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The GEM Premier 7000 with iQM3 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 pH, pCO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin, and CO-Oximetry (tHb, O2Hb, MetHb, HHb, sO2*) parameters from arterial, venous, or capillary lithium 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.

*s02 = 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 insividus, 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 and dysfunctional hemoglobin species.

– Total Hemoglobin (tHb): Total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.

• COHo: 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 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 7000 with iQMs system provides health care professionals with quantitative measurements of lithium heparinized whole blood pH, pCO2, pO2, Na*, K*, Ch, Ca**, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO₂*) from arterial, venous or capillary samples at the point of health care delivery in a clinical setting and in a central laboratory.

*sO₂ = Ratio between the concentration of oxyhemoglobin plus deoxyhemoglobin plus deoxyhemoglobin.

Key Components:
Instrument: 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): All required components for sample analysis are contained in the GEM PAK, including sensors, optical cell for CO-Oximetry and total bilirubin, sampler, pump tubing, distribution valve, waste container and Process Control Solutions. The GEM PAK is an entirely closed analytical system. The operator cannot introduce changes to the analytical process before or during the GEM PAK's use-life on board the instrument. The GEM PAK has flexible menus and test volume options to assist facilities in maximizing efficiency. The EEPROM on the GEM PAK includes all solution values and controls the analyte menu and number of tests. The setup of the instrument consists of inserting the GEM PAK into the instrument. The instrument will perform an automated GEM PAK start-up during which the following is performed: warm-up (15 minutes), sensor conditioning (10 minutes), Process Control Solution (PCS) performance (15 minutes), all of which take about 40 minutes. After GEM PAK start-up, Auto PAK Validation (APV) process is automatically completed: two completely independent solutions traceable to NIST standards, CLSI procedures or internal standards, containing two levels of concentration for each analyte (PC Solution D and E), are run by the analyzer to validate the integrity of the PC Solutions and the overall performance of the analytical system. Note: GEM PAKs that include tBili analyte will require the successful performance of CVP 5 tBili. Includes all necessary components for hemolysis detection, such as an acoustofluidic flow cell, an LED light source and an optical detector, for appropriate flagging of potassium measurements in whole blood samples without additional sample volume or sample processing steps.
Intelligent Quality Management (iQM3): iQM3 is used as the quality control and assessment system for the GEM Premier 7000 system. iQM3 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, replacing the use of traditional external QC. iQM3 introduces hemolysis detection in whole blood samples, enhancing quality assessment in the pre-analytical phase of testing.

Based on the provided text, the device in question is the GEM Premier 7000 with iQM3, which is a portable critical care system for analyzing blood samples. The document describes its comparison to a predicate device, the GEM Premier 5000, and discusses its performance studies.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

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

The document does not provide a direct table of specific numerical acceptance criteria for each analyte's performance (e.g., pH, pCO2, Na+, etc.) nor does it list the reported device performance in those exact terms. Instead, it states that "All verification activities were performed in accordance to established plans and protocols and design control procedures. Testing verified that all acceptance criteria were met."

The "Performance Summary" section lists the types of studies conducted to demonstrate that the modifications (specifically the new iQM quality check/Hemolysis detection module) do not impact the performance data represented in the Operators Manual, aligning with recognized guidelines. This implies the acceptance criteria are tied to maintaining performance comparable to the predicate device and being within acceptable ranges as defined by the mentioned CLSI guidelines.

Therefore, a table of explicit numerical acceptance criteria and reported performance values for each analyte is NOT AVAILABLE in the provided text. The document broadly states that the device met its acceptance criteria.

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 mentions several types of performance studies:

• Verification (Internal Method Comparison, Internal Whole Blood Precision, Hemolysis Interference on Potassium, Hemolysis Verification)
• Shelf-life and Use-life studies

However, the specific sample sizes used for these test sets are NOT provided in the text. There is also no information about the data provenance (e.g., country of origin of the data, retrospective or prospective).

