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The i-STAT CG8+ cartridge with the i-STAT 1 System is in the in vitro quantification of sodium and potassium in arterial or venous whole blood in point of care or clinical laboratory settings.

The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of sodium in capillary whole blood in point of care or clinical laboratory settings.

Sodium measurements are used for monitoring electrolyte imbalances.

Potassium measurements are used in the diagnosis and cinical conditions that manifest high and low potassium levels.

The i-STAT CG8+ cartridge is used with the i-STAT 1 analyzer as part of the i-STAT 1 System and contains test reagents to measure sodium (Na) in arterial, venous or capillary whole blood and to measure potassium (K) in arterial and venous whole blood.

The i-STAT 1 System is an in vitro diagnostic (IVD) medical device intended for the quantitative determination of various clinical chemistry tests contained within i-STAT cartridges using whole blood. The i-STAT 1 System consists of a portable blood analyzer (i-STAT 1 analyzer), single-use disposable test cartridges (i-STAT cartridges), liquid quality control and calibration verification materials, and accessories (i-STAT 1 Downloader/Recharger, i-STAT Electronic Simulator and i-STAT 1 Printer). The i-STAT 1 System, including the i-STAT CG8+ cartridge, is designed for use by trained medical professionals in point of care or clinical laboratory settings and is for prescription use only.

The i-STAT CG8+ cartridge contains the required sensors, a fluid pack (calibrant pouch), a sample entry well and closure, fluid channels, waste chamber, and the necessary mechanical features for controlled fluid movement within cartridge. The i-STAT cartridge format allows all the tests in the cartridge to be performed simultaneously. All the test steps and fluid movement occur within the i-STAT CG8+cartridge. Cartridges require two to three drops of whole blood applied to the cartridge using a transfer device by the trained user before the cartridge is placed within the analyzer.

The i-STAT 1 analyzer is a handheld, in vitro diagnostic analytical device designed to run only i-STAT test cartridges. The instrument interacts with the i-STAT CG8+ cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).

This document describes the performance of the i-STAT CG8+ cartridge with the i-STAT 1 System for the in vitro quantification of sodium (Na) and potassium (K) in whole blood. This is a medical device, and the provided text is a 510(k) summary, which is typically submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

It's important to note that the provided text focuses on the analytical performance of a diagnostic device (measuring concentrations of substances), not an AI-assisted diagnostic device for interpreting images or other complex data. Therefore, many of the requested points regarding AI/MRMC studies, number of experts, adjudication methods, and ground truth establishment for complex AI algorithms are not applicable to this type of device and will not be found in the document.

Here's a breakdown of the requested information based on the provided text, focusing on the analytical performance validation:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a single table. Instead, it presents performance characteristic studies (precision, linearity, detection limit, interference, method comparison, and matrix equivalence) with their respective results. The success of these studies implicitly serves as the acceptance criteria for the device to be considered substantially equivalent.

Below is a summary of the reported device performance for key analytical characteristics:

• Cholesterol: Decreased Na results > 400 mg/dL
• Nithiodote (Sodium Thiosulfate): Increased Na results ≥ 2.1 mmol/L |
  | Method Comparison | | | Slope near 1, Intercept near 0, High r | Substantially equivalent to predicate device |
  | K (mmol/L) vs. Predicate (i-STAT CHEM8+) | Arterial/Venous | n=340 | Strong correlation & agreement | Slope: 1.00, Intercept: 0.00, r: 1.00. Bias at Medical Decision Levels (3.0, 5.8, 7.5): 0.00 |
  | Na (mmol/L) vs. Predicate (i-STAT CHEM8+ or epoc Blood Analysis System) | Pooled: Arterial/Venous/Capillary | n=551 (pooled), n=209 (capillary only) | Strong correlation & agreement | Pooled: Slope: 1.00, Intercept: 0.00, r: 0.99. Bias at Medical Decision Levels (115, 135, 150): 0.0. Capillary only: Slope 1.00, Intercept 0.00, r 0.98. Bias 0.0. |
  | Matrix Equivalence | | | Slope near 1, Intercept near 0, High r | Equivalence demonstrated |
  | Na (mmol/L) | Venous/Arterial non-anticoagulated vs. with anticoagulant | n=295 | Strong correlation & agreement | r: 0.99, Slope: 1.00, Intercept: 0.00 |
  | K (mmol/L) | Venous/Arterial non-anticoagulated vs. with anticoagulant | n=292 | Strong correlation & agreement | r: 0.99, Slope: 1.00, Intercept: 0.00 |

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

The "test set" in this context refers to the samples used in the analytical performance studies. The data provenance is described within each study:

• Precision/Reproducibility (Aqueous materials):
  • 20-day precision: N=80 per level (5 levels) for Na and K. Conducted at "one site."
  • Multi-site/operator precision: N=90-97 per level (5 levels) for Na and K. Conducted at "three (3) sites."
• Precision (Whole Blood):
  • N varies by analyte and sample type/range (e.g., Na venous: 17, 99, 67; Na arterial: 2, 89, 62; Na capillary: 3, 56, 95; K venous: 27, 135, 19; K arterial: 23, 124, 6).
  • Whole blood specimens collected "across multiple point of care sites." Capillary specimens involved "two individual fingersticks, collected independently by two operators."
• Linearity:
  • Whole blood samples of "varying analyte levels" were used. Specific N not provided for this study.
• Detection Limit (LoQ):
  • Whole blood that was altered to a low analyte level. Specific N not provided.
• Analytical Specificity (Interference):
  • Whole blood samples were used. Specific N not provided, but interference determined by comparing "control sample" to "test sample."
• Method Comparison:
  • K (Arterial/Venous): N=340. "Lithium heparin venous and arterial whole blood specimens collected across multiple point of care sites."
  • Na (Pooled: Arterial/Venous/Capillary): N=551. "Venous and arterial" data pooled with "capillary whole blood specimens."
  • Na (Capillary only): N=209. "Native and Contrived Capillary Specimens." Bias at Medical Decision Levels for "Native Capillary Specimens" (N=194).
• Matrix Equivalence:
  • N=295 for Na, N=292 for K. "non-anticoagulated venous and arterial whole blood specimens."

