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The Beckman Coulter AQUA CAL 1, 2, and 3 are intended for use on SYNCHRON LX® and UniCel® DxC Systems for the calibration of Sodium, Potassium, Chloride, Urea Nitrogen, Urea, Glucose Creatinine, Calcium, Carbon Dioxide, and Phosphorus.

CREm reagent, when used in conjunction with SYNCHRON LX® System(s), UniCel® DxC 800 System and SYNCHRON® Systems AQUA CAL 1 and 2, is intended for the quantitative determination of Creatinine concentration in human serum, plasma or urine.

The SYNCHRON LX20 System determines creatinine concentration by means of the Jaffe rate method. A precise volume of sample is injected into the reaction cup with CREm reagent containing picric acid. Absorbance readings are taken at 520 nm between 19 to 25 seconds after sample introduction. The SYNCHRON LX20 System utilizes a two level calibrator for the creatinine test. Beckman Coulter AQUA Cal is designed for optimal performance on the SYNCHRON LX20 Clinical and UniCel DxC Svstems. AQUA Cal is an aqueous based calibrator made by New England Reagent Laboratory (NERL) to Beckman Coulter specifications. This product is tested during manufacturing using standards traceable to National Institute of Standard and Technology (NIST) reference materials. The creatinine concentrations are established based on addition of weighed-in specific quantities of creatinine to achieve the appropriate level of each calibrator. Each calibrator level is packaged individually in 25 mL bottles, 6 to a package.

The provided text is a 510(k) Summary for a modification to the SYNCHRON® LX20 Clinical System, specifically concerning the creatinine measurement. It describes the device, its intended use, and a comparison to a predicate device, focusing on the change to calibrator set points.

However, the summary does not contain acceptance criteria or detailed study data proving the device meets acceptance criteria. It states "Performance data from validation testing supports equivalency" but does not elaborate on what that data is, what the acceptance criteria were, or the specifics of the study design.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated from the document:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in the provided text.
• Reported Device Performance: Not explicitly stated in the provided text, beyond "Performance data from validation testing supports equivalency."

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

• Sample Size for Test Set: Not specified. The document mentions "a one time correlation of serum creatinine sample set to Isotope Dilution Mass Spectrometry (IDMS)", but the size of this set is not provided.
• 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):

• This is not applicable as the ground truth was established by Isotope Dilution Mass Spectrometry (IDMS), a reference method, not by expert consensus. Even if experts were involved in the IDMS process, their number and qualifications are not mentioned.

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

• Not applicable as the ground truth was established by IDMS, not human adjudication.

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 an in vitro diagnostic (IVD) system for quantitative determination of creatinine, not an imaging device or an AI application with human readers.

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

• Yes, the performance of the SYNCHRON® LX20 Clinical System is inherently standalone, as it's an automated analyzer. The "modification to the creatinine module (CREm) involves modification of the calibrator set points coded in the chemistry database." The performance evaluation would be of the instrument's accuracy and precision against the IDMS reference method. However, the details of this standalone performance data are not provided.

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

• Ground Truth Type: Isotope Dilution Mass Spectrometry (IDMS). This is a highly accurate and precise analytical technique often used as a reference method for determining the true concentration of substances in biological samples.

8. The sample size for the training set:

• Not applicable. This device is a modification of an existing IVD system, and the change is to calibrator set points based on a "one time correlation" to IDMS. It's not a machine learning model that typically has a distinct training set. If 'training' refers to the set used to establish the new calibrator set points, its size is not provided.

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

• The new calibrator set points were "value assigned... to values determined by a one time correlation of serum creatinine sample set to Isotope Dilution Mass Spectrometry (IDMS)." This indicates IDMS was used to establish the "ground truth" (reference values) for the samples that informed the new calibrator set points.

