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510(k) Data Aggregation
(59 days)
The GEM Premier 5000 is a portable critical care system for use by health care professionals to rapidly analyze heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCO2, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O2Hb, MetHb, HHb, sO2*) parameters from arterial, venous or capillary heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity. *sO2 = ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin.
· pH, pCO2, and pO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid-base disturbances.
· Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes:
· Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
· Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
• Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
• Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders, such as cystic fibrosis and diabetic acidosis.
· Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells),
· Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
· Lactate (Lac) measurement is used:
· to evaluate the acid-base status of patients suspected of having lactic acidosis;
· to monitor tissue hypoxia and strenuous physical exertion:
· in the diagnosis of hyperlactatemia.
· Total Bilirubin (tBili) measurement is used to aid in assessing the risk of kernicterus and hyperbilirulyinemia in neonates.
• CO-Oximetry (tHb, COHb, MetHb, O2Hb, HHb, and sO2) evaluates the ability of the blood to carry oxygen by measuring total hemoglobin and determining the percentage of functional hemoglobin species.
• Total Hemoglobin (tHb): Total hemoglobin measure the hemoglobin content of whole blood for the detection of anemia.
· COHb: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.
· MetHb: Methemoglobin measurements are used to determine different conditions of methemoglobinemia.
· HHb: Deoxyhemoglobin, as a fraction of total hemoglobin, is used in combination with oxyhemoglobin to measure oxygen status.
· O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with decxyhemoglobin to measure oxygen status.
· sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin, is used to measure oxygen status.
The GEM Premier 5000 system provides health care professionals with fast, accurate, quantitative measurements of pH, pCO2, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O₂Hb, MetHb, HHb, sO₂*) parameters from arterial, venous or capillary heparinized whole blood in central laboratory or point-of-care clinical settings.
*sO2 = Ratio between the concentration of oxyhemoglobin plus deoxyhemoglobin plus deoxyhemoglobin.
Here's an analysis of the acceptance criteria and study detailed in the provided document, addressing each of your requested points:
The document describes the GEM Premier 5000 device, an in vitro diagnostic system for analyzing blood gases and other parameters. The purpose of this specific 510(k) submission is to expand capillary heparinized whole blood claims for pCO2, potassium, chloride, hematocrit, and total hemoglobin. Therefore, the acceptance criteria and study focus on establishing the performance of these analytes with capillary samples on the GEM Premier 5000, demonstrating substantial equivalence to the predicate device (GEM Premier 4000).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a separate table. Instead, it demonstrates performance by showing that "All results met specification" for precision studies and by providing bias and Total Error (TEa) ranges for method comparison, which implicitly serve as acceptance criteria. For the regression analysis, the slope and intercept being close to 1 and 0 respectively, and a high correlation coefficient (r), are the performance indicators.
Here's a breakdown of the reported device performance for the analytes relevant to the expanded claims:
Precision Studies (Internal Precision - Capillary Transfer Samples)
(N=120 per analyte per level, 5 levels each)
| Analyte (Unit) | Level | Mean | Within Run SD | Within Run %CV |
|---|---|---|---|---|
| pCO2 (mmHg) | 1 | 9.9 | 0.5 | 5.1% |
| 2 | 34.5 | 0.6 | 1.9% | |
| 3 | 49.0 | 0.5 | 1.1% | |
| 4 | 68.9 | 1.6 | 2.3% | |
| 5 | 108.9 | 2.4 | 2.2% | |
| K+ (mmol/L) | 1 | 1.46 | 0.05 | 3.2% |
| 2 | 2.70 | 0.06 | 2.1% | |
| 3 | 5.43 | 0.04 | 0.8% | |
| 4 | 7.16 | 0.07 | 1.0% | |
| 5 | 17.29 | 0.15 | 0.9% | |
