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

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

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

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

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

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

The "Performance Conclusions" section on page 6 and 15 state that the device "performs equivalently to the predicate device" and is "safe and effective for its intended purpose and equivalent in performance to the reference device," implying all acceptance criteria were met.

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

• Precision Studies (Aqueous Controls):
  • Each of the three quality control levels (tri-level aqueous EasyQC material) was analyzed.
  • Tested in three EasyStat 300 analyzers.
  • Tested for twenty days.
  • Duplicate readings in the morning (AM) and afternoon (PM).
  • Total samples: 3 (levels) * 3 (analyzers) * 20 (days) * 2 (readings/day) = 360 data points per analyte for aqueous controls.
  • Provenance: "in a laboratory setting (Bench test)" using "aqueous controls."
• Repeatability (5-Day) Study – Whole Blood Samples:
  • Five replicates of whole blood samples.
  • Tested over five days.
  • Number of distinct whole blood samples is not explicitly stated, but it was "whole blood from adult volunteers."
  • Provenance: "venous whole blood from adult volunteers," "in a laboratory setting (Bench test)."
• Linearity Study:
  • Nine (9) to eleven (11) spiked and diluted whole blood specimens per analyte.
  • Tested on three EasyStat 300 analyzers.
  • Tested in triplicate.
  • Total samples: (9 to 11) * 3 (analytes) * 3 (analyzers) * 3 (replicates) = approximately 243 to 297 data points.
  • Provenance: "spiked and diluted whole blood specimens."
• Method Comparison Study:
  • 192 donors.
  • Six modified whole blood samples (spiked and diluted).
  • Total of 198 samples.
  • Tested on the reference device twice.
  • Tested on three EasyStat 300 analyzers in duplicate.
  • Total samples: 198 (unique samples).
  • Provenance: "whole blood from 192 donors plus six modified whole blood samples (spiked and diluted)." The donors' country of origin is not specified, but the study was conducted "in a laboratory setting (Bench test)." This is a prospective collection for the study.
• Sensitivity Study:
  • Performed on three ES 300 analyzers.
  • Specific number of blanks/low-concentration samples not explicitly stated but implies sufficient measurements as per CLSI EP17-A.
  • Provenance: Not specified, but likely laboratory-prepared samples.
• Selectivity Study:
  • Provenance: "spiked whole blood samples collected from healthy donors." Country/origin not specified.

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

The document describes performance studies for an in-vitro diagnostic device that measures potassium, calcium, and chloride levels. The "ground truth" for such devices is typically established by:

• Reference methods/predicate devices.
• Certified reference materials.
• Laboratory-prepared controls with known concentrations.

The document states:

• For the Method Comparison Study, the "reference analyzer was the EasyStat, K063376."
• For Precision Studies, "EasyStat 300 tri-level aqueous EasyQC material" was used, implying certified or well-characterized control materials.
• For Linearity, "pre-assayed whole blood samples" were used.

Therefore, the ground truth was established by:

• A predicate device/reference analyzer (EasyStat, K063376).
• Certified/characterized quality control materials (EasyQC material).
• Pre-assayed/spiked laboratory samples.

There is no mention of "experts" in the context of clinical interpretation or subjective assessment to establish ground truth because this is a quantitative measurement device, not an image-based or qualitative diagnostic. The "experts" in this context would be the technicians operating the reference methods and preparing the samples, ensuring accurate measurement. Their specific qualifications are not detailed beyond "trained technicians in clinical laboratories" mentioned in the Indications for Use.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used for studies where subjective interpretation is involved, such as reading medical images, to establish a consensus ground truth.

For the EasyStat 300, which is a quantitative measurement device, the "ground truth" is established through:

• Reference instrument measurements.
• Known concentrations of control materials.
• Statistical comparison to established methods (e.g., linear regression, bias analysis).

Therefore, no multi-reader adjudication method (like 2+1 or 3+1) was used or is relevant for these types of analytical performance studies. The comparison is between the new device's readings and the established/known values.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, 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-assisted diagnostic tools that involve human interpretation (e.g., radiologists reading images with or without AI assistance).

The EasyStat 300 is an in-vitro diagnostic instrument that performs automated quantitative measurements; it does not involve human interpretation of complex data that could be augmented by AI.

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

Yes, the studies performed for the EasyStat 300 represent standalone performance of the device. The device itself (the "algorithm" or instrumentation in this context) performs the measurements and generates results. While it requires a trained technician to operate it and load samples, the performance metrics (precision, linearity, method comparison, sensitivity) evaluate the inherent analytical capabilities of the analyzer without a human "in-the-loop" making diagnostic interpretations based on the device's output. The device provides quantitative results; it doesn't provide interpretations that a human would then refine.

