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The Blood Urea Nitrogen and Total Carbon Dioxide tests, as part of the epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.

Blood Urea Nitrogen measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of certain renal and metabolic diseases.

Total Carbon Dioxide measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of disorders associated with changes in body acid-base balance.

The epoc Blood Analysis System is an in vitro diagnostic device system for the quantitative testing of blood gases, electrolytes, and metabolites in venous, arterial, and capillary whole blood samples. The epoc System is comprised of 3 major subsystems: epoc Host, epoc Reader and epoc BGEM Test Card. The main accessory used with the epoc System includes the epoc Care-Fill Capillary Tubes used to collect and introduce capillary blood samples into the epoc Test Card.

The epoc Blood Analysis System was previously cleared for prescription use to quantitate pH, pCO2, pO2, Na, K, iCa, Cl, Glu, Lact, Crea, and Hct in arterial, venous, and capillary blood samples per K061597, K090109, K092849, K093297, and K113726. This premarket notification submission adds blood urea nitrogen (BUN) and total carbon dioxide (TCO2) quantitation to the epoc BGEM Test Card and Blood Analysis System.

The epoc Blood Urea Nitrogen Test and epoc Total Carbon Dioxide Test, as part of the epoc Blood Analysis System, are intended for use by trained medical professionals as an in vitro diagnostic device for quantitative testing of heparinized or un-anticoagulated arterial, venous or capillary whole blood.

The acceptance criteria and device performance are described in several studies:

Acceptance Criteria and Device Performance:

Study Information:

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

   • Analytical Sensitivity (LoB, LoD, LoQ): Test samples were prepared from dialyzed whole blood. The specific number of samples or runs is not explicitly stated, but the study was conducted according to CLSI EP17-A2.
   • Linearity: Multiple whole blood samples were used, spanning the reportable range. Conducted per CLSI EP06-A. Specific number not provided.
   • Precision (Aqueous Controls): 320 replicates for each level of both BUN and TCO2. These were in-house measurements.
   • Clinical Field Precision (Aqueous Controls): N=170 for BUN Level 1, 171 for Level 2, 168 for Level 3. N=172 for TCO2 Level 1, 170 for Level 2, 169 for Level 3. Data provenance is from "three different clinical sites."
   • Clinical Field Precision (Whole Blood): N=134-136 for BUN samples, N=134-139 for TCO2 samples, depending on the type (syringe/cap tube) and level (high/NB/low). Data provenance is from "three different clinical sites."
   • Precision (Duplicate Epoc Test Results): Over 430 patient tests run in duplicate. "Approximately equal numbers of venous, arterial and capillary samples." Data provenance not explicitly stated (e.g., country of origin), assumed to be from clinical sites in the context of "Clinical Field Precision." This is prospective clinical data.
   • Method Comparison (BUN): N=433 venous, arterial, and capillary blood samples. Performed at "three clinical sites." This is prospective clinical data.
   • Method Comparison (TCO2): N=574 venous, arterial, and capillary patient samples. Performed at "three clinical sites." This is prospective clinical data.
   • Matrix Comparison: Anticoagulant: Over 60 volunteer donors, with samples further aliquoted into 3 vacutainers each. Data provenance not explicitly stated.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a quantitative diagnostic test for chemical analytes (BUN, TCO2), not an imaging or qualitative diagnostic device requiring expert interpretation for ground truth. The ground truth for analytical performance studies is typically established using reference methods (e.g., IDMS-traceable laboratory system) or prepared reference materials.

3. Adjudication method for the test set: Not applicable. The ground truth for quantitative chemical analytes is established by reference methods or gravimetric preparation, not through human adjudication.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a diagnostic testing system for chemical analytes, not an AI-assisted diagnostic imaging or qualitative interpretation tool for human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the entire performance characterization (analytical sensitivity, linearity, precision, interference, method comparison, and matrix comparison) represents standalone algorithm/device performance. The device provides quantitative results directly. Human-in-the-loop performance is about accuracy of human readers, and the clinical field precision study assesses the precision of the device in the hands of intended users, not the interpretative performance of those users.

