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The ISE Electrodes on the RX Imola can be used for measurement of the electrolytes sodium, potassium and chloride in serum and urine and for use in diagnosis and treatment of electrolyte imbalance. For in vitro diagnostic use only.

RX imola is an automated clinical chemistry analyzer complete with dedicated analyzer software. Software functions of the analyzer include the facility to interact with a host computer for direct download of test method selection details for individual samples. A barcode system is used for the rapid identification of patient samples, reagents and QC samples, In addition, the RX imola is fitted with an Ion Selective Electrode (ISE) module that operates in conjunction with specific electrodes for the quantitative in vitro diagnostic determination of Sodium, Potassium and Chloride in serum and urine.

The provided document is a 510(k) summary for a medical device (ISE Electrodes) and outlines the performance characteristics to demonstrate substantial equivalence to a predicate device. It focuses on the analytical performance of the device rather than a clinical study involving human patients or complex AI algorithms. Therefore, many of the requested points related to multi-reader multi-case studies, expert ground truth establishment for AI, and training/test set sample sizes for AI are not applicable to this type of submission.

The document details the acceptance criteria and the study that proves the device meets those criteria for analytical performance.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (Ion Selective Electrodes for measuring common electrolytes), the "acceptance criteria" are typically defined by demonstrating that the new modified device performs equivalently to the existing cleared predicate device and meets established analytical performance guidelines (e.g., CLSI standards for precision, linearity, and interference). The document implicitly defines acceptance by stating "The acceptance criteria ... was met" or "The results... support the claimed measuring ranges."

Here's a summary of the performance demonstrated based on the provided text:

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

The "test set" in this context refers to the samples used for analytical validation studies.

• Precision Studies:
  • Serum: Two levels of control material and at least five human serum samples for each analyte (Sodium, Potassium, Chloride). Tested twice per day for 20 non-consecutive days, two replicates per run. This totals 80 data points per measured sample/control (20 days * 2 runs/day * 2 replicates/run).
  • Urine: Two levels of urine controls and at least five urine patient pools for each analyte. Tested twice per day for 20 non-consecutive days, two replicates per run. This totals 80 data points per measured sample/control.
• Linearity Studies: 9 levels of samples used for each analyte and specimen type.
• Method Comparison (Correlation):
  • Serum: 105 patient serum samples for Sodium, 109 for Potassium, 104 for Chloride.
  • Urine: 72 patient urine samples for Sodium, 84 for Potassium, 90 for Chloride.
• Data Provenance: The document does not explicitly state the country of origin for the patient samples. The studies were conducted in-house by Randox Laboratories Limited, which is based in the United Kingdom. The studies were retrospective in the sense that they used collected samples to validate the device's performance, not in the sense of analyzing pre-existing patient data outside a controlled study.

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

• N/A. This is an in vitro diagnostic (IVD) device for measuring electrolyte concentrations using Ion Selective Electrodes. The "ground truth" for analytical performance studies is established by quantitative measurements using reference methods or by the known concentrations of controls/calibrators, not by human expert interpretation like radiologists.

4. Adjudication Method for the Test Set

• N/A. As this is an analytical performance study for an IVD device, there is no human adjudication method required. Performance is based on quantitative measurements.

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

• N/A. This is not an AI-based device, nor is it a device that involves human "readers" interpreting images or clinical data. Therefore, an MRMC study is not relevant.

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

• Partially Applicable / Context Dependent. The device (ISE Electrodes on the RX Imola) performs measurements automatically. The performance data presented (precision, linearity, interference, method comparison) is the "standalone" performance of the device as it directly measures the analytes, without requiring human "interpretation" of the analytical result itself beyond standard lab procedures. There is no separate algorithm being tested in the AI sense.

7. The Type of Ground Truth Used

• Reference Method / Known Concentration:
  • For precision and linearity studies, ground truth is established by using control materials and prepared linearity samples with known, validated concentrations or statistically derived consensus values from repeated measurements.
  • For method comparison, the "ground truth" is effectively the measurements obtained from the predicate device (the RX imola with the previous ISE unit, K052914), against which the new device (RX imola with new ISE electrodes, K230890) is correlated to demonstrate equivalence.
  • For interference studies, known interfering substances are added at specific concentrations to samples to evaluate their effect on the measurement.

8. The Sample Size for the Training Set

• N/A (in the AI/machine learning sense). This device does not involve a "training set" in the context of machine learning. It's a chemical measurement system with established electrochemical principles. Standard calibration and quality control procedures are part of its normal operation, but these are not "training sets" in the AI development sense.

