(47 days)
For the quantitative measurement of CK-MB, Myoglobin and Troponin-I in heparinized whole blood. To be as an aid in the diagnosis of myocardial infarction.
Not Found
Here's an analysis of the provided text regarding the Triage® Cardiac Panel, focusing on the information requested for acceptance criteria and study details:
Unfortunately, the provided text is an FDA 510(k) clearance letter and does not contain the specific technical details about acceptance criteria, device performance, sample sizes, ground truth establishment, or study methodologies that you've asked for.
The FDA letter confirms that the device, Triage® Cardiac Panel (which includes Triage® Troponin-I, Triage® CK-MB, and Triage® Myoglobin), has been found substantially equivalent to previously marketed devices. It allows the manufacturer to market the device for the quantitative measurement of CK-MB, Myoglobin, and Troponin-I in heparinized whole blood as an aid in the diagnosis of myocardial infarction.
Therefore, I cannot directly answer most of your questions based solely on the provided document. The document describes the regulatory outcome but not the underlying data from the studies used to achieve that outcome.
To answer your questions accurately, I would need to review the actual 510(k) submission document itself, which would contain the detailed study reports and performance data.
However, I can extract the following limited information:
- Device Name: Triage® Cardiac Panel (Triage® Troponin-I, Triage® CK-MB, Triage® Myoglobin)
- Indications for Use: For the quantitative measurement of CK-MB, Myoglobin and Troponin-I in heparinized whole blood. To be an aid in the diagnosis of myocardial infarction.
- Product Code: JHX, MMI, DDR
- Regulatory Class: II
Since I cannot provide direct answers from the text, here's what those answers would typically look like if the information were available in a performance study report:
Hypothetical Example (What would typically be provided in a study report, NOT found in this document):
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sensitivity (Troponin-I) | > 90% at 0-3 hours post-symptom onset | 92.5% (95% CI: 89.1-94.8%) |
| Specificity (Troponin-I) | > 85% at 0-3 hours post-symptom onset | 87.2% (95% CI: 84.0-89.8%) |
| Coefficient of Variation (CV) (CK-MB) | 5 ng/mL | 7.8% at 7 ng/mL, 9.1% at 15 ng/mL |
| Correlation with Reference Method (Myoglobin) | R² > 0.95 vs. GC/MS | R² = 0.97 |
| Limit of Detection (LoD) (Troponin-I) | 15 years of experience in emergency medicine and cardiac diagnostics. |
4. Adjudication Method for the Test Set
- Adjudication Method: 2+1 consensus. If two out of three cardiologists agreed on the diagnosis, that was taken as the ground truth. If all three disagreed or there was a 1-1-1 split, an independent fourth senior cardiologist reviewed the case to break the tie.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: Not applicable for this type of in-vitro diagnostic device (IVD), which is a quantitative measurement, not an AI image interpretation system. MRMC studies are typically for AI-assisted image analysis to see if AI improves human reader performance.
6. Standalone Performance Study
- Standalone Performance Study Done: Yes, the described performance metrics (sensitivity, specificity, CV, LoD, correlation) are inherently standalone performance measures for the device itself.
7. Type of Ground Truth Used
- Ground Truth Type: Clinical diagnosis of Myocardial Infarction, based on a combination of:
- Electrocardiogram (ECG) changes (e.g., ST-elevation, pathologic Q waves)
- Imaging findings (e.g., echocardiography, cardiac MRI)
- Serial cardiac biomarker trends (e.g., serial troponin measurements from a reference laboratory method, not the device under test)
- Clinical presentation and follow-up data.
8. Sample Size for the Training Set
- Training Set Size: Not applicable for this type of device. IVD devices like the Triage® Cardiac Panel are not typically "trained" in the same way machine learning algorithms are. Their performance is established through analytical and clinical validation studies. If there were a machine learning component for results interpretation (unlikely for a basic quantitative assay), then a training set would be relevant.
9. How the Ground Truth for the Training Set was Established
- Not applicable (see point 8). Performance for such devices is established through rigorous analytical verification and clinical validation against established diagnostic criteria and/or reference methods.
I hope this helps clarify what kind of information you were looking for, even though the provided document (the FDA clearance letter) does not contain those specifics.
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.