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

   • Analytical Sensitivity, Linearity, Precision: Ground truth established via prepared reference materials (dialyzed whole blood, gravimetric mixtures of high/low samples) and aqueous controls with known concentrations.
   • Method Comparison (BUN): Ground truth established by an "IDMS-traceable plasma/serum-based laboratory system" (Roche Cobas 8000).
   • Method Comparison (TCO2): Ground truth established by a "whole blood point-of-care system" (i-STAT-CHEM8+), which is also a predicate device.
   • Interference and Matrix Comparison: Comparisons were made against control samples (e.g., solvent added, or anticoagulant-free) to assess the impact of interfering substances or different matrices.

7. The sample size for the training set: Not applicable. This document describes the performance of a chemical analyte detection system, not a machine learning or AI model that requires a training set.

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

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Eurotrol Hct Control is an assayed hematocrit reference material, to verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit. Eurotrol Hct Control is for in vitro diagnostic use only.

epoc® Hematocrit Verification Fluids is an assayed hematocrit reference material, to verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit.

epoc® Hematocrit Verification Fluids is for in vitro diagnostic use only.

Eurotrol Hct Control and epoc® Hematocrit Verification Fluids are assayed hematocrit reference materials, to verify the precision and accuracy of the epoc@ Blood Analysis System, manufactured by Epocal Inc., Ottawa, ON K1G3P5, Canada, as cleared by FDA, K061597. Eurotrol Hematocrit Control was designed to test the following analytes: Hematocrit.

Eurotrol Hot Control and epoc® Hematocrit Verification Fluids electrolyte solutions with conductivity at five levels appropriate to simulate clinically relevant hematocrit concentrations useful to evaluate the measurement of the epoc Blood Analysis System.

Depending the sales unit, 10 ampules of the same level are packed in a carton box for Eurotrol Hct Control, or 5 ampule per level, are packed in a carton box for epoc®Hematocrit Verification Fluids. A product insert with Intended Use is inserted in each product box.

The assigned values of each batch are printed on a value sheet as available from the Epocal website: http://www.epocal.com/doc_library.html

The provided text describes a 510(k) submission for "Eurotrol Hct Control and epoc® Hematocrit Verification Fluids," which are quality control materials for hematocrit measurements. This document is a premarket notification for a medical device that verifies the precision and accuracy of another device (the epoc Blood Analysis System). It is not a diagnostic device that performs a clinical diagnosis; thus, the concepts of sensitivity, specificity, human reader performance, MRMC studies, or training/test sets for AI models as typically applied to image-based diagnostic AI devices are not applicable here.

The "acceptance criteria" and "device performance" in this context refer to the characteristics and performance of the control fluid itself in demonstrating its suitability for verifying other devices.

Here's the breakdown based on the provided text, adapted for a quality control material:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for a quality control material revolve around its ability to provide stable and accurate reference values. The "performance" is demonstrated by its inherent properties and its equivalence to a predicate device.

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

This is not applicable in the typical sense of a diagnostic device's test set for patient data. For this quality control material, the "test set" would refer to the samples of the QC fluid itself tested during its development and validation.

• Test Samples: The document states "Tests were conducted to verify specific performance requirements: a) Real-time evaluation of the products to support stability. b) Test precision." The exact number of ampules or batches tested for these purposes is not specified in the summary but would have been part of the non-clinical testing data submitted to the FDA.
• Data Provenance: The testing was conducted by Eurotrol B.V. in The Netherlands. This is a non-clinical, controlled laboratory setting, not patient data. It is inherently prospective testing of the manufactured QC material.

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

Not applicable. The ground truth for a quality control material is established by:

• Its chemical formulation.
• The highly precise and accurate methods used to assign values to each lot/batch in a reference laboratory setting (e.g., using reference methods and highly calibrated instruments).
• Comparative testing against established predicate devices.

There are no "experts" in the sense of clinical reviewers establishing diagnoses as ground truth for this type of device.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or diagnostic decision-making involved that would require adjudication.

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

No. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, especially in the context of AI assistance. A quality control material does not involve human readers for diagnostic interpretation.

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

Not applicable. This device is a fluid, not an algorithm. Its "performance" is its chemical stability and its ability to act as a reliable reference standard for an analytical instrument.

