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

Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes:

· Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.

· Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

· Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. · Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders, such as cystic fibrosis and diabetic acidosis.

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

· Lactate (Lac) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis, to monitor tissue hypoxia and strenuous physical exertion, and in the diagnosis of hyperlactatemia.

· Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

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

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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The Urea Nitrogen2 assay is used for the quantitation of Urea Nitrogen in human serum, plasma, or urine on the ARCHITECT c System.

The Urea Nitrogen2 assay is to used as an aid in the diagnosis and treatment of certain renal and metabolic diseases.

The Urea Nitrogen2 assay is an automated clinical chemistry assay. The Urea Nitrogen2 assay is a modification of a totally enzymatic procedure. The test is performed as a kinetic assay in which the initial rate of the reaction is linear for a limited period of time. Urea in the sample is hydrolyzed by urease to ammonia and carbon dioxide. The second reaction, catalyzed by glutamate dehydrogenase (GLDH), converts ammonia and a-ketoglutarate to glutamate and water with the concurrent oxidation of reduced nicotinamide adenine dinucleotide (NADH) to nicotinamide adenine dinucleotide (NAD). Two moles of NADH are oxidized for each mole of urea present. The initial rate of decrease in absorbance at 340 nm is proportional to the urea concentration in the sample.

The provided document is a 510(k) premarket notification for a new in vitro diagnostic device, the Urea Nitrogen2 assay. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive clinical effectiveness studies as might be seen for novel devices. Therefore, the information provided primarily concerns non-clinical performance characteristics of the assay itself, rather than human-in-the-loop performance or diagnostic accuracy evaluated in a clinical setting with patient outcomes.

Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

Core Purpose of the Submission: To demonstrate that the Urea Nitrogen2 assay is substantially equivalent to the predicate device (Urea Nitrogen assay, K981918) for the quantitative measurement of urea nitrogen in human serum, plasma, and urine on the ARCHITECT c System. This means proving the new device performs similarly and is as safe and effective as the predicate.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from established clinical laboratory standards (CLSI guidelines) and comparison to the predicate device's known performance. The performance metrics evaluated are standard for in vitro diagnostic assays.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details

The studies described are primarily analytical performance studies, characteristic of a 510(k) submission for an in vitro diagnostic device, especially a chemical analyzer assay. They demonstrate the device's technical specifications and how it performs compared to a reference method or the predicate device.

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

• Precision Studies (Within-Laboratory):
  • Serum/Plasma: 3 human serum panels + 2 controls. Each tested in duplicate, twice per day, for 20 days on 3 reagent lot/calibrator lot/instrument combinations. For a representative combination, n=80 per sample/control.
  • Urine: 3 human urine panels + 2 controls. Each tested in duplicate, twice per day, for 20 days on 3 reagent lot/calibrator lot/instrument combinations. For a representative combination, n=80 per sample/control.
  • Data Provenance: Not explicitly stated but inferred to be laboratory-based analytical studies, likely from the manufacturer's R&D facilities. No country of origin is specified. The studies are retrospective analytical evaluations of manufactured samples and controls.
• Accuracy (Bias): 3 concentrations of standard across 3 reagent lots, 2 calibrator lots, and 1 instrument. (NIST SRM 912b is the standard).
• Lower Limits of Measurement (LoB, LoD, LoQ): n ≥ 60 replicates of zero-analyte samples for LoB, n ≥ 60 replicates of low-analyte level samples for LoD/LoQ. Conducted using 3 reagent lots on 2 instruments over a minimum of 3 days.
• Linearity: Not explicitly stated sample count, but typically involves preparing a dilution series of samples across the range.
• Interference: "Each substance was tested at 2 levels of the analyte (approximately 10 mg/dL and 30 mg/dL for serum/plasma; 700 mg/dL and 1500 mg/dL for urine)." No specific N for how many replicates or individual samples are run per interferent level, but implied to be sufficient for statistical analysis (e.g., 95% CI).
• Method Comparison:
  • Serum: n=124 samples.
  • Urine: n=121 samples.
  • Data Provenance: Not explicitly stated, but these would be clinical or proficiency samples analyzed side-by-side with the predicate.
• Tube Type: Samples collected from a minimum of 40 donors.
• Dilution Verification: 5 human serum samples (spiked with urea). Each sample tested with automated dilution and 3 manual dilutions (by 2 technicians). Tested in replicates of 5.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• For this type of in vitro diagnostic device (a quantitative chemical assay), "ground truth" is established by:
  • Reference materials: e.g., NIST SRM 912b for accuracy. This is a primary standard, not established by human experts.
  • Predicate device measurements: For method comparison, the predicate device provides the comparative 'truth' (or established method performance).
  • Clinical laboratory professional consensus/guidelines: Standards like CLSI (Clinical and Laboratory Standards Institute) guidelines (EP05-A3, EP17-A2, EP06-A, EP07, EP09-A3, EP34) serve as the "expert consensus" on how to conduct and interpret these analytical studies. These are published by committees of experts in laboratory medicine, clinical chemistry, and statistics.
• No "expert readers" in the traditional sense (e.g., radiologists interpreting images) are involved in establishing ground truth for this type of device. The validation is based on metrological traceability to standards and comparison to an established analytical method.

4. Adjudication Method for the Test Set

• Not applicable as this is an analytical performance study of a chemical assay, not a diagnostic accuracy study relying on human interpretation of subjective data (like imaging or pathology). Results are quantitative measurements read by the instrument.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is relevant for diagnostic devices that involve human interpretation (e.g., AI-assisted image interpretation) and aim to show an improvement in human reader performance. This device is a quantitative chemical assay that provides a numerical result; there is no human "reader" to assist in the primary measurement. The comparison is between the new assay's performance and the predicate assay's performance, as well as against analytical standards.

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

• Yes, effectively. The entire submission details the standalone analytical performance of the Urea Nitrogen2 assay system (reagents + ARCHITECT c System instrument). Its performance (precision, accuracy, linearity, etc.) is evaluated independently of human interpretation of the final numerical result, beyond the standard operation and quality control typically performed in a clinical lab.

7. The Type of Ground Truth Used

• Analytical Standards and Reference Methods/Predicate Device:
  • NIST SRM 912b: Used as the true value for accuracy determination.
  • Predicate Device (Urea Nitrogen assay): Used as the comparative reference for method comparison studies, demonstrating substantial equivalence.
  • CLSI Guidelines: Act as the "ground truth" for the methodologies and acceptance criteria applied to evaluate the analytical performance (e.g., how LoQ is defined and determined, how precision is calculated).

