(21 days)
VITROS CK-MB Reagent Pack - Creatine phosphokinase/creatine kinase or isoenzymes test systems is a device intended to measure the enzyme creatine phosphokinase or its isoenzymes in serum and plasma in the diagnosis and treatment of myocardial infarction.
VITROS CK-MB Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of CK-MB in human serum and plasma.
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
- The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products CK-MB Reagent Pack, VITROS Immunodiagnostic Products CK-MB Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS CK-MB assay, and VITROS Immunodiagnostic Products High Sample Diluent B).
- The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits.
- Common reagents used by the VITROS System in each assay.
The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.
The provided text describes a 510(k) summary for the VITROS CK-MB assay but it does not contain the specific details about acceptance criteria, detailed performance metrics, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, or MRMC studies that would allow for a complete response to all aspects of your request. It mainly focuses on demonstrating substantial equivalence to a predicate device.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with quantitative targets and a "reported device performance" against those targets in the format requested. Instead, it describes characteristics of the new device and compares them to the predicate device to demonstrate substantial equivalence. The overall conclusion is that the performance is "substantially equivalent."
| Device Characteristic | VITROS CK-MB assay for use with human serum and plasma (EDTA or heparin) (New Device) | VITROS CK-MB assay for use with human serum (Predicate Device) |
|---|---|---|
| Calibration range | 0-400 ng/mL | 0-400 ng/mL |
| Basic principle | Solid phase immunoassay | Solid phase immunoassay |
| Tracer | Enzyme labeled | Enzyme labeled |
| Antibody | Mouse monoclonal anti-CK-BB antibody (Biotinylated antibody reagent). Mouse monoclonal anti-CK-MB antibody (HRP-Conjugate reagent). | Mouse monoclonal anti-CK-BB antibody (Biotinylated antibody reagent). Mouse monoclonal anti-CK-MB antibody (HRP-Conjugate reagent). |
| Instrumentation | VITROS Immunodiagnostic System | VITROS Immunodiagnostic System |
| Sample type | Serum and plasma (EDTA or heparin) | Serum |
| Sample volume | 40μL | 40μL |
| Incubation time and temperature | 16 minutes at 37°C with shaking | 16 minutes at 37°C with shaking |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "Equivalence was demonstrated using currently commercially available reagents along with patient samples covering a variety of clinical categories." However, it does not specify the sample size used for the test set, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective nature of the samples).
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)
This is an in-vitro diagnostic (IVD) device, specifically an immunoassay for measuring CK-MB. The "ground truth" for such devices is typically established through reference methods or quantitative chemical analysis, not by human expert interpretation of images or clinical data in the same way as, for example, a radiology AI device. Therefore, the concept of "experts used to establish ground truth" with their qualifications is not applicable in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for an in-vitro diagnostic immunoassay. The evaluation relies on quantitative measurements against reference standards, not on human adjudication of ambiguous cases.
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 immunoassay, not an AI or imaging device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the immunoassay itself in producing quantitative measurements of CK-MB. The entire submission describes the standalone performance of this diagnostic assay. The device is intended for in vitro quantitative measurement and operates without a human-in-the-loop directly influencing the measurement result once the sample is processed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For an immunoassay like the VITROS CK-MB assay, the "ground truth" is typically established by:
- Reference methods: Highly accurate and precise analytical methods.
- Known concentrations: Samples with precisely known concentrations of the analyte (CK-MB) through gravimetric preparation or using certified reference materials.
- Clinical correlation: While not technically "ground truth" for the measurement itself, the clinical utility of the measurement (i.e., its correlation with myocardial infarction) is a broader context.
The document states that equivalence was demonstrated using "patient samples covering a variety of clinical categories," implying that the measurements from the new device were compared to those from the predicate device on these samples, with the predicate device's results serving as the de facto reference for demonstrating equivalence in clinical performance.
8. The sample size for the training set
This document describes a 510(k) submission for an immunoassay, not a machine learning or AI algorithm that requires a "training set" in the computational sense. Therefore, the concept of a training set sample size is not applicable here.
9. How the ground truth for the training set was established
As explained above, the concept of a "training set" is not applicable 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.