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The GEM Premier ChemSTAT is a portable critical care system for use by health care professionals to rapidly analyze lithium 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 (Na+), Potassium (K+), Ionized Calcium (Ca++), Chloride (Cl-), Glucose (Glu), Lactate (Lac), Hematocrit (Hct), Creatinine (Crea), Blood Urea Nitrogen (BUN), Total Carbon Dioxide (tCO2), pH, and partial pressure of carbon dioxide (pCO2) from arterial and venous heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance.

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.

· Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and of 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, and in the diagnosis of hyperlactatemia.

· 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).

· Creatinine (Crea) measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

· Blood Urea Nitrogen (BUN) or urea measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases.

· Total carbon dioxide/tCO2 (also referred to as bicarbonate/HCO3-) is used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

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

The GEM Premier ChemSTAT system provides fast, accurate, quantitative measurements of Sodium (Na"), Potassium (K*), Ionized Calcium (Ca*), Chloride (Cl·), Glucose (Glu), Lactate (Lac), Hematocrit (Hct), Creatinine (Crea), Blood Urea Nitrogen (BUN), Total Carbon Dioxide (tCO2), pH, and partial pressure of carbon dioxide (pCO2) from arterial and venous lithium heparinized whole blood.

The provided text describes a Special 510(k) submission for an upgrade to the operating system of the GEM Premier ChemSTAT device. The device itself is an in vitro diagnostic (IVD) system for quantitative measurements of various blood parameters. The submission focuses on the software upgrade rather than a change in the device's fundamental function or performance.

Therefore, the "acceptance criteria" and "reported device performance" in this context refer to the successful verification and validation of the software upgrade and the continued adherence to the established performance of the unmodified device, as the indications for use and performance claims remain unchanged. The study proving this essentially consists of the software verification and validation activities.

Here's the information extracted from the document, tailored to the context of a software upgrade:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a software upgrade with no changes to the performance claims of the device, the general acceptance criteria are that the upgraded software performs as intended without adversely affecting the device's established performance specifications. The reported device performance is that these criteria were met.

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

The document does not specify a "test set sample size" or "data provenance" in the traditional sense for evaluating diagnostic performance. The focus is on software verification and validation. Therefore, the "sample" for testing the software functionality would be the various test cases and scenarios designed to validate the operating system upgrade and its interaction with the GEM Premier ChemSTAT application software.

The document states: "Performance data is limited to Software Verification and Validation as the scope of this Special 510(k) is specific to an operating system upgrade from Fedora 17 Linux to WindRiver LTS 18 Linux."

Further details on the specific number of test cases, the nature of the data (e.g., simulated, actual runs on the device), or its origin are not provided in this summary.

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)

This information is not applicable to a software operating system upgrade as described. "Ground truth" in the context of expert consensus is typically relevant for diagnostic performance studies where human interpretation or a gold standard reference is needed (e.g., pathology for an imaging device). Here, the "ground truth" is the proper functioning of the software and its integration with the hardware, which is evaluated through engineering and software testing.

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

This information is not applicable for a software operating system upgrade. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies in expert interpretation of diagnostic results. Software verification and validation typically rely on predefined test outcomes and engineering assessments.

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

This information is not applicable. An MRMC comparative effectiveness study is used to evaluate the impact of an AI algorithm on human reader performance, usually for diagnostic tasks. This submission is for a software operating system upgrade for an existing IVD device, not for a new AI algorithm.

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

The concept of "standalone performance" in the context of an algorithm's diagnostic capability (like an AI algorithm) is not directly applicable here. The device itself (GEM Premier ChemSTAT) operates to provide quantitative measurements. The software upgrade ensures the continued, correct operation of the device. The verification and validation activities demonstrate that the upgraded software performs its functions correctly as part of the overall device system.

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

For this software upgrade, the "ground truth" is the expected behavior and functionality of the software and the device. This is established through:

• Functional specifications: The software is expected to perform according to its design specifications.
• Risk analysis: The software should not introduce new risks or fail to mitigate existing ones.
• Cybersecurity standards: The software should meet cybersecurity requirements.
• Established device performance: The software upgrade should not negatively impact the established analytical and clinical performance of the GEM Premier ChemSTAT device (which relies on the physical and chemical principles of its measurements).