7. The Type of Ground Truth Used

The ground truth used for the studies includes:

• Reference method/predicate device measurements: For the Method Comparison study, the "EasyStat, K063376" was the reference analyzer.
• Reference materials/known concentrations: "Tri-level aqueous EasyQC material" and "spiked and diluted whole blood specimens" with known or established values were used for precision, linearity, and sensitivity studies.
• Venous whole blood from adult volunteers and healthy donors: Used for precision and selectivity studies, where the measurements were compared against expected ranges or changes from a baseline.

8. The Sample Size for the Training Set

The provided document describes analytical validation studies for regulatory submission (510(k)) of an in-vitro diagnostic device. These types of submissions typically focus on analytical performance testing rather than machine learning model validation with distinct "training" and "test" sets. The EasyStat 300 is an instrument using "Ion Selective Electrode" (ISE) sensors and doesn't explicitly describe a machine learning algorithm that undergoes a training phase in the context of this document.

Therefore, the concept of a "training set" in the context of artificial intelligence/machine learning is not applicable to this device as described. The document does not mention any training data or set used for an algorithm.

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

Since there is no "training set" identified for an AI/ML algorithm in the provided document, the question of how its ground truth was established is not applicable. The device's performance relies on its hardware (ISE sensors) and predefined algorithms for calculation and calibration, not on a machine learning model trained on a data set.

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

4. Adjudication Method for the Test Set

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

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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The GEM Premier 7000 with iQM3 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 pH, pCO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin, and CO-Oximetry (tHb, O2Hb, MetHb, HHb, sO2*) parameters from arterial, venous, or capillary lithium heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity.

*s02 = ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin.

• · pH, pCO2, and pO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid- base disturbances.
• · 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 insividus, 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 treatment of electrolyte and metabolic disorders, such as cystic fibrosis and diabetic acidosis.
• · Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).
• · Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism
• disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
• · Lactate (Lac) measurement is used:
• to evaluate the acid-base status of patients suspected of having lactic acidosis;
• to monitor tissue hypoxia and strenuous physical exertion;
• in the diagnosis of hyperlactatemia.
• · Total Bilirubin (tBili) measurement is used to aid in assessing the risk of kernicterus and hyperbilirubinemia in neonates.

• CO-Oximetry (tHb, COHb, MetHb, O2Hb, HHb, and sO2) evaluates the ability of the blood to carry oxygen by measuring total hemoglobin and determining the percentage of functional and dysfunctional hemoglobin species.

– Total Hemoglobin (tHb): Total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.

• COHo: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.

• MetHb: Methemoglobin measurements are used to determine different conditions of methemoglobinemia.

• HHb: Deoxyhemoglobin, as a fraction of total hemoglobin, is used in combination with oxyhemoglobin to measure oxygen status.

• O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with deoxyhemoglobin to measure oxygen status.

• sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin, is used to measure oxygen status.

The GEM Premier 7000 with iQMs system provides health care professionals with quantitative measurements of lithium heparinized whole blood pH, pCO2, pO2, Na*, K*, Ch, Ca**, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO₂*) from arterial, venous or capillary samples at the point of health care delivery in a clinical setting and in a central laboratory.

*sO₂ = Ratio between the concentration of oxyhemoglobin plus deoxyhemoglobin plus deoxyhemoglobin.

Key Components:
Instrument: 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): All required components for sample analysis are contained in the GEM PAK, including sensors, optical cell for CO-Oximetry and total bilirubin, sampler, pump tubing, distribution valve, waste container and Process Control Solutions. The GEM PAK is an entirely closed analytical system. The operator cannot introduce changes to the analytical process before or during the GEM PAK's use-life on board the instrument. The GEM PAK has flexible menus and test volume options to assist facilities in maximizing efficiency. The EEPROM on the GEM PAK includes all solution values and controls the analyte menu and number of tests. The setup of the instrument consists of inserting the GEM PAK into the instrument. The instrument will perform an automated GEM PAK start-up during which the following is performed: warm-up (15 minutes), sensor conditioning (10 minutes), Process Control Solution (PCS) performance (15 minutes), all of which take about 40 minutes. After GEM PAK start-up, Auto PAK Validation (APV) process is automatically completed: two completely independent solutions traceable to NIST standards, CLSI procedures or internal standards, containing two levels of concentration for each analyte (PC Solution D and E), are run by the analyzer to validate the integrity of the PC Solutions and the overall performance of the analytical system. Note: GEM PAKs that include tBili analyte will require the successful performance of CVP 5 tBili. Includes all necessary components for hemolysis detection, such as an acoustofluidic flow cell, an LED light source and an optical detector, for appropriate flagging of potassium measurements in whole blood samples without additional sample volume or sample processing steps.
Intelligent Quality Management (iQM3): iQM3 is used as the quality control and assessment system for the GEM Premier 7000 system. iQM3 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external QC. iQM3 introduces hemolysis detection in whole blood samples, enhancing quality assessment in the pre-analytical phase of testing.

