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The Diamedix Is-HSV 1 & 2 IgG is an indirect Enzyme Immunoassay (EIA) for the qualitative and semi-quantitative determination of IgG antibodies to herpes simplex virus (HSV) type 1 and/ or type 2 in human serum. This test is useful for indicating a past infection with HSV in a single specimen, including females of child-bearing age. The evaluation of acute and convalescent specimens, by demonstrating seroconversion or a significant increase in antibody level, can aid in the diagnosis of primary infection with HSV. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.

The Is-HSV 1 & 2 IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to HSV 1 and/or HSV 2 antigens in human serum

Here's a breakdown 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 acceptance criteria are not explicitly stated in a quantitative manner (e.g., "sensitivity must be > X%"). Instead, the study aims to demonstrate "substantial equivalence" to a legally marketed predicate device (Incstar HSV I/II IgG "fast" ELISA Kit). The performance data presented shows the agreement, sensitivity, and specificity of the new device relative to this predicate device across multiple sites. The implicit acceptance criterion is that the new device performs comparably to the predicate.

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

• Sample Size for Test Set: A total of 645 different patient sera were evaluated across 3 test sites.
• Data Provenance: Not explicitly stated regarding country of origin. The study was a "Performance Data" evaluation, implying it was a prospective or retrospective collection of patient sera for the purpose of testing the device. It was tested at "3 different test sites," suggesting real-world clinical samples, but whether they were newly collected (prospective) or previously banked (retrospective) is not specified. The CDC serum panel for HSV serology assays was also tested, which suggests a well-characterized, potentially external, reference set.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• The text states the Is-HSV 1 & 2 IgG Test System was "evaluated relative to the predicate device and to other legally marketed devices". This implies the predicate device and other legally marketed devices served as the reference standard (ground truth). It is not specified if there was a separate expert adjudication process to establish the ground truth for the 645 patient sera. Equivocal samples were excluded from calculations, but the method for resolving discrepancies or establishing initial truth is not detailed beyond comparison to existing devices.

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

• No, a MRMC comparative effectiveness study was not done. This study is focused on an in-vitro diagnostic (IVD) ELISA test, not an imaging device requiring human interpretation, so the concept of "human readers" and "AI assistance" in the traditional sense of an MRMC study does not apply.

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

• Yes, this was a standalone performance study. The device itself is an ELISA test system designed to detect antibodies. Its performance (sensitivity, specificity, agreement) was evaluated directly, both manually and with an automated processor (MAGO Plus), without a human-in-the-loop scenario where a physician interprets the results with or without the device's output. The device is the "algorithm" in this context, providing a direct measurement.

7. The Type of Ground Truth Used

• Comparison to legally marketed devices (predicate and others). The performance of the Is-HSV 1 & 2 IgG Test System was evaluated "relative to the predicate device and to other legally marketed devices." This means the results from these established, cleared tests served as the reference or "ground truth" against which the new device was compared. Additionally, the CDC serum panel for HSV serology assays was used, which represents a highly characterized reference standard.

8. The Sample Size for the Training Set

• Not applicable / Not specified. ELISA assay development does not typically involve a "training set" in the same way machine learning algorithms do. The development involves optimizing reagents, conditions, and cutoff values through laboratory studies, but not a distinct "training set" of patient samples for algorithm learning.

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

• Not applicable. As noted above, the concept of a training set and its ground truth establishment in the machine learning sense does not apply to this type of IVD device development. The performance characteristics of the assay (e.g., linearity, cross-reactivity, precision) would be established through laboratory experiments and optimization during development.

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