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

• N/A (in the AI/machine learning sense). As there is no AI training set, this question is not applicable. The device's operational "knowledge" comes from its manufacturing specifications, calibration protocols using reference materials, and the underlying physical and chemical principles of ion-selective electrodes.

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The Randox Calcium (Ca) device is intended for the quantitative in vitro determination in serum, plasma and urine. This product is suitable for use on the RX series analyzer, RX daytona plus. Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases and chronic renal failure.

The Randox Calcium (Ca) kit consists of a ready to use reagent solution.

The Randox Calcium (Ca) device is an in vitro diagnostic intended for the quantitative determination of calcium concentration in serum, plasma, and urine on the RX series analyzer RX daytona plus. The device demonstrates substantial equivalence to the predicate device, the ADVIA Chemistry Calcium_2 (CA_2) Method (K083386), based on performance characteristics including precision, linearity, analytical specificity, and method comparison.

1. Table of Acceptance Criteria and Reported Device Performance

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The Randox RX daytona plus magnesium (Mg) test system is intended for the quantitative in vitro determination of magnesium concentration in serum, urine and lithium heparinized plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).

The Magnesium kit assay consists of a ready to use reagent solution.

The document describes the analytical performance characteristics of the Randox RX daytona plus magnesium (Mg) test system, which is a quantitative in vitro diagnostic device for measuring magnesium levels in serum, urine, and lithium heparinized plasma. The study aims to demonstrate substantial equivalence to a predicate device, the Siemens Magnesium (MG) test system (K991576).

Here's a breakdown of the requested information based on the provided text:

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

Please note that the document does not explicitly state predetermined acceptance criteria for all performance characteristics. Instead, it often describes the methodology and then presents the results. For some sections, like Analytical Specificity, an acceptance criterion is mentioned. I will infer or state the presented performance for others.

The studies described in the document, demonstrating good precision (low CVs), linearity over the stated ranges, low detection limits, minimal interference from common analytes, and strong correlation with the predicate device, collectively prove that the device meets the implicit acceptance criteria for analytical performance of a magnesium test system.

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

• Precision Test Set: Not explicitly stated as "test set" in the context of ground truth, but for the precision study:

  • Serum: 5 different levels of unaltered human serum samples, spiked or diluted. Each level run in 80 replicates (2 replicates per run for 20 non-consecutive days, across 2 systems). So, a total of 5 levels * 80 replicates = 400 measurements for serum samples, plus control samples.
  • Urine: 3 levels of human urine supplemented with magnesium chloride, plus one "LIN" sample (normal urine pool spiked). Each level run in 80 replicates. So, a total of 4 levels * 80 replicates = 320 measurements for urine samples, plus control samples.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The use of "unaltered human serum samples" and "human urine supplemented with magnesium chloride" suggests real human samples, and the study design implies a prospective collection for the purpose of the study.

• Linearity Test Set:

  • Serum & Urine: 11 levels of samples, created by mixing low and high serum/urine pools. Each level run in 5 replicates. This means 11 levels * 5 replicates = 55 measurements per matrix (serum/urine).
  • Data Provenance: Not explicitly stated. The samples were prepared from "low and high serum pools," indicating human samples were used as a base.

• Detection Limit Test Set:

  • Serum & Urine: 4 low-level samples for LoD/LoB/LoQ. Based on 240 determinations.
  • Data Provenance: Not explicitly stated.

• Analytical Specificity / Interference Test Set:

  • Serum & Urine: Not specific sample sizes per interferent listed, but analytes tested at specific magnesium concentrations (e.g., 3.89 mg/dl and 6.32 mg/dl for serum; 4.87mg/dl and 24.33mg/dl for urine). Interferent levels tested are specified.
  • Data Provenance: Not explicitly stated. The samples were likely prepared in-house by spiking interferents into human control matrices.

• Method Comparison Test Set:

  • Serum: 108 serum patient samples.
  • Urine: 108 urine patient samples.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). These are "patient samples," which typically implies retrospective or prospectively collected clinical samples.

• Matrix Comparison Test Set:

  • Serum vs. Lithium Heparin Plasma: A minimum of 42 matched patient sample pairs (serum and lithium heparin plasma).
  • Data Provenance: Not explicitly stated. These are "patient samples," implying clinical samples.

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) for quantitative measurement of magnesium, not an imaging device or a device requiring human interpretation for "ground truth" in the typical sense of expert consensus. The ground truth for such devices is established through reference methods, traceability to certified reference materials, and the inherent analytical measurement of the analyte.

