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510(k) Data Aggregation
(42 days)
The SYNCHRON® Systems Enzyme Validator Set, in conjunction with specified enzyme assays on Beckman SYNCHRON Systems, is intended to provide points of reference in the measurement of selected human enzymes. Use of this product will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie (DGKCh). Lipase values for specific for the LIP chemistry on SYNCHRON Systems.
The SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2 are used for calibration of various enzymes in the clinical laboratory. This consists of 3 X 5 mL bottles each of Levels 1 and 2. The storage temperature for this product is -15℃ to -20°C.
The provided text does not contain detailed acceptance criteria or a study that extensively proves the device meets specific performance metrics in the way a typical medical device study would describe.
However, based on the information provided, here's a summary tailored to the request, extracting what is available and noting what is not.
Explanation of Device Acceptance and Study:
The "SYNCHRON® Systems Enzyme Validator Set" is a calibrator intended for use with Beckman SYNCHRON Systems to establish reference points for measuring selected human enzymes. The regulatory submission (510(k)) focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than detailed performance against specific acceptance criteria in a quantitative study.
The primary "study" mentioned is "Stress stability studies," which supports the product's 18-month stability claim. The core of the acceptance for this device is its intended use to provide assay values compatible with methods recommended by the IFCC and DGKCh, and for lipase values specific to the LIP chemistry on SYNCHRON Systems.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Intended Use & Regulatory Equivalence) | Reported Device Performance |
|---|---|
| Primary Claim: Provide points of reference in the measurement of selected human enzymes. | Not explicitly stated as a numerical performance metric. The "Summary of Performance Data" (Section 8.0) states: "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to calibrators already in commercial distribution." |
| Compatibility: Result in assay values compatible with IFCC and DGKCh recommended methods. | Not explicitly stated as a numerical performance metric. Implied to be met through substantial equivalence to the predicate, which presumably already demonstrated this compatibility. |
| Lipase Specificity: Lipase values specific for LIP chemistry on SYNCHRON Systems. | Not explicitly stated as a numerical performance metric. Implied to be met through substantial equivalence and the addition of assigned lipase analyte values which were identical to the predicate. |
| Shelf-Life Stability: Maintain performance over an 18-month shelf-life. | "Stress stability studies of the Enzyme Validator support the Beckman stability claim of 18 months." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail a "test set" in the context of human samples or clinical data. The studies performed were "Stress stability studies" on the calibrator itself. No sample size for a "test set" of human specimens is mentioned, nor is there information on data provenance (country of origin, retrospective/prospective) for such a test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. The nature of the device (a calibrator) and the regulatory pathway (510(k) substantial equivalence) typically do not involve expert consensus on clinical "ground truth" for a test set in the way an imaging or diagnostic algorithm might. The "ground truth" for a calibrator relates to its assigned values, which are typically established through metrological traceability and standard reference materials.
4. Adjudication Method for the Test Set
Not applicable/Not mentioned, as there is no described test set requiring expert adjudication for ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study is not relevant to a calibrator device and is not mentioned in the provided text.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not relevant to this device. The device is a calibrator, which provides reference points for an instrument (SYNCHRON Systems), but it is not an algorithm or an AI system.
7. The Type of Ground Truth Used
For the calibrator itself, the "ground truth" is its assigned analyte values, which are made "compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (DGKCh)." The document also notes that "Lipase values for specific for the LIP chemistry on SYNCHRON Systems" were assigned. This implies the use of internationally recognized reference methods and established analytical protocols to define the target values for the calibrator.
8. The Sample Size for the Training Set
The document does not describe a "training set" as this device is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI/ML algorithm. The "ground truth" for the calibrator's values would be established through metrological procedures and reference methods, as mentioned in point 7.
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