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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, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MHb, 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 plus deoxyhemoglobin 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 hyperbilirubinemia 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 measurements are used to 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.

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· 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 deoxyhemoglobin 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 fast, accurate, quantitative measurements of heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2) from arterial, venous or capillary samples.

The provided text is a 510(k) summary for the GEM Premier 5000 device, detailing an operating system upgrade. This document is a regulatory submission for a device change and does not contain the information requested regarding acceptance criteria, device performance tables, study specifics (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), or ground truth establishment.

The submission is a Special 510(k), which indicates a modification to an already cleared device, not a de novo clearance requiring extensive clinical performance studies. The core of this submission is a software update (operating system change from Fedora 17 Linux to WindRiver LTS 18 Linux) with the stated reason to "accommodate long-term support of resolutions for common vulnerability exposures."

The document explicitly states:

• "Performance data is limited to Software Verification as the scope of this Special 510(k) is specific to an operating system upgrade..."
• "The changes in this submission do not introduce: Changes to indications for use or intended use, Changes to the fundamental scientific technology, Changes to operating principle, Changes to labeled performance claims."

Therefore, the requested information, which typically pertains to the establishment of initial clinical performance and effectiveness, is not present in this regulatory document for this specific submission. The focus here is on ensuring the device continues to meet its previously established performance claims after a technical software upgrade, rather than demonstrating new performance capabilities.

Ask a specific question about this device

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)

Precision Studies (Internal Precision - Capillary Finger-stick Samples)
(N=56 per analyte, single GEM Premier 5000, 2 POC operators, 28 donor samples)

Precision Studies (External POC Precision – Capillary Transfer Samples)
(N=minimum 20 residual whole blood samples over 5 days, triplicate runs, 3 POC operators)

Method Comparison (Pooled Point-of-Care Site and CSL Data with Native Capillary Samples)
(Reference: GEM Premier 4000)

Method Comparison (Pooled Point-of-Care Site and CSL Data with Additional Contrived Capillary Results - Regression Analysis)
(Reference: GEM Premier 4000)

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 (

Ask a specific question about this device

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 sodium from venous, arterial and capillary heparinized whole blood, as well as quantitative measurements of potassium and chloride from venous and arterial heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of electrolyte balance.

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.

Chloride (Cl-) measurements are used in the diagnosis and metabolic disorders, such as cystic fibrosis and diabetic acidosis.

Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

GEM System Evaluator is a three-level assayed quality control material for evaluating performance characteristics of pH, pCO2, pO2, Electrolytes, Metabolites, Total Bilirubin (tBili) and CO-Oximetry on the GEM Premier 4000 and GEM Premier 5000 analyzers.

GEM Hematocrit Evaluator is a three-level assayed quality control material intended for evaluating performance characteristics of hematocrit on the GEM Premier 4000 and GEM Premier 5000 analyzers.

GEM CVP 5 tBili is an external Calibration Valuation Product used to complete the callbration process of the GEM Premier 4000 and GEM Premier 5000 analyzers prior to use with patient samples for total bilirubin (tBili) testing.

The GEM Premier 5000 system provides health care professionals in central laboratory or point-of-care clinical settings with fast, accurate, quantitative measurements of sodium and ionized calcium from venous, arterial and capillary heparinized whole blood, as well as quantitative measurements of potassium and chloride from venous and arterial heparinized whole blood.

Key Components:
Analyzer: Employs a unique color touch screen and a simple set of menus and buttons for user interaction. The analyzer guides operators through the sampling process with simple, clear messages and prompts.
GEM Premier 5000 PAK (disposable, multi-use GEM PAK): Houses all required components necessary to operate the instrument once the cartridge is validated. These components include the sensors, CO-Ox/tBili optical cell, Process Control (PC) Solutions, sampler, pump tubing, distribution valve and waste bag. The GEM PAK has flexible menus and test volume options to assist facilities in maximizing efficiency.
Intelligent Quality Management 2 (iQM2): iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions. iQM2 is a statistical process control system that performs 5 types of continuous, quality checks to monitor the performance of the GEM PAK, sensors, CO-Ox, and reagents. These checks include System, Sensor, IntraSpect, Pattern Recognition and Stability Checks.

Here's a summary of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

Device: GEM Premier 5000 (Measured Parameters: Sodium, Potassium, Chloride, Ionized Calcium) and associated evaluators.

Clinical Context: Rapid analysis of heparinized whole blood samples in clinical and central laboratory settings for diagnosis and treatment of electrolyte imbalances.

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" with numerical targets for each performance metric, but rather presents the results of various studies and states that "all results were within specification" or "all parameter levels passed specification," implying that the observed performance met predefined internal acceptance criteria.

Below is a table summarizing the reported device performance from the various studies. The "Acceptance Criteria" column reflects the implied successful performance indicated by the text.

