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The ABL90 FLEX PLUS System is an in vitro diagnostic, portable, automated analyzer that quantitatively measures electrolytes (cK+, cNa+, cCa2+), glucose, and lactate in heparinized arterial and venous whole blood.

The ABL90 FLEX PLUS System is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient, or point-of-care setting. These tests are only performed under a physician's order.

Potassium (cK+): Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

Sodium (cNa+): Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, delydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.

Calcium (cCa2+): Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

Glucose (cGlu): Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Lactate (cLac): The lactate measure the concentration of lactate. Lactate measurements are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidity of the blood).

The ABL90 FLEX PLUS System consists of the ABL90 FLEX PLUS analyzer, sensor cassette and solution pack consumables, and related accessories for the analyzers. The ABL90 FLEX PLUS is a portable, automated system intended for in vitro testing of samples of balanced heparinized whole blood for electrolytes (cK+, cNa*, cCa²), glucose, and lactate. The ABL90 FLEX PLUS System has an automated sample inlet mechanism, which can collect blood through two different measuring modes: the S65 syringe mode and the SP65 short probe mode.

The provided text is a 510(k) Summary for the ABL90 FLEX PLUS System, an in vitro diagnostic device. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (ABL90 FLEX) rather than proving the device meets specific acceptance criteria as might be defined for a novel AI/ML device.

Therefore, much of the requested information regarding acceptance criteria for AI/ML performance, study design (test set, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set details) is not applicable to this type of device and its regulatory submission.

The document primarily proves the analytical performance of the new device is comparable to the predicate device through various analytical studies.

Here's a breakdown of the applicable information based on the provided text, and an explanation of why other requested information is not present:

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

The document does not explicitly present "acceptance criteria" in a pass/fail table for each performance metric in the way it might for a novel AI/ML device. Instead, it presents analytical performance data (linearity, precision, detection, method comparison, interference) which is implicitly compared against pre-defined internal specifications or what is considered acceptable for the similar predicate device. The goal is to show the new device performs equivalently to the predicate.

Below is a summary of the reported device performance from the tables in the document. The "Acceptance Criteria" column cannot be fully populated as precise numerical thresholds are not explicitly stated as "acceptance criteria" in this 510(k) summary, but are rather implied by the successful demonstration of performance often within CLSI guidelines and comparable to the predicate.

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

• Test Set (for performance validation):
  • Linearity: The specific number of samples tested for linearity is not explicitly stated as 'N' values in Table 1 but ranges presented (e.g., 1.896-11.146 for cCa2+) imply a sufficient number of points across the range were used.
  • Detection (LoB, LoD, LoQ): Not explicitly stated as 'N' values in Table 2.
  • Precision (using stable, aqueous ampoule-based QC material): Varies per parameter/level, but generally 243-244 replicates (N) per parameter/level.
  • Precision (using blood): Varies per parameter/mode/interval, ranging from 2 to 202 replicates (N).
  • Method Comparison:
    • Arterial blood (S65 mode): 221-225 samples (N) across parameters.
    • Arterial blood (SP65 mode): 214-218 samples (N) across parameters.
    • Venous blood (S65 mode): 231-234 samples (N) across parameters.
    • Venous blood (SP65 mode): 219-225 samples (N) across parameters.
    • Combined (S65 mode): 436-441 samples (N) for combined arterial/venous.
    • Combined (SP65 mode): 420-425 samples (N) for combined arterial/venous.
  • Interference: "Large panel of likely interferents" for paired-difference study; dose-response studies for significant interferents. Specific sample sizes for each interferent are not detailed in the summary.
• Data Provenance: The document states that precision studies using QC material were conducted at "three external sites." Method comparison and precision studies using blood were conducted using both arterial and venous blood, and in both sample collection modes. The country of origin for the data (patients or samples) is not specified in this summary. The studies are described as "analytical performance testing," implying they are prospective or controlled laboratory studies rather than retrospective analysis of existing clinical data.

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)

• Not Applicable: This device is an in vitro diagnostic (IVD) analyzer that quantitatively measures analytes. Its performance is evaluated against reference measurement procedures or highly controlled materials, not by expert interpretation of images or clinical cases requiring expert consensus or qualifications. Ground truth is established by the reference method itself or the known concentration of QC materials.

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

• Not Applicable: As this is an IVD device measuring quantitative analytes, there is no expert adjudication process in this context, unlike an AI/ML device interpreting medical images. Performance is determined by comparison to reference methods or statistical analysis against known values.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable: This is an IVD analyzer, not an AI/ML device that assists human readers. Therefore, an MRMC study is not relevant to its regulatory approval process.

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

• Partially Applicable (in a different sense): The ABL90 FLEX PLUS System is a standalone automated analyzer. Its performance is measured directly (algorithm only, if you consider the device's internal measurement algorithm) against reference methods or known concentrations, without a human-in-the-loop interpretation being the primary output that's being evaluated for accuracy. The results presented (linearity, precision, method comparison) are representative of its standalone performance.