• Reference Methods: The predicate device itself (Siemens Magnesium (MG)) serves as the "reference" for method comparison.
• Traceability: The Randox Calibration Serum Level 3 is stated to be traceable to Magnesium reference material NIST 909b. This NIST standard is the ultimate "ground truth" for magnesium concentration.
• No human experts are mentioned or typically involved in establishing the "ground truth" for the concentration values in these types of analytical studies. The "ground truth" is analytical, not interpretive.

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 used in studies where human readers provide interpretations and discrepancies need to be resolved. This document describes analytical performance studies of a laboratory diagnostic assay, where quantitative results are compared to known concentrations or a predicate device. There is no human interpretation involved in generating the "ground truth" for the concentrations themselves, nor in interpreting the results of the device in a way that would require 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 is an in vitro diagnostic (IVD) device for quantitative measurement of magnesium, not an AI-powered imaging device or a device requiring human readers/interpreters. Therefore, no MRMC study was conducted, and there's no concept of human readers improving with or without AI assistance for this type of device.

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

This is an analytical instrument and reagent system. By its nature, its performance is "standalone" in generating a quantitative result. The device (Randox RX daytona plus system with Randox Magnesium reagents) processes samples and provides a numerical magnesium concentration. There is no "human-in-the-loop" in the sense of modifying or assisting the algorithmic output of the concentration measurement. The operator's role is to load samples and reagents and initiate the automated analysis, and then review the instrument's quantitative output.

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

The ground truth for the analytical performance studies is established by:

• Reference materials/standards: Traceability to NIST 909b for calibrators, and the use of control materials with known concentrations.
• Known sample preparations: For linearity and detection limit studies, samples are often prepared by spiking or diluting to known target concentrations.
• Predicate device: For method comparison, the results obtained from the new device are compared to results obtained from a legally marketed predicate device (Siemens Magnesium (MG) on Advia 1800), which itself is established as accurate.

There is no expert consensus, pathology, or outcomes data used to establish the "ground truth" for magnesium concentration values in these studies.

8. The sample size for the training set

The provided document describes studies for demonstrating analytical performance and substantial equivalence to a predicate device. These are validation studies, not machine learning or AI development studies that typically involve "training sets." Therefore, the concept of a training set as understood in AI/ML is not applicable here, and no training set sample size is mentioned.

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

As there is no "training set" in the context of AI/ML, this question is not applicable. The ground truth for the validation of the device (as discussed in point 7) is established through analytical traceability, known preparations, and comparison to an established predicate device.

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For the quantitative in vitro determination of Carbon Dioxide in serum and plasma. Carbon Dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

This in vitro diagnostic device is intended for Rx Only.

The Liquid CO2-2 (LCO2-2) kit assay consists of ready to use reagent solutions.

The provided text describes the acceptance criteria and performance of the LIQUID CO2-2 (LCO2-2) device, which is an in vitro diagnostic for quantitative determination of Carbon Dioxide in serum and plasma.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

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For the quantitative in vitro determination of HDL Cholesterol in serum and plasma. Such measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and renal diseases and for the assessment for the risk of developing cardiovascular disease.

This in vitro diagnostic device is intended for Rx Only.

The Direct HDL Cholesterol (HDL) kit assay consists of ready to use reagent solutions.

CATALOGUE NUMBER: CH8311

R1. Enzyme Reagent 1 4 x 20 ml
R2. Enzyme Reagent 2 4 x 9 ml

REAGENT COMPOSITION

R1. Enzyme Reagent 1 N,N-Bis(2-hydroxyethyl)- 2-aminoethanesulfonic acid N-(2-hydroxy-3-Sulfopropyl)- 3,5-dimethoxyaniline, sodium salt (HDAOS) Cholesterol Esterase [E.C.3.1.1.13. Microorganism] Cholesterol Oxidase [E.C.1.1.3.6. Streptomyces sp] Catalase [E.C.1.11.1.6. Microbial] Ascorbate oxidase [EC.1.10.3.3. Acremonium sp.] Initial Concentration of Solution 100 mM, pH 6.6 (+25 °C) 0.7 mM ≥800 U/L ≥500 U/L ≥300 KU/L ≥3000 U/L
R2. Enzyme Reagent 2 N,N-Bis(2-hydroxyethyl)- 2-aminoethanesulfonic acid 4-Aminoantipyrine Peroxidase [E.C.1.11.1.7, Horse Radish, +25°C] Sodium Azide Surfactants Initial Concentration of Solution 100 mM, pH 7.0 (+25 °C) 4.0 mM ≥3500 U/L 0.05 w/v % 1.4 % w/v %

This looks like a 510(k) summary for an in vitro diagnostic (IVD) device, specifically for a Direct HDL Cholesterol (HDL) test system. Since IVD devices, especially Class I, do not typically involve AI or machine learning components as described in the prompt's questions, many of the requested fields (such as "number of experts used to establish ground truth", "adjudication method", "MRMC study", "standalone performance", "training set size", and "how ground truth for training set was established") are not applicable.