| Cl- (mmol/L) | 1 | 53.4 | 0.4 | 0.8% |
| 2 | 75.8 | 0.4 | 0.5% | |
| 3 | 89.8 | 0.4 | 0.4% | |
| 4 | 110.7 | 0.4 | 0.4% | |
| 5 | 152.8 | 0.7 | 0.4% | |
| Hct (%) | 1 | 19.3 | 0.6 | 2.9% |
| 2 | 32.8 | 0.6 | 1.9% | |
| 3 | 44.7 | 0.6 | 1.3% | |
| 4 | 55.0 | 0.8 | 1.5% | |
| 5 | 63.7 | 1.3 | 2.0% | |
| tHb (g/dL) | 1 | 7.02 | 0.16 | 2.3% |
| 2 | 11.06 | 0.09 | 0.8% | |
| 3 | 14.47 | 0.10 | 0.7% | |
| 4 | 17.34 | 0.09 | 0.5% | |
| 5 | 19.92 | 0.25 | 1.3% | |
| All results for these internal precision studies met specification. |
Precision Studies (Internal Precision - Capillary Finger-stick Samples)
(N=56 per analyte, single GEM Premier 5000, 2 POC operators, 28 donor samples)
| Analyte (Unit) | N | Mean | Within Sample SD | Within Sample %CV |
|---|---|---|---|---|
| pCO2 (mmHg) | 56 | 39 | 1.3 | 3.3 |
| K+ (mmol/L) | 56 | 4.1 | 0.11 | 2.6 |
| Cl- (mmol/L) | 56 | 106 | 0.3 | 0.3 |
| Hct (%) | 56 | 43 | 0.7 | 1.7 |
| tHb (g/dL) | 56 | 14.2 | 0.14 | 1.0 |
| All results for these internal precision studies met specification. |
Precision Studies (External POC Precision – Capillary Transfer Samples)
(N=minimum 20 residual whole blood samples over 5 days, triplicate runs, 3 POC operators)
| Analyte (Unit) | N | Mean | Within Sample SD | Within Sample %CV |
|---|---|---|---|---|
| pCO2 (mmHg) | 63 | 42 | 0.9 | 2.0 |
| 3 | 88 | 0.6 | 0.7 | |
| K+ (mmol/L) | 66 | 4.0 | 0.05 | 1.2 |
| Cl- (mmol/L) | 66 | 107 | 0.5 | 0.5 |
| Hct (%) | 66 | 30 | 0.7 | 2.4 |
| tHb (g/dL) | 60 | 11.0 | 0.29 | 2.6 |
| All results for these external POC precision studies met specification. |
Method Comparison (Pooled Point-of-Care Site and CSL Data with Native Capillary Samples)
(Reference: GEM Premier 4000)
| Analyte (Unit) | N | Range Min | Range Max | MDL | Bias at MDL | 95% CI of Bias at MDL | TEa Value (Implied Acceptance) |
|---|---|---|---|---|---|---|---|
| pCO2 (mmHg) | 130 | 26 | 50 | 35 | 1.0 | 1.0 to 2.0 | ± 5.0 |
| 50 | 1.0 | 1.0 to 2.0 | ± 5.0 | ||||
| 70 | 1.4% | 1.4% to 3.1% | ± 8% | ||||
| K+ (mmol/L) | 130 | 3.1 | 6.7 | 3.0 | 0.1 | -0.03 to 0.19 | ± 0.5 |
| 5.8 | 0.1 | 0.05 to 0.30 | ± 0.5 | ||||
| 7.5 | 1.3% | 0.7% to 6.8% | ± 7% | ||||
| Cl- (mmol/L) | 129 | 90 | 111 | 90 | -1.1% | -1.1% to 0.0% | ± 5% |
| 112 | -0.9% | -0.9% to 0.0% | ± 5% | ||||
| Hct (%) | 130 | 24 | 51 | 21 | -0.4 | -1.3 to 0.5 | ± 4 |
| 33 | -0.3 | -0.7 to 0.1 | ± 4 | ||||
| 56 | -0.1 | -0.7 to 0.5 | ± 4 | ||||
| tHb (g/dL) | 131 | 6.9 | 17.3 | 7.0 | -0.27 | -0.43 to -0.12 | ± 0.7 |
| 10.5 | -0.17 | -0.25 to -0.09 | ± 0.7 | ||||
| 18.0 | 0.05 | -0.07 to 0.16 | ± 1.0 |
Method Comparison (Pooled Point-of-Care Site and CSL Data with Additional Contrived Capillary Results - Regression Analysis)
(Reference: GEM Premier 4000)
| Analyte (Unit) | N | Slope | Intercept | r | Sample Range |
|---|---|---|---|---|---|
| pCO2 (mmHg) | 139 | 1.000 | 1.000 | 0.980 | 11 to 87 |
| K+ (mmol/L) | 140 | 1.000 | 0.100 | 0.995 | 1.5 to 17.6 |
| Cl- (mmol/L) | 141 | 1.000 | -1.000 | 0.995 | 45 to 149 |
| Hct (%) | 136 | 1.003 | -0.407 | 0.987 | 15 to 64 |
| tHb (g/dL) | 137 | 1.028 | -0.470 | 0.994 | 4.5 to 20.5 |
Implied Acceptance Criteria:
- Precision: Standard Deviation (SD) and Coefficient of Variation (%CV) values for each analyte at various levels must meet an internal "specification" (not explicitly stated in the table, but indicated as "All results met specification."). The document mentions analysis being separated for "fixed acceptance criteria range (SD)" and "variable acceptance criteria range (%CV)".
- Method Comparison (Bias): The observed biases at the medical decision levels and their 95% Confidence Intervals (CI) should be within the Total Error (TEa) values provided.
- Method Comparison (Regression): Slope close to 1, intercept close to 0, and a high correlation coefficient (r) (typically >0.975 for quantitative assays).
2. Sample Size Used for the Test Set and Data Provenance
The test sets were derived from various sources:
- Internal Precision - Capillary Transfer Samples:
- Sample Size: 5 different concentrations of whole blood per analyte, each run on 3 analyzers for 5 days, 1 run/day, 8 replicates/run/level. Total N = 120 per analyte per level.
- Data Provenance: Internal laboratory setting. Samples were "whole blood... transferred from syringe to a capillary device," implying controlled, possibly contrived, whole blood samples.