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

This information is NOT available in the provided text. The device is an in-vitro diagnostic (IVD) instrument that provides quantitative measurements of various blood parameters. The "ground truth" for such devices typically comes from reference methods, calibrated standards, or comparative analyses with established, highly accurate laboratory instruments, rather than human expert consensus on interpretations like with imaging.

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

Given that this is an IVD device for quantitative measurements of blood parameters, the concept of "adjudication" by multiple human readers (like in imaging studies) does not directly apply. Performance is assessed through analytical accuracy, precision, and interference studies against known standards or reference methods. Therefore, no adjudication method in the sense of expert consensus on interpretations is described or implied.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. This type of study is relevant for AI-assisted diagnostic tools where human interpretation is part of the workflow. The GEM Premier 7000 with iQM3 is described as an analytical instrument providing direct quantitative measurements, not an AI system assisting human readers with interpretation. The "iQM3" refers to Intelligent Quality Management, which is an automated quality control system for the instrument itself, not an AI for human diagnostic assistance.

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

The device itself is a standalone analytical instrument. The performance studies described (Internal Method Comparison, Internal Whole Blood Precision, Hemolysis Verification, etc.) essentially represent "standalone" performance, as they evaluate the accuracy and precision of the instrument's measurements directly. The iQM3 system is an internal quality control mechanism for the device's measurements. Therefore, yes, a standalone performance evaluation of the device's analytical capabilities was implicitly done.

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

For a device that provides quantitative measurements of blood parameters, the "ground truth" for the test set would typically be established using:

• Reference methods: Highly accurate and precise laboratory methods for measuring each analyte.
• Calibrated standards: Solutions with precisely known concentrations of the target analytes.
• Comparison to predicate device: As this is a 510(k) submission, a primary method of establishing "ground truth" performance for the new device is by comparing its measurements against those of a legally marketed predicate device (GEM Premier 5000), which itself would have been validated against reference methods and standards.

The text mentions "two completely independent solutions traceable to NIST standards, CLSI procedures or internal standards" for "Auto PAK Validation (APV)". This strongly suggests that traceable standards and potentially CLSI-defined reference methods were used to establish the ground truth for performance evaluation.

8. The sample size for the training set

The document describes the GEM Premier 7000 with iQM3 as a medical device for quantitative measurements, not explicitly as a machine learning/AI model that requires a "training set" in the conventional sense (i.e., for supervised learning). The iQM3 is an "active quality process control program" with "Pattern Recognition (PR) software." While pattern recognition might involve some form of "training" or calibration, the document does not specify a separate "training set" in terms of data volume for such a process. It focuses on the validation of the device's analytical performance. Therefore, the concept of a "training set" sample size as applicable to AI/ML devices is not explicitly discussed or provided.

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

As noted above, the primary function of GEM Premier 7000 with iQM3 is quantitative measurement. If the "iQM3" component involved training for its "Pattern Recognition (PR) software," the document does not detail how a specific ground truth for such training was established. It primarily discusses the use of "Process Control Solutions (PCS)" and "Calibration Valuation Product (CVP 5)" for system checks and validation ("Auto PAK Validation (APV) process"). These solutions, traceable to NIST or CLSI standards, function as internal reference points for the device's operational checks and quality control, which could be considered an ongoing form of "ground truth" to maintain analytical performance, rather than a one-time "training set" for model development.

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+), 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 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.

3

· 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 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 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 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.

Ask a specific question about this device

The GEM Premier 3000 is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood pH, pCO2, pO2, Na+, K+, Ca++, Glucose, Lactate and Hct. These parameters along with derived parameters aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.

The GEM Premier 3000 is designed as a portable system for use by health care professionals to rapidly analyze whole blood samples, in central laboratory or point-of-care clinical settings. The instrument provides both measured and calculated results for blood gases, hematocrit, electrolytes, glucose, and lactate.