However, I can extract the relevant information regarding acceptance criteria and performance from the document.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Precision/Reproducibility:
  • Control material and human serum samples: 80 determinations per control level/serum pool (2 replicates/run x 2 runs/day x 20 days).
  • Provenance: "unaltered human serum samples" and "control material." The documentation does not specify the country of origin of the human serum samples. The study design (testing over 20 non-consecutive days) suggests it's a prospective study for data collection, but the samples themselves could be retrospective.
• Linearity/Reportable Range:
  • Samples: 11 levels, each run in replicates of five.
  • Provenance: Low and high serum pool samples. Not specified for country of origin or retrospective/prospective.
• Detection Limit:
  • Samples: 240 determinations (4 low-level samples) for LoD.
  • Provenance: Not specified for country of origin or retrospective/prospective.
• Analytical Specificity (Interference):
  • Samples: Spiked samples at 34.8 mg/dL and 70 mg/dL HDL Cholesterol concentrations. The number of individual samples is not explicitly stated.
  • Provenance: Not specified for country of origin or retrospective/prospective.
• Method Comparison:
  • Patient Samples: 103 serum patient samples.
  • Provenance: Not specified for country of origin or retrospective/prospective.
• Matrix Comparison:
  • Patient Samples: 45 matched patient sample pairs (serum and lithium heparin plasma).
  • Provenance: Not specified for country of origin or retrospective/prospective.

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

• Not applicable as this is an in vitro diagnostic (IVD) device for quantitative biochemical analysis, not an AI/image-based diagnostic device requiring expert interpretation for ground truth. Ground truth is typically established by reference methods or validated laboratory measurements.

4. Adjudication Method for the Test Set:

• Not applicable for this type of IVD device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• Not applicable as this is an IVD device, not an AI-assisted diagnostic system involving human readers.

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

• This device is a standalone in the sense that its performance characteristics (precision, linearity, interference, method comparison) are evaluated for the device itself as an assay system. There is no "algorithm only" vs. "human-in-the-loop" distinction because it's a quantitative chemical assay.

7. The Type of Ground Truth Used:

• For precision, linearity, and detection limit: The "ground truth" is implied to be the actual concentration of HDL Cholesterol, which is determined by the preparation of controls, spiked samples, and dilutions, or by the inherent properties of the samples themselves, and measured by the device and predicate.
• For analytical specificity (interference): The ground truth is the presence/absence of interferents at specific concentrations and their impact on the HDL measurement.
• For method comparison: The "ground truth" for comparison is the measurement obtained from the predicate device (Randox Laboratories Ltd, Direct HDL Cholesterol reagent, K982341). This represents a legally marketed device against which equivalence is demonstrated.
• For matrix comparison: The ground truth for comparison is the measurement obtained from serum samples when comparing to plasma samples.

8. The Sample Size for the Training Set:

• Not applicable in the context of machine learning/AI where "training set" has a specific meaning. For an IVD, the development and optimization of the reagent formulation and assay parameters would be an analogous "training" phase, but it doesn't involve a distinct "training set" of patient data in the AI sense.

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

• Not applicable for the same reasons as above. The "ground truth" for developing the assay itself would be established through chemical principles, optimization experiments, and validation against known standards and reference materials.

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For the quantitative in vitro determination of Cholesterol in serum and plasma. Cholesterol measurements are used in the diagnosis and treatments of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders.

The Cholesterol kit assay consists of ready to use reagent solutions.

