(54 days)
Ouantex Myoglobin is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of myoglobin concentration in human serum or plasma (EDTA or Lithium Heparin) on Clinical Chemistry Systems as an aid in the diagnosis of myocardial infarction. For in vitro diagnostic use.
Ouantex Ferritin / Myoglobin controls I/II are intended for use in monitoring the quality control of results obtained with the quantex Myoglobin reagents by turbidimetry. (NOTE: These controls were previously FDA cleared for use with quantex Ferritin, reference K040879.) For in vitro diagnostic use.
Quantex Myoglobin standard multipoint is intended for use in establishing the calibration curve for the quantex Myoglobin reagents by turbidimetry. For in vitro diagnostic use.
Ouantex Myoglobin is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of myoglobin concentration in human serum or plasma (EDTA or Lithium Heparin) on Clinical Chemistry Systems as an aid in the diagnosis of myocardial infarction. For in vitro diagnostic use.
Quantex Ferritin / Myoglobin controls I/II are intended for use in monitoring the quality control of results obtained with the quantex Myoglobin reagents by turbidimetry. (NOTE: These controls were previously FDA cleared for use with quantex Ferritin, reference K040879.) For in vitro diagnostic use.
Quantex Myoglobin standard multipoint is intended for use in establishing the calibration curve for the quantex Myoglobin reagents by turbidimetry. For in vitro diagnostic use.
Here's a breakdown of the acceptance criteria and study information for the quantex Myoglobin device, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Derived from Predicate) | Reported Device Performance |
|---|---|---|
| Method Comparison | Strong correlation with predicate device (N Latex Myoglobin) | Slope: 0.99, Correlation Coefficient (r): 0.999 |
| Precision (Within-Run) | Low coefficient of variation (CV) | 1.1% CV (at 71.4 ng/ml myoglobin) |
| 1.3% CV (at 229 ng/ml myoglobin) |
Note: The document focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" are not explicitly stated as numerical targets but are inferred from the performance of the predicate device and what is considered acceptable for such assays. The reported device performance metrics are presented to show the new device meets or exceeds these implied standards.
Study Details
-
Sample Size used for the test set and the data provenance:
- Sample Size: 67 samples
- Data Provenance: Not explicitly stated, but based on the context of a 510(k) summary for a US FDA submission, it is likely that the data was generated within a controlled, possibly clinical, setting. It is not specified if the data was retrospective or prospective.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. This device is an in vitro diagnostic assay for a quantitative measurement (myoglobin concentration), not an imaging or diagnostic AI requiring expert interpretation of ground truth. Its performance is compared to a reference method (the predicate device) or internal quality control standards.
-
Adjudication method for the test set:
- Not applicable/Not mentioned. As this is a quantitative measurement, the "ground truth" for the method comparison study is the result obtained from the predicate device, or the mean of multiple measurements for precision. Adjudication by multiple experts is not relevant here.
-
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:
- No, an MRMC comparative effectiveness study was not done. This device is a diagnostic assay for quantitative determination of myoglobin, not an AI-assisted diagnostic tool that aids human readers.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance data presented (method comparison and precision) represents the standalone performance of the quantex Myoglobin assay system. There is no human-in-the-loop component described for its basic operation as a laboratory test.
-
The type of ground truth used:
- For the method comparison study, the "ground truth" was established by the predicate device's measurements (N Latex Myoglobin). The new device's results were compared against these established values.
- For precision, the "ground truth" (or target values) were the mean concentration levels of the quality control materials (quantex Ferritin/Myoglobin controls I/II).
-
The sample size for the training set:
- Not applicable/Not mentioned. This device is a traditional immunoturbidimetric assay, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The development of such an assay involves analytical validation, not model training.
-
How the ground truth for the training set was established:
- Not applicable. As there is no "training set" in the context of an AI/ML device, this question is not relevant. The assay's analytical characteristics are developed and verified through standard laboratory procedures and calibration.
§ 866.5680 Myoglobin immunological test system.
(a)
Identification. A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.(b)
Classification. Class II (performance standards).