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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 pH, Partial Pressure of Carbon Dioxide (pCO2), Partial Pressure of Oxygen (pO2), Hematocrit, Sodium, Chloride, Ionized Calcium, Ionized Magnesium, Gucose, and Lactate in heparinized capillary whole blood.

Indication for Use: pH, pCO2, pO2 measurements are used in the diagnosis and treatment of life-threatening acid base disturbances.

Hematocrit (Hct) measurements of the packed red blood cell volume are used to distinguish normal states, such as anemia and erythrocytosis.

Glucose (Glu) measurement is used in the diagnosis and treatment of carbohydrate metabolism distuding diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Lactate (lactic acid) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis.

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

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

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

Ionized Calcium (iCa) 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).

Ionized Magnesium (iMg) 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 an analyzer for use in 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.

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: .
  • PO2, PCO2, pH, Hct, tHb, SO2, O2Hb, COHb, MetHb, HHb, Glu, Lactate, Sodium, o Potassium, Chloride, Calcium, Ionized Magnesium
• Primary Sensor Card 2 shall enable and report the following listed analytes: .
  • PO2, PCO2, pH, Hct, tHb, SO2, Glu, Lactate, Sodium, Chloride, Calcium, Ionized o Magnesium

Auxiliarv Sensor Card Port:
The reporting of Creatinine and BUN parameters (or not reporting them) shall be determined by the selection of the Auxiliary Sensor Card

• . Auxiliary Sensor Card 1 shall enable the Creatinine and BUN parameters
• Auxiliary Sensor Card 2 shall be a "dummy" sensor card and will not report any parameters. .

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 ensures the analyzer is working properly.

The Stat Profile Prime Plus Analyzer accepts samples from syringes, open tubes, and capillary tubes. The sample size for analysis is 135 µL for the complete test panel or 90 µL for the capillary panel.

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 Ampule Control
• . IFU/Labeling

Sample Types:
The Stat Profile Prime Plus Analyzer System accepts lithium heparinized arterial, venous, and capillary whole blood.

Measured Parameters:
The Stat Profile Prime Plus Analyzer measures:

• . pH
• . Partial Pressure of Carbon Dioxide (pCO2)
• Partial Pressure of Oxygen (pO2) ●
• Hematocrit (Hct) ●
• . Glucose (Glu)
• . Lactate (Lac)
• Sodium (Na) ●
• Potassium (K)
• Chloride (CI)
• . Ionized Calcium (iCa)
• . lonized Magnesium (iMg)

The Nova Biomedical Stat Profile Prime Plus Analyzer System is undergoing a 510(k) premarket notification to expand its indications for use to include capillary whole blood specimen testing for pH, pCO2, pO2, Sodium (Na+), Potassium (K+), Chloride (Cl-), Ionized Calcium (Ca2+), Ionized Magnesium (Mg2+), Glucose, Lactate, and Hematocrit. The study described focuses on demonstrating the substantial equivalence of the Stat Profile Prime Plus Analyzer system to its predicate device, the Nova Biomedical Stat Profile pHOx Ultra Analyzer, specifically for capillary whole blood samples.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are primarily demonstrated through method comparison and precision studies. While explicit numerical acceptance criteria for each parameter (e.g., specific ranges for slope, intercept, r-value in method comparison, or max SD/CV% for precision) are not directly stated in the provided text as a standalone table, the conclusion sections for each study indicate that the device "met the clinical accuracy acceptance criteria" or "met the performance criteria for precision." The reported performance is shown in the tables below, which are the primary evidence for meeting the implicit acceptance criteria.