Here's an analysis of the provided text regarding the acceptance criteria and study for the GEM Premier 3000 device, formatted to answer your questions.

It's important to note that this document is a 510(k) summary for a special FDA submission, specifically for an operating system update. Therefore, the details about original device validation and comprehensive performance studies might be summarized or assumed to be met from the predicate device.

Acceptance Criteria and Study for GEM Premier 3000 (Software V6.3.0 Update)

This submission describes an update to the GEM Premier 3000 device's software (V6.3.0) and operating system (Linux Fedora Core 21) due to component obsolescence. The primary focus of the provided text is to demonstrate that these changes do not alter the previously established performance and safety of the device.

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states: "No change to labeled performance claims." This indicates that the performance criteria for the updated device are identical to those of the predicate device (GEM Premier 3000, K052121), which was already cleared by the FDA. The submission's goal is to prove that the software/OS update maintains these pre-existing performance claims.

Therefore, the acceptance criteria are not new performance metrics but rather the demonstration that the updated device performs equivalently to the predicate device across all its established parameters. The "reported device performance" in this context refers to the verification and validation activities showing that the device continues to meet those original, unlabeled performance claims.

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

The document details software verification and validation activities. However, it does not specify a particular sample size for a "test set" in terms of patient samples or clinical data from a specific geographic region. The testing appears to be focused on software functionality and its impact on performance rather than a new clinical study with patient samples.

• Sample Size: Not explicitly stated for testing of the updated software/OS in a clinical or laboratory setting with a defined number of cases. The testing appears to be centered on software function verification and validation.
• Data Provenance: Not specified. Given it's a software/OS update, the "data" would primarily be software test results rather than patient data. The original predicate device presumably had data provenance established during its clearance.
• Retrospective/Prospective: Not applicable to the software/OS update described.

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

This information is not provided in the document. The nature of this submission (a Special 510(k) for an OS update) means that new ground truth establishment by external experts for device performance is likely not required, as the performance claims are carried over from the predicate device. The verification and validation would be internal engineering and quality assurance activities.

4. Adjudication Method for the Test Set

This information is not provided and is unlikely to be relevant for a software/OS update focused on maintaining equivalence to a predicate device's performance. Adjudication methods are typically used in clinical studies where multiple human readers interpret data that requires consensus for ground truth.

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

No, an MRMC comparative effectiveness study was not done. This device is an analyzer for blood samples, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, the concept of "human readers improve with AI" does not apply here.

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

The device itself, the GEM Premier 3000, is a standalone instrument that provides quantitative measurements. The update discussed here is for its internal operating system and software. The "standalone" performance for the measurements is inherent to the device's function, and the submission's purpose is to confirm this performance is maintained after the software/OS update. It is not an AI algorithm in the typical sense.

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

For the original predicate device's performance, the ground truth for parameters like pH, pCO2, pO2, Na+, K+, Ca++, Glucose, Lactate, and Hct would typically be established through reference methods (e.g., highly accurate laboratory methods, calibrated standards). The current submission relies on the established performance of the predicate device, implying that the ground truth for its performance was originally established via these reference methods and that the updated device continues to align with those.

The "ground truth" for the software update itself is that the software performs its functions correctly and reliably, and that no regression or new hazards are introduced. This is verified through software testing against design specifications.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The GEM Premier 3000 is a measurement device, not a machine learning or AI algorithm that requires a "training set" in the context of developing a diagnostic model. The software update is for an operating system and application software, not for an AI model.

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

This information is not applicable as there is no "training set" in the context of this device and its software update.

