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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 Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings for quantitative determination of Hematocrit, Oxygen Saturation, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin, in heparinized arterial and venous whole blood.

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, calibrator packs, auto-cartridge quality control packs (internal controls), ampuled quality control materials (external controls) 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 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.

Similar to the 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, 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.

The provided text describes the Nova Stat Profile Prime Plus Analyzer System, an in vitro diagnostic device. This document is a 510(k) summary submitted to the FDA, detailing the device's substantial equivalence to a predicate device.

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

Acceptance Criteria and Reported Device Performance

The general acceptance criteria for "Method Comparison Studies" is that "The blood comparison data for Hematocrit, Oxygen Saturation, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin for the Stat Profile Prime Plus analyzers meet the acceptance criteria." Specific numerical acceptance criteria are not explicitly detailed in the provided text, but the study concluded that the device did meet them.

Similarly, for "Precision/Reproducibility," the text states: "The precision data for all parameters meet the within run imprecision specifications for the Stat Profile Prime Plus analyzers." and "The precision data for all parameters meet the between analyzer run to run imprecision specifications for the Stat Profile Prime Plus analyzers." No specific numerical targets for imprecision are given.

For "Linearity Testing", the conclusion is: "The linearity comparison data for all parameters for the Stat Profile Prime Plus analyzers shows good correlation and linearity to the reference analyzers across the claimed measurement range for all parameters and met the acceptance criteria."

The table below summarizes the claimed measurement ranges, which serve as a form of acceptance criteria for the operational limits of the device. The reported performance is a general statement that the device meets "the acceptance criteria."

Note on "Reported Device Performance": The document states that the studies "meet the acceptance criteria." It does not provide specific numerical results or performance metrics (e.g., bias, CV%) for the Nova Stat Profile Prime Plus Analyzer System itself, but rather confirms that its performance is equivalent to the predicate and within acceptable ranges.

Study Information:

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

   • Method Comparison Studies: The study compared the Stat Profile Prime Plus to the Nova Stat Profile pHOx Ultra analyzer using an unspecified number of "heparinized whole blood" samples. The provenance of this blood data (country, retrospective/prospective) is not specified.
   • Precision/Reproducibility - Within Run and Run to Run Studies:
     • Within Run Precision: "one run of each of the following sample types and levels was performed, 20 replicates per run." Sample types included: Stat Profile Prime Plus Internal Controls (Levels 1-5), Stat Profile Prime Plus Ampuled Controls (Levels 1-5), and "Two whole bloods, sampled from syringes."
     • Run to Run Precision: "triplicate analyses were performed on a single whole blood sample in ten separate runs during a single day."
     • The provenance of these whole blood samples (country, retrospective/prospective) is not specified.
   • Linearity Testing: Used "whole blood" to establish/verify the Analytical Measurement Range (AMR). The number of samples is not specified. Provenance is not specified.
   • Specificity / Interference Testing: "whole blood collected in lithium heparin vacutainers." The number of samples for screening or dose-response is not specified. Provenance is not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is an in vitro diagnostic analyzer that measures objective chemical and physiological parameters in blood samples, not image interpretation or diagnosis by experts. The "ground truth" for the performance studies would be established by the reference methods (e.g., the predicate device or other highly accurate laboratory methods) against which the new device's measurements are compared.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used in studies involving subjective interpretation (e.g., by experts) to reach a consensus for ground truth. This is a device measuring objective parameters.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device requiring human interpretation; it directly measures parameters.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The studies described (Method Comparison, Precision, Linearity, Interference) assess the standalone performance of the device's measurement capabilities. The device is designed to provide quantitative measurements and does not involve a human-in-the-loop for interpreting its direct output in the way an AI diagnostic tool might.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance studies appears to be:

   • Method Comparison: Measurements from the legally marketed predicate device (Stat Profile pHOx Ultra analyzer) served as the reference.
   • Precision: Internal controls, ampuled controls, and whole blood samples with expected values.
   • Linearity: Comparison against a "reference analyzer and/or the product specifications."
   • Specificity/Interference: Comparison of measurements with and without potential interfering substances.