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

• Quantitative Reference Methods / Known Concentrations:
  • Linearity/Detection: Ground truth is established by preparing samples with known, precise concentrations across the measurement range, or by the inherent properties of the measurement system for LoB/LoD/LoQ.
  • Precision: Ground truth is the expected value of the quality control (QC) materials or the prepared blood samples, or simply the reproducibility of measurements on the same sample.
  • Method Comparison: Ground truth is the measurement from the legally marketed predicate device (ABL90 FLEX, specifically "ABL90 FLEX PLUS analyzer as it was designed at the time of the clearance of K160153") that the new device is being compared against. This device itself serves as the "reference method" for substantial equivalence.
  • Interference: Ground truth is the expected measurement of known samples, with and without the interferent, using a reference method, to identify if the interferent causes a clinically significant deviation.

8. The sample size for the training set

• Not Applicable (in the AI/ML sense): This document describes the analytical validation of a traditional IVD device, not an AI/ML algorithm. There is no "training set" in the machine learning sense for this type of submission. The device is a physical instrument with established chemical/electrochemical measurement principles.

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

• Not Applicable: As there is no "training set" in the AI/ML context, this question is not relevant. The device's internal parameters and calibration would be established through a manufacturing and calibration process, not through a "training" phase with a ground truth dataset in the way an AI model is trained.

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The EasyStat 300 is designed for clinical laboratory use, making quantitative measurements of potassium (K+), ionized calcium (Ca++), and chloride (Cl-) in whole blood (arterial/venous) samples from Li-Heparinized Syringes. This Analyzer should only be used by trained technical laboratories to aid in the dagnosis and treatment of patients with electrolyte and/or acid-base disturbances.

Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Calcium (Ca++) (ionized) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The EasyStat 300 is a system for use by health care professionalsto rapidly analyze venous and arterial whole blood samples in a clinical laboratory setting. The analyzer incorporates a Reagent Module containing the "calibrating" solutions A2, B2, and a "conditioning" solution C2. Calibrations are performed automatically or on-demand by the user to establish the "slope" of each sensor, used in the calculation of the patient sample.

The analyzer employs "Ion Selective Electrode" (ISE) sensors for K*, Ca**, Cl¯.

The EasyStat 300 uses 175µL of whole blood in the "Syringe" mode to analyze patient samples. The EasyStat 300 reports results for Potassium (K+), Calcium (Ca++), Chloride (Cl-). Additionally, it provides a number of calculated parameters based on the reported results and a number of input parameters as described in the Operator's Manual.

Medica's EasyQC materials (REF 8315/8316/8317) are specifically formulated for the EasyStat 300. Medica requires the use of quality controls every day patient samples are analyzed and after any troubleshooting is performed, as instructed in the Operator's Manual, to validate the performance of the analyzer. The analyzer stores QC results and provides a statistical analysis of its performance using Levey-Jennings plots for the last 30 consecutive days.

The Reagent Module (REF 8101) has a twelve-month shelf-life when stored at 4º-25ºC.

The electrolyte sensors (K, Ca, Cl) have one-year shelf-life when stored at 4º-25ºC. Use-Life of the sensors is determined from their calibration profiles and from the reported results during the EasyQC analysis. Sensors are replaced by the operator as described in the Operator's Manual. An automatic calibration is performed after installation to qualify the new sensor(s) and the operator is instructed to use the EasyQC multi-level QC materials to validate the EasyStat 300 performance.

The EasyStat 300 may be equipped with a Medica provided barcode scanner (REF 8420) via a USB port to automatically enter patient sample and EasyQC material information. Details are provided in the operator's Manual.

To maintain the performance of the analyzer Medica provides a cleaning solution (REF 8305) and a troubleshooting kit (REF 8250). Their proper uses are described also in the operator's Manual.

Here's an analysis of the provided text to extract the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details various performance studies (Precision, Linearity, Method Comparison, Sensitivity, Selectivity) and lists specifications or desired outcomes that serve as acceptance criteria. The actual performance is described within each study's results.

Note: The document does not explicitly present a "table of acceptance criteria and reported device performance" as a single, consolidated table. I will construct it based on the details provided in different sections.

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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 SmartLyte® Plus is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in Serum, Sodium Heparin Plasma, and Venous Whole Blood, as well as measurement of sodium, potassium and chloride in pre-diluted Urine samples.

The SmartLyte® Plus Sodium Assay is intended to measure sodium in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute Urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

The SmartLyte® Plus Potassum Assay is intended to measure potassium in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

The SmartLyte® Plus Chloride Assay is intended to measure the level of chloride in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The SmartLyte® Plus Calcium Assay is intended to measure ionized calcium levels in Venous Whole Blood, Sodium Heparin Plasma, and Serum on the SmartLyte® Plus Electrolyte Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

The SmartLyte® Plus Lithium Assay is intended to measure lithium carbonate) in Venous Whole Blood, Sodium Heparin Plasma, and Serum on the SmartLyte® Plus Electrolyte Analyzer. Measurements of ithium are used to assure that the proper drug dosage is administered in the treatment with mental disturbances, such as manic-depressive illness (bipolar disorder).

For in-vitro diagnostic use only.