The document explicitly states that the changes "do not introduce...changes to labeled performance claims." This implies that the performance of the device (e.g., accuracy, precision of Na+, K+, Glu measurements) remains the same as previously cleared, and the software upgrade was validated not to alter these.

8. The sample size for the training set

This information is not applicable. Training sets are used for machine learning models. This submission describes a conventional software operating system upgrade (Fedora 17 Linux to WindRiver LTS 18 Linux) for an existing IVD device, not the development or retraining of a machine learning algorithm.

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

This information is not applicable, as there is no training set for a machine learning model; it is a software operating system upgrade.

Ask a specific question about this device

The GEM Premier ChemSTAT is a portable critical care system for use by health care professionals to rapidly analyze lithium 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 (Glu), Lactate (Lac), Hematocrit (Hct), pH and partial pressure of carbon dioxide (pCO2) from arterial and venous heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status and metabolite balance.

• · Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
• · Lactate (Lac) measurement is used to evaluate the acid-base status of patients suspected of having lacidosis, to monitor tissue hypoxia and strenuous physical exertion, and in the diagnosis of hyperlactatemia.
• 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 ed cells).
• · DH and pCO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid-base disturbances.

The GEM Premier ChemSTAT is a portable system that analyzes arterial and venous lithium heparinized whole blood at the point of health care delivery in a clinical setting and in a central laboratory for Glu, Lac, Hct, pH, and pCO2. All tests are included in a single self-contained, disposable GEM Premier ChemSTAT PAK (cartridge).

Key Components:
Analyzer: The GEM Premier ChemSTAT analyzer has the internal logic and processing power necessary to perform analysis. It employs a unique touch-sensitive color 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.
PAK (Cartridge): The disposable, multi-use GEM Premier ChemSTAT PAK is a completely closed cartridge that houses all components necessary to operate the instrument once the GEM PAK is validated. These components include the sensors, Process Control (PC) Solutions, sampler, and waste bag. The values of all PC Solutions are read from the GEM PAK Electronically Erasable Programmable Read Only Memory (EEPROM) chip. The components and processes used to manufacture the PC Solutions in the GEM PAK are traceable to National Institute of Standards and Technology (NIST) standards, Clinical & Laboratory Standards Institute (CLSI) procedures or other internal standards, where available and appropriate. The GEM Premier ChemSTAT PAK has flexible menus to assist facilities in maximizing efficiency. As part of this program, GEM ChemSTAT CVP (Calibration Valuation Products) are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration following warm-up.
Intelligent Quality Management (iQM): Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier ChemSTAT system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process before and after sample measurement with real-time, automatic error detection, automatic correction and automatic documentation of all corrective actions. iQM performs 4 types of continuous, quality checks to monitor the performance of the GEM PAK, sensors, and reagents throughout the cartridge use-life. These checks include System, Sensor, Pattern Recognition (PR) and Stability Checks.

The provided text describes a 510(k) premarket notification for the GEM Premier ChemSTAT device, a portable system for analyzing whole blood samples. The document focuses on demonstrating substantial equivalence to a predicate device (GEM Premier 4000) through various performance studies.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets in a single table, but rather implied through the successful completion of various performance studies and the conclusion that "All results were within specification." The reported device performance is presented in several tables detailing precision, linearity, and method comparison.