Method Comparison (Clinical Accuracy - Comparison to Predicate Device)

Precision (Laboratory and Point-of-Care Settings)

The precision data is presented across multiple tables (Tables 4, 5, 6, 7, 8, 9, 10). Rather than reiterating all data here, the text explicitly states:

• "The precision data for all samples in capillary mode met the within run and between analyzer imprecision specifications for the Prime Plus analyzers." (Summary of Capillary Mode Within Sample Precision)
• "This study demonstrates the Stat Profile Prime Plus analyzer exhibits clinically acceptable imprecision specifications for pH, pCO2, pO2, sodium (Na+), chloride (C1-), potassium (K+), ionized calcium (Ca2+), ionized magnesium (Mg2+), glucose, lactate, and hematocrit measured by the Stat Profile Prime Plus Analyzer System in Capillary mode." (Conclusion of Within-Run Imprecision - Capillary Mode Fingerstick (External POC))
• "The analyzer used for this evaluation met the performance criteria for within sample precision on capillary fingerstick specimens run by POC operators." (Conclusion of Within-Sample Imprecision - Capillary Mode Fingerstick (Internal POC))
• "The Stat Profile Prime Plus analyzers provided consistently reliable performance throughout the evaluation study. The analyzers used for this evaluation met the acceptance criteria for precision." (Conclusion of Within-Run Imprecision - Capillary Mode)

The acceptance criteria are therefore implicitly met by the reported r-values nearing 1.0 and slopes nearing 1.0 with intercepts near 0 for method comparison, and the CV% and SD values falling within acceptable limits (though the limits themselves are not numerically specified in the provided text).

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

• Method Comparison Test Set (Capillary Mode):

  • For each measured parameter, the sample size (N) ranged from 118 to 123 at the ER site and 123 to 128 at the Hemodialysis site. The combined sample size (N) for each parameter ranged from 241 to 251.
  • Provenance: This was a prospective clinical study conducted at two external Point-of-Care (POC) sites within the United States (an Emergency Room and a Hemodialysis Unit). Some samples (less than 10%, indicating "Altered Samples" ranging from 5 to 10 for each site) were altered to cover the full dynamic range. These were "de-identified and discarded arterial blood specimens" for the external precision study (implicitly reflecting human samples, though the exact origin beyond "external POC site" is not specified beyond being collected from patients).

• Precision Test Set (Capillary Mode):

  • Within Run Precision (Internal Lab): 20 replicates for each parameter, tested on two Prime Plus analyzers from venous blood transferred to capillary tubes. This appears to be lab-based, controlled samples.
  • Within Sample Precision (Internal Lab): 2 replicates from 30 different donors (Total N=60 for each analyte) of capillary whole blood. This implies human subjects.
  • Within-Run Imprecision (External POC): Sample analysis involved transferring discarded arterial blood specimens from a lithium heparin syringe to three balanced heparin capillary tubes. The number of unique discarded specimens is not explicitly stated but "each whole blood specimen" suggests multiple, distinct specimens were used.
  • Within-Sample Imprecision (Internal POC - Fingerstick): Capillary whole blood was collected via fingerstick puncture from individuals, with 2 replicates for each. N=60 for all sample pairs. This explicitly involves human subjects/donors.
  • Within-Run Imprecision (Internal Study - Lab): 5 different concentrations of deidentified venous whole blood specimens per analyte. Each concentration was run on 3 Prime Plus analyzers, 5 days, 1 run/day, 8 replicates/run/level. This totals 120 (5 concentrations * 3 analyzers * 5 days * 8 replicates) data points per analyte for the "N" value in Table 10. These are likely controlled lab samples simulating human blood.

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

The provided text does not explicitly state the number of experts used or their specific qualifications for establishing ground truth.

• For the method comparison study, the predicate device (Nova Stat Profile pHOx Ultra Analyzer) serves as the "ground truth" or reference method for comparison. The performance of this predicate device itself is assumed to be established and accepted.
• For the precision studies, the intrinsic analytical performance of the device is assessed, rather than against a human expert's interpretation.

4. Adjudication Method for the Test Set

This information is not applicable as the device measures objective chemical and physical parameters rather than interpreting images or clinical signs that would require human adjudication. The "ground truth" is the measurement from the predicate device or the inherent value in the sample for precision studies.

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

This information is not applicable as the device is an in-vitro diagnostic (IVD) analyzer for quantitative measurements, not an AI imaging or diagnostic algorithm requiring human reader performance studies. The study focuses on instrument performance and equivalence rather than human reader improvement with AI assistance.

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

Yes, the studies conducted (method comparison and precision) are standalone performance evaluations of the device's accuracy and precision in measuring the analytes. There is no "human-in-the-loop" aspect to the analytical performance being evaluated; the device provides direct quantitative measurements.