CATALOGUE NUMBER: CH8310

R1. Reagent 4 x 20 ml

REAGENT COMPOSITION

Contents: R1. Reagent 4-Aminoantipyrine, Phenol, Peroxidase (E.C.1.11.1.7, Horse Radish, +25°C), Cholesterol esterase (E.C.3.1.1.13. Pseudomonas, +37°C), Cholesterol oxidase (E.C.1.1.3.6. Nocardia, +37°C), Sodium Azide

Concentrations in the Test: 0.25 mmol/l, 6.00 mmol/l, >=0.50 U/ml, >= 0.20 U/ml, >=0.10 U/ml, 0.09%

MATERIALS REQUIRED BUT NOT PROVIDED: Randox Assayed Multisera Level 2 (Cat. No. HN 1530) and Level 3 (Cat. No. HE 1532); 510(k) # K942458, Randox Calibration Serum Level 3 (Cat. No. CAL 2351); 510(k) # K053153, RX series Saline (Cat. No. SA 8396)

Here's a breakdown of the acceptance criteria and study information for the Randox Laboratories Ltd. Cholesterol device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for all tests in a single table, but rather presents the performance results of various analytical studies that demonstrate the device's capability. I've compiled the relevant performance data from the document into a table, noting the implicit acceptance measures (e.g., meeting CLSI guidelines, certain correlation coefficients, or imprecision percentages).

2. Sample Sizes and Data Provenance for the Test Set

• Precision/Reproducibility:
  • Controls: Not explicitly stated as "sample size" but data is reported for commercial control materials (717UE, 724UE, 952UN).
  • Patient Samples: 4 concentrations of unaltered human serum samples (3 diluted, 1 spiked for Linearity Pool, 1 Sensitivity Pool). Each sample run in 2 replicates per run, twice per day for 20 non-consecutive days, using 2 reagent lots on 2 RX Daytona plus systems.
  • Data Provenance: "unaltered human serum samples" implies human origin, likely retrospective for spiking/dilution. No country of origin is specified.
• Linearity/Assay Reportable Range:
  • Sample Size: 11 levels of samples covering the measuring range. Each level run in 5 replicates.
  • Data Provenance: "linearity samples" were prepared. Implies in-vitro prepared samples to cover the range, likely based on human serum/plasma.
• Detection Limit (LoD), Limit of Blank (LoB), Limit of Quantitation (LoQ):
  • Sample Size: LoD was based on 240 determinations with 4 low-level samples.
  • Data Provenance: Not specified, but generally prepared samples for low-level determination.
• Analytical Specificity (Interference):
  • Sample Size: Not explicitly stated for the number of interferent samples, but tested at Cholesterol concentrations of 150 mg/dl and 250 mg/dl for each interferent.
  • Data Provenance: Prepared samples spiked with interferents.
• Method Comparison with Predicate Device:
  • Sample Size: 107 serum patient samples.
  • Data Provenance: "serum patient samples" spanning 25 to 599 mg/dl. Retrospective. No country of origin specified.
• Matrix Comparison:
  • Sample Size (Lithium Heparin): Minimum of 54 matched patient sample pairs (serum vs. lithium heparin plasma).
  • Sample Size (Potassium 2 EDTA): Minimum of 50 matched patient sample pairs (serum vs. potassium 2 EDTA plasma).
  • Data Provenance: "Patient samples were drawn in matched pairs". Retrospective from human subjects. No country of origin specified.

3. Number of Experts and Qualifications for Ground Truth for the Test Set

This device is an in vitro diagnostic (IVD) for quantitative measurement of cholesterol. The "ground truth" for such devices is established by precise laboratory reference methods or established commercially available controls and calibrators with known values.

• No "experts" in the sense of radiologists or pathologists establishing ground truth as would be the case for imaging devices.
• Ground truth is established by:
  • Reference materials (e.g., NIST 1952a for the calibrators, mentioned under traceability).
  • Established analytical methods used by the predicate device and in clinical laboratories.
  • CLSI guidelines for experimental design and data analysis.

4. Adjudication Method for the Test Set

Not applicable for this type of quantitative IVD device. Adjudication methods (like 2+1, 3+1) are typically used for qualitative or semi-quantitative assessments, especially in imaging or pathology, where human expert discrepancy resolution is needed. For quantitative chemical measurements, the ground truth is often numerical and objectively determined.

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

No. This is an in vitro diagnostic device for chemical analysis of cholesterol, not an imaging or qualitative assessment device involving human readers. Therefore, an MRMC study is not relevant.

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

Yes, the entire performance evaluation presented is a standalone study of the device (Cholesterol assay on the RX Daytona plus system). The device performs the analytical measurement autonomously once the sample is loaded. The studies demonstrate the analytical performance of the device itself.