8. The Sample Size for the Training Set

• For this type of in vitro diagnostic assay, there isn't a "training set" in the machine learning sense (where an algorithm learns from data). The "training" for such an assay primarily refers to:
  • Reagent formulation and optimization: This involves extensive R&D to achieve desired chemical reactions and stability.
  • Instrument calibration: The ARCHITECT c System is calibrated using specific calibrators (Consolidated Chemistry Calibrator mentioned, which is itself traceable to standards) to ensure accurate measurement across the range.
• The "training" is inherent in the chemical and engineering development of the assay and the instrument, rather than an algorithmic learning process on a large dataset. Therefore, a specific "training set sample size" as one would discuss for an AI model is not applicable.

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

• As explained above, there isn't a "training set" with ground truth in the AI/ML context for this device. Instead, the assay's performance characteristics (calibration, linearity, reaction kinetics, etc.) are optimized and confirmed through:
  • Chemical principles and R&D: The enzymatic reaction (urease, GLDH kinetics) is based on established biochemical mechanisms.
  • Quality control materials and calibrators: These materials have assigned values, often traceable to international standards (like NIST SRM), and are used to "train" or calibrate the instrument system.
  • Iterative laboratory testing and optimization: The assay's components and instrument parameters are refined through repeated experiments to meet performance specifications.

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Medicon Hellas Albumin: Reagent for the quantitative measurement of albumin in serum. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Medicon Hellas Calcium: Reagent for the quantitative measurement of calcium in serum or urine. 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).

Medicon Hellas Creatinine: Reagent for the quantitative measurement of creatinine in serum and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

Medicon Hellas Glucose: Reagent for the quantitative measurement of glucose in serum and urine. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Medicon Hellas Direct Bilirubin; Reagent for the quantitative measurement of direct bilirubin (conjugated) in serum. Measurements of the level of direct bilirubin is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall blader block.

Medicon Hellas Total Bilirubin: Reagent for the quantitative measurements of total bilirubin in serum. Measurements of the levels of total bilirubin is used in the diagnosis and treatment of liver. hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Medicon Hellas Urea Nitrogen: Reagent is for the quantitative measurement of urea nitrogen in serum and urine. Measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

The Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Glucose, Medicon Hellas Direct Bilirubin, Medicon Hellas Total Bilirubin, and Medicon Hellas Urea Nitrogen are reagents for use with Diatron Pictus 500 Clinical Chemistry Analyzers. They are test systems for the quantitative measurement of albumin, calcium, creatinine, glucose, direct and total bilirubin, and urea nitrogen in human serum and urine where clinically applicable. The methods employed are photometric, utilizing reactions between the sample and reagents to produce a colored chromophore or a change in absorbance that is proportional to the concentration of the analyte. The analyzer photometer reads the absorbances at time intervals dictated by the method application stored in the analyzer memory, and the change in absorbance is calculated automatically.

The provided text describes the performance of several Medicon Hellas assays (Albumin, Calcium, Creatinine, Glucose, Direct Bilirubin, Total Bilirubin, and Urea Nitrogen) when run on the Diatron Pictus 500 Clinical Chemistry Analyzer, demonstrating their substantial equivalence to predicate devices (Beckman Coulter AU reagents on AU2700 analyzer, and Abbott Architect Direct Bilirubin on Architect c8000 analyzer).

Here's an analysis of the provided information, structured to address your specific points regarding acceptance criteria and study details:

1. A Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a single, overarching table with pass/fail remarks. Instead, it describes each performance characteristic and then presents the results. The "Summary" sections for each study type imply that the results met the pre-defined acceptance criteria for demonstrating substantial equivalence. For instance, for accuracy, it states "Accuracy studies completed on at least three lots of each candidate reagent confirm that Medicon albumin... are substantially equivalent to the related predicate devices." This implies that the statistical analyses (Deming regression, R2, slope, intercept) fell within acceptable ranges. Similarly, for precision, it states "All lots passed acceptance criteria for each applicable sample type at each level."

Since explicit acceptance criteria are not presented, they are inferred from the demonstrated performance and the statement that the devices "passed acceptance criteria" or "met statistical acceptance criteria." Below is a table summarizing the reported device performance for each analyte. The "Acceptance Criteria" column will reflect the general statements of success or the implied ranges from the results themselves, as explicit numerical targets for individual tests are not given.

Implied Acceptance Criteria and Reported Device Performance

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The i-STAT CHEM8+ cartridge with the i-STAT 1 System is in the in vitro quantification of sodium, potassium, chloride, ionized calcium, glucose, blood urea nitrogen, creatinine, hematocrit, and total carbon dioxide in arterial or venous whole blood in point of care or clinical laboratory settings.

Sodium measurements are used for monitoring electrolyte imbalances.

Potassium measurements are used in the diagnosis and clinical conditions that manifest high and low potassium levels.

Chloride measurements are primarily used in the diagnosis, monitoring, and treatment of electrolyte and metabolic disorders including, but not limited to, cystic fibrosis, diabetic acidosis, and hydration disorders.

Ionized calcium measurements are used in the diagnosis and treatment of parathyroid disease, chronic renal disease and tetany.

Glucose measurements are used in the diagnosis, monitoring, and treatment of carbohydrate metabolism disorders including, but not limited to, diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma.

Blood urea nitrogen measurements are used for the diagnosis, and treatment of certain renal and metabolic diseases.

Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Hematoorit measurements can aid in the determination and monitoring of normal total red cell volume status that can be associated with conditions including anemia and erythrocytosis. The i-STAT Hematocrit test has not been evaluated in neonates.

Carbon dioxide measurements are used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

The i-STAT CHEM8+ test cartridge contains test reagents to analyze whole blood at the point of care or in the clinical laboratory for sodium (Na), potassium (K), chloride (CI), ionized calcium (iCa), glucose (Glu), blood urea nitrogen (BUN), creatinine (Crea), hematocrit (Hct), and total carbon dioxide (TCO2). The test is contained in a single-use, disposable cartridge. Cartridges require two to three drops of whole blood which are typically applied to the cartridge using a transfer device.

The i-STAT 1 Analyzer is a handheld, in vitro diagnostic analytical device designed to run only i-STAT test cartridges. The instrument interacts with the cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).

The i-STAT 1 System is comprised of the i-STAT 1 analyzer, the i-STAT test cartridges and accessories (i-STAT 1 Downloader/Recharger, electronic simulator and portable printer). The system is designed for use by trained medical professionals at the patient point of care or in the clinical laboratory and is for prescription use only.

The provided text describes a 510(k) premarket notification for the i-STAT CHEM8+ cartridge with the i-STAT 1 System, specifically addressing the addition of an anticoagulant-free whole blood matrix. The document references several previous 510(k) clearances for various analytical performance characteristics and presents a new "Matrix Equivalence" study for the anticoagulant-free whole blood.

