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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 un-anticoagulated arterial, venous, or capillary whole blood in the laboratory or at the point of care.
The Blood Gas Electrolyte and Metabolite (BGEM) Test Card panel configuration includes sensors that quantitate pH, pCO2, oO2, Sodium, Potassium, Ionized Calcium, Chloride, Total Carbon Dioxide, Glucose, Lactate, Blood Urea Nitrogen, Creatinine, and Hematocrit.
pH, pCO2, pO2 (blood gases) measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of lifethreatening acid-base disturbances.
Sodium and Potassium measurements from the epoc Blood Analysis System are treatment of diseases involving electrolyte imbalance.
lonized Calcium measurements from the epoc Blood Analysis System are treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
Chloride measurements from the epoc Blood Analysis System are used in the treatment of electrolyte and metabolic disorders.
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.
Glucose measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of carbolism disorders, including diabetes mellitus and idiopathic hypodycemia, and of pancreatic islet cell tumors.
Lactate measurements from the epoc Blood Analysis System are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood),
Blood Urea Nitrogen measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of certain renal and metabolic diseases.
Creatinine measurements from the epoc Blood Analysis System are used in the diagnosis and treatment diseases and in monitoring renal dialysis.
Hematocrit measurements from the epoc Blood Analysis System are used to distinguish normal states of blood volume, such as anemia and erythrocytosis.

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 three (3) major subsystems: epoc® Host, epoc® Reader and epoc® BGEM Test Card.

• epoc® Blood Gas Electrolyte Metabolite (BGEM) Test Card: single-use, device with . port for blood sample introduction which contains the sensor configurations for testing Sodium (Na+), Potassium (K+), Calcium (Ca++), Chloride (C)I-, pH, partial pressure of carbon dioxide (pCO2), partial pressure of oxygen (pO2), Glucose (Glu), Lactate (Lact), Creatinine (Crea), Hematocrit (Hct), Blood Urea Nitrogen (BUN) and Total Carbon Dioxide (TCO2).
• . epoc® Reader: portable, battery-powered device component that measures electrical signals from the test card sensors during blood testing and transmits this sensor data wirelessly via Bluetooth to the epoc Host.
• . epoc® Host: mobile computer-based device component for calculating test results from the sensor data sent by the epoc Reader and displaying these results on the graphical user interface. The epoc Host component can be physically connected to the Reader by a cradle component. The epoc Host also incorporates an internal laser barcode scanner for scanning patient and operator IDs. The epoc Host component currently runs on Microsoft® Windows Mobile 6.5 Operating System (OS).

Based on the provided text, the "epoc® Blood Analysis System with NXS Host" is being submitted as a modified device, and the submission primarily focuses on hardware and software updates to the epoc Host component. The document explicitly states that "No performance data was required to evaluate the changes introduced with the alternate epoc Host component" and that there is "no change to labeled performance claims." Therefore, there isn't a comprehensive study proving the device meets new acceptance criteria. Instead, the submission argues for substantial equivalence to a previously cleared predicate device by demonstrating that the modifications do not negatively impact safety and effectiveness.

Here's an analysis based on the provided information, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not detail specific acceptance criteria for new performance claims or provide a table of performance data because the submission states "No performance data was required to evaluate the changes introduced with the alternate epoc Host component." The device is intended to meet the same performance specifications as the predicate device. The change is in the host component (hardware and OS), not the core measurement technology or labeled performance.

The submission is essentially asserting that the "epoc® Blood Analysis System with NXS Host" (Modified Device) is substantially equivalent to the "epoc® Blood Analysis System" (Predicate Device) and thus relies on the predicate device's existing performance data and acceptance criteria.

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

Not applicable. No new clinical performance or analytical performance study with a test set is described. The submission focuses on verification and validation activities for hardware, software, and usability to support substantial equivalence due to a change in the host component.

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

Not applicable. As no new performance study is described, there's no mention of experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. No new performance study is described.

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

No. This device is an in vitro diagnostic system for quantitative testing of blood parameters, not an imaging AI device that would typically involve a multi-reader multi-case study with human readers.

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

The device is an analytical instrument. Its performance is inherent to the system (sensors, reader, software). While the software is a key component, the "standalone" concept as typically applied to AI in imaging doesn't directly map. However, the document states: "No performance data was required to evaluate the changes introduced with the alternate epoc Host component." This implies that the core analytical performance (algorithm) is considered unchanged from the predicate device and its previous clearances. Verification and validation activities were done on the new host component, but not necessarily a "standalone" re-evaluation of the core measurement algorithm's performance on a new dataset.

