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510(k) Data Aggregation
(58 days)
This in vitro diagnostic procedure is a solid phase immunoassay intended for the quantitative determination of Myoglobin in human serum or heparin plasma on the Technicon Immuno 1 system. When used in combination with other clinical data such as presenting symptoms and EKG values, measurement of Myoglobin aides in the early phase diagnosis of Myocardial Infarctions.
The method described is an enzyme label sandwich assay using a monoclonal (mouse) capture and a polyclonal (goat) detector antibody. The monoclonal antibody is labelled with fluorescein and the polyclonal antibody labelled with alkaline phosphatase (ALP). The two reagents are the active compounds of the R1 and the R2 reagent, respectively. The solid phase consists of a suspension of magnetizable particles coated with antibody to fluorescein (mIMP reagent). Sample or calibrator, R1and R2 reagent and mIMP reagent are mixed simultaneously and incubated at 37 °C. In the presence of Myoglobin fluorescein-conjugate= Myoglobin=ALPa conjugate complex is formed and captured by the antiFluorescein antibodies on the magnetic particles. The particles are precipitated by an external magnetic field, washed and para-Nitrophenylphosphate is added as the enzyme substrate. The increase in absorbance due to the formation of p-Nitrophenolate is monitored spectrophotometrically at 405 and 450 nm. The concentration of Myoglobin in a sample. A Cubic Fit Through Zero is used to calculate the dose response curve. The assay is depicted schematically in fig. 1.
This document describes the performance characteristics of the MYOGLOBIN METHOD FOR THE IMMUNO 1 SYSTEM.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the provided text. Instead, the document presents performance data to demonstrate the device's characteristics. The reported performance metrics are summarized below:
| Performance Characteristic | Reported Device Performance |
|---|---|
| Imprecision (Total CV) | |
| Sample 1 (14.8 ng/mL) | 5.5 % |
| Sample 2 (52.6 ng/mL) | 3.6 % |
| Sample 3 (75.6 ng/mL) | 3.9 % |
| Sample 4 (131.3 ng/mL) | 3.6 % |
| Sample 5 (247 ng/mL) | 4.4 % |
| Sample 6 (278.1 ng/mL) | 3.0 % |
| Sample 7 (639.7 ng/mL) | 3.6 % |
| Sample 8 (1557.6 ng/mL) | 3.6 % |
| Sample 9 (2718.9 ng/mL) | 3.4 % |
| Correlation with Behring Nephelometer A | |
| Correlation Equation (y = Immuno 1, x = BNA) | y = 1.02 × x + 1.05 |
| Slope (b) | 1.02 (Limits: 0.98 - 1.06) |
| Intercept (a) | 1.05 (Limits: -3.2 - 4.5) |
| Confidence of Correlation | 0.99314 |
| Interference (measured concentration as % of -2 pool) | |
| Bilirubin (25 mg/dL) | 100.3% - 101% |
| Albumin (6.5 g/dL) | 100.9% - 101.5% |
| Hemoglobin (1 g/dL) | 100.1% - 102% |
| Gamma Globulins (5.3 g/dL) | 78.6% - 103.5% (The result for 1+ (95) and 2+ (103.5) are presented in a confusing manner, but the measured concentrations are within a reasonable range of the -2 pool) |
| Triglycerides (supertrate) | 93.8% - 104.5% |
| Heparin (65 IU/mL) | 99.9% - 101.5% |
| Citrate (50 mg/mL) | 96% - 99% |
| Urea and Creatine (200 mg/dL Urea, 2.5 mg/dL Creatine) | 99.8% - 101.2% |
| Rheumatoid Factor (567 IU/mL) | 100.2% - 103.9% |
| Linearity (deviation from calculated) | |
| Range | -21% to 1.6% |
| Sample Dilution (Recovery) | |
| Serum samples dilated with Immuno 1 Sample Diluent B | 93.9% - 108% |
| Serum samples dilated with Immuno 1 Calibrator Level 1 | 93.2% - 107.2% |
| Plasma samples dilated with Immuno 1 Sample Diluent B | 99.9% - 105.4% |
| Plasma samples diluted with Immuno 1 Calibrator Level 1 | 88.9% - 111.8% |
| Hook Effect | No erroneous results within the calibration range for Myoglobin content < 150,000 ng/mL. |
| Recovery of spiked samples | |
| Serum samples | 96.5% - 105.2% |
| Plasma samples | 97.7% - 103% |
| Expected Values (Normal Distribution) | 98% of values were 88 ng/mL or less for non-AMI individuals (n=77). |
| Minimum Detectable Concentration | 1.8 ng/mL |
| Assay Range | 0 to 3000 ng/mL |
| Sensitivity | 1.8 ng/mL |
2. Sample sizes used for the test set and the data provenance
- Imprecision:
- Sample Size: 160 replicates for each of the 9 samples/levels tested (total of 1440 measurements across two instruments, 20 days, 4 replicates/day/system).
- Data Provenance: Not explicitly stated, but the "human serum controls" suggest a clinical laboratory setting. It is not specified if these were retrospective or prospective.
- Correlation with Behring Nephelometer A:
- Sample Size: 100 serum and plasma samples.
- Data Provenance: Not explicitly stated, but the use of "serum and plasma samples" implies clinical samples. It is not specified if these were retrospective or prospective.