Here's an analysis of the acceptance criteria and study information provided, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for the "Matrix Equivalence" study in a tabulated format. However, it implicitly uses a Passing-Bablok linear regression analysis to demonstrate equivalence. The reported device performance is presented as the results of this regression analysis. We can infer the expected performance from general expectations for method comparisons in analytical chemistry, where a slope close to 1, an intercept close to 0, and a high correlation coefficient (r) indicate good agreement.

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

• Sample Size (Test Set for Matrix Equivalence): The sample sizes vary slightly per analyte:
  • Na, Cl, iCa: 314
  • K, Glu: 313
  • BUN: 310
  • Crea: 312
  • Hct: 311
  • TCO2: 273
• Data Provenance: The study was conducted at "three (3) point of care sites." The document does not specify the country of origin, but given the FDA submission, it is likely the US or a region with equivalent regulatory standards. The data is prospective in nature, as it involved collecting samples (both anticoagulant-free and anticoagulated) for direct comparison.

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

This type of study (matrix equivalence for IVD devices) does not typically involve human experts establishing "ground truth" in the way a diagnostic imaging study would. The ground truth (or reference method) for comparison is the measurement obtained from the previously cleared device using anticoagulated samples. The expertise lies in the calibration of the reference method and the design and execution of the analytical study, not in human interpretation of results.

4. Adjudication Method for the Test Set

Not applicable for this type of analytical method comparison study. Adjudication is relevant for subjective assessments, typically in diagnostic imaging or clinical outcomes, to resolve discrepancies among human readers or between AI and human readers. Here, the comparison is between two quantitative measurement methods.

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 analytical performance study for an in vitro diagnostic device, not a diagnostic imaging or clinical decision support AI.

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

Yes, the analytical performance (precision, linearity, LoQ, LoB/LoD, interference, and method comparison) of the i-STAT CHEM8+ cartridge with the i-STAT 1 System, and its equivalence between different sample matrices, primarily represents standalone performance of the device without human intervention beyond sample collection and device operation. The "Matrix Equivalence" study directly compares the results of the device using two different sample types.

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

The ground truth for the "Matrix Equivalence" study was established by the mean result from the primary sample, which refers to measurements obtained from whole blood samples collected with balanced heparin or lithium heparin anticoagulant using the previously cleared i-STAT CHEM8+ system. This acts as the "reference method" for comparison to the anticoagulant-free samples.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the purpose of the Matrix Equivalence study. This study is a validation study demonstrating that a new sample matrix (anticoagulant-free whole blood) yields equivalent results to the established (anticoagulated) sample matrix. The device itself (i-STAT CHEM8+ with i-STAT 1 System) would have undergone extensive development and internal testing (which could be considered a form of "training") prior to its initial clearances (K183678, K183680, K183688, K191298, K191360). The current submission focuses on extending the indications for use.

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

As no explicit "training set" is mentioned for this specific submission's study, this question is not directly answerable from the provided text. The "ground truth" for the reference method within the Matrix Equivalence study, as stated above, derives from the previously cleared performance of the i-STAT CHEM8+ system using anticoagulated samples, which would have been established through robust analytical validation studies (e.g., comparison to laboratory reference methods).

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The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of Glucose, Lactate, Creatinine, and Blood Urea Nitrogen in heparinized arterial and venous whole blood.

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.
Lactate (lactic acid) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis.
Creatinine measurement is used in the diagnosis and treatment of certain renal conditions and for monitoring adequacy of dialysis.
Blood Urea Nitrogen measurement is used in the diagnosis and treatment of certain renal and metabolic diseases.

The Stat Profile Prime Plus Analyzer System is a low cost, low maintenance analyzer for hospital laboratory and point-of-care settings. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).

The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed.

Primary Sensor Card Port:
There are two options for the primary sensor card:

• Primary Sensor Card 1 shall enable and report the following listed analytes: o Glu. Lactate
• Primary Sensor Card 2 shall enable and report the following listed analytes: o Glu, Lactate

Auxiliary Sensor Card Port:
The reporting of Creatinine and BUN parameters (or not reporting them) shall be determined by the selection of the Auxiliary Sensor Card

• Auxiliary Sensor Card 1 shall enable Creatinine and BUN parameters .
• . Auxiliary Sensor Card 2 shall be a "dummy" sensor card, and will not report any parameters.

As with the predicate, the Stat Profile Prime Plus Analyzer is a blood gas, co-oximetry, electrolyte, chemistry, and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control is available, as well as an on-board Quality Management System (QMS), and an electronic monitoring approach that insures the analyzer is working properly at all times.

The Stat Profile Prime Plus Analyzer accepts samples from syringes and open tubes. The minimum sample size for analysis is 135 µL.

Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.

Stat Profile Prime Plus Analyzer System Components:
The Stat Profile Prime Plus Analyzer System is comprised of the following components.

• Stat Profile Prime Plus Analyzer System .
• Primary Sensor Cartridge .
• Auxiliary Sensor Cartridge
• Stat Profile Prime Plus Auto-Cartridge Quality Control Pack ●
• Stat Profile Prime Plus Calibrator Cartridge ●
• Stat Profile Prime Plus External Ampuled Control .
• . IFU/Labeling

This document describes the performance of the Stat Profile Prime Plus Analyzer System for the quantitative determination of Glucose, Lactate, Creatinine, and Blood Urea Nitrogen in heparinized arterial and venous whole blood. The submission specifically focuses on the modification of the device to include Point-of-Care (POC) use.

It is important to note that this document is a 510(k) summary for a medical device. This type of document typically focuses on demonstrating substantial equivalence to a previously cleared device, rather than proving novel clinical effectiveness with large-scale comparative effectiveness studies. Therefore, not all requested sections directly apply, especially those related to AI model development (training set, human-in-the-loop, MRMC studies) common in submissions for AI/ML-based diagnostic software. This device is a point-of-care blood analyzer, not an AI diagnostic software.

Here's the breakdown of the provided information within the context of this device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit "acceptance criteria" in a singular table for all parameters as one might find for a pass/fail threshold in an AI/ML study. Instead, performance is demonstrated through various analytical validation studies (precision, linearity, interference, detection limit) and a method comparison study to show equivalence to a predicate device and laboratory methods. The "acceptance criteria" are implicitly met if the performance data supports substantial equivalence for the intended use and accuracy compared to established methods.