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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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The UniCel DxC SYNCHRON Systems are fully automated, computer-controlled clinical chemistry analyzers 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 UniCel DxC 600 and 800 Systems are the next generation of clinical chemistry analyzers in Beckman Coulter's SYNCHRON instrument family. The analyzers operate in conjunction with reagents, calibrators, and controls designed for use with SYNCHRON Systems. The DxC instruments feature bar code identification of samples and reagents, Closed Tube Sampling, Obstruction Detection and Correction, and a dual carousel reagent storage compartment with an onboard capacity of 59 cartridges. Major system components include sample and reagent handling systems, bar code readers, modular chemistry sections, cartridge chemistry systems, and reagent storage compartment, supported by power and hydropneumatic utilities.

The provided text describes the UniCel® DxC SYNCHRON® Clinical Systems (UniCel DxC 600 and 800) and their substantial equivalence to predicate devices, focusing on the performance of various chemistry assays.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides summary performance data comparing the UniCel DxC 800 System to the SYNCHRON LX20 PRO (predicate device) through method comparison studies (slope, intercept, and correlation coefficient (R)) and imprecision studies (mean, within-run SD, within-run %CV, total SD, total %CV). The document implies that the acceptance criteria are met if the values obtained from the UniCel DxC 800 are similar to or within acceptable ranges compared to the predicate device, demonstrating "substantial equivalence."

A direct table of explicit acceptance criteria (e.g., "Slope must be between 0.95 and 1.05") is not explicitly stated in detail for each analyte. Instead, the reported performance (slope, intercept, R, and imprecision) is the evidence presented to demonstrate that the device meets the implied acceptance of being substantially equivalent to the predicate device.

Implied Acceptance Criteria (based on comparison to predicate performance) and Reported Device Performance:

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

The "test set" consists of human biological fluid samples (serum, plasma, urine, cerebrospinal fluid, depending on the chemistry).

• Sample Sizes (N) for Method Comparison Studies:
  • Modular Assays: Range from 111 (BUNm) to 219 (CO2).
  • Cartridge Assays: Range from 91 (PHE) to 181 (LD).
  • Qualitative Drug Assay (BENZ): 43 positive samples and 57 negative samples (total 100).
• Sample Sizes (N) for Imprecision Studies:
  • The table states "Unicel 800 System Estimated Serum Imprecision (N=80)". This refers to 80 replicates per control level, per analyte, for the imprecision study.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies are internal ("Summary of Performance Data" is submitted by Beckman Coulter). The types of samples (serum, plasma, urine, CSF) indicate they are from human subjects, likely clinical samples. No indication of retrospective or prospective is given, but typically such studies for regulatory submissions would be prospectively collected or a well-defined retrospective cohort.

3. 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. For these types of in vitro diagnostic devices, "ground truth" is typically established by comparing the device's results to a legally marketed predicate device (as done here with the SYNCHRON LX20 PRO Systems) or a reference method. It's unlikely human experts were establishing a qualitative "ground truth" for quantitative chemistry assays in the way they might for an imaging AI device. The predicate device's measured values served as the reference for method comparison.

4. Adjudication Method for the Test Set

This information is not applicable/provided in the context of this type of analytical performance study. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human readers are interpreting images or making diagnoses, and discrepancies need to be resolved. For analytical performance of chemistry analyzers, the "accuracy" is determined by comparing measured values to a reference method (the predicate device) or known concentrations in controls/calibrators, not by human adjudication of qualitative results.

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

An MRMC comparative effectiveness study is not applicable to this type of device. This device is a clinical chemistry analyzer, not an AI or imaging diagnostic device that assists human readers in interpretation. Therefore, there is no "human reader improvement with AI vs without AI assistance" to report.

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

Yes, the performance data presented (method comparison and imprecision) represents the standalone performance of the UniCel DxC SYNCHRON Clinical Systems (the "algorithm/device only" in this context). The device directly measures chemical analytes in biological samples and provides quantitative or qualitative results without human-in-the-loop interpretation of the measurement itself. The human "in the loop" would be the lab technician operating the machine and interpreting the numerical results in the context of a patient's clinical picture.

7. The Type of Ground Truth Used

For the method comparison studies, the "ground truth" or reference was the results obtained from the predicate device (SYNCHRON LX®20 PRO Systems). The study aimed to show that the new device's measurements correlated well with, and were equivalent to, the established predicate device's measurements.

For the imprecision studies, the ground truth was the known concentrations/activities of the control materials used. The goal was to show that the device produced consistent and reproducible results around these known values.