The SmartLyte® Plus Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer which can test Serum, Sodium Heparin Plasma, Venous Whole Blood, pre-diluted Urine samples, and QC materials is substantially equivalent to it's predicate SmartLyte® Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer which tests Serum, Sodium Heparin Plasma, Venous Whole Blood, pre-diluted Urine samples, and QC materials. Both are microprocessor-controlled analyzers which utilize ion-selective electrodes for the measurement of Sodium, Potassium, Chloride, Calcium and Lithium in Serum, Sodium Heparin Plasma, Venous Whole Blood, pre-diluted Urine samples, and QC materials. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack (510(k) 013850) every 4 hours throughout the day or on request. Sodium. Potassium. Chloride and Calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness. Mission controls (510 (k) 033063) are the recommended quality control material to be used daily.

The SmartLyte® Plus is intended to be a direct replacement for the SmartLyte® Electrolyte Analyzer (K082462).

The SmartLyte® Plus Electrolyte Analyzer is designed for clinical laboratory professionals to assess the levels of Sodium, Potassium, Chloride, Calcium and Lithium found in Venous Whole Blood, Sodium Heparin Plasma, Serum, and Urine of patients. The analysis is performed in-vitro, and neither the analyzer nor any of its components come in contact with the patient.

The document describes the performance of the SmartLyte® Plus Electrolyte Analyzer. This device is an in-vitro diagnostic instrument, and the provided information details its analytical performance characteristics rather than the performance of an AI algorithm with human readers or a medical imaging device. Therefore, many of the requested points related to AI, MRMC studies, human experts, and ground truth establishment for complex data like images are not directly applicable or available in this document.

However, I can extract and present the acceptance criteria and reported device performance for the SmartLyte® Plus Electrolyte Analyzer as it relates to its analytical accuracy and precision.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The document presents performance data for Precision and Linearity for each analyte (Na+, K+, Cl-, Ca++, Li+) across different sample types (Serum, Plasma, Whole Blood, Urine). The acceptance criteria are implicitly quantitative, as the 'Status' for each test is reported as "Pass" against numerical criteria.

1. Table of Acceptance Criteria and Reported Device Performance (Summary)

Since the document provides extensive tables for precision (within-run and run-to-run) and linearity for each analyte and matrix, I will summarize the general acceptance criteria and indicate that the device passed all these criteria as reported in the document. Presenting every single data point for all analytes and matrices would be too large for this format.

Precision (for Serum/Blood/Plasma)

Precision (for Urine)

Linearity (General Acceptance Criterion)

Detection Limit

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The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory.

The system consolidates analytical instruments, such as the ARCHITECT c8000 System into a unified workstation that performs a variety of instrument specific assays such as Sodium, Potassium and Chloride.

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

The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory.

The system consolidates multiple Analytical instruments into a unified workstation.

The Automation software provides for workload management, sample routing to relevant Analytical instrument based on sample orders coming from LIS (Laboratory Information System) and instrument operational status monitoring. This is accomplished through communication connections between the Automation, Analytical instruments and LIS (Laboratory Information System) or middleware.

Pre-Analytical and Post-Analytical processing in details are as follows: sample loading and unloading and sample identification, sample transport along the system and routing to relevant modules, loading and unloading in centrifuge, decapping, sealing, storing in a temperature controlled environment, aliquot samples capping, sample presentation to connected Analytical instruments.

The FlexLab 3.6 Automation Systems perform the following pre and post analytical functions:

Sample bar code identification (previously performed by the analyzer) Sample transport and tracking Sample centrifugation (Optional functionality) Sample de-capping (Optional functionality) Sample re-capping (Optional functionality) Sample sealing (Optional functionality) Sample de-sealing (Optional functionality) Sample aliquoting (Optional functionality) Sample Storage and Retrieval (Optional functionality)

The provided document describes a 510(k) submission for the FlexLab 3.6 / ACCELERATOR a3600 system, a laboratory automation system designed to automate pre-analytical and post-analytical processing and sample handling.

The study presented focuses on demonstrating substantial equivalence to an existing predicate device (APS Accelerator, K093318) rather than meeting specific performance acceptance criteria for a new clinical device. The primary aim is to show that the new system, when integrated with an ARCHITECT c8000 analyzer, produces comparable results for Sodium, Potassium, and Chloride assays as the predicate system.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a substantial equivalence study for a laboratory automation system, the "acceptance criteria" are implied to be the demonstration of comparable performance to the predicate device. The performance is measured by method comparison statistics.

Acceptance Criteria (Implied): For a substantial equivalence claim, the expectation is that the comparative statistics (slope, intercept, bias) demonstrate close agreement between the FlexLab 3.6 integrated system and the ACCELERATOR APS integrated system. Ideally, slopes should be close to 1, intercepts close to 0, and biases minimal, indicating no significant difference in analytical results due to the automation system change. The reported 95% Confidence Intervals for slopes generally include 1, and for intercepts, they often include 0 or are small, supporting the claim of substantial equivalence.

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

• Sample Size (Test Set): 100 samples (indicated by "N=100" in all method comparison tables for Chloride, Potassium, and Sodium).
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It describes a "Method Comparison Study" which typically involves prospective collection of samples to run on both systems simultaneously or in close sequence. The use of "individual sample tube barcode labels (SID)" suggests careful sample tracking.

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

This type of study (method comparison for a laboratory automation system) does not rely on "experts" to establish a ground truth in the traditional sense of clinical diagnosis. Instead, the "ground truth" is the measurement obtained from the predicate device system (ARCHITECT c8000 integrated with ACCELERATOR APS). The comparison is between two automated systems, not against a human expert interpretation or a gold standard diagnostic.

