Search Results

The TEG® Platelet Mapping Assay is intended for use with the Thrombelastograph (TEG) Hemostasis Analyzer to assess platelet function in patients who have received platelet inhibiting drugs such as aspirin, clopidogrel, abciximab, tirofiban, or eptifibatide.

The TEG Platelet Mapping Assay consists of a set of blood modifiers, ADP and AA platelet agonists together with ActivatorF, which when used on a heparinized blood sample can measure the inhibition of platelet function.

The provided text is a 510(k) summary for the Thrombelastograph® (TEG®) Platelet Mapping™ Assay. It describes the device's intended use and claims substantial equivalence to predicate devices based on a summary of studies. However, the document does not provide specific acceptance criteria or detailed results of a study that proves the device meets those criteria. The "Summary of Studies" section is very high-level and lacks the quantitative data, sample sizes, and methodological details required to answer most of your questions.

Therefore, I cannot populate the table or provide detailed answers to many of your questions based solely on the provided text.

Here's an attempt to answer what is possible and highlight what's missing:

Acceptance Criteria and Device Performance Study

As per the provided text, specific quantitative acceptance criteria for the TEG® Platelet Mapping™ Assay are not explicitly stated. The "Summary of Studies" broadly indicates that "Test results demonstrate that the TEG reliably detects a reduction in platelet function (aggregation) in the presence of anti-platelet drugs, and that the TEG measurements correlate well with the optical aggregometry method." Without specific metrics (e.g., sensitivity, specificity, correlation coefficient thresholds), it is impossible to create a table of acceptance criteria and reported performance.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not specified in the provided text. The study design details are absent.

4. Adjudication method for the test set

• Not specified in the provided text.

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/Not specified. The device is a diagnostic assay, and the context does not suggest a multi-reader, multi-case study in the typical sense for image interpretation or similar AI-assisted diagnostic tasks. There is no mention of "human readers" or "AI assistance" in the description of the TEG Platelet Mapping Assay.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The TEG® Platelet Mapping™ Assay is described as components (blood modifiers, agonists) used with the Thrombelastograph (TEG) Hemostasis Analyzer. The summary states that "the TEG reliably detects a reduction in platelet function." It implies an automated measurement by the device itself, rather than human interpretation. So, yes, the study primarily focused on the standalone performance of the assay and analyzer system. However, specific details of this standalone performance are not provided.

7. The type of ground truth used

• The text states the TEG measurements "correlate well with the optical aggregometry method." This suggests that optical aggregometry (a recognized method for assessing platelet function) was likely used as a comparator or a form of "ground truth" for validation. The "presence of anti-platelet drugs" also indicates a clinical context for evaluating reduced platelet function, implying either known drug administration or clinical outcomes as partial ground truth.

8. The sample size for the training set

• Not specified in the provided text. This device is described as an "assay" and a "system," not explicitly an AI/ML algorithm that undergoes discrete "training" and "test" phases in the modern sense. While internal development and calibration would involve data, it's not documented as a distinct "training set" in this summary.

9. How the ground truth for the training set was established

• Not specified in the provided text.

Ask a specific question about this device