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510(k) Data Aggregation
(57 days)
SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR
Salicylate (SALY) Reagent, when used in conjunction with SYNCHRON® Systems Salicylate Calibrator, is intended for the quantitative determination of salicylate in serum and plasma on Beckman Coulter's SYNCHRON Systems by a colorimetric timed-endpoint method. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.
The SYNCHRON System Salicylate (SALY) Reagent is designed for optimal performance on the SYNCHRON CX and LX Systems. The assay is intended for use in the quantitative determination of salicylate concentration in serum or plasma by a colorimetric timed-endpoint method. The reagent kit contains two 45-test cartridges and is packaged with the single-level calibrator.
The document provided is a 510(k) summary for the SYNCHRON® Systems Salicylate Reagent, an in vitro diagnostic device used for quantitative determination of salicylate concentration in serum or plasma. It is not an AI/ML device, and therefore, many of the requested criteria (like sample size for test/training set, expert ground truth, adjudication methods, MRMC studies, standalone performance for AI, etc.) are not applicable.
However, based on the information available in the document, here's a description related to its performance validation:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes performance in terms of Method Comparison and Imprecision. While explicit acceptance criteria (e.g., "slope must be between X and Y") are not detailed as such, the results presented demonstrate performance compared to a predicate device and show reproducibility.
| Performance Metric | Acceptance Criteria (Implied / Not Explicitly Stated) | Reported Device Performance (SYNCHRON® Salicylate Assay) |
|---|---|---|
| Method Comparison | Close agreement with predicate device (High 'r', slope close to 1, intercept close to 0) | |
| N (Samples) | -- | 75 |
| Slope | -- | 1.096 |
| Intercept | -- | -0.14 |
| Correlation Coefficient (r) | -- | 0.989 |
| Predicate Method | -- | Abbott TDx Salicylate Assay |
| Within-Run Imprecision | (Low %C.V. for reproducibility) | |
| Level 1 (9.7 mg/dL) | -- | 3.8% C.V. |
| Level 2 (31.7 mg/dL) | -- | 2.0% C.V. |
| Level 3 (82.7 mg/dL) | -- | 1.0% C.V. |
| Total Imprecision | (Low %C.V. for reproducibility) | |
| Level 1 (9.7 mg/dL) | -- | 6.7% C.V. |
| Level 2 (31.7 mg/dL) | -- | 2.7% C.V. |
| Level 3 (82.7 mg/dL) | -- | 2.3% C.V. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Method Comparison): 75 serum patient specimens.
- Data Provenance: The specimens were "serum patient specimens." The country of origin is not specified, but the submission is from Beckman Coulter in Brea, CA, suggesting US-based data is likely. The study appears to be retrospective, using existing patient specimens.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This is an in vitro diagnostic (IVD) device, not an AI/ML device that requires human expert review for image interpretation or similar. The "gold standard" or "ground truth" for the method comparison is the predicate device, the Abbott TDx Salicylate Assay. For imprecision, the ground truth is statistical reliability based on repeat measurements of control samples.
4. Adjudication Method for the Test Set:
- Not applicable. This concept relates to reconciling discrepancies between human readers or between AI and human readers, which is not relevant for an IVD device measuring analyte concentrations.
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. MRMC studies are for AI/ML devices involving human readers. This device is an automated reagent system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit. The performance data presented (Method Comparison and Imprecision) are for the SYNCHRON® Systems Salicylate Reagent and system stand-alone, meaning its performance is evaluated based on its own measurements compared to a predicate or its own reproducibility, independent of human interpretive intervention. The device's output is a quantitative value, not an interpretation requiring human review. User input for sample loading and initiating tests is implied, but the core measurement and result generation are automated.
7. The type of ground truth used:
- For Method Comparison: A legally marketed predicate device (Abbott TDx Salicylate Assay) was used as the comparative "ground truth" to establish substantial equivalence.
- For Imprecision: Statistical measures of variability (Standard Deviation and % Coefficient of Variation) across repeated measurements of control samples served as the basis for assessing precision.
8. The sample size for the training set:
- Not applicable. This device is a reagent for a colorimetric timed-endpoint method, not an AI/ML algorithm that requires a training set. Its development would involve chemical and analytical optimization, not machine learning training.
9. How the ground truth for the training set was established:
- Not applicable. As stated above, there is no AI/ML training set for this type of IVD device.
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