4. Adjudication Method for the Test Set

No adjudication method is relevant for this type of test. The comparison is between two objective measurement systems.

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

No, an MRMC comparative effectiveness study was not done. This study is about the analytical performance of an automation system in a clinical laboratory setting, not diagnostic interpretation by human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.

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

Yes, in a sense, this is a standalone performance comparison of the new automation system (FlexLab 3.6) against the predicate automation system (ACCELERATOR APS), both integrated with the same analytical instrument (ARCHITECT c8000). The focus is on the impact of the automation system on the analytical results.

7. The Type of Ground Truth Used

The "ground truth" for this substantial equivalence comparison is the results obtained from the predicate device system (ARCHITECT c8000 analyzer integrated with the ACCELERATOR APS). The study aims to show that the new device system yields clinical measurements that are equivalent to a legally marketed predicate device, thereby confirming its safety and effectiveness.

8. The Sample Size for the Training Set

This study describes a verification and validation study, not a machine learning model development. Therefore, there is no "training set" in the context of AI/ML. The 100 samples mentioned were for the performance comparison.

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

As there is no training set for an AI/ML model, this question is not applicable. The study is a direct comparison of analytical measurements between two laboratory automation systems.

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The SMARTLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples. In addition, the analyzer can also measure sodium, chloride and calcium in dialysate samples.

The SMARTLYTE Sodium Assay is intended to measure sodium in whole blood, serum, plasma, pre-diluted urine and dialysate on the SMARTLYTE Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

The SMARTLYTE Potassium Assay is intended to measure potassium in whole blood, serum, plasma, urine and dialysate. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

The SMARTLYTE Chloride Assay is intended to measure the level of chloride in whole blood, serum, plasma, urine and dialysate. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The SMARTLYTE Calcium Assay is intended to measure ionized calcium levels in whole blood, plasma, serum, and dialysate. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

The SMARTLYTE Lithium Assay is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma, and serum. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

The SMARTLYTE Nat, K", CT, Ca*, Li Electrolyte Analyzer which can test serum, plasma, whole blood, pre-diluted urine samples, dialysate solutions and QC materials is identical to GEMLYTE Electrolyte Analyzer ( cleared under K082462) which tests serum, plasma, whole blood, pre-diluted urine samples, and QC materials. Both are microprocessor-controlled analyzers which utilize ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples, dialysate solutions and QC materials. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack (510(k) 013850) every 4 hours through out the day or on request. Sodium, potassium, chloride and calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness. Mission controls (510 (k) 033063) are the recommended . quality control material to be used daily.

Here's an analysis of the provided text, outlining the acceptance criteria and the study that proves the device meets them, based on your requested format:

Acceptance Criteria and Device Performance Study for SMARTLYTE Electrolyte Analyzer

The SMARTLYTE Electrolyte Analyzer is an automated, microprocessor-controlled device using ion-selective electrodes to measure sodium, potassium, chloride, calcium, and lithium in various sample types, including dialysate. The study aimed to demonstrate the substantial equivalence of the SMARTLYTE to its predicate device, the AVL 9180 (K961458), particularly for dialysate measurements, which represent a modification from previously cleared uses.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the predicate device's performance characteristics or defined in the "Reproducibility" section as maximum allowable CVs or SDs. The reported device performance is from the "Precision Dialysate" and "Dialysate Comparison" sections.

Note on Acceptance Criteria: The document primarily compares the SMARTLYTE's performance to the predicate device's expected values and establishes its own internal precision targets. For the method comparison, "good correlation to predicate with correlation coefficients typically greater than 0.99 and slope values between 0.96 and 1.04" serves as a key acceptance criterion for the clinical claims (correlation with a predicate device). For precision, specific CV/SD targets are given.

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

• Precision (Dialysate):
  • Within-run: 30 replicates for each of three dialysate samples (low, mid, high concentrations) per measurand.
  • Between-run (Total precision): 40 replicates (4 groups of 10 replicates over 10 days) for each of three dialysate samples per measurand.
• Linearity (Dialysate):
  • Sodium: 34 samples
  • Potassium: 36 samples
  • Chloride: 34 samples
  • Calcium: 48 samples
• Method Comparison (Dialysate):
  • Sodium: 43 samples
  • Potassium: 56 samples
  • Chloride: 51 samples
  • Calcium: 43 samples

Data Provenance: The document implies these were prospective studies conducted to support the 510(k) submission for the specific device modifications. No explicit country of origin is stated for data collection, but given it's a US FDA submission, it's typically assumed to be North American or adhering to international standards accepted by the FDA. The samples were "dialysates collected" and some were "spiked or diluted" to span the measurement ranges, suggesting a mix of clinical and artificially prepared samples. Prior data for whole blood, serum, plasma, and urine were "previously cleared (K082462)".

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

Not applicable. This is an in-vitro diagnostic device measuring analytes. The "ground truth" for the test set is established by the reference methods or the predicate device that the SMARTLYTE is compared against, not by human expert assessment of images or clinical cases. The reference for comparison would be the AVL 9180 predicate device.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1 for consensus among experts) are used in studies involving human interpretation or subjective assessments. This study evaluates the analytical performance of an IVD device against a predicate or defined analytical targets.