Based on the provided text, the device in question is the GEM Premier 7000 with iQM3, which is a portable critical care system for analyzing blood samples. The document describes its comparison to a predicate device, the GEM Premier 5000, and discusses its performance studies.

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

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

The document does not provide a direct table of specific numerical acceptance criteria for each analyte's performance (e.g., pH, pCO2, Na+, etc.) nor does it list the reported device performance in those exact terms. Instead, it states that "All verification activities were performed in accordance to established plans and protocols and design control procedures. Testing verified that all acceptance criteria were met."

The "Performance Summary" section lists the types of studies conducted to demonstrate that the modifications (specifically the new iQM quality check/Hemolysis detection module) do not impact the performance data represented in the Operators Manual, aligning with recognized guidelines. This implies the acceptance criteria are tied to maintaining performance comparable to the predicate device and being within acceptable ranges as defined by the mentioned CLSI guidelines.

Therefore, a table of explicit numerical acceptance criteria and reported performance values for each analyte is NOT AVAILABLE in the provided text. The document broadly states that the device met its acceptance criteria.

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

The document mentions several types of performance studies:

• Verification (Internal Method Comparison, Internal Whole Blood Precision, Hemolysis Interference on Potassium, Hemolysis Verification)
• Shelf-life and Use-life studies

However, the specific sample sizes used for these test sets are NOT provided in the text. There is also no information about the data provenance (e.g., country of origin of the data, retrospective or prospective).

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

This information is NOT available in the provided text. The device is an in-vitro diagnostic (IVD) instrument that provides quantitative measurements of various blood parameters. The "ground truth" for such devices typically comes from reference methods, calibrated standards, or comparative analyses with established, highly accurate laboratory instruments, rather than human expert consensus on interpretations like with imaging.

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

Given that this is an IVD device for quantitative measurements of blood parameters, the concept of "adjudication" by multiple human readers (like in imaging studies) does not directly apply. Performance is assessed through analytical accuracy, precision, and interference studies against known standards or reference methods. Therefore, no adjudication method in the sense of expert consensus on interpretations is described or implied.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. This type of study is relevant for AI-assisted diagnostic tools where human interpretation is part of the workflow. The GEM Premier 7000 with iQM3 is described as an analytical instrument providing direct quantitative measurements, not an AI system assisting human readers with interpretation. The "iQM3" refers to Intelligent Quality Management, which is an automated quality control system for the instrument itself, not an AI for human diagnostic assistance.

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

The device itself is a standalone analytical instrument. The performance studies described (Internal Method Comparison, Internal Whole Blood Precision, Hemolysis Verification, etc.) essentially represent "standalone" performance, as they evaluate the accuracy and precision of the instrument's measurements directly. The iQM3 system is an internal quality control mechanism for the device's measurements. Therefore, yes, a standalone performance evaluation of the device's analytical capabilities was implicitly done.

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

For a device that provides quantitative measurements of blood parameters, the "ground truth" for the test set would typically be established using:

• Reference methods: Highly accurate and precise laboratory methods for measuring each analyte.
• Calibrated standards: Solutions with precisely known concentrations of the target analytes.
• Comparison to predicate device: As this is a 510(k) submission, a primary method of establishing "ground truth" performance for the new device is by comparing its measurements against those of a legally marketed predicate device (GEM Premier 5000), which itself would have been validated against reference methods and standards.

The text mentions "two completely independent solutions traceable to NIST standards, CLSI procedures or internal standards" for "Auto PAK Validation (APV)". This strongly suggests that traceable standards and potentially CLSI-defined reference methods were used to establish the ground truth for performance evaluation.

8. The sample size for the training set

The document describes the GEM Premier 7000 with iQM3 as a medical device for quantitative measurements, not explicitly as a machine learning/AI model that requires a "training set" in the conventional sense (i.e., for supervised learning). The iQM3 is an "active quality process control program" with "Pattern Recognition (PR) software." While pattern recognition might involve some form of "training" or calibration, the document does not specify a separate "training set" in terms of data volume for such a process. It focuses on the validation of the device's analytical performance. Therefore, the concept of a "training set" sample size as applicable to AI/ML devices is not explicitly discussed or provided.

