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HemosIL D-Dimer is an automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on IL Coagulation Systems as an aid in the diagnosis of venous thromboembolism (VTE) [deep venous thrombosis (DVT) and pulmonary embolism (PE)].

The D-Dimer Latex Reagent is a suspension of latex particles coated with a monoclonal antibody specific for the D-Dimer domain included in fibrin soluble derivatives. When plasma containing D-Dimer is mixed with the D-Dimer Latex Reagent and Reaction Buffer, the coated latex particles agelutinate. The degree of agglutination is directly proportional to the concentration of D-Dimer in the sample and is determined by measuring the decrease of the transmitted light caused by the aggregates (turbidimetric immunoassay).

The HemosIL D-Dimer device is an automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on IL Coagulation Systems as an aid in the diagnosis of venous thromboembolism (VTE) [deep venous thrombosis (DVT) and pulmonary embolism (PE)].

Here's a breakdown of its acceptance criteria and the study that proves it meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly uses sensitivity and Negative Predictive Value (NPV) as key performance metrics, with a required sensitivity of 100% and NPV of 100% at a specific cut-off.

Note: While specificity is reported, the context of D-Dimer as a rule-out test for VTE typically prioritizes very high sensitivity and NPV, suggesting these are the primary implicit acceptance criteria for confirming its utility as an "aid in diagnosis" by ruling out the condition.

2. Sample Sizes Used for the Test Set and Data Provenance:

• ACL 9000 Test Set Sample Size: 297
• ACL TOP Test Set Sample Size: 294
• Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, whether retrospective or prospective).

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

This information is not provided in the given summary. The document does not specify how the DVT/PE diagnoses (the ground truth for VTE) were established, nor does it mention the number or qualifications of experts involved.

4. Adjudication Method for the Test Set:

This information is not provided in the given summary. There is no mention of an adjudication process for resolving discrepancies in ground truth determination.

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

No. The study described is a standalone performance evaluation of the HemosIL D-Dimer device against a clinical outcome, not a comparative effectiveness study involving human readers with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes. The reported performance metrics (Sensitivity, Specificity, NPV) are for the HemosIL D-Dimer device acting as an automated assay by itself, without explicit human intervention in interpreting the D-Dimer result beyond the established cut-off. The device determines the D-Dimer concentration, and this concentration is then used with a pre-defined cut-off to aid in diagnosis.

7. The Type of Ground Truth Used:

The ground truth used is the diagnosis of venous thromboembolism (VTE), specifically deep venous thrombosis (DVT) and pulmonary embolism (PE). This implies clinical diagnosis, likely established through standard diagnostic imaging (e.g., ultrasound for DVT, CT pulmonary angiography for PE) and clinical assessment, though the specifics are not detailed.

8. The Sample Size for the Training Set:

The provided text does not include information about a training set or its sample size. The focus is on the performance of the device on a validation or test set. As this is an immunoassay, the concept of a "training set" in the context of machine learning for image analysis might not directly apply here; instead, the assay's development would involve reagent optimization and calibration.

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

Since there is no mention of a training set, this information is not applicable/provided in the document.

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