2. Sample Sizes and Data Provenance

• Test Set Sample Sizes:

  • Internal Precision (Aqueous Controls): 120 replicates per control level per analyte (3 analyzers x 20 days x 2 runs/day x 1 replicate = 120).
  • Internal Precision (Process Control Solutions D & E): 120 replicates per PCS per analyte (3 analyzers x 20 days x 2 runs/day x 1 replicate = 120).
  • Internal Precision (Whole Blood): 120 replicates per concentration level per analyte (3 analyzers x 5 days x 1 run/day x 8 replicates = 120).
  • Reproducibility (Aqueous Controls - POC): 90 replicates per control level per analyte (3 sites x 3 replicates/run x 2 runs/day x 5 days = 90).
  • External Precision (Whole Blood):
    • POC Sites: 30-54 samples for Na+, 30-54 for K+, 30-54 for Cl-, 27-54 for Ca++ (per site)
    • Central Labs (Lab1, Lab2) / CSL: 30-33 samples for Na+, 30-33 for K+, 30-36 for Cl-, 27-33 for Ca++ (per site/lab)
  • Linearity: 9 or 10 levels per analyte, each analyzed in triplicate (9-10 levels x 3 replicates per level = 27-30 measurements per analyte).
  • Method Comparison (GEM Premier 5000 vs. GEM Premier 4000): 373 samples for each analyte (Na+, K+, Cl-, Ca++).
  • Clinical Testing (Normal Mode Syringe Samples): 485-491 samples per analyte.
  • Clinical Testing (Native Capillary Samples): 171 samples for Na+ and Ca++.
  • Clinical Testing (Pooled Native & Contrived Capillary Samples): 201 samples for Na+, 205 samples for Ca++.

• Data Provenance: The data is a mix of internal studies (Instrumentation Laboratory Co.) and external studies at clinical point-of-care (POC) sites and central laboratories.

  • Internal Studies: Conducted by Instrumentation Laboratory Co. (Bedford, MA, USA). Some CSL (Customer Simulation Laboratory) data included contrived samples.
  • External Studies: Performed at:
    • Three (3) external clinical point-of-care (POC) sites.
    • Two (2) external central laboratories.
    • One (1) internal Customer Simulation Laboratory (CSL) at IL, with POC users.
  • Retrospective/Prospective: The studies appear to be prospective, designed specifically to evaluate the GEM Premier 5000's performance as per CLSI guidelines. The whole blood samples used in precision and method comparison studies include both native patient samples and, in some cases, contrived samples. The native clinical samples would be analogous to retrospective data if collected prior, but the studies describe active collection and testing to compare performance.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly mention the number or qualifications of "experts" used to establish ground truth in the traditional sense (e.g., radiologists, pathologists). Instead, laboratory reference methods and predicate devices are used as the "ground truth" or reference for comparison.

• Ground Truth for Analytical Studies:
  • Traceability: For Process Control Solutions (PCS), it states "traceable to NIST standards, CLSI procedures or internal standards."
  • Reference Analyzers: For Linearity, results were "compared to reference analyzers."
  • Predicate Device: For Method Comparison and Clinical Testing, the GEM Premier 4000 (K133407) served as the predicate device for comparison.

Since this is a clinical chemistry device for measuring electrolytes, the "ground truth" is typically established by highly calibrated and validated laboratory reference methods or proven predicate devices, rather than expert interpretation of images or clinical assessments.

4. Adjudication Method

Not applicable for this type of device performance study. Adjudication methods (like 2+1 or 3+1 expert consensus) are typically used in studies involving subjective assessments, such as radiology image interpretation, to establish a definitive ground truth when there might be inter-reader variability. For quantitative measurements by clinical chemistry analyzers, the ground truth is established by objective reference methods or well-characterized predicate devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are specific to evaluating the impact of an AI system on human reader performance, often in diagnostic imaging. This document describes the analytical and clinical performance of a clinical chemistry device, which does not involve human "readers" interpreting cases in the same way. The studies focus on the device's accuracy, precision, linearity, and comparability to a predicate device.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance assessment was conducted for the device. The entire suite of analytical and clinical studies (precision, linearity, analytical specificity, method comparison) evaluates the performance of the GEM Premier 5000 system (which includes its embedded processing/algorithm) as a standalone diagnostic tool without direct human-in-the-loop interpretation of results that would alter the quantitative measurement it produces. The output values are direct physical measurements.

