(127 days)
INNOVANCE™ D-Dimer: For the quantitative determination of cross-linked fibrin degradation products (Ddimers) in human plasma on the Siemens and Sysmex Coagulation Systems. The INNOVANCE™ D-Dimer assay is intended for use as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)].
INNOVANCE™ D-Dimer Controls: INNOVANCE™ D-Dimer Control 1 and INNOVANCE™ D-Dimer Control 2 are assayed, normal and pathological level, intralaboratory quality controls for assessment of precision and analytical bias in the quantitative determination of D-dimer on the Siemens and Sysmex Coagulation Systems.
Polystyrene particles covalently coated with a monoclonal antibody (8D3) are aggregated when mixed with samples containing D-dimer. The D-dimer crosslinkage region has a stereosymmetrical structure, i.e. the epitope for the monoclonal antibody occurs twice. Consequently, one antibody suffices in order to triager an aggregation reaction, which is then detected turbidimetrically via the increase in turbidity.
The provided 510(k) summary describes the INNOVANCE™ D-Dimer Assay, an in vitro diagnostic device used for the quantitative determination of D-dimers in human plasma to aid in the diagnosis of Venous Thromboembolism (VTE).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Strong correlation with predicate device (Stratus® CS DDMR). | Regression Statistics: |
| - Slope: 0.951 | |
| - Intercept: 0.059 mg/L FEU | |
| - Correlation Coefficient: 0.97 | |
| Sufficient sensitivity for aiding in VTE diagnosis. | Clinical Study Summary (Cutoff 0.5 mg/L): |
| - Sensitivity: 98% | |
| Sufficient specificity for aiding in VTE diagnosis. | - Specificity: 48.2% |
Note: The document only provides performance metrics and does not explicitly state acceptance criteria in a quantitative manner. The acceptance criteria are inferred from the demonstrated performance in comparison to the predicate device and the typical requirements for a diagnostic assay.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Method Comparison (Test Set): 318 samples.
- Data Provenance: Not explicitly stated, but method comparison studies typically use patient samples for which both the new device and the predicate device can be run. It is retrospective in the sense that existing samples are tested. The country of origin is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This section is not applicable as the INNOVANCE™ D-Dimer Assay is a laboratory diagnostic test and does not involve human expert interpretation of images or clinical findings to establish a ground truth. The "ground truth" in this context refers to the D-dimer concentrations measured by a reference method (the predicate device) and clinical outcomes for VTE.
4. Adjudication Method for the Test Set
This is not applicable. The method comparison study is a direct comparison of quantitative results between the INNOVANCE™ D-Dimer Assay and the predicate device (Stratus® CS DDMR). There is no "adjudication" in the sense of resolving discrepancies between human interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. The INNOVANCE™ D-Dimer Assay is an in vitro diagnostic test that provides a quantitative measurement. It is not an AI-powered image analysis or diagnostic assist tool that human readers would use. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is implicitly done as the device itself is a standalone assay providing a quantitative result. The performance characteristics (sensitivity, specificity, correlation) are derived directly from the device's output without human intervention in the interpretation of the D-dimer level itself. The "human-in-the-loop" decision is for the physician using the D-dimer result as an aid in diagnosis, not for interpreting the assay's output.
7. The Type of Ground Truth Used
- For Method Comparison: The "ground truth" was essentially the D-dimer values obtained from the legally marketed predicate device, Stratus® CS DDMR. This establishes the analytical equivalence with a recognized method.
- For Clinical Study (Sensitivity/Specificity): The specific ground truth for VTE diagnosis (DVT or PE) is not explicitly detailed but would typically involve definitive clinical diagnoses and/or objective imaging techniques (e.g., ultrasound for DVT, CT Pulmonary Angiography for PE) for the clinical outcomes.
8. The Sample Size for the Training Set
- For Method Comparison: Not applicable as this study is a validation against a predicate, not a training exercise for a machine learning model.
- For Clinical Study: The clinical study mentions a total of "1041 patients" and then broken down into different patient groups (e.g., "Patients," "Patients," etc.). However, given this is an in vitro diagnostic assay, there isn't a "training set" in the machine learning sense. The "training" or development of the assay would involve internal R&D and optimization, not a distinct "training set" that is later tested with a "test set" in the way an AI algorithm is typically validated. The clinical study samples would be considered the performance evaluation samples.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no explicitly defined "training set" in the context of an in vitro diagnostic device like an assay, in the same way, an AI model would have one. The assay's development and optimization would rely on established biochemical principles and extensive internal testing, not a formal labeled "training set" with established ground truth as presented in this document.
§ 864.7320 Fibrinogen/fibrin degradation products assay.
(a)
Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).(b)
Classification. Class II (performance standards).