For Lactate (specifically detailed in the provided text):

• Within-Run (Quality Control Ampules Levels 4 & 5): CV% ranged from 0.00% to 1.6%.
• Within-Run (Whole Blood from Syringes, 5 samples): CV% ranged from 1.3% to 8.0%.
• Run-to-Run (Auto QC Cartridge Levels 4 & 5): Total Imprecision %CV ranged from 1.4% to 3.5%.
• Run-to-Run (Whole Blood, 5 samples): CV% ranged from 1.8% to 14.7%. Note: Blood #1 showed a higher CV of 13.3-14.7% across devices. |
  | Linearity | Demonstrates linearity across the claimed measurement range, with a high correlation (r-value) to established methods. | - Claimed Measurement Range: 0.3 - 20.0 mmol/L.
• Specimen Range Tested: 0.2 - 23.5 mmol/L.
• Analyzers (PP1, PP2, PP3): r-values were 0.9983, 0.9982, and 0.9988, respectively.
• Comment: Results support the claimed measurement range. |
  | Specificity / Interference | Identifies substances that may interfere and quantifies the highest concentration tested that shows no significant interference. | - Dose response study performed for glycolic acid and hydroxyurea showed interference at all concentrations. (Specific concentrations not given, but the fact of interference is noted).
• Table 7 lists the highest non-interfering concentrations for 23 other common substances (e.g., Acetaminophen, Ascorbic Acid, Bilirubin, Ethanol, Heparin, Ibuprofen). |
  | Detection Limit (LoB, LoD, LoQ) | LoB, LoD, and LoQ should be below the lower limit of the claimed measurement range. | - LoB: 0.0 mmol/L
• LoD: 0.1 mmol/L
• LoQ: 0.1 mmol/L.
• Comment: All are below the claimed lower limit of 0.3 mmol/L. |
  | Method Comparison (POC vs. Lab) | Statistical agreement between the Stat Profile Prime Plus system (operated at POC by various personnel) and laboratory reference methods (implicitly, lab instruments or methodologies used for comparison). | - Analyte: Lactate
• N: 413 samples
• Range: 0.5 - 16.5
• Slope: 1.0181
• Intercept: -0.0796
• r (correlation coefficient): 0.9975
• 95% Confidence Interval Bias (2 mmol/L): 1.9-2.0
• 95% Confidence Interval Bias (6 mmol/L): 6.0-6.1 |
  | Total Imprecision Performance (POC)| Demonstrates acceptable total imprecision when operated by POC personnel. | - Lactate (Level 4): Mean 1.8 mmol/L, Total SD 0.1, Total %CV 3.2%
• Lactate (Level 5): Mean 6.7 mmol/L, Total SD 0.2, Total %CV 3.4%
• Lactate (Linearity Level 4): Mean 16.5 mmol/L, Total SD 0.4, Total %CV 2.2% |
  | Within-Run Whole Blood Precision (POC)| Demonstrates acceptable within-run precision for fresh whole blood samples in POC setting. | - Lactate (7 samples): Mean values varied (e.g., 3.30, 1.43, 2.47, 2.49, 1.24, 4.69, 11.4 mmol/L). Reported %CVs ranged from 4.08% to 6.68%. |

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

The "test set" in this context refers to the samples used in the analytical performance and method comparison studies.

• Sample Sizes:

  • Lactate Precision (Within-Run): 20 replicates for each level/sample type (QC, Ampules, Whole Blood) on 3 analyzers.
  • Lactate Precision (Run-to-Run): QC samples: 240 samples (2 runs/day for 40 runs * 3 analyzers); Whole Blood samples: 30 samples (triplicate analyses over 10 runs * 3 analyzers).
  • Linearity: 9 levels tested on 3 analyzers.
  • Interference: Not explicitly stated for each substance, but dose-response performed for problematic interferents.
  • Detection Limit: LoB: 5 runs on 2 analyzers; LoD: 4 runs on 2 analyzers for 5 low-level samples over 3 days (total 60 replicates per reagent lot); LoQ: 3 runs on 2 analyzers for 4 low-level samples over 3 days (total 36 replicates per reagent lot).
  • Method Comparison (POC vs. Lab): For Lactate: N=413 samples.
  • Total Imprecision (POC): 3 levels of QC/Linearity materials, run in duplicate each day for 20 runs on 3 analyzers.
  • Within-Run Whole Blood Precision (POC): 10 replicate measurements for 7 different whole blood samples at each site, by a minimum of 2 POC operators at 3 sites (total 9 operators).

• Data Provenance:

  • Country of Origin: Not explicitly stated but inferred to be the United States (given the FDA submission and the company address in Waltham, Massachusetts).
  • Retrospective or Prospective: The studies described (e.g., precision, linearity, method comparison) are typically prospective analytical validation studies conducted specifically for regulatory submission, using controlled conditions and fresh/altered samples collected for the purpose of the study. The POC study involved current operations ("discarded blood gas specimens" and "fresh, native and altered whole blood samples") and training of personnel for the study.

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

For this type of in vitro diagnostic device (blood analyzer), "ground truth" is established by comparison to reference methods or calibrated standards rather than expert consensus on images.

• Number of Experts: Not applicable in the context of expert readers for imaging or clinical diagnosis. The "experts" are the laboratory personnel operating the reference instruments and the Point-of-Care personnel who were "trained, qualified staff found in typical POC sites where blood gas analyzers are utilized."
• Qualifications of Experts:
  • Laboratory Personnel: Implied to be qualified professionals operating the reference analyzers (e.g., Stat Profile pHOx Ultra Analyzer System, K110648).
  • Point-of-Care Personnel: A total of 61 Respiratory Care, 12 Nursing, and 1 Exercise Physiology personnel participated from 3 POC settings (Cardiothoracic Intensive Care Unit (CTICU), Emergency Department (ED), Respiratory Therapy Lab (RT)). They are described as "trained, qualified staff."

4. Adjudication Method for the Test Set

Not applicable. This is not an AI/ML diagnostic software involving subjective interpretation or multiple expert reads needing adjudication. Performance is assessed analytically against reference methods or statistical metrics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted. This type of study is primarily relevant for AI/ML-based diagnostic software where the AI assists human readers in tasks like image interpretation. This submission is for an in vitro diagnostic device that directly measures analytes in blood. The study compared the device's performance to predicate devices and laboratory methods.

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

While the device's measurement process for each analyte (e.g., impedance, amperometry) can be considered "standalone" in that it performs the measurement algorithmically, the term "standalone performance" in the context of AI/ML usually refers to the accuracy of the algorithm without any human input during the diagnostic process.

For this device, the "measurements" are the direct outputs from the instrument. Its analytical performance (precision, linearity, detection limits, interference) is evaluated intrinsically (standalone from a human operator's interpretation, though a human initiates the test). The "Method Comparison Studies" then compare these outputs to a reference method, which is the closest equivalent to a "standalone" performance assessment for an IVD, demonstrating how well the device matches established lab results.