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

No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers evaluating cases with and without AI assistance to measure a change in human performance (e.g., diagnostic accuracy, reading time). The SMARTLYTE is an automated IVD device; it does not involve human readers interpreting output in the same way an imaging AI would.

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

Yes, the studies described (precision, linearity, method comparison) represent standalone performance of the SMARTLYTE device. The device operates automatically to measure analyte concentrations. The "human-in-the-loop" aspect is limited to operating the device and collecting samples, not interpreting an AI's output to make a diagnosis.

7. The Type of Ground Truth Used

The "ground truth" for the performance studies can be defined as:

• Reference Intervals/Expected Values: For linearity studies, expected values based on known dilutions of stock solutions serve as the ground truth.
• Predicate Device Measurements: For the method comparison study, the measurements from the predicate device (AVL 9180) on the same dialysate samples served as the comparative ground truth.
• Internal Precision Targets: For the precision studies, the acceptance criteria (max CV/SD) are internal performance targets, and the reported values are measured against these.

8. The Sample Size for the Training Set

Not applicable. The SMARTLYTE Electrolyte Analyzer is an IVD device based on ion-selective electrode technology, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance is based on its hardware, chemistry, and pre-programmed algorithms, which are calibrated and verified through analytical studies.

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

Not applicable, as there is no "training set" in the context of this device's technology. The device uses established physical and chemical principles (ion-selective electrodes). Calibrations are performed using certified calibration fluids.

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The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCO2 pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus.

The GEM Premier 4000 is a portable critical care system. The potassium (K+) sensor membrane on the GEM Premier 4000 is being modified to lower the valinomycin concentration, along with a proportional decrease in the amount of counterion.

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

Device: GEM® Premier 4000 with modified K+ sensor membrane

1. Table of Acceptance Criteria and Reported Device Performance (Summary derived from the document):

• Level 1 (2.90 mmol/L): Total Imprecision %CV = 1.51%
• Level 2 (3.88 mmol/L): Total Imprecision %CV = 1.32%
• Level 3 (7.41 mmol/L): Total Imprecision %CV = 0.86%
  Full Capillary Mode:
• Level 1 (3.06 mmol/L): Total Imprecision %CV = 3.55%
• Level 2 (4.06 mmol/L): Total Imprecision %CV = 2.71%
• Level 3 (7.44 mmol/L): Total Imprecision %CV = 2.16%
  Micro Capillary Mode:
• Level 1 (3.34 mmol/L): Total Imprecision %CV = 3.31%
• Level 2 (4.25 mmol/L): Total Imprecision %CV = 2.66%
• Level 3 (7.83 mmol/L): Total Imprecision %CV = 1.27%
  Conclusion: All K+ results for whole blood precision were within specification. |
  | Linearity | Support the current claimed reportable range of 0.2 to 19.0 mmol/L. | Syringe Mode: y = 1.0144x - 0.0612 (R² = 0.9999), y = 1.0085x - 0.0038 (R² = 0.9999), y = 1.0438x - 0.165 (R² = 1)
  Full Capillary Mode: y=1.0115x + 0.0251 (R² = 0.9997); y = 1.0302x - 0.1058 (R² = 0.9998); y = 1.0324x - 0.0435 (R² = 0.9996)
  Micro Capillary Mode: y = 1.068x - 0.136 (R² = 0.9999), y = 1.0791x - 0.2189 (R² = 0.9998), y = 1.1017x - 0.2881 (R² = 0.9994)
  Conclusion: Linearity results support the claimed reportable range of 0.2 to 19.0 mmol/L for all sampling modes. |
  | Interferences | No clinically significant interference from common substances, or a specific limitation added if observed. | Only citrate at concentrations ≥ 7.3 mmol/L showed a clinically significant interference effect. A limitation was added to labeling: "Blood collection tubes containing sodium citrate as an additive will produce a clinically significant change in potassium and should be avoided." |
  | Method Comparison (Internal) | K+ performance comparable to the GEM Premier 3000. | Syringe: Slope = 0.978, R² = 0.998
  Full Capillary: Slope = 0.980, R² = 0.997
  Micro Capillary: Slope = 0.987, R² = 0.997
  Conclusion: K+ performance is comparable to the GEM Premier 3000 for all sample modes. |
  | Field Site Testing (External) | K+ performance comparable to the GEM Premier 3000/3500 in a clinical setting. | Syringe: Slope = 1.050, R² = 0.989 (Range 2.0 to 7.5 mmol/L)
  Full Capillary: Slope = 1.018, R² = 0.957 (Range 2.3 to 5.6 mmol/L)
  Micro Capillary: Slope = 0.996, R² = 0.963 (Range 2.3 to 5.6 mmol/L)
  Conclusion: K+ performance in the clinical setting is comparable to the GEM Premier 3000/3500 for all sample modes. |

