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510(k) Data Aggregation
(122 days)
SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
The Bayer ADVIA IMS Salicylate method is an in vitro diagnostic device intended to measure salicylate levels in human serum or plasma (Lithium heparin). Such measurements are used in the diagnosis of salicylate toxicity and overdose.
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Here's a breakdown of the acceptance criteria and study details for the Salicylate method for ADVIA® IMS™, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly tied to demonstrating "equivalence" to the predicate device, the Abbott/TDx Salicylate assay. The reported device performance is compared against the predicate in terms of correlation and imprecision.
| Acceptance Criteria (Implicit) | Reported Device Performance (ADVIA IMS Salicylate) |
|---|---|
| Imprecision (Total CV%) | |
| Comparable to predicate device across various salicylate levels. | Level 4.8 mg/dL: 9.6% |
| Level 32.1 mg/dL: 2.7% | |
| Level 64.6 mg/dL: 2.5% | |
| (Predicate for reference: 7.5 mg/dL: 4.48%; 30 mg/dL: 2.95%; 60 mg/dL: 2.98%) | |
| Correlation to Predicate Device | |
| Regression equation close to Y=X (slope ~1, intercept ~0) and high correlation coefficient (R value close to 1). | Serum vs. Abbott/TDx: Y=0.997X - 1.39, R = 0.996 |
| Low Syx (standard error of the estimate). | Serum vs. Abbott/TDx: Syx = 2.88 mg/dL |
| Plasma vs. Serum Correlation | |
| Regression equation close to Y=X and high correlation coefficient (R value close to 1). | Plasma(y) vs. Serum(x): Y=0.985X + 0.00, R = 0.988 |
| Low Syx. | Plasma(y) vs. Serum(x): Syx = 2.73 mg/dL |
| Interfering Substances | |
| Minimal effect (% change) from common interfering substances. | Bilirubin (unconjugated 25 mg/dL): 0.0% change |
| Bilirubin (conjugated 25 mg/dL): 0.0% change | |
| Hemoglobin (1000 mg/dL): +6.0% change | |
| Lipids (Triglycerides 500 mg/dL): +7.0% change | |
| Analytical Range | |
| Defined and consistent with intended use. | 0 to 120 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Sizes:
- Correlation (Serum vs. Abbott/TDx): N = 47
- Correlation (Plasma vs. Serum): N = 49
- Imprecision and Interfering Substances: Specific sample size for these tests is not explicitly stated as 'N' values for individual runs but implies multiple measurements for statistical evaluation.
- Data Provenance: Not explicitly stated. It is common for these types of studies to be conducted internally by the manufacturer or a contract research organization. Given it's a diagnostic assay, the samples would likely be human serum and plasma. The country of origin and whether it's retrospective or prospective are not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of diagnostic assay, measuring specific analyte concentrations, does not typically involve human experts for establishing ground truth in the same way an image analysis algorithm would. The "ground truth" for the test set is established by:
- Reference Method Measurement: The Abbott/TDx Salicylate assay serves as the comparator (predicate device), and its measurements are used as the reference for correlation.
- Known Concentrations: For imprecision and interfering substances, samples are likely spiked with known concentrations of salicylate and/or interfering substances.
Therefore, the concept of "experts" and their qualifications as described for image analysis is not fully applicable here.
4. Adjudication Method for the Test Set
Not applicable. As explained above, the ground truth is based on quantitative measurements from a reference method or known concentrations, not subjective expert judgment requiring adjudication.
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 a standalone in-vitro diagnostic method for measuring a chemical analyte, not an AI-assisted diagnostic tool that aids human readers in interpreting complex data (like medical images).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, this study represents a standalone performance evaluation. The ADVIA IMS Salicylate method is an automated assay that provides a quantitative measurement of salicylate levels. Its performance is assessed independently against a predicate device and established analytical criteria, without a human "reading" the final output beyond interpreting the numerical result.
7. The Type of Ground Truth Used
The ground truth used is primarily:
- Reference Method Comparability: Measurements from the legally marketed predicate device (Abbott/TDx Salicylate) serve as the comparative ground truth for evaluating correlation.
- Known Concentrations: For imprecision and interference studies, samples are likely prepared with precisely known concentrations of salicylate and interfering substances.
8. The Sample Size for the Training Set
Not applicable. This is a chemical assay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The method relies on established chemical reaction principles and calibration curves rather than learning from a large dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The assay's analytical performance (linearity, sensitivity, specificity) is based on its chemical design and optimization, which would involve internal development and validation using various control materials and known concentrations to establish calibration and performance characteristics.
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