7. The Type of Ground Truth Used

The ground truth for this quality control material is its precisely manufactured and characterized chemical composition and its assigned hematocrit values, which are determined by highly accurate reference measurement procedures. This is essentially a "reference standard" or "master value" derived from rigorous chemical and metrological characterization. Its primary evidence for substantial equivalence relies on comparison to a predicate device (RNA Medical QC 900 Hematocrit Control) that is already legally marketed and accepted as a reliable standard.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI models that require training sets of data.

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

Not applicable, as there is no training set for an AI model.

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The Chloride test, as part of the epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care. Chloride measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of electrolyte and metabolic disorders.

The Creatinine test, as part of the epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care. Creatinine measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of certain renal diseases and in monitoring renal dialysis.

The epoc Blood Analysis System is an in vitro analytical system comprising a network of one or more epoc Readers designed to be used at the point of care (POC). The readers accept an epoc single use test card containing a group of sensors that perform diagnostic testing on whole blood. The blood test results are transmitted wirelessly to an epoc Host, which displays and stores the test results. The epoc System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of whole blood. The test card panel configuration currently includes sensors for Sodium Na, Potassium K, Ionized Calcium iCa, pH, pCO2, pO2, Lactate, Glucose and Hematocrit Hct. This submission adds Chloride and Creatinine to this list of approved tests.

This medical device (epoc System) is an in vitro analytical system that provides diagnostic testing for various analytes in whole blood. This submission adds Chloride and Creatinine tests to its existing capabilities.

Here’s a breakdown of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied through the comparison with predicate devices and established standards like CLSI recommendations. The reported device performance is presented in various non-clinical and clinical studies.

Chloride Test

Creatinine Test

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

Chloride Test:

• Method Comparison (Clinical Field Trials, Patient Samples):
  • vs. non-POC Systems (Roche Cobas 6000, Siemens Advia): N = 96 (pooled venous samples, approximately equal numbers vs. each system). Data provenance not explicitly stated but implies clinical sites (hospitals).
  • vs. Abbott i-STAT 300 (Predicate): N = 155 (patient samples, approximately equal numbers of venous, arterial, and capillary samples). Data provenance implies clinical sites (hospitals).
  • Matrix Effects (Clinical Field Trials, Patient Samples):
    • Venous: N = 49
    • Arterial: N = 43
    • Capillary: N = 63
    • All: N = 155 (These are subsets of the Abbott i-STAT comparison data)
• Blood Precision (Clinical Sites, End Users):
  • Chloride Blood Precision Site 1: 4 users, 10-10 replicates each for normal/spiked syringe samples. Total N around 80.
  • Chloride Blood Precision Site 2: 8 users for syringe, 4 users for capillary. 10-11 replicates each. Total N around 220.
  • Overall Blood Precision Summary:
    • Normal Syringe: 120 tests (12 runs, 10 replicates)
    • Spiked Syringe: 119 tests (12 runs, 10 replicates)
    • Normal Capillary: 40 tests (4 runs, 10 replicates)
    • Spiked Capillary: 40 tests (4 runs, 10 replicates)
• Anticoagulant Effect: 46 samples from a hospital, supplemented with 29 in-house samples.
• Provenance: Clinical field trials at two hospitals (patient samples), and in-house studies (aqueous precision, linearity, detection limit, analytical specificity, some anticoagulant effect evaluation). The data is a mix of prospective (patient samples collected in clinical field trials) and retrospective (in-house studies using prepared samples).

Creatinine Test:

• Method Comparison (Clinical Field Trials, Patient Samples):
  • vs. Roche Cobas 6000 (Predicate): N = 144 (patient samples, approximately equal numbers of venous, arterial, and capillary samples). Data provenance implies clinical sites (hospitals).
  • Matrix Effects (Clinical Field Trials, Patient Samples):
    • Venous: N = 53
    • Arterial: N = 42
    • Capillary: N = 49
    • All: N = 144 (These are subsets of the Roche Cobas comparison data)
• Blood Precision (Clinical Sites, End Users):
  • Creatinine Blood Precision (multiple sites, multiple users): Each user performed 9-10 replicates for normal/spiked syringe and capillary samples. Total N is around 118 for syringe (normal and spiked), and around 30 for capillary (normal and spiked).
  • Overall Blood Precision Summary:
    • Normal Syringe: 118 tests (12 runs, 10 replicates)
    • Spiked Syringe: 118 tests (12 runs, 10 replicates)
    • Normal Capillary: 29 tests (3 runs, 10 replicates)
    • Spiked Capillary: 30 tests (3 runs, 10 replicates)
• Anticoagulant Effect: 46 samples from a hospital, supplemented with 29 in-house samples.
• Provenance: Clinical field trials at a hospital site (patient samples), and in-house studies (aqueous precision, linearity, detection limit, analytical specificity, some anticoagulant effect evaluation). The data is a mix of prospective (patient samples collected in clinical field trials) and retrospective (in-house studies using prepared samples).

