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The DiaSorin LIAISON® XL Zika Capture IgM II assay is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human sera collected from individuals meeting CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). Specimens from symptomatic patients or returning travelers from endemic areas must be collected not earlier than day 8 after the onset of symptoms or risk of exposure, respectively. Positive results must be confirmed by following the latest CDC quidelines for the diagnosis of Zika virus infection.

Results of this test are intended to be used in combination with clinical observations, patient history, epidemiological information, and other laboratory evidences. Zika IqM levels over the course of illness are not well characterized. IqM levels are variable, may be detectable near day 4 post onset of symptoms and persist up to approximately 12 weeks following initial infection.

Negative results may be seen in specimens collected before day four post onset of symptoms or after the window of detectable IgM closes, and therefore do not preclude the possibility of Zika virus infection, past or present.

This LIAISON® XL Zika Capture IgM II assay is not indicated for testing blood or plasma donors.

The test has to be performed on the LIAISON® XL Analyzer.

The DiaSorin LIAISON® XL Zika Capture IgM II Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® XL Zika Capture IgM II assay. The performance characteristics of the LIAISON® XL Zika Capture IgM II controls have not been established for any other assay or instrument platforms different from the LIAISON® XL.

The LIAISON® XL Zika Capture IqM II assay is an automated immunoassay utilizing chemiluminescent (CLIA) detection technology for the detection of human IgM antibodies against Zika Virus in patient sera.

The LIAISON® XL Zika Capture IgM II assay consists of the components described in the following tables.

Magnetic Particles (2.4 mL): Magnetic particles coated with a mouse monoclonal antibody to human IgM diluted in phosphate buffer containing BSA, surfactant, and

The provided text describes the performance characteristics of the DiaSorin LIAISON® XL Zika Capture IgM II assay. However, it does not describe a study comparing the device's performance against human readers or establishing acceptance criteria in the context of an Artificial Intelligence (AI) enabled device. This document is a 510(k) summary for an in-vitro diagnostic (IVD) device, which typically focuses on demonstrating substantial equivalence to a predicate device through analytical and clinical performance studies, not AI-assisted human reading performance.

Therefore, many of the requested points related to AI acceptance criteria, MRMC studies, expert adjudication, and training/test set ground truth establishment for an AI model cannot be extracted from this document.

Here's what can be extracted, interpreted, and what is missing based on the provided text:

Device: LIAISON® XL Zika Capture IgM II Assay

Device Type: In-vitro diagnostic (IVD) immunoassay for the presumptive qualitative detection of Zika virus IgM antibodies. This is not an AI-enabled device.

1. A table of acceptance criteria and the reported device performance

Since this is an IVD device, the "acceptance criteria" are typically defined by performance metrics like positive percent agreement (PPA), negative percent agreement (NPA), precision (reproducibility), analytical specificity (cross-reactivity), and stability. The performance is compared against a comparator assay (predicate device) and clinical observations/nucleic acid testing for ground truth.

