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The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of ionized calcium and hematocrit in arterial or venous whole blood in point of care or clinical laboratory settings.

The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of hematocrit in capillary whole blood in point of care or clinical laboratory settings.

Ionized calcium measurements are used in the diagnosis, monitoring, and treatment of conditions including, but not limited to, parathyroid disease, a variety of bone disease, chronic renal disease, tetany, and disturbances related to surgical and intensive care.

Hematocrit measurements can aid in the determination of normal or abnormal total red cell volume status that can be associated with conditions including anemia, erythrocytosis, and blood loss related to trauma and surgery.

The i-STAT CG8+ cartridge is used with the i-STAT 1 analyzer as part of the i-STAT 1 System and contains test reagents to measure hematocrit (Hct) in arterial, venous or capillary whole blood and to measure ionized calcium (iCa) in arterial and venous whole blood.

The i-STAT 1 System is an in vitro diagnostic (IVD) medical device intended for the quantitative determination of various clinical chemistry tests contained within i-STAT cartridges using whole blood. The i-STAT 1 System consists of a portable blood analyzer (i-STAT 1 analyzer), single-use disposable test cartridges (i-STAT cartridges), liquid quality control and calibration verification materials, and accessories (i-STAT 1 Downloader/Recharger, i-STAT Electronic Simulator and i-STAT 1 Printer). The i-STAT 1 System, including the i-STAT CG8+ cartridge, is designed for use by trained medical professionals in point of care or clinical laboratory settings and is for prescription use only.

The i-STAT CG8+ cartridge contains the required sensors, a fluid pack (calibrant pouch), a sample entry well and closure, fluid channels, waste chamber, and the necessary mechanical features for controlled fluid movement within cartridge. The i-STAT cartridge format allows all the tests in the cartridge to be performed simultaneously. All the test steps and fluid movement occur within the i-STAT CG8+ cartridges require two to three drops of whole blood which are applied to the cartridge using a transfer device by the trained user before the cartridge is placed within the analyzer.

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 i-STAT CG8+ cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).

The provided text describes the analytical performance studies for the i-STAT CG8+ cartridge with the i-STAT 1 System, a device for in vitro quantification of ionized calcium (iCa) and hematocrit (Hct). This submission sought to demonstrate substantial equivalence to a predicate device (i-STAT CHEM8+ cartridge with the i-STAT 1 System, K191360).

Here's an analysis of the acceptance criteria and study details based on the provided information:

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

The document does not explicitly state pre-defined acceptance criteria (e.g., target ranges for precision, linearity, or bias). Instead, it presents the results of various analytical performance studies. The conclusion states that the studies demonstrate substantial equivalence to the predicate device, implying that the reported performance metrics met the internal or regulatory thresholds for such a claim.

However, we can infer performance targets for some aspects by comparing the reported results to general expectations for such devices or by looking at the predicate device's characteristics mentioned (though the predicate's detailed performance is not provided in this document).

For the purpose of this request, I will present the reported performance values. The "Acceptance Criteria" column will reflect the general expectation of "demonstrating substantial equivalence" or meeting regulatory standards for the tested parameter, as specific numerical acceptance criteria are not provided in the document.

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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 pH, Partial Pressure of Carbon Dioxide (pCO2), Partial Pressure of Oxygen (pO2), Hematocrit, Sodium, Chloride, Ionized Calcium, Ionized Magnesium, Gucose, and Lactate in heparinized capillary whole blood.

Indication for Use: pH, pCO2, pO2 measurements are used in the diagnosis and treatment of life-threatening acid base disturbances.

Hematocrit (Hct) measurements of the packed red blood cell volume are used to distinguish normal states, such as anemia and erythrocytosis.

Glucose (Glu) measurement is used in the diagnosis and treatment of carbohydrate metabolism distuding 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.

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

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

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

Ionized Calcium (iCa) 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).

Ionized Magnesium (iMg) 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 an analyzer for use in 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: .
  • PO2, PCO2, pH, Hct, tHb, SO2, O2Hb, COHb, MetHb, HHb, Glu, Lactate, Sodium, o Potassium, Chloride, Calcium, Ionized Magnesium
• Primary Sensor Card 2 shall enable and report the following listed analytes: .
  • PO2, PCO2, pH, Hct, tHb, SO2, Glu, Lactate, Sodium, Chloride, Calcium, Ionized o Magnesium

Auxiliarv 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 the 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 ensures the analyzer is working properly.

The Stat Profile Prime Plus Analyzer accepts samples from syringes, open tubes, and capillary tubes. The sample size for analysis is 135 µL for the complete test panel or 90 µL for the capillary panel.

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 Ampule Control
• . IFU/Labeling

Sample Types:
The Stat Profile Prime Plus Analyzer System accepts lithium heparinized arterial, venous, and capillary whole blood.