Here's a compilation of the reported device performance, which implies the acceptance criteria were met if these results were deemed "within specification":

Table of Reported Device Performance (Implied Acceptance Criteria)

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • Internal Precision Study – Whole Blood: 5 concentrations of whole blood per analyte, run on 3 analyzers for 5 days, 8 replicates per run per level (N=120 per level/analyte).
   • Reproducibility Study with Aqueous Controls – Point-of-Care (POC) Setting: 7 levels (Glucose, Lactate) or 6 levels (Hct, pH, pCO2) of quality control material, run in triplicate, twice a day for 5 days (30 replicates per level). Pooled N=90 across 3 sites for each control level for each analyte.
   • External Precision – Whole Blood: Various N values per analyte and POC site, ranging from 3 to 198 (pooled). The text states "Less than 10% of samples included in the study were contrived." This indicates the majority are real patient samples.
   • LoB, LoD, and LoQ: Not specified how many physical samples, but performed using three (3) lots of GEM Premier ChemSTAT PAKs (cartridges).
   • Linearity: Minimum of 9 levels per analyte (whole blood spiked or diluted). Each blood level analyzed in triplicate on six (6) GEM Premier ChemSTAT test analyzers (except pH and pCO2, which were tested on 3 analyzers). N per level: 18 for Glucose, Lactate, Hematocrit; 9 for pH, pCO2.
   • Analytical Specificity: Not explicitly stated N, but various test substances were screened at specified concentrations.
   • Clinical Testing (Method Comparison):
     • Glucose: N=432
     • Lactate: N=432
     • Hematocrit: N=431
     • pH: N=552
     • pCO2: N=559
     • Provenance: Lithium heparinized whole blood patient samples from the intended use population. Samples from three (3) external point-of-care (POC) sites and an internal Customer Simulation Laboratory (CSL). Less than 10% of samples were contrived. This implies the data is a mix of prospective (patient samples from POC sites) and potentially some retrospective (if sourced from a biobank, though "patient samples" often implies prospective collection for the study) and/or controlled spiked samples. The specific country of origin is not stated but "external point-of-care (POC) sites" and "internal Customer Simulation Laboratory (CSL) at IL" (Instrumentation Laboratory Co., Bedford, MA) suggest US-based data.

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

   • This document describes in vitro diagnostic (IVD) device performance against established analytical methods and a predicate device, not an AI/ML device relying on human expert interpretation of images. Therefore, the concept of "experts establishing ground truth" in the sense of radiologists or pathologists for an AI model's output does not directly apply here.
   • The "ground truth" for the test set values (sample concentrations) for analytes like Glucose, Lactate, Hct, pH, and pCO2 would typically be established by a reference method or the established predicate device (GEM Premier 4000) itself, which is considered the "truth" for comparison in the method comparison study. The laboratory professionals operating these devices and following standard protocols implicitly ensure the accuracy of these reference values.
   • For the reproducibility study, "nine (9) different operators" were involved at "three (3) external clinical point-of-care (POC) sites". These would be healthcare professionals (e.g., nurses, lab technicians) trained to use the device. Their qualifications are not specified beyond being "health care professionals."

3. Adjudication Method for the Test Set:

   • Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective human interpretation of data, often for diagnostic image analysis where disagreement among readers needs resolution.
   • For an IVD device measuring quantitative analytes, the "ground truth" is typically the result from a reference standard instrument or method. Discrepancies are usually investigated through analytical means (re-testing, troubleshooting) rather than human adjudication of interpretive differences. The document does not mention any such adjudication process.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size:

   • No, an MRMC study was not done. MRMC studies are specifically designed for evaluating diagnostic tools where human readers interpret cases, often with and without AI assistance (e.g., radiology AI).
   • This submission is for an IVD device for quantitative measurements of analytes, not an AI/ML-driven diagnostic imaging device. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant here.

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

   • This device is an IVD instrument, not an algorithm/software in the typical AI sense. Its performance (accuracy, precision, linearity) is inherently "standalone" in how it processes a blood sample to produce a result, without needing human "in-the-loop" interpretation of the measurement itself.
   • Clinical testing (method comparison) directly assesses the device's standalone performance against a predicate device.

6. The Type of Ground Truth Used:

   • The ground truth for the analytical studies (precision, linearity, LoB/D/Q, specificity) is based on analytical standards, control materials with known concentrations, and comparison to a legally marketed predicate device (GEM Premier 4000).
   • For the clinical testing/method comparison, the predicate device (GEM Premier 4000) provides the comparative "ground truth" for patient samples, ensuring the new device yields comparable results within acceptable ranges. This is a common approach for IVD substantial equivalence.

