(60 days)
For the qualitative determination of cardiac troponin I (cTnI) and myoglobin in numali whole blood, prasilia of the many of the of-care, and hospital settings.
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Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:
The provided document is an FDA 510(k) clearance letter for the "Spectral's 2 in 1 (TnI-Myo) test." This type of document primarily confirms substantial equivalence to a predicate device and provides regulatory information. It does not typically contain the detailed study results, acceptance criteria, or ground truth establishment methods that would be found in a clinical study report or a 510(k) submission itself.
Therefore, much of the requested information cannot be directly extracted from the provided text. I will explicitly state if the information is "Not available in the provided text."
Acceptance Criteria and Device Performance (Based on available information and typical device regulation)
Since the document is an FDA clearance letter for a diagnostic test, the "acceptance criteria" generally refer to the performance characteristics that render the device substantially equivalent to a legally marketed predicate device. While specific numerical acceptance criteria are not in this document, the overall acceptance standard is "substantial equivalence."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Inferred) | Reported Device Performance (Inferred from 510(k) clearance) |
|---|---|
| Qualitative Determination | Device performs qualitative determination of cTnI and myoglobin. |
| Sample Types | Validated for whole blood, plasma, or serum. |
| Indications for Use | "Aid in the diagnosis of Myocardial Infarction (MI) at the bedside, point-of-care, and hospital settings." |
| Substantial Equivalence | Found substantially equivalent to legally marketed predicate devices. (This is the overarching "acceptance criterion" for 510(k) clearance). |
| Accuracy / Performance | Not available in the provided text. (Specific sensitivity, specificity, or agreement rates are not detailed here, but would have been part of the 510(k) submission that led to this clearance). |
| Precision / Reproducibility | Not available in the provided text. |
| Interference | Not available in the provided text. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not available in the provided text.
- Data Provenance: Not available in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not available in the provided text. This information would typically be in the clinical study section of the 510(k) submission. For a diagnostic cardiac marker test, the "ground truth" (e.g., diagnosis of MI) is often established by a combination of clinical assessment, ECG changes, and serial biomarker measurements using a laboratory reference method, not necessarily by a panel of "experts" in the same way an imaging study might be.
4. Adjudication Method for the Test Set
- Not available in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is typically for imaging devices where human readers interpret images with and without AI assistance. This device is an in-vitro diagnostic (IVD) test, where a machine or visual reading (depending on the format) produces a result. Human interpretation of the test result occurs, but it's not an MRMC study in the traditional sense of comparing human reader performance on complex cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. For an IVD device like this, the device itself provides a result (qualitative determination of cTnI and myoglobin). The performance metrics (e.g., sensitivity, specificity, analytical accuracy) would represent the "standalone" performance of the test kit against a reference standard. While the document doesn't provide these specific metrics, they are a fundamental part of the 510(k) submission for IVD devices.
7. The Type of Ground Truth Used
- Not explicitly stated in the provided text. For cardiac biomarker IVDs, the "ground truth" for a positive MI diagnosis in clinical studies usually involves a composite endpoint, which may include:
- Expert Consensus: A panel of cardiologists reviewing all available clinical data (symptoms, ECG, imaging, clinical course).
- Outcomes Data: Definitive diagnosis of MI based on all clinical evidence and patient outcomes.
- Validated Reference Method: Comparison against a highly accurate laboratory-based immunoassay for cTnI and Myoglobin as a primary reference for analytical performance, and then correlated with clinical outcomes for diagnostic performance.
8. The Sample Size for the Training Set
- Not available in the provided text. (IVD devices typically refer to "development" or "validation" sets rather than "training" sets in the context of traditional machine learning, though modern IVDs can incorporate AI/ML).
9. How the Ground Truth for the Training Set Was Established
- Not available in the provided text.
§ 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.