7. The Type of Ground Truth Used

The ground truth for this device's performance validation is based on reference methods and calibrated standards.

• Reference Methods: The "Method Comparison Studies" compare the Stat Profile Prime Plus Analyzer System's results (both in the lab and at POC) to those obtained from the predicate device (K180340) and/or other validated laboratory methods/instruments. For Lactate, the predicate K110648 (Stat Profile pHOx Ultra Analyzer System) was used for comparison.
• Calibrated Standards: Precision, linearity, and detection limit studies utilize quality control materials, calibrators, and prepared solutions with known concentrations. The linearity study specifically states comparison to "the reference analyzer and/or the product specifications defined in the Stat Profile Prime Marketing Requirements document."

8. The Sample Size for the Training Set

Not applicable. This device is an in vitro diagnostic analyzer (hardware and embedded software for physical measurement), not an AI/ML algorithm that is "trained" on a dataset in the conventional sense. The "development" of its analytical components involves traditional engineering and chemistry, not machine learning training.

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

Not applicable, as there is no "training set" in the context of AI/ML for this device. The physical and chemical principles of measurement (e.g., enzymatic reactions, amperometry, potentiometry) form the basis of the device's function.

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The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of sodium, potassium, chloride and blood urea nitrogen in arterial or venous whole blood in point of care or clinical laboratory settings.

Sodium measurements are used for monitoring electrolyte imbalances.

Potassium measurements are used in the diagnosis and monitoring of diseases and clinical conditions that manifest high and low potassium levels.

Chloride measurements are primarily used in the diagnosis, monitoring, and treatment of electrolyte and metabolic disorders including, but not limited to, cystic fibrosis, diabetic acidosis, and hydration disorders.

Blood urea nitrogen measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases.

The i-STAT CHEM8+ test cartridge contains test reagents to analyze whole blood at the point of care or in the clinical laboratory for sodium, potassium, chloride and blood urea nitrogen. The test is contained in a single-use, disposable cartridges require two to three drops of whole blood which are typically applied to the cartridge using a transfer device.

The i-STAT 1 Analyzer is a handheld, in vitro diagnostic analytical device designed to run only i-STAT test cartridges. The instrument interacts with the cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).

The i-STAT 1 System is comprised of the i-STAT 1 analyzer, the i-STAT test cartridges and accessories (i-STAT 1 Downloader/Recharger, electronic simulator and portable printer). The system is designed for use by trained medical professionals at the patient point of care or in the clinical laboratory and is for prescription use only.

The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for in vitro quantification of sodium, potassium, chloride, and blood urea nitrogen (BUN) in arterial or venous whole blood in point-of-care or clinical laboratory settings.

Here's an analysis of the acceptance criteria and the study results:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the precision and method comparison studies aiming to demonstrate substantial equivalence to a predicate device (Beckman DxC). While explicit "acceptance criteria" are not listed in terms of specific thresholds for precision or correlation, the studies aim to show that the i-STAT CHEM8+ performs comparably to the predicate. The "Reportable Range" serves as one aspect of the acceptance criteria for each analyte.

Interference:

• Sodium: Increased results ≥ 3.1 mmol/L with Sodium Thiosulfate.
• Potassium: No identified interferents from the tested substances.
• Chloride: Increased results ≥ 2.4 mmol/L with Lithium Bromide, Increased results ≥ 4.19 mmol/L with Sodium Thiosulfate.
• BUN: Increased results ≥ 10.2 mmol/L with Triglyceride.

Limit of Quantitation (LoQ):

• Sodium: 91 mmol/L
• Potassium: 1.5 mmol/L
• Chloride: 56 mmol/L
• BUN: 1 mg/dL

2. Sample Sizes and Data Provenance

• Precision (Aqueous Materials):

  • Sample Size: 80 or 81 data points for each of 5 levels per analyte (e.g., 81 for Sodium CV L1, 80 for Sodium CV L4). This study was conducted using multiple instruments and one test cartridge lot (implied prospective, in-house laboratory study).
  • Data Provenance: Not explicitly stated as country of origin, but implies an in-house or specialized laboratory setting. It is a prospective analytical study.

• Precision (Whole Blood):

  • Sample Size: 21 test results per sample per instrument (total of 21 test results per sample). This study involved at least 3 levels per analyte, 3 point of care sites, and 7 i-STAT 1 Analyzers. The number of unique whole blood samples is not specified, but the total number of measurements is significant (e.g., for Sodium, there are 19 rows of data, each representing a mean derived from 20 or 21 measurements).
  • Data Provenance: Not explicitly stated as country of origin, but indicates multiple point-of-care sites. This is a prospective analytical study.

• Linearity:

  • Sample Size: Not explicitly stated as a number of individual samples, but involves preparing "whole blood samples of varying analyte levels that spanned the reportable range of the tests."
  • Data Provenance: Implied laboratory-based prospective analytical study.

• Limit of Quantitation (LoQ):

  • Sample Size: Not explicitly stated, but involved whole blood samples (and plasma for Chloride) altered to low concentrations and two test cartridge lots.
  • Data Provenance: Implied laboratory-based prospective analytical study.

• Interference:

  • Sample Size: Not explicitly stated ("whole blood samples").
  • Data Provenance: Implied laboratory-based prospective analytical study.

• Method Comparison:

  • Sample Size:
    • Sodium: N=187
    • Potassium: N=189
    • Chloride: N=176
    • BUN: N=184
  • Data Provenance: Venous and arterial blood specimens were evaluated. Not explicitly stated as country of origin, but indicates clinical laboratory settings. This is a prospective analytical study comparing the i-STAT 1 System to the Beckman DxC.

3. Number of Experts and Qualifications for Ground Truth

This type of device (in vitro diagnostic for laboratory analytes) does not typically involve human expert adjudication for ground truth. The "ground truth" for analytical performance studies is established by:

• The reference method (Beckman DxC in the method comparison study).
• Precisely prepared calibrators or control materials with known concentrations (for precision, linearity, LoQ, and interference studies).
• NIST Standard Reference Materials (SRM) were used for traceability and calibration (NIST SRM 918, 919, 956, 912, 909).

4. Adjudication Method for the Test Set

Not applicable, as this is an analytical device for quantitative measurements, not an imaging device requiring expert clinical interpretation. The ground truth is established by reference measurement systems and documented analytical methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is typically for evaluating the performance of diagnostic imaging devices that rely on human interpretation, often with and without AI assistance. This device is an in vitro diagnostic (IVD) analyzer that provides quantitative results.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Yes, the studies presented (precision, linearity, LoQ, interference, and method comparison) represent the standalone performance of the i-STAT CHEM8+ cartridge with the i-STAT 1 System. The device provides a direct quantitative measurement without human interpretation of its internal algorithm's output in the manner implied by "human-in-the-loop performance" for AI/ML devices.

