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The SYNCHRON 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 are specific for the LIP chemistry on SYNCHRON Systems.

The SYNCHRON Systems Enzyme Validator Set is designed for optimal performance on the SYNCHRON CX (CX4/CX4CE/CX4A/CX4PRO, CX5/CX5CE/CX5A/CX5PRO. CX7/CX7RTS/CX7Δ/CX7PRO, CX9ALX /CX9PRO) and LX (LX20/LXPRO/LXi) Systems. Each kit of SYNCHRON Enzyme Validator consists of 3 X 5 mL each of Levels 1 and 2 of SYNCHRON Enzyme Validator, two (2) calibration diskettes, one (1) instruction insert, and one (1) Assigned Values sheet.

The provided text describes a submission for a medical device called the "SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2". This device is a calibrator for selected human enzymes on SYNCHRON® Systems.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states: "Performance data from validation testing supports equivalency." However, it does not provide a specific table of acceptance criteria or quantitative performance metrics for the revised device (SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2). It only mentions that the device has been value assigned for ALT, AMY, AST, CK, GGT and LD using the new 2002 IFCC reference method, and that Amylase (AMY) has been added to the list of analytes traceable to the IFCC reference method. The core claim is substantial equivalence to a legally marketed predicate device (SYNCHRON® Systems Validator Set, K984014).

Therefore, a detailed table cannot be created from the given information. The implicit acceptance criterion is that the new validator set provides "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)."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for validation testing of the SYNCHRON Enzyme Validator Set. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of the study).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide details on the number of experts or their qualifications used to establish ground truth for the test set. It mentions that the device was "value assigned ... using the new 2002 IFCC reference method," implying that the ground truth directly stems from these established reference methods rather than expert clinical review of specific test cases.

4. Adjudication Method for the Test Set

No information is provided regarding an adjudication method for a test set. The validation process appears to rely on concordance with established reference methods rather than human review of cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC study is mentioned. This device is a calibrator, not a diagnostic imaging or screening tool that would typically involve human readers. Therefore, an MRMC study and effect size for human reader improvement with AI assistance are not applicable to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a calibrator, which inherently functions as a "standalone" product in the sense that it provides reference points for automated assays. The performance data would be generated directly by the SYNCHRON® Systems using the calibrator, comparing the results to the IFCC reference methods. Therefore, in a sense, the performance evaluation is of the calibrator's ability to enable the SYNCHRON® Systems to produce accurate readings, which is an algorithm-only (instrument-only) performance. However, the document doesn't explicitly frame it as an "algorithm-only" study in the modern sense of AI device evaluation.

7. The Type of Ground Truth Used

The ground truth used for value assignment is based on International Federation of Clinical Chemistry (IFCC) reference methods and methods recommended by the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie (DGKCh)).

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is not a machine learning device in the typical sense; it's a calibrator designed to work with existing analytical systems. Building a "training set" for an algorithm, as understood in AI, is not part of this device's development or validation described here.

9. How the Ground Truth for the Training Set Was Established

Given that there's no mention of a traditional "training set" for an AI algorithm, this question is not applicable. The device's "ground truth" (its assigned values) is established by its manufacturing process and verified against IFCC and DGKCh reference methods.

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