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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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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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