7. Type of Ground Truth Used

The ground truth for the performance studies is multi-faceted:

• Reference Materials: Randox Calibration Serum Level 3 is traceable to Cholesterol reference material NIST 1952a. This is a primary ground truth for calibration and accuracy.
• Predicate Device: For method comparison studies, the predicate device (Randox Cholesterol reagent, K923504) serves as a comparative ground truth, aiming to demonstrate substantial equivalence rather than absolute biological truth.
• CLSI Guidelines: The studies adhere to CLSI (Clinical and Laboratory Standards Institute) guidelines (EP5-A2 for precision, EP6-A for linearity, EP17-A2 for detection limits, EP9-A2 for method comparison), which represent an industry-accepted "ground truth" for how these analytical performance characteristics should be determined and evaluated.
• Prepared Samples: For linearity, sensitivity, detection limits, and interference, samples were prepared to known concentrations or spiked with known substances to create specific "ground truth" scenarios.

8. Sample Size for the Training Set

There is no mention of a "training set" in the context of machine learning or AI, as this device is a traditional in vitro diagnostic reagent system, not an AI/ML-based device.

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

Not applicable, as there is no training set for an AI/ML algorithm in this context.

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The RX Daytona Plus Chemistry analyzer is a bench top fully automated random access clinical chemistry analyzer intended for use in clinical laboratories. It is intended to be used for a variety of assay methods. The RX Daytona Plus includes an optional Ion Selective Electrode (ISE) module for the measurement of sodium, potassium and chloride in serum and urine. The RX Daytona Plus is not for Point-Of-Care testing.

Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.

Potassium measurements 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.

The RX Daytona Plus AST reagent is for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate aminotransferase (AST) in human serum. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

The RX Daytona Plus is a bench-top fully automated random access clinical analyser intended for use in clinical laboratories.

The RX Daytona Plus contains an ISE .module for the measurement of Potassium, Chloride and Sodium. The RX Daytona Plus has the capacity to perform up to 270 photometric tests or 450 tests per hour with ISE's and offers primary tube sampling, on-board sample dilution and a cooled reagent compartment.

• Cuvette wash system .
• STAT facility .
• Direct interface with host computer .
• . Automatic re-run and pre-dilution functions

The RX Daytona Plus uses dedicated software for easy access to all system facilities and functions. operating functions and provides a comprehensive data management system.

Reagents:
AST reagent is supplied in a kit containing:

• . 4 x 20.0 mL Buffer/ enzyme
• . 4 x 7.0 mL α-οχοςlutarate/Coenzyme.

The primary reagent contains L-Aspartic acid, MDH, Tris Buffer and preservative, The secondary reagent contains a-oxoglutarate, NADH and preservatives.

ISE Electrodes, Sodium, Potassium and Chloride are comprised of ISE Calibrator H and L, ISE diluent, ISE reference solution and ISE etching solution.

Here's a summary of the acceptance criteria and study information for the RX Daytona Plus Instrument, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implied by the results of the precision, linearity, detection limit, analytical specificity, and method comparison studies. The device aims to demonstrate substantial equivalence to its predicate devices for each analyte (AST, Sodium, Potassium, Chloride) in the relevant sample types (serum, urine). The performance metrics reported directly represent if these implied criteria were met.

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

• Precision/Reproducibility:

  • AST, Sodium, Potassium, Chloride (Serum): Two levels of control material, calibration material, unaltered human serum samples, and altered human serum samples. Tested twice per day for 20 non-consecutive days, with two replicates per sample. This totals approximately 80 test points per sample type for control/calibrator, and 40 test points per patient pool (20 days * 2 replicates).
  • Sodium, Potassium, Chloride (Urine): Two levels of urine controls and two urine patient pools. Tested twice per day for 20 non-consecutive days, with two replicates per sample. Totals approximately 80 test points per control, and 40 test points per patient pool.
  • Data Provenance: Not explicitly stated, but the submission is from Randox Laboratories Limited in the United Kingdom, suggesting the studies were likely conducted there. The samples were human serum and urine. Retrospective or prospective nature is not specified, but the "non-consecutive days" suggests prospective testing over a period.

• Linearity/Assay Reportable Range:

  • AST, Sodium, Potassium, Chloride (Serum & Urine): Studies performed at 11 levels.
  • Data Provenance: Implied to be derived from the UK.

• Detection Limit (AST):

  • 360 determinations, with 1 blank and 2 low-level samples.
  • Data Provenance: Implied to be derived from the UK.

• Analytical Specificity (Interference):

  • Interferents (Hemoglobin, Bilirubin, Triglycerides, Intralipid, various drugs) were "spiked" into relevant control/sample solutions. The number of samples/replicates isn't specified beyond this.
  • Data Provenance: Implied to be derived from the UK.

