(44 days)
The SYNCHRON Systems Valproic Acid reagent in conjunction with the SYNCHRON Drug Calibrator 1 is intended for use in the quantitative determination of valproic acid in human serum and plasma. This assay is designed for use with the family of SYNCHRON System analyzers which include the SYNCHRON CX®4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.
The Beckman SYNCHRON Systems Valproic Acid (VPA) test system used in conjunction with the SYNCHRON Systems Drug Calibrator 1 is designed for optimal performance on the Beckman SYNCHRON family of clinical analyzers for the quantitative measurement of valproic acid in serum and plasma . The SYNCHRON family of clinical analyzers include the SYNCHRON CX®4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.
The provided text describes a 510(k) premarket notification for a medical device (Beckman SYNCHRON Systems Valproic Acid Reagent) and not an AI/ML powered device. As such, information regarding AI-specific evaluation metrics like sample size for training and test sets, provenance of data, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this document. The study described focuses on analytical performance characteristics typical for an in vitro diagnostic (IVD) device.
However, I can extract the relevant information pertaining to its analytical performance, which serves as its "acceptance criteria" for regulatory submission.
1. A table of acceptance criteria and the reported device performance
For a traditional IVD like this, "acceptance criteria" are typically defined by regulatory standards (e.g., CLIA, FDA guidelines) for analytical performance, which are demonstrated through studies like method comparison and imprecision. The "performance" is the result of these studies.
| Performance Metric | Acceptance Criteria (Implied by Regulatory Standards / Predicate Device Performance) | Reported Device Performance (SYNCHRON VPA Reagent) |
|---|---|---|
| Method Comparison | Close agreement with predicate device | |
| Slope | Ideally close to 1.0 (e.g., 0.95 - 1.05) | 1.0443 |
| Intercept | Ideally close to 0 (e.g., +/- 5) | 2.00 |
| Correlation Coefficient (r) | High (e.g., >0.97) | 0.9857 |
| Within-Run Imprecision | %CV ≤ ~5-10% (depending on analyte and concentration) | Low: 3.1% CV; Mid-Range: 2.0% CV; High: 2.4% CV |
| Total Imprecision | %CV ≤ ~8-15% (depending on analyte and concentration) | Low: 4.6% CV; Mid-Range: 3.8% CV; High: 2.7% CV |
| Measuring Range (Linearity) | Linear over stated range | 10-150 µg/mL (Assessed as Linear) |
| Stability (Reagent) | Stable for claimed shelf-life | 24 Months |
| Stability (Calibrator) | Stable for claimed shelf-life | 24 Months |
2. Sample size used for the test set and the data provenance
- Method Comparison Test Set: n = 104 samples.
- Imprecision Study Test Set: n = 80 for each of the three concentration levels (low, mid-range, high) for both within-run and total imprecision studies.
- Data Provenance: Not specified in the document, but typically for IVD performance studies, samples would be human serum/plasma. The country of origin and retrospective/prospective nature are not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For an IVD reagent measuring a chemical analyte, the "ground truth" for method comparison and imprecision studies is established by the analytical method itself or by the predicate device's measurement. There is no expert "ground truthing" in the sense of human interpretation being applied here.
4. Adjudication method for the test set
- Not Applicable. As there are no human interpretations or expert consensus involved, no adjudication method is needed.
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 traditional IVD device, not an AI-powered device. Therefore, no MRMC comparative effectiveness study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a chemical reagent-based assay, not an algorithm. The "algorithm only" performance is equivalent to the device's analytical performance studies listed above.
7. The type of ground truth used
- For the Method Comparison, the "ground truth" is essentially the results obtained from the predicate device (Abbott TDxFLx Valproic Acid Reagent). The study aims to show agreement of the new device with the established predicate.
- For Imprecision, the "ground truth" is statistical reproducibility around the mean concentration determined for each sample.
- For Measuring Range (Linearity), the "ground truth" is a demonstration that the device accurately measures concentrations across its stated range, typically compared to known spiked samples or diluted samples.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no "training set" in that context. The development of the reagent and assay involves analytical chemistry principles and optimization, not machine learning training.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML model, this question is irrelevant to the provided document.
§ 862.3645 Neuroleptic drugs radioreceptor assay test system.
(a)
Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.(b)
Classification. Class II.