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The UniCel® DxC 600i System combines the UniCel® DxC 600 analyzer and the Access® 2 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a Closed Tube Aliquoter (CTA) unit. The CTA functions as a sample processing manager by aliquotting and routing samples to the Access 2 and/or UniCel DxC 600 analyzer according to programming requirements.

The UniCel DxC 600 Synchron® Clinical System is a fully automated, computercontrolled clinical chemistry analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid, (sample type is chemistry dependent).

The Access 2 Immunoassay Analyzer is a microcomputer controlled, random access instrument. The analyzer performs enzyme immunoassays utilizing paramagnetic particle solid phase and chemiluminescent detection. The Access 2 Analyzer is intended for the in vitro determination of a variety of analytes of clinical interest in biological fluids such as serum, plasma, urine, and cerebral spinal fluid, (sample type is chemistry dependent).

The UniCel DxC 600i System combines the UniCel DxC 600 analyzer and Access 2 immunoassay analyzer into a single instrument presentation. Samples are loaded from a single point of entry through the Closed Tube Aliquoter (CTA) connector unit. The CTA functions as a sample processing manager by aliquotting and routing samples to the Access 2 and/or DxC 600 modules according to programming requirements. The DxC 600 and Access 2 systems then deliver samples to the appropriate reaction vessel along with reagents and reaction constituents. The DxC 600-based console functions as the main user interface for managing routine operations such as sample programming, results management, and QC functions.

The DxC 600i system provides analysis of up to 94 analytes per sample, operating in conjunction with the existing reagents, calibrators, and controls designed for use with Beckman Coulter's SYNCHRON and Access instrument families. The instrument features bar code identification of samples and reagents, Closed Tube Sampling (CTS), and obstruction detection and correction capability. DxC 600i system components include the DxC 600 analyzer and console, the CTA module, and the Access 2 module and console. The subsystem hardware components for the analytical units include reagent storage compartments, sample and reagent delivery systems, cap piercing assemblies, sample carousels and cranes, hydropneumatics, fluidics, photometric detectors, electronics, and power supplies.

The DxC 600i System incorporates the following upgrades to the LXi 725 System:

1. General Chemistry Module: The UniCel DxC 600 System (previously reviewed/cleared under K042291) replaces the LX20 PRO System as the general chemistry module and main system console. The DxC 600 implements a dual-carousel refrigeration unit to increase reagent cartridge storage capacity and expand the onboard test menu. The DxC 600 offers robustness and feature enhancements over the LX20 PRO, and has a smaller instrument footprint to reduce the overall size of the "i" configuration.
2. Hardware Modifications: The CTA unit upgrades address parts obsolescence and performance quality issues related to the barcode reader, syringe module and pump. The Access 2 module has updated electronic components to support the obstruction detection feature. There are also instrument cover changes to match the DxC 600 design.
3. Software Modifications: The DxC 600i System utilizes DxC operating software version 1.4. Version 1.4 contains the information necessary to configure, order, and report results for Access 2 tests and an updated chemistry database. The Access 2 module operating software is updated to achieve alignment with stand-alone Access 2 operating software. The CTA module software is updated to implement robustness improvements and new features.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the UniCel® DxC 600i System.

Important Note: The provided document is a 510(k) summary for a medical device – a clinical chemistry and immunoassay analyzer. This type of device is very different from an AI/ML-driven diagnostic tool. Therefore, many of the requested fields (like "Number of experts used to establish ground truth," "Adjudication method," "MRMC study," "stand-alone study," "Training set sample size," and "How ground truth for training set was established") are not applicable in the context of this device. The document describes an instrument system that performs established chemical and immunological assays, not an AI model that interprets images or other complex data.

The "acceptance criteria" for such a system typically relate to its analytical performance (e.g., accuracy, precision, linearity, limits of detection) for each assay it performs, as compared to its predicate device or established standards. The document states "Performance data from validation testing supports equivalency," implying that these analytical performance characteristics were measured and met the expected standards for substantial equivalence. However, specific numerical acceptance criteria and detailed performance results are not explicitly provided in this 510(k) summary. These details would typically be found in the full 510(k) submission, not the summary.