7. The Type of Ground Truth Used

The ground truth for the analytical performance studies was established using:

• Reference instrumentation run by trained laboratory personnel: For the method comparison, the Beckman DxC clinical analyzer served as the comparative method.
• Prepared aqueous and whole blood materials with known analyte concentrations: Used for precision, linearity, LoQ, and interference studies.
• NIST Standard Reference Materials (SRM): Used for traceability and calibration.

8. The Sample Size for the Training Set

Not applicable. This device is a traditional in vitro diagnostic device, not an AI/ML device that requires a "training set" in the machine learning sense. The "training" for such devices typically refers to the development and optimization of the electrochemical sensors and algorithms during the R&D phase, which is not described in terms of a quantifiable "training set size" in a regulatory submission for a traditional IVD.

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

Not applicable, as there is no "training set" in the AI/ML context for this traditional IVD device. The accuracy of the device's measurement principles is established through rigorous analytical verification and validation using reference materials and comparative methods, as detailed in the performance characteristics section.

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For in vitro diagnostic use only

The UREA test within the VITROS XT Chemistry Products UREA-CREA Slides quantitatively measures urea concentration, reported either as urea nitrogen or as urea (UREA), in serum, plasma, and urine using the VITROS XT 7600 Integrated System. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases

The CREA test within the VITROS XT Chemistry Products UREA-CREA Slides quantitatively measures creatinine (CREA) concentration in serum, plasma, and urine using the VITROS XT 7600 Integrated System. Creatinine measurements are used in the diagnosis and treatment of renal dialysis, and as a calculation basis for measuring other urine analytes.

Special conditions for use statement: For prescription use only.

The new device, the VITROS XT Chemistry Products UREA-CREA Slide is a single device that contains both a UREA test and a CREA test multilayered, analytical element coated on a polyester support separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur and test results are generated for each analyte independently of the other analyte.

To perform the UREA test, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. Water and nonproteinaceous components then travel to the underlying reagent layer, where the urease reaction generates ammonia. The semipermeable membrane allows only ammonia to pass through to the colorforming layer, where it reacts with the indicator to form a dye. The reflection density of the dye is measured and is proportional to the concentration of urea in the sample.

To perform the CREA test, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. Creatinine diffuses to the reagent layer, where it is hydrolyzed to creatine in the rate-determining step. The creatine is converted to sarcosine and urea by creatine amidinohydrolase. The sarcosine, in the presence of sarcosine oxidase, is oxidized to glycine, formaldehyde, and hydrogen peroxide. The final reaction involves the peroxidase-catalyzed oxidation of a leuco dye to produce a colored product. Following addition of the sample, the slide is incubated. During the initial reaction phase, endogenous creatine in the sample is oxidized. The resulting change in reflection density is measured at 2 time points. The difference in reflection density is proportional to the concentration of creatinine present in the sample.

This document describes the analytical performance of the VITROS XT Chemistry Products UREA-CREA Slides for quantitatively measuring urea and creatinine concentrations. The information provided is for an in-vitro diagnostic device and does not involve AI assistance, human readers, or image analysis, thus many of the requested elements are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is primarily assessed through method comparison (against predicate devices), precision, detection limits, and linearity. The "acceptance criteria" are implied by the measured performance demonstrating substantial equivalence to the predicate devices and meeting clinical laboratory standards for accuracy and precision.

2. Sample Size and Data Provenance

• Method Comparison Test Set:
  • UREA Serum: 124 samples
  • UREA Urine: 128 samples
  • CREA Serum: 130 samples
  • CREA Urine: 116 samples
• Precision Test Set: Not specified as a separate patient sample set, but rather "patient pools and quality control materials." Each precision study included "a minimum of 80 observations (2 replicates per run, 2 runs per day over 20 days)" for serum and urine pools/controls.
• Detection Limits (LoQ) Test Set: 72 determinations for serum (UREA and CREA) and 64 for urine (CREA). 72 for urine (UREA).
• Linearity Test Set: Twenty proportionally related admixtures of low and high test fluids, each tested in quadruplicate. Specific number of patient samples not stated, as it uses contrived samples.
• Specificity (Interference) Test Set: Not explicitly stated how many patient samples were used, but rather "96 test substances" and "88 test substances" were spiked into serum samples, and "two substances" and "nineteen test substances" for urine.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the studies used standard clinical laboratory protocols (e.g., CLSI EP09-A3, EP05-A3, EP17-A2, EP06-A) which typically involve fresh or appropriately preserved clinical samples. The reference interval studies mention "an internal study of 3160 apparently healthy adults" and "an external study" (for UREA) or "an external study of apparently healthy adults (serum: 180 males and 180 females)" and "a separate external study" (for CREA).

3. Number of Experts and Qualifications for Ground Truth

• This is an in-vitro diagnostic device (chemistry analyzer) measuring chemical concentrations. The "ground truth" is established by the reference methodology (predicate devices on a different system) and gravimetric/analytical preparation of calibrators and quality controls. It does not involve human expert interpretation of images or other subjective assessments. Therefore, the concept of "experts establishing ground truth" in the context of radiology or pathology (e.g., radiologists interpreting images) is not applicable here.

4. Adjudication Method for the Test Set

• Not applicable. This is not a study involving human reader interpretation requiring adjudication. Performance is assessed analytically against quantitative measurements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, an MRMC study was not done. This device is an automated in-vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers.

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

• Yes, this study represents a standalone analytical performance evaluation of the device's ability to accurately measure urea and creatinine concentrations. "Algorithm" in this context refers to the chemical reactions and measurement principles of the assay, not a software algorithm that processes medical images or data for interpretation. The performance metrics (method comparison, precision, detection limits, linearity, specificity) directly quantify the device's analytical capabilities without human intervention in the measurement process itself.

7. The type of ground truth used

• The ground truth is established through:
  • Reference Methods/Predicate Devices: For method comparison, the results generated by the predicate devices (VITROS BUN/UREA Slides and VITROS CREA Slides on the VITROS 5600 Integrated System) serve as the comparative ground truth.
  • Analytically Prepared Materials: For precision, detection limits, and linearity, the "ground truth" concentrations of control materials, patient pools, and serially diluted samples are established through precise gravimetric and volumetric preparations, often traceable to certified reference materials.
  • Clinical Laboratory Standards (CLSI Protocols): The studies adhered to widely accepted CLSI guidelines for analytical performance evaluation, implying that the methodologies used to establish "ground truth" for each parameter meet industry standards for accuracy and rigor in a clinical lab setting.

