffered Saline packet; Tween 20/Sodium Azide Solution (100X) vial, and Mounting Fluid vial. The kit utilizes specific reagents for the detection and identification of HSV-1 and HSV-2, therefore two cell spots on slides of specimens are required to identify the type of HSV. The HSV-1 Typing Reagent consists of two fluorescein-labeled monoclonal antibodies specific for HSV-1 glycoprotein C and ICP35 respectively. The HSV-2 Typing Reagent consists of two fluorescein-labeled monoclonal antibodies that specifically bind HSV-2 polypeptides. In Western blots these appear as two major bands with molecular weights of between 110-120 kD and between 78-82 kD and are consistent with the monoclonal antibodies recognizing epitopes within glycoprotein G of HSV-2. The typing reagents will bind to HSV-1 or HSV-2 infected cells fixed on microscope slides specifically. Separate cell spots on slides should be prepared for use with each reagent. Unbound reagent is removed by rinsing with phosphate-buffered saline (PBS). Illumination with ultraviolet light allows visualization of the antigen-antibody complexes by fluorescence microscopy. HSV-infected cells will exhibit apple-green fluorescence with the specific reagent while cells stain a dull red due to the presence of Evans blue in the typing reagents. The controls contained in this kit are acetone fixed slides with one well containing HSV-1 infected cells, one well containing HSV-2 infected cells, and one well containing uninfected cells to verify functioning of reagents, culture methodology and functioning of the microscope.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "Sensitivity must be >= X%"). Instead, it presents the performance characteristics found and concludes that they demonstrate substantial equivalence to the predicate device. The comparison studies were performed against "Culture Confirmation with HSV typing reagent," which served as the reference standard.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Direct Specimen Testing:
  • Total collected: 454 specimens
  • Excluded for HSV-1 direct analysis due to insufficient cells: 16 specimens
  • Excluded for HSV-2 direct analysis due to insufficient cells: 18 specimens
  • Culture results not recorded for: 3 specimens
  • Effective Sample Size (HSV-1 Direct): 438 specimens (454 - 16)
  • Effective Sample Size (HSV-2 Direct): 436 specimens (454 - 18)
• Sample Size for Culture Testing (Amplified Specimens):
  • Total: 176 specimens (from the initial 454 specimens that grew on culture)
• Data Provenance: Clinical specimens were collected from three sites in the United States: 258 samples from the Eastern region and 196 from the Southeastern region. The study explicitly states it was a "Clinical Evaluation" using "specimens collected from three sites from symptomatic patients with lesions," indicating a prospective collection of real-world patient samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number or qualifications of experts involved in establishing the ground truth. It states that "Culture Confirmation with HSV typing reagent" was used as the reference standard. For direct specimen analysis, fluorescence microscopy was used to examine slides stained with the Light Diagnostics™ kit and a reference HSV typing reagent. For cell culture, observers would typically assess cytopathic effect (CPE) for the presence of HSV. The interpretation of these methods would usually be performed by trained laboratory personnel or clinical microbiologists, but no specific details on their number or qualifications are provided.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The reference standard for comparison was "Culture Confirmation with HSV typing reagent." It implies a direct comparison of the investigational device's results against this established reference, rather than a multi-reader adjudication process for the ground truth itself.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study focuses on evaluating the performance of the device against a predicate or reference method (cell culture with HSV typing reagent) rather than assessing human reader improvement with or without AI assistance. The device itself is an immunofluorescence assay kit, not an AI-based system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense, a standalone performance was done. The Light Diagnostics™ HSV 1/2 Typing DFA Kit is an in vitro diagnostic test kit. Its "performance" is measured by its ability to detect and differentiate HSV-1 and HSV-2 antigens in patient samples via immunofluorescence without human "interpretation assistance" beyond standard laboratory procedures (e.g., slide reading under a microscope). The results presented (sensitivity and specificity) represent the performance of the kit itself when compared to the reference standard. There is no AI algorithm involved.

7. The Type of Ground Truth Used

The primary ground truth used was molecular/biological confirmation via cell culture (with HSV typing reagent). For direct specimen testing, the device's results were compared to "culture isolation." For culture testing (amplified specimens), the device's performance was compared against a "Predicate HSV typing reagent" used on culture-amplified specimens. This implies that the presence or absence and typing of HSV were determined by cell culture methods and confirmed with a reference HSV typing reagent.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI. This is a traditional in vitro diagnostic device, and thus, the concept of a training set for an algorithm is not applicable. The non-clinical evaluations involving reference strains and clinical isolates (e.g., 8 HSV-1 isolates, 7 HSV-2 isolates, other viruses, bacteria, and cell lines) served as an internal validation and specificity check (see "Non-clinical evaluation" section), rather than a training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the AI sense, this question is not applicable. For the non-clinical evaluation, the ground truth was established by using known reference strains (e.g., ATCC VR733/735 for HSV-1, ATCC VR734 for HSV-2) and "previously typed clinical isolates," indicating these were characterized and verified prior to being used in the specificity assessment.

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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.

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This test system is designed for the manual or automated, qualitative detection of IgG antibodies to HSV-1 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-2 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 an FDA 510(k) clearance letter for the "Aptus (automated) Application for the HSV-1 IgG ELISA Test". It grants permission to market the device but does not contain the acceptance criteria or a detailed description of the study that proves the device meets those criteria.

The document primarily focuses on:

• Confirming the substantial equivalence of the device to a predicate device.
• Outlining regulatory classifications and general controls.
• Providing contact information for various FDA departments.
• Stating the intended use of the device.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) directly from the provided text. To answer your questions, the actual 510(k) submission document or a summary of safety and effectiveness would be required, which typically includes performance data and the criteria used for evaluation.

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