7. Type of Ground Truth Used

The ground truth used for this device includes:

• Reference Methods/Standards: For internal precision and calibration, traceability to NIST standards, CLSI procedures, or internal standards is mentioned for Process Control Solutions. "Reference analyzers" were used for linearity comparisons.
• Predicate Device Performance: For method comparison and clinical testing, the GEM Premier 4000 served as the gold standard or reference for comparison, indicating substantial equivalence.
• Known Concentrations: Contrived samples (e.g., in the CSL) were used to cover medical decision levels, implying that their concentrations were known or precisely measured by a separate method.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI models. Given that this is a 510(k) submission for an in vitro diagnostic device, the "training" for such devices typically refers to the extensive development and internal testing/calibration cycles that occur before formal validation studies (like those presented in the performance section) are conducted. These early development data sets are generally not disclosed in 510(k) summaries but are part of the design control process. The performance data presented are from validation studies, which serve as the test set.

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

As noted above, a distinct "training set" with established ground truth in the AI/ML sense is not detailed. However, the process for establishing "ground truth" during device development (analogous to training) would involve:

• Calibration Standards: Using certified reference materials and multi-point calibration procedures to ensure the device's sensors and algorithms accurately translate raw signals into quantitative concentrations.
• Inter-Instrument Reproducibility: Extensive internal testing against known values to optimize sensor performance and ensure consistency across multiple manufacturing units.
• Method Development & Optimization: Iterative testing with various samples (potentially including contrived and real patient samples) to refine the measurement algorithms and internal quality control mechanisms (like iQM2) to detect and correct errors. These steps would ensure measurements align with established reference methods or predicate devices.

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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 Hematocrit and Total Hemoglobin from venous and arterial heparinized whole blood, as well as quantitative measurements of O2Hb. COHb. MetHb. HHb. sO2 from venous, arterial and capillary heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's oxygen delivery capacity.

• 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).
• 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 oxygenation status.

· O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with deoxyhemoglobin to measure oxygenation status.

· sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin, is used to measure oxygenation status.

The GEM Premier 5000 system provides health care professionals in central laboratory or point-of-care clinical settings with fast, accurate, quantitative measurements of Hematocrit and Total Hemoglobin from venous and arterial heparinized whole blood, as well as quantitative measurements of O₂Hb, COHb, MetHb, HHb, sO2 from venous, arterial and capillary heparinized whole blood.

Key Components:
Analyzer: Employs a unique color touch screen and a simple set of menus and buttons for user interaction. The analyzer guides operators through the sampling process with simple, clear messages and prompts.
GEM Premier 5000 PAK (disposable, multi-use GEM PAK): Houses all required components necessary to operate the instrument once the cartridge is validated. These components include the sensors, CO-Ox optical cell, Process Control (PC) Solutions, sampler, pump tubing, distribution valve and waste bag. The GEM PAK has flexible menus and test volume options to assist facilities in maximizing efficiency. NOTE: The EEPROM on the GEM PAK includes all solution values and controls the analyte menu and number of tests.
Intelligent Quality Management 2 (iQM2): iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions. iQM2 is a statistical process control system that performs 5 types of continuous, quality checks to monitor the performance of the GEM PAK, sensors, CO-Ox, and reagents. These checks include System.

The provided text describes the GEM Premier 5000, a portable critical care system for analyzing heparinized whole blood samples. It focuses on the device's technical specifications and performance studies to demonstrate substantial equivalence to a predicate device (GEM Premier 4000) for Hematocrit and CO-Oximetry measurements.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for precision or method comparison studies in a single table with target values. Instead, it presents the "Within Analyzer SD/CV" and "Total SD/CV" or "Bias" for various analytes and compares them to specifications which are indirectly implied to be the acceptance criteria. For the purpose of this response, I will interpret "SD/CV Spec" as the acceptance criteria for reproducibility and "Medical Decision Levels" with a calculated "Total Error Observed" compared to an unstated "GEM Premier 5000 Total Error Specifications" as acceptance criteria for accuracy.

Here's a table summarizing the reported device performance based on the precision and method comparison studies:

