(104 days)
For in vitro diagnostic use with the BioCentrex Analyzer to quantitatively measure cardiac troponin-I, creatine kinase MB and myoglobin concentrations in anti-coagulated whole blood, serum or plasma.
For in vitro diagnostic use with the BioCentrex Analyzer to measure cardiac troponin I, creatine kinase-MB, and myoglobin from whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with myocardial infarction.
BioCentrex Cardiac Panel cartridges are used with the BioCentrex Analyzer to measure cardiac troponin I (CTnI), creatine kinase-MB, and myoglobin concentrations in whole blood, serum or plasma specimens.
The provided text is a 510(k) summary for the BioCentrex Cardiac Panel System. It details the device's technical specifications and performance characteristics, but does not explicitly lay out "acceptance criteria" in a structured table or specifically describe a "study that proves the device meets the acceptance criteria" in the way one might find in a clinical trial report.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through analytical studies. The performance metrics presented are common for in vitro diagnostic devices and are compared against the predicate devices for equivalency.
Here’s an interpretation of the available information structured to address your request, acknowledging the limitations of the provided document in explicitly defining "acceptance criteria" and a "single study report" in the typical sense.
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit "acceptance criteria" are not listed in the document as such, I will infer what would likely be considered acceptable performance based on common standards for diagnostic assays and the predicate devices' performance. The reported device performance will be taken directly from the "Summary of Analytical Studies."
| Performance Metric | Inferred Acceptance Criteria (e.g., comparable to predicate device, within acceptable precision ranges) | Reported Device Performance |
|---|---|---|
| Cardiac Troponin I | ||
| Within-run Imprecision | Low %CV, comparable to predicate | 3.1 to 4.7 %CV |
| Total Imprecision | Low %CV, comparable to predicate | 5.6 to 8.3 %CV |
| Analytical Sensitivity (LOD) | Low detectable level, comparable to predicate | 0.04 ng/mL |
| Dilution Recovery | Near 100% recovery | 99.7 % (average) |
| Method Comparison (r) | High correlation (e.g., r > 0.95), comparable to predicate | r = 0.9953 (vs. predicate) |
| Method Comparison (slope) | Slope near 1.0 | y = 0.992x + 0.316 (vs. predicate) |
| Functional Sensitivity (20% imprecision) | Defined limit for reliable detection | 0.15 ng cTnI/mL |
| CK-MB | ||
| Within-run Imprecision | Low %CV, comparable to predicate | 6.3 to 7.8 %CV |
| Total Imprecision | Low %CV, comparable to predicate | 7.7 to 8.9 %CV |
| Analytical Sensitivity (LOD) | Low detectable level, comparable to predicate | 0.41 ng/mL |
| Dilution Recovery | Near 100% recovery | 100.9 % (average) |
| Method Comparison (r) | High correlation (e.g., r > 0.95), comparable to predicate | r = 0.995 (vs. predicate) |
| Method Comparison (slope) | Slope near 1.0 | y = 0.995x + 0.313 (vs. predicate) |
| Myoglobin | ||
| Within-run Imprecision | Low %CV, comparable to predicate | 6.1 to 7.5 %CV |
| Total Imprecision | Low %CV, comparable to predicate | 7.0 to 7.8 %CV |
| Analytical Sensitivity (LOD) | Low detectable level, comparable to predicate | 2.8 ng/mL |
| Dilution Recovery | Near 100% recovery | No specific myoglobin recovery % given for dilution, but "average recoveries ... of 99.7 %, and 100.9 %" for cTnI and CK-MB are mentioned. It can be inferred that myoglobin also met similar linearity expectations. |
| Method Comparison (r) | High correlation (e.g., r > 0.95), comparable to predicate | r = 0.985 (vs. predicate) |
| Method Comparison (slope) | Slope near 1.0 | y = 0.965x + 6.5 (vs. predicate) |
| Analytical Specificity | No significant interference/cross-reactivity | No significant interference from therapeutic drugs, biological substances, heterophilic specimens, or cross-reactivity with other cardiac contractile proteins or CK isoenzymes. |
| Stability | Cartridge stable for stated period | 1 year at 2-8 °C (unopened); 24 hours at ambient (opened) |
2. Sample Size Used for the Test Set and Data Provenance
The document only provides sample sizes for the Method Comparison studies:
- Cardiac Troponin I: 101 specimens
- CK-MB: 73 specimens
- Myoglobin: 70 specimens
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "cardiac specimens," suggesting they were samples from patients, but further details are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For in vitro diagnostic assays, "ground truth" (or reference method results) is typically established by comparative analysis with a legally marketed predicate device (as done here) or a recognized gold standard laboratory method, rather than expert consensus on individual cases. The "experts" in this context would be the technicians or laboratory personnel performing the predicate method tests.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is needed to determine the true clinical status of a patient, especially when imaging or clinical assessment is subjective. For analytical performance studies of an IVD device, the "ground truth" is typically the result from the established predicate/reference method, and no human adjudication process for interpreting these results is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
This information is not applicable. The BioCentrex Cardiac Panel System is an in vitro diagnostic (IVD) device that measures biomarkers, not an AI-assisted diagnostic imaging or clinical decision support system that involves human readers interpreting cases. Therefore, an MRMC study or AI-related effect size data would not be relevant or expected for this type of device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not directly applicable in the context of an AI algorithm. However, the entirety of the analytical studies described (precision, sensitivity, linearity, method comparison, specificity, stability) represent the standalone performance of the BioCentrex Cardiac Panel System without human interpretation beyond standard laboratory procedures for running the assay and reporting results. The device is the "algorithm" and performs its measurements autonomously once the sample is loaded.
7. The Type of Ground Truth Used
The "ground truth" for the performance studies was established by comparison to predicate devices (Access® AccuTnI™, Access® CK-MB, and Access® Myoglobin) which are legally marketed immunoassays. This is a common and accepted method for demonstrating substantial equivalence for new IVD devices. The results from the predicate devices served as the reference standard.
8. The Sample Size for the Training Set
This information is not provided and is likely not relevant in the context of this device. The BioCentrex Cardiac Panel System is an immunoassay, not a machine learning or AI-driven system that requires a "training set" in the typical sense. Its performance is based on biochemical reactions and optical detection, calibrated by known standards or calibrators rather than a large dataset of patient samples used for algorithmic training.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" in the machine learning sense is not applicable for this immunoassay device. The device would be "calibrated" using manufacturer-provided calibrators, and quality control materials would be run to ensure ongoing performance. These calibrators would have known concentrations of the target analytes.
§ 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.