7. The Sample Size for the Training Set:

   • This document describes a conventional IVD device, not an AI/ML device that requires a "training set" in the machine learning sense. The device is based on established electrochemical and conductivity principles (Amperometry, Potentiometry, Conductivity), not on learning from a large dataset.
   • Therefore, there is no explicit "training set" size or process described. The "training" of such a device involves its initial design, calibration protocols, and quality control procedures during manufacturing, which are validated through the performance studies presented.

8. How the Ground Truth for the Training Set Was Established:

   • As there is no "training set" in the AI/ML context, this question is not applicable to the GEM Premier ChemSTAT device as described. The "ground truth" for calibrating and setting up an IVD device's internal algorithms (e.g., sensor response curves, temperature compensation) would be established using traceable reference materials and industry-standard analytical methods during the device's development and manufacturing.

Ask a specific question about this device

The GEM Premier ChemSTAT is a portable critical care system for use by health care professionals to rapidly analyze lithium 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 (Na+), Ionized Calcium (Ca++) and Chloride (C1-) from arterial and venous heparinized whole blood. These parameters. along with derived parameters, aid in the diagnosis of a patient's electrolyte balance.

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 metabolic and metabolic disorders, such as, cystic fibrosis and diabetic acidosis.

The GEM Premier ChemSTAT is a portable system that analyzes arterial and venous lithium heparinized whole blood at the point of health care delivery in a clinical setting and in a central laboratory for Na*, K*, Ca** and Cl . All tests are included in a single self-contained, disposable GEM Premier ChemSTAT PAK (cartridge).

Key Components:
Analyzer: The GEM Premier ChemSTAT analyzer has the internal logic and processing power necessary to perform analysis. It employs a unique touch-sensitive color 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.
PAK (Cartridge): The disposable, multi-use GEM Premier ChemSTAT PAK is a completely closed cartridge that houses all components necessary to operate the instrument once the GEM PAK is validated. These components include the sensors, Process Control (PC) Solutions, sampler, and waste bag. The values of all PC Solutions are read from the GEM PAK Electronically Erasable Programmable Read Only Memory (EEPROM) chip. The components and processes used to manufacture the PC Solutions in the GEM PAK are traceable to National Institute of Standards and Technology (NIST) standards, Clinical & Laboratory Standards Institute (CLSI) procedures or other internal standards, where available and appropriate. The GEM Premier ChemSTAT PAK has flexible menus to assist facilities in maximizing efficiency. As part of this program, GEM ChemSTAT CVP (Calibration Valuation Products) are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration following warm-up.
Intelligent Quality Management (iQM): Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier ChemSTAT system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process before and after sample measurement with real-time, automatic error detection, automatic correction and automatic documentation of all corrective actions. iQM performs 4 types of continuous, quality checks to monitor the performance of the GEM PAK, sensors, and reagents throughout the cartridge use-life. These checks include System, Sensor, Pattern Recognition (PR) and Stability Checks.

The provided FDA 510(k) summary for the GEM Premier ChemSTAT describes the device's analytical performance, which is a type of acceptance criteria study. This document is not for an AI/ML device, but rather for an in-vitro diagnostic device that measures specific analytes. Therefore, many of the requested elements pertaining to AI/MRMC studies, expert ground truth, and training sets are not applicable or not provided in this type of submission. However, I can extract information related to the device's analytical performance and the studies conducted to demonstrate its performance against predefined criteria.

Here's a breakdown of the acceptance criteria and performance study details, focusing on what is available in the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the analytical performance specifications and the comparison to the predicate device. The performance studies aim to demonstrate that the device meets these standards.

