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510(k) Data Aggregation
(14 days)
ELECSYS MYOGLOBIN STAT ASSAY
For the in vitro quantitative determination of myoglobin in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim immunoassay analyzers.
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 and renal disease.
The Elecsys ® Myoglobin test principle is based on the sandwich principal. Total duration of assay: 9 minutes, 37 ℃.
·1st incubation (4.5 minutes): By incubating the sample (15 uL) with a biotinylated monoclonal myoglobin-specific antibody (75 ul) and a monoclonal myoglobin -specific antibody labeled with a ruthenium-complex** (75 uL), a sandwich immunocomplex is formed, the amount of which is dependent upon the analyte concentration in the sample.
·2nd incubation (4.5 minutes): After addition of streptavidin-coated microparticles (35 uL) the complex becomes bound to the solid phase via interaction of biotin and streptavidin.
· The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame).
·Results are determined via a calibration curve that is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.
**Tris(2,2'-bipyridyl)ruthenium(II) complex (Ru(bpy)2+22)
The device, Elecsys® Myoglobin STAT Assay, is an electrochemiluminescence immunoassay (ECLIA) intended for the in vitro quantitative determination of myoglobin in human serum and plasma, for use on Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state "acceptance criteria" for the Elecsys® Myoglobin STAT Assay. Instead, it presents performance characteristics in comparison to a predicate device, the Tina-quant® Myoglobin Assay. The implicit acceptance criteria would be that the Elecsys® Myoglobin STAT Assay performs comparably or better than the predicate device, especially in aspects like precision, linearity, and method comparison.
Here's a table summarizing the reported device performance (Elecsys® Myoglobin STAT Assay) and the predicate device's performance:
| Feature | Elecsys® Myoglobin STAT (Reported Performance) | Tina-quant® Myoglobin (Predicate Device Performance) |
|---|---|---|
| Precision | ||
| Level HS1 (43.0 ng/mL) | Intra-assay: SD 0.89, %CV 2.1 | Intra-assay: SD 0.9, %CV 1.2 |
| Total: SD 1.11, %CV 2.6 | Total: SD 1.6, %CV 2.3 | |
| Level HS4 (1147 ng/mL) | Intra-assay: SD 39.5, %CV 3.4 | Not directly comparable (HS2 536.7 ng/mL) |
| Total: SD 46.3, %CV 4.0 | Not directly comparable (HS2 528.2 ng/mL) | |
| Level HS5 (3056 ng/mL) | Intra-assay: SD 161, %CV 5.3 | Not directly comparable (Control 53.1 ng/mL) |
| Total: SD 204, %CV 6.7 | Not directly comparable (Control 51.8 ng/mL) | |
| Level PCC1 (82.5 ng/mL) | Intra-assay: SD 1.03, %CV 1.3 | Not reported |
| Total: SD 1.31, %CV 1.6 | Not reported | |
| Level PCC2 (672 ng/mL) | Intra-assay: SD 12.5, %CV 1.9 | Not reported |
| Total: SD 15.6, %CV 2.3 | Not reported | |
| Lower Detection Limit | 15 ng/mL | 3.0 ng/mL |
| Linearity | 15 - 3,000 ng/mL | 3.0 - 560 ng/mL |
| Method Comparison | Vs Tina-quant Myoglobin | N/A (this is the predicate for comparison) |
| Passing/Bablok | y = 1.01x - 0.13, r = 1.0, SEE = 4.54, N = 398 | |
| Least Squares | y = 1.0x + 1.28, r = 1.0, SEE = 7.58, N = 398 | |
| Interfering Substances | No interference at: | No interference at: |
| Bilirubin 65 mg/dL | Bilirubin 60 mg/dL | |
| Hemoglobin 1.4 g/dL | Hemoglobin 0.5 g/dL | |
| Lipemia 2200 mg/dL | Lipemia 1500 mg/dL | |
| Biotin 50 ng/mL | Not reported |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- Precision: For each precision level (HS1, HS4, HS5 for Elecsys; HS1, HS2, Control for Tina-quant; PCC1, PCC2 for Elecsys), the sample size was N = 60 for the Elecsys device and N = 21 for the Tina-quant device. The details of the "Modified NCCLS" method likely specify the number of replicates and runs that sum up to this 'N' value.
- Method Comparison: N = 398 samples were used for the method comparison study between the Elecsys Myoglobin STAT Assay and the Tina-quant Myoglobin Assay.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the context of a 510(k) summary for a US FDA submission, it is typically expected that studies are conducted in a manner consistent with US regulatory standards, but this is not explicitly stated.
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 product is an in vitro diagnostic (IVD) assay for quantitative measurement of a biomarker (myoglobin). The "ground truth" for such assays is typically established by reference methods, independent laboratory testing, or the established values of commercially available controls and calibrators, rather than by human expert review in the sense of image interpretation. The document does not mention the use of human experts to establish ground truth. Instead, the ground truth for method comparison is the measurement obtained from the predicate device (Tina-quant Myoglobin Assay) which is itself an IVD.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As described above, the ground truth for this type of IVD is based on quantitative measurements and comparison to a predicate device, not on interpretive human expert review that would require an adjudication method.
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 device is a fully automated in vitro diagnostic assay, not an AI-assisted diagnostic tool that involves human readers or interpretation of medical images. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance data presented (precision, linearity, lower detection limit, interfering substances, and method comparison) represents the standalone performance of the Elecsys® Myoglobin STAT Assay algorithm (the entire assay system including reagents and analyzer). The device is fully automated, and the results are quantitatively generated without human interpretation or intervention in the measurement process itself.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the method comparison study was the measurements obtained from the predicate device, the Tina-quant® Myoglobin Assay. For other performance characteristics like precision, linearity, and detection limit, the ground truth is based on the inherent analytical capabilities of the system when processing known control materials or serially diluted samples.
8. The sample size for the training set
The document does not specify a separate "training set" or its sample size. For IVD devices like this, the development process typically involves internal studies to optimize assay parameters and establish analytical performance. This often uses various samples (e.g., patient samples, spiked samples, control materials) during the development phase. However, the provided 510(k) summary focuses on the validation studies, which are akin to the "test set" in AI/ML terminology.
9. How the ground truth for the training set was established
Since a "training set" is not explicitly mentioned or quantified in the document in the context of AI/ML, the method for establishing its ground truth is not described. For traditional IVD development, the "ground truth" during development (analogous to training) would generally involve reference methods, highly characterized samples, and internal laboratory standards to ensure the assay's accuracy and reliability.
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