(22 days)
For the in vitro quantitative measurement of myoglobin concentration in human serum or plasma (EDTA or heparin) to aid in the diagnosis of myocardial infarction.
For in vitro use in the calibration of the Vitros Immunodiagnostic System for the quantitative measurement of Myoglobin in human serum and plasma (EDTA or heparin).
Assayed for use in verifying the calibration range of the Vitros Immunodiagnostic System when used for the measurement of Myoglobin. For in vitro use.
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:
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- The Vitros Immunodiagnostic Products range of immunoassay products: Vitros Immunodiagnostic Products Myoglobin Reagent Pack, the Vitros Immunodiagnostic Products Myoglobin Calibrators and the Vitros Immunodiagnostic Products Myoglobin Range Verifiers, (which are combined by the Vitros Immunodiagnostic System to perform the Vitros Myoglobin assay), and Vitros Immunodiagnostic Products High Sample Diluent B.
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- The Vitros Immunodiagnostic System -- instrumentation, which provides automated use of the immunoassay kits.
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- 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 the 510(k) summary for the Vitros Immunodiagnostic Products Myoglobin Reagent Pack, Calibrators, and Range Verifiers. This is an in vitro diagnostic (IVD) device, and the information typically required for an AI/ML SaMD acceptance criteria study (e.g., sample size for test set, number of experts, adjudication method) does not directly apply in the same way.
However, I can extract information related to the device's performance compared to a predicate device, which serves a similar purpose in demonstrating functional equivalence.
Here's an analysis based on the provided text, adapted for IVD devices:
Acceptance Criteria and Study for Vitros Immunodiagnostic Products Myoglobin Assay
The Vitros Immunodiagnostic Products Myoglobin Reagent Pack, Calibrators, and Range Verifiers were shown to be substantially equivalent to predicate devices through various analytical studies. The primary goal was to demonstrate comparable characteristics and performance to legally marketed devices.
1. Table of Acceptance Criteria and Reported Device Performance
For IVD devices, "acceptance criteria" for demonstrating substantial equivalence often involve comparisons of analytical performance characteristics (e.g., calibration range, precision, correlation) with a predicate device.
| Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (Vitros Myoglobin Assay) |
|---|---|---|
| Reagent Pack & Calibrators: | ||
| Calibration range | 0-1000 ng/mL (DADE Dimension RxL Myoglobin) | 0-2000 ng/mL (Vitros Myoglobin assay) |
| Basic principle | Solid phase immunoassay (DADE Dimension RxL Myoglobin) | Solid phase immunoassay (Vitros Myoglobin assay) |
| Tracer | Enzyme labeled (DADE Dimension RxL Myoglobin) | Enzyme labeled (Vitros Myoglobin assay) |
| Instrumentation | DADE Dimension Immunoassay System | Vitros Immunodiagnostic System |
| Antibody | Mouse monoclonal anti-myoglobin antibodies | Mouse monoclonal anti-myoglobin antibodies |
| Sample type | Serum and plasma (heparin) | Serum and plasma (EDTA or heparin) |
| Sample volume | 20μL | 10μL |
| Incubation time and temperature | 7 minutes at 37°C | 8 minutes at 37°C |
| Correlation to Predicate | Not explicitly stated as a strict acceptance criterion in the summary, but a correlation coefficient close to 1 and a slope close to 1 with minimal bias are generally expected for substantial equivalence. | Vitros Myoglobin = 0.990 x X + 0.81 (ng/mL), with a correlation coefficient of 0.997 (where X is DADE Dimension RxL Myoglobin Method). |
| Other performance characteristics | (Implied to be comparable) | Precision, analytical sensitivity, specificity, and expected values studies were performed (details in package insert). |
| Range Verifiers: | ||
| Intended Use | Verifying calibration range for cardiac Troponin I | Verifying calibration range for Myoglobin |
| Matrix | Freeze-dried human serum spiked with human analyte | Freeze-dried horse serum spiked with human analyte |
| Levels | Low and High | Low and High |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The text states, "This relationship was determined from a panel of patient samples from a variety of clinical categories." A specific number for this panel is not provided within the summary.
- Data Provenance: The origin (e.g., country) of the patient samples or whether they were retrospective or prospective is not specified in the provided summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable to this type of IVD device submission. The "ground truth" for an assay is typically established through a reference method or target values assigned to calibrators, not through expert consensus on medical images or clinical judgment. The DADE Dimension RxL Myoglobin Method acts as the reference for comparison studies.
4. Adjudication Method for the Test Set
This is not applicable as the "test set" here refers to patient samples analyzed by two different diagnostic assays for comparison, not a set of cases requiring adjudication by human readers.
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
This is not applicable. This device is an immunoassay, not an AI/ML-driven diagnostic imaging or clinical decision support tool that involves human readers interpreting AI output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is applicable in the sense that the device's performance as an assay system (analyzer + reagents) was evaluated independently and then compared to the predicate device. The correlation study directly assesses the "standalone" analytical performance of the new Vitros Myoglobin assay compared to the predicate. The reported correlation coefficient of 0.997 and the regression equation demonstrate this standalone analytical performance.
7. The Type of Ground Truth Used
The "ground truth" was established by the results from the predicate device (DADE Dimension RxL Myoglobin Method) when analyzing the same patient samples. This is a common method for demonstrating substantial equivalence for new IVD assays by comparing them to an already cleared and accepted method. Additional studies on precision, analytical sensitivity, specificity, and expected values provide further grounding for the assay's performance characteristics.
8. The Sample Size for the Training Set
This is not applicable. Immunoassays are not "trained" in the same way AI/ML algorithms are. There isn't a defined training set in the context of machine learning. The assay's analytical characteristics are developed and verified through chemical and biological experimentation, calibration, and validation with various samples (including spiked samples, proficiency samples, and patient samples).
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the AI/ML sense for this type of device. The accuracy of the assay is established through its analytical and clinical performance studies, often referencing established methodologies or certified reference materials.
§ 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).