(71 days)
Advanced D-Dimer is a latex-enhanced turbidimetric test for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in human plasma for use with Dade Behring Coagulation Analyzes and Sysmex® Coagulation Systems. The Advanced 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)].
Polystyrene particles covalently linked to a monoclonal antibody (DD5) to the crosslinkage region of cross-linked fibrin degradation products (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.
The provided document is a 510(k) summary for a medical device called "Advanced D-Dimer Assay." This device is an in-vitro diagnostic test and does not fall under the typical scope of AI/ML-driven devices that would require the description of acceptance criteria, study details, and performance metrics as outlined in the request.
Therefore, many of the requested fields are not applicable to this type of traditional in-vitro diagnostic device and its 510(k) submission.
However, I can extract the relevant information that is present in the document.
1. Table of acceptance criteria and the reported device performance:
The document describes the device performance in a table format, but it does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve >X% sensitivity and >Y% specificity"). Instead, it presents some numerical data, which given the context of a D-Dimer assay, likely refers to patient numbers or performance characteristics, but without clear labels, it's hard to interpret precisely. The table is also poorly formatted and illegible in parts.
| Performance Metric | Reported Device Performance (Dade Behring BCS System) | Reported Device Performance (Sysmex A-1500) |
|---|---|---|
| A Book Same Bear washing more and | 000 SIL | 297 |
| and and a province | 108% 3-2 1 4 hours and 11 8 2 4 1 4 5 3 4 1 1 7 3 1 1 1 1 1 1 1 1 1 1 1 | 100 |
| A BAND BE PART A C R C S . C . S. | છેકે 38 | 100 |
| STORES OF COLLECTION | 173 2008 200 | ਰੇਰੇ 100 |
Note: The content and labels in this table are heavily garbled and appear to be misinterpretations of the original text. It is highly likely the original document contained clinical performance data (sensitivity, specificity, NPV, PPV) based on the intended use for DVT/PE diagnosis, but this specific section is unreadable in the provided text.
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated for performance evaluation. The table includes numbers like "173 2008 200" and "297", which could relate to sample sizes or collection sites, but without a clear label, it's impossible to confirm.
- Data provenance: Not explicitly stated (e.g., country of origin). The study is simply referred to as "Advanced D-Dimer Clinical Study Summary."
- Retrospective or prospective: Not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For a D-Dimer assay, the "ground truth" for VTE diagnosis would typically be established through definitive objective diagnostic tests (e.g., venography, CT pulmonary angiography) rather than expert consensus on device output. The document describes a laboratory test, not an interpretive image or signal.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically for interpreting subjective outputs (e.g., radiology images) to establish ground truth. For a quantitative D-Dimer assay, the "ground truth" for the presence or absence of DVT/PE would come from objective diagnostic tests.
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 is an in-vitro diagnostic assay, not an AI-driven imaging or diagnostic tool intended to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a laboratory assay; its performance is inherently "standalone" in the sense that it measures a biomarker concentration. It doesn't involve an "algorithm" in the AI sense or a "human-in-the-loop" for interpretation of its primary result. Its clinical utility is then interpreted by a clinician in the context of other patient information.
7. The type of ground truth used:
- Implied: For a D-Dimer assay intended as an aid in diagnosing DVT/PE, the ground truth for the presence or absence of DVT/PE would typically be established by definitive objective diagnostic imaging studies (e.g., venography for DVT, CT pulmonary angiography for PE) or a combination of clinical assessment and follow-up. The document does not explicitly state which gold standard tests were used.
8. The sample size for the training set:
- Not applicable/Not mentioned. This is a traditional chemical assay, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set" for this type of device.
§ 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).