(148 days)
Advanced D-Dimer is a latex-enhanced turbidimetric test for the quantitative measurement of cross-linked fibrin degradation products containing D-dimer in human plasma, and aids 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).
Polystyrene particles covalently linked to a monoclonal antibody (DD5) to the crosslinkage region of cross-linked fibrin degradation products containing D-dimer are agglutinated when mixed with samples containing D-dimer. The cross-linkage region has a stereosymmetrical structure, i.e. the epitope for the monoclonal antibody occurs twice. Consequently, one antibody suffices in order to trigger an agglutination reaction, which is then detected turbidimetrically via the increase in turbidity.
Here's a breakdown of the acceptance criteria and study information for the Advanced D-Dimer device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state pre-defined "acceptance criteria" in a numerical or categorical format for the correlation and precision studies. Instead, it presents the results of a comparison against a predicate device and internal precision measurements. However, we can infer the performance that was demonstrated andpresumably deemed acceptable for substantial equivalence.
| Performance Metric | Implied ("Accepted") Criteria (Inferred from Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Correlation to Predicate Device (Asserachrom® D-Di) | High correlation (e.g., above 0.90) | Correlation coefficient: 0.91 |
| Near 1.0 slope | Slope: 0.98 | |
| Near 0.0 y-intercept | Y-intercept: 0.54 | |
| Inter-assay Precision | Low variability | Ranged from 0.8% to 3.8% |
| Intra-assay Precision | Low variability | Ranged from 1.3% to 3.0% |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Correlation Study (Test Set): 316 samples
- Data Provenance: The document does not specify the country of origin of the data or whether the samples were collected retrospectively or prospectively. It only states "human plasma".
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The study described is a comparison of the Advanced D-Dimer assay to a legally marketed predicate device (Asserachrom® D-Di), not a study against a clinical ground truth established by experts.
4. Adjudication Method for the Test Set:
This information is not applicable/provided. The study compared the new device to a predicate device, not to a ground truth adjudicated by experts.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The study presented compares the performance of the Advanced D-Dimer assay to an existing diagnostic assay (Asserachrom® D-Di), not the performance of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance evaluation was done. The Advanced D-Dimer is an in vitro diagnostic device, and its performance (e.g., correlation and precision) was evaluated independently as a standalone assay. It is designed to provide quantitative measurements without human interpretation or intervention in the measurement process itself, beyond laboratory operation.
7. The Type of Ground Truth Used:
The "ground truth" for the correlation study was the results obtained from the legally marketed predicate device, Asserachrom® D-Di. For the precision studies, the ground truth was implied by the expected values of the control materials and human plasma pools, evaluated for consistency.
8. The Sample Size for the Training Set:
This information is not applicable/provided. The Advanced D-Dimer is a conventional in vitro diagnostic assay, not an AI/machine learning algorithm that requires a "training set" in the computational sense. Its performance is based on the chemical and immunological principles of the assay itself.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/provided for the reason mentioned in point 8.
§ 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).