7. The Type of Ground Truth Used

Not applicable for new performance data. The device measures objective chemical and physical properties of blood samples. The ground truth for such devices is typically established through reference methods and calibrated controls, not expert consensus or pathology in the same way as an imaging AI. The submission relies on the established ground truth methodologies for the predicate device.

8. Sample Size for the Training Set

Not applicable. This document describes a modification to an existing IVD device (updating hardware and operating system for the host component). It does not describe the development of a new AI algorithm or machine learning model that would involve a "training set" in the conventional sense. The "epoc Host Application Software has been modified to support the Android-based Operating System" but this is a software porting/adaptation, not a new algorithm being trained on data.

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

Not applicable, as there is no mention of a training set for a new AI algorithm.

Summary of the Study and Why it Meets (Implied) Acceptance Criteria:

The study detailed in this 510(k) submission is not a clinical performance study generating new acceptance criteria or performance data for the analytes measured. Instead, it is a Special 510(k) submission designed to demonstrate that hardware and software updates to the epoc Host component of the epoc® Blood Analysis System do not alter the safety or effectiveness of the device and thus maintain substantial equivalence to the previously cleared predicate device.

The "study" or evidence provided to meet acceptance criteria consists of:

• Verification and Validation Activities: "All software, hardware and usability verification and validation activities were performed in accordance to relevant standards, established plans and protocols and Design Control procedures."
• Meeting Acceptance Criteria: "Testing verified all acceptance criteria were met." (These are acceptance criteria related to software, hardware function, and usability for the new host component, ensuring it performs its intended role without impacting the core analytical performance).
• Risk Management: A risk management process compliant with EN ISO 14971:2012 and ISO 14971:2007 was performed, concluding that "the overall residual risk of the epoc System with the epoc NXS host is acceptable."
• Cybersecurity Information: Cybersecurity design inputs were established, risks assessed, and controls designed within the software.

The core argument for meeting acceptance criteria (by proving substantial equivalence) is that:

• There is no change to the intended use or indications for use.
• There is no change to the fundamental scientific technology (the epoc Reader and Test Card, which contain the sensors, remain unchanged).
• There is no change to labeled performance claims.
• There is no change to the principle of operation.
• There is no change to cartridge (test card) calibrator formulation and technology.

Therefore, the "acceptance criteria" here are implicitly that the new epoc NXS Host component, through its verification and validation, functions correctly, safely, and does not introduce new risks, thereby maintaining the established performance and safety profile of the predicate device.

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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 whole blood in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions.

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

Measurement of Sodium and Potassium are used in diagnosis and treatment diseases involving electrolyte imbalance. Measurement of lonized Calcium is used in diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. Measurement of ph pCO2, p02 (blood gases) is used in the diagnosis and treatment of life-threatening acid-base disturbances. Measurement Hct distinguish normal from abnormal states of blood volume, such as anemia and erythrocvtosis.

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

1. EPOC Test Card: The single use blood test card comprises a port for introduction of a blood sample to an array of sensors on a sensor module. The sensor module is mounted proximal to a fluidic channel contained in a credit-card sized housing. The card has an on-board calibrator contained in a sealed reservoir fluidically connected to the senor array through a valve.
2. EPOC Card Reader: The reader is a minimally featured raw-signal acquisition peripheral. The reader comprises a card orifice for accepting a test card, and a mechanical actuation assembly for engaging the test card after it is inserted into the card orifice. Within the reader's card orifice there is a bar code scanner, an electrical contact array for contacting the card's sensor module, and a thermal subsystem for heating the card's measurement region to 37°C during the test. The reader also comprises circuits for amplifying, digitizing and converting the raw sensor signals to a wireless transmittable Bluetooth™ format.
3. EPOC Host: The host is a dedicated use Personal Digital Assistant (PDA) computing device with custom software that displays the test results. The reader and host computer together constitute all of the subsystems generally found in a traditional analyzer that operates on unit-use sensors and reagents.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the EPOC™ Blood Analysis System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for each parameter in the same way a regulatory body might define them (e.g., "bias must be less than X," or "CV must be less than Y"). However, the non-clinical and clinical test results implicitly serve as the demonstrated "performance" against which substantial equivalence is claimed to a predicate device. For the purpose of this analysis, I will synthesize the linearity data as a primary indicator of performance across relevant ranges.