7. The Type of Ground Truth Used

• Method Comparison: The "ground truth" or reference standard for comparison was the predicate device, the Nova Stat Profile pHOx Ultra Analyzer. This is a comparative method where the new device's performance is assessed against an already legally marketed and accepted device.
• Precision Studies: The "ground truth" for precision is the measured value itself and its statistical variation across multiple runs or samples. It's an assessment of the device's inherent reproducibility and repeatability, not against an external truth source like pathology or outcomes data. Human samples (venous and capillary whole blood) were used to test performance under realistic conditions.

8. The Sample Size for the Training Set

The provided text does not mention a training set as this is not a machine learning or AI-driven device in the sense of requiring an explicit training phase with labeled data in the way an imaging algorithm would. This is an analytical instrument based on established sensor technology and algorithms. Therefore, discussions of training sets and their sample sizes are typically not relevant for this type of device submission. The device uses "the same sensor technology, measurement algorithms, formulations of the internal and external controls, and calibrator cartridge" as its predicate, implying a well-established design.

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

As no training set is discussed or implied to be applicable for this type of analytical device in the provided context, this question is not applicable.

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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 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 pH, Hematocrit, Ionized Calcium and Ionized Magnesium in heparinized venous whole blood, and pH. Ionized Calcium and Ionized Magnesium in plasma and serum.

Ionized Calcium (iCa) measurements are used in the diagnosis and treatment of parathyroid disease, a variety ofbone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Ionized Magnesium (iMg) measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).

pH measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Hematocrit measurements of the packed red blood cell volume are used to distinguish normal from abnormal states, such as anemia and erythrocytosis.

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, Cl, 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 pH, ionized calcium, ionized magnesium.

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 calibrator 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.

The provided text describes a 510(k) premarket notification for the "Stat Profile Prime ES Comp Plus Analyzer System," an in vitro diagnostic device for measuring various blood parameters. It does NOT describe an AI/ML-based device. Therefore, the requested information regarding AI/ML acceptance criteria, training/test sets, expert ground truth establishment, MRMC studies, etc., cannot be extracted from this document as it is not relevant to the described device.

The document focuses on demonstrating substantial equivalence to a predicate device (Nova Stat Profile pHOx Ultra Blood Gas Analyzer) through performance testing typically required for in vitro diagnostic devices, such as method comparison, precision, linearity, specificity/interference, detection limit, and shelf life stability.

Here's a breakdown of what can be extracted, addressing the closest relevant points, and explicitly stating what cannot be found:

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

The document does not explicitly present a table of acceptance criteria paired with the specific numerical reported device performance for each analyte (e.g., pH, iCa, iMg, Hct). Instead, it broadly states that "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)." The study types performed are listed as:

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

Without the detailed test reports attached to this summary, the specific acceptance criteria thresholds and the measured performance values for each of these studies (e.g., specific bias ranges for method comparison, CV% limits for precision) are not available in this document.

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

• Sample Size: The document does not specify the exact sample sizes used for each performance test (method comparison, precision, linearity, etc.).
• Data Provenance: Not explicitly stated, but clinical laboratory settings are mentioned for intended use, implying laboratory-conducted studies. No information on country of origin or whether the data was retrospective or prospective is provided.

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

This question is not applicable. This device is an in vitro diagnostic analyzer, not an AI/ML system requiring human expert interpretation as ground truth for imaging or similar applications. The "ground truth" for the performance studies would be reference methods (for method comparison), known concentrations/values (for linearity/detection limit), or repeated measurements (for precision), all performed using established laboratory techniques, not expert consensus.

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

Not applicable. This is not a human interpretation study.

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 for human readers.

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

Not applicable. This is a standalone analytical device, but the term "standalone performance" in the context of your prompt usually refers to the accuracy of an AI algorithm on its own. For this device, all performance listed (method comparison, precision, etc.) is its standalone performance. The device operates without human-in-the-loop interpretation assistance, but rather as an automated analyzer whose results are then used by healthcare professionals.

