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510(k) Data Aggregation
(298 days)
The Zeus Scientific, Inc. AtheNA Multi-Lyte® HSV 1 & 2 IgG Test System is intended for the qualitative detection of the presence or absence of human IqG class antibodies to Herpes Simplex virus I and 2 in human sera. The test is indicated for sexually active adults and expectant mothers, as an aid for presumptively diagnosing Herpes Simplex 1 and 2. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-1 and 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, immunocompromised patients, for use by point of care facilities or for use with automated equipment.
The AtheNA Multi-Lyte HSV 1 & 2 IgG Test System is a microparticle immunoassay system intended for the qualitative detection of distict IgG antibody to HSV 1 and/or HSV 2. The test is a multiplexed immunoassay designed to simultaneously detect and distinguish IgG antibody to HSV 1 and/or 2 using recombinant HSV gG-1 and HSV gG-2 antigens. The test system is comprised of the AtheNA Multi-Lyte HSV 1 & 2 kit and the Luminex Corp instrument and software.
Here's a summary of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:
AtheNA Multi-Lyte HSV 1 & 2 IgG Test System - Acceptance Criteria and Performance Study
The AtheNA Multi-Lyte HSV 1 & 2 IgG Test System is a microparticle immunoassay intended for the qualitative detection of distinct IgG antibodies to HSV 1 and/or HSV 2 in human sera. It is designed to aid in the presumptive diagnosis of diseases caused by exposure to Herpes Simplex Virus 1 and 2 in sexually active adults and expectant mothers.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a single, consolidated section. However, based on the performance data presented, the implicit acceptance criteria are high sensitivity and specificity compared to a predicate immunoblot device, and strong agreement with a CDC reference panel.
| Metric (HSV-1) | Acceptance Criteria (Implicit) | Reported Device Performance (Combined Sites - Sexually Active Adults) |
|---|---|---|
| Sensitivity (Positive Agreement) | High | 98.4% (180/183) (95% CI: 95.3% to 99.7%) |
| Specificity (Negative Agreement) | High | 92.5% (124/134) (95% CI: 86.7% to 96.3%) |
| CDC Panel Positive Agreement | 100% | 100.0% (95% CI: 94.2% to 100.0%) |
| CDC Panel Negative Agreement | 100% | 100.0% (95% CI: 94.2% to 100.0%) |
| Metric (HSV-2) | Acceptance Criteria (Implicit) | Reported Device Performance (Combined Sites - Sexually Active Adults) |
| Sensitivity (Positive Agreement) | High | 97.6% (80/82) (95% CI: 91.4% to 99.7%) |
| Specificity (Negative Agreement) | High | 96.2% (226/235) (95% CI: 92.9% to 98.2%) |
| CDC Panel Positive Agreement | 100% | 100.0% (95% CI: 94.0% to 100.0%) |
| CDC Panel Negative Agreement | High | 98.1% (95% CI: 89.7% to 100.0%) |
Note: The "Acceptance Criteria (Implicit)" are inferred from the strong performance shown and the context of a 510(k) submission seeking substantial equivalence to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Sexually Active Adults: A total of 317 prospective samples were used. These were sequentially submitted to the laboratories, archived, and masked. The samples were collected from sexually active adults between the ages of 17 and 70. Data provenance appears to be internal (Zeus Scientific) and "two outside investigators," implying a multi-center study in the US.
- Expectant Mothers: 150 retrospective samples were used. These archived, masked sera were obtained from a serum vendor. The expectant mothers ranged in age from 18 to 48, with 50 samples from each trimester of pregnancy. Provenance is described as "Zeus Scientific using archived, masked sera obtained from a serum vendor," implying a US or commercially sourced retrospective dataset.
- CDC Panel: An unspecified number of samples from a "serum panel obtained from the CDC." This represents a well-characterized, presumably US-sourced, masked dataset.
- Low Prevalence Population: The sample size for HSV-1 was 67 samples (7 positive, 60 negative by predicate). For HSV-2, it was 67 samples (0 positive, 67 negative by predicate). These were archived, masked serum samples from 18 and 19-year-old subjects stored in a serum bank at the manufacturer site (Zeus Scientific), previously tested for non-sexual infections. This is a retrospective dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth for the test set was established using a predicate immunoblot device: the Focus Technologies HerpeSelect 1 and 2 Immunoblot IgG Test System (K000238). This is a commercial device, suggesting an established and validated method for determining HSV IgG status. No human experts are explicitly mentioned as establishing the ground truth from raw data; rather, the predicate device serves as the reference standard.
The CDC panel likewise acts as a reference standard, having been "characterized" by the CDC.
4. Adjudication Method for the Test Set
No explicit adjudication method is mentioned. The comparison is directly between the AtheNA Multi-Lyte system and the predicate immunoblot device. In cases where the predicate device reported "Indeterminate" results, these samples were noted separately in the performance tables and typically excluded from sensitivity/specificity calculations for positive/negative agreement, or shown as a separate category.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This device is an in-vitro diagnostic (IVD) assay, not an AI-assisted diagnostic tool for human readers. Therefore, there is no mention of human readers or "AI vs. without AI assistance."
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Yes, the performance studies presented are for the standalone device (algorithm only). The AtheNA Multi-Lyte HSV 1 & 2 IgG Test System is an automated immunoassay system that relies on its internal instrument and software to analyze bead sets and determine reactivity. There is no human intervention in the result interpretation process beyond running the test and reading the output.
7. The Type of Ground Truth Used
The primary ground truth used was a predicate immunoblot device (Focus Technologies HerpeSelect 1 and 2 Immunoblot IgG Test System). Additionally, a CDC-characterized serum panel was used for further validation.
8. The Sample Size for the Training Set
- Cut-off Establishment:
- 27 known negative samples (confirmed by a commercially distributed ELISA assay) were used to establish the cut-off.
- A minimum of 5 known positive samples (confirmed by a commercially distributed ELISA assay) were used to confirm results above the theoretical cut-off.
- The text does not specify a separate "training set" in the context of machine learning. The focus is on validation against established methods and populations. The samples used for "cut-off establishment" would be analogous to a small training/calibration set in some contexts, but the bulk of the performance data relies on comparison to a predicate device on distinct test sets.
9. How the Ground Truth for the Training Set Was Established
For the cut-off establishment, the ground truth for the "known negative" and "known positive" samples was established using a commercially distributed ELISA assay. This means another established diagnostic method was used to classify these samples before they were used to define the AtheNA Multi-Lyte's cut-off.
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