Ask a specific question about this device

The i15 Blood Gas and Chemistry Analysis System (including Blood Gas and Chemistry Analyzer, Calibrant Fluid Pack, Test Cartridge) is a portable, automated system that measures pH and blood gases (pCO2, pO2), electrolytes (Na+, K+, Ca++, Cl-) and hematocrit in arterial and venous whole blood samples with lithium heparin or calcium balanced heparin. The system is intended for in-vitro diagnostic use only by trained health care professionals in a laboratory environment, near patient or point-of-care settings.

pH, pCO2, pO2: Whole blood measurement of certain gases in whole blood, or pH of whole blood, is used in the diagnosis and treatment of life-threatening acid-base and/or oxygenation disturbances.
Hct: Whole blood measurements of the packed 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 blood cells)
Na+: Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance.
K+: Potassium measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels
Cl-: Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Ca++: Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

The EDAN i15 Calibrant Fluid Pack is intended for the calibration of pH, pO2, pCO2, Na+, K+ Ca++, Cl-, and Hct as part of the EDAN i15 Blood Gas and Chemistry Analysis System.

The EDAN i15 Blood Gas and Electrolyte Controls are external multi-analyte quality control material intended to be used for the verification of correct operation and measurement of the EDAN i15 Blood Gas and Electrolyte Analyze, together with i15 Calibrant Fluid Pack and i15 Test Cartridge for the analysis of pH, blood gases (pCO2 pO2), and electrolytes (Na+, K+, Ca++, and Cl').

The EDAN i15 Hematocrit Controls are intended to be used for the verification of correct operation and measurement of the EDAN i15 Blood Gas and Chemistry Analysis System, together with i15 Calibrant Fluid Pack and i15 Test Cartridge for the analysis of hematocrit.

The EDAN i15 Blood Gas and Chemistry Analysis System, including the Blood Gas and Chemistry Analyzer, Calibrant Fluid Pack, Test Cartridge, and Quality Controls) is a system for in-vitro analysis of whole blood, delivering quantitative results for panels of tests determined by the Test Cartridge type used in the measurement. The Analyzer incorporates a large graphical user interface with a large color touch screen interfacing the analyzer electronic, Test Cartridge (containing the sensors) and Calibrant Fluid Pack. The sensors, flow path and waste are integrated into a single-use Test Cartridge. The calibration solution is contained in the Calibrant Fluid Pack which is available in versions for 50 or 100 tests. The product, consumables, installation instructions and packaging are designed for easy customer installation and operation.

The EDAN i15 Analyzer accepts lithium- or calcium-balanced heparinized whole blood samples from syringes and capillary tube. The minimum volume for samples from both syringe and capillary tube is 140 µL.

As with the predicate device, the EDAN i15 Blood Gas and Chemistry Analysis System is microprocessor-based and incorporates traditional sensor technology for measurement.

• pH, pCO2, Na*, K*, Cl , and Ca** (potentiometric measurement) .
• pO2 (amperometric measurement)
• Hct (conductivity measurement) ●

The Test Cartridge is available in three (3) versions, with different test panels, but with identical sample paths and calibration fluid:
BG8: pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct
BG3: pH, pCO2, pO2
BC4: Na+, K+, Cl-, Ca++, Hct

The Test Cartridge aspirates the sample directly from a syringe, or capillary fitted with an adaptor, and requires a minimum sample volume of 140 µL.

The provided text describes the performance testing and acceptance criteria for the EDAN i15 Blood Gas and Chemistry Analysis System.

1. Table of Acceptance Criteria and Reported Device Performance

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The Stat Profile Prime CCS Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of pH, PCO2, PO2, Hct, Na+. K-, CL-, iCa, Glu (Glucose), and Lac (Lactate) in heparinized whole blood.

PC02,P02,pH: Whole blood measurement of certain gases in whole blood,or pH of whole blood,is used in the diagnosis and treatment of life-threatening acid-base disturbances.

Hct: Whole blood measurements 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).

Na+: Sodium measurement is used in the diagnosis and treatment of aldosteronism,diabetes insipidus, adrenal hypertension, Addison's disease,dehydration,or diseases involving electrolyte imbalance.