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

As noted above, the primary function of GEM Premier 7000 with iQM3 is quantitative measurement. If the "iQM3" component involved training for its "Pattern Recognition (PR) software," the document does not detail how a specific ground truth for such training was established. It primarily discusses the use of "Process Control Solutions (PCS)" and "Calibration Valuation Product (CVP 5)" for system checks and validation ("Auto PAK Validation (APV) process"). These solutions, traceable to NIST or CLSI standards, function as internal reference points for the device's operational checks and quality control, which could be considered an ongoing form of "ground truth" to maintain analytical performance, rather than a one-time "training set" for model development.

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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:

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

The studies used various sample sizes for different tests, primarily patient samples and prepared sample pools. The provenance of the data is not explicitly stated in terms of country of origin, but it is implied to be clinical laboratory data. The studies are non-clinical (bench) studies following CLSI protocols, which suggests they were conducted in a controlled laboratory environment. The data is retrospective in the sense that it relies on established methods and samples to evaluate the new device against a predicate.

• Method Comparison:

  • hsCRP (Cardiac): 115 serum samples
  • CRP Normal: 120 serum samples
  • Glucose (Serum): 133 serum samples
  • Glucose (Urine): 113 urine samples
  • Glucose (CSF): 111 CSF samples
  • ISE Sodium (Serum): 120 serum samples
  • ISE Potassium (Serum): 119 serum samples
  • ISE Chloride (Serum): 120 serum samples
  • ISE Sodium (Urine): 117 urine samples
  • ISE Potassium (Urine): 120 urine samples
  • ISE Chloride (Urine): 114 urine samples

• Linearity/Reportable Range: High and low sample pools were prepared and inter-diluted. Test samples were assayed in quadruplicate. The total number of unique samples is not specified, but multiple dilutions were tested.

• Sensitivity (Detection Limits): Replicate measurements on blank and low-level samples across multiple days using multiple reagent lots. The specific number of samples is not detailed, but the method suggests an adequate number of replicates for statistical determination.

• Precision/Reproducibility: Duplicate sample analysis, twice daily, over 20 days (n=80) for multiple sample levels (typically 3-5 levels per test).

• Interferences: 5 replicates of test samples at two analyte levels.

• Reference Interval: At least 20 reference individuals (e.g., 25 for CRP Latex Serum, 23 for Glucose Serum, 24 for Glucose Urine, 20 for ISE Serum tests).

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

This submission is for an in vitro diagnostic (IVD) device, specifically a clinical chemistry analyzer and its reagents. For such devices, "ground truth" is typically established by comparing the device's results to established, legally marketed predicate devices and reference methods, as well as adherence to recognized industry standards (CLSI guidelines).

• Experts: The document does not describe the use of human experts to establish "ground truth" in the way it might for an AI-powered image analysis device (e.g., radiologists). Instead, the "ground truth" for the test set values themselves is derived from the established analytical performance of the predicate device and the reference methods outlined in the CLSI guidelines.
• Qualifications: The "experts" in this context would be the skilled laboratory personnel performing the CLSI guideline-based studies and the manufacturers establishing the performance claims for both the candidate and predicate devices. Their qualifications align with standard laboratory practices and regulatory requirements for IVD development and validation.

4. Adjudication Method for the Test Set

No explicit adjudication method (like 2+1 or 3+1 consensus) is described, as this would typically apply to subjective interpretations (e.g., image reading by multiple human experts). For an IVD device measuring analytes, the evaluation is based on quantitative data comparison against established reference methods and performance specifications, using statistical analysis. The "pass" criteria for each test inherently serve as the "adjudication" against the set performance targets.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

No MRMC study was done, nor is it applicable. This submission is for an automated clinical chemistry analyzer and its reagents, which quantitatively measure analytes. It is not an AI-assisted diagnostic imaging or interpretation device that clinicians would use to read cases or images. Therefore, there is no human-in-the-loop component for which an AI assistance effect size would be relevant.

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

Yes, the studies presented are essentially standalone performance evaluations of the DxC 500 AU Clinical Chemistry Analyzer and its associated reagents. The "algorithm" here refers to the instrument's automated analytical processes (photometric, ISE, etc.) and the reagent chemistries. The performance data (method comparison, linearity, precision, sensitivity, interference) directly reflects the device's analytical capability without direct human interpretation or intervention in the measurement process itself, beyond sample preparation and loading. Human oversight is involved in quality control and interpretation of results, but the core analytical performance is standalone.