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

The "ground truth" or reference values for this type of device would typically be:

• For Method Comparison: Results obtained from a well-established, validated reference method or another legally marketed device known for its accuracy.
• For Linearity: Samples with precisely known concentrations prepared gravimetrically or volumetrically.
• For Precision/Reproducibility: Statistical analysis of repeated measurements on stable samples.

The document does not specify the exact reference instruments or methods used, but this is the general approach for IVD devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set." Its operating principles are based on ion-selective electrodes and impedance sensors, as described.

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

Not applicable. See point 8.

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The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine on the ARCHITECT c8000 System.

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 Magnesium reagent kit contains Reagent 1 and Reagent 2. Magnesium present in the sample is a cofactor in an enzymatic reaction with isocitrate dehydrogenase. The rate of increase in absorbance at 340 nm, due to the formation of NADPH, is directly proportional to the magnesium concentration.

The provided document is a 510(k) summary for a medical device called "Magnesium" from Abbott Laboratories. It details the performance testing conducted to demonstrate its substantial equivalence to a predicate device. This document describes an in vitro diagnostic (IVD) device for measuring magnesium levels, not an AI/ML-based device. Therefore, many of the requested elements related to AI (e.g., ground truth establishment by experts, adjudication, MRMC studies, training set details) are not applicable to this submission.

However, I can extract information relevant to the acceptance criteria and performance of this IVD device.

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

Device: Abbott Laboratories Magnesium Assay (List No. 3P68)
Intended Use: Quantitation of magnesium in human serum, plasma, or urine on the ARCHITECT c8000 System for diagnosis and treatment of hypomagnesemia and hypermagnesemia.
Predicate Device: Roche Magnesium Gen.2 (K983416)

1. Acceptance Criteria and Reported Device Performance

The document describes various performance studies and their results. The implicit acceptance criteria are that the device's performance characteristics demonstrate substantial equivalence to the predicate device and are within acceptable ranges for clinical utility.

• Bio-Rad Level 1: 1.3 %CV
• Bio-Rad Level 2: 1.3 %CV
• LoQ Urine Pool -Low Mg: 2.4 %CV
• Human Urine Pool - Normal Mg: 1.8 %CV
• Human Urine Pool Abnormal Mg: 1.8 %CV |
  | Interference | Assay results should be impacted by no more than ±10% for specific interferent levels. | For magnesium samples targeted to 5 mg/dL: no more than ±10% interference for listed substances (Albumin ≤ 64.0 mg/dL, Ascorbic Acid ≤ 200 mg/dL, Bilirubin (Conjugated) ≤ 59.9 mg/dL, Calcium ≤ 26.0 mg/dL, Glucose ≤ 1220 mg/dL, Hemoglobin ≤ 1200 mg/dL, Phosphorous ≤ 307 mg/dL, Boric Acid ≤ 1000 mg/dL, 6N Hydrochloric Acid ≤ 3.0 mL/dL, Copper ≤ 21.6 µg/dL, Zinc ≤ 3504 µg/L, Iron ≤ 0.6 mg/dL).

For magnesium samples targeted to 14 or 15 mg/dL: similar results for the same interferents with slightly different calcium and bilirubin levels.

Acetic acid, nitric acid, and sodium fluoride did not meet the ±10% criterion and are noted as limitations. |
| Linearity | The assay should be linear across its analytical measuring interval. (No explicit R-squared or slope criterion, but stated that it was "demonstrated to be linear"). | Urine application demonstrated linearity across 1.04 to 36.24 mg/dL, spanning the analytical measuring interval of 1.81 to 26.35 mg/dL. |
| Measuring Interval (Analytical Measuring Range) | Defined by LoQ and highest linear point. | 1.81 to 26.35 mg/dL |
| Method Comparison (Correlation to Predicate) | Demonstrate acceptable correlation (slope and correlation coefficient) to the predicate device across the measuring interval. | Urine application showed acceptable correlation to predicate:

• pH

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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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The Magnesium assay is used for the quantitation of magnesium in human serum or plasma on the ARCHITECT e8000 System.