Measured Parameters:
The Stat Profile Prime Plus Analyzer measures:

• . pH
• . Partial Pressure of Carbon Dioxide (pCO2)
• Partial Pressure of Oxygen (pO2) ●
• Hematocrit (Hct) ●
• . Glucose (Glu)
• . Lactate (Lac)
• Sodium (Na) ●
• Potassium (K)
• Chloride (CI)
• . Ionized Calcium (iCa)
• . lonized Magnesium (iMg)

The Nova Biomedical Stat Profile Prime Plus Analyzer System is undergoing a 510(k) premarket notification to expand its indications for use to include capillary whole blood specimen testing for pH, pCO2, pO2, Sodium (Na+), Potassium (K+), Chloride (Cl-), Ionized Calcium (Ca2+), Ionized Magnesium (Mg2+), Glucose, Lactate, and Hematocrit. The study described focuses on demonstrating the substantial equivalence of the Stat Profile Prime Plus Analyzer system to its predicate device, the Nova Biomedical Stat Profile pHOx Ultra Analyzer, specifically for capillary whole blood samples.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are primarily demonstrated through method comparison and precision studies. While explicit numerical acceptance criteria for each parameter (e.g., specific ranges for slope, intercept, r-value in method comparison, or max SD/CV% for precision) are not directly stated in the provided text as a standalone table, the conclusion sections for each study indicate that the device "met the clinical accuracy acceptance criteria" or "met the performance criteria for precision." The reported performance is shown in the tables below, which are the primary evidence for meeting the implicit acceptance criteria.

Method Comparison (Clinical Accuracy - Comparison to Predicate Device)

Precision (Laboratory and Point-of-Care Settings)

The precision data is presented across multiple tables (Tables 4, 5, 6, 7, 8, 9, 10). Rather than reiterating all data here, the text explicitly states:

• "The precision data for all samples in capillary mode met the within run and between analyzer imprecision specifications for the Prime Plus analyzers." (Summary of Capillary Mode Within Sample Precision)
• "This study demonstrates the Stat Profile Prime Plus analyzer exhibits clinically acceptable imprecision specifications for pH, pCO2, pO2, sodium (Na+), chloride (C1-), potassium (K+), ionized calcium (Ca2+), ionized magnesium (Mg2+), glucose, lactate, and hematocrit measured by the Stat Profile Prime Plus Analyzer System in Capillary mode." (Conclusion of Within-Run Imprecision - Capillary Mode Fingerstick (External POC))
• "The analyzer used for this evaluation met the performance criteria for within sample precision on capillary fingerstick specimens run by POC operators." (Conclusion of Within-Sample Imprecision - Capillary Mode Fingerstick (Internal POC))
• "The Stat Profile Prime Plus analyzers provided consistently reliable performance throughout the evaluation study. The analyzers used for this evaluation met the acceptance criteria for precision." (Conclusion of Within-Run Imprecision - Capillary Mode)

The acceptance criteria are therefore implicitly met by the reported r-values nearing 1.0 and slopes nearing 1.0 with intercepts near 0 for method comparison, and the CV% and SD values falling within acceptable limits (though the limits themselves are not numerically specified in the provided text).

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

• Method Comparison Test Set (Capillary Mode):

  • For each measured parameter, the sample size (N) ranged from 118 to 123 at the ER site and 123 to 128 at the Hemodialysis site. The combined sample size (N) for each parameter ranged from 241 to 251.
  • Provenance: This was a prospective clinical study conducted at two external Point-of-Care (POC) sites within the United States (an Emergency Room and a Hemodialysis Unit). Some samples (less than 10%, indicating "Altered Samples" ranging from 5 to 10 for each site) were altered to cover the full dynamic range. These were "de-identified and discarded arterial blood specimens" for the external precision study (implicitly reflecting human samples, though the exact origin beyond "external POC site" is not specified beyond being collected from patients).

• Precision Test Set (Capillary Mode):

  • Within Run Precision (Internal Lab): 20 replicates for each parameter, tested on two Prime Plus analyzers from venous blood transferred to capillary tubes. This appears to be lab-based, controlled samples.
  • Within Sample Precision (Internal Lab): 2 replicates from 30 different donors (Total N=60 for each analyte) of capillary whole blood. This implies human subjects.
  • Within-Run Imprecision (External POC): Sample analysis involved transferring discarded arterial blood specimens from a lithium heparin syringe to three balanced heparin capillary tubes. The number of unique discarded specimens is not explicitly stated but "each whole blood specimen" suggests multiple, distinct specimens were used.
  • Within-Sample Imprecision (Internal POC - Fingerstick): Capillary whole blood was collected via fingerstick puncture from individuals, with 2 replicates for each. N=60 for all sample pairs. This explicitly involves human subjects/donors.
  • Within-Run Imprecision (Internal Study - Lab): 5 different concentrations of deidentified venous whole blood specimens per analyte. Each concentration was run on 3 Prime Plus analyzers, 5 days, 1 run/day, 8 replicates/run/level. This totals 120 (5 concentrations * 3 analyzers * 5 days * 8 replicates) data points per analyte for the "N" value in Table 10. These are likely controlled lab samples simulating human blood.

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

The provided text does not explicitly state the number of experts used or their specific qualifications for establishing ground truth.

• For the method comparison study, the predicate device (Nova Stat Profile pHOx Ultra Analyzer) serves as the "ground truth" or reference method for comparison. The performance of this predicate device itself is assumed to be established and accepted.
• For the precision studies, the intrinsic analytical performance of the device is assessed, rather than against a human expert's interpretation.

