(22 days)
Immunoturbidimetric assay for the in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers in plasma.
The Tina-quant® D-Dimer Test system is a particle enhanced immunoturbidimetric assay. Latex particles are coated with monoclonal antibodies to the D-Dimer epitope. The antigen/antibody complexes produced by the addition of samples containing D-Dimer lead to an increase in turbidity.
This is a 510(k) summary for a D-Dimer test system, which is an in vitro diagnostic device. The provided text does not include the specific acceptance criteria or the study data proving the device meets those criteria. It focuses on the device's description, intended use, and substantial equivalence to a predicate device.
Therefore, I cannot provide the requested table of acceptance criteria and reported device performance, nor the details about the study design, sample sizes, expert involvement, and ground truth for a performance study.
The text does provide information in some of the other requested categories based on the context of a 510(k) submission for an in vitro diagnostic:
1. A table of acceptance criteria and the reported device performance:
* Not Available in the provided text. This information is typically found in the performance studies section of a 510(k) submission, detailing sensitivity, specificity, accuracy, precision, linearity, etc., and statistical results compared to pre-defined acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
* Not Available in the provided text.
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):
* Not Applicable/Available in the provided text. For an in vitro diagnostic device like a D-Dimer test, "ground truth" for a test set would typically be established by a reference method (e.g., another established D-Dimer assay, or clinical outcome data if demonstrating clinical utility), rather than by human expert consensus in the way a medical imaging device might. The document does not mention details of the reference method used in any performance studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not Applicable/Available in the provided text. Adjudication methods are typically used when human interpretation of data (e.g., images) forms part of the ground truth or comparison, which is not the case for this type of quantitative biochemical assay.
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:
* Not Applicable. This device is an automated in vitro diagnostic assay, not an AI-assisted diagnostic tool requiring human reader interpretation in the context of MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Yes, by nature of the device. The Tina-quant® D-Dimer Test System is an automated immunoturbidimetric assay. Its performance is inherently standalone, as it provides quantitative results directly from a plasma sample without human interpretation of raw data beyond reading the numerical output. The "algorithm" in this context refers to the chemical and optical reactions and the instrument's processing of the turbidity changes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not explicitly stated in the provided text. For an in vitro diagnostic device like this, the "ground truth" in a validation study would typically be established by a well-characterized reference method or by clinical diagnosis/outcomes against which the D-Dimer levels are correlated.
8. The sample size for the training set:
* Not Applicable/Available in the provided text. This is an automated assay, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The "development" of such an assay involves chemical formulation and calibration, not algorithm training on data.
9. How the ground truth for the training set was established:
* Not Applicable/Available in the provided text due to the nature of the device (see 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).