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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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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

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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