• Method Comparison with Predicate Device:

  • AST (Serum): 92 serum patient samples.
  • Sodium (Serum): 50 serum patient samples.
  • Sodium (Urine): 42 urine patient samples.
  • Potassium (Serum): 56 serum patient samples.
  • Potassium (Urine): 43 urine patient samples.
  • Chloride (Serum): 61 serum patient samples.
  • Chloride (Urine): 44 urine patient samples.
  • All samples were tested in singlicate across 5 working days.
  • Data Provenance: Not explicitly stated, but given the submitter's location (UK), the data is most likely from the UK. The studies used "patient samples," which suggests real-world specimens, likely collected prospectively for the purpose of the study or retrospectively from a patient cohort.

• Expected Values/Reference-range Verification:

  • Sodium, Potassium, Chloride (Serum): Human serum from 30 normal donors, tested in singlicate.
  • Data Provenance: Implied to be derived from the UK.

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

Not applicable. This device is a clinical chemistry analyzer. The "ground truth" for the test set values (e.g., concentrations of AST, sodium) is established by reference methods or validated laboratory procedures, not by human expert interpretation like in imaging studies. The predicate device's performance also serves as a benchmark.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in subjective diagnostic tasks, such as radiology image interpretation. In this context, the "ground truth" values for chemical analytes are obtained through highly standardized and quantitative laboratory methods (e.g., reference methods, predicate device results).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is relevant for evaluating the impact of AI on human readers' performance in diagnostic tasks (e.g., radiology). This device is a fully automated chemistry analyzer, not an AI-assisted diagnostic tool for human readers.

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

Yes, essentially all the performance data (precision, linearity, detection limits, analytical specificity, method comparison) reflects the standalone performance of the RX Daytona Plus Chemistry Analyzer as an automated instrument. There is no human-in-the-loop aspect for the analysis itself; human intervention is only involved in loading samples and interpreting the final results generated by the machine.

7. The Type of Ground Truth Used

The ground truth for the performance studies was established using a combination of:

• Reference materials/control materials: For precision and linearity studies.
• Validated methods/Predicate device results: For method comparison studies, where the results from the RX Daytona Plus were compared against a legally marketed predicate device (Randox RX Imola Chemistry Analyzer with ISE, Randox AST assay).
• Gravimetric preparation from purified salts: For ISE (Sodium, Potassium, Chloride) calibrators traceability.
• Standardized reference procedures (JSCC TS01): For AST traceability.
• Clinical literature: For establishing expected values/reference ranges.

8. The Sample Size for the Training Set

Not applicable. This is a traditional automated chemistry analyzer, not a machine learning or AI-driven device that requires a training set in the typical sense. The "parameters" and "algorithms" (e.g., Nernst equation for ISE, kinetic reaction for AST) are based on established chemical and physical principles, not learned from a large dataset.

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

Not applicable, as there is no "training set" for this type of device. The operating principles are based on fundamental scientific laws and established chemical diagnostic assays.

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Randox Liquid CK-MB: The Randox Liquid CK-MB test system is a device intended for the quantitative in vitro determination of CK-MB concentration in serum and plasma. Measurements of CK-MB are used in the diagnosis and treatment of myocardial infarction (MI). This product is suitable for use on the RX series instruments including the RX Daytona and the RX Imola.
Randox CK-MB Calibrator: The Randox CK-MB calibrator is an in vitro diagnostic product intended for use in the calibration of Randox CK-MB methods.
The Randox Liquid CK-MB test system for the RX Imola is a prescription use device intended to be used in clinical laboratories only.

Liquid CK-MB is supplied in a kit containing:

• 4 x 20.0 mL CK-MB Buffer
• 4 x 6.0 mL CK-MB Substrate.
  The CK-MB calibrator is lyophilised, single analyte, human serum based product. The kit contains ten vials (single level) with 1.0 mL per vial. Double de-ionised water is required for reconstitution.

Here's a summary of the acceptance criteria and the study details for the Randox Liquid CK-MB and Randox CK-MB Calibrator, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document outlines performance characteristics rather than explicit "acceptance criteria" in a pass/fail table. However, implied acceptance is demonstrated by the reported empirical results.

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The Randox CSF Controls Levels 2 and Level 3 are intended for in vitro diagnostic use as assayed quality control material to monitor the precision of laboratory testing procedures for Clinical Chemistry systems. This device is intended for prescription use only.

The Randox CSF controls consist of a buffered aqueous solution with biological materials; they are supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the following analytes at both levels: Chloride, Glucose, IgG, Lactic Acid, Sodium, Total Protein (Pyrogallol Red), and % Total Protein quoted for Electrophoresis regions at both levels: Albumin, Alpha-1-Globulin, Alpha-2-Globulin, Beta Globulin and Gamma Globulin.