7. The sample size for the training set: Not applicable. This device does not appear to employ machine learning algorithms that require a separate "training set" in the conventional sense. Its principles of measurement are based on established spectrophotometric and impedance sensor technologies.

8. How the ground truth for the training set was established: Not applicable, as there is no mention of a machine learning training set. The device's underlying principles are based on known physical and chemical measurement techniques.

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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 sodium, chloride, ionized calcium, and ionized magnesium in heparinized arterial and venous whole blood.

Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance.

Potassium measurements are used in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

lonized 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).

lonized magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium),

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.

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 sodium, potassium, chloride, ionized calcium, and ionized magnesium
. Primary Sensor Card 2 shall enable and report the following listed analytes:

• sodium, potassium, chloride, ionized calcium, and ionized magnesium o

Similar to the primary predicate device, the Stat Profile Prime Plus Analyzer is a blood qas/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 .

Here's a summary of the acceptance criteria and study information for the Nova Biomedical Corporation Stat Profile Prime® Plus Analyzer System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the studies "meet the acceptance criteria" or "met the acceptance criteria" without explicitly listing the numerical acceptance criteria for many tests. The performance is reported as meeting these unstated criteria.

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

• Method Comparison Study:

  • Sample Size: Not explicitly stated. The study compared the Stat Profile Prime Plus to the Nova Stat Profile pHOx Ultra analyzer using "blood comparison data."
  • Data Provenance: Conducted in a "clinical laboratory setting" as indicated by the study description. It is a prospective study as it involves active comparison of devices.

• Precision/Reproducibility Studies:

  • Within Run Precision: 20 replicates per run for each of the following: Stat Profile Prime Plus Internal Controls (Levels 4-5), Stat Profile Prime Plus Ampuled Controls (Levels 4-5), and three whole blood samples from syringes.
  • Run to Run Precision: Triplicate analyses on four whole blood samples in ten separate runs during a single day.
  • Data Provenance: The document doesn't specify country of origin. This appears to be prospective data generated for the study.

• Linearity Testing:

  • Sample Size: Not explicitly stated, beyond indicating "various medical decision limits" and "lower and upper limits of the AMR."
  • Data Provenance: Generated for the study.

• Specificity / Interference Testing:

  • Sample Size: Not explicitly stated for the number of samples, but tests were performed at "two analyte concentrations" for each potential interferent.
  • Data Provenance: Whole blood collected in lithium heparin vacutainers was used for this study. Generated for the study.

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

Not applicable. This device is an in vitro diagnostic device that directly measures analytes. The ground truth for performance studies is typically established by reference methods or validated predicate devices, not human expert consensus.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers are interpreting images or data, and their initial interpretations need to be resolved by a consensus process. For an IVD device measuring analytes, the 'ground truth' is determined by the reference method's result, or the established result of 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 (IVD) analyzer, not an AI-assisted diagnostic imaging or interpretation device that involves human readers.

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

Yes, the studies described (Method Comparison, Precision, Linearity, Specificity/Interference) evaluate the standalone performance of the Stat Profile Prime Plus Analyzer System. The device directly measures the analytes and reports the results without human interpretation as part of its core function, other than healthcare professionals using the results for diagnosis and treatment.

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

The ground truth for the performance studies was established by:

• Comparison to a predicate device: For the method comparison study, the Nova Stat Profile pHOx Ultra analyzer (K110648) served as the reference point for equivalence.
• Reference analyzers/specifications: For linearity testing, results were compared to "the reference analyzer and/or the product specifications."
• Internal controls and ampuled controls: For precision, these served as samples with known or expected values.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device that requires a separate training set. The device operates based on established electrochemical principles (Ion-Selective Electrode) and measurement algorithms.

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

Not applicable, as no training set in the context of machine learning was used.

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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 pH, Partial Pressure of Carbon Dioxide, and Partial Pressure of Oxygen in heparinized arterial and venous whole blood.