Table 1: Acceptance Criteria (Implicit from Study Outcomes) and Reported Device Performance for GEM Premier ChemSTAT

Details of the Study

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

   • Internal Precision Study – Whole Blood: 120 replicates per level for each of 5 levels (N=600 total samples analyzed for each analyte). Data provenance is internal (Instrumentation Laboratory Co.). The study simulates an internal lab environment.
   • Reproducibility Study with Aqueous Controls – POC Setting: 90 pooled replicates per level for each of 7 levels (N=630 samples analyzed for each analyte). The study was performed at three (3) external clinical point-of-care (POC) sites.
   • External Precision – Whole Blood: Variable N per site. For the Na+, K+, Ca++, Cl- main ranges, N=~63-69 samples per site for 3 sites, pooled N=195. For specific lower/higher ranges, N=3 samples per site for 3 sites, pooled N=9. The study was performed at three (3) external clinical point-of-care (POC) sites. Less than 10% of samples were "contrived" (meaning artificially prepared or modified) and the rest were patient samples from the intended use population. Data provenance is implied to be mixed: patient samples are real-world, while contrived samples are laboratory-sourced. The locations are referred to as "external clinical point-of-care (POC) sites", implying real-world clinical settings, likely within the US given FDA submission. It is a prospective study as samples were "run" during the study.
   • LoB, LoD, LoQ: No specific N mentioned, but involved testing with three (3) lots of GEM Premier ChemSTAT PAKs.
   • Linearity: 18 replicates per level (9 levels, total of 162 samples) for each analyte. Whole blood samples, prepared by spiking or diluting, were used.
   • Analytical Specificity (Interference): Not explicitly stated, but various substances were screened at different concentrations. Implied to be laboratory-based evaluation.
   • Clinical Testing (Method Comparison):
     • Na+: N=436 patient samples.
     • K+: N=442 patient samples.
     • Ca++: N=444 patient samples.
     • Cl-: N=435 patient samples.
     • Data provenance: Patient samples from the intended use population, collected at three (3) point-of-care (POC) sites. Less than 10% of samples were contrived. Implied to be prospective as a method comparison study involving running samples.

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

   • For this type of in-vitro diagnostic device, "ground truth" for clinical samples is typically established by comparative measurement against a predicate device or a reference method, rather than by expert consensus (as would be the case for image interpretation, for example).
   • The "ground truth" in the Clinical Testing (Method Comparison) was established by comparing the GEM Premier ChemSTAT's measurements to those of the GEM Premier 4000 (K133407), which is the legally marketed predicate device. Operator qualifications involved "health care professionals" for point-of-care use, and "internal precision studies" would be performed by qualified lab personnel. Specific expert qualifications are not detailed beyond "health care professionals."

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

   • Not applicable/Not mentioned. This is a quantitative measurement device, not an interpretation task requiring adjudication. The performance is assessed statistically (SD, CV, R, slope, intercept).

4. 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 not an AI/ML device or an imaging device requiring human reader interpretation. It is an IVD device providing quantitative measurements.

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

   • This is an in-vitro diagnostic instrument. Its primary function is "standalone" measurement of analytes. The performance studies (precision, linearity, interference, method comparison) assess the instrument's inherent analytical capabilities. There is no "human-in-the-loop performance" in the sense of an AI assisting human interpretation; direct measurement is the output.

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

   • For LoB, LoD, LoQ, Linearity, Analytical Specificity, and Internal Precision: Ground truth is against known concentrations in prepared samples (standards, calibrators, controls, spiked/diluted samples). This is a metrological approach.
   • For Clinical Testing (Method Comparison) and External Precision (Whole Blood): Ground truth is established by the measurements from the predicate device (GEM Premier 4000) for patient samples. The assumption is that the predicate device provides clinically acceptable and accurate measurements for comparison.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, so there is no "training set" in the machine learning sense. The device is based on established electrochemical principles (potentiometry).

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

   • Not applicable, as there is no "training set" for an AI/ML model. The device's calibration and internal quality control use known standards and calibrated reference materials.

Ask a specific question about this device

The GEM Premier ChemSTAT is a portable critical care system for use by health care professionals to rapidly analyze lithium 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 Creatinine (Crea), Blood Urea Nitrogen (BUN) and Total Carbon Dioxide (tCO2) from arterial and venous heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status and metabolite balance.