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

• Precision Study:
  • Sample Size: 3 sample levels (whole blood). Each level was assayed twice per day in eight replicates for five days. This totals 2 (assays/day) * 8 (replicates) * 5 (days) = 80 measurements per level per analyzer for each mode. With 2 analyzers, this is 160 measurements per level per mode.
  • Data Provenance: Not explicitly stated, but implied to be laboratory-based (internal testing) using whole blood samples. It's retrospective in the sense that the data was collected for the purpose of this submission, but not from an ongoing patient cohort.
• Linearity Study:
  • Sample Size: Whole blood samples at 7 different K+ concentrations. Each concentration was tested in duplicate on the reference Flame Photometer and in triplicate on 3 different GEM Premier 4000 analyzers for each of the 3 sample modes. This implies 7 (concentrations) * 3 (replicates) * 3 (analyzers) = 63 measurements per sample mode.
  • Data Provenance: Not explicitly stated, but implied to be laboratory-based (internal testing) using manipulated whole blood samples.
• Interference Study:
  • Sample Size: Substances were tested, but the number of samples or replicates is not specified.
  • Data Provenance: Not explicitly stated, but implied to be laboratory-based (internal testing).
• Method Comparison (Internal):
  • Sample Size: 220 samples for each sample mode (syringe, full capillary, micro capillary).
  • Data Provenance: Internal study, likely laboratory-based.
• Field Site Testing (External):
  • Sample Size: 454 samples for syringe mode, 304 samples for full capillary, and 304 samples for micro capillary.
  • Data Provenance: Clinical setting at three field sites. This implies prospective collection or anonymized retrospective patient samples from those sites.

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

• This is not an AI/imaging device study, so the concept of experts establishing ground truth for a test set in the traditional sense is not directly applicable.
• For the Linearity study, "Flame atomic emission photometry (flame photometry)" was used as the reference method (ground truth). This is an established analytical technique, not a human expert.
• For Method Comparison and Field Site Testing, the predicate devices (GEM Premier 3000 and 3500) served as the reference standard for comparison, rather than human expert opinion.

4. Adjudication Method for the Test Set:

• Not applicable as this is a medical device performance study, not a study involving human interpretation needing adjudication. The "ground truth" was established by objective reference methods or comparison to predicate devices.

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

• No, this was not an MRMC comparative effectiveness study. This is a performance study for an in vitro diagnostic (IVD) device (blood analyzer) measuring specific analytes, not a study evaluating human reader performance with or without AI assistance for tasks like image interpretation.

6. Standalone (Algorithm Only) Performance:

• Yes, the studies are primarily standalone performance assessments of the device itself. The device, the GEM Premier 4000 with the modified K+ sensor, is an automated analytical instrument. The studies evaluated its analytical performance (precision, linearity, interference, method comparison) without direct human intervention in the K+ measurement process beyond sample collection and instrument operation.

7. Type of Ground Truth Used:

• Objective Reference Methods and Predicate Device Comparison:
  • Precision: Internal specifications (implied criterion).
  • Linearity: Flame atomic emission photometry (a recognized gold standard analytical method for K+).
  • Interferences: Clinical significance based on established medical understanding of K+ variations.
  • Method Comparison: GEM Premier 3000 (the previous version of the device).
  • Field Site Testing: GEM Premier 3000/3500 (predicate devices in a clinical setting).

8. Sample Size for the Training Set:

• Not Applicable. This submission describes modifications to an existing device's sensor and subsequent validation studies. There is no mention of a "training set" in the context of machine learning or AI models. The device's underlying technology (potentiometric measurement) is based on electrochemical principles, not trained algorithms.

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

• Not Applicable. As there is no training set for an AI model, this question is not relevant to the described device and studies. The device's performance is governed by its sensor design and calibration, which are validated through the studies outlined.

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The Biolis 12i is a discrete photometric chemistry analyzer with ion-selective electrode (ISE), with direct quantitative measurement of sodium, potassium, chloride, and glucose in serum. It is a device intended for the in-vitro, spectrophotometric determination of general chemistry assays for clinical use. The Biolis 12i includes an optional lon Selective Electrode (ISE) module for the measurement of sodium, potassium and chloride in serum. The Biolis 12i is not for Point-Of-Care testing. It is for vitro diagnostic use only.

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

Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.

The Biolis 12i analyzer with glucose hexokinase assay is intended to measure glucose quantitatively in human serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic glycemia, and of the pancreatic islet cell carcinoma.

Using photometry, the Biolis 12i instrument measures the glucose concentration in serum by monitoring the change in absorbance at 340 nm. Additionally, the Biolis 12i with lon-Selective Elective module additionally measures the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry.

The provided 510(k) summary describes the Biolis 12i, a clinical chemistry analyzer with an optional Ion-Selective Electrode (ISE) module, and its performance for measuring glucose, sodium, potassium, and chloride in serum. The study focuses on demonstrating substantial equivalence to predicate devices (Sirrus for Glucose and Prestige 24i for ISE).

Here's an analysis of the acceptance criteria and study as requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical "acceptance criteria" in the format of a predefined pass/fail threshold. Instead, it presents performance characteristics (correlation, linearity, precision, and interference) and asserts "substantial equivalence" to the predicate devices. The implicit acceptance criterion is that the performance of the Biolis 12i must be comparable or equivalent to the predicate devices.

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

• Test Set Sample Size: The document does not explicitly state the total number of patient samples (serum) used for the correlation, linearity, and interference studies.
  • For precision studies:
    • ISE (Sodium, Potassium, Chloride): N=20 for Within Run (repeated measurements of 3 samples), N=15 for Day-by-Day (measurements of 3 samples over 15 days).
    • Glucose: N=20 for Within-run (repeated measurements of 3 samples), N=20 for Between-run (measurements of 3 samples over 20 runs, likely implying 20 days if one run/day).
• Data Provenance: The document does not specify the country of origin of the data or explicitly state whether the study was retrospective or prospective. Given that the manufacturer is in Japan, it's possible the studies took place there, but this is not confirmed in the text.