Table 1: Summary of Device Performance against Implicit Criteria

Note: For the Total Error Observed, the document states these were compared to "GEM Premier 5000 Total Error Specifications," but these specifications are not explicitly provided in the text for all analytes. However, for capillary clinical testing, specific TEa values are given for some analytes, which are used here as proxies for acceptance criteria where available.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Internal Precision Study (Aqueous Controls):
  • Sample Size: 120 per analyte/level (3 analyzers, 20 days, 2 runs/day, 1 replicate/run).
  • Data Provenance: Internal study (Instrumentation Laboratory Co.), prospective.
• Internal Precision Study (GEM PAK Process Control Solutions):
  • Sample Size: 120 per analyte/level (3 analyzers, 20 days, 2 runs/day, 1 replicate/run).
  • Data Provenance: Internal study (Instrumentation Laboratory Co.), prospective.
• Internal Precision Study (Whole Blood):
  • Sample Size: 120 per analyte/sample mode (3 analyzers, 5 days, 1 run/day, 8 replicates/run).
  • Data Provenance: Internal study (Instrumentation Laboratory Co.), prospective. Origin of whole blood samples likely internal or procured, not specified by country.
• Reproducibility Study (Aqueous Controls – Point-of-Care (POC) Setting):
  • Sample Size: 90 per analyte/level (3 external POC sites, 3 different GEM Premier 5000 instruments, triplicate measurements, twice a day, total 30 replicates per level, pooled).
  • Data Provenance: External clinical POC settings, prospective. Country of origin not specified, but likely USA based on the FDA submission.
• External Precision (Whole Blood - Central Lab and POC settings):
  • Sample Size: Varies by analyte and site (e.g., Hct Normal Mode POC-All N=126, CSL N=36, Lab1 N=30, Lab2 N=30). The overall study involved multiple whole blood specimens (at least two per day) analyzed in triplicate daily for 5 days.
  • Data Provenance: 2 external central laboratories, 1 internal Customer Simulation Laboratory (CSL), and 3 external POC locations. Prospective, "contrived whole blood specimens were analyzed in addition to native specimens" in the CSL. Country of origin not specified, but likely USA based on the FDA submission.
• Analytical Specificity (Interference Study):
  • Sample Size: Not explicitly stated as a single "test set" size for all substances, but experiments were conducted with various concentrations of interfering substances.
  • Data Provenance: Internal study (Instrumentation Laboratory Co.), prospective.
• Internal Method Comparison (Clinical Samples):
  • Sample Size: Varies by analyte (N=376 for Hct, N=373 for O2Hb, etc.).
  • Data Provenance: Clinical samples (heparinized whole blood) altered as needed to cover medical decision levels. Internal study, retrospective/prospective hybrid (samples altered to cover ranges).
• Clinical Testing (Point-of-Care Setting - Normal Mode):
  • Sample Size: Varies by analyte (e.g., N=490 for Hct, N=485 for COHb).
  • Data Provenance: Three (3) external point-of-care (POC) sites and one (1) internal Customer Simulation Laboratory (CSL) at IL. Heparinized whole blood patient samples from the intended use population. Samples spiked in CSL to cover reportable ranges. Provenance likely USA, prospective.
• Clinical Testing (Capillary Samples):
  • Sample Size: Native capillary samples: N=52 (external POC), N=100 (IL CSL) for a total of 152 native samples for O2Hb, HHb, sO2. Total N becomes 180-182 when pooled with additional internally prepared contrived capillary samples for specific analytes (pages 29-30).
  • Data Provenance: One external POC site and the IL internal Customer Simulation Laboratory (CSL). Native finger-stick samples and contrived capillary samples. Provenance likely USA, prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document relates to an in-vitro diagnostic device measuring blood parameters. Ground truth in this context is typically established by comparative measurements against a recognized reference method or a predicate device, not by expert consensus in the same way an imaging AI would use expert radiologist reads.

For the Internal Method Comparison and Clinical Testing studies, the GEM Premier 5000 was compared to the predicate device, the GEM Premier 4000. The predicate device itself serves as the "reference standard" or "ground truth" for demonstrating substantial equivalence. The document does not specify human experts establishing ground truth for the test set; rather, the predicate device and established analytical methods (e.g., CNMetHb procedure - CLSI H15-A3 for tHb) are used as comparators.

The Linearity study also mentions comparing results to "reference analyzers or standard reference procedures (i.e. CNMetHb procedure - CLSI H15-A3 for tHb)".

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this type of in-vitro diagnostic device. "Adjudication" typically refers to the process of resolving discrepancies between human readers or between human readers and an AI output, especially in imaging studies where subjective interpretation is involved. For this device, ground truth is established through quantitative comparisons against established reference methods or a 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

Not applicable. This is an in-vitro diagnostic device that provides quantitative measurements of blood parameters, not an AI-based imaging or diagnostic aid that assists human readers/clinicians in interpretation. Therefore, no MRMC study or assessment of human reader improvement with/without AI assistance was conducted or would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the studies presented evaluate the performance of the device itself in a standalone capacity. The GEM Premier 5000 provides quantitative measurements directly. Operators interact with the device to load samples and retrieve results, but the analytical process and result generation are entirely performed by the instrument's internal "algorithm" (i.e., its measurement and data processing capabilities).

The device description on page 5 highlights its autonomy:

• "The analyzer guides operators through the sampling process with simple, clear messages and prompts."
• "After inserting the GEM PAK, the instrument will perform an automated PAK warm-up..."
• "Auto PAK Validation (APV) process is automatically completed..."
• "iQM2 manages the quality control process, replacing external quality controls."