The Randox CSF Controls Levels 2 and 3 are in vitro diagnostic devices. The acceptance criteria and the study proving the device meets these criteria are detailed below, primarily focusing on stability and value assignment studies.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Open Vial Stability: For open vial stability, a "set" of CSF Controls Levels 2 and 3 was used. On day 14, a "fresh sample" was reconstituted and compared. This implies at least two reconstituted vials (one fresh, one 14-day aged) for comparison for each control level, and "replicates" were performed, though the specific number of replicates is not stated.
• Shelf Life (Real-time Stability): For real-time stability, "10 sets of each control" (Level 2 and Level 3) were used. This means 10 vials of Level 2 and 10 vials of Level 3 were stored at ultra-frozen conditions, and another 10 vials of Level 2 and 10 vials of Level 3 were stored at routine temperature (2-8°C).
• Value Assignment: "Several replicates" were used for both electrophoresis measurements and for the remaining analytes, but the exact number of replicates is not specified.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given that it's a submission for a new device manufactured by Randox Laboratories Limited in the United Kingdom, it's highly probable the studies were conducted prospectively by the manufacturer.

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

• The document describes the establishment of target values for the control material (which serves as the "ground truth" for quality control purposes).
• For electrophoresis analytes, vials were "analyzed at an external site." The number of experts or the specific qualifications of those performing the analysis are not explicitly stated, but it's implied that these are qualified professionals at a specialized laboratory.
• For other analytes, comparison was made against a "master lot." This does not involve human expert interpretation in the same way as, for example, image analysis.

4. Adjudication Method for the Test Set

• Adjudication methods like 2+1 or 3+1 typically apply to studies where human interpretation of results is involved and discrepancies need to be resolved.
• For laboratory control materials, the "ground truth" (target values and acceptable ranges) is established through analytical processes and statistical analysis of multiple replicates. Discrepancies would be resolved by re-running samples, checking instrument calibration, or investigating analytical issues, rather than through expert adjudication in the human-reader sense. The value assignment methods described involve calculating means of "several replicates" and comparing against established criteria, implicitly handling variability through statistical methods rather than human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
• This device is a quality control material for in vitro diagnostic tests, not an algorithm or imaging device that requires human interpretation or comparison of human reader performance. The studies focus on the analytical performance (stability, value assignment) of the control material itself.

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

• This device is a quality control material, not an algorithm. Therefore, a standalone performance study (in the context of an algorithm's performance independent of human input) is not applicable or described. The performance studies focus on the intrinsic properties and stability of the control material.

7. The Type of Ground Truth Used

• The ground truth for this device (Randox CSF Controls) is its assigned target values and acceptable ranges for various analytes.
• This ground truth is established through:
  • Analytical Testing and Expert Consensus (implicit for electrophoresis): For electrophoresis analytes (Albumin, Alpha-1-globulin, etc.), the mean of "several replicates" analyzed at an external site is taken, and percentages of total protein are calculated. This implies the analytical results from a qualified external lab are considered the definitive "ground truth."
  • Comparison to a Master Lot and Analytical Testing: For other analytes (Chloride, Glucose, Immunoglobulin G, Lactate, Sodium, Total Protein), the test controls are assessed against a "master lot" using analytical methods. The mean of several replicates and CV are calculated, and recovery of the master lot is measured against predefined acceptance criteria.

8. The Sample Size for the Training Set

• The concept of a "training set" is typically associated with machine learning algorithms.
• For this quality control material, there isn't a "training set" in that sense. The manufacturing process and formulation are developed, and then the stability and value assignment studies (described above) act as validation and characterization. The "master lot" mentioned in value assignment method 2 could be considered a reference or calibration standard that helps establish the "ground truth" for new lots, but it's not a training set for an AI model.

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

• As there is no "training set" in the context of an algorithm for this device, this question is not fully applicable.
• However, if we interpret "ground truth for the training set" as the basis for establishing the expected values for the control material, it's established through:
  • Reference materials and methods: For individual analytes, traceable sources are used, such as "Synthetic Analytical Grade chemical" from commercial suppliers (e.g., SIGMA, EUROPA) or biological materials "derived from Human serum" (e.g., Intergen).
  • Comprehensive analytical testing: As described in section 9 "Summary of Value Assignment," extensive laboratory analysis involving "several replicates" and comparison to a master lot or external site analysis is performed to determine the "Target Value" and "Acceptable range" for each analyte.

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