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The Synermed ISE Reagents are used for in-vitro diagnostic use to quantitate levels of Sodium, Potassium and Chloride in serum. This device is for use in clinical laboratories only. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Device Description

The Synermed ISE reagents contain the following ingredients: Sodium Chloride, Potassium Chloride, Sodium Bicarbonate, Potassium Phosphate. The ISE buffer contains trlethanolamine preservatives 0.1M, phosphoric acid 0.3% and nonreactive preservatives. The ISE Mid-Standard contains sodium chloride 2.96mM, potassium chloride 0.12M, buffer and non-reactive preservatives. The ISE Reference contains 1M potassium chloride.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Synermed ISE Reagents, based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

Device: Synermed ISE Reagents for Sodium, Potassium, and Chloride.

Test Category	Analyte	Acceptance Criteria	Reported Device Performance (Summary)
Precision	Sodium	Within-Run %CV & Run-to-Run %CV less than Westgard requirements.	Achieved; all Within-Run and Run-to-Run %CVs for Sodium at various concentrations (81-180 mEq/L) were lower than the specified Westgard requirements (e.g., Target Conc. 135 mEq/L: Westgard Within-Run %CV Req = 0.6%, Actual = 0.05%; Westgard Run-to-Run %CV Req = 0.7%, Actual = 0.04%).
	Potassium	Within-Run %CV & Run-to-Run %CV less than Westgard requirements.	Achieved; all Within-Run and Run-to-Run %CVs for Potassium at various concentrations (1.5-10 mEq/L) were lower than the specified Westgard requirements (e.g., Target Conc. 5.8 mEq/L: Westgard Within-Run %CV Req = 4.6%, Actual = 0.12%; Westgard Run-to-Run %CV Req = 5.6%, Actual = 0.1%).
	Chloride	Within-Run %CV & Run-to-Run %CV less than Westgard requirements.	Achieved; all Within-Run and Run-to-Run %CVs for Chloride at various concentrations (60-130 mEq/L) were lower than the specified Westgard requirements (e.g., Target Conc. 101 mEq/L: Westgard Within-Run %CV Req = 1.2%, Actual = 0.48%; Westgard Run-to-Run %CV Req = 1.5%, Actual = 0.43%).
Linearity/Reportable	Sodium	Slope, Intercept, R² within acceptable limits. Claimed Measuring Range (80-180 mmol/L).	Slope: 0.9987, Intercept: 1.1021, R²: 0.9995. Sample Range Tested: 80-180 mmol/L. Claimed Measuring Range: 80-180 mmol/L. These values indicate good linearity across the claimed range.
Range	Potassium	Slope, Intercept, R² within acceptable limits. Claimed Measuring Range (1.5-10 mmol/L).	Slope: 1.0048, Intercept: 0.0237, R²: 0.9999. Sample Range Tested: 1.5-10 mmol/L. Claimed Measuring Range: 1.5-10 mmol/L. These values indicate good linearity across the claimed range.
	Chloride	Slope, Intercept, R² within acceptable limits. Claimed Measuring Range (60-140 mmol/L).	Slope: 0.9814, Intercept: 1.3911, R²: 0.9998. Sample Range Tested: 60-140 mmol/L. Claimed Measuring Range: 60-140 mmol/L. These values indicate good linearity across the claimed range.
Analytical Specificity	All	Analyte Target Concentration ≤ ± 10% bias in the presence of interfering substances.	No bias greater than 10% was observed for Sodium and Chloride with Hemoglobin (500mg/dL), Bilirubin (342umol/L), and Triglycerides (37mmol/L). No bias greater than 10% was observed for Potassium with Bilirubin (342umol/L) and Triglycerides (37mmol/L). Hemolysis is a known factor for high potassium and hemolyzed samples should not be used. Other exogenous substances referenced Young, et al.
Comparison Studies	All	High correlation coefficient, slope near 1, intercept near 0, and acceptable bias against predicate.	Comparison between Synermed IR-1200 and Hitachi 717 shows strong correlation: Sodium (r=0.992246, slope=0.990656, intercept=0.943789), Potassium (r=0.993021, slope=0.985861, intercept=-0.10291), Chloride (r=0.993346, slope=0.998305, intercept=0.122558). These values demonstrate good agreement with the predicate.

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

Precision/Reproducibility: The tables show "80 results" for each analyte (Sodium, Potassium, Chloride) across various target concentrations. This implies a sample size of 80 measurements for each analyte to calculate precision metrics.
Linearity/Reportable Range: The document lists "Sample Range Tested" for each analyte, indicating the range of control samples or diluted patient samples used to assess linearity. The exact number of discrete samples within these ranges is not specified beyond the range itself.
Analytical Specificity: The document mentions testing "the following concentrations of endogenous substances" but does not specify the number of samples or replicates used for these interference studies.
Comparison Studies: The document does not explicitly state the sample size (number of patient samples) used for the comparison study between the IR-1200 and Hitachi 717.
Data Provenance: Not explicitly stated. The studies were conducted in accordance with CLSI/NCCLS guidelines, which are international standards, but the country of origin of the data or whether it was retrospective or prospective is not provided. Given these are in vitro diagnostic reagents, the data would likely be from laboratory testing rather than patient cohorts in the way typical of imaging studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is not applicable to this type of device. The Synermed ISE Reagents are in vitro diagnostic devices for quantitative measurement of electrolytes. The "ground truth" for these tests is established by reference methods or highly accurate laboratory instruments, not by expert human interpretation (e.g., radiologists interpreting images). The accuracy of the measurements is compared against known standards or predicate devices.

4. Adjudication Method

This section is not applicable as the device involves quantitative laboratory measurements rather than subjective interpretation requiring adjudication among experts. The performance is assessed through statistical analysis of numerical results against predefined criteria and reference methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable. An MRMC study assesses the impact of AI on human readers' performance (e.g., diagnostic accuracy in interpreting medical images). This document is for in vitro diagnostic reagents, which do not involve human interpretation in the same manner.

6. Standalone Performance Study

Yes, the studies presented are primarily standalone (algorithm only without human-in-the-loop performance), as they evaluate the intrinsic performance characteristics of the reagents and their compatibility with the Synermed IR-1200 instrument.

Precision/Reproducibility: This measures the inherent consistency of the device's measurements.
Linearity/Reportable Range: This assesses the device's ability to accurately measure across its claimed concentration range.
Analytical Specificity: This evaluates the device's resilience to common interfering substances.
Comparison Studies: This evaluates the device's concordance with a predicate device.

These studies assess the direct analytical performance of the reagents.

7. Type of Ground Truth Used

The ground truth for evaluating the Synermed ISE Reagents is established through:

Reference materials/standards: Used to set target concentrations for precision and linearity studies.
Predicate device measurements: For the comparison studies, the results from the legally marketed predicate device (Synermed ISE Reagents using the Hitachi 717) serve as a comparative "ground truth" or reference for demonstrating substantial equivalence.
Defined concentrations of interfering substances: For analytical specificity, known concentrations of substances like bilirubin, hemoglobin, and triglycerides are used.

8. Sample Size for the Training Set

This information is not provided. The document details performance testing for validation (test set), but does not discuss any "training set." This device is a chemical reagent product, not a machine learning or AI algorithm in the typical sense that would require a distinct training data set to "learn." Its performance is based on chemical and electrochemical principles.