4. Adjudication Method for the Test Set

This information is not applicable as the device measures objective chemical and physical parameters rather than interpreting images or clinical signs that would require human adjudication. The "ground truth" is the measurement from the predicate device or the inherent value in the sample for precision studies.

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

This information is not applicable as the device is an in-vitro diagnostic (IVD) analyzer for quantitative measurements, not an AI imaging or diagnostic algorithm requiring human reader performance studies. The study focuses on instrument performance and equivalence rather than human reader improvement with AI assistance.

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

Yes, the studies conducted (method comparison and precision) are standalone performance evaluations of the device's accuracy and precision in measuring the analytes. There is no "human-in-the-loop" aspect to the analytical performance being evaluated; the device provides direct quantitative measurements.

7. The Type of Ground Truth Used

• Method Comparison: The "ground truth" or reference standard for comparison was the predicate device, the Nova Stat Profile pHOx Ultra Analyzer. This is a comparative method where the new device's performance is assessed against an already legally marketed and accepted device.
• Precision Studies: The "ground truth" for precision is the measured value itself and its statistical variation across multiple runs or samples. It's an assessment of the device's inherent reproducibility and repeatability, not against an external truth source like pathology or outcomes data. Human samples (venous and capillary whole blood) were used to test performance under realistic conditions.

8. The Sample Size for the Training Set

The provided text does not mention a training set as this is not a machine learning or AI-driven device in the sense of requiring an explicit training phase with labeled data in the way an imaging algorithm would. This is an analytical instrument based on established sensor technology and algorithms. Therefore, discussions of training sets and their sample sizes are typically not relevant for this type of device submission. The device uses "the same sensor technology, measurement algorithms, formulations of the internal and external controls, and calibrator cartridge" as its predicate, implying a well-established design.

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

As no training set is discussed or implied to be applicable for this type of analytical device in the provided context, this question is not applicable.

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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 Hematocrit, Oxygen Saturation, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin in heparinized arterial and venous whole blood.

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.

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.

The provided text describes the performance validation of the Stat Profile® Prime Plus Analyzer System, specifically focusing on its point-of-care (POC) capabilities and comparability to a predicate device. This is a medical device, not an AI/ML software. Therefore, many of the requested categories related to AI/ML software development (e.g., number of experts for ground truth, adjudication method, MRMC studies, training set details) are not applicable to this document.

However, I can extract information related to the device's acceptance criteria and how its performance was proven.

Here's the breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating "substantial equivalence" to the predicate device and by meeting established criteria for method comparison and imprecision, based on CLSI guidelines. The performance data is presented as method comparison statistics (slope, intercept, r-value) and total imprecision (SD, %CV).

Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria thresholds for each parameter prior to the results. Instead, it presents the quantitative results from the study and concludes that these results "confirmed that the performance of the Stat Profile Prime Plus Analyzer System is substantially equivalent to that of the Nova Stat Profile pHOx Ultra Analyzer System (predicate device)."

Therefore, I will present the reported device performance, and the implicit acceptance can be inferred as meeting industry standards for substantial equivalence in medical devices of this type.

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Method Comparison (POC vs. Lab):
    • Hct: 417 samples
    • SO2: 398 samples
    • tHb: 416 samples
    • O2Hb: 422 samples
    • COHb: 425 samples
    • MetHb: 437 samples
    • HHb: 322 samples
  • Total Imprecision Performance: 20 runs performed on 3 analyzers, using 3 levels of quality control/linearity materials.
  • Within-Run Whole Blood Precision: Minimum of 2 operators per site across 3 POC sites (total 9 operators). Each precision run consisted of 10 replicate measurements using 7 different whole blood samples (5 native, 2 altered).
• Data Provenance: The study was conducted in the United States, across three Point-of-Care (POC) sites: a Cardiothoracic Intensive Care Unit (CTICU), an Emergency Department (ED), and a Respiratory Therapy Lab (RT). The data utilized a mix of quality control materials and discarded blood gas specimens. This suggests prospective collection of real-world samples within a clinical setting.

3. Number of Experts and Qualifications for Ground Truth

• This device is a medical diagnostic instrument, not an AI/ML algorithm. Ground truth for the method comparison study was established by laboratory measurements (presumably using the established predicate device or a gold standard lab method) which the new device's results were compared against.
• The study involved "trained Healthcare Professionals" and "POC personnel". These personnel performed the tests on the new device. Their qualifications are described as "trained, qualified staff found in typical POC sites where blood gas analyzers are utilized," including Respiratory Care, Nursing, and Exercise Physiology personnel. No "experts" in the sense of adjudicating image interpretations are mentioned, as this is not an imaging AI.

4. Adjudication Method for the Test Set

• Not applicable. This is a quantitative measurement device, not an interpretive one requiring expert adjudication. The comparison was quantitative against a reference method.

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

• Not applicable. This is a quantitative measurement device, not an AI-assisted diagnostic tool that would be evaluated for human reader improvement. The study compares the new device's performance to a predicate device and laboratory methods.