Data Provenance: The data was collected from "multiple point of care sites" in the precision and method comparison studies. The document does not specify the country of origin or whether the studies were retrospective or prospective, though typical 510(k) studies for new devices are prospective analytical performance studies.

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

This type of device (in vitro diagnostic for chemical analysis) does not typically involve expert readers or adjudication for "ground truth" in the same way an AI imaging algorithm would. The "ground truth" for analytical performance is the reference measurement provided by a comparator method (e.g., the i-STAT CHEM8+ predicate device or "comparative method" lab instrument) or gravimetric/volumetric preparation for linearity and precision studies.

Therefore, there is no mention of "experts" (e.g., radiologists) establishing ground truth, nor their qualifications or numbers.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this device does not involve human interpretation requiring adjudication. Performance is assessed by comparing quantitative results from the device against a known reference or comparative method.

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 not an AI-assisted diagnostic device, nor does it involve human readers interpreting data. It's a quantitative measurement device.

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

This is an algorithm/device-only performance study, as it's a fully automated in vitro diagnostic device. The performance data presented (precision, linearity, method comparison, etc.) reflects the standalone performance of the i-STAT CG8+ cartridge with the i-STAT 1 System. There is no human interpretation component in the measurement or output of the device.

7. The Type of Ground Truth Used

The "ground truth" in these analytical performance studies is established by:

• Reference materials/calibrators: For precision, linearity, and detection limit studies, defined aqueous or whole blood materials with known (or precisely determined) analyte concentrations are used.
• Comparator methods: For method comparison studies, the device's results are compared against a legally marketed predicate device (i-STAT CHEM8+ cartridge on the i-STAT 1 System) or another established "comparative method" (e.g., epoc Blood Analysis System) which serves as the reference, assumed to be accurate.
• Prepared samples: For linearity, samples are prepared with varying analyte levels.

8. The Sample Size for the Training Set

This document does not specify a "training set" size. For traditional in vitro diagnostic devices, there isn't a "training" phase in the machine learning sense. The device's algorithms (for sensor interpretation and calculation) are developed and validated in a more traditional engineering sense, not through iterative machine learning on a large dataset. The studies described are for validation or testing the final product's performance.

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

Not applicable, as there's no "training set" in the context of machine learning for this type of device. The ground truth for development and internal validation of such a device would likely be established through highly controlled laboratory measurements using reference methods and materials.

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The A-LYTE® Integrated Multisensor (IMT Na K Cl) is for in vitro diagnostic use in the quantitative determination of sodium, potassium, and chloride (Na, K, Cl) in human serum, plasma (lithium heparin) and urine using the Atellica® Cl Analyzer. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of arge 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. Measurements of potassium obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The A-LYTE Na, K, and Cl assays use indirect Integrated Multisensor Technology (IMT). There are four electrodes used to measure electrolytes. Three of these electrodes are ionselective for sodium, potassium and chloride. A reference is also incorporated in the multisensor.

A diluted sample (1:10 with A-LYTE IMT Diluent)) is positioned in the sensor and Na+. K+ or Cl- ions establish equilibrium with the electrode surface. A potential is generated proportional to the logarithm of the analyte activity in the sample. The electrical potential generated on a sample is compared to the electrical potential generated on a standard solution, and the concentration of the desired ions is calculated by use of the Nernst equation.

This document describes the performance characteristics of the A-LYTE® Integrated Multisensor (IMT Na K Cl) device, which is used for the quantitative determination of sodium, potassium, and chloride in human serum, plasma, and urine. The information provided outlines the acceptance criteria for various performance metrics and the study results demonstrating that the device meets these criteria.

Here's a breakdown of the requested information:

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

The document doesn't explicitly list "acceptance criteria" in a separate table, but rather describes the design goals or target performance for each characteristic, followed by the obtained results. I will present these as acceptance criteria and reported performance.

Table 1: Acceptance Criteria and Reported Device Performance

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 Sample Sizes:

  • Detection Capability (LoQ): 180 determinations for each analyte (Na, K, Cl) in both serum/plasma and urine.
  • Linearity: 5 replicates per level for at least nine levels, implying a minimum of 45 measurements per analyte and sample type.
  • Precision: N ≥ 80 for each sample type (serum and urine) for each analyte (Na, K, Cl).
  • Assay Comparison:
    • Na (Serum): 123 samples
    • Na (Urine): 117 samples
    • K (Serum): 119 samples
    • K (Urine): 117 samples
    • Cl (Serum): 123 samples
    • Cl (Urine): 127 samples
  • Reproducibility: N=225 results for each sample type (serum QC, human serum, human urine) per analyte (Na, K, Cl), with n=5 assays in 1 run for 5 days using 3 instruments and 3 sensor lots.
  • Specimen Equivalency:
    • Na (Lithium heparin plasma vs Serum): 138 samples
    • K (Lithium heparin plasma vs Serum): 56 samples
    • Cl (Lithium heparin plasma vs Serum): 136 samples
  • Interferences: Not explicitly stated as a single "sample size," but implied from the number of test concentrations and conditions evaluated (e.g., specific concentrations of hemoglobin, bilirubin, lipemia).
  • Non-Interfering Substances: Not explicitly stated as a single "sample size," but implied from the number of test concentrations and conditions evaluated.

• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission for an in vitro diagnostic device, these studies are typically prospective validation studies conducted at the manufacturer's R&D facilities or contracted labs, adhering to CLSI guidelines.