8. The Sample Size for the Training Set

• This is not an AI/machine learning study that involves "training sets" in the conventional sense. The device's performance is based on the inherent chemical and optical principles of the dry-slide technology. There's no AI model being trained with data.

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

• Not applicable, as there is no AI training set.

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

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The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings for quantitative determination of Glucose, Creatinine, and Blood Urea Nitrogen, in heparinized arterial and venous whole blood.

Glucose (Glu) Measurements are used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell tumor.
Creatinine (Creat) Measurements are used in the diagnosis and treatment of certain renal conditions and for monitoring adequacy of dialysis.
Blood Urea Nitrogen (BUN) Measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

The Stat Profile Prime Plus Analyzer System is designed to be a low cost, low maintenance analyzer for the hospital laboratory setting. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).

The system architecture and user interface for this proposed device is based on the previously cleared Stat Profile Prime CCS Analyzer System (K131703). The primary predicate for this proposed device is the Stat Profile pHOx Ultra Analyzer System (K110648).

The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed. The reporting of CO-Oximeter parameters (or not reporting them) will also be determined by the selection of the Sensor Cards:

Primary Sensor Card Port:
There are two options for the primary sensor card:
. Primary Sensor Card 1 shall enable and report the following listed analytes:
o PO2, PCO2, pH, Hct, tHb, Na, Cl, K, iCa, iMg, Glu, SO2, O2Hb, COHb, MetHb, HHb
. Primary Sensor Card 2 shall enable and report the following listed analytes:
o PO2, PCO2, pH, Hct, tHb, Na, Cl, K, iCa, iMg, Glu, SO2

Auxiliary Sensor Card Port:
The reporting of Creatinine and BUN parameters (Or not reporting them) shall be determined by the selection of the Auxiliary Sensor Card
Auxiliary Sensor Card 1 enables Creatinine and BUN parameters
. Auxiliary Sensor Card 2 is a "dummy" sensor card, and will not report any parameters.

Similar to the primary predicate device, the Stat Profile Prime Plus Analyzer is a blood gas/cooximetry/electrolyte/chemistry and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control will be used, as well as an on-board Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly at all times.

The Stat Profile Prime Plus Analyzer accepts samples from syringes, open tubes, and small cups. The minimum sample size for analysis is 135 µL.

Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.

Stat Profile Prime Plus Analyzer System Components:
The Stat Profile Prime Plus Analyzer System is comprised of the following components.
. Stat Profile Prime Plus Analyzer System
Primary Sensor Cartridge
. Auxiliary Sensor Cartridge
Stat Profile Prime Plus Auto-Cartridge Quality Control Pack
. Stat Profile Prime Plus Calibrator Cartridge
Stat Profile Prime Plus External Ampuled Control
IFU/Labeling

The provided text describes the acceptance criteria and study proving the device meets those criteria. The device in question is the Stat Profile Prime Plus Analyzer System, and the studies focus on its performance for measuring Glucose, Creatinine, and Blood Urea Nitrogen (BUN) in whole blood.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria & Reported Device Performance

The document states that the "blood comparison data for Glucose, Creatinine, and BUN, for the Stat Profile Prime Plus analyzers meet the acceptance criteria." While explicit numerical acceptance criteria are not presented in a table form, the performance is described relative to a predicate device (Stat Profile pHOx Ultra Analyzer System) and internal specifications. The linearity and precision studies also explicitly state that the acceptance criteria were met.

For a clearer representation, we can infer the acceptance criteria and performance based on the descriptions:

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

• Sample Size for Test Set:

  • Precision/Reproducibility - Within Run: 20 replicates for one run of each of the following: internal controls (Levels 1-5), ampuled controls (Levels 1-5), and two whole blood samples (from syringes).
  • Precision/Reproducibility - Run to Run: Triplicate analyses performed on a single whole blood sample in ten separate runs.
  • Linearity Testing: Not explicitly stated, but performed using "various medical decision limits" and comparing to reference analyzers.
  • Specificity/Interference Testing: Conducted using whole blood collected in lithium heparin vacutainers. Possible interfering substances tested at two analyte concentrations for each. The number of unique samples or overall sample size for this study is not explicitly stated beyond "many substances were screened".
  • Method Comparison Studies: Performed to compare the Stat Profile Prime Plus to the Nova Stat Profile pHOx Ultra analyzer in a clinical laboratory setting. The number of samples is not specified.

• Data Provenance: The studies were performed in a "clinical laboratory setting" and involved "whole blood" samples. The document does not specify the country of origin for the data or explicitly state whether it was retrospective or prospective. Given the nature of performance testing for a medical device, it is typically prospective.

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

This information is not applicable (N/A) to this device and study type. This device is an in-vitro diagnostic (IVD) analyzer that quantitatively measures analytes (Glucose, Creatinine, BUN). The "ground truth" for its performance studies is established by:

• Reference Methods/Analyzers: For method comparison and linearity studies.
• Known Concentrations: For controls and linearity samples.
• Established Analytical Specifications: For precision and interference studies.

There are no human experts classifying images or clinical conditions, so there is no panel of experts to establish a "ground truth" in the way described for AI/CADe systems.

4. Adjudication Method for the Test Set

This information is N/A. As explained above, the ground truth is based on quantitative measurements against reference methods or known concentrations, not on expert consensus requiring adjudication.

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

This information is N/A. This device is an analytical instrument for quantitative measurements, not an AI/CADe system designed to assist human readers (e.g., radiologists) in interpreting medical images. Therefore, an MRMC study is not relevant.

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

This information is N/A. This device is a standalone analyzer. Its "performance" is its standalone capability to accurately and precisely measure analytes. There is no human-in-the-loop component in its direct operation for measurement that would require a separate "human-in-the-loop performance" study. The studies described (method comparison, precision, linearity, interference) directly evaluate the standalone performance of the instrument.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for this device's performance studies is based on:

• Reference Measurement Methods/Instruments: For comparison studies (e.g., comparing the Prime Plus Analyzer's results to those from the predicate device or other established reference analyzers).
• Known and Certified Control Materials: For quality control and precision studies, where the true concentration of analytes in the control samples is known.
• Spiked Samples: For linearity and interference studies, where samples are spiked with known concentrations of analytes or interfering substances.

8. The Sample Size for the Training Set

This information is N/A. This document describes the validation of a hardware-based analytical instrument with established biochemical measurement principles, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The device's measurement algorithms are based on scientific principles (e.g., enzymatic reactions, electrochemistry, Nernst equation) and are not "trained" on data in the way an AI model would be.

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

This information is N/A for the same reasons as point 8.