6. Standalone Performance

• Yes, effectively. The "Stat Profile® Prime Plus Analyzer System" provides quantitative measurements. The performance data presented (Method Comparison, Total Imprecision, Within-Run Whole Blood Precision) represents the standalone performance of the device in generating these measurements, compared against established laboratory methods or statistical precision targets. There is no "human-in-the-loop" performance as the human simply operates the device to obtain the measurement.

7. Type of Ground Truth Used

• Comparative ("Reference") Method: For the method comparison study, the ground truth was the results obtained from analyses performed by "Lab" (laboratory reference methods, presumably the predicate device or another validated laboratory analyzer). This is a comparative ground truth against an established standard.
• Statistical Targets: For precision studies, the ground truth is implicitly defined by the acceptable statistical variance and bias from the mean of repeated measurements, often against known control material values.

8. Sample Size for the Training Set

• Not applicable. This is a physical, chemical, and optical measurement device, not a machine learning model that requires a "training set" in the computational sense. The device's measurement algorithms are fixed based on spectrophotometric and impedance principles.

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

• Not applicable, as there is no "training set" for an AI/ML model for this device. The principles of measurement are based on established scientific methods (e.g., spectrophotometry and impedance) and not trained on data in the AI/ML sense.

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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 hematocrit in arterial or venous whole blood in point of care or clinical laboratory settings. Hematocrit 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.

The i-STAT CHEM8+ test cartridge contains test reagents to analyze whole blood at the point of care or in the clinical laboratory for hematocrit (HCT). 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 medical device discussed in these documents is the i-STAT CHEM8+ cartridge with the i-STAT 1 System for measuring hematocrit.

Here's a breakdown of the acceptance criteria and the study information, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criteria (Performance Metric)	Acceptance Criteria	Reported Device Performance
   Precision (Aqueous Materials)	Not explicitly stated as acceptance criteria, but study results presented for various levels.	CV L2/Control L1: 1.1%
   Precision (Whole Blood) - Venous	Not explicitly stated as acceptance criteria, but study results presented for various ranges.	≤ 35%PCV: 1.6% CV
   Precision (Whole Blood) - Arterial	Not explicitly stated as acceptance criteria, but study results presented for various ranges.	≤ 35%PCV: 7.1% CV
   Linearity	Absolute degree of nonlinearity results meet acceptance criteria.	Demonstrated linearity over 15 - 75 %PCV. (Regression R² = 0.9973)
   Limit of Quantitation (LoQ)	LoQ must be below the lower limit of the reportable range.	LoQ = 12.4 %PCV (below reportable range of 15%PCV)
   Limit of Blank (LoB)	Not explicitly stated as a numerical acceptance criteria.	LoB = 0.66 %PCV
   Limit of Detection (LoD)	Not explicitly stated as a numerical acceptance criteria.	LoD = 1.38 %PCV
   Interference	95% CI of the difference between test & control samples must be within allowable error (Ea).	Most substances showed no interference. Lithium Bromide, Total Protein (high/low), and White Blood Cells (>50,000 WBC/uL) showed interference.
   Method Comparison (Slope vs. Predicate)	Not explicitly stated as a numerical acceptance criteria.	1.030
   Method Comparison (Intercept vs. Predicate)	Not explicitly stated as a numerical acceptance criteria.	-0.530
   Method Comparison (Correlation vs. Predicate)	Not explicitly stated as a numerical acceptance criteria.	1.00

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

   • Precision (Aqueous Materials): N=80-81 for each of the 4 levels. Data provenance not specified (likely internal laboratory data).
   • Precision (Whole Blood): 190 samples (123 venous, 67 arterial). Data collected across three point-of-care sites. Data provenance not specified (implies retrospective collection from clinical sites).
   • Linearity: Whole blood samples of varying analyte levels. Number of samples not specified. Data provenance not specified.
   • Limit of Quantitation: Four whole blood samples. Study conducted over 3 days using 2 cartridge lots. Data provenance not specified.
   • Limit of Blank/Detection: Whole blood samples (one "blank" and two "low" Hct concentrations). Data provenance not specified.
   • Interference: Whole blood test samples. Number of samples not specified for each substance. Data provenance not specified.
   • Method Comparison: N=194 (venous and arterial blood specimens). Data provenance not specified (implies collection at sites performing method comparison).

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

   • No information provided regarding the use of experts to establish a "ground truth" in the traditional sense. These are analytical performance studies, where the reference method (e.g., predicate device, microhematocrit method) serves as the comparator or reference.

4. Adjudication Method for the Test Set

   • Not applicable/Not mentioned. These are objective analytical measurements compared against established reference methods or statistical criteria, not subjective interpretations 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 device is an in-vitro diagnostic (IVD) instrument for quantitative measurement of hematocrit, not an AI imaging or diagnostic algorithm that assists human readers.

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

   • Yes, the entire submission focuses on the standalone analytical performance of the i-STAT CHEM8+ cartridge with the i-STAT 1 System, a fully automated measurement device. There is no human-in-the-loop component in the measurement itself, beyond loading the sample and operating the device.