Note on "Acceptance Criteria": The document claims the device performs effectively based on the non-clinical data and that its clinical performance is equivalent to the predicate device. The strong linearity and high R-squared values for the in-house linearity study (indicating a close fit to a linear model) and the clinical method comparison study (comparing the device to the predicate) would be the basis for these conclusions. Specific numerical acceptance cutoffs are not provided in this summary.

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

• Non-Clinical (Precision Study - Aqueous Controls):
  • Sample Size: Not explicitly stated as a number of unique samples, but refers to "n=20 replicates on each of 2 controls per day over 20 days" for the 20-day precision study with aqueous controls. This implies 800 measurements for blood gases and electrolytes (20 days * 2 controls * 20 replicates) and 400 measurements for hematocrit (20 days * 2 controls * 10 replicates for each level A and B, assuming 10 replicates per control per day).
  • Data Provenance: In-house laboratory.
• Non-Clinical (Precision Study - Whole Blood Field Trials):
  • Sample Size: 10 replicates of different whole blood patient samples for each operator at each site. There were 7 operators across 3 sites.
  • Data Provenance: Three point-of-care sites (hospitals, nursing homes, or other clinical care institutions), located in Canada (judging by the company address).
• Non-Clinical (Linearity Study):
  • Sample Size: Not explicitly stated, but performed "in-house." The results are presented for a "Test range" rather than a number of distinct samples.
  • Data Provenance: In-house laboratory.
• Non-Clinical (Interference Studies):
  • Sample Size: Not explicitly stated.
  • Data Provenance: Not explicitly stated, but implied to be in-house.
• Clinical (Method Comparison Study):
  • Sample Size:
    • pH: 149
    • pCO2: 143
    • pO2: 142
    • K: 146
    • Na: 156
    • iCa: 156
    • Hct: 142
  • Data Provenance: Patient samples of whole blood from a hospital in a field trial. Locations included the intensive care unit, cardiac intensive care unit, hematology/oncology department, and the central lab. Sample types included arterial, venous, and mixed venous/arterial. The country of origin is not explicitly stated in this section, but the company is Canadian, suggesting Canadian sites.

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

• This information is not provided in the document. For device performance studies like these, the "ground truth" is typically established by measurements from a reference method (often a central lab analyzer or a predicate device, as used here). The expertise would lie in the operation and validation of these reference methods, rather than clinical consensus.

4. Adjudication Method for the Test Set

• This concept is not directly applicable to the type of device performance studies described (analytical accuracy and precision studies). Adjudication usually pertains to human expert review of clinical cases, particularly in imaging or diagnostic accuracy studies where there's subjectivity. In this case, results are quantitative measurements compared to a reference standard or predicate device.

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

• No, an MRMC comparative effectiveness study was not done. This type of study applies to diagnostic devices where human interpretation is involved, often with AI assistance. The EPOC Blood Analysis System is an in vitro diagnostic device providing quantitative measurements, not an interpretive aid for human readers.

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

• Yes, the performance studies presented (precision, linearity, interference, and method comparison) are essentially standalone performance studies of the device's ability to accurately measure the target analytes. The device generates quantitative results without requiring human interpretation of raw signals; human-in-the-loop performance is not a relevant concept for this type of automated analyzer. The "operators" in the field trial precision study are performing the sample introduction and use of the device, not interpreting results in a subjective manner.

7. The Type of Ground Truth Used

• Non-Clinical (Precision, Linearity, Interference): The ground truth was established using in-house standard methods with traceability to NIST standards (for linearity) and aqueous controls or prepared samples with known concentrations.
• Clinical (Method Comparison): The ground truth was established by comparing the EPOC system's measurements to those obtained from the predicate device, the i-Stat™ Model 300 Portable Clinical Analyzer. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices.

8. The Sample Size for the Training Set

• Not explicitly stated. The document describes performance testing, but there is no explicit mention of a "training set" in the context of machine learning or AI models. This device is an automated sensor-based system, not a machine learning algorithm that requires a distinct training phase in the same way. The development and calibration would involve internal testing, but not a formally defined "training set" as understood in AI studies. The "calibration materials" and "quality control materials" mentioned contribute to the device's operational robustnes and accuracy.

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

• As noted above, a "training set" as in machine learning is not applicable here. However, the reference materials used for calibration (which could be considered analogous in a broad sense to establishing a "truth" for the device's internal algorithms) are:
  • On-board calibration material: Prepared gravimetrically and assayed on reference systems calibrated with traceability to NIST standards.
  • Calibration verification fluids: Commercially available, traceable to NIST standards.
  • Quality control materials: Commercially available, traceable to NIST standards.

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