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

• Experts: Not applicable. For this type of in vitro diagnostic device, "ground truth" is established by reference methods or predicate devices, not human expert consensus on interpretations. The ground truth for the correlation studies was the measurements obtained from the predicate devices (Prestige 24i for ISE and Sirrus for glucose) and for linearity studies, it would be prepared known concentrations. For calibrator verification, the ground truth for glucose was NIST SRM 965b.
• Qualifications: Not applicable in the context of expert interpretation for ground truth.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. This is an IVD device measuring analytes, not making diagnostic interpretations that require human adjudication. The performance is assessed by direct comparison to established methods or known concentrations.

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:

• This is not applicable. The Biolis 12i is an automated clinical chemistry analyzer, not an AI-assisted diagnostic tool that involves human readers interpreting images or data outputs and making diagnoses. Therefore, an MRMC study and effects on human reader improvement are not relevant to this device.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Yes, this study essentially represents standalone performance. The Biolis 12i is an automated analyzer. The performance characteristics (correlation, linearity, precision, interference) are measured for the device itself using predefined protocols, without a "human-in-the-loop" interaction for interpretation that would alter its output. The results are quantitative measurements directly from the algorithm/instrument.

7. The Type of Ground Truth Used:

• For Correlation Studies: The ground truth was the measurements obtained from the predicate devices (Sirrus for Glucose, Prestige 24i for Na, K, Cl).
• For Linearity Studies: The ground truth was based on a range of known concentrations (likely serially diluted or prepared samples).
• For Calibrator Verification (Glucose): The ground truth was NIST SRM 965b, Glucose in Frozen Serum, which is a certified reference material.

8. The Sample Size for the Training Set:

• Not applicable / Not disclosed. Automated clinical chemistry analyzers typically do not have a "training set" in the machine learning sense. Their operational parameters are often determined by engineering design, chemical principles, and calibration curves established with known standards. The document clarifies how calibrators were verified but does not mention a distinct "training set" for an algorithm.

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

• Not applicable. As a traditional in vitro diagnostic device, it does not involve machine learning "training sets" and associated ground truth establishment in the way AI/ML devices do. Its "calibration" is performed using known concentration calibrator materials and validated against reference standards. For instance, the glucose calibrator was verified against NIST SRM 965b.

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The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and ion selective electrode.

The Glucose test system is for the quantitative measurement of glucose in human serum, plasma, urine and cerebrospinal fluid on Beckman Coulter AU analyzers. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The Potassium test system is for the quantitative measurement of potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

The Magnesium test system is for the quantitative measurement of Magnesium in human serum, plasma and urine on Beckman Coulter AU analyzers. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

The AU5800 clinical chemistry analyzer is a fully automated, random access analyzer, designed for ultra-high throughput laboratories. This system is designed to suit varying workloads and is available in different configurations, from a one-single photometric module AU5810, up to a four-photometric module AU5840. The AU5800 analyzer measures analytes in samples using the same reagents, calibrators, quality control (QC) materials and other consumables used within the AU series of instruments. This ensures the same reliable results and references ranges across the AU family members. This system carries out automated analysis of serum, plasma, urine samples and other body fluids and automatically generates results. Electrolyte measurement is performed using a single or double cell lon Selective Electrode (ISE) which is also common among the other members of the AU family.

The provided 510(k) summary for the AU5800 Clinical Chemistry Analyzer describes a predicate device comparison and does not include acceptance criteria or a study design in the traditional sense of a standalone algorithm or a comparative effectiveness study involving human readers. Instead, it focuses on demonstrating substantial equivalence to a previously cleared device (AU2700 Clinical Chemistry Analyzer) through performance validations and comparisons of representative assays.

Here's an breakdown based on the information provided, recognizing that many requested fields are not applicable to this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state numerical acceptance criteria for the AU5800 against each specific performance metric (like accuracy, sensitivity, specificity, etc.) as would be seen for a novel device. Instead, the acceptance criterion is "demonstrate equivalence between the proposed AU5800 and the predicate device (AU2700)" across various performance parameters.

The reported performance is qualitative, stating that "The submission provides the data necessary to demonstrate this equivalence based on the performance validations and comparisons conducted between the representative reagents and analyzer platforms. Based on this data, the new AU5800 Chemistry Analyzer is substantially equivalent to the referenced predicate(s)."

The performance testing indicated for demonstrating equivalence includes:

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

The document states that "Representative assays from the AU chemistry menu were selected to demonstrate equivalency between the proposed AU5800 and the predicate device." However, specific sample sizes for the test sets (patient samples, controls, standards) used for each performance validation (linearity, precision, etc.) are not provided in this summary.

The data provenance is implicit: it's laboratory data generated internally by Beckman Coulter during the development and validation of the AU5800. The data is prospective in the sense that it was generated for the purpose of demonstrating equivalence for this submission. The country of origin is not specified, but given Beckman Coulter's location in Brea, CA, USA, it's likely primarily US-based, though this is not explicitly stated.