7. The Type of Ground Truth Used

The ground truth for evaluating the device's performance is primarily established through:

• Comparison to Predicate Device: The DxC 700 AU Clinical Chemistry Analyzer (K161837), which is a legally marketed device with established performance.
• CLSI Guidelines: Standardized laboratory protocols (e.g., EP09C-ED3 for Method Comparison, EP06-ED2 for Linearity, EP17-A2 for Sensitivity, EP05-A3 for Precision) that define acceptable analytical performance.
• Established Reference Ranges: For reference interval studies, existing medical literature or established clinical laboratory reference intervals are used, with verification that a high percentage of samples fall within these ranges on the new device.
• Spiked Samples and Known Concentrations: For linearity, sensitivity, and interference studies, samples are engineered with known concentrations of analytes and/or interferents to challenge the device across its claimed range and conditions.

8. The Sample Size for the Training Set

This type of product (clinical chemistry analyzer and reagents) does not typically involve a "training set" in the context of machine learning or AI models. The development process for such devices relies on chemical and engineering principles, followed by rigorous analytical validation (the studies described above). Therefore, a "training set" size is not applicable.

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

As explained above, there is no "training set" for this type of medical device. The "ground truth" and performance establishment for the device's design and analytical methods would be rooted in fundamental scientific knowledge of chemistry, reagent interactions, and photometric/electrochemical detection, corroborated by extensive internal development and testing against established analytical standards and predicate devices.

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The Alinity ci-series is intended for in vitro diagnostic use only.

The Alinity ci-series is a System comprised of inity i or Alinity c analyzers/processing modules that may be arranged into individual or multimodule configurations including up to four Alinity i processing modules, up to four Alinity c processing modules, or a combination of up to four of Alinity i and Alinity c processing modules with a shared system control module to form a single workstation.

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 i System is a fully automated analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology is used to determine the presence of antigens, antibodies, and analytes in samples.

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 Alinity c Glucose Reagent Kit is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the Alinity c analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The Alinity i Total B-hCG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative and qualitative determination of beta-human chorionic gonadotropin (B-hCG) in human serum and plasma for the early detection of pregnancy on the Alinity i analyzer.

The Alinity ci-series is comprised of individual Alinity i or Alinity c analyzers/processing modules that may be arranged into individual or multimodule configurations which include either multiple Alinity i processing modules, multiple Alinity c processing modules, or a combination of up to four of both Alinity i and Alinity c processing modules with a shared system control module (SCM). The SCM includes the reagent and sample manager (RSM). The multimodule configurations do not have a separate device label or list number. In a multimodule configuration, each processing module retains its original unique identification label.

The document describes the non-clinical performance evaluation of the Alinity ci-series system, Alinity i Total ß-hCG Reagent Kit, Alinity c Glucose Reagent Kit, and Alinity c ICT Sample Diluent. The study focuses on demonstrating equivalent performance between the original single-module configurations and the new multi-module configurations.

Here's an breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on demonstrating "equivalent performance" between the investigational multimodule system and the previously cleared single-module predicate devices. The reported performance metrics are precision (%CV) and method comparison parameters (slope and correlation coefficient). The document doesn't explicitly state numerical acceptance criteria thresholds, but rather implies that the observed results were within an acceptable range for "equivalent performance."

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

The document does not explicitly state the exact sample sizes (number of patient samples) for the precision and method comparison studies. It provides ranges of analyte concentrations, implying that multiple samples spanning these ranges were tested.

• Precision Studies: Samples across various concentration ranges (e.g., 5.25 to 12,850 mIU/mL for ß-hCG, 7 to 688 mg/dL for glucose serum, etc.) were used. The term "5-day precision" suggests a study design where samples are run over 5 days to assess within-laboratory variability.
• Method Comparison Studies: Samples across various concentration ranges were used (e.g., 2.74 to 14,998.60 mIU/mL for ß-hCG, 14 to 659 mg/dL for glucose serum, etc.).

Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that it's a pre-market submission to the FDA, the studies are typically prospective and conducted by the manufacturer, often at their own facilities or clinical study sites.

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

Not applicable for this type of device. The ground truth for quantitative laboratory assays is typically established by reference methods or the performance of a cleared predicate device, not by expert consensus or physician review in the way it would be for imaging diagnostics. The "ground truth" here is the measurement obtained from the previously cleared single-module systems.

