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The IL Test™ 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 agglutinate. 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).

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the IL Test™ D-Dimer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on predicate equivalence)	Reported Device Performance (IL Test™ D-Dimer)
Correlation to Predicate	r ≥ 0.95 (typical for method comparison studies)	0.998 on ACL 6000 and ACL Futura
Precision (CV)	Generally < 10% for clinical assays	ACL 6000:4.4% (at 390 ng/mL)2.4% (at 888 ng/mL)2.2% (at 1055 ng/mL)ACL Futura:6.9% (at 411 ng/mL)2.1% (at 912 ng/mL)2.7% (at 1051 ng/mL)
Intended Use	Quantitative in vitro diagnostic determination of D-Dimer in human plasma by turbidimetry	Matches predicate's intended use
Safety and Effectiveness	Substantially equivalent to predicate device	Substantially equivalent to predicate device

Note: The document doesn't explicitly state numerical acceptance criteria for correlation or precision. However, for a 510(k) submission, the device must demonstrate performance that is "substantially equivalent" to a legally marketed predicate device. This implies that the performance metrics (like correlation and precision) of the new device should be comparable to or better than generally accepted standards for such assays, and in this case, implicitly compared to the performance of the predicate device.

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

Sample Size: 105 plasma samples.
Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "human plasma," which suggests it's likely from human subjects. The text does not specify if the data was retrospective or prospective, but clinical method comparison studies typically use prospectively collected or retrospectively accessed existing clinical samples.

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

Not applicable / Not explicitly stated. This study is a method comparison study between a new device and a predicate device (AGEN's Dimertest® Gold EIA Kit K945642). The "ground truth" for each sample's D-Dimer concentration is established by the reading from the predicate device itself. It doesn't involve expert interpretation of images or clinical outcomes that require a panel of human experts for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. As this is a quantitative assay comparison against a predicate device, there is no expert adjudication process for establishing ground truth for individual cases, unlike studies involving subjective interpretation (e.g., radiology reads). The agreement is based on numerical correlation between the two assay methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is not a MRMC comparative effectiveness study. It's a method comparison study for an in vitro diagnostic (IVD) assay, comparing the performance of a new automated D-Dimer test to an existing one. Such studies typically involve human readers interpreting complex medical data (like images) and analyzing the improvement with AI assistance.

6. Standalone Performance Study

Yes. The data presented focuses on the standalone performance of the IL Test™ D-Dimer device. It evaluates its correlation with the predicate device and its precision independently. The device itself is an automated in vitro diagnostic test, meaning its output (D-Dimer concentration) is generated by the algorithm/instrument without direct human-in-the-loop interpretation during the measurement process.

7. Type of Ground Truth Used

Comparison to a Predicate Device. The "ground truth" for the performance evaluation of the IL Test™ D-Dimer is the D-Dimer concentration determined by the legally marketed predicate device, AGEN's Dimertest® Gold EIA Kit (K945642). This is a common approach for IVD 510(k) clearances, demonstrating substantial equivalence rather than absolute accuracy against a gold standard like pathology or clinical outcomes for every sample.

8. Sample Size for the Training Set

Not explicitly stated in the provided text. For IVD devices, a "training set" in the context of machine learning (AI) as commonly understood today (neural networks, etc.) is not typically described in these older 510(k) submissions, as these were often traditional algorithms/reagent systems. The "training" for such systems would involve assay development and optimization, which isn't described in terms of a specific data set size here. If the device uses a statistical model or calibration curve, the data used to establish that curve would be analogous to a training set, but its size is not specified.

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

Not applicable / Not explicitly stated. Similar to point 8, the concept of a "training set" with established ground truth for an AI algorithm is not directly relevant or explicitly discussed in this context. The "ground truth" for any internal calibration or development work for this type of turbidimetric immunoassay would typically involve reference materials with known D-Dimer concentrations, often calibrated against international standards if available, or against highly characterized internal reference preparations.

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