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

This device is an in vitro diagnostic (IVD) for quantitative determination of electrolytes. The "ground truth" (or reference values) for these types of devices is established through:

• Reference Methods: Comparison against established, well-characterized reference methods or instruments (e.g., the predicate device in the assay comparison, or other highly accurate laboratory methods). In this case, "Atellica CH Na/K/Cl on Atellica CH Analyzer" served as the comparative assay, which itself would have been validated against reference standards.
• Certified Reference Materials: Use of calibrated standards and controls with known analyte concentrations derived from definitive methods.

Therefore, the concept of "experts" (like radiologists interpreting images) establishing ground truth does not directly apply here. Instead, ground truth is based on physical/chemical measurements and their traceability to metrological standards. There are no human experts involved in adjudicating the "truth" of an electrolyte concentration in a sample as there would be in image interpretation.

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

Not applicable. As explained in point 3, the ground truth for this type of quantitative IVD assay is established through comparison to reference methods, not human adjudication of a qualitative or semi-quantitative outcome.

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

Not applicable. This device is an automated laboratory analyzer, specifically an Integrated Multisensor for electrolyte measurement. It is not an imaging AI device that assists human readers.

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

Yes, the performance data presented (Detection Capability, Linearity, Precision, Reproducibility, Interferences) represent the standalone performance of the A-LYTE® Integrated Multisensor (IMT Na K Cl) on the Atellica® CI Analyzer. These are direct measurements of the device's analytical precision, accuracy, and interference profiles under controlled laboratory conditions, without human interpretation influencing the quantitative results. The Assay Comparison also represents the device's performance against another automated laboratory system (the predicate device).

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

The ground truth for this device's performance studies is based on:

• Reference Standards/Methods: Calibrated reference materials and comparison to a legally marketed predicate device (TD-LYTE Integrated Multisensor on Trinidad CH System, now Atellica CH System). This ensures that the measured concentrations are accurately determined against established analytical benchmarks.
• Known Concentrations: For linearity, precision, and interference studies, samples are often spiked or diluted to known concentrations, or quality control materials with certified values are used.

8. The sample size for the training set:

Not applicable. This device is a measurement instrument based on established potentiometric technology (Ion-Selective Electrodes). It does not employ machine learning or AI models that require a separate "training set" in the conventional sense. The development and calibration of such devices rely on comprehensive analytical chemistry and engineering principles, using calibration standards, quality control materials, and extensive internal testing during the development phase. The data presented here are for the validation of the finalized device, not for its iterative training.

9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" for an AI model. For the development and calibration of the IMT, the ground truth would be established through a combination of:

• Primary Reference Materials: Use of highly pure chemical standards with accurately known concentrations.
• Secondary Reference Standards: Calibrated solutions traceable to primary standards.
• Reference Measurement Procedures: Highly accurate and precise analytical methods (e.g., flame photometry, coulometry, or isotope dilution mass spectrometry for elemental analysis) used to assign values to control materials and calibrators.
• Internal R&D and Optimization: Extensive testing and refinement of the sensor and instrument performance using these traceable standards during the development process.

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The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

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

System reagent for the quantitative determination of C-Reactive Protein in human serum and plasma on Beckman Coulter AU/DxC AU Analyzers. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Measurements may also be useful as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes. Reagents for the quantitative determination of Sodium, Potassium and Chloride concentrations in human serum, plasma and urine on the Beckman Coulter ISE modules.

The sodium test system is intended for the quantitative measurement of sodium in serum, plasma, and urine.

Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion 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 potassium test system is intended 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 disease conditions characterized by low or high blood potassium levels.

The chloride test system is intended for the quantitative measurement of the level of chloride in plasma, serum, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer carries out automated analysis of serum, plasma, urine samples and other body fluids and automatically generates results. The device is an automated photometric clinical analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Electrolyte measurement is performed using a single cell lon Selective Electrode (ISE) which is also common among the other members of the AU family.

The ISE module for Na+, K+, and Cl- employs crown ether membrane electrodes for sodium and potassium and a molecular oriented PVC membrane for chloride that are specific for each ion of interest in the sample. An electrical potential is developed according to the Nernst Equation for a specific ion. When compared to the Internal Reference Solution, this electrical potential is translated into voltage and then into the ion concentration of the sample.

In this Beckman Coulter procedure, glucose is phosphorylated by hexokinase (HK) in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6phosphate dehydrogenase (G6P-DH) specifically oxidizes G-6-P to 6phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide (NAD+) to nicotinamide adenine dinucleotide, reduced (NADH). The change in absorbance at 340/660 nm is proportional to the amount of glucose present in the sample.

The CRP Latex reagent is an in vitro diagnostic device that consists of ready to use buffer and latex particles coated with rabbit anti-CRP antibodies. In this procedure, the measurement of the rate of decrease in light intensity transmitted through particles suspended in solution is the result of complexes formed during the immunological reaction between the CRP of the patient serum and rabbit anti-CRPantibodies coated on latex particles. Two measuring range settings are available: Normal application (CRP Concentrations ranging between 5.0-480 mg/L) and Highly Sensitive (Cardiac) Application- (CRP concentrations ranging between 0.2-80mg/L).

This document describes the acceptance criteria and supporting study for the Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer and its associated reagents (Glucose, CRP Latex, ISE Reagents for Sodium, Potassium, and Chloride).

1. Table of Acceptance Criteria and Reported Device Performance

The device performance was evaluated across several metrics. The table below summarizes the acceptance criteria (often implied by the "Pass" result and the specific targets within the CLSI guidelines references) and the reported performance for key tests:

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The GLP systems Track is a modular laboratory automation system designed to automate pre-analytical and postanalytical processing, including sample handling, in order to automate sample processing in clinical laboratories. The system consolidates multiple analytical instruments into a unified workflow.

The Alinity c System is a fully automated, random/continuous access, clinical chemistry analyzer intended for the in vitro determination of analytes in body fluids.

The Alinity c ICT (Integrated Chip Technology) is used for the quantitation of sodium, and chloride in human serum, plasma, or urine on the Alinity c 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.