• · Creatinine (Crea) measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
• · Blood Urea Nitrogen (BUN) or urea measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases.
• · Total carbon dioxide/tCO2 (also referred to as bicarbonate/HCO3-) is used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

The GEM Premier ChemSTAT is a portable system that analyzes arterial and venous lithium heparinized whole blood at the point of health care delivery in a clinical setting and in a central laboratory for Creatinine, BUN and tCO₂. All tests are included in a single self-contained, disposable GEM Premier ChemSTAT PAK (cartridge).

Key Components:
Analyzer: The GEM Premier ChemSTAT analyzer has the internal logic and processing power necessary to perform analysis. It employs a unique touch-sensitive color 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.
PAK (Cartridge): The disposable, multi-use GEM Premier ChemSTAT PAK is a completely closed cartridge that houses all components necessary to operate the instrument once the GEM PAK is validated. These components include the sensors, Process Control (PC) Solutions, sampler, and waste bag. The values of all PC Solutions are read from the GEM PAK Electronically Erasable Programmable Read Only Memory (EEPROM) chip. The components and processes used to manufacture the PC Solutions in the GEM PAK are traceable to National Institute of Standards and Technology (NIST) standards, Clinical & Laboratory Standards Institute (CLSI) procedures or other internal standards, where available and appropriate. The GEM Premier ChemSTAT PAK has flexible menus to assist facilities in maximizing efficiency. As part of this program, GEM ChemSTAT CVP (Calibration Valuation Products) are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration following warm-up.
Intelligent Quality Management (iQM): Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier ChemSTAT system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process before and after sample measurement with real-time, automatic error detection, automatic correction and automatic documentation of all corrective actions. iQM performs 4 types of continuous, quality checks to monitor the performance of the GEM PAK, sensors, and reagents throughout the cartridge use-life. These checks include System, Sensor, Pattern Recognition (PR) and Stability Checks.

Here's a breakdown of the acceptance criteria and study information for the GEM Premier ChemSTAT device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a dedicated table format. However, it indicates that "All results were within specification" and successful performance in comparison to predicate devices. For this summary, I've inferred the performance metrics as the reported study outcomes.

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

The document describes several studies, and the test sets are detailed separately for each:

• Internal Precision Study – Whole Blood:

  • Sample Size: 5 different concentrations of whole blood per analyte, with 8 replicates per run, 1 run per day for 5 days on 3 analyzers. Total N = 120 (5 concentrations * 8 replicates * 5 days * 3 analyzers).
  • Data Provenance: Not explicitly stated, implied as internal lab data ("internal precision study"). No country of origin mentioned. Likely prospective, as it's a controlled study.

• Reproducibility Study with Aqueous Controls – Point-of-Care (POC) Setting:

  • Sample Size: 9 levels for Creatinine (4 CVP, 5 PVP) and 7 levels for BUN and tCO2 (2 CVP, 5 PVP). Each control level run in triplicate, twice a day for 5 days. Total N = 90 (3 replicates * 2 times/day * 5 days * 3 sites) pooled across 3 sites per level for each analyte.
  • Data Provenance: Conducted at "control clinical point-of-care (POC) sites." No specific country of origin mentioned. Likely prospective, as it's a controlled study.

• External Precision – Whole Blood:

  • Sample Size: Patients samples (whole blood). N = 147 for Creatinine (fixed), 54 for Creatinine (variable), 132 for BUN (fixed), 66 for BUN (variable), 81 for tCO2 (fixed), 120 for tCO2 (variable). Less than 10% of samples were "contrived."
  • Data Provenance: Conducted at "three (3) external clinical point-of-care (POC) sites." No specific country of origin mentioned. Likely a mix of prospective (as part of the study) and retrospective (existing patient samples) given the mention of "patient samples" and "contrived" samples.

• LoB, LoD, and LoQ:

  • Sample Size: 3 lots of GEM Premier ChemSTAT PAKs (cartridges). Specific number of measurements not detailed but implied to be sufficient for CLSI EP17-A2.
  • Data Provenance: Internal laboratory study. Likely prospective.

