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510(k) Data Aggregation
(263 days)
Dimension Vista® MMB Assay:
The MMB method is an in vitro diagnostic test for the quantitative measurement of mass creatine kinase MB isoenzyme in human serum and plasma on the Dimension Vista® System for confirmation of acute myocardial infarction.
Dimension Vista® 1500 System:
The Siemens Healthcare Diagnostics Dimension Vista® 1500 System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista® chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use.
Dimension Vista® MMB Assay:
The MMB method is a homogeneous sandwich chemiluminescent immunoassay based on LOCI® technology. LOC10 reagents include two synthetic bead reagents and a biotinylated antimass creatine kinase MB isoenzvme monoclonal antibody fragment. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitive dye. The second bead reagent (Chemibeads) is coated with a second anti-mass creatine kinase MB isoenzyme monoclonal antibody and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibody to form a beadmass creatine kinase MB isoenzyme-biotinylated antibody sandwich. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex by light at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of the mass creatine kinase MB isoenzyme concentration in the sample.
The Dimension Vista® 1500 System:
The Dimension Vista® 1500 System is a floor model, fully automated, microprocessor-controlled, integrated instrument system that uses prepackaged Flex reagent test cartridges to measure a variety of analytes in human body fluids. The system is a multi-functional analytical tool that processes chemical and immunochemical methodologies, utilizing photometric, turbidimetric, chemiluminescence, nephelometric, and integrated ion selective multisensor detection technologies for clinical use. The Dimension Vista® 1500 System can analyze up to 1500 tests/hour (typical, depending on the method mix) using a variety of analytical detection capabilities. Dimension Vista® 1500 System detection technologies are: Photometric, Turbidimetric, Chemiluminescent, Nephelometric, Multisensor, ion selective technology
The Siemens Healthcare Diagnostics Dimension Vista® MMB Assay is an in vitro diagnostic test for the quantitative measurement of mass creatine kinase MB isoenzyme in human serum and plasma for confirmation of acute myocardial infarction. The K143720 submission describes the modification of the Dimension Vista® 1500 System with a new photomultiplier tube (PMT) and its impact on the MMB assay.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a separate section with pass/fail thresholds. Instead, it presents performance characteristics (method comparison, precision, linearity, LoB, LoD, LoQ) for the modified system and implicitly assumes that these demonstrate substantial equivalence to the predicate device. For this response, I will interpret the performance data provided as the "reported device performance" and infer the implied "acceptance criteria" based on the comparison to the existing predicate and typical performance expectations for such devices.
| Performance Characteristic | Implicit Acceptance Criteria (Inferred) | Reported Device Performance (Modified System) |
|---|---|---|
| Method Comparison | Close agreement with predicate device (slope near 1, intercept near 0, high correlation). | Passing-Bablok Regression: Slope = 0.99 (95% CI: 0.98 - 0.99), Intercept = -0.16 ng/dL (95% CI: -0.20 - -0.10). Linear Regression: Slope = 0.97, Intercept = 0.64, Correlation Coefficient = 0.999. (Range: 1.0 - 274.0 ng/mL) |
| Precision (Repeatability) | Low coefficient of variation (CV) at various concentration levels. | QC1 (8.66 ng/mL): SD = 0.15, %CV = 1.72. QC2 (24.13 ng/mL): SD = 0.36, %CV = 1.50. QC3 (70.73 ng/mL): SD = 0.91, %CV = 1.28. Plasma Pool 1 (3.26 ng/mL): SD = 0.15, %CV = 4.71. Plasma Pool 2 (6.15 ng/mL): SD = 0.15, %CV = 2.45. |
| Precision (Within-Lab) | Low coefficient of variation (CV) at various concentration levels. | QC1 (8.66 ng/mL): SD = 0.22, %CV = 2.59. QC2 (24.13 ng/mL): SD = 0.56, %CV = 2.30. QC3 (70.73 ng/mL): SD = 1.27, %CV = 1.80. Plasma Pool 1 (3.26 ng/mL): SD = 0.19, %CV = 5.99. Plasma Pool 2 (6.15 ng/mL): SD = 0.21, %CV = 3.40. |
| Linearity | Demonstrated linearity across the assay range (slope near 1, intercept near 0, high correlation). | Range: 0 – 313.5 ng/mL. Slope = 1.004, Intercept = 0.170, Correlation Coefficient = 0.999. |
| Limit of Blank (LoB) | Acceptably low. | 0.4 ng/mL. |
| Limit of Detection (LoD) | Acceptably low (proportion of false positives/negatives < 5%). | 0.8 ng/mL (α < 5%, β < 5%, based on 260 determinations). |
| Limit of Quantitation (LoQ) | CV ≤ 20% at a low concentration. | CV ≤ 20% at a mass creatine kinase MB isoenzyme concentration ≤ 1.0 ng/mL. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 111 native de-identified human serum and plasma samples were used for the method comparison study.
- Data Provenance: The samples were described as "native de-identified human serum and plasma samples," implying they were clinical samples. The country of origin is not explicitly stated, but given the manufacturer (Siemens Healthcare Diagnostics Inc. Newark, DE) and the submission to the FDA, it is likely the studies were conducted in the US or using samples relevant to the US market. The study is prospective in the sense that the samples were analyzed on both the predicate and modified devices specifically for this comparison study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A - This device is an in vitro diagnostic assay that provides a quantitative measurement of an analyte (CK-MB). The "ground truth" for method comparison and performance evaluation is typically established by comparing the device's results to a legally marketed predicate device, a reference method, or by analyzing samples with known concentrations (e.g., in linearity or precision studies using controls or spiked samples). There are no human "experts" establishing a "ground truth" diagnosis for the purpose of validating the assay's analytical performance; rather, the predicate device serves as the comparator.
4. Adjudication Method for the Test Set
N/A - No human adjudication was performed or is relevant for this type of analytical performance study. The comparison is objective, based on quantitative measurements against a predicate device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for devices where human interpretation of images or other qualitative data is involved, and the AI's role is to assist human readers. The Dimension Vista® MMB Assay is an IVD device that provides quantitative measurements, not requiring interpretation by multiple readers in an MRMC setting for its analytical validation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Yes, the studies presented are effectively "standalone" performance evaluations of the Dimension Vista® MMB Assay on the modified Dimension Vista® 1500 System. The device's performance (accuracy, precision, linearity, limits) is assessed purely analytically, without human intervention in the measurement process itself, beyond sample loading and general system operation. The comparison is between two automated systems (predicate vs. modified).
7. The Type of Ground Truth Used
The "ground truth" for the test set (111 samples) in the method comparison study was the measurements obtained from the predicate device (Dimension Vista® MMB assay on the Dimension Vista® 1500 Integrated System K051087). For precision, linearity, LoB, LoD, and LoQ studies, the ground truth was established by using characterized control materials, pooled plasma samples, or serially diluted samples with known theoretical concentrations.
8. The Sample Size for the Training Set
N/A - This device is not an AI/ML-driven algorithm that requires a "training set" in the conventional sense of machine learning. The system is based on chemiluminescent immunoassay technology and instrumental measurements, not a learned algorithm that processes data like images. Therefore, the concept of a "training set" for an algorithm is not applicable here.
9. How the Ground Truth for the Training Set Was Established
N/A - As explained above, there is no "training set" for this type of IVD device.
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