K+: Potassium Measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.

Cl-: Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

iCa: Calcium measurements are used in the diagnosis and treatment of parathyroid disease,a variety of bone diseases,chronic renal disease and tetany (intermittent muscular contractions or spasms).

Glu: Glucose measurement is used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus,neonatal hypoglycemia,and idiopathic hypoglycemia,and of pancreatic islet cell carcinoma.

Lac: Lactate (lactic acid) measurement is used to evaluate the acid-base status of patients lactic acidosis.

The Stat Profile Prime Auto QC Cartridge CCS is a quality control intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of the Stat Profile Prime CCS Analyzer.

The Stat Profile Prime Ampuled Control ABG/CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Stat Profile Prime CCS Analyzer.

The Stat Profile Prime Calibrator Cartridge CCS is intended for the calibration of pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, Glucose and Lactate using the Stat Profile Prime CCS Analyzer.

Linearity Standard Set A is intended for in vitro diagnostic use with Stat Profile Prime CCS Analyzers to verify calibration, analytical linearity, estimate test imprecision, and detect systematic analytical deviations that may arise from calibrator cartridge or analytical instrument variation.

The Stat Profile Prime CCS Analyzer is a small, low cost blood gas, metabolite and electrolyte analyzer for laboratory use. The sensors and flow path have been integrated into one replaceable microsensor card, which is replaced periodically according to usage. The product, consumables, installation instructions and packaging are designed for easy customer installation.

Whole blood specimens are aspirated into the analyzer's microsensor card from syringes, tubes, or capillary blood collection devices using a peristaltic pump and a sampling probe. The disposable microsensor card contains the analytical flow path and all of the measurement sensors (pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, Glu (Glucose) and Lac (Lactate). Once the analysis measurement is complete, the whole blood specimen is automatically flushed out of the microsensor card flow path and into a self-contained waste collection bag contained within the disposable calibrator cartridge.

The Stat Profile Prime CCS Analyzer will have an enhanced test menu and multiple quality control options. Both traditional Internal and External liquid QC shall be offered, as well as an onboard Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly.

As with the predicate, the Stat Profile Prime CCS Analyzer is microprocessor-based and incorporates:

• traditional sensor technology to measure blood pO2 ●
• ion selective electrode technology to measure pH, pCO2, blood sodium, potassium, chloride, and ionized calcium
• enzyme/Amperometric technology for glucose measurements

Liquid quality control materials are available as internal auto-cartridge quality control packs and as external ampules. The sampling, calibration and quality control functions are fully automated.

Internal Calibration standards with dissolved gases are provided in sealed pouches eliminating the need for users to calibrate the blood gas electrodes using external compressed gas cylinders. The Calibration Cartridges contain aqueous solutions within individual flexible bags housed in a cardboard box and a flexible waste bag. Each bag includes a fitment with septa that is pierced during the insertion of the cartridge into the analyzer. The Calibration Cartridge agueous solutions allow for 2 point calibration of each parameter as follows:

• Calibrator A pH, PCO2, Na, K, Cl, iCa, Glu and Lactate (Volume > 500 mL) ●
• Calibrator B pH, PO2, Na, K, Cl, iCa, Glu and Lactate (Volume > 250 mL) .
• Calibrator F PCO2, PO2 (Volume > 720 mL) ●
• Reference Solution KCI (Volume > 300 mL) .

The external glass ampule controls contain a buffered bicarbonate solution with a known pH and known levels of Na, K, Cl, iCa, Glucose (Glu) and Lactate. The solutions are equilibrated with known levels of 02, CO2, and N2. Each ampule contains 1.7 ml volume.

