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510(k) Data Aggregation
(45 days)
In vitro diagnostic reagent system intended for use on COBAS INTEGRA system for the quantitative immunological determination of human apolipoprotein A-1 in serum and plasma.
For the quantitative determination of apolipoprotein A-1 in serum and plasma. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis.
Human apolipoprotein A-1 forms a precipitate with a specific antiserum which is determined turbidimetrically at 340 nm.
The provided text describes the regulatory submission for the Tina-quant Apolipoprotein A-1 ver.2 Assay, claiming substantial equivalence to a previously marketed device (COBAS Integra Tina-quant Apolipoprotein A-1, K990594). While it details performance characteristics of the new device and compares them to the predicate, it does not explicitly state "acceptance criteria" as a set of predefined thresholds. Instead, the submission demonstrates that the new device's performance is comparable to or better than the predicate device across various metrics, thus implicitly meeting an "acceptance criteria" of being substantially equivalent.
Here's an attempt to extract and interpret the information based on the typical structure of such submissions, acknowledging that explicit "acceptance criteria" might not be numerically stated but rather inferred through comparison to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit "acceptance criteria" are not listed, the table below will present the performance characteristics of the new device (Tina-quant Apolipoprotein A-1 ver.2) and the predicate device as a basis for comparison, implying that the Tina-quant Apolipoprotein A-1 ver.2's performance is considered "acceptable" because it is comparable to or improved over the legally marketed predicate.
| Feature | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (Tina-quant Apolipoprotein A-1 ver.2) |
|---|---|---|
| Precision | ||
| Within run CV | ≤1.5% @ 0.68 g/L; ≤1.0% @ 2.7 g/L | 1.0% @ 0.88 g/L; 0.8% @ 1.64 g/L (Improved) |
| Between Day CV | ≤1.2% @ 0.68g/L; ≤0.78% @ 2.7 g/L | 2.4% @ 0.88 g/L; 1.7% @ 1.64 g/L (Higher for low values, higher for high values) |
| Method Comparison | Correlation coefficient (r) indicative of strong agreement (Predicate: r = 0.993) | y = 0.87x + 0.25 g/L; r = 0.940 (Good, but slightly lower correlation than predicate) |
| Prozone Effect | >5.8 g/L | >6 g/L (Improved) |
| Analytical Sensitivity (LDL) | 0.37 g/L (37mg/dL) | 0.058 g/L (5.8 mg/dL) (Significantly improved/lower detection limit) |
| Limitations (Interference) | No significant interference from Icterus, Hemolysis, Lipemia, Rheumatoid factors | No significant interference from Icterus, Hemolysis, Lipemia (up to 1000 mg/dL Intralipid), Rheumatoid factors (Comparable) |
| Reagent Stability (On-board) | 12 weeks | 4 weeks (Lower than predicate) |
| Measuring Range (with rerun) | 0.12 - 5.6 g/L | 0.10 - 4.0 g/L (Lower upper limit, comparable lower limit) |
Summary of Acceptance: The device is accepted on the basis of "substantial equivalence" to the predicate. The performance data for the Tina-quant Apolipoprotein A-1 ver.2 shows areas of improvement (e.g., precision within run, prozone effect, analytical sensitivity) and areas of minor differences (e.g., between-day CV, reagent stability, measuring range, method correlation) that are deemed acceptable for the intended use.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). Studies for precision typically use multiple replicates over several days with control materials, while method comparison studies involve a number of patient samples. The values provided for "Method Comparison" (y = 0.87x + 0.25 g/L, r = 0.940) suggest a linear regression analysis, which would require a set of patient samples, but the number is not disclosed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number and qualifications of experts) is typically relevant for diagnostic imaging or subjective interpretation devices. For an in vitro diagnostic (IVD) reagent system like the Tina-quant Apolipoprotein A-1 ver.2, the "ground truth" for the test set values would be established through laboratory reference methods or certified reference materials, rather than expert interpretation. Therefore, this question is not directly applicable in the context of this device.
4. Adjudication Method for the Test Set
As the "ground truth" for this IVD device is based on quantitative measurements and reference methods, not subjective interpretation, no adjudication method (like 2+1 or 3+1 by experts) would be applicable or required.
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
A Multi-Reader Multi-Case (MRMC) study is typically performed for devices that involve human interpretation of images alongside an AI algorithm. The Tina-quant Apolipoprotein A-1 ver.2 is an in vitro diagnostic (IVD) reagent system that automates the quantitative immunological determination of apolipoprotein A-1 in serum and plasma, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study was not performed, and thus, there is no effect size related to human readers improving with AI assistance. This question is not applicable to the described device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance characteristics provided (Precision, Method Comparison, Prozone Effect, Analytical Sensitivity, Limitations) are all reflective of the standalone performance of the Tina-quant Apolipoprotein A-1 ver.2 reagent system operating on the COBAS Integra Clinical Chemistry Analyzers. There is no human interpretation or intervention in the measurement process beyond standard laboratory operating procedures and maintenance.
7. The Type of Ground Truth Used
The ground truth used for evaluating the performance characteristics would be:
- Certified Reference Materials/Control Materials: For precision and analytical sensitivity, the device's measurements are compared against known concentrations in control materials.
- Validated Reference Methods: For method comparison, the device's results are compared against results obtained from a predicate device or a well-established, commercially available system, which would themselves be validated against reference methods. While "pathology" or "outcomes data" are not directly used as ground truth for this device's performance, the clinical utility of Apolipoprotein A-1 measurements is linked to "diagnosis and treatment of lipid disorders and atherosclerosis," implying that the measurements are expected to correlate with relevant clinical states.
8. The Sample Size for the Training Set
The document describes a reagent system and its performance characteristics rather than a machine learning model that requires a "training set." Therefore, the concept of a "training set" in the context of AI/ML is not applicable here. The development of such a system involves empirical testing and optimization but not in the same way as training a neural network.
9. How the Ground Truth for the Training Set was Established
As explained above, the concept of a "training set" in the AI/ML sense is not relevant for this device. The development of such an IVD system involves extensive analytical method development, optimization, and validation using various samples (e.g., patient samples, spiked samples, control materials) to ensure accuracy, precision, and robustness. The "ground truth" during this development would be established through highly accurate reference methods or known concentrations in prepared samples.
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