(89 days)
The SYNCHRON® Systems Vancomycin (VANC) Reagent, in conjunction with the SYNCHRON® Systems Vancomycin Calibrator set, is intended for the quantitative determination of vancomycin concentration in human serum and plasma on SYNCHRON Systems by turbidimetric immunoassay.
The SYNCHRON® Systems Vancomycin Calibrator, used in conjunction with THE OTHON® Vancomycin Reagent, is intended for use on the SYNCHRON Systems fof the calibration of Yancomycin.
The SYNCHRON System Vancomycin (VANC) Reagent and Calibrator are designed for use on SYNCHRON CX (CX440CF/404PRO, CX5/6CE/5/5PRO, CX7/7RTS/7/47PRO, CX9ALX/9PRO) and LX (LX20/PRO) Systems. The assay is intended for use in the quantitative determination of vancomycin concentration in human serum or plasma. The reagent is supplied in two 100-test cartridges and is packaged separately from the six-level calibrator set.
Here's a breakdown of the acceptance criteria and study details for the SYNCHRON® Systems Vancomycin Reagent and Calibrator, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined acceptance criteria in terms of performance thresholds. However, we can infer the performance metrics used for comparison.
| Performance Metric | Acceptance Criteria (Implied by Predicate Performance / Regulatory Aims) | Reported Device Performance (SYNCHRON Vancomycin Assay) |
|---|---|---|
| Method Comparison | ||
| N | Sufficient sample size for statistical significance | 100 |
| Slope | Close to 1.0 (indicating proportional agreement) | 1.096 |
| Intercept | Close to 0.0 (indicating systematic agreement) | -2.63 |
| r (Correlation Coefficient) | High (e.g., >0.95, indicating strong linear relationship) | 0.983 |
| Imprecision | ||
| Within-Run Imprecision | Low coefficient of variation (%C.V.) at different levels | Level 1: 5.3% |
| Level 2: 1.7% | ||
| Level 3: 1.9% | ||
| Total Imprecision | Low coefficient of variation (%C.V.) at different levels | Level 1: 7.0% |
| Level 2: 2.2% | ||
| Level 3: 2.5% | ||
| Reportable Range | Comparative to predicate, or clinically adequate | CX: 3.5 - 50 µg/mL |
| LX: 3.5 - 40 µg/mL | ||
| LX ORDAC: 30-60 µg/mL | ||
| Sensitivity | Comparative to predicate, or clinically adequate | 3.5 µg/mL |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Method Comparison: 100 patient serum specimens.
- Imprecision: 80 replicates (N) for each of the three levels tested (Level 1, Level 2, Level 3) for both within-run and total imprecision.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It mentions "Serum patient specimens were analyzed," which typically implies prospective collection for such validation studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of in vitro diagnostic device (IVD) for quantitative measurement of an analyte like vancomycin does not typically rely on "experts" to establish ground truth in the same way an imaging or diagnostic AI model would.
- Ground Truth Establishment for IVDs: The "ground truth" for method comparison and imprecision studies for an IVD is established by the predicate device (Abbott AxSYM Vancomycin Assay) and the reference analytical methods used to prepare the control samples for imprecision. The predicate device itself has undergone its own validation to establish performance against a known reference.
4. Adjudication Method (for the test set)
- Not applicable. As noted above, this is an IVD for quantitative measurement, not a subjective diagnostic assessment requiring adjudication by multiple readers or experts. The comparison is between quantitative results.
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 for quantitative measurement of an analyte. It is not an imaging or AI-assisted diagnostic device used by human readers for interpretation, so an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, this is effectively a standalone performance evaluation. The SYNCHRON Vancomycin Assay is an automated system (algorithm/instrument + reagent) that generates a quantitative result directly. Its performance is assessed independently against a predicate device and through imprecision studies. Human input is limited to sample preparation and loading, and interpreting the final quantitative value; there's no "human-in-the-loop" decision-making assisted by the device in the sense of AI diagnostics.
7. The type of ground truth used
- For Method Comparison: The results obtained from the Abbott AxSYM Vancomycin Assay on the same patient specimens served as the comparative "ground truth" or reference for the new SYNCHRON system.
- For Imprecision: The "truth" is established by the known concentrations of the control samples (Level 1, Level 2, Level 3) used, which would have been meticulously prepared and verified using a highly accurate reference method.
8. The sample size for the training set
- The document does not specify a separate "training set" sample size. For IVDs, assay development and internal validation (which might be analogous to "training") would typically involve a larger number of samples and controls during calibration and optimization processes. The presented data represents the performance validation study.
9. How the ground truth for the training set was established
- As above, for IVDs, the "ground truth" during development/training would be established through:
- Reference Methods: Using highly accurate and precise reference methods (e.g., mass spectrometry, certified reference materials) to assign target values to calibrators and controls.
- Known Concentrations: Preparing samples with precisely known concentrations of the analyte.
- Comparison to Established Systems: Benchmarking against already established and validated commercial assays (like the predicate device mentioned).
§ 862.3950 Vancomycin test system.
(a)
Identification. A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.(b)
Classification. Class II.