8. The Sample Size for the Training Set

This information is not applicable/provided in the context of this traditional in vitro diagnostic device submission. These chemistry analyzers are not "trained" in the machine learning sense. Their performance is based on established electrochemical or photometric principles, reagent chemistry, and instrument calibration. There isn't a "training set" of data used to develop an algorithm in the way an AI model would be trained. The development and calibration processes are based on analytical chemistry principles and established quality control practices.

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

As noted above, there isn't a "training set" with ground truth in the AI sense for this device. The development and validation of the device would have involved:

• Analytical Chemistry Principles: Calibrators with known, highly accurate concentrations are used to establish a calibration curve for each assay. These calibrators represent the "ground truth" for the instrument's quantitative measurements.
• Quality Control Materials: Internal and external quality control materials with known target ranges are regularly run to verify the instrument's ongoing performance.
• Predicate Device Comparison: The "ground truth" for demonstrating substantial equivalence for the new device's performance often comes from comparing its results to results generated by a legally marketed predicate device using the same or similar samples.

The "software development statement of compliance" mentions "Validation" and "acceptance criteria" for the software, but this refers to the functionality and reliability of the software controlling the instrument, not the training of an AI algorithm based on clinical data.

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The SYNCHRON Systems Uric Acid (URIC) Reagent, in conjunction with SYNCHRON MULTI™ Callbrator, is intended for use in the quantitative determination of uric acid in serum, plasma, and urine samples. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems.

The SYNCHRON Systems Uric Acid (URIC) reagent is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LXTM Clinical Systems When used in conjunction with SYNCHRON MULTI™ Calibrator, it is intended for use in the quantitative determination of uric acid concentration in serum, plasma, and unne samples. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis. starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

Here's a summary of the acceptance criteria and study details for the SYNCHRON® Systems Uric Acid (URIC) Reagent, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against a predicate device (Beckman SYNCHRON Uric Acid Reagent on the SYNCHRON CX System) to demonstrate substantial equivalence. The document doesn't explicitly state quantitative acceptance criteria thresholds but implies that performance values that are comparable to the predicate are acceptable.

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

• Sample Size:
  • Method Comparison (Serum/Plasma): 79 samples
  • Method Comparison (Urine): 78 samples
  • Imprecision (Within-Run & Total): 80 replicates per level (Level 1 and Level 2)
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

Not applicable. This device is a diagnostic reagent for quantitative measurement of uric acid, not an image analysis or interpretive device that requires expert review for ground truth. The "ground truth" in this context is the actual uric acid concentration as measured by the predicate device and the inherent chemical properties of the samples.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is a quantitative chemical assay, not an interpretive task requiring expert adjudication. The comparison is between the new device's readings and the predicate device's readings.

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

No. An MRMC comparative effectiveness study is designed for evaluating the performance of diagnostic tools that involve human interpretation (e.g., radiologists reading images). This document describes a chemical reagent; therefore, such a study would not be relevant.

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

Yes, this entire study is a standalone performance evaluation of the SYNCHRON® Systems Uric Acid (URIC) Reagent on the SYNCHRON LX System. The performance metrics (method comparison, linearity, imprecision) directly reflect the device's analytical capabilities without human intervention in the measurement process itself, beyond operating the instrument.

7. The Type of Ground Truth Used

The ground truth for the performance studies was:

• Method Comparison: The measurements obtained from the Beckman SYNCHRON Uric Acid Reagent (URIC) on the SYNCHRON CX System (the predicate device) served as the reference for comparison.
• Linearity and Imprecision: The inherent chemical concentrations within the control samples and patient samples were the "ground truth." Linearity confirms the device's ability to accurately measure these concentrations across its claimed range, and imprecision evaluates the reproducibility of these measurements.

8. The Sample Size for the Training Set

Not applicable. This device is a chemical reagent and an associated analytical system. It is not an AI/ML device that requires a "training set" in the conventional sense. The performance characteristics described are based on analytical validation studies, not machine learning model training.

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

Not applicable, as there is no "training set" in the context of this chemical reagent and analytical system.

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