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 Magnesium reagent kit contains Reagent 1 and Reagent 2. Reagent 1 contains Isocitrate dehydrogenase and D-Isocitrate potassium salt. Reagent 2 contains NADP. Both reagents contain sodium azide (0.1%) as a preservative. The assay principle is enzymatic, where magnesium acts as a cofactor in a reaction with isocitrate dehydrogenase, and the rate of increase in absorbance at 340 nm due to NADPH formation is directly proportional to magnesium concentration.

The Abbott Laboratories Magnesium assay (LN 3P68) is intended for the quantitative determination of magnesium in human serum or plasma on the ARCHITECT c8000 System. This device is a Class I, reserved product, with product code JGJ.

Study Type: Analytical Performance Study

Acceptance Criteria and Reported Device Performance:

Details of the Studies:

1. Sample Size used for the test set and the data provenance:

   • Limit of Blank, Limit of Detection, and Limit of Quantitation:
     • Test Set: LoB: 4 saline samples (zero-analyte), each tested in 10 replicates. LoD and LoQ: Minimum of 2 low-analyte level samples at each of 4 target concentrations (0.05, 0.15, 0.30, and 0.60 mg/dL), each tested in 10 replicates.
     • Data Provenance: Not explicitly stated, but likely laboratory-prepared samples. Retrospective/Prospective not specified.
   • Within-Laboratory Precision (20-Day):
     • Test Set: 6 control materials (Bio-Rad Level 1, Bio-Rad Level 2, LoQ Serum Pool, Human Serum Pool – Normal Mg, Human Serum Pool – Elevated Mg, Human Serum Pool – Abnormal Mg). Each tested in 2 replicates, 2 times per day for 20 days.
     • Data Provenance: Laboratory-prepared and commercially available controls. Human serum pools and diluted normal human serum used. Retrospective/Prospective not specified.
   • Specimen Tube Type (Matrix Comparison):
     • Test Set: Minimum of 40 sample sets for each evaluated tube type. 36 unaltered, 3 spiked, 1 diluted. These samples spanned the measuring interval (0.60 to 9.50 mg/dL).
     • Data Provenance: Fresh or frozen patient samples. Country of origin not specified. Retrospective/Prospective not specified.
   • Interference:
     • Test Set: Control and test level samples for each potential interferent. Tested in a minimum of 6 valid replicates for general interferents, 3 replicates for sulfasalazine and sulfapyridine, and a minimum of 7 replicates for copper, iron, zinc, ibuprofen, acetaminophen, salicylic acid, and triglycerides.
     • Data Provenance: Likely laboratory-prepared samples (spiked serum) and control samples. Retrospective/Prospective not specified.
   • Linearity:
     • Test Set: 3 sets of linearity standards, each with 12 levels of magnesium target concentrations (0.30 to 12.50 mg/dL). Each level tested in a minimum of 4 replicates.
     • Data Provenance: Laboratory-prepared standards using magnesium standard and 4% HSA. Retrospective/Prospective not specified.
   • Method Comparison:
     • Test Set: 122 patient serum specimens. 11 of these were normal serum samples spiked with magnesium hexachloride.
     • Data Provenance: Patient serum specimens, some spiked. One replicate of the predicate device was run at UT Southwestern Medical Center (UTSW, Dallas). Country of origin not specified, but UTSW suggests USA. Retrospective/Prospective not specified.
   • Manual Dilution:
     • Test Set: Three serum pools (human serum and magnesium chloride) at magnesium concentrations of 8, 15, and 25 mg/dL (±10%). Each pool evaluated neat, 1:2 diluted, and 1:5 diluted. Samples tested in a minimum of 7 replicates.
     • Data Provenance: Laboratory-prepared human serum pools. Retrospective/Prospective not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are analytical performance studies for an in-vitro diagnostic device measuring a chemical analyte (Magnesium), not studies requiring expert interpretation of images or clinical outcomes. The "ground truth" for these tests refers to the known concentrations or characteristics of the prepared samples or reference methods.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used in studies involving subjective expert review (e.g., image interpretation). These are objective analytical measurements.