This indicates that the device operates autonomously for its core measurements, with human intervention for sample loading and result review, but not for interpreting the raw measurement signals.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the performance studies was established through:

• Comparison to a Legally Marketed Predicate Device: The GEM Premier 4000 served as the primary comparator for method comparison studies, demonstrating substantial equivalence.
• Standard Reference Procedures/Analyzers: For linearity studies and potentially for other analytical performance aspects, comparison to "reference analyzers or standard reference procedures (i.e. CNMetHb procedure - CLSI H15-A3 for tHb)" was used.
• Certified Control Materials: Aqueous controls and GEM PAK Process Control Solutions that are "traceable to NIST standards, CLSI procedures or internal standards" were used for precision and reproducibility studies. These materials have known, certified values which serve as ground truth for assessing device accuracy and precision.

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 focus is on proving the analytical performance of an in-vitro diagnostic instrument through traditional analytical validation studies (precision, linearity, method comparison, etc.).

However, the device incorporates "Intelligent Quality Management 2 (iQM2)" which is described as "an active quality process control program designed to provide continuous monitoring of the analytical process... with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions." While iQM2 itself would have been developed and "trained" or calibrated using extensive internal data during the device's R&D phase, the public 510(k) summary does not provide details on a specific training set size for the iQM2 component. The studies presented are for the validation of the final device's performance, not the internal development of iQM2.

The "internal precision study" and "internal method comparison" are validation studies of the final device. The data shown in these tables is for testing the device's performance, not training it.

9. How the ground truth for the training set was established

As noted in point 8, a "training set" in the context of typical AI/ML models is not explicitly described or relevant for the approval justification in this 510(k) summary. The document validates the measurement accuracy and precision of the device against predicate devices and reference methods, not an AI model that learns from data in the field.

If "training set" refers to the data used to initially calibrate the instrument's sensors and algorithms during development, this ground truth would have been established through:

• Primary Reference Methods: Employing highly accurate and precise laboratory methods (e.g., gas chromatography, certified spectrophotometric methods, gravimetric/volumetric methods) to determine the true concentration of analytes in reference materials and clinical samples.
• Reference Materials/Standards: Calibrating the device using NIST-traceable standards and other certified reference materials with known analyte concentrations.
• Extensive Internal Testing and Optimization: Using a large array of characterized samples (e.g., blood samples with varying analyte concentrations, interfering substances) to optimize the device's measurement algorithms and ensure accurate performance across its claimed reportable range.

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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 glucose, lactate and total bilirubin from venous, arterial and capillary heparinized whole blood. These parameters aid in the diagnosis of a patient's metabolite balance.

Glucose (Clu) 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 measurement is used to aid in assessing the risk of kernicterus and hyperbilirubinemia in neonates.

The GEM Premier 5000 system provides health care professionals in central laboratory or point-of-care clinical settings with fast, accurate, quantitative measurements of glucose, lactate and total bilirubin from venous, arterial and capillary heparinized whole blood.

Key Components:

• Analyzer: Employs a unique color touch screen and a simple set of menus and buttons for user interaction. The analyzer guides operators through the sampling process with simple, clear messages and prompts.
• GEM Premier 5000 PAK (disposable, multi-use GEM PAK): Houses all required components necessary to operate the instrument once the cartridge is validated. These components include the sensors, CO-Ox/tBili optical cell, Process Control (PC) Solutions, sampler, pump tubing, distribution valve and waste bag. The GEM PAK has flexible menus and test volume options to assist facilities in maximizing efficiency.
• Intelligent Quality Management 2 (iQM2): iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions. iQM2 is a statistical process control system that performs 5 types of continuous, quality checks to monitor the performance of the GEM PAK, sensors, CO-Ox, and reagents. These checks include System, Sensor, IntraSpect, Pattern Recognition and Stability Checks.

The provided text describes the performance of the GEM Premier 5000 device for measuring Glucose, Lactate, and Total Bilirubin. The document primarily focuses on analytical and clinical studies to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria against a specific benchmark.

However, we can infer acceptance criteria based on the "Total Error Observed" compared to "Total Error Specifications" in the "Whole Blood Performance at Medical Decision Levels" section. The document states, "Total Error was computed based on the following equation and the results were compared to the GEM Premier 5000 Total Error Specifications." This implies that the 'Total Error Specifications' are the acceptance criteria.

1. Table of acceptance criteria and the reported device performance:

Note: The document explicitly states "All results were within specification" for precision studies and "All parameter levels passed specification for all sample modes" for internal method comparison, and "The analytical and clinical study results demonstrate that the GEM Premier 5000 is safe and effective for its intended purpose and equivalent in performance to the predicate devices." While specific numerical acceptance criteria (Total Error Specifications) are not detailed in the provided excerpts, the text indicates that the observed total error for Glucose, Lactate, and tBili met these internal specifications. For the clinical testing section concerning capillary samples, a "TEa" (Total Error Allowable) is given, which serves as an acceptance criterion for those specific tests.