The GLP systems Track is a modular laboratory automation system (LAS) used to perform multiple pre-analytical and post-analytical steps to automate sample preparation and distribution processes in clinical laboratories. These processes include bar code identification of samples, centrifugation, aliquoting of samples, decapping of samples, transport of samples between processes (modules), delivery of samples to 1 or more Abbott and Third Party commercially available laboratory analyzer(s), capping of samples, and storage of samples. Due to the modular nature of the LAS, customers may select modules and configurations to fit their laboratory needs.

The provided text describes a 510(k) premarket notification for the "GLP systems Track" device. However, it does not contain the detailed acceptance criteria for performance, the study that proves the device meets those criteria, or information on sample sizes for test/training sets, expert qualifications, or adjudication methods.

The document states that "Nonclinical testing was performed on-site at Abbott to ensure the product met the requirements and aligned with the quality system. This testing included design verification, including both software and hardware verification, as well as design validation. Testing was performed for Chain of Custody of the sample ID, and a Method Comparison study comparing the use of the GLP systems Track to a manual method was also performed. Additionally, Electromagnetic Compatibility and Electrical Safety testing was completed."

This broadly indicates that testing was conducted, but the specific details requested in your prompt (Acceptance Criteria, reported performance, sample sizes, expert involvement, etc.) are absent from this regulatory summary.

Therefore, I cannot populate the table or answer most of your questions based on the information provided.

Here's what I can extract based on the limited information:

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

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

• Sample size for test set: Not specified.
• Data provenance: "Nonclinical testing was performed on-site at Abbott." The country of origin and retrospective/prospective nature are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not specified. The testing mentions "Chain of Custody of the sample ID" and a "Method Comparison study comparing the use of the GLP systems Track to a manual method," but details on ground truth establishment and expert involvement are absent.

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

• Not specified.

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 specified. This device is a modular laboratory automation system, not typically a device that involves human readers interpreting results in the same way as, for example, a medical imaging AI. The "human-in-the-loop" aspect does not directly apply here in the context of interpretation improvement assisted by AI.

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

• The document presents the "GLP systems Track" as a modular laboratory automation system. Its performance evaluation would likely focus on its ability to automate pre-analytical and post-analytical processing steps accurately and efficiently, rather than "algorithm-only" performance in the sense of a diagnostic AI. A "Method Comparison study comparing the use of the GLP systems Track to a manual method" was performed, which implies a comparison of the automated system's output to a reference method, but details are not provided.

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

• For the "Method Comparison study comparing the use of the GLP systems Track to a manual method," the "manual method" likely serves as the reference or ground truth. No further details are provided on its establishment.

8. The sample size for the training set

• Not specified. (This device is a hardware/software system for lab automation, not an AI model in the common sense that requires a "training set" for machine learning, although its software components would certainly undergo extensive testing and validation.)

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

• Not applicable/Not specified, as there is no mention of a "training set" in the context of machine learning model development.

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The Stat Profile® Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of Sodium, Potassium, Chloride, Ionized Calcium, and Ionized Magnesium in heparinized arterial and venous whole blood.

The Stat Profile Prime Plus Analyzer System is a low cost, low maintenance analyzer for hospital laboratory and point-of-care settings. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).

The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed.

As with the predicate, the Stat Profile Prime Plus Analyzer is a blood gas, co-oximetry, electrolyte, chemistry, and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control is available, as well as an on-board Quality Management System (QMS), and an electronic monitoring approach that insures the analyzer is working properly at all times.

The Stat Profile Prime Plus Analyzer accepts samples from syringes and open tubes. The minimum sample size for analysis is 135 µL.

Sample collection, preparation and application to the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.

Here's a breakdown of the acceptance criteria and study information for the Stat Profile® Prime Plus Analyzer System, 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" in a quantitative table format. Instead, it presents performance data (method comparison, imprecision) that would be evaluated against established clinical or analytical goals to demonstrate substantial equivalence. The predicate device's performance often serves as the de facto acceptance benchmark.

I will interpret the "Measurement Range" from Table 4 as an implicit acceptance criterion for the device's operational range, and the "Method Comparison Studies" and "Total Imprecision Performance" tables as reported device performance demonstrating equivalence.

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

• Method Comparison Studies (Test Set):

  • Sample Sizes:
    • Na: 432 samples (18 altered samples)
    • K: 435 samples (21 altered samples)
    • Cl: 434 samples (20 altered samples)
    • iCa: 434 samples (20 altered samples)
    • iMg: 426 samples (13 altered samples)
  • Data Provenance: The study was a Point-of-Care (POC) study conducted at 3 POC sites including a Cardiothoracic Intensive Care Unit (CTICU), an Emergency Department (ED), and a Respiratory Therapy Lab (RT). The data provenance is described as comparing "results obtained by trained Healthcare Professionals to results obtained by POC personnel on the same specimens using the same analyzer." The specimens were either quality control materials or discarded blood gas specimens.
  • Retrospective or Prospective: Not explicitly stated, but the description of "comparing results obtained by trained Healthcare Professionals to results obtained by POC personnel" suggests a prospective collection or at least a controlled, concurrent comparison for the purpose of the study. It's not described as a retrospective analysis of existing patient data.

• Total Imprecision Performance (Test Set):

  • The estimates were obtained from different POC personnel running 3 levels of Quality Control/Linearity Materials in duplicate each day for a total of 20 runs on 3 analyzers. (Implies a substantial number of measurements, but the exact N for each measurement type is not detailed beyond "20 runs").

• Within-Run Whole Blood Precision (Test Set):

  • Each precision run consisted of ten (10) replicate measurements. A total of five (5) different native samples and two (2) altered samples were evaluated at each site. This was done by a minimum of two (2) point-of-care operators at each of the three (3) POC sites, for a total of nine (9) operators.

