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

The SYNCHRON Systems Lipid Calibrator Set is a two level ready-to-use human serum-based liquid calibrator set manufactured by Beckman Coulter, Inc. Each kit contains 3 X 2 mL bottles of a specific level of calibrator (identified as Level 1 and Level 2). Once opened, the calibrators are stable for 65 days when stored at +2℃ to +8℃.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (e.g., performance metrics like sensitivity, specificity, accuracy, and associated statistical analyses characteristic of AI/diagnostic device studies).

The document is a "Summary of Safety & Effectiveness" for a Lipid Calibrator (SYNCHRON® Systems Lipid Calibrator), which is a and a reagent used to calibrate other diagnostic devices, not a diagnostic device itself with typical performance metrics.

The "Summary of Performance Data" section only mentions:

• "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution."
• "Stress stability and open bottle stability studies of the lipid calibrator support the Beckman stability claim of 24 months and 65 days for open bottles."

This indicates that the performance evaluation was focused on stability and establishing substantial equivalence to a predicate device, as required for a 510(k) submission for a calibrator. It does not contain information on the performance metrics or study designs typically used for AI or diagnostic devices, such as those that would involve ground truth determination by experts, sample sizes for test/training sets, or MRMC studies.

Therefore, most of the requested fields cannot be answered from the provided text.

Here's an attempt to answer the parts that can be inferred or directly stated:

1. A table of acceptance criteria and the reported device performance
   • Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., accuracy, precision) in the provided text. The primary acceptance criterion for a calibrator, based on the document, appears to be demonstrating substantial equivalence to a predicate device and meeting stability claims.
   • Reported Device Performance:

     Performance Aspect	Reported Finding
     Stability (Stress)	Supports Beckman's claim of 24 months.
     Stability (Open)	Supports Beckman's claim of 65 days when stored at +2℃ to +8℃.
     Equivalence	Substantial equivalence to predicate device (Beckman™ VIGIL Lipid

Control) confirmed. |

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size: Not specified.
   • Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable. The device is a calibrator, not a diagnostic tool that requires expert interpretation of results for ground truth establishment in this context. The "ground truth" for a calibrator would typically be its assigned values based on reference methods, not expert consensus on diagnostic images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable. See point 3.

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

   • No. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable. This product is a physical calibrator.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not applicable as typically defined for diagnostic tests. For a calibrator, "ground truth" would relate to the accuracy of its assigned analyte concentrations, typically established through rigorous analytical methods (e.g., gravimetric measurements, reference methods, certified reference materials). The document states "Value Assignment Methodology" is a characteristic, implying this process was performed, but details are not provided.

8. The sample size for the training set

   • Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established

   • Not applicable. This is not an AI/machine learning device.

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