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

The document does not explicitly state the number of experts used or their specific qualifications (e.g., "radiologist with 10 years of experience") for establishing ground truth for the test set. Instead, the "ground truth" or reference values for the clinical method comparison studies were established by:

• Predicate Devices: i-Stat™ Model 300 Portable Clinical Analyzer (for Chloride) and Roche Cobas c 511/512 CREP2 Creatinine Plus ver. 2 assay (for Creatinine). These are legally marketed devices that provide accepted reference measurements.
• Comparative Instruments/Laboratory Methods: Other non-point-of-care systems (e.g., Roche Cobas 6000, Siemens Advia for Chloride) and a serum-based laboratory method (for Creatinine) at clinical sites.
• Traceability: Both Chloride and Creatinine concentration values assigned to controls and calibrator fluids are traceable to NIST standards.

The expertise lies in the established and validated methodologies of these predicate and comparative devices/laboratory methods, rather than individual expert adjudication for each test case.

4. Adjudication Method for the Test Set

No explicit "adjudication method" in the sense of expert review for discrete cases (like 2+1, 3+1) is described. For in vitro diagnostic devices like this, the performance is typically evaluated by comparing the device's measurements against established reference methods (predicate devices or laboratory analyzers) which are considered the "ground truth." The statistical analysis (regression, bias, R²) serves as the method to determine agreement.

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

An MRMC study, particularly in the context of human readers and AI assistance, is not applicable to this device. This is an automated in vitro diagnostic system that directly measures analytes in blood. There are no "human readers" interpreting images or data that AI would assist. The device itself performs the analysis, and the studies assess its accuracy, precision, and agreement with reference methods.

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

Yes, the studies presented are essentially "standalone" performance evaluations of the device. The epoc Blood Analysis System is an automated system where the test card is inserted, blood is introduced, and analytical steps are performed automatically. The output is a direct measurement of analyte concentrations. The "human-in-the-loop" aspect primarily involves trained medical professionals collecting samples and operating the device, but not in interpreting raw data or making diagnostic decisions that the device's algorithm would assist. The performance data (precision, linearity, method comparison) reflects the device's inherent analytical capabilities.

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

The ground truth used for these studies is primarily:

• Reference Method Comparison: Measurements from legally marketed and established predicate devices (i-Stat™ for Chloride, Roche Cobas for Creatinine) and other validated laboratory methods (e.g., Roche Cobas 6000, Siemens Advia).
• Traceability to Standards: Calibration and control values are traceable to NIST (National Institute of Standards and Technology) standards (SRM 967 for Creatinine).

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI algorithms as the primary component of the device's measurement principle. The device relies on electrochemical sensors (ion-selective membrane potentiometry for Chloride, enzymatic cascade with amperometric detection for Creatinine).

However, in the broader sense of device development and calibration:

• In-house aqueous precision study: N=240 for Chloride (L1, L3) and N=239/241 for Creatinine (L1, L3) are mentioned (Figure 5.3). While these are presented as evaluation data, similar-sized or larger datasets would likely be used during initial development and calibration.
• Linearity study: Involved nine blood samples prepared from two pools, evaluated against an in-house standard method.
• The development and optimization of the enzymatic reactions and sensor response curves would involve extensive testing with many samples during the device's R&D phase, which functionally serves a "training" purpose for the device's internal calibration and algorithms. This specific data is not detailed as a distinct "training set" with a quantifiable size in this 510(k) summary.

