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The SYNCHRON® CX Systems Prealbumin Calibrator, used in conjunction with SYNCHRON® Systems Prealbumin reagent, is intended for use on Beckman's SYNCHRON CX Systems for the calibration of prealbumin test systems.

The SYNCHRON CX Systems Prealbumin Calibrator Set is a six level ready-to-use human serum-based liquid calibrator set manufactured by Beckman Coulter, Inc. Each kit contains 1 X 3 mL bottles of a specific level of calibrator (identified as Levels 1 to Level 6).

Here's an analysis of the provided text regarding the acceptance criteria and study for the SYNCHRON® CX Systems Prealbumin Calibrator:

Acceptance Criteria and Device Performance

The provided document does not explicitly state specific numerical acceptance criteria for the SYNCHRON® CX Systems Prealbumin Calibrator. Instead, the primary basis for acceptance is a finding of "substantial equivalence" to a legally marketed predicate device.

The "Summary of Performance Data" states: "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution."

The comparison to the predicate device focuses on characteristics rather than quantitative performance metrics. While the document doesn't list specific performance criteria with numerical targets (e.g., accuracy within X%, precision with CV < Y%), the implication of "substantial equivalence" is that the new device performs comparably to the predicate for its intended use.

Table of Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • The document does not specify a distinct "test set" sample size for evaluating the calibrator's performance in terms of clinical samples.
   • The performance data primarily focuses on the calibrator's characteristics and stability.
   • Data Provenance: Not explicitly stated regarding specific patient samples. The calibrator itself is human serum-based. The stress stability studies mentioned are likely internal lab studies, possibly using spiked samples or existing quality control materials.

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

   • This information is not provided in the document. Given that this is a calibrator for an in vitro diagnostic (IVD) device, "ground truth" for the calibrator's value assignment would typically be established through rigorous metrological traceability to international reference standards, rather than expert consensus on individual "test set" cases.
   • The document states, "Traceable to the IFCC reference preparation for plasma proteins, lot CRM 470," which describes the method for establishing the ground truth (i.e., assigned values) for the calibrator levels.

3. Adjudication Method for the Test Set:

   • Not applicable/Not mentioned. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which isn't the primary focus for the performance evaluation of a calibrator.

4. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

   • No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the impact of AI on human reader performance, which is not relevant for a calibrator device.

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

   • This is an in vitro diagnostic calibrator, not an algorithm, so the concept of "standalone performance" in the context of AI algorithms doesn't directly apply. The calibrator's performance is intrinsically linked to the SYNCHRON CX Systems and the PAB reagent it calibrates. The "performance data" presented focuses on its characteristics and stability.

6. The Type of Ground Truth Used:

   • For the calibrator's assigned values, the ground truth is established through metrological traceability to an international reference standard: "Traceable to the IFCC reference preparation for plasma proteins, lot CRM 470." This is a highly controlled and standardized method for assigning accurate values to calibrators.

7. The Sample Size for the Training Set:

   • Not applicable/Not mentioned. This device is a calibrator, not an AI algorithm that requires a "training set" of data.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable. As noted above, there is no "training set" in the context of this calibrator device. The "ground truth" for its assigned values (calibration levels) is established through traceability to the IFCC reference preparation.

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