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

The study compares the performance of the Stat Profile® Prime Plus Analyzer System against existing laboratory methods (referred to as "Lab" in Table 1) and its own predicate device.
For the Method Comparison Studies, the "ground truth" or reference method is the "Lab" result, which would typically be generated by a validated, high-accuracy laboratory analyzer. The document does not specify individual human experts or their qualifications for establishing this ground truth; rather, it refers to the "Lab" as the reference. For clinical laboratory devices, the "ground truth" is usually the result from a recognized reference standard method or a highly accurate laboratory instrument rather than individual expert consensus.

For the Imprecision studies, the "ground truth" is typically the measured mean of repeated measurements, and the accuracy is relative to a known value for Quality Control materials. Again, this doesn't involve human experts establishing ground truth in the way it might for imaging studies.

4. Adjudication Method for the Test Set

This type of diagnostic device (blood analyzer) does not typically involve human adjudication in the same way as, for example, image-based diagnostic systems. The method comparison studies compare the device's quantitative output to that of a reference laboratory method. No specific adjudication method like "2+1" or "3+1" is mentioned or applicable here.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-based diagnostic systems where human readers interpret medical images or data. The Stat Profile® Prime Plus Analyzer System is a quantitative in vitro diagnostic device, not an AI-assisted diagnostic tool that supports human interpretation in that manner. The study focused on demonstrating the analytical performance and equivalence of the device to a predicate and laboratory methods.

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

The device itself is a standalone analyzer that measures parameters and produces results. The performance studies (Method Comparison, Imprecision) evaluate the device's standalone analytical performance. Although POC personnel operate the device, the data presented (slopes, intercepts, r-values, %CV) reflects the intrinsic performance of the algorithm/hardware combination (the "device") in generating quantitative measurements, rather than human interpretation. So, yes, the performance metrics reported are for the device operating in a standalone capacity (as a measurement instrument).

7. The Type of Ground Truth Used

• Method Comparison Studies: The ground truth for the method comparison studies was obtained from a reference laboratory method or a "Lab" analyzer. This implies comparison to established, presumably accurate, laboratory instrumentation with well-defined performance characteristics.
• Imprecision and Within-Run Precision Studies: The ground truth for these studies relies on the known concentration values of quality control materials and the statistical analysis of repeated measurements to determine the reproducibility and variability of the device.

8. The Sample Size for the Training Set

The document does not describe the device as employing a machine learning or AI algorithm that requires a distinct "training set" in the conventional sense of AI/ML development. The device uses established "Ion-Selective Electrode (ISE)" technology and measurement algorithms. Therefore, there is no mention of a "training set" for an AI model.

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

As there is no mention of a "training set" for an AI model, this question is not applicable. The measurement principles are based on known electrochemical properties rather than learned patterns from a training dataset.

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The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of sodium, potassium, chloride and blood urea nitrogen in arterial or venous whole blood in point of care or clinical laboratory settings.

Sodium measurements are used for monitoring electrolyte imbalances.

Potassium measurements are used in the diagnosis and monitoring of diseases and clinical conditions that manifest high and low potassium levels.

Chloride measurements are primarily used in the diagnosis, monitoring, and treatment of electrolyte and metabolic disorders including, but not limited to, cystic fibrosis, diabetic acidosis, and hydration disorders.

Blood urea nitrogen measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases.

The i-STAT CHEM8+ test cartridge contains test reagents to analyze whole blood at the point of care or in the clinical laboratory for sodium, potassium, chloride and blood urea nitrogen. The test is contained in a single-use, disposable cartridges require two to three drops of whole blood which are typically applied to the cartridge using a transfer device.

The i-STAT 1 Analyzer is a handheld, in vitro diagnostic analytical device designed to run only i-STAT test cartridges. The instrument interacts with the cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).

The i-STAT 1 System is comprised of the i-STAT 1 analyzer, the i-STAT test cartridges and accessories (i-STAT 1 Downloader/Recharger, electronic simulator and portable printer). The system is designed for use by trained medical professionals at the patient point of care or in the clinical laboratory and is for prescription use only.

The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for in vitro quantification of sodium, potassium, chloride, and blood urea nitrogen (BUN) in arterial or venous whole blood in point-of-care or clinical laboratory settings.

Here's an analysis of the acceptance criteria and the study results:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the precision and method comparison studies aiming to demonstrate substantial equivalence to a predicate device (Beckman DxC). While explicit "acceptance criteria" are not listed in terms of specific thresholds for precision or correlation, the studies aim to show that the i-STAT CHEM8+ performs comparably to the predicate. The "Reportable Range" serves as one aspect of the acceptance criteria for each analyte.

Interference:

• Sodium: Increased results ≥ 3.1 mmol/L with Sodium Thiosulfate.
• Potassium: No identified interferents from the tested substances.
• Chloride: Increased results ≥ 2.4 mmol/L with Lithium Bromide, Increased results ≥ 4.19 mmol/L with Sodium Thiosulfate.
• BUN: Increased results ≥ 10.2 mmol/L with Triglyceride.

Limit of Quantitation (LoQ):

• Sodium: 91 mmol/L
• Potassium: 1.5 mmol/L
• Chloride: 56 mmol/L
• BUN: 1 mg/dL

2. Sample Sizes and Data Provenance

• Precision (Aqueous Materials):

  • Sample Size: 80 or 81 data points for each of 5 levels per analyte (e.g., 81 for Sodium CV L1, 80 for Sodium CV L4). This study was conducted using multiple instruments and one test cartridge lot (implied prospective, in-house laboratory study).
  • Data Provenance: Not explicitly stated as country of origin, but implies an in-house or specialized laboratory setting. It is a prospective analytical study.

• Precision (Whole Blood):

  • Sample Size: 21 test results per sample per instrument (total of 21 test results per sample). This study involved at least 3 levels per analyte, 3 point of care sites, and 7 i-STAT 1 Analyzers. The number of unique whole blood samples is not specified, but the total number of measurements is significant (e.g., for Sodium, there are 19 rows of data, each representing a mean derived from 20 or 21 measurements).
  • Data Provenance: Not explicitly stated as country of origin, but indicates multiple point-of-care sites. This is a prospective analytical study.