- Internal Precision - Capillary Finger-stick Samples:
- Sample Size: 28 donor samples, each collected into 2 capillary tubes and run in singlicate. Total N = 56 for each analyte (28 donors * 2 samples).
- Data Provenance: "IL Customer Simulation Laboratory (CSL), using finger-stick samples drawn and run by two (2) point-of-care (POC) operators." This indicates a prospective collection of real human samples in a simulated clinical environment.
- External POC Precision - Capillary Transfer Samples:
- Sample Size: Minimum of 20 residual whole blood samples run over 5 days, each run in triplicate. Total N = 60-66 samples per analyte (e.g., 63 for pCO2 for main range, 3 for high range; 66 for K+ and Cl-; 60 for tHb).
- Data Provenance: "External point-of-care (POC) site, using heparinized whole blood patient samples transferred from syringe to a capillary device and run by three (3) POC operators." This suggests prospective collection of residual patient samples in a real clinical POC setting.
- Point-of-Care (POC) Method Comparison - Native Capillary Finger-stick Samples:
- Sample Size: Minimum of 40 native capillary samples from an external POC site + minimum of 80 native samples from IL CSL. Total N = 129-131 samples for each analyte.
- Data Provenance: "Native capillary finger-stick samples... collected via finger-stick by six (6) POC operators at an external POC site... and three (3) POC operators in the IL internal Customer Simulation Laboratory (CSL)." This is a prospective collection of real human finger-stick samples from both real-world POC and simulated environments.
- Point-of-Care (POC) Method Comparison - Pooled Data (Regression Analysis):
- Sample Size: The native capillary samples (N=129-131) were pooled with "contrived whole blood samples (< 10%) prepared internally to span the claimed reportable range." Total N = 136-141 samples for each analyte.
- Data Provenance: A mix of prospectively collected native human samples (from external POC and CSL) and internally prepared contrived samples.
No specific country of origin for the human data is explicitly stated. Given "Instrumentation Laboratory Co." is based in Bedford, MA, USA, it's reasonable to infer the studies likely took place in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not describe the use of "experts" to establish a ground truth in the way one might for image interpretation or diagnosis. Instead, the ground truth for performance studies of in-vitro diagnostic devices for quantitative measurements like PCO2, K+, etc., is established:
- For Precision studies: By the instrument itself and its internal consistency.
- For Method Comparison studies: By a predicate device (GEM Premier 4000), which is itself an FDA-cleared device. The "ground truth" is the measurement provided by the established, legally marketed predicate device.
- Operators: The studies involved "two (2) point-of-care (POC) operators" for internal finger-stick precision, "three (3) POC operators" for external POC transfer precision, and "six (6) POC operators at an external POC site" and "three (3) POC operators in the IL internal Customer Simulation Laboratory (CSL)" for the method comparison study. While these are healthcare professionals, they are operating the devices, not acting as "experts" adjudicating clinical ground truth.
4. Adjudication Method for the Test Set
No explicit adjudication method (like 2+1 or 3+1) is mentioned or applicable here. For quantitative IVD devices when comparing to a predicate, the comparison is direct between the numerical outputs of the new device and the predicate device. Where there are multiple operators, their data is pooled or analyzed for variability, but not "adjudicated" in the sense of reaching a consensus on a diagnosis.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study (often used for imaging devices where human interpretation is assisted by AI) is not relevant for this device, which provides direct quantitative measurements of blood parameters. The device itself performs the analysis; it does not assist human "readers" in making a diagnosis from images or complex data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance studies described are essentially standalone algorithm performance (instrument only). The operators are introducing the sample and initiating the test, but the measurement and analysis are performed by the device (its embedded algorithms and sensors) without human interpretation or intervention in the measurement process itself. The precision studies and method comparison directly assess the device's measurement accuracy and reproducibility.
7. The Type of Ground Truth Used
The ground truth used for proving substantial equivalence is:
- Predicate Device Measurements: For method comparison studies, the measurements obtained from the FDA-cleared GEM Premier 4000 device served as the comparative "ground truth." This is a common approach for 510(k) submissions seeking substantial equivalence for new IVD devices.
- Internal Specifications/Reference Materials: For precision and linearity studies, the device performance is evaluated against its own internal specifications and, implicitly, against calibrated reference materials that define precise analyte concentrations.
8. The Sample Size for the Training Set
The document does not specify a training set. This is because the GEM Premier 5000 is an in vitro diagnostic (IVD) device that performs direct measurements based on established electrochemical and optical principles. It does not use machine learning or AI models that typically require a distinct "training set" of data in the same way an AI-based image analysis tool would.
The document mentions "cartridge EEPROM coefficient adjustments (for pCO2, potassium and hematocrit)" were implemented. These adjustments involve recalibrating the device parameters, which might be informed by historical performance data or initial development tests, but these are not typically referred to as a "training set" in the context of IVD devices.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" in the context of machine learning/AI is not applicable or specified, the concept of establishing ground truth for it is also not applicable here. The device's foundational measurement principles and calibration are based on established analytical chemistry and physics.
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