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

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.

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
• . Primary Sensor Card 2 shall enable and report the following listed analytes: o PO2, PCO2, pH

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, and small cups. The minimum sample size for analysis is 135 uL.

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

Sample Types:

The Stat Profile Prime Plus Analyzer System accepts lithium heparinized arterial and venous whole blood.

Measured Parameters:

The Stat Profile Prime Plus Analyzer measures:

• . pH
• Partial Pressure of Carbon Dioxide (pCO2)
• Partial Pressure of Oxygen (pO2)

Calculated Parameters:

The following parameters are calculated by the Prime Plus Analyzer based on results of the directly measured parameters.

• Base Excess of Extracellular Fluid (BE-ecf)
• Base Excess of the Blood (BE-b)
• Standard Bicarbonate Concentration (SBC) ●
• Bicarbonate level (HCO3) ●
• Oxygen Content (O2Ct) .
• P50 ●
• Respiratory Index (RI)
• PO2 to FIO2 Ratio (PO2/FIO2) ●
• Normalized Calcium (nCa) ●
• Normalized Magnesium (nMq)
• Anion Gap (Gap) ●
• nCA to nMg Ratio (nCa/nMg) ●
• Arterial Oxygen Content (CaO3) .

Here's a breakdown of the acceptance criteria and the study proving the device's performance, based on the provided FDA 510(k) summary for the Stat Profile Prime Plus Analyzer System:

Device: Stat Profile Prime Plus Analyzer System
Intended Use: Quantitative determination of pH, Partial Pressure of Carbon Dioxide, and Partial Pressure of Oxygen in heparinized arterial and venous whole blood by healthcare professionals in clinical laboratory settings.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for each test in a formal table format. Instead, it describes general compliance with "acceptance criteria" and "specifications" for each study. However, the "Measurement Range" provides a key acceptance criterion for the device's operational limits. The study's reported "performance" is stated as meeting these range and precision requirements.

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

• Sample Size for Method Comparison: Not explicitly stated as a number, but involved "blood comparison data" for pH, PCO2, and PO2. The study compared the Stat Profile Prime Plus to the Nova Stat Profile pHOx Ultra analyzer.
• Sample Size for Precision/Reproducibility (Within Run):
  • 20 replicates per run for each of the following:
    • Stat Profile Prime Plus Internal Controls: Levels 1-3
    • Stat Profile Prime Plus Ampuled Controls: Levels 1-3
    • Two whole blood samples (from syringes)
• Sample Size for Precision/Reproducibility (Run to Run): Triplicate analyses of a single whole blood sample performed in ten separate runs during a single day.
• Sample Size for Linearity Testing: Not explicitly stated as a number, but covered "lower and upper limits of the AMR and various medical decision limits" using whole blood.
• Sample Size for Specificity/Interference Testing: Not explicitly stated as a number, but "Many substances were screened" using whole blood collected in lithium heparin vacutainers, with potential interferents tested at two analyte concentrations.
• Data Provenance: The studies were conducted in a "clinical laboratory setting." The document does not specify the country of origin of the data or explicitly state whether the studies were retrospective or prospective, but clinical laboratory testing for device validation is typically prospective.

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

This document describes a medical device (analyzer) that quantifies blood gas parameters, not an AI or imaging diagnostic tool. Therefore, the concept of "experts" establishing ground truth in the way it applies to image interpretation (e.g., radiologists) is not applicable here.

• Ground Truth Establishment: The ground truth for the test set (e.g., blood gas values) was established by reference analyzers (specifically, the Nova Stat Profile pHOx Ultra analyzer for method comparison, and potentially other reference analyzers for linearity calibration). The performance is assessed against these established values, not against human expert interpretations.

4. Adjudication Method for the Test Set

Not applicable. This is a measurement device where the "ground truth" is established by a reference method/analyzer, not by human interpretation requiring adjudication.

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 a standalone medical device for quantitative measurement, not an AI-assisted diagnostic tool that aids human readers.