• Linearity:

  • Sample Size: Not explicitly stated as a number of individual samples, but involves preparing "whole blood samples of varying analyte levels that spanned the reportable range of the tests."
  • Data Provenance: Implied laboratory-based prospective analytical study.

• Limit of Quantitation (LoQ):

  • Sample Size: Not explicitly stated, but involved whole blood samples (and plasma for Chloride) altered to low concentrations and two test cartridge lots.
  • Data Provenance: Implied laboratory-based prospective analytical study.

• Interference:

  • Sample Size: Not explicitly stated ("whole blood samples").
  • Data Provenance: Implied laboratory-based prospective analytical study.

• Method Comparison:

  • Sample Size:
    • Sodium: N=187
    • Potassium: N=189
    • Chloride: N=176
    • BUN: N=184
  • Data Provenance: Venous and arterial blood specimens were evaluated. Not explicitly stated as country of origin, but indicates clinical laboratory settings. This is a prospective analytical study comparing the i-STAT 1 System to the Beckman DxC.

3. Number of Experts and Qualifications for Ground Truth

This type of device (in vitro diagnostic for laboratory analytes) does not typically involve human expert adjudication for ground truth. The "ground truth" for analytical performance studies is established by:

• The reference method (Beckman DxC in the method comparison study).
• Precisely prepared calibrators or control materials with known concentrations (for precision, linearity, LoQ, and interference studies).
• NIST Standard Reference Materials (SRM) were used for traceability and calibration (NIST SRM 918, 919, 956, 912, 909).

4. Adjudication Method for the Test Set

Not applicable, as this is an analytical device for quantitative measurements, not an imaging device requiring expert clinical interpretation. The ground truth is established by reference measurement systems and documented analytical methods.

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

No, an MRMC study was not done. This type of study is typically for evaluating the performance of diagnostic imaging devices that rely on human interpretation, often with and without AI assistance. This device is an in vitro diagnostic (IVD) analyzer that provides quantitative results.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Yes, the studies presented (precision, linearity, LoQ, interference, and method comparison) represent the standalone performance of the i-STAT CHEM8+ cartridge with the i-STAT 1 System. The device provides a direct quantitative measurement without human interpretation of its internal algorithm's output in the manner implied by "human-in-the-loop performance" for AI/ML devices.

7. The Type of Ground Truth Used

The ground truth for the analytical performance studies was established using:

• Reference instrumentation run by trained laboratory personnel: For the method comparison, the Beckman DxC clinical analyzer served as the comparative method.
• Prepared aqueous and whole blood materials with known analyte concentrations: Used for precision, linearity, LoQ, and interference studies.
• NIST Standard Reference Materials (SRM): Used for traceability and calibration.

8. The Sample Size for the Training Set

Not applicable. This device is a traditional in vitro diagnostic device, not an AI/ML device that requires a "training set" in the machine learning sense. The "training" for such devices typically refers to the development and optimization of the electrochemical sensors and algorithms during the R&D phase, which is not described in terms of a quantifiable "training set size" in a regulatory submission for a traditional IVD.

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

Not applicable, as there is no "training set" in the AI/ML context for this traditional IVD device. The accuracy of the device's measurement principles is established through rigorous analytical verification and validation using reference materials and comparative methods, as detailed in the performance characteristics section.

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The Stat Profile Prime ES Comp Plus Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of Sodium, Potassium, and Chloride in heparinized venous whole blood, plasma and serum.

Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension. Addison's disease, dehydration, or diseases involving electrolyte imbalance.

Potassium Measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.

Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The Stat Profile Prime ES Comp Plus Analyzer is a small, low cost blood electrolyte analyzer. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).

The Stat Profile Prime ES Comp Plus Analyzer has an enhanced test menu and multiple quality control options. External Control Solutions (ampules) shall be offered, as well as an on-board Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly.

The Stat Profile Prime ES Comp Plus Analyzer can accommodate either of two sensor cards in the sensor card housing. The analyzer will determine the test configuration of the system by detecting which sensor card is installed.

The two options for the sensor card are:

• . Sensor Card 1 (Basic Electrolyte Panel plus Hct) shall enable and report the following listed analytes: Hct, Na, K, Cl
• Sensor Card 2(Full Electrolyte Panel plus pH & Hct) shall enable and report the following listed ● analytes: pH, Hct, Na, K, CI, iCa, iMg

As with the predicates, the Stat Profile Prime ES Comp Plus Analyzer is microprocessor-based and incorporates ion selective electrode technology to measure sodium, potassium, and chloride.

The Prime ES Comp Plus can be configured with an optional sample tray, which allows the user to run up to 10 consecutive samples may be any combination of Serum/Plasma or control solutions. Whole Blood samples may only be run in STAT Mode (not tray mode).

Calibration standards are provided in sealed pouches within a callbrator pack. Liquid quality control materials are available as external ampules. Sampling and calibration are fully automated.

The Stat Profile Prime ES Comp Plus Analyzer accepts lithium heparinized whole blood sample from syringes, open tubes, and small cups. The minimum sample sizes for analysis is 100 µL.

This document describes the premarket notification for the Stat Profile Prime ES Comp Plus Analyzer System, a medical device for in vitro diagnostic use. It outlines the device's intended use, performance testing, and the conclusion that it is substantially equivalent to a predicate device.

Here's an analysis of the provided text, broken down by your requested categories:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative table format. Instead, it states that "Performance testing was completed to demonstrate that the Stat Profile Prime ES Comp Plus Analyzer is substantially equivalent in performance, safety and efficacy to the predicate Nova Stat Profile pHOx Ultra Blood Gas Analyzer (K110648)."