• Linearity:

  • Sample Size: 9 levels per analyte, prepared by spiking or diluting whole blood. Each blood level analyzed in triplicate on 6 GEM Premier ChemSTAT test analyzers. Total N per level = 18 (3 replicates * 6 analyzers).
  • Data Provenance: "whole blood" samples, but could be internal or simulated. Likely prospective.

• Analytical Specificity (Interference Study):

  • Sample Size: Various test substances at specified concentrations mentioned in tables. Specific number of replications or blood samples not detailed.
  • Data Provenance: Not explicitly stated, implied as internal lab study. Likely prospective.

• Clinical Testing (Method Comparison Study):

  • Sample Size: N = 405 for Creatinine and BUN, N = 416 for tCO2. These were "lithium heparinized whole blood patient samples." Less than 10% of samples were "contrived."
  • Data Provenance: Conducted at "three (3) point-of-care (POC) sites." No specific country of origin mentioned. This is a clinical study, likely a mix of prospective and retrospective patient samples.

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

The device is an in-vitro diagnostic (IVD) for quantitative measurements of analytes (Creatinine, BUN, tCO2) using established laboratory methods. For such devices, "ground truth" is typically established by comparative analysis against a reference method or predicate device, which are themselves considered gold standards in laboratory medicine. There is no mention of human experts establishing a "ground truth" through interpretation or consensus for these quantitative measurements, as would be the case for image-based diagnostic AI.

The method comparison study compares the candidate device to legally marketed predicate devices:

• Cobas Integra Creatinine Plus Ver. 2 (K024098)
• Cobas Integra Urea/BUN (K954000)
• Cobas Integra Bicarbonate Liquid (K031879)

These predicate devices serve as the reference standard for the "ground truth" in the clinical method comparison.

4. Adjudication Method for the Test Set:

Not applicable. For this type of quantitative IVD device, ground truth for patient samples is typically established by measurement on a reference method/predicate device, not through expert adjudication in the way it's done for qualitative interpretations (e.g., radiology reads). The comparison involves statistical analyses (slope, intercept, R-value) rather than an adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This device is an automated in-vitro diagnostic (IVD) system that provides direct quantitative measurements. It does not involve human "readers" interpreting cases with or without AI assistance, nor is it an AI-powered diagnostic aid to human interpretation. Therefore, an MRMC study is not relevant here.

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

Yes, the studies presented (internal precision, external precision, LoB/LoD/LoQ, linearity, analytical specificity) all demonstrate the standalone performance of the GEM Premier ChemSTAT device. The device operates automatically to provide quantitative measurements without human intervention in the measurement process itself, beyond sample loading and initiation. The "clinical testing" (method comparison) also evaluates the device's performance against predicate devices as a standalone instrument.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the performance studies of the GEM Premier ChemSTAT is established by:

• Reference Methods/Predicate Devices: For the method comparison study, the measurements obtained from the predicate devices (Cobas Integra Creatinine Plus Ver. 2, Cobas Integra Urea/BUN, Cobas Integra Bicarbonate Liquid) served as the reference standard for patient samples.
• Prepared Standards/Controls: For precision, linearity, LoB/LoD/LoQ, and analytical specificity studies, the ground truth is established by precisely prepared control materials, aqueous solutions, or spiked/diluted whole blood samples with known concentrations of the analytes. These are traceable to national or international standards (e.g., NIST, CLSI).

8. The Sample Size for the Training Set:

This document describes a pre-market notification (510(k)) for a medical device (IVD analyzer). It does not explicitly mention a "training set" in the context of machine learning or AI models. The performance studies detailed are for verification and validation of the device's analytical and clinical performance against predicate devices and controlled materials, not for training a model. Therefore, this information is not provided because the device is not an AI/ML-driven product in the described context.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as a "training set" in the context of AI/ML is not described or implied for this device. The development process for such IVD devices typically involves rigorous analytical characterization and clinical validation against reference methods, rather than machine learning training.

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