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

Yes, the studies described (Method Comparison, Precision/Reproducibility, Linearity, Specificity/Interference) are all forms of standalone performance studies for the Stat Profile Prime Plus Analyzer System. The device measures the parameters without human interpretation of its internal "algorithm" or direct human intervention in the measurement itself, other than sample loading. The "algorithm" here refers to the device's internal measurement processes and calculations.

7. The Type of Ground Truth Used

The ground truth used was comparative analytical data against:

• Reference Analyzers: Specifically, the predicate device (Nova Stat Profile pHOx Ultra analyzer) for method comparison. It also states "comparison to the reference analyzer and/or the product specifications" for linearity.
• Known Control Values: For precision studies, internal controls and ampuled controls with known analyte levels were used.

This is a form of analytical or technical ground truth, not clinical outcomes or pathology.

8. The Sample Size for the Training Set

Not applicable. This is a traditional medical device (analyzer) cleared through a 510(k) pathway, not an AI/Machine Learning device that requires a distinct "training set" in the context of model development. The device's measurement principles are based on established electrochemistry and physics, not statistical learning from a data set.

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

Not applicable, as there is no "training set" in the AI/ML sense for this device. The device's operational parameters and measurement principles are designed and validated based on scientific understanding, not learned from a data set.

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The Stat Profile® Prime ABG Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of pH, PCO2, and PO2 in heparinized whole blood.

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

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

The Stat Profile Prime Calibrator Cartridge ABG is intended for the calibration of pH, PCO₂, and PO₂ using the Stat Profile Prime ABG Analyzer.

The Stat Profile® Prime ABG Analyzer System is a small, low cost blood gas 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. The Stat Profile® Prime ABG Analyzer System is not intended for Point of Care Use.

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 the measurement sensors (PCO2, PO2, and pH). 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.

As in the predicate Stat Profile® Prime CCS Analyzer System (K131703), the Stat Profile Prime ABG 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 on-board Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly.

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

• traditional sensor technology to measure blood pO₂
• . ion selective electrode technology to measure PCO2 and, pH

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 external glass ampule controls contain a buffered bicarbonate solution with a known pH level. 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 and PO2. The aqueous quality control materials are composed of a buffered bicarbonate solution, with a known pH. Solutions are equilibrated with known levels of O2, CO2, and N2. Each bag contains a minimum volume of 100 mL.

The Stat Profile Prime ABG 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 50 µL.

Measured Parameters:
The Stat Profile Prime ABG Analyzer measures pH. PCO2, and PO2.

Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Stat Profile® Prime ABG Analyzer System, Stat Profile Prime Auto QC Cartridge ABG, Stat Profile Prime Ampuled Control ABG/CCS, Stat Profile Prime Calibrator Cartridge ABG

Indications for Use: The Stat Profile Prime ABG Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of pH, PCO2, and PO2 in heparinized whole blood. (Similar indications are provided for the QC and Calibrator cartridges, intended for monitoring performance and calibration, respectively).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria values for bias, precision, or linearity. Instead, it presents the study results for these performance metrics and implies their acceptability by concluding the device is "substantially equivalent" to predicate devices. For the purpose of this table, "Reported Device Performance" will reflect the ranges found in the study results. The ranges provided are from the various analyzers tested (Analyzer #1, #2, #3).

Note: The document explicitly states "Bench testing was completed to demonstrate that the Stat Profile Prime ABG Analyzer is substantially equivalent in performance, safety and efficacy to the Stat Profile Prime CCS Analyzer System." and "The comparison data for all parameters for the Stat Profile Prime analyzers shows good correlation with the reference analyzer across the claimed measurement range for all parameters." indicating that the reported performance met the unstated acceptance criteria for substantial equivalence.