The internal auto QC cartridge consists of 3 flexible bags within a cardboard carton. Each bag contains an aqueous quality control material for monitoring the measurement of pH, PCO2, PO2, hematocrit (Hct) Na, K, Cl, iCa, Glucose (Glu) and Lactate. The aqueous quality control materials are composed of a buffered bicarbonate solution, each with a known pH and known level of Na, K, Cl. iCa. Glucose (Glu) and Lactate. Solutions are equilibrated with known levels of O2, CO2, and N2. Each bag contains a minimum volume of 100 mL. The aqueous quality control materials are formulated at three levels:

• . Control 1: Acidosis, with High Electrolyte, Low Normal Glu, and Lactate
• Control 2: Normal pH, Low-Normal Hct, Normal Electrolyte, High Glu, and Lactate ●
• . Control 3: Alkalosis, High Hct, Low Electrolyte, High Abnormal Glu, and Lactate

Linearity Standard Set A consists of ampuled buffered solutions containing Ca++, Glu, Lactate, K+, and Cl-. Each ampule contains 1.8 ml volume.

The Stat Profile Analyzer accepts Lithium heparin whole blood sample from syringes, open tubes, small cups, and capillary tubes. The minimum sample size for both syringe and capillary samples analysis is 100 µL.

Here's a summary of the acceptance criteria and the study details for the Stat Profile® Prime CCS Analyzer System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for each parameter (e.g., a specific bias range for method comparison). Instead, it presents the results of equivalency studies against a predicate device and within the device itself (capillary vs. syringe, POC vs. trained healthcare professional). The implication is that the performance shown in these tables met the internal acceptance criteria for substantial equivalence to the predicate and for safe and effective use.

I will formulate a table focusing on the Method Comparison and Point-of-Care (POC) vs. Trained Healthcare Professional (THP) studies, as these directly compare the device's performance to established methods or user groups. The "Acceptance Criteria" column will represent the implicit expectation of strong correlation (high 'r' value, slope near 1, intercept near 0) for substantial equivalence and reliable performance.

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The Stat Profile Prime CCS Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, and Glu (Glucose), in heparinized whole blood.

PCO2, PO2, pH: Whole blood measurement of certain gases in whole blood, or pH of whole blood, is used in the diagnosis and treatment of life-threatening acid-base disturbances.

Hct: Whole blood measurements 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).

Na +: Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance.

K+: Potassium Measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.

Cl-: Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

ICa: Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Glu: Glucose measurement is used in the diagnosis and treatment of carbohydrate metabollsm disturbances Including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The Stat Profile Prime Auto QC Cartridge CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of the Stat Profile Prime CCS Analyzer.

The Stat Profile Prime Ampuled Control ABG/CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Stat Profile Prime CCS Analyzer.

The Stat Profile Prime Calibrator Cartridge CCS is intended for the callbration of pH, PCO2, PO2, Hct, Na+, K+, C-, ICa, and Glucose using the Stat Profile Prime CCS Analyzer.

Linearity Standard Set A is intended for in vitro diagnostic use with Stat Profile Prime CCS Analyzers to verify calibration, analytical linearity, estimate test imprecision, and detect systematic analytical deviations that may arise from callbrator cartridge or analytical instrument variation.

The Stat Profile Prime CCS Analyzer is a small, low cost blood gas, metabolite and electrolyte analyzer for laboratory use. The sensors and flow path have been integrated into one replaceable microsensor card, which is replaced periodically according to usage. The product, consumables, installation instructions and packaging are designed for easy customer installation.

Whole blood specimens are aspirated into the analyzer's microsensor card from syringes, tubes, or capillary blood collection devices using a peristaltic pump and a sampling probe. The disposable microsensor card contains the analytical flowpath and all of the measurement sensors (pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, and Glu (Glucose). Once the analysis measurement is complete, the whole blood specimen is automatically flushed out of the microsensor card flowpath and into a self contained waste collection bag contained within the disposable calibrator carridge.

The Stat Profile Prime CCS Analyzer will have an enhanced test menu and multiple quality control options. Both traditional Internal and External liquid QC shall be offered, as well as an onboard Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly.

As with the predicate, the Stat Profile Prime CCS Analyzer is microprocessor-based and incorporates:

• . traditional sensor technology to measure blood pO2
• ion selective electrode technology to measure pH, pCO₂, blood sodium, potassium, . chloride, and ionized calcium
• enzyme/Amperometric technology for glucose measurements .

Liquid quality control materials are available as internal auto-cartridge quality control packs and as external ampules. The sampling, calibration and quality control functions are fully automated.

Internal Calibration standards with dissolved gases are provided in sealed pouches eliminating the need for users to calibrate the blood gas electrodes using external compressed gas cylinders. The Calibration Cartridges contain aqueous solutions within individual flexible bags housed in a cardboard box and a flexible waste bag. Each bag includes a fitment with a septa that is pierced during the insertion of the cartridge into the analyzer. The Calibration Cartridge aqueous solutions allow for 2 point calibration of each parameter as follows.

• Calibrator A pH, PCO2, Na, K, Cl, iCa, and Glu (Volume > 500 mL) .
• Calibrator B pH, PO2, Na, K, Cl, iCa, and Glu (Volume > 250 mL) .
• . Calibrator F - PCO2, PO2 (Volume > 720 mL)
• Reference Solution KCI (Volume > 300 mL) .

The external glass ampule controls contain a buffered bicarbonate solution with a known pH and known levels of Na, K, CI, iCa, and Glu. The solutions are equilibrated with known levels of O2, CO2, and N2. Each ampule contains 1.7 ml volume.

The internal auto QC cartridge consists of 3 flexible bags within a cardboard carton. Each bag contains an aqueous quality control material for monitoring the measurement of pH, PCO2, PO2, hematocrit (Hct) Na, K, Cl, iCa, and Glucose (Glu). The aqueous quality control materials are composed of a buffered bicarbonate solution, each with a known pH and known level of Na, K, Cl, iCa, and Glu. Solutions are equilibrated with known levels of O2, CO2, and N2. Each bag contains a minimum volume of 100 mL. The aqueous quality control materials are formulated at three levels:

• . Control 1: Acidosis, with High Electrolyte, Low Normal Glu
• . Control 2: Normal pH, Low-Normal Hct, Normal Electrolyte, High Glu
• Control 3: Alkalosis, High Hct, Low Electrolyte, High Abnormal Glu, .

Linearity Standard Set A consists of ampuled buffered solutions containing Ca++, Glu, K+, and Cl-. Each ampule contains 1.8 ml volume.

The Stat Profile Analyzer accepts Lithium heparin whole blood sample from syringes, open tubes, small cups, and capillary tubes. The minimum sample size for both syringe and capillary samples analysis is 100 µL.

Measured Parameters:

The Stat Profile Prime CCS Analyzer measures pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, and Glu (Note: Glucose is optional).

Calculated Parameters:

• . pH, PCO2, PO2 (corrected to patient temperature)
• . Bicarbonate level (HCO3-)
• Total Carbon Dioxide (TCO2) .
• Base Excess of the blood (BE-b) .
• Base Excess of extracellular fluid (BE-ecf) .
• Standard Bicarbonate Concentration (SBC) .
• . Oxygen Content (O2Ct)
• . Oxygen Capacity (O2Cap)
• Alveolar Oxygen (A) .
• Arterial Alveolar Oxygen Tension Gradient (AaDO2) .
• Arterial Alveolar Oxygen Tension Ratio (a/A) .
• Respiratory Index (RI) .
• P50 .
• PO2/FIO2 ratio .
• Oxygen Saturation (SO2%) .
• Hemoglobin .
• Anion Gap .
• Normalized Calcium, nCa ●

The Nova Stat Profile Prime CCS Analyzer System is intended for in vitro diagnostic use for the quantitative determination of blood gases (pH, PCO2, PO2), hematocrit (Hct), and electrolytes/metabolites (Na+, K+, Cl-, iCa, and Glucose) in heparinized whole blood. The acceptance criteria for the device's performance are established through bench testing, demonstrating substantial equivalence to its predicate device, the Nova Stat Profile pHOx Ultra Analyzer System (K110648).

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines acceptance criteria by comparing the proposed device to the predicate device and asserting substantial equivalence. While explicit numerical acceptance ranges are not provided for all parameters in a pass/fail format, the comparison table and the conclusion of the study indicate that the Stat Profile Prime CCS Analyzer met the performance levels demonstrated by the predicate.

2. Sample Sizes used for the Test Set and Data Provenance:

The document states that "Bench testing was completed to demonstrate that the Stat Profile Prime CCS Analyzer is substantially equivalent in performance, safety and efficacy to the Stat Profile pHOx Ultra Analyzer System." However, it does not provide specific sample sizes for the test sets used in the method comparison, precision, linearity, specificity/interference, or detection limit studies.

The data provenance is not explicitly stated. Given that the testing was bench testing for regulatory submission, it is highly likely to be prospective data collected specifically for this submission, rather than retrospective. The country of origin for the data is also not specified, but the applicant, Nova Biomedical Corporation, is based in Waltham, MA, USA, suggesting the testing likely occurred in the USA.

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

This device is an in-vitro diagnostic (IVD) analyzer for quantitative measurements. The ground truth for such devices is typically established through reference methods or certified reference materials, not by expert consensus in the same way an image analysis AI might be. Therefore, the concept of "experts used to establish ground truth" with specific qualifications like "radiologist with 10 years of experience" does not apply in this context. The ground truth would be determined by the accuracy of the reference methods or the certified values of the reference materials used in the bench testing.

4. Adjudication Method for the test set:

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human readers are making subjective interpretations, such as in medical imaging. For an IVD analyzer performing quantitative measurements, the ground truth is objective (e.g., a measured concentration or value). Therefore, the concept of an adjudication method does not apply to the bench testing conducted for this device. Discrepancies would be resolved through re-testing, calibration, or investigation of the reference method's accuracy.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study is used to assess the impact of an AI algorithm on human readers' performance, typically in diagnostic imaging. This device is an automated IVD analyzer, not an AI-assisted diagnostic tool that aids human interpretation. Therefore, an MRMC study was not performed, and the concept of human readers improving with/without AI assistance does not apply.

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

The performance evaluation described ("Method Comparison Studies," "Precision/Reproducibility Studies," "Linearity Testing," "Specificity / Interference Testing," "Detection Limit") primarily assesses the standalone performance of the Stat Profile Prime CCS Analyzer. This type of testing evaluates the algorithm and hardware's ability to accurately and precisely measure the specified analytes without direct human intervention in the measurement process (beyond sample loading and initiation). The human role is in setting up the device and interpreting the final quantitative result.

7. The type of ground truth used:

The ground truth for the performance testing (method comparison, precision, linearity, etc.) would be established using:

• Reference methods: Comparing the device's measurements to established, highly accurate laboratory methods for each analyte.
• Certified reference materials: Using materials with known, precisely determined concentrations of the analytes.

The document does not explicitly state which specific reference methods or certified materials were used, but these are standard practices for IVD device validation.

8. The sample size for the training set:

This document describes a submission for an in-vitro diagnostic analyzer based on established sensor technologies and measurement algorithms, not a machine learning or AI model that requires a distinct "training set." Therefore, the concept of a "training set sample size" as understood in AI/ML development does not apply in this context. The underlying algorithms for measurement are based on known chemical and physical principles and extensive historical validation, not iterative training on a large dataset.

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

As mentioned above, this device does not utilize a training set in the AI/ML sense. The "ground truth" for the device's core measurement principles is based on validated scientific principles, sensor calibration procedures, and the established performance characteristics of the predicate device. Changes or improvements from the predicate would be validated against established reference methods.

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