(195 days)
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:
- epoc Test Card: single use blood test card with sensors, fluidic channel, and on-board calibrator.
- 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.
- 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.
| Parameter | Performance Metric | Reported Value (Method Comparison: epoc/CareFill vs i-STAT/CliniTube, Clinical Study) | Reported Value (Precision Study: epoc/CareFill, Field Trial) - Example Range |
|---|---|---|---|
| pH | Average Bias (Y-X) | -0.02 | N/A (Bias not measured against a predicate in precision study) |
| SD (%CV) - Example from Clinical Precision Study | N/A | 0.006-0.013 (0.1%-0.2%) | |
| pCO2 | Average Bias (Y-X) | 1.5 | N/A |
| SD (%CV) - Example from Clinical Precision Study | N/A | 0.5-1.2 (1.6%-2.8%) | |
| pO2 | Average Bias (Y-X) | 2.3 | N/A |
| SD (%CV) - Example from Clinical Precision Study | N/A | 1.2-9.1 (1.6%-7.4%) | |
| Na | Average Bias (Y-X) | -2.5 | N/A |
| SD (%CV) - Example from Clinical Precision Study | N/A | 0.5-1.5 (0.4%-1.0%) | |
| K | Average Bias (Y-X) | -0.2 | N/A |
| SD (%CV) - Example from Clinical Precision Study | N/A | 0.04-0.24 (1.4%-3.5%) | |
| iCa | Average Bias (Y-X) | -0.041 | N/A |
| SD (%CV) - Example from Clinical Precision Study | N/A | 0.008-0.028 (0.8%-2.5%) | |
| Glu | Average Bias (Y-X) | 0.53 (for all capillary) | N/A |
| Average Bias (Y-X) - Neonatal Capillary | 1.8 (at Decision Level 1), -5.2 (at Decision Level 2) | N/A | |
| SD (%CV) - Example from Clinical Precision Study | N/A | 1.5-8.6 (2.9%-3.9%) | |
| Hct | Average Bias (Y-X) | -4.5 | N/A |
| SD (%CV) - Example from Clinical Precision Study | N/A | 0.3-1.4 (1.4%-2.9%) |
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.
§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.