The performance tests conducted include:

• Method Comparison Studies
• Precision/Reproducibility Studies
• Run to Run Precision
• Linearity Testing
• Specificity / Interference Testing
• Detection Limit
• Shelf Life Stability Testing

The reported device performance, in relation to these tests, is a general conclusion: "The results of the testing confirmed that the performance of the Stat Profile Prime ES Comp Plus Analyzer System is substantially equivalent to that of the Nova Stat Profile pHOx Ultra Blood Gas Analyzer (predicate device)."

Without specific numerical acceptance criteria (e.g., minimum accuracy, maximum bias, %CV for precision), a direct table comparison with specific values is not possible from the provided text. The acceptance criteria are implicitly that the new device's performance metrics (accuracy, precision, linearity, etc.) met or exceeded those of the predicate device, or fell within clinically acceptable ranges for such devices. The reported device performance is simply that it met these implicit criteria by demonstrating substantial equivalence.

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

The document does not specify the sample sizes used for any of the performance tests (Method Comparison, Precision, Linearity, etc.).

It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) for the test sets.

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

This information is not provided in the document. The device is an in vitro diagnostic blood analyzer, and its ground truth would typically be established by reference methods or other validated laboratory instruments, not by expert consensus in the way an imaging AI might.

4. Adjudication method for the test set

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human readers or expert consensus to resolve discrepancies, particularly for subjective assessments. This document describes an objective measurement device for chemical analytes, where "ground truth" is typically established instrumentally through reference methods, not through human interpretation requiring 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

No, an MRMC comparative effectiveness study was not done. This device is an automated in vitro diagnostic analyzer, not an AI-assisted diagnostic tool that aids human readers. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

Yes, the studies described are essentially standalone performance evaluations of the device. The "Stat Profile Prime ES Comp Plus Analyzer System" is an automated instrument that measures analytes. The performance tests (Method Comparison, Precision, Linearity, etc.) evaluate the device's output (measurements of Na+, K+, Cl-) against either reference methods or expected values, without human interpretive input affecting the measurement itself.

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

The document does not explicitly state the specific type of ground truth used for each test. However, for in vitro diagnostic devices like this, the ground truth for performance studies is typically established by:

• Reference methods: For method comparison studies, the device's measurements are compared against a recognized, often more laborious or expensive, reference measurement method or a well-established, previously validated clinical laboratory analyzer (the predicate device, in this case).
• Known concentrations: For linearity and detection limit studies, samples with precisely known concentrations of the analytes (e.g., prepared standards) are used as ground truth.
• Internal quality control materials: For precision and run-to-run variation, the consistency of measurements on stable, characterized quality control materials acts as a ground truth for reproducibility.

Given the context, the ground truth would be based on analytical reference methods or established comparator devices/standards, not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

The document does not provide any information regarding a training set sample size. This device is an analyzer that utilizes established ion-selective electrode technology and measurement algorithms. It's unlikely to have a "training set" in the sense of machine learning/AI models. The algorithms are based on electrochemical principles, not data-driven learning that requires a distinct training phase.

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

As there is no mention of a training set (as discussed in point 8), this question is not applicable. The device's "ground truth" for its development would be based on the established scientific principles of electrochemical measurement for ions.

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The LIASYS 600 Electrolyte Measurement System is intended for the quantitative determination of sodium, chloride, and potassium in human serum. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of hormone aldosterone), diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The LIASYS 600 creatinine reagent is intended for the quantitative determination of creatinine in human serum. Packaged for the ease of use with LIASYS 600. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

The LIASYS 600 is a random access, computer controlled, standalone clinical analyzer intended for the in-vitro determination of analytes in human serum.

The LIASYS 600 is a random access, computer controlled, standalone clinical analyzer intended for the in-vitro determination of analytes in human serum.

This FDA document describes the clearance of the LIASYS 600 Electrolyte Measurement System and LIASYS 600 Creatinine reagent. It does not contain information about acceptance criteria or specific study results that proves the device meets acceptance criteria. The document only confirms that the device is substantially equivalent to legally marketed predicate devices for the specified indications for use.

Therefore, I cannot provide the requested information based on the provided text. The document is a 510(k) clearance letter, which affirms substantial equivalence rather than detailing performance acceptance criteria and study findings.

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The GEM Premier ChemSTAT is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized 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 Sodium (Na+), Ionized Calcium (Ca++) and Chloride (C1-) from arterial and venous heparinized whole blood. These parameters. along with derived parameters, aid in the diagnosis of a patient's electrolyte balance.

Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes:

• · Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
• · Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
• Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
• · Chloride (Cl-) measurements are used in the diagnosis and metabolic and metabolic disorders, such as, cystic fibrosis and diabetic acidosis.

The GEM Premier ChemSTAT is a portable system that analyzes arterial and venous lithium heparinized whole blood at the point of health care delivery in a clinical setting and in a central laboratory for Na*, K*, Ca** and Cl . All tests are included in a single self-contained, disposable GEM Premier ChemSTAT PAK (cartridge).

Key Components:
Analyzer: The GEM Premier ChemSTAT analyzer has the internal logic and processing power necessary to perform analysis. It employs a unique touch-sensitive color screen and a simple set of menus and buttons for user interaction. The analyzer guides operators through the sampling process with simple, clear messages and prompts.
PAK (Cartridge): The disposable, multi-use GEM Premier ChemSTAT PAK is a completely closed cartridge that houses all components necessary to operate the instrument once the GEM PAK is validated. These components include the sensors, Process Control (PC) Solutions, sampler, and waste bag. The values of all PC Solutions are read from the GEM PAK Electronically Erasable Programmable Read Only Memory (EEPROM) chip. The components and processes used to manufacture the PC Solutions in the GEM PAK are traceable to National Institute of Standards and Technology (NIST) standards, Clinical & Laboratory Standards Institute (CLSI) procedures or other internal standards, where available and appropriate. The GEM Premier ChemSTAT PAK has flexible menus to assist facilities in maximizing efficiency. As part of this program, GEM ChemSTAT CVP (Calibration Valuation Products) are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration following warm-up.
Intelligent Quality Management (iQM): Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier ChemSTAT system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process before and after sample measurement with real-time, automatic error detection, automatic correction and automatic documentation of all corrective actions. iQM performs 4 types of continuous, quality checks to monitor the performance of the GEM PAK, sensors, and reagents throughout the cartridge use-life. These checks include System, Sensor, Pattern Recognition (PR) and Stability Checks.

The provided FDA 510(k) summary for the GEM Premier ChemSTAT describes the device's analytical performance, which is a type of acceptance criteria study. This document is not for an AI/ML device, but rather for an in-vitro diagnostic device that measures specific analytes. Therefore, many of the requested elements pertaining to AI/MRMC studies, expert ground truth, and training sets are not applicable or not provided in this type of submission. However, I can extract information related to the device's analytical performance and the studies conducted to demonstrate its performance against predefined criteria.

Here's a breakdown of the acceptance criteria and performance study details, focusing on what is available in the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the analytical performance specifications and the comparison to the predicate device. The performance studies aim to demonstrate that the device meets these standards.

Table 1: Acceptance Criteria (Implicit from Study Outcomes) and Reported Device Performance for GEM Premier ChemSTAT

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The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings for quantitative determination of sodium, chloride, ionized calcium, and ionized magnesium in heparinized arterial and venous whole blood.

Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance.

Potassium measurements are used in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.

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

lonized 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).

lonized magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium),

The Stat Profile Prime Plus Analyzer System is designed to be a low cost, low maintenance analyzer for the hospital laboratory setting. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).

The system architecture and user interface for this proposed device is based on the previously cleared Stat Profile Prime CCS Analyzer System (K131703). The primary predicate for this proposed device is the Stat Profile pHOx Ultra Analyzer System (K110648).

The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed.

Primary Sensor Card Port:

There are two options for the primary sensor card:

. Primary Sensor Card 1 shall enable and report the following listed analytes: o sodium, potassium, chloride, ionized calcium, and ionized magnesium
. Primary Sensor Card 2 shall enable and report the following listed analytes:

• sodium, potassium, chloride, ionized calcium, and ionized magnesium o

Similar to the primary predicate device, the Stat Profile Prime Plus Analyzer is a blood qas/cooximetry/electrolyte/chemistry and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control will be used, as well as an on-board Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly at all times.

The Stat Profile Prime Plus Analyzer accepts samples from syringes, open tubes, and small cups. The minimum sample size for analysis is 135 µL.

Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.

Stat Profile Prime Plus Analyzer System Components:

The Stat Profile Prime Plus Analyzer System is comprised of the following components.

• Stat Profile Prime Plus Analyzer System .
• Primary Sensor Cartridge
• Auxiliary Sensor Cartridge ●
• Stat Profile Prime Plus Auto-Cartridge Quality Control Pack ●
• Stat Profile Prime Plus Calibrator Cartridge ●
• Stat Profile Prime Plus External Ampuled Control ●
• IFU/Labeling .

Here's a summary of the acceptance criteria and study information for the Nova Biomedical Corporation Stat Profile Prime® Plus Analyzer System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the studies "meet the acceptance criteria" or "met the acceptance criteria" without explicitly listing the numerical acceptance criteria for many tests. The performance is reported as meeting these unstated criteria.

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

• Method Comparison Study:

  • Sample Size: Not explicitly stated. The study compared the Stat Profile Prime Plus to the Nova Stat Profile pHOx Ultra analyzer using "blood comparison data."
  • Data Provenance: Conducted in a "clinical laboratory setting" as indicated by the study description. It is a prospective study as it involves active comparison of devices.

• Precision/Reproducibility Studies:

  • Within Run Precision: 20 replicates per run for each of the following: Stat Profile Prime Plus Internal Controls (Levels 4-5), Stat Profile Prime Plus Ampuled Controls (Levels 4-5), and three whole blood samples from syringes.
  • Run to Run Precision: Triplicate analyses on four whole blood samples in ten separate runs during a single day.
  • Data Provenance: The document doesn't specify country of origin. This appears to be prospective data generated for the study.

• Linearity Testing:

  • Sample Size: Not explicitly stated, beyond indicating "various medical decision limits" and "lower and upper limits of the AMR."
  • Data Provenance: Generated for the study.

• Specificity / Interference Testing:

  • Sample Size: Not explicitly stated for the number of samples, but tests were performed at "two analyte concentrations" for each potential interferent.
  • Data Provenance: Whole blood collected in lithium heparin vacutainers was used for this study. Generated for the study.

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

Not applicable. This device is an in vitro diagnostic device that directly measures analytes. The ground truth for performance studies is typically established by reference methods or validated predicate devices, not human expert consensus.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers are interpreting images or data, and their initial interpretations need to be resolved by a consensus process. For an IVD device measuring analytes, the 'ground truth' is determined by the reference method's result, or the established result of a predicate device.

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) analyzer, not an AI-assisted diagnostic imaging or interpretation device that involves human readers.

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

Yes, the studies described (Method Comparison, Precision, Linearity, Specificity/Interference) evaluate the standalone performance of the Stat Profile Prime Plus Analyzer System. The device directly measures the analytes and reports the results without human interpretation as part of its core function, other than healthcare professionals using the results for diagnosis and treatment.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance studies was established by:

• Comparison to a predicate device: For the method comparison study, the Nova Stat Profile pHOx Ultra analyzer (K110648) served as the reference point for equivalence.
• Reference analyzers/specifications: For linearity testing, results were compared to "the reference analyzer and/or the product specifications."
• Internal controls and ampuled controls: For precision, these served as samples with known or expected values.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device that requires a separate training set. The device operates based on established electrochemical principles (Ion-Selective Electrode) and measurement algorithms.

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

Not applicable, as no training set in the context of machine learning was used.

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