4. Adjudication method for the test set

Not applicable for this type of device. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation (e.g., radiology reads) to resolve discrepancies among multiple expert reviewers. Here, the comparison is against quantitative measurements from a reference or predicate system.

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 submission is for an in vitro diagnostic (IVD) system that performs automated quantitative measurements, not an AI-assisted diagnostic imaging device that involves human readers.

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

This refers to the performance of the automated Alinity ci-series system. The studies described (precision and method comparison) are essentially standalone performance evaluations comparing the new multimodule system to the existing single-module systems. There is no "human-in-the-loop" component in the sense of an operator making diagnostic interpretations based on the output. Operators load samples and reagents and manage the system, but the analytical measurement itself is automated.

7. The type of ground truth used

The ground truth used for comparison in these non-clinical studies is the performance of the predicate devices (Alinity i System for Alinity i Total ß-hCG, and Alinity c System for Alinity c Glucose and ICT assays) in their single-module configurations. The goal was to demonstrate "equivalent performance" of the new multimodule configurations to these already cleared systems. This is a form of comparative effectiveness against a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This document describes the validation of a laboratory instrument system and reagent kits through non-clinical performance studies (precision, method comparison), not an AI/machine learning model that requires a distinct "training set." The methodology involves biochemical reactions and optical/potentiometric detection, which are established principles, not learned from a dataset.

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

Not applicable, as there is no "training set" in the context of an AI/ML model for this device.

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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+), Potassium (K+), Ionized Calcium (Ca++), Chloride (Cl-), Glucose (Glu), Lactate (Lac), Hematocrit (Hct), Creatinine (Crea), Blood Urea Nitrogen (BUN), Total Carbon Dioxide (tCO2), pH, and partial pressure of carbon dioxide (pCO2) from arterial and venous heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite 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 treatment of electrolyte and metabolic disorders, such as cystic fibrosis and diabetic acidosis.

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

· Lactate (Lac) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis, to monitor tissue hypoxia and strenuous physical exertion, and in the diagnosis of hyperlactatemia.

· Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).

· Creatinine (Crea) measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

· Blood Urea Nitrogen (BUN) or urea measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases.

· Total carbon dioxide/tCO2 (also referred to as bicarbonate/HCO3-) is used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

· pH and pCO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid-base disturbances.

The GEM Premier ChemSTAT system provides fast, accurate, quantitative measurements of Sodium (Na"), Potassium (K*), Ionized Calcium (Ca*), Chloride (Cl·), Glucose (Glu), Lactate (Lac), Hematocrit (Hct), Creatinine (Crea), Blood Urea Nitrogen (BUN), Total Carbon Dioxide (tCO2), pH, and partial pressure of carbon dioxide (pCO2) from arterial and venous lithium heparinized whole blood.

The provided text describes a Special 510(k) submission for an upgrade to the operating system of the GEM Premier ChemSTAT device. The device itself is an in vitro diagnostic (IVD) system for quantitative measurements of various blood parameters. The submission focuses on the software upgrade rather than a change in the device's fundamental function or performance.

Therefore, the "acceptance criteria" and "reported device performance" in this context refer to the successful verification and validation of the software upgrade and the continued adherence to the established performance of the unmodified device, as the indications for use and performance claims remain unchanged. The study proving this essentially consists of the software verification and validation activities.

Here's the information extracted from the document, tailored to the context of a software upgrade:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a software upgrade with no changes to the performance claims of the device, the general acceptance criteria are that the upgraded software performs as intended without adversely affecting the device's established performance specifications. The reported device performance is that these criteria were met.

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

The document does not specify a "test set sample size" or "data provenance" in the traditional sense for evaluating diagnostic performance. The focus is on software verification and validation. Therefore, the "sample" for testing the software functionality would be the various test cases and scenarios designed to validate the operating system upgrade and its interaction with the GEM Premier ChemSTAT application software.

The document states: "Performance data is limited to Software Verification and Validation as the scope of this Special 510(k) is specific to an operating system upgrade from Fedora 17 Linux to WindRiver LTS 18 Linux."

Further details on the specific number of test cases, the nature of the data (e.g., simulated, actual runs on the device), or its origin are not provided in this summary.

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 information is not applicable to a software operating system upgrade as described. "Ground truth" in the context of expert consensus is typically relevant for diagnostic performance studies where human interpretation or a gold standard reference is needed (e.g., pathology for an imaging device). Here, the "ground truth" is the proper functioning of the software and its integration with the hardware, which is evaluated through engineering and software testing.