Capillary Samples Acceptance Criteria (TEa) and Performance:

2. Sample sizes used for the test set and data provenance:

• Internal Precision Study - Aqueous Controls: N=120 per analyte/level for each of the 3 controls (GEM System Evaluator and CVP 5 tBili). The study was internal to the manufacturer (Instrumentation Laboratory Co.).
• Internal Precision Study – GEM PAK (Cartridge) Process Control Solutions D and E: N=120 per analyte/level for each of the 2 solutions. The study was internal to the manufacturer.
• Internal Precision Study – Whole Blood: N=120 per analyte/level/sample mode (Normal and Micro) for five different concentrations of whole blood. The study was internal to the manufacturer.
• Reproducibility Study with Aqueous Controls – Point-of-Care (POC) Setting: N=90 pooled data (30 replicates per level) per analyte/level. This involved 3 external clinical POC sites, suggesting prospective data collection in a point-of-care setting.
• External Precision - Whole Blood: Patient samples were tested at 2 external central laboratories and 1 internal Customer Simulation Laboratory (CSL), and 3 external POC locations. At least two whole blood specimens were analyzed in triplicate daily for 5 days. Specific "N" values for each site and analyte are provided in the tables within the document (e.g., for Glu Normal Mode, POC1 N=51, POC2 N=39, POC3 N=27, CSL N=33, Lab1 N=30, Lab2 N=30). Data provenance is a mix of internal CSL (contrived and native specimens) and external clinical labs and POC sites (patient samples), implying prospective collection of patient samples.
• LoB, LoD, LoQ: Three (3) lots of GEM Premier 5000 PAKs (cartridges) were used.
• Linearity: Nine (9) levels per analyte, each analyzed in triplicate on three (3) GEM Premier 5000 test analyzers. Data provenance appears to be internal.
• Analytical Specificity: Interference study conducted on the GEM Premier 5000. Data provenance appears to be internal.
• Internal Method Comparison: N=373 for Glucose and Lactate, N=163 for tBili. Clinical samples were used, and samples were altered as needed to cover medical decision levels. Data provenance appears to be internal to the manufacturer, comparing to predicate devices.
• Clinical Testing (Method Comparison in POC):
  • Glucose and Lactate (Normal Mode): N=489 for Glucose, N=488 for Lactate. Pooled results from 3 external POC sites and 1 internal CSL. This included patient samples and spiked samples (at CSL).
  • Glucose and Lactate (Native Capillary Samples): N=171. Pooled results from an external POC site and the internal CSL using finger-stick samples.
  • Glucose and Lactate (Contrived Capillary Samples): N=197 for Glucose, N=201 for Lactate. Pooled native capillary samples with additional contrived capillary samples prepared internally.
  • Total Bilirubin (Normal, Capillary, and tBili/CO-Ox Modes): Against Roche Cobas 6000: N=53 (Normal), N=58 (Capillary), N=53 (tBili/CO-Ox). Against Ortho Clinical Diagnostics Vitros 5600: N=76 (Normal), N=77 (Capillary), N=77 (tBili/CO-Ox). Pooled results from external POC sites with neonate samples, adult samples, and spiked samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not specify the number or qualifications of experts for establishing ground truth. The devices being compared are laboratory diagnostic instruments. Therefore, "ground truth" is likely established by reference methods or predicate devices, which are themselves high-accuracy laboratory instruments (e.g., GEM Premier 4000, ABL 837, Roche Cobas 6000, Ortho Clinical Diagnostics Vitros 5600). The "experts" in this context would be the technicians or clinical laboratory scientists operating these reference systems, though their specific qualifications are not stated.

4. Adjudication method for the test set:

Not applicable. This is a medical device performance study, not a clinical trial with human interpretation requiring adjudication. Performance is assessed by comparing results to established reference methods or predicate devices.

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:

Not applicable. This document pertains to an in vitro diagnostic device for quantitative measurements of analytes, not an AI-assisted diagnostic imaging or interpretation system involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, the studies presented are essentially "standalone" evaluations of the device's analytical performance, without direct human interpretation being part of the measurement process itself. The device (GEM Premier 5000) provides quantitative measurements, and its accuracy and precision are assessed against reference methods. While human operators are involved in running the device and collecting samples, the device's output is a direct quantitative result, not an interpretation that is then refined or improved by a human.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance studies is established through comparative analysis with predicate devices (GEM Premier 4000 for glucose and lactate, ABL 837 for total bilirubin) and commercially available laboratory reference analyzers (e.g., Roche Cobas 6000, Ortho Clinical Diagnostics Vitros 5600) for total bilirubin. These predicate and reference devices represent highly accurate and established measurement methods in clinical chemistry.