- Interference:
- Sample Size: For each interferent, multiple "pools" (-2, -1, 0, +1, +2) were prepared and measured. The exact number of replicates for each pool is not specified, but the setup implies multiple measurements for each.
- Data Provenance: "Myoglobin in serum" and "Myoglobin-stripped serum" with added interfering substances indicates a laboratory-controlled study.
- Linearity:
- Sample Size: Not explicitly stated, but the creation of five equally spaced controls (-2, -1, 0, +1, +2) for three different series (A, B, C) suggests multiple measurements. For data analysis, linear regression was calculated from the -2, -1 and 0 Pools of each series.
- Data Provenance: "Serum sample with a high Myoglobin level (+2 Pool) and a low sample (-2 Pool)" indicates laboratory-controlled experiments.
- Sample Dilution:
- Sample Size: Multiple dilution series were performed for both serum (5 samples tested with 2 diluent types) and plasma (5 samples tested with 2 diluent types). Each series involved 6 different dilution points (100%, 75%, 50%, 25%, 10%, 0%). This is a total of 10 samples for serum and 10 samples for plasma being tested across different dilutions with two different diluents, meaning 20 samples in total tested across 6 dilution points.
- Data Provenance: "Clinical serum and plasma samples" were used, suggesting human origin. It's not specified if these were retrospective or prospective.
- Hook Effect:
- Sample Size: Not explicitly stated, but "Samples with Myoglobin concentrations up to 1 Million ng/mL were assayed." The figure shows data points from 500 ng/mL to 1 Million ng/mL.
- Data Provenance: Laboratory-controlled samples.
- Recovery:
- Sample Size: Four clinical samples (two serum, two plasma). Each sample was spiked at multiple levels (6 different concentrations, including the unspiked sample).
- Data Provenance: "Clinical samples" suggest human origin. Not specified if retrospective or prospective.
- Expected Values:
- Sample Size: 77 non-AMI individuals.
- Data Provenance: "Samples from 77 non AMI individuals." This indicates human clinical samples. It's not specified if these were retrospective or prospective, or their country of origin.
- Minimum Detectable Concentration:
- Sample Size: The L1 calibrator (0 Myoglobin) was measured 576 times.
- Data Provenance: Laboratory-controlled measurements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes an in vitro diagnostic assay. For such devices, "ground truth" typically refers to established analytical methods or reference values for the analytes being measured, or clinical diagnoses for determining clinical performance (e.g., AMI status).
- For analytical performance (Imprecision, Correlation, Interference, Linearity, Sample Dilution, Hook Effect, Recovery, Minimum Detectable Concentration): The ground truth is intrinsically defined by the analytical methods used (e.g., mass spectrometry, existing validated assays like the Behring Nephelometer A), and the precise concentrations of prepared standards or spiked samples. No human experts are described as establishing this analytical ground truth in the document.
- For clinical performance (Expected Values): The "non AMI individuals" represent the "ground truth" for a normal population. The method for determining "non AMI" status is not detailed, but it would typically be established by physicians using clinical criteria (symptoms, EKG, other biomarkers). No specific number or qualification of experts is mentioned for this.
4. Adjudication method for the test set
Not applicable. This is an in vitro diagnostic device for quantitative determination of Myoglobin. The "test set" in this context refers to samples used to validate the device's analytical performance against known concentrations or a comparator device, not typically requiring human adjudication in the way an imaging AI algorithm might.
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 device, not an AI algorithm assisting human readers (e.g., radiologists) in interpreting medical images or clinical data. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the study describes the standalone performance of the Immuno 1 Myoglobin method, which is an automated in vitro diagnostic assay. Its performance characteristics (imprecision, linearity, sensitivity, correlation with a comparator) are measured directly from the device's output. The "human-in-the-loop" equivalent would be the laboratory technician running the assay, but the output itself is quantitative and objective, not subject to human interpretation like imaging.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Analytical Ground Truth:
- Known concentrations: For imprecision, interference, linearity, sample dilution, hook effect, recovery, and minimum detectable concentration, the ground truth was established by preparing samples with known, controlled concentrations of Myoglobin and/or interfering substances.
- Comparator Device: For correlation, the "ground truth" was derived from measurements obtained by a cleared predicate device, the Behring Nephelometer A.
- Clinical Ground Truth:
- Clinical Status: For "Expected Values," the ground truth was the clinical status of "non AMI individuals," presumably diagnosed by standard clinical criteria, although details of this diagnosis are not provided.
8. The sample size for the training set
This document describes the performance of an in vitro diagnostic assay. Assays like the Immuno 1 Myoglobin method use calibrators to establish a dose-response curve, but this curve fitting is not analogous to "training" an AI algorithm with a large dataset. The six calibrators with specified Myoglobin concentrations (0, 60, 180, 600, 1500, and 3000 ng/mL) are used to generate the dose response curve. These calibrators are essentially the "training data" for the internal calculation process of the Immuno 1 system. The document does not specify a separate, distinct "training set" in the context of machine learning.
9. How the ground truth for the training set was established
As noted above, for this type of IVD, the "training set" refers to the calibrators. The ground truth for these calibrators (i.e., their Myoglobin concentrations) would be established through a rigorous manufacturing process, typically by gravimetric or volumetric methods, and validated against reference materials or established analytical techniques. The document provides the specific Myoglobin concentrations for each of the six calibrators, indicating these are known and controlled values.
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