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

As noted above, a distinct "training set" with specific ground truth establishment isn't explicitly detailed in the context of an AI/ML device. For a sensor-based diagnostic device like this, the "ground truth" for calibrating and optimizing the sensors (analogous to training) would be established through:

• NIST Traceability: Calibrator and control fluids are assigned values traceable to NIST standards. This is the ultimate ground truth for establishing the accuracy of the measurements.
• Reference Laboratory Methods: During development, the device would have been extensively correlated with established laboratory methods to ensure its measurements align with accepted clinical standards.
• Controlled Samples: Use of precisely prepared aqueous solutions, spiked blood samples, and pooled human serum with known concentrations, following guidelines like CLSI EP6-A and EP7-A2 for linearity, detection limits, and analytical specificity.

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The epoc Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or unanticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions.

Care-Fill Capillary Tubes are intended for use with the epoc Blood Analysis system and are used for the collection and dispensing of capillary blood samples with epoc Test Cards.

The Blood Gas Electrolyte (BGE) test card panel configuration includes sensors for Sodium -Na, Potassium - K, Calcium - iCa, pH, pCO2, pO2 and Hematocrit - Hct.

The Blood Gas Electrolyte (BGEM) test card panel configuration includes sensors for Sodium - Na, Potassium - K, Calcium - iCa, pH, pCO2, pO2, Hematocrit - Hct and Glucose -Glu.

Measurement of sodium is used in diagnosis and treatment of diseases involving electrolyte imbalance.

Measurement of potassium is used in diagnosis and treatment of diseases involving electrolyte imbalance.

Measurement of Ionized Calcium is used in diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

Measurement of pH, pCO2, pO2 (blood gases) is used in the diagnosis and treatment of lifethreatening acid-base disturbances.

Measurement of Hct distinguishes normal from abnormal states of blood volume, such as anemia and erythrocytosis.

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia, and of pancreatic islet cell tumors.

The epoc Blood Analysis System consists of three (3) components:

1. epoc Test Card: single use blood test card with sensors, fluidic channel, and on-board calibrator.
2. epoc Card Reader: raw-signal acquisition peripheral with card orifice, mechanical actuation assembly, bar code scanner, electrical contact array, thermal subsystem, and circuits for signal processing and wireless transmission.
3. epoc Host: dedicated-use Personal Digital Assistant (PDA) computing device with custom software for displaying test results.

The epoc Care-Fill Capillary Tube is intended for use only with epoc Blood Analysis System for the collection and dispensing of capillary blood samples.

Acceptance Criteria and Study Details for epoc® Blood Analysis System for Capillary Samples

The epoc® Blood Analysis System sought clearance to use capillary blood specimens and to remove the limiting labeling regarding the glucose test using neonatal samples. The acceptance criteria were implicitly established by demonstrating substantial equivalence to the predicate device, the i-STAT® Model 300 Portable Clinical Analyzer, primarily through method comparison studies and precision studies. The core of the acceptance criteria is the observed bias between the epoc system and the i-STAT system, and the precision (SD and %CV) of the epoc system.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly defined as numerical thresholds in the provided document. Instead, the study aims to demonstrate that the epoc system's performance, when using capillary blood, is "substantially equivalent" to the predicate device (i-STAT Model 300). This is assessed by comparing the biases and precision against the predicate device in clinical and non-clinical settings.

For both method comparison studies, the key performance indicator is the average(Yii-Xii), which represents the bias between the epoc system (Y) and the predicate i-STAT system (X). For precision, SD and %CV are used.

Implicit Acceptance Criteria (interpreted from "Substantially Equivalent" and comparison to predicate):

• Bias (epoc vs. i-STAT): The measured biases should be clinically acceptable and comparable to or better than previously cleared devices and clinical standards. The document presents the observed biases without stating explicit thresholds for acceptance a priori.
• Precision (epoc system): The standard deviation (SD) and coefficient of variation (%CV) for each analyte should be within clinically acceptable ranges and consistent with expected performance for point-of-care blood gas and electrolyte analyzers.

Reported Device Performance (from studies):

The following table summarizes the reported performance of the epoc system when using capillary samples, compared to the i-STAT system, and its precision.

2. Sample Sizes and Data Provenance

Equivalence of Care-Fill vs. Syringe (Non-Clinical Study):

• Sample Size: N = 42 for all analytes.
• Data Provenance: Retrospective, "in house" experiments. The origin of the blood samples (e.g., human, animal, spiked, etc.) and country are not explicitly stated, but the context implies laboratory-controlled samples, potentially modified to extend analyte ranges.