8. The sample size for the training set:

Not applicable. This document describes the validation of a laboratory instrument, not a machine learning model that requires a "training set." The device's performance is based on its internal design, sensors, and chemical reactions, which are validated through empirical studies rather than algorithm training.

9. How the ground truth for the training set was established:

Not applicable, as there is no "training set" in the context of this device validation.

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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 and pO2 from venous, arterial and capillary heparinized whole blood, as well as quantitative measurements of pCO2 from venous and arterial heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status.

pH, pCO2 and pO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid-base disturbances.

The GEM Premier 5000 system provides health care professionals in central laboratory or point-of-care clinical settings with fast, accurate, quantitative measurements of pH and pQ2 from venous, arterial and capillary heparinized whole blood, as well as quantitative measurements of pCO₂ from venous and arterial heparinized whole blood.

Key Components:
Analyzer: Employs a unique color touch screen and a simple set of menus and buttons for user interaction. The analyzer guides operators through the sampling process with simple, clear messages and prompts.
GEM Premier 5000 PAK (disposable, multi-use GEM PAK): Houses all required components necessary to operate the instrument once the cartridge is validated. These components include the sensors, CO-Ox optical cell, Process Control (PC) Solutions, sampler, pump tubing, distribution valve and waste bag. The GEM PAK has flexible menus and test volume options to assist facilities in maximizing efficiency. NOTE: The EEPROM on the GEM PAK includes all solution values and controls the analyte menu and number of tests.
Step 1: After inserting the GEM PAK, the instrument will perform an automated PAK warm-up during which the sensors are hydrated and a variety of checks occur, all of which take about 40 minutes. During warm-up, the instrument requires no user intervention.
Step 2: After GEM PAK warmup, Auto PAK Validation (APV) process is automatically completed: two completely independent solutions (PC Solution D and E) that are traceable to NIST standards, CLSI procedures or internal standards, containing two levels of concentration for each analyte, are run by the analyzer to validate the integrity of the PC Solutions and the overall performance of the analytical system.
Step 3: After successful performance of APV, iQM2 manages the quality control process, replacing external quality controls.
Intelligent Quality Management 2 (iQM2): iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions. iQM2 is a statistical process control system that performs 5 types of continuous, quality checks to monitor the performance of the GEM PAK, sensors, CO-Ox, and reagents. These checks include System, Sensor, IntraSpect, Pattern Recognition and Stability Checks.

The GEM Premier 5000 is a medical device designed for the rapid analysis of heparinized whole blood samples for pH, pCO2, and pO2 measurements. The provided document is a 510(k) summary, which demonstrates substantial equivalence to a predicate device (GEM Premier 4000) for these parameters.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets in the document. Instead, the studies aim to demonstrate that the device performs "within specification" or shows "substantial equivalency" to the predicate device and recognized standards (CLSI guidelines). The reported performance is summarized below, with an implied acceptance that these values fall within expected clinical or analytical ranges and compare favorably to the predicate.

The reported performance values are presented as part of precision studies, linearity studies, analytical specificity (absence of interference), and method comparison against predicate devices or reference methods. The "acceptance criteria" are implicitly met if the reported values demonstrate acceptable precision, linearity, and agreement with reference methods/predicate devices.

The total error calculations are compared against "GEM Premier 5000 Total Error Specifications," which are not explicitly provided in the document but are indicated as having been met.

2. Sample Sizes and Data Provenance

The document provides sample sizes for various tests:

• Internal Precision Study - Aqueous Controls: n=120 per analyte per level (3 analyzers, 20 days, 2 runs/day, 1 replicate/run). Data provenance is internal (Instrumentation Laboratory Co.).
• Internal Precision Study - GEM PAK Process Control Solutions D and E: n=120 per analyte per level (3 analyzers, 20 days, 2 runs/day, 1 replicate/run). Data provenance is internal (Instrumentation Laboratory Co.).
• Internal Precision Study - Whole Blood: n=120 per analyte per sample mode per level (3 analyzers, 5 days, 1 run/day, 8 replicates/run). Data provenance is internal (Instrumentation Laboratory Co.).
• Reproducibility Study with Aqueous Controls – POC Setting: n=90 per material/level (3 external POC sites, 9 operators, 3 instruments, 5 days, 2 runs/day, 3 replicates/run). Data provenance is external Point-of-Care sites within the USA (implied as no other country explicitly mentioned). This was a prospective study.
• External Precision – Whole Blood:
  • POC Setting: n=30 to 54 per site (various N given per analyte/mode/site) for pH, pCO2, pO2. Pooled POC data: pH (N=102-126), pCO2 (N=117), pO2 (N=45-51). Performed by 11 operators on 3 instruments. Data provenance is 3 external POC locations, prospective.
  • Central Lab Setting: n=24 to 30 per site. Pooled lab data: pH (N=90), pCO2 (N=78), pO2 (N=66-72). Performed by 3 operators on 3 instruments. Data provenance is 2 external central laboratories and 1 internal Customer Simulation Laboratory (CSL). It includes native and contrived specimens. This was a prospective study.
• LoB, LoD, and LoQ: LoB, LoD, LoQ were established using three (3) lots of GEM Premier 5000 PAKs (cartridges). Specific sample sizes for individual measurements within the establishment process are not detailed, but the method used is CLSI EP17-A2. Data provenance is internal (Instrumentation Laboratory Co.).
• Linearity: 8 or 9 levels per analyte, 9 replicates per level (on 3 test analyzers). Total N per analyte: 72-81. Data provenance is internal (Instrumentation Laboratory Co.).
• Analytical Specificity: Interference study with various substances. Specific N for each substance not detailed, but it involves screening tests at two different analyte concentrations. Data provenance is internal (Instrumentation Laboratory Co.).
• Internal Method Comparison:
  • pH: N=373 clinical samples.
  • pCO2: N=150 clinical samples.
  • pO2: N=148 clinical samples.
    Data provenance is internal, using clinical samples. These were retrospective or prospective, but likely prospective as samples were "altered as needed to cover the medical decision levels."
• Clinical Testing (Method Comparison):
  • Normal Mode (Syringe Samples): pH: N=479; pCO2: N=492; pO2: N=506. Pooled data from 3 external POC sites and 1 internal Customer Simulation Laboratory (CSL). Data includes patient samples. This was a prospective study.
  • Native Capillary Samples: N=171 for pH, N=167 for pO2. Collected at an external POC site (N=65) and an internal CSL (N=106). Data provenance is external POC site and internal CSL. This was a prospective study.
  • Pooled Capillary Results (Native + Contrived): pH: N=189; pO2: N=218. The contrived samples were prepared internally. Data provenance is external POC site, internal CSL, and internal contrived samples. This was a prospective study.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of human "experts" in the traditional sense (e.g., radiologists, pathologists) to establish ground truth for the device's performance. Instead, ground truth for quantitative measurements of blood gases and pH is established using:

• Reference materials/standards: NIST standards, CLSI procedures, internal standards (for calibration and control solutions).
• Predicate devices: The GEM Premier 4000 serves as the predicate for method comparison studies.
• Reference methods: Tonometry is used as a reference for pO2 and pCO2 in Linearity and Internal Method Comparison studies due to instability of blood gases.

The quality control process (iQM2) also uses "Process Control (PC) Solutions" whose values are traceable to NIST standards, CLSI procedures, or internal standards.

4. Adjudication Method

No adjudication method (e.g., 2+1, 3+1 consensus) is described because the ground truth is established through quantitative measurements against reference materials, reference methods, or comparison to a predicate device, rather than subjective expert interpretation requiring consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The device measures quantitative laboratory parameters (pH, pCO2, pO2) and does not involve human readers interpreting images or data where "AI assistance" would be relevant in the context of diagnostic performance improvement. The studies focus on analytical performance metrics like precision, accuracy, and linearity.

6. Standalone Performance Study

Yes, standalone performance was done. All the precision, linearity, LoB/LoD/LoQ, analytical specificity, and method comparison studies described are standalone performance studies. These studies evaluate the device's ability to accurately and precisely measure pH, pCO2, and pO2 in various conditions (aqueous controls, whole blood, different modes) independently. The "method comparison" studies compare the device's readings directly against a predicate device or a reference method.

7. Type of Ground Truth Used

The ground truth used for the studies is based on:

• Calibration and Control Solutions: Values traceable to NIST standards, CLSI procedures, or internal standards.
• Reference Methods: Tonometry for pCO2 and pO2 in linearity and method comparison studies.
• Predicate Device: The GEM Premier 4000 for method comparison studies for pH.
• Clinical Samples: Patient samples (heparinized whole blood, native capillary samples) are used for precision and method comparison studies, with their "true" values established by the reference methods or predicate device for comparison. For some internal precision studies and clinical testing, contrived samples are also used to extend the tested range.

8. Sample Size for the Training Set

The document describes premarket validation studies for a medical device that performs quantitative measurements, not a machine learning or AI model that requires a "training set." Therefore, there is no "training set" in the context of AI model development mentioned or implied in this document. The studies are validation studies demonstrating the device's performance against established analytical standards.

9. How Ground Truth for the Training Set Was Established

As noted above, this device does not involve a "training set" in the context of AI/ML. The measurements and comparisons are against established analytical methodologies and reference values.

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