• Day 8-14: 94.6%
• Day 15-28: 100%
• Day 29-42: 100%
• Day 43-56: 82.4%
• Day 57-70: 77.8%
• Day 71-84: 100%
  Note: Time frame 0-7 days (35.3%) is outside claimed window of detection. Some samples in the 0-7 day window were only positive by nucleic acid testing, or negative by comparator assay but positive by the device, making direct comparison complex for this early phase. |
  | Negative Agreement (NPA)| High agreement with confirmed negative samples/comparator. | Overall: 98.6% (493/500) with comparator assay (95%CI 97.1%-99.3%)
• Non-endemic (U.S.): 99.6% (249/250)
• Endemic (Dominican Republic): 97.6% (244/250) |
  | Percision/Reproducibility | Low %CV for various samples across runs, days, lots, and sites. | Within-laboratory Precision (ZIKV-M):
• Neg Ctrl: 15.0% CV
• Pos Ctrl: 5.4% CV
• Sample #1 (low signal): 15.5% CV
• Sample #2: 11.9% CV
• Sample #3: 10.6% CV
• Sample #4: 9.5% CV
  Between-Site Reproducibility (ZIKV-M):
• Neg Ctrl: 13.8% CV
• Pos Ctrl: 9.7% CV
• Sample #1 (low signal): 15.3% CV
• Sample #2: 11.1% CV
• Sample #3: 7.0% CV
• Sample #4: 8.4% CV
  Similar comprehensive data provided for ZIKV-C with varying %CVs. |
  | Analytical Specificity/Cross-Reactivity | Low reactivity (ideally 0%) to related pathogens or interfering substances. | Cross-Reactivity:
• 1/43 (2.33%) Dengue IgM samples reactive (also reactive with comparator).
• 1/14 (7.14%) Parvovirus B19 IgM reactive (negative with comparator).
• 1/16 (6.25%) Rheumatoid Factor reactive (negative with comparator).
• No reactivity for many other tested organisms (Chikungunya, Cytomegalovirus, Epstein Barr, Varicella Zoster, Yellow Fever, West Nile, Malaria, Adenovirus, Enterovirus, Hepatitis (C/B), HSV-1/2, Rubella, Borrelia, Treponema pallidum, HAMA, ANA).
  Interfering Substances: Hemoglobin (positive interference at 10 mg/mL, minimal at 2 mg/mL). Others (Bilirubin, Triglycerides, Cholesterol, Albumin, HAMA, RF) showed no significant interference. |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Positive Agreement Study:

  • Sample Size: 244 specimens from 79 subjects.
  • Data Provenance: Prospectively collected from the Dominican Republic (endemic region), including 22 pregnant women.
  • Nature: Serial serum samples from 46 symptomatic subjects, and 33 single bleeds.

• Negative Agreement Study:

  • Sample Size: 500 serum samples.
  • Data Provenance:
    • 250 subjects from a non-endemic region (continental United States - Texas and Florida, collected June 2017). Pregnancy status unknown for US subjects.
    • 250 subjects from an endemic region (Dominican Republic), including 37 pregnant women.
  • Nature: Confirmed negative for Zika IgM by a comparator assay.

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)

This section is not applicable as the ground truth was established by:

• A "commercially available Zika IgM assay" (predicate device).
• Nucleic acid testing (for positive cases).
• Clinical criteria, patient history, and epidemiological information.
  This is a diagnostic kit, not an AI review system, so human expert interpretation (like radiologists) for ground truth is not relevant in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The ground truth for this IVD device's clinical performance was established by laboratory methods (comparator assay, nucleic acid tests) and patient epidemiology/clinical data, not by human expert review that would require adjudication.

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

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted. This is an in-vitro diagnostic (IVD) test kit, not an AI-assisted diagnostic tool for human readers.

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

This refers to the device itself. The LIAISON® XL Zika Capture IgM II assay is a standalone automated immunoassay. Its performance characteristics (accuracy, precision, etc.) are reported independently of human interpretation in the way an AI algorithm's standalone performance might be. It generates a quantitative "Index value" which is then interpreted as positive, negative, presumptively positive, or presumptively recent based on pre-defined cut-off values.

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

The ground truth for the clinical studies was primarily established by:

• Comparator Assay: A "commercially available Zika IgM assay" (the predicate device)
• Nucleic Acid Testing: For confirmation of Zika virus infection in symptomatic subjects.
• Clinical/Epidemiological Data: CDC Zika virus clinical criteria (signs/symptoms) and/or epidemiological criteria (residence/travel to endemic region).

8. The sample size for the training set

The document does not describe a training set as this is a traditional IVD device, not a machine learning/AI model. The "training" of such a device is typically through its chemical and biological formulation and optimization during development, not data-driven model training.

9. How the ground truth for the training set was established

Not applicable as there is no training set mentioned for an AI model.

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