(103 days)
The CardioQuant™ Troponin I Test is intended for use for as an in vitro diagnostic product to measure by immunochemical techniques the cardiac troponin I in serum and plasma. Measurement of troponin I aids in the rapid diagnosis of heart disease.
The Spectral Diagnostics CardioQuant 1 Troponin 1 Test is an automated latex immunoturbidometric method. The test utilizes monoclonal and polyclonal antibodies each covalently bound to polystyrene supercarboxylated latex particles. When serum or plasma and assay buffer are combined with the latex particles, troponin I in the specimen cross-links adjacent latex beads and produces an increase in the turbidity of the solution. The turbidity, measured at 600mm, is proportional to the concentration of troponin I present in the serum or plasma.
The provided text describes the Spectral Diagnostics Inc. CardioQuant™ Troponin I Test 510(k) Notification. This submission does not pertain to an AI/ML device but rather to an in vitro diagnostic (IVD) test. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample size for training set, number of experts for ground truth, MRMC study, AI vs. human improvement) are not applicable.
Here's an analysis based on the information provided for this IVD device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Primary Acceptance Criterion (Substantial Equivalence to Predicate) | Substantially equivalent to Dade-Behring Stratus® Troponin I Fluorometric Assay. |
| Correlation with Predicate Device (Correlation Coefficient) | 0.87 |
| Correlation with Predicate Device (Regression Equation) | CardioQuant™ = 0.18(Stratus) + 0 |
| Within Assay Precision (at 5.3 ng/mL Troponin I) | 4.0 % |
| Total Assay Precision (at 5.3 ng/mL Troponin I) | 4.7 % |
| Within Assay Precision (at 16.7 ng/mL Troponin I) | 2 % |
| Total Assay Precision (at 16.7 ng/mL Troponin I) | 1.4 % |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: N = 281
- Data Provenance: Serum samples. The document does not specify the country of origin or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as this is an IVD device measuring a biochemical marker, not an AI/ML device requiring expert interpretation of complex data for ground truth. The "ground truth" implicitly refers to the measurement by the predicate device.
4. Adjudication method for the test set
- Not applicable for this type of IVD device. The comparison is a quantitative measurement against a predicate device.
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 IVD device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a laboratory diagnostic test that produces a quantitative result; it's inherently "standalone" in its measurement function, but there's no "algorithm" in the sense of AI/ML.
7. The type of ground truth used
- The "ground truth" in this context is the measurement obtained from the Dade-Behring Stratus® Troponin I Fluorometric Assay, which is the predicate device. This is a form of comparative measurement against an established method.
8. The sample size for the training set
- Not applicable. This is an IVD chemical assay, not an AI/ML model that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.
§ 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.