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The SYNCHRON LX Clinical 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, and cerebral spinal fluid (sample type is chemistry dependant).

SYNCHRON LX ISE Electrolyte Buffer Reagent, SYNCHRON LX ISE Electrolyte Reference Reagent, and CO2 Alkaline Buffer and Acid Reagent, in conjunction with SYNCHRON LX AQUA CAL 1 and 3, are intended for quantitative determination of carbon dioxide (CO2) in serum or plasma on SYNCHRON LX Systems.

SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1 and 2, are intended for quantitative determination of calcium (CALC) in serum, plasma or urine on SYNCHRON LX Systems.

SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1 and 2, are intended for quantitative determination of chloride (CL) in serum, plasma, urine or cerebrospinal fluid (CSF) on SYNCHRON LX Systems.

SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1, 2 and 3, are intended for the quantitative determination of potassium (K) in serum, plasma or urine on the SYNCHRON LX System.

SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1, 2 and 3, are intended for the quantitative determination of sodium (NA) in serum, plasma or urine on the SYNCHRON LX System.

The SYNCHRON LX Clinical 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, and cerebral spinal fluid (sample type is chemistry dependent). The analyzers operate in conjunction with reagents, calibrators, and controls designed for use with the system. The instruments feature bar code identification of samples and reagents. Thev automatically dilute samples and deliver them to the associated reaction vessel for each system module (cuvette, cup, or ISE flowcell) along with reagents and reaction constituents. The systems analyze up to 41 analytes per sample.

Major hardware components include a reagent compartment, sample and reagent cranes, cartridge chemistry section, modular chemistry section, sample carousel and crane, hydropneumatics, electronics, and power supplies.

The LX20 PRO is differentiated from the standard LX20 system with the following hardware: LPIA (Large Particle Immunoassay) Module and TS-CTS (Thick Stopper-Closed Tube Sampling) Module

The fixed menu ISE flow cell module is contained in the modular chemistry area. The ISE flow cell contains ISE electrodes for the measurement of Sodium (NA), Potassium (K), Chloride (CL), carbon dioxide (CO2), and Calcium (CALC).

The modified SYNCHRON LX Systems utilize a new ISE (Ion Selective Electrode) sample volume of 40 µL. The prior sample volume was 62µL.

The provided text is a 510(k) Summary for the SYNCHRON LX® Clinical Systems (ISE Module Chemistries). It describes a modification to an existing device rather than a new diagnostic algorithm. Therefore, the traditional "acceptance criteria" and "study" framework for diagnostic devices (especially those involving image analysis or AI) does not directly apply in the same way.

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared device, specifically highlighting changes to the ISE sample volume. The performance data mentioned in section 8.0 ("Performance data from validation testing supports equivalency") would relate to verifying that this change does not negatively impact the accuracy, precision, and other operational characteristics of the device, ensuring it still performs as expected for its intended use.

Here's how to interpret the request in the context of this document:

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

The document does not explicitly list numerical acceptance criteria or detailed performance metrics. It generally states that "Performance data from validation testing supports equivalency." For medical devices like these, acceptance criteria would typically involve demonstrating that the modified device's performance (e.g., accuracy, precision, linearity, limits of detection) falls within predefined ranges relative to the predicate device or established clinical standards. Without the full validation report, specific numbers cannot be extracted.

2. Sample size used for the test set and the data provenance:

The document doesn't specify the sample size for the test set or the data provenance (country of origin, retrospective/prospective). This information would usually be found in the detailed validation study report, not typically summarized in the 510(k) summary itself, which focuses on the overall conclusion of substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable to the type of device and study described. This device measures chemical analytes (Sodium, Potassium, Chloride, Carbon Dioxide, Calcium) in bodily fluids. The "ground truth" for these measurements is established through calibrated reference methods, internal laboratory controls, and potentially external quality assessment schemes, not by expert consensus (e.g., radiologists interpreting images).

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used when there's subjective interpretation involved, such as in image analysis, where multiple readers might disagree, and a tie-breaking mechanism is needed. For an automated clinical chemistry analyzer, the results are quantitative measurements, and "adjudication" in this sense doesn't occur.

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:

This question is not applicable. The device is a clinical chemistry analyzer, not an AI-powered diagnostic tool for image analysis or other subjective assessments requiring human readers. Therefore, an MRMC study or AI assistance is not relevant.

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

This question is partially applicable, but rephrased. The SYNCHRON LX Clinical Systems are inherently "standalone" in their measurement function; they are automated instruments that perform the assays without direct human intervention in the measurement process itself. The "algorithm" here would be the instrument's internal logic for sample processing, reagent mixing, detection, and calculation of analyte concentrations. The validation would demonstrate the accuracy and reliability of this automated process. The primary function is to provide an objective measurement.

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

The ground truth for this type of device (clinical chemistry analyzer) would be established using:

• Calibrated reference materials: Solutions with known, highly accurate concentrations of the analytes.
• Reference methods: Established, highly accurate laboratory methods (e.g., isotope dilution mass spectrometry for some analytes) against which the device's measurements are compared.
• Internal quality control materials: Samples with established expected ranges that are run regularly to ensure the device is performing correctly.
• Patient samples compared to a predicate device: As this is a modification, a key part of the validation would involve comparing results from the modified device to the predicate device using a range of patient samples.

8. The sample size for the training set:

This question is not applicable in the typical sense of machine learning "training sets." While the instrument's development certainly involved extensive testing and optimization (which could be considered a form of "training" in engineering terms), it's not a machine learning model that learns from labeled data in the way AI algorithms do. The design is based on established electrochemical principles.

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

Not applicable for the reasons stated above.

Summary Table based on the provided input (and acknowledging non-applicability):

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