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

   • Analytical Performance: The ground truth or reference method for analytical performance studies is implicitly or explicitly stated.
     • Precision: Statistical variability of repeated measurements.
     • Linearity: Expected values based on dilutions or known concentrations.
     • LoQ/LoB/LoD: Statistical determination from low-level samples.
     • Interference: Comparison of spiked samples to unspiked controls.
     • Method Comparison: The predicate device (i-STAT Hematocrit test on the i-STAT Alinity Instrument) was used as the comparative method. The "Test Traceability" section also notes the Microhematocrit Method as the basis for traceability.

8. The Sample Size for the Training Set

   • Not applicable. This device is a quantitative measurement system, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance is based on its electrochemical sensing mechanisms and calibration, rather than on parameters learned from a data set.

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

   • Not applicable, as no training set (for machine learning) is relevant to this device.

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The Stat Profile Prime ES Comp Plus Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of pH, Hematocrit, Ionized Calcium and Ionized Magnesium in heparinized venous whole blood, and pH. Ionized Calcium and Ionized Magnesium in plasma and serum.

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

Ionized Magnesium (iMg) measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).

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

Hematocrit measurements of the packed red blood cell volume are used to distinguish normal from abnormal states, such as anemia and erythrocytosis.

The Stat Profile Prime ES Comp Plus Analyzer is a small, low cost blood electrolyte analyzer. 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 ES Comp Plus Analyzer has an enhanced test menu and multiple quality control options. External Control Solutions (ampules) shall be offered, as well as an on-board Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly.

The Stat Profile Prime ES Comp Plus Analyzer can accommodate either of two sensor cards in the sensor card housing. The analyzer will determine the test configuration of the system by detecting which sensor card is installed.

The two options for the sensor card are:

• Sensor Card 1 (Basic Electrolyte Panel plus Hct) shall enable and report the following listed analytes: Hct, Na, K, Cl
• Sensor Card 2(Full Electrolyte Panel plus pH & Hct) shall enable and report the following listed analytes: pH, Hct, Na, K, Cl, iCa, iMg

As with the predicates, the Stat Profile Prime ES Comp Plus Analyzer is microprocessor-based and incorporates ion selective electrode technology to measure pH, ionized calcium, ionized magnesium.

The Prime ES Comp Plus can be configured with an optional sample tray, which allows the user to run up to 10 consecutive samples may be any combination of Serum/Plasma or control solutions. Whole Blood samples may only be run in STAT Mode (not tray mode).

Calibration standards are provided in sealed pouches within a calibrator pack. Liquid quality control materials are available as external ampules. Sampling and calibration are fully automated.

The Stat Profile Prime ES Comp Plus Analyzer accepts lithium heparinized whole blood sample from syringes, open tubes, and small cups. The minimum sample sizes for analysis is 100 µL.

The provided text describes a 510(k) premarket notification for the "Stat Profile Prime ES Comp Plus Analyzer System," an in vitro diagnostic device for measuring various blood parameters. It does NOT describe an AI/ML-based device. Therefore, the requested information regarding AI/ML acceptance criteria, training/test sets, expert ground truth establishment, MRMC studies, etc., cannot be extracted from this document as it is not relevant to the described device.

The document focuses on demonstrating substantial equivalence to a predicate device (Nova Stat Profile pHOx Ultra Blood Gas Analyzer) through performance testing typically required for in vitro diagnostic devices, such as method comparison, precision, linearity, specificity/interference, detection limit, and shelf life stability.

Here's a breakdown of what can be extracted, addressing the closest relevant points, and explicitly stating what cannot be found:

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

The document does not explicitly present a table of acceptance criteria paired with the specific numerical reported device performance for each analyte (e.g., pH, iCa, iMg, Hct). Instead, it broadly states that "The results of the testing confirmed that the performance of the Stat Profile Prime ES Comp Plus Analyzer System is substantially equivalent to that of the Nova Stat Profile pHOx Ultra Blood Gas Analyzer (predicate device)." The study types performed are listed as:

• Method Comparison Studies
• Precision/Reproducibility Studies
• Run to Run Precision
• Linearity Testing
• Specificity / Interference Testing
• Detection Limit
• Shelf Life Stability Testing

Without the detailed test reports attached to this summary, the specific acceptance criteria thresholds and the measured performance values for each of these studies (e.g., specific bias ranges for method comparison, CV% limits for precision) are not available in this document.

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

• Sample Size: The document does not specify the exact sample sizes used for each performance test (method comparison, precision, linearity, etc.).
• Data Provenance: Not explicitly stated, but clinical laboratory settings are mentioned for intended use, implying laboratory-conducted studies. No information on country of origin or whether the data was retrospective or prospective is provided.

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 question is not applicable. This device is an in vitro diagnostic analyzer, not an AI/ML system requiring human expert interpretation as ground truth for imaging or similar applications. The "ground truth" for the performance studies would be reference methods (for method comparison), known concentrations/values (for linearity/detection limit), or repeated measurements (for precision), all performed using established laboratory techniques, not expert consensus.

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

Not applicable. This is not a human interpretation study.

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 not an AI-assisted diagnostic device for human readers.