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

• Method Comparison (Whole Blood Patient Specimens):
  • Sample Size: A minimum of 150 whole blood specimens were analyzed for each parameter (pH, pCO2, pO2). The exact 'N' values vary slightly for each parameter and analyzer combination (e.g., pH: 170-187, pCO2: 161-168, pO2: 153-165).
    • Additionally, "altered samples" were included: pH (14-18), pCO2 (10-16), pO2 (9-11).
  • Data Provenance: Retrospective, from hospital patients ("Discarded heparinized arterial whole blood specimens from hospital patients"). Some samples were also prospectively collected and altered ("venous whole blood from male and female donors was tonometered to cover the analytical measurement range"). The country of origin of the data is not specified but is implied to be from the USA given the FDA submission.
• Precision/Reproducibility Studies:
  • Run-to-Run Precision (Whole Blood): Single whole blood sample analyzed in triplicate over 10 separate runs (N=30 per analyzer for each parameter).
  • Run-to-Run Precision (Control Solutions): Quality Control solutions (3 levels) analyzed in duplicate, two runs per day for a total of 40 runs (N=240 per parameter/level).
  • Within-Run Precision (Whole Blood & Control Solutions): One run of 20 replicates (N=20 per analyzer for each parameter/level).
  • Data Provenance: Not explicitly stated, but clinical laboratory settings are mentioned for the device's intended use, suggesting an internal lab setting for these studies.
• Linearity Testing:
  • Sample Size: 10-14 levels were prepared for each parameter. Each level was analyzed in duplicate on each of the three test analyzers.
  • Data Provenance: Not explicitly stated, but implied to be from an internal lab setting.

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

The document describes performance testing against a "reference analyzer" (Stat Profile Prime CCS Comp analyzers) for method comparison and linearity studies.

• Method Comparison and Linearity: The ground truth was established by the Stat Profile Prime CCS Comp analyzers. These are other devices from the same manufacturer, acting as the reference method.
• Precision Studies: The ground truth for precision studies is the measurement itself, demonstrating the device's consistency, not comparison to an expert.

No human experts were used to establish the ground truth for the test set. The comparative method was another medical device.

4. Adjudication Method for the Test Set

Since the ground truth was established by a reference medical device (Stat Profile Prime CCS Comp analyzers), no human adjudication method was employed. The quantitative measurements from the test device were compared directly to the quantitative measurements from the reference device.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document pertains to an in vitro diagnostic (IVD) device for quantitative biochemical measurements, not an image-based diagnostic or AI-assisted diagnostic device where human reader performance is typically assessed.

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

Yes, the studies described are standalone performance evaluations of the device (analyzer and its consumables/controls). The method comparison, precision, and linearity studies directly assess the device's analytical performance without human intervention in the measurement process itself or its interpretation for the purpose of the study. The device is intended for use by healthcare professionals in clinical laboratory settings, implying that human professionals operate the device and interpret its results within a clinical context. However, the performance studies outlined here are standalone in terms of the device's measurement accuracy and precision.

7. The Type of Ground Truth Used

• Method Comparison and Linearity: The ground truth was established by comparison to a legally marketed predicate device (Stat Profile® Prime CCS Analyzer System) acting as the reference method. The document states: "The Prime CCS Comp analyzers were used to establish the target value of each blood level for each parameter."
• Precision/Reproducibility: The ground truth for these studies is the measured value itself, with the goal of demonstrating consistency and repeatability, rather than accuracy against an external standard. For control solutions, the "Target Range" acts as a reference for expected values.
• Traceability: For pH, pCO2, and pO2, the standards and reagents are traceable to NIST (National Institute of Standards and Technology) primary reference materials. This establishes a higher-level metrological ground truth for calibration.

8. The Sample Size for the Training Set

This document describes the regulatory submission for a medical device (a blood gas analyzer). It does not discuss a "training set" in the context of an AI/machine learning model. The device uses traditional sensor technology and algorithms, not machine learning that would require a separate training phase with a distinct dataset.

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

As mentioned above, there is no "training set" in the context of AI/ML for this device. The device relies on established electrochemical and optical principles for measurement. Its calibration system for the training set (if we interpret "training set" loosely as the data used to fine-tune the device's internal calibration parameters during development) would have been established using reference materials traceable to NIST standards. However, this is part of standard IVD development and not ML training.

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