Search Results

CardioQuant™ Cardiac Assessment Controls are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of clinical diagnostic test methods for troponin I, CK-MB and myoglobin. These external controls compliment the monitoring of the test performance by the kit specific controls provided by each test device manufacturer.

Not Found

This is a New 510(k) K991447 for a Class I device, CardioQuant™ Cardiac Assessment Controls. As such, there is no discussion of acceptance criteria, device performance, or study design. There would have been no requirement for clinical studies to prove substantial equivalence. All the information that can be extracted is described below.

1. A table of acceptance criteria and the reported device performance

Not applicable for this device and 510(k) submission.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable for this device and 510(k) submission.

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 for this device and 510(k) submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable for this device and 510(k) submission.

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 for this device and 510(k) submission.

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

Not applicable for this device and 510(k) submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable for this device and 510(k) submission.

8. The sample size for the training set

Not applicable for this device and 510(k) submission.

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

Not applicable for this device and 510(k) submission.

Ask a specific question about this device