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

Not applicable. This is a standalone analytical device, but the term "standalone performance" in the context of your prompt usually refers to the accuracy of an AI algorithm on its own. For this device, all performance listed (method comparison, precision, etc.) is its standalone performance. The device operates without human-in-the-loop interpretation assistance, but rather as an automated analyzer whose results are then used by healthcare professionals.

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

The "ground truth" or reference values for this type of device would typically be:

• For Method Comparison: Results obtained from a well-established, validated reference method or another legally marketed device known for its accuracy.
• For Linearity: Samples with precisely known concentrations prepared gravimetrically or volumetrically.
• For Precision/Reproducibility: Statistical analysis of repeated measurements on stable samples.

The document does not specify the exact reference instruments or methods used, but this is the general approach for IVD devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set." Its operating principles are based on ion-selective electrodes and impedance sensors, as described.

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

Not applicable. See 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 i-STAT Alinity instrument with i-STAT tests is intended for use in point of care or clinical laboratory settings. The i-STAT Alinity system is intended for the quantitative measurement of various analytes in arterial and venous whole blood.

The i-STAT Hematocrit test is intended for use in the in vitro quantification of packed red blood cell volume fraction in arterial or venous heparinized whole blood, or in arterial or venous non-anticoagulated whole blood.

Hematocrit measurements can aid in the determination of normal or abnormal total red cell volume status that can be associated with conditions including anemia and erythrocytosis.

The i-STAT Hematocrit test with the i-STAT Alinity System has not been evaluated in neonates.

The i-STAT Hematocrit test with the i-STAT Alinity System is not for use with capillary samples.

For in vitro diagnostic use.

The i-STAT Alinity System is a handheld, in vitro diagnostic analytical device designed to run i-STAT test cartridges. The system is designed for use at or near point of patient care, by trained medical professionals and is for prescription use only.

The i-STAT Alinity System is comprised of the instrument, rechargeable battery, base station, electronic simulator, control material, printer and i-STAT test cartridges. The i-STAT Alinity Instrument features a barcode scanner, user interface with touch screen display and wireless capability. The instrument reports quantitative results within approximately 2 minutes.

The i-STAT test cartridge contains sensors which are located on the biosensors chips. The instrument interacts with the cartridge to move fluid across the sensors and generate a quantitative result. Cartridges require two to three drops of whole blood which are typically applied to the cartridge using a syringe.

The provided document describes the FDA 510(k) premarket notification for the i-STAT Hematocrit test with the i-STAT Alinity System. This is a point-of-care device for quantitative measurement of packed red blood cell volume fraction (hematocrit) in whole blood.

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

Important Note: This document primarily focuses on demonstrating substantial equivalence to a predicate device (i-STAT Hematocrit test with i-STAT 1 Wireless Analyzer). Therefore, the "acceptance criteria" are largely implied by the performance characteristics demonstrated to be comparable or better than the predicate, or to fall within acceptable laboratory limits for precision, linearity, etc. There isn't an explicit table of pre-defined acceptance criteria with pass/fail thresholds in the same way one might find for, say, an AI diagnostic algorithm's sensitivity/specificity. The criteria are implicitly the successful demonstration of analytical performance, rather than clinical efficacy against a true disease state, as it's a quantitative measurement device.

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit, pre-defined acceptance criteria with numerical thresholds (e.g., "sensitivity > 90%") are not stated for this type of device and submission. Instead, the acceptance is based on demonstrating sound analytical performance characteristics comparable to or better than a legally marketed predicate device. The performance data presented below indicate that the device met its internal performance specifications, which are implicitly the "acceptance criteria" for this submission type.

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

For a quantitative measurement device like this, there isn't a single "test set" in the context of an AI model. Instead, various test samples are used for different analytical performance studies:

• Precision (Aqueous Materials): 4 levels of aqueous materials tested over 20 days. N=80 for each level (total of 320 measurements).
• Precision (Whole Blood): Venous whole blood samples (native or altered) at low abnormal, normal, and high abnormal hematocrit levels. N=21 for each level at each of 3 sites (total of 9 samples, each tested 21 times, so 9 * 21 = 189 measurements described in the table, across an unspecified total number of individual blood samples).
• Linearity: A series of whole blood samples used to span the reportable range. (Specific N not provided, but typically would involve multiple dilutions).
• Recovery: A series of whole blood samples spanning the reportable range. (Specific N not provided).
• Limit of Quantitation (LoQ): Whole blood samples altered to low hematocrit levels (

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The Nova Stat Profile pHOx Ultra Analyzer with CO-Oximeter is intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Deoxyhemoglobin (HHb), and total bilirubin (tBil) in heparinized whole blood; Na+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma. Total Bilirubin (tBil) was not evaluated on neonatal samples.

The Nova Stat Profile pHOx Ultra Analyzer without CO-Oximeter is intended for in vitro diagnostic use by health care professionals and/or point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Hemoglobin (Hb) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma.

The intended use of the Nova STP pHOx Ultra Calibrator Cartridge is for the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Hemoglobin (Hb) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma.