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

This information is not applicable for a software operating system upgrade. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies in expert interpretation of diagnostic results. Software verification and validation typically rely on predefined test outcomes and engineering assessments.

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

This information is not applicable. An MRMC comparative effectiveness study is used to evaluate the impact of an AI algorithm on human reader performance, usually for diagnostic tasks. This submission is for a software operating system upgrade for an existing IVD device, not for a new AI algorithm.

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

The concept of "standalone performance" in the context of an algorithm's diagnostic capability (like an AI algorithm) is not directly applicable here. The device itself (GEM Premier ChemSTAT) operates to provide quantitative measurements. The software upgrade ensures the continued, correct operation of the device. The verification and validation activities demonstrate that the upgraded software performs its functions correctly as part of the overall device system.

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

For this software upgrade, the "ground truth" is the expected behavior and functionality of the software and the device. This is established through:

• Functional specifications: The software is expected to perform according to its design specifications.
• Risk analysis: The software should not introduce new risks or fail to mitigate existing ones.
• Cybersecurity standards: The software should meet cybersecurity requirements.
• Established device performance: The software upgrade should not negatively impact the established analytical and clinical performance of the GEM Premier ChemSTAT device (which relies on the physical and chemical principles of its measurements).

The document explicitly states that the changes "do not introduce...changes to labeled performance claims." This implies that the performance of the device (e.g., accuracy, precision of Na+, K+, Glu measurements) remains the same as previously cleared, and the software upgrade was validated not to alter these.

8. The sample size for the training set

This information is not applicable. Training sets are used for machine learning models. This submission describes a conventional software operating system upgrade (Fedora 17 Linux to WindRiver LTS 18 Linux) for an existing IVD device, not the development or retraining of a machine learning algorithm.

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

This information is not applicable, as there is no training set for a machine learning model; it is a software operating system upgrade.

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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 GEM Premier 5000 is a portable critical care system for use by health care professionals to rapidly analyze 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 pH, pCO2, pO2, sodium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MHb, sO2*) parameters from arterial, venous or capillary heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity.

*sO2 = ratio between the concentration of oxyhemoglobin plus deoxyhemoglobin plus deoxyhemoglobin.

· pH, pCO2, and pO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid-base disturbances.

· 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 treatment of electrolyte and metabolic disorders, such as cystic fibrosis and diabetic acidosis.

· Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).

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

• · Lactate (Lac) measurement is used:
• · to evaluate the acid-base status of patients suspected of having lactic acidosis;
• · to monitor tissue hypoxia and strenuous physical exertion;
• in the diagnosis of hyperlactatemia.

· Total Bilirubin (tBili) measurement is used to aid in assessing the risk of kernicterus and hyperbilirubinemia in neonates.

· CO-Oximetry (tHb, COHb, MetHb, O2Hb. HHb, and sO2) evaluates the ability of the blood to carry oxygen by measuring total hemoglobin and determining the percentage of functional hemoglobin species.

• Total Hemoglobin (tHb): Total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.

· COHb: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.

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· MetHb: Methemoglobin measurements are used to determine different conditions of methemoglobinemia.

· HHb: Deoxyhemoglobin, as a fraction of total hemoglobin, is used in combination with oxyhemoglobin to measure oxygen status.

· O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with deoxyhemoglobin to measure oxygen status.

• sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin, is used to measure oxygen status.

The GEM Premier 5000 system provides fast, accurate, quantitative measurements of heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2) from arterial, venous or capillary samples.

The provided text is a 510(k) summary for the GEM Premier 5000 device, detailing an operating system upgrade. This document is a regulatory submission for a device change and does not contain the information requested regarding acceptance criteria, device performance tables, study specifics (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), or ground truth establishment.

The submission is a Special 510(k), which indicates a modification to an already cleared device, not a de novo clearance requiring extensive clinical performance studies. The core of this submission is a software update (operating system change from Fedora 17 Linux to WindRiver LTS 18 Linux) with the stated reason to "accommodate long-term support of resolutions for common vulnerability exposures."

The document explicitly states:

• "Performance data is limited to Software Verification as the scope of this Special 510(k) is specific to an operating system upgrade..."
• "The changes in this submission do not introduce: Changes to indications for use or intended use, Changes to the fundamental scientific technology, Changes to operating principle, Changes to labeled performance claims."

Therefore, the requested information, which typically pertains to the establishment of initial clinical performance and effectiveness, is not present in this regulatory document for this specific submission. The focus here is on ensuring the device continues to meet its previously established performance claims after a technical software upgrade, rather than demonstrating new performance capabilities.

