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510(k) Data Aggregation
(179 days)
The Diazyme Myoglobin Assay is for the quantitative determination of myoglobin in human serum and plasma. Measurement of myoglobin is used as an aid in the diagnosis of acute myocardial infarction. For in vitro diagnostic use only.
The Diazyme Myoglobin Calibrator Set is intended for use in the calibration of the Diazyme Myoglobin Assay. For in vitro diagnostic use only.
The Diazyme Myoglobin Control Set is intended for use as quality controls for the Diazyme Myoglobin Assay. For in vitro diagnostic use only.
The Diazyme Myoglobin Assay is based on a latex enhanced immunoturbidimetric assay. When an antigen-antibody reaction occurs between myoglobin in a sample and anti-myoglobin antibodies which have been sensitized to latex particles, agglutination occurs. This agglutination is detected as an absorbance change (570 nm), with the magnitude of the change being proportional to the quantity of myoglobin in the sample. The actual concentration is then determined by the interpolation from a calibration curve prepared from calibrators of known concentration.
The Diazyme Myoglobin Assay's acceptance criteria and performance are detailed across sections of the provided document. The study primarily relies on method comparison and precision evaluations to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Method Comparison | High correlation (R² close to 1) and a slope close to 1 with an intercept close to 0 when compared to the predicate device. | R² = 0.9855, Slope = 0.9526, Y-intercept = -4.2228. This is reported as correlating "well" with the predicate method. |
| Precision - Within-Run CV% | Not explicitly stated but generally expected to be low (e.g., typically < 10% for diagnostic assays, especially at higher concentrations) | Control Level 1: 3.71%Control Level 2: 3.87%Control Level 3: 3.54%Serum Level 1: 4.69%Serum Level 2: 2.37%Serum Level 3: 4.80% |
| Precision - Total CV% | Not explicitly stated but expected to be low and within acceptable laboratory limits. A total precision of <10% to 15% is common, with lower percentages desired. | Control Level 1: 5.10%Control Level 2: 4.30%Control Level 3: 4.40%Serum Level 1: 5.20%Serum Level 2: 3.58%Serum Level 3: 5.30% |
| Linearity | The assay should demonstrate linearity across its reportable range. | Linear from 13.2 to 615.9 ng/mL. |
| Interference | Less than 10% deviation from the true value when tested with common interferents at specified concentrations. | Less than 10% deviation for all listed interferents at specified concentrations, except for Intralipid above 125 mg/dL. |
The document states, "These results meet the acceptance criteria" under the "Precision" section, implying that the reported precision values are within the pre-defined limits. The "Method Comparison" also states that the results "correlated well," implying acceptance.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Method Comparison: 66 human plasma samples.
- Precision:
- 3 levels of serum-based controls (N=80 for each level across 20 days, 2 runs/day, duplicates means 2022 = 80 measurements per control level).
- 3 serum samples (N=80 for each level, calculated the same way as controls).
- Linearity: Not specified as a number of individual samples, but prepared by mixing a low and high serum-based sample.
- Interference: Not specified.
- Data Provenance: The document does not explicitly state the country of origin for the human plasma and serum samples. It implies prospective testing, as samples were "tested with the Diazyme Myoglobin Assay," suggesting they were collected for the purpose of this study, but this is not explicitly confirmed for all studies. The samples are described as "human plasma samples" and "serum samples", indicating clinical origin rather than synthetic.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an in vitro diagnostic (IVD) assay for quantitative measurement of myoglobin. Ground truth for such assays is typically established through reference methods or highly characterized predicate devices, not expert consensus, pathology reviews, or outcome data in the same way an imaging or classification AI/CAD device would use. In this case, the ground truth for method comparison was the result obtained from the predicate device (Roche Tina-Quant Myoglobin Gen. 2 Test System).
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is an IVD assay, not a device requiring human expert adjudication for ground truth establishment. The performance is assessed against quantitative measurements from a predicate device or by statistical methods for precision and linearity.
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 in vitro diagnostic assay. MRMC studies are typically performed for imaging devices or CAD systems where human readers interpret results, and the impact of AI assistance on their performance is evaluated. This device provides a quantitative measurement, not an interpretation for a human reader to improve upon.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies reported (method comparison, precision, linearity, interference) represent standalone performance of the Diazyme Myoglobin Assay. The device directly produces a quantitative result of myoglobin concentration in human serum and plasma, with no explicit human-in-the-loop component for result generation. Its performance is evaluated intrinsically through laboratory experiments.
7. The Type of Ground Truth Used
- For Method Comparison: The performance of the predicate device (Roche Tina-Quant Myoglobin Gen. 2 Test System) served as the comparator or "ground truth" to which the Diazyme Myoglobin Assay was compared.
- For Precision, Linearity, and Interference: The "ground truth" is established by the known concentrations of myoglobin in the control materials and the carefully prepared linearity and interference samples. These are quantitative studies where the expected value is either known (for controls/calibrators) or mathematically derived (for linearity/interference).
8. The Sample Size for the Training Set
Not applicable. This device is a chemical assay, not an AI/Machine Learning algorithm that requires a "training set" in the conventional sense. Its performance characteristics are inherent to the chemical reactions and detection system, and are established through analytical verification studies (like those described) rather than machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
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