The intended use of the Nova Stat Profile pHOx Ultra Analyzer CO-Oximeter Calibrator Cartridge with Bilirubin and Deproteinizing Solution is for the quantitative determination of total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Deoxyhemoglobin (HHb), and total bilirubin (tBil) in human blood using the Nova Stat Profile pHOx Ultra Analyzer System with CO-Oximeter.

Nova Stat Profile pHOx Ultra Analyzer CO-Oximeter Controls and Autocartridge QC are intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Nova Stat Profile pHOx Ultra Analyzer.

As in the Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System (K061830) predicate device, the Nova Stat Profile pHOx Ultra Analyzer System combines Blood Gas/pH, Chemistry, bilirubin and CO-Oximetry testing into one Point-of-Care Analyzer. This device is analyte configurable by the end user, based on tests needed.

As with the predicate, this device is microprocessor-based and incorporates:

• traditional electrode technology to measure blood pH, pCO2, pO2 .
• Nova Biomedical proprietary optical reflectance technology for the measurement of oxygen . saturation
• ion selective electrode technology to measure blood sodium, chloride, ionized . calcium, ionized magnesium
• enzyme/amperometric technology for glucose, urea nitrogen, lactate and creatinine . measurements
• conductivity/Na+ correction for hematocrit .
• multi-wavelength reflectance/conductivity correction for hemoglobin. .

Calibration standards with dissolved gases are provided in sealed pouches eliminating the need for users to calibrate the blood qas electrodes using external compressed gas cylinders. Quality control materials are available as external ampules and as internal auto-cartridge quality control packs. Sampling, calibration and quality control are fully automated.

Nova will market the Nova Stat Profile pHOx Ultra Analyzer System in two configurations. The proposed Nova Stat Profile pHOx Ultra Analyzer System with CO-Ox module (Catalog #42013) will be offered with all the parameters listed above. A second configuration will be offered, called the Nova Stat Profile pHOx Ultra Analyzer System without the CO-Ox module (Catalog #42014). This configuration will not have the capability to measure Oxyhemoglobin (O₂Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), and Reduced Hemoglobin (HHb) or bilirubin.

This 510(k) summary (K110648) describes the Nova Stat Profile pHOx Ultra Analyzer System as substantially equivalent to the predicate device, the Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System (K061830). The submission primarily focuses on demonstrating equivalence due to component obsolescence, rather than presenting a study to prove new performance criteria.

Therefore, the acceptance criteria are implicitly those established for the predicate device, and the "study" is a comparison and verification that the changes to the Nova Stat Profile pHOx Ultra Analyzer System did not affect the performance and maintain equivalence.

Here's the information broken down based on the provided text, recognizing the nature of this 510(k) (substantial equivalence based on component updates):

1. Table of Acceptance Criteria and Reported Device Performance

(Note: Since this is a substantial equivalence claim based on component changes, explicit acceptance criteria values for each analyte are not provided in this document. Instead, the "acceptance criteria" for the new device is to perform equivalently to the predicate. The reported device performance is that it met this equivalence.)

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

The document does not explicitly state the sample size or data provenance (country of origin, retrospective/prospective) for the "performance verification testing." Given the nature of a 510(k) for component changes, this testing would typically involve a series of internal laboratory tests comparing the updated device's output to the predicate's output across a range of relevant samples (e.g., blood controls, patient samples).

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

This type of 510(k) submission, focused on component equivalence for an in vitro diagnostic device, typically relies on established reference methods or calibrated controls as the "ground truth" rather than expert consensus on individual cases. The document does not specify the use of "experts" to establish ground truth for a test set in the traditional sense of clinical imaging or diagnostic interpretation.

4. Adjudication Method for the Test Set

Not applicable. This submission does not describe a process involving adjudication of test results, as it is focused on technical equivalence to a predicate device rather than human interpretation or complex diagnostic assessment.

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

Not applicable. This is an IVD device for quantitative measurements, not an AI-assisted diagnostic imaging device. An MRMC study is not relevant to this submission.

6. Standalone Performance Study

Yes, in essence, a "standalone" performance verification for the new device was implicitly conducted against the predicate device. The submission states: "The results of software validation and performance verification testing confirmed that the modifications made to the hardware and software of the Nova Stat Profile pHOx Ultra Analyzer System did not affect the safety, efficacy or performance of the system is substantially equivalent to the predicate device." This indicates that the device was tested to ensure its standalone performance matches that of the predicate.

7. Type of Ground Truth Used

The ground truth for this device would be established through a combination of:

• Traceability to Reference Methods: Calibrators and controls used for the device would be traceable to recognized reference measurement procedures or certified reference materials for each analyte.
• Comparison to Predicate Device: The primary "ground truth" in this context is the established performance of the legally marketed predicate device (Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System). The new device's performance was verified to be equivalent.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that relies on a "training set" to learn. It is a measurement device with established electrochemical and optical principles.

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

Not applicable, as there is no "training set" for this type of IVD device.

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The i-STAT 1 Wireless Analyzer is used by trained medical professionals for running a variety of clinical chemistry tests and test panels contained in i-STAT test cartridges. These tests include hematocrit, glucose, blood urea nitrogen, sodium, potassium, chloride, ionized calcium, blood gases (oxygen, carbon dioxide and pH), creatinine, lactate, activated clotting time, prothrombin time, bicarbonate/carbon dioxide, troponin, creatine phosphokinase, and beta natriuretic peptide.

• Sodium measurements are used for monitoring electrolyte imbalances.
• Potassium measurements are used for 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.
• Glucose measurements are used in the diagnosis, monitoring and treatment of carbohydrate metabolism disorders including but not limited to diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
• Hematocrit measurements can aid in the determination and monitoring of normal or abnormal total red cell volume status including but not limited to conditions such anemia and erythrocytosis and blood loss related to trauma and surgery.
• Blood urea nitrogen measurements are used for the diagnosis, monitoring and treatment of certain renal and metabolic diseases.
• Ionized calcium measurements are used in the diagnosis, monitoring and treatment of conditions including but not limited to parathyroid disease, a variety of bone diseases, chronic renal disease and tetany and disturbances related to surgical and intensive care.
• pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-base disturbances.
• 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.
• The i-STAT lactate test is useful for (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood acid/base status, (2) monitoring tissue hypoxia and strenuous physical exertion, and (3) diagnosis of hyperlactatemia.
• The i-STAT Kaolin Activated Clotting Time (ACT) test is an in vitro diagnostic test used to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.
• The i-STAT PT, a prothrombin time test. is useful in monitory patients receiving oral anticoagulation therapy such as Coumadin or warfarin.
• Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
• The i-STAT Cardiac Troponin I (cTnl) test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
• The i-STAT CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myocardial infarction (MI).
• The i-STAT BNP test is an in vitro diagnostic test for the quantitative measurement of B-Type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.
• The i-STAT Celite ACT test is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients undergoing medical procedures such as catheterization, cardiac surgery, surgery, organ transplant and dialysis

The i-STAT 1 Wireless Analyzer (Model 300W) is a variant of the predicate i-STAT 1 Analyzer (Model 300) (K001387) and it provides an additional and alternate method for communication of data to a facility database. The i-STAT 1 Analyzer together with single use i-STAT Cartridges is a complete analytical system that can be used at the point of patient care. The primary purpose of the analyzer is to run a variety of tests contained in disposable. single-use i-STAT Cartridges. The enabling technology for the i-STAT system is in the microfabricated electrochemical sensors located in the disposable cartridges. The functions related to testing patient samples using this technology are not affected by the addition of the wireless capability. The capability of the Wireless Analyzer to transmit test results and information by Radio Frequency (RF) transmission is an option that the user may choose but it is not required for the Wireless analyzer to fulfill the intended use or to meet the indications for use.

This document is a 510(k) summary for the i-STAT 1 Wireless Analyzer, which is a modified version of the i-STAT 1 Analyzer. The submission argues for substantial equivalence primarily based on the fact that the measurement cycle of the device is identical to the predicate device, and the wireless functionality is temporally distinct and does not affect the core measurement performance. As such, the document does not report on a study comparing the diagnostic performance of the i-STAT 1 Wireless Analyzer against specific acceptance criteria for each analyte. Instead, it focuses on the differences and safety aspects related to the addition of wireless communication.

Therefore, much of the requested information cannot be extracted directly from this 510(k) summary because the evaluation approach was not based on a new clinical performance study for the analytes.

Here's the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

This section cannot be fully constructed as a typical acceptance criteria table for diagnostic accuracy because the submission's core argument is that the measurement performance of the i-STAT 1 Wireless Analyzer is identical to the predicate device (i-STAT 1 Analyzer) for all cartridge tests. The only "performance" discussed in relation to the new wireless feature is its safety and data integrity.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided for diagnostic accuracy. As noted, no new cartridge tests were performed to compare the diagnostic performance because the measurement cycle is identical to the predicate device. The testing focused on the wireless functionality itself, which does not involve patient samples or diagnostic data in the same way.

The document discusses "Specific Absorption Rate tests conducted by the supplier of the radio frequency module" but does not provide sample sizes or data provenance for these engineering tests.

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

Not applicable. No diagnostic ground truth was established for a new clinical performance test set, as the device's diagnostic measurement capabilities are considered identical to its predicate.

4. Adjudication method for the test set

Not applicable. No new clinical performance test set was conducted that would require adjudication of diagnostic results.

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 device is an in vitro diagnostic analyzer, not an AI-assisted diagnostic imaging or interpretation system for human readers. No MRMC study was conducted.

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

Yes, implicitly in the context of the device's core function. The i-STAT 1 Wireless Analyzer, like its predicate, is a standalone device that performs quantitative measurements of various analytes. The output (a numerical value for an analyte) does not require human-in-the-loop for its generation. However, the study supporting this submission did not involve a new standalone performance evaluation for the analytes; it relied on the established performance of the predicate device. The wireless functionality itself is an "algorithm only" in terms of data transmission, operating independently of human intervention during the transmission process once configured.

7. The type of ground truth used

Not applicable for a new clinical performance study. The original ground truth for the predicate i-STAT 1 Analyzer's diagnostic measurements would have been established through methods appropriate for each analyte (e.g., comparison to laboratory reference methