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C-RP reagent, when used in conjunction with SYNCHRON CAL 5 Plus on SYNCHRON LX Systems and CX C-RP Calibrator on SYNCHRON CX Systems, is intended for use in the quantitative determination of human C-reactive protein in human serum and plasma samples on SYNCHRON Systems by rate turbidimetry. CX C-RP Calibrator, when used in conjunction with SYNCHRON Systems C-RP Reagent, is intended for the calibration of C-reactive protein test systems on SYNCHRON CX Systems.

The SYNCHRON Systems C-RP reagent is designed for optimal performance on the SYNCHRON CX (CX4/4CE/4/4PRO, CX5/5CE/54/5PRO, CX7/7RTS/7/2/7PRO, CX9ALX/9PRO) and LX (LX20/PRO) Systems. The reagent kit contains two 200-test cartridges that are packaged separately from the associated calibrators.

The provided text describes the 510(k) summary for the SYNCHRON® Systems C-Reactive Protein (C-RP) Reagent and Calibrator. It outlines the device's intended use, comparison to a predicate device, and performance data to demonstrate substantial equivalence.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for the studies, but it presents performance data for method comparison and imprecision. The implicit acceptance criteria are that the device performs comparably to the predicate device and demonstrates acceptable linearity and imprecision.

Table of Performance Results:

Note: The imprecision data presented is under the "SYNCHRON LX System C-RP Estimated Imprecision" heading. It's not explicitly stated if both CX and LX platforms showed similar imprecision, but the method comparison includes both platforms.

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

• Method Comparison Test Set Sample Sizes:
  • CX Platform: 132 samples (n=132)
  • LX Platform: 143 samples (n=143)
• Imprecision Test Set Sample Sizes:
  • For each of the 4 levels tested: 80 samples (N=80) for both within-run and total imprecision.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). The study is described as "SYNCHRON Systems C-RP Method Comparison Study Results" and "SYNCHRON LX System C-RP Estimated Imprecision," which indicates internal testing by the manufacturer, Beckman Coulter, Inc.

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)

This device is an in vitro diagnostic (IVD) reagent and calibrator used for quantitative determination of C-reactive protein. The "ground truth" for such devices is typically established through reference methods or predicate devices, rather than expert consensus in the same way it would be for an imaging AI device.

• Ground Truth Establishment: For the method comparison study, the predicate device (SYNCHRON LX Systems CRPH Assay) served as the reference for comparative measurements. For imprecision and linearity, the "ground truth" is based on the known concentrations of quality control materials or spiked samples.
• Number of Experts/Qualifications: The document does not mention the involvement of experts (e.g., laboratory specialists, clinical chemists) for reviewing or establishing the ground truth beyond the use of the predicate device and standard laboratory practices.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation where multiple experts might disagree). For objective quantitative laboratory measurements like C-RP, adjudication in this sense is not employed. The performance is assessed by comparing quantitative results against a reference method or expected values.

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 device is a diagnostic reagent and calibrator kit, not an AI or imaging device that would involve human readers or MRMC studies. Its purpose is to quantitatively measure C-reactive protein in serum and plasma samples, not to assist human interpretation of complex data like images.

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

Yes, the performance presented is a standalone performance of the reagent and calibrator system on the SYNCHRON CX and LX platforms. The device itself performs the quantitative measurement without human interpretation or intervention in the measurement process. The results are then reported for clinical interpretation by healthcare professionals.

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

• Method Comparison: The predicate device, SYNCHRON LX Systems CRPH Assay, served as the reference standard for comparison. This is a form of comparative ground truth against an established, legally marketed device.
• Imprecision and Linearity: The ground truth for these studies relies on known concentrations of prepared samples (e.g., quality control materials, spiked samples) to assess the device's accuracy and reproducibility across its measuring range. This implicitly uses defined analytical ground truth.

8. The sample size for the training set

Not applicable. This device is a chemical reagent and calibrator, not a machine learning or AI model that requires a "training set" in the computational sense. Its performance is based on chemical reactions and optical measurement principles.

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

Not applicable, as there is no "training set" for this type of medical device as understood in AI/ML contexts.

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