(111 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 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:
- 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.
- 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.
- 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.
| Parameter | Accepted Study Performance (Linearity Slope & R²) | Performance against Predicate (Slope & R) |
|---|---|---|
| pH | Slope: 1.021, R²: 0.998 | Slope: 0.966, R: 0.991 |
| pCO2 | Slope: 1.058, R²: 0.998 | Slope: 1.041, R: 0.990 |
| pO2 | Slope: 1.022, R²: 0.999 | Slope: 1.053, R: 0.978 |
| Na | Slope: 0.973, R²: 0.999 | Slope: 1.077, R: 0.953 |
| K | Slope: 1.006, R²: 0.999 | Slope: 1.013, R: 0.993 |
| iCa | Slope: 1.017, R²: 0.998 | Slope: 1.021, R: 0.985 |
| Hct | Slope: 1.005, R²: 0.999 | Slope: 1.066, R: 0.987 |
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.
- Sample Size:
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.
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure 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 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.(b)
Classification. Class II.