4. 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 analytical performance study for an in-vitro diagnostic device, not an AI-assisted diagnostic imaging study involving human readers.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Yes, all studies described are standalone analytical performance evaluations of the device (Magnesium assay on the ARCHITECT c8000 System). There is no "human-in-the-loop" component in the measured performance of this chemical assay.

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

   • Limit of Blank, Limit of Detection, and Limit of Quantitation: Gravimetrically prepared low-analyte samples and saline.
   • Within-Laboratory Precision: Commercially available control materials and laboratory-prepared human serum pools with known target concentrations.
   • Specimen Tube Type (Matrix Comparison): Comparison against results from the control tube type (serum glass tube).
   • Interference: Comparison against control samples without the interferent, with target magnesium levels.
   • Linearity: Laboratory-prepared linearity standards with known magnesium target concentrations.
   • Method Comparison: Comparison against a legally marketed predicate device (Roche Magnesium Gen.2).
   • Manual Dilution: Laboratory-prepared serum pools with known magnesium concentrations and expected dilution values.

7. The sample size for the training set: Not applicable. This device is an in-vitro diagnostic assay for measuring magnesium, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The development of such assays involves reagent formulation and optimization, calibration, and validation, but not a distinct "training set" like in AI.

8. How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

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

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

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

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

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

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

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

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

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

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

• Linearity Test Set:

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

• Detection Limit Test Set:

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

• Analytical Specificity / Interference Test Set:

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

• Method Comparison Test Set:

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

• Matrix Comparison Test Set:

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

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

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

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

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

Not applicable. Adjudication methods like "2+1" or "3+1" are used in studies where human readers provide interpretations and discrepancies need to be resolved. This document describes analytical performance studies of a laboratory diagnostic assay, where quantitative results are compared to known concentrations or a predicate device. There is no human interpretation involved in generating the "ground truth" for the concentrations themselves, nor in interpreting the results of the device in a way that would require adjudication.

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

Not applicable. This is an in vitro diagnostic (IVD) device for quantitative measurement of magnesium, not an AI-powered imaging device or a device requiring human readers/interpreters. Therefore, no MRMC study was conducted, and there's no concept of human readers improving with or without AI assistance for this type of device.

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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The Atellica™ CH Magnesium (Mg) assay is for in vitro diagnostic use in the quantitative determination of magnesium in human serum, plasma (lithium heparin), and urine using the Atellica™ CH Analyzer. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).

The Atellica CH Mg assay is based on the modified xylidyl blue reaction, which was first described by C.K. Mann and J.H. Yoe. 1-2 The reagent was modified to eliminate the use of organic solvents. Magnesium ions react with xylidyl blue in an alkaline medium to form a water-soluble purple-red complex. The increase in absorbance of xylidyl blue at 505/694 nm is proportional to the concentration of magnesium in the sample. Calcium is excluded from the reaction by complexing with EGTA.

This document describes the performance assessment of the Siemens Atellica CH Magnesium (Mg) assay, an in vitro diagnostic device used for the quantitative determination of magnesium in human serum, plasma, and urine.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the performance characteristics demonstrated in the study and compared to the predicate device. The document does not explicitly list "acceptance criteria" as a separate column with pass/fail remarks, but rather presents the study results, implying that these results met the internal validation requirements for substantial equivalence.

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The Dimension Vista® Magnesium Flex® reagent cartridge (MG) method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista® System. 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 Dimension Vista® Chemistry 1 Calibrator (CHEM 1 CAL) is an in vitro diagnostic product for the calibration of Blood Urea Nitrogen (BUN),Calcium (CA), Cholesterol (CHOL), Creatinine (CRENCRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU) and Uric Acid (URCA) methods on the Dimension Vista® System.

CHEM 1 CAL is a liquid, frozen multi-analyte, bovine serum albumin based product used to calibrate blood urea nitrogen, calcium, cholesterol, creatinine, glucose, lactic acid, magnesium, thyroxine, thyronine uptake and uric acid. The kit consists of six vials, three vials of Calibrator A and three vials of Calibrator B.

The Dimension Vista® MG Flex® reagent cartridge uses a modified methylthymol blue (MTB) complexometric technique. MTB forms a blue complex with magnesium. Calcium interference is minimized by forming a complex between calcium and Ba-EGTA (chelating agent). The amount of MG-MTB complex formed is proportional to the magnesium concentration and is measured using a bichromatic (600 and 510 nm) endpoint technique.

