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510(k) Data Aggregation
(47 days)
The SYNCHRON Systems Cholesterol (CHOL) Reagent, when used in conjunction with SYNCHRON Systems Multi Calibrator, is intended for the quantitative determination of human cholesterol in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.
The SYNCHRON Systems Cholesterol (CHOL) Reagent in conjunction with SYNCHRON Systems Multi Calibrator, is intended for use on Beckman's SYNCHRON Systems Clinical Systems.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the SYNCHRON® Systems Cholesterol (CHOL) Reagent:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a separate section with specific numerical thresholds for performance. Instead, it presents performance data (method comparison and imprecision) which is presumably used to demonstrate substantial equivalence to the predicate device. The implied acceptance criteria are that the new device's performance should be comparable to or better than the predicate's and generally accepted clinical standards for cholesterol measurement.
| Performance Metric | Implied Acceptance Criteria (Based on general clinical standards for cholesterol) | Reported Device Performance |
|---|---|---|
| Method Comparison (vs. Predicate) | Close to 1.0 (slope), close to 0 (intercept), high correlation (r > 0.99) | Slope: 0.983 Intercept: 2.41 mg/dL r (correlation coefficient): 0.9996 (Compared to SYNCHRON Systems Cholesterol (CHOL) Reagent predicate) |
| Method Comparison (vs. Reference Method) | Close to 1.0 (slope), close to 0 (intercept), high correlation (r > 0.99) | Slope: 1.002 Intercept: -2.07 mg/dL r (correlation coefficient): 0.9961 (Compared to Abell-Kendall Reference Method) |
| Within-Run Imprecision (Default Range) | Typical CVs for cholesterol assays are generally < 5-10%, often striving for < 2-3% | Level 1 (98.7 mg/dL): 1.09 %CV Level 2 (155.4 mg/dL): 1.06 %CV Level 3 (213.2 mg/dL): 0.98 %CV |
| Within-Run Imprecision (Extended Range) | Similar to default range, potentially slightly higher at extreme concentrations | Level 1 (716.2 mg/dL): 2.28 %CV Level 2 (876.25 mg/dL): 1.74 %CV |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Sizes:
- Method Comparison (vs. Predicate): 79 samples (n=79)
- Method Comparison (vs. Abell-Kendall Reference Method): 39 samples (n=39)
- Within-Run Imprecision (Default Range): 80 samples for each of the three levels (Level 1, Level 2, Level 3).
- Within-Run Imprecision (Extended Range): 20 samples for each of the two levels (Level 1, Level 2).
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It implies the studies were conducted by Beckman Instruments, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. The device is a diagnostic reagent for quantitative measurement of a biochemical analyte (cholesterol). The "ground truth" for method comparison studies in this context is established by a reference method (Abell-Kendall) or a predicate device. It does not involve expert interpretation of images or clinical cases requiring multiple expert opinions.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. This is a quantitative chemical assay, not a device requiring human adjudication of results in a diagnostic context like imaging or pathology. The "adjudication" is inherent in the comparison against a reference method or predicate.
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 not an AI-assisted diagnostic device, nor is it a device that requires human readers. It is a chemical reagent used on automated clinical systems.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a way. The performance data presented (method comparison, imprecision) represents the "standalone" performance of the reagent and the SYNCHRON Systems when performing the cholesterol assay. "Human-in-the-loop" for this type of device typically refers to a lab technician operating the analyzer, but the performance metrics provided are for the analytical system itself.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for method comparison studies was:
- The results obtained from the SYNCHRON Systems Cholesterol (CHOL) Reagent (predicate device).
- The results obtained from the Abell-Kendall Reference Method, which is a recognized gold standard for cholesterol measurement.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of device development. This is a chemical reagent, not a machine learning or AI algorithm that typically requires a large training dataset. The development process for such a reagent would involve analytical optimization and validation, rather than machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a "training set" for an AI or machine learning model.
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