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

Not Applicable. This is an in vitro diagnostic (IVD) device for clinical chemistry analysis. Ground truth for chemical measurements is typically established through reference methods, certified reference materials (NIST SRMs are mentioned for traceability), and established analytical practices, not by expert human graders or reviewers in the way that, for example, an imaging AI would be.

4. Adjudication Method for the Test Set

Not Applicable. See point 3.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, sometimes with AI assistance. The AU5800 is a clinical chemistry analyzer that produces quantitative measurements, not interpretations requiring human reader input in the same way.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, in essence, the entire submission describes standalone performance testing. The AU5800 is an automated analyzer. The "performance validation and comparisons conducted between the representative reagents and analyzer platforms" demonstrate the performance of the device itself (the "algorithm" being the instrument's analytical processes) in producing measurements. There is no human-in-the-loop component for the analytical process of the device itself; it is fully automated.

7. Type of Ground Truth Used

The ground truth for the performance validations, particularly for method comparison, linearity, and precision, would be established by:

• Predicate Device Results: For method comparison, the results obtained from the predicate AU2700 would serve as a comparative "ground truth" or reference to assess the agreement of the AU5800.
• Certified Reference Materials/Standards: For linearity and calibration, measurements against materials with known, accurately determined concentrations (e.g., NIST SRMs like 916a, 965a, 909a-2, 909b mentioned for traceability) are used.
• Established Analytical Methods: For accuracy and other parameters, results might be compared to recognized reference methods in clinical chemistry.

8. Sample Size for the Training Set

Not Applicable. The AU5800 is a clinical chemistry analyzer, not a machine learning or AI algorithm that requires a "training set" in the conventional sense of developing a predictive model. Its "training" is in its engineering design, calibration, and validation against known standards and the predicate device.

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

Not Applicable. See point 8.

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The Poly-Chem 90 ISE Module is for the quantitative in vitro measurement of sodium, potassium, and chloride in human serum on the Poly-Chem 90 clinical chemistry analyzer.

Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases 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.

Poly-Chem 90 ISE Module is for the quantitative in vitro measurement of the level of sodium, potassium and chloride in human serum on the Poly-Chem 90 clinical chemistry analyzer. The ISE module measures sodium, potassium and chloride using ion selective electrode technology.

Here's an analysis of the Poly-Chem 90 ISE Module's acceptance criteria and the study proving it meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Poly-Chem 90 ISE Module appear to be established by demonstrating substantial equivalence to the predicate device (Randox RX Daytona ISE Module) across various performance characteristics. While explicit numerical "acceptance criteria" are not stated as pass/fail thresholds independent of the predicate, the comparison implicitly sets the predicate's performance as the benchmark.

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

The document provides sample sizes for the method comparison studies (where the device is compared to the predicate), which can be considered part of the test set:

• Sodium (Na): 63 samples
• Potassium (K): 74 samples
• Chloride (Cl): 74 samples

The precision, linearity, and sensitivity tests also involved samples, but the exact number of unique patient samples isn't specified in detail beyond "Samples from [range] mmol/L" for precision.

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions the measurement of levels in "human serum."

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

This information is not provided in the document. For an in vitro diagnostic device like this, "ground truth" would typically refer to the reference method (the predicate device in this case, or a gold standard method) rather than expert interpretation of images or clinical data. There is no mention of human experts being involved in establishing the "ground truth" for the performance characteristics of this chemical analyzer.

4. Adjudication Method for the Test Set

This is not applicable as the ground truth is established by chemical measurement, not through expert review and adjudication.

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

A MRMC comparative effectiveness study is not applicable to this type of device (in vitro diagnostic for chemical analysis). This study design is typically used for imaging diagnostics where human readers interpret results, often with and without AI assistance.

6. Standalone Performance

Yes, a standalone performance evaluation was done. The precision, linearity, and sensitivity studies presented in the "Summary of performance testing" section (pages 3-4) directly demonstrate the performance of the Poly-Chem 90 ISE Module itself, without comparison to the predicate. The method comparison studies (page 4) also provide the device's measurements, which are then compared to the predicate, implicitly showing its standalone output.

7. Type of Ground Truth Used

The "ground truth" for evaluating this device's performance appears to be primarily:

• Reference measurements/Method comparison: The predicate device (Randox RX Daytona ISE Module) serves as the comparator for method comparison studies, implying that its measurements are considered the "truth" for this comparison.
• Established analytical methods: For precision, linearity, and sensitivity, the ground truth is based on the inherent principles of analytical chemistry and expected performance characteristics for such assays. For example, linearity is assessed against a theoretical linear response, and precision against statistical variability.

8. Sample Size for the Training Set

The document does not provide information about a specific "training set" or its sample size. This device is an in vitro diagnostic analyzer, not an AI/ML algorithm that typically undergoes a distinct training phase on a dataset. Its performance is characterized through analytical validation studies (precision, linearity, etc.), not a machine learning training process.

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

As there is no mention of a "training set" in the context of an AI/ML algorithm, this question is not applicable. The device's operational parameters and calibration are established through standard analytical chemistry principles and calibration procedures (e.g., using Medica Calibrator A and B, as mentioned) during its manufacturing and setup, not through a data-driven training process.

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