In-house Method Comparison (Capillary samples, epoc vs. i-STAT):

• Sample Size: N = 51 for pH/pCO2, N = 52 for pO2/Na/K/Ca/Glu/Hct.
• Data Provenance: Retrospective, "in-house" study using capillary blood samples. Origin and country are not specified.

Clinical Precision Study (Care-Fill capillary tubes):

• Sample Size: N = 10 replicates per study, across 6 precision studies (3 pools of blood, 2 POC locations, 6 different operators). So, 60 measurements per analyte in total, distributed.
• Data Provenance: Prospective, patient samples, collected at "2 POC locations" (Nursery and NICU), implying a hospital setting. Country not explicitly stated but implied to be where epoc is manufactured/marketed (Canada/USA).

Clinical Method Comparison (Capillary samples, epoc vs. i-STAT):

• Sample Size: N = 47 for pH/iCa/Hct, N = 48 for pCO2/pO2/Na/K/Glu. For neonatal glucose specifically, N = 36.
• Data Provenance: Prospective, patient samples of whole blood (12 adult capillary, 36 neonatal capillary). Performed "at a hospital" in "four (4) locations: NICU, Wellbaby Nursery and two (2) different outpatient drawing areas." Country not explicitly stated, but implied as per above.

3. Number of Experts and Qualifications for Ground Truth

The concept of "experts" and "ground truth" as typically used in AI/image analysis studies (e.g., radiologists interpreting images) is not directly applicable here. This submission is for a medical device that measures physiological parameters.

• Ground Truth Establishment: The ground truth or reference standard for comparison in these studies is the predicate device, the i-STAT Model 300 Portable Clinical Analyzer. The i-STAT system itself is a cleared device already accepted as an accurate measurement tool for these parameters. There is no mention of human experts establishing a separate "ground truth" or reference, beyond the inherent accuracy of the predicate device.

4. Adjudication Method

Not applicable. As explained in point 3, the ground truth is established by the predicate device, not by human interpretation or consensus that would require an adjudication method.

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

Not applicable. This is not a study involving human readers interpreting cases (e.g., medical images) with and without AI assistance. It is a device performance study comparing a new device (epoc) to a predicate device (i-STAT) for quantitative measurements. Therefore, there is no "effect size of how much human readers improve with AI vs without AI assistance."

6. Standalone Performance Study

Yes, a standalone performance study was conducted.

• Equivalence of Care-Fill vs. Syringe (Non-Clinical Study): This study directly compared two delivery methods on the epoc system, not against an external reference, to ensure the new capillary tube delivery method did not alter results.
• Clinical Precision Study: This study evaluated the precision (repeatability) of the epoc system itself when using capillary samples collected via the Care-Fill tubes, without direct comparison to a predicate device for each measurement. It assessed the algorithm's consistency and reliability in real-world use.

7. Type of Ground Truth Used

The ground truth used for the comparative studies (method comparison) was the measurements obtained from the predicate device, the i-STAT Model 300 Portable Clinical Analyzer. This is considered "reference method" ground truth, where a previously validated and cleared device serves as the standard.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" as would be typical for machine learning algorithms. The epoc system is described as having "on-board calibrator" and "custom software that displays the test results" and "software to control the test and calculate analytical values from raw sensor signals." This implies a rule-based or empirically calibrated system rather than a machine learning model that requires a distinct training phase with a labeled dataset in the contemporary sense. The calibration and development likely involved extensive in-house testing and engineering, but these are not referred to as a "training set."

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

Given that a distinct "training set" in the context of machine learning is not mentioned (see point 8), the concept of establishing ground truth for it also does not directly apply. The calibration and performance optimization of the epoc system's algorithms/software would have been established through a combination of:

• Reference materials/standards: Calibrators are mentioned as "on-board" the test card.
• Extensive laboratory testing: Comparison against established laboratory methods and reference analyzers during the development and validation phases.
• Empirical data collection: Using various blood samples (e.g., with known concentrations, or compared to highly accurate laboratory instruments) to optimize the sensor responses and calculation algorithms.

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