The provided text describes the performance characteristics of the Dimension Vista® Magnesium Flex® reagent cartridge (MG) and the Dimension Vista® Chemistry 1 Calibrator (CHEM 1 CAL). The focus is on demonstrating substantial equivalence to predicate devices and meeting established clinical laboratory guidelines. However, the information is primarily focused on analytical performance rather than clinical effectiveness or diagnostic accuracy in specific patient populations.

Here's an attempt to extract the requested information, acknowledging that some categories may not be directly applicable or fully detailed given the nature of an in vitro diagnostic device's analytical validation.

1. Table of Acceptance Criteria and Reported Device Performance

Device: Dimension Vista® Magnesium Flex® reagent cartridge (MG) for quantitative measurement of magnesium.

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The ACE Carbon Dioxide (CO2-LC) Reagent is intended for the quantitative determination of carbon dioxide concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Direct Bilirubin Reagent is intended for the quantitative determination of direct bilirubin concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Total Bilirubin Reagent is intended for the quantitative determination of total bilirubin concentration in serum and lithium heparin plasma using the ACE, ACE Alera and ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Magnesium Reagent is intended for the quantitative determination of magnesium in serum and lithium heparin plasma using the ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems. 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). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

In the ACE Carbon Dioxide (CO2-LC) Reagent assay, serum carbon dioxide (in the form of bicarbonate) reacts with phosphoenolpyruvate in the presence of phosphoenolpyruvate carboxylase and magnesium to yield oxaloacetic acid and phosphate. In the presence of malate dehydrogenase, the reduced cofactor is oxidized by oxaloacetic acid. The reduced cofactor absorbs strongly at 408 nm whereas its oxidized form does not. The rate of decrease in absorbance, monitored bichromatically at 408 nm/692 nm, is proportional to the carbon dioxide content of the sample.

In the ACE Direct Bilirubin Reagent assay, sodium nitrite added to sulfanilic acid forms diazotized sulfanilic acid. Bilirubin glucuronide in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The increase in absorbance, measured bichromatically at 554 nm/692 nm, one minute after sample addition, is directly proportional to the direct bilirubin concentration.

In the ACE Total Bilirubin Reagent assay, sodium nitrite, when added to sulfanilic acid, forms diazotized sulfanilic acid. Bilirubin in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The inclusion of dimethyl sulfoxide (DMSO) in the reagent as an accelerator causes both direct and indirect bilirubin to react rapidly. The increase in absorbance, measured bichromatically at 554 nm/692 nm, is directly proportional to the total bilirubin concentration in the sample.

Magnesium ions in serum react with Xylidyl blue-1 in an alkaline medium to produce a red complex which is measured bichromatically at 525 nm/692 nm. The intensity of color produced is directly proportional to the magnesium concentration in the sample. EGTA prevents calcium interference by preferential chelation of calcium present in the sample. A surfactant system is included to remove protein interference.

The provided text describes several in vitro diagnostic reagents (ACE Carbon Dioxide (CO2-LC) Reagent, ACE Direct Bilirubin Reagent, ACE Total Bilirubin Reagent, and ACE Magnesium Reagent) and their associated performance data. There isn't information about an AI-powered device or software. Therefore, questions related to AI aspects like multi-reader multi-case studies, effect size of AI assistance, or standalone algorithm performance are not applicable.

The acceptance criteria are not explicitly stated as clear thresholds in the provided document; rather, the document presents detailed performance data (precision, linearity, interference, and method comparison) that demonstrates the device's capability to perform as intended and to be substantially equivalent to its predicate devices. The "reported device performance" is presented directly through tables and statistical analyses for each reagent.

Here's an attempt to structure the available information based on the request, interpreting "acceptance criteria" as the performance demonstrated to support substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit "acceptance criteria" (i.e., predefined thresholds for performance metrics) are not provided in the document, the "Reported Device Performance" below represents the data presented that presumably met the internal criteria for demonstrating substantial equivalence. The document primarily focuses on precision, linearity, interference, and method comparison with predicate devices and between different systems (ACE, ACE Alera, ACE Axcel).

ACE Carbon Dioxide (CO2-LC) Reagent

ACE Direct Bilirubin Reagent

ACE Total Bilirubin Reagent

ACE Magnesium Reagent

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

The document describes several types of studies:

• In-House Precision:

  • CO2-LC: Low, Mid, High serum and plasma samples were tested (number of replicates per sample and runs is implicitly part of SD/CV calculation, but not explicitly stated).
  • Direct Bilirubin: Low, Mid, High serum and plasma samples.
  • Total Bilirubin: Low, Mid, High serum and plasma samples.
  • Magnesium: Low, Mid, High serum and plasma samples.
  • Data Provenance: In-house (Alfa Wassermann Diagnostic Technologies, LLC, West Caldwell, NJ), prospective testing.

• POL (Physician Office Laboratory) Precision: Studies conducted at 3 POL sites.

  • CO2-LC: 3 samples at each of 3 POL sites and in-house.
  • Direct Bilirubin: 3 samples at each of 3 POL sites and in-house.
  • Total Bilirubin: 3 samples at each of 3 POL sites and in-house.
  • Magnesium: 3 samples at each of 3 POL sites and in-house.
  • Data Provenance: Not explicitly stated but inferred to be from POLs in the USA (prospective testing under typical POL conditions).

• In-House Matrix Comparison (Serum vs. Plasma):

  • CO2-LC: 53-54 pairs (serum/plasma) on ACE and ACE Alera; 51 pairs on ACE Axcel.
  • Direct Bilirubin: 102 pairs on ACE; 101 pairs on ACE Alera; 56 pairs on ACE Axcel.
  • Total Bilirubin: 102 pairs on ACE and ACE Alera; 56 pairs on ACE Axcel.
  • Magnesium: 101 pairs on ACE and ACE Alera; 55 pairs on ACE Axcel.
  • Data Provenance: In-house, retrospective (presumably collected for a range of values).

• POL Method Comparison (In-House ACE vs. POL ACE/Alera):

  • CO2-LC: 45-46 samples per POL site comparison.
  • Direct Bilirubin: 49-51 samples per POL site comparison.
  • Total Bilirubin: 48-50 samples per POL site comparison.
  • Magnesium: 50-52 samples per POL site comparison.
  • Data Provenance: Not explicitly stated but inferred to be from POLs in the USA (prospective testing under typical POL conditions) compared against in-house data.

• Detection Limits (LoB, LoD, LoQ), Linearity, Interferences (ACE Alera):

  • Sample sizes for detection limits and linearity: Not explicitly stated, typically involves multiple replicates at various concentrations.
  • Sample sizes for interferences: Not explicitly stated, typically involves samples spiked with various concentrations of interferents.
  • Data Provenance: In-house.

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. For in vitro diagnostic assays, the "ground truth" is typically the reference method or established clinical laboratory results obtained from a highly accurate and calibrated instrument or laboratory using validated methods, rather than human expert consensus for image or clinical interpretation. The document compares performance against other (presumably established) methods and predicate devices.

4. Adjudication Method for the Test Set

This concept (e.g., 2+1, 3+1 for resolving discrepancies) is not applicable to these types of in vitro diagnostic device studies. Performance is measured numerically and objectively.

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

No. This is an in vitro diagnostic assay, not an AI-powered diagnostic imaging device.

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

Not applicable. This is not an AI algorithm. The performance data presented are for the reagent and instrument system.

7. The Type of Ground Truth Used

For precision studies, the "ground truth" is the true concentration of the analyte in the control material or patient sample, which is established by reference methods or manufacturing specifications of the control materials. For method comparison studies, the predicate device's results or an established in-house method are used as the comparative reference. The document states the intended use is for "quantitative determination" of analytes, implying comparison to a quantitative gold standard.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning device and therefore does not have a "training set" in that context. The development of reagents and the establishment of their performance characteristics do not involve machine learning training sets.

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

Not applicable, as there is no "training set" for these reagents in the context of AI/ML.

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