1. Acceptance Criteria and Reported Device Performance

As noted above, specific numerical acceptance criteria and detailed performance statistics for the UniCel® DxC 600i System are not explicitly detailed in this 510(k) summary. The summary states that "Performance data from validation testing supports equivalency" to the predicate device (SYNCHRON LXi 725 System). For a device like this, acceptance criteria would typically involve demonstrating:

• Accuracy/Correlation: How well the results from the new device correlate with the predicate device or a reference method for various analytes across their reportable ranges.
• Precision/Reproducibility: The consistency of results when the same sample is tested multiple times.
• Linearity/Dilution Linearity: The ability of the system to accurately measure samples across a range of concentrations.
• Limit of Detection/Quantitation: The lowest concentration of an analyte the system can reliably detect/quantify.
• Interference: Lack of significant interference from common substances in biological fluids.
• Carryover: Minimal transfer of analyte from a high-concentration sample to a subsequent low-concentration sample.

Since these specific numerical performance metrics are not given in the summary, the table below reflects the general statement provided.

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

The 510(k) summary does not explicitly state the sample sizes used for the test sets or the data provenance (e.g., country of origin, retrospective/prospective). "Validation testing" is mentioned, which would involve testing various samples (e.g., patient samples, spiked samples, control materials) to assess the device's analytical performance.

• Sample Size for Test Set: Not specified in the provided summary.
• Data Provenance: Not specified in the provided summary. It typically involves samples relevant to the diverse populations encountered in clinical laboratories.

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

This question is Not Applicable (N/A) for this type of device.

For a clinical chemistry and immunoassay analyzer, "ground truth" for analytical performance studies is established by:

• Reference Methods: Comparing the device's results to a recognized, highly accurate reference method (e.g., gas chromatography-mass spectrometry for drugs, isotope dilution mass spectrometry, or certified reference materials).
• Trueness/Accuracy Studies: Using samples with known, verified concentrations (e.g., certified reference materials, proficiency testing samples).
• Clinical Correlation: Assessing the device's results in the context of clinical diagnoses, but this is usually a secondary validation step, not the primary means of establishing "ground truth" for analytical performance.

There are no "experts" in the sense of human readers/interpreters establishing a consensus for diagnostic outcomes from the device's raw signals. The device itself is designed to quantitatively measure analytes from biological samples.

4. Adjudication Method for the Test Set

This question is Not Applicable (N/A) for this type of device.

Adjudication methods (like 2+1, 3+1) are employed when human interpreters are involved in labeling or assessing complex data (e.g., medical images). For a chemistry analyzer, the "ground truth" is determined by objective analytical measurements or reference methods, not subjective human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size with/without AI Assistance

This question is Not Applicable (N/A) for this type of device.

An MRMC study is relevant for interpreting diagnostic tests where human readers' performance is being evaluated, especially with AI assistance. The UniCel® DxC 600i System is an automated instrument performing quantitative assays; it does not involve human interpretation of complex data that would be "assisted" by AI in the conventional MRMC sense.

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

This question is Not Applicable (N/A) in the context of an AI algorithm, as this device itself is the standalone "algorithm" (i.e., the automated analytical process).

The device is designed to operate autonomously, executing predefined protocols to measure analytes. Its performance is inherent in its design and operation; there isn't a separate "algorithm" being evaluated beyond the instrument's overall analytical function. The performance data mentioned in the summary "supports equivalency," implying that the instrument's output by itself was evaluated against established benchmarks or the predicate device.

7. The Type of Ground Truth Used

For this type of device, the "ground truth" for analytical performance studies typically involves:

• Reference Methods: Highly accurate, validated analytical methods used to determine true analyte concentrations.
• Certified Reference Materials: Samples with precisely known concentrations of analytes.
• Predicate Device Comparison: Used to demonstrate substantial equivalence by showing equivalent performance to an already legally marketed device for the same assays. The summary explicitly states, "Performance data from validation testing supports equivalency," indicating this was a primary method.
• Split Samples: Testing the same biological samples on both the new device and the predicate or reference method.

8. The Sample Size for the Training Set

This question is Not Applicable (N/A) for this type of device, as it is not an AI/ML system that requires a "training set."

The development and "calibration" of an instrument like this involve extensive engineering, chemical/biochemical optimization, and analytical validation. It's not "trained" on data in the way a machine learning model is.

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

This question is Not Applicable (N/A) for this type of device. As explained above, there is no "training set" in the context of AI/ML. The device's operational parameters and assay specifications are established through chemical and engineering principles, extensive experimentation, and internal validation processes by the manufacturer.

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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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