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The Comprehensive Metabolic Panel is intended to be used for the quantitative determination of Alkaline Phosphate (ALP), Alanine Aminotransferase (ALP/GPT), Aspartate Aminotransferase (AST/GOT), Blood Urea Nitrogen (BUN) and Creatinine (CREA) in concentrations in lithium-heparinized venous whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

• Alkaline phosphatase or its isoenzymes measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

• Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

• Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

• Blood urea nitrogen measurements are used in the diagnosis and treatment of certain types of renal and metabolic diseases.

• Creatinine measurements are used in the diagnosis and treatment of renal dialysis, and as a calculation basis for measuring other urine analytes.

The skyla Clinical Chemistry Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use.

The Minicare C300 Clinical Analyzer is an in-vitro diagnostic devices for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use.

The skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer (private label) and Comprehensive Metabolic Panel is an automatic chemistry system intended for use in clinical laboratories or point-of-care locations. The system consists of a portable analyzer and single-use disposable reagent panel discs.

The analyzer utilizes precision photometric measurement technology, combined with the use of specific reagent panel disc, to measure the amount of substance in blood. The analyzer measures absorbance change of each reaction well in reagent panel disc and covert it to a concentration value for each analyte included on the panel.

The skyla and Minicare Comprehensive Metabolic Panel reagent disc (which contains the Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Blood Urea Nitrogen and Creatinine test systems) is designed to separate a heparinized venous whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer.

The Lite-On Technology Corp.'s Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, and Minicare C300 Clinical Chemistry Analyzer (K171971) were evaluated for substantial equivalence. The acceptance criteria and performance data are primarily based on precision, matrix comparison, detection limits, linearity, and interference testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the predicate device's performance and the established clinical laboratory standards (e.g., CLSI guidelines, recovery within 90-110% for interference). The reported device performance aligns with these expectations.

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

• Internal Precision/Reproducibility: 80 runs per level (quadruplicate testing a day for 20 working days) for each of the three serum levels for all 5 analytes. Data provenance is not specified (e.g., country of origin) but refers to "patient serum samples." Implied prospective collection for the study.
• Matrix Comparison: 40 human samples. Data provenance not specified. Implied prospective collection for the study.
• Detection Limit: LoB: 60 measurements of a near-zero sample over 10 days. LoD/LoQ: serum samples containing very low concentrations, tested in triplicate using 2 lots of reagent discs for 10 days. Data provenance not specified. Implied prospective collection.
• Linearity: 9 intermediate dilutions created from high and low human serum pool samples, plus spiked samples. Data provenance not specified. Implied prospective collection.
• Endogenous Interferences: Not explicitly stated, but implies multiple samples to test two different concentrations (normal and abnormal) of analytes against specified interference levels. Data provenance not specified. Implied prospective collection.
• Exogenous Substances: Two concentrations (low and high level) of samples for each of the 10 potential interferents. Data provenance not specified. Implied prospective collection.
• Point-of-Care (POC) Method Comparison: Over 120 heparinized venous whole blood and serum samples for each analyte. Data provenance not specified; likely collected from the three POC sites, implying prospective collection.
• Point-of-Care (POC) Precision Studies: Three levels of human serum samples from POC sites, assayed in quadruplicate twice a day for 20 days. Data provenance not specified. Implied prospective collection.
• Point-of-Care (POC) Whole Blood Precision: Not explicitly stated, but tabular data suggests multiple analyses (mean, SD, CV) for low, medium, and high samples across 3 POC sites and multiple operators (OP1, OP2, OP3).

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

This type of submission (510k for a clinical chemistry analyzer) does not typically involve human experts establishing a "ground truth" for the test set in the same way an image analysis or diagnostic AI device would. Instead, the ground truth is established by:

• Reference Methods/Materials: Traceability to established reference methods (e.g., IFCC reference method for ALT/ALP/AST, CDC reference method for BUN, IDMS Reference Method for CREA) and reference materials (NIST SRM967).
• Comparative Clinical Analyzers: For method comparison studies, the Beckman Coulter AU2700 clinical analyzer served as the comparative (reference) method.

Therefore, the "experts" in this context are the established, validated, and traceable laboratory methods and instruments, rather than individual human practitioners.

4. Adjudication Method for the Test Set

Not applicable. Diagnostic test performance for clinical chemistry analyzers is typically evaluated by statistical comparison to a reference method or established clinical ranges, not by an adjudication process as seen in clinical trial settings for diagnostic imaging.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where multiple human readers interpret cases with and without AI assistance. This submission is for a clinical chemistry analyzer.

However, the "POC Precision studies" did evaluate performance across multiple operators (9 operators) at three POC sites. This demonstrates inter-operator variability, which is a related concept to multi-reader studies in a laboratory context, but it does not measure an "improvement with AI vs. without AI assistance" since the device itself is the primary measurement tool, not an AI assistant to a human reader.

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

Yes, the studies presented are generally "standalone" performance evaluations of the device (skyla/Minicare Clinical Chemistry Analyzer with Comprehensive Metabolic Panel) itself. The device automatically measures analytes and displays results; there isn't an "algorithm only" component separate from the integrated device performance. All performance data (precision, linearity, detection limits, interference) are solely based on the device's output.

7. The Type of Ground Truth Used

The ground truth for the device's performance is established through:

• Traceability to Reference Methods/Materials: For calibration and analytical accuracy (e.g., IFCC, CDC, IDMS reference methods, NIST reference materials).
• Comparative Clinical Analyzers: The Beckman Coulter AU2700 served as the comparative method for method comparison studies, essentially acting as the "ground truth" or reference for evaluating the test device's performance on patient samples.
• Known Concentrations: For studies like linearity, detection limits, and interference, samples with known or spiked concentrations are used.

8. The Sample Size for the Training Set

This document does not specify a separate "training set" in the context of machine learning or AI. This device is a traditional in-vitro diagnostic (IVD) clinical chemistry analyzer. Its development would involve internal validation and optimization processes by the manufacturer, which might loosely be considered "training," but it's not described as an AI model training set with a specific size or provenance.

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

As this is a traditional IVD device, the concept of a "training set" for an AI model's ground truth is not applicable in the way it would be for AI-powered diagnostic software. The "ground truth" for the development and internal validation of such a device is established through:

• Chemical Principles and Reactions: The underlying scientific principles of colorimetry and specific reagent reactions form the fundamental 'ground truth' for measurement.
• Calibration Standards: The device is calibrated using standards whose concentrations are traceable to recognized reference methods and materials, ensuring accurate quantitative measurements.
• Quality Control Materials: Known quality control materials are used to ensure the device performs within expected ranges over time.

These elements collectively serve as the basis for ensuring the device's accuracy and reliability during its design, development, and manufacturing phases.

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