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The i-STAT CHEM8+ cartridge with the i-STAT 1 System is in the in vitro quantification of sodium, potassium, chloride, ionized calcium, glucose, blood urea nitrogen, creatinine, hematocrit, and total carbon dioxide 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 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.

Ionized calcium measurements are used in the diagnosis and treatment of parathyroid disease, chronic renal disease and tetany.

Glucose measurements are used in the diagnosis, monitoring, and treatment of carbohydrate metabolism disorders including, but not limited to, diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma.

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

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.

Hematoorit measurements can aid in the determination and monitoring of normal total red cell volume status that can be associated with conditions including anemia and erythrocytosis. The i-STAT Hematocrit test has not been evaluated in neonates.

Carbon dioxide measurements are used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

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 (Na), potassium (K), chloride (CI), ionized calcium (iCa), glucose (Glu), blood urea nitrogen (BUN), creatinine (Crea), hematocrit (Hct), and total carbon dioxide (TCO2). The test is contained in a single-use, disposable cartridge. 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 provided text describes a 510(k) premarket notification for the i-STAT CHEM8+ cartridge with the i-STAT 1 System, specifically addressing the addition of an anticoagulant-free whole blood matrix. The document references several previous 510(k) clearances for various analytical performance characteristics and presents a new "Matrix Equivalence" study for the anticoagulant-free whole blood.

Here's an analysis of the acceptance criteria and study information provided, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for the "Matrix Equivalence" study in a tabulated format. However, it implicitly uses a Passing-Bablok linear regression analysis to demonstrate equivalence. The reported device performance is presented as the results of this regression analysis. We can infer the expected performance from general expectations for method comparisons in analytical chemistry, where a slope close to 1, an intercept close to 0, and a high correlation coefficient (r) indicate good agreement.

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

• Sample Size (Test Set for Matrix Equivalence): The sample sizes vary slightly per analyte:
  • Na, Cl, iCa: 314
  • K, Glu: 313
  • BUN: 310
  • Crea: 312
  • Hct: 311
  • TCO2: 273
• Data Provenance: The study was conducted at "three (3) point of care sites." The document does not specify the country of origin, but given the FDA submission, it is likely the US or a region with equivalent regulatory standards. The data is prospective in nature, as it involved collecting samples (both anticoagulant-free and anticoagulated) for direct comparison.

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

This type of study (matrix equivalence for IVD devices) does not typically involve human experts establishing "ground truth" in the way a diagnostic imaging study would. The ground truth (or reference method) for comparison is the measurement obtained from the previously cleared device using anticoagulated samples. The expertise lies in the calibration of the reference method and the design and execution of the analytical study, not in human interpretation of results.

4. Adjudication Method for the Test Set

Not applicable for this type of analytical method comparison study. Adjudication is relevant for subjective assessments, typically in diagnostic imaging or clinical outcomes, to resolve discrepancies among human readers or between AI and human readers. Here, the comparison is between two quantitative measurement methods.

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 analytical performance study for an in vitro diagnostic device, not a diagnostic imaging or clinical decision support AI.

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

Yes, the analytical performance (precision, linearity, LoQ, LoB/LoD, interference, and method comparison) of the i-STAT CHEM8+ cartridge with the i-STAT 1 System, and its equivalence between different sample matrices, primarily represents standalone performance of the device without human intervention beyond sample collection and device operation. The "Matrix Equivalence" study directly compares the results of the device using two different sample types.

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

The ground truth for the "Matrix Equivalence" study was established by the mean result from the primary sample, which refers to measurements obtained from whole blood samples collected with balanced heparin or lithium heparin anticoagulant using the previously cleared i-STAT CHEM8+ system. This acts as the "reference method" for comparison to the anticoagulant-free samples.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the purpose of the Matrix Equivalence study. This study is a validation study demonstrating that a new sample matrix (anticoagulant-free whole blood) yields equivalent results to the established (anticoagulated) sample matrix. The device itself (i-STAT CHEM8+ with i-STAT 1 System) would have undergone extensive development and internal testing (which could be considered a form of "training") prior to its initial clearances (K183678, K183680, K183688, K191298, K191360). The current submission focuses on extending the indications for use.

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

As no explicit "training set" is mentioned for this specific submission's study, this question is not directly answerable from the provided text. The "ground truth" for the reference method within the Matrix Equivalence study, as stated above, derives from the previously cleared performance of the i-STAT CHEM8+ system using anticoagulated samples, which would have been established through robust analytical validation studies (e.g., comparison to laboratory reference methods).

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