(68 days)
The Multiquant® Quantitative Myoglobin Test is intended for use for as an in vitro diagnostic product to measure by immunochemical techniques the myoglobin ( an oxygen storage protein found in muscle) in serum and plasma. Measurement of myoglobin aids in the rapid diagnosis of heart disease.
The Spectral Diagnostics Multiquant® Quantitative Myoglobin Test is an automated latex immunoturbidometric method. The test utilizes a monoclonal antibody and a polyclonal antibody each covalently bound to polystyrenesupercarboxylated latex particles. When serum or plasma and assay buffer are combined with the latex particles, myoglobin in the specimen crosslinks adjacent latex beads and produces an increase in the turbidity of the solution. The turbidity, measured at 600nm, is proportional to the concentration of myoglobin present in the serum or plasma.
Here's an analysis of the acceptance criteria and study detailed in the provided document for the Spectral Diagnostics Multiquant® Quantitative Myoglobin Test:
Acceptance Criteria and Device Performance for Spectral Diagnostics Multiquant® Quantitative Myoglobin Test
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Method Correlation | Correlation coefficient (r) with predicate device | 0.99 |
| Regression Equation (vs. predicate) | Slope and Y-intercept comparable to predicate | Multiquant® = 1.04(Stratus®) + 0.0 |
| Precision (Within Run) | Not explicitly stated as a numerical criterion for acceptance, but demonstrated for specific concentrations. | 3.59% for 32.08 mg/mL myoglobin, 2.03% for 288.72 mg/mL myoglobin |
| Precision (Between Run) | Not explicitly stated as a numerical criterion for acceptance, but demonstrated for specific concentrations. | 6.48% for 32.08 mg/mL myoglobin, 2.74% for 288.72 mg/mL myoglobin |
Rationale for Acceptance Criteria: The primary acceptance criterion for substantial equivalence was method correlation with a legally marketed predicate device (Dade-Behring Stratus® Myoglobin Fluorometric Assay). A correlation coefficient of 0.99, indicating a very strong linear relationship, along with a regression equation close to y=x (or a slope near 1 and y-intercept near 0), demonstrates that the new device performs comparably to the predicate. Precision data supports the reliability and reproducibility of the device.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 172 serum samples (N = 172).
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for an in vitro diagnostic product, it is most likely that the samples were collected in a clinical setting (e.g., hospital laboratory) and were retrospective (pre-existing samples) or collected via a prospective study for the purpose of this validation. No specific country of origin is mentioned, but the manufacturer is Canadian (Spectral Diagnostics Inc. 135-2 The West Mall Toronto, Ontario Canada M9C 1C2) and the regulatory body is the US FDA, so the study could have been conducted in either country or internationally.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not applicable to this type of device and study. For in vitro diagnostic assays like the Multiquant® Quantitative Myoglobin Test, the "ground truth" for the test set is established by testing the samples with a predicate device (the Dade-Behring Stratus® Myoglobin Fluorometric Assay). The performance of the new device is then compared against the results generated by this established predicate method. No human experts are used to interpret the results and establish a "ground truth" in the way they would for image-based diagnostic aids.
4. Adjudication Method for the Test Set:
- Not applicable. As described above, the ground truth is established by the predicate device's measurement. There is no subjective human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study is not applicable to this type of in vitro diagnostic device. MRMC studies are typically used to assess human reader performance, often in the context of imaging diagnostics where radiologists interpret images. This device measures a biomarker concentration, which is an objective numerical result, not subject to human interpretation in the same way. Therefore, there is no "human reader" component to improve.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes. The study described (method correlation and precision) represents the standalone performance of the Spectral Diagnostics Multiquant® Quantitative Myoglobin Test. It evaluates the device's ability to accurately and precisely measure myoglobin concentrations in serum/plasma samples, independently of human interpretation. The output is a quantitative value, not a diagnosis requiring human augmentation.
7. Type of Ground Truth Used:
- Predicate Device Results (Comparative Ground Truth): The "ground truth" for the performance evaluation of the Multiquant® test was the results obtained from the Dade-Behring Stratus® Myoglobin Fluorometric Assay. The study aimed to demonstrate substantial equivalence by showing that the new device's measurements correlated highly with those of an already legally marketed and accepted device.
8. Sample Size for the Training Set:
- Not explicitly stated/Likely not applicable in the classical sense. For an immunoassay like this, there isn't a "training set" in the machine learning sense that would be used to develop an algorithm. The "training" of such a device primarily involves optimizing the chemical reagents, reaction conditions, and calibration curve during the product development phase. This optimization process would typically involve numerous experiments and testing of different concentrations of myoglobin, but not a distinct "training set" of patient samples in the way that an AI algorithm has a training dataset. The 172 validation samples would be its primary performance assessment.
9. How the Ground Truth for the Training Set Was Established:
- Not explicitly stated/Likely not applicable as described above. Since there isn't a classical training set for a machine learning algorithm, the concept of establishing "ground truth" for it is not directly applicable. The "ground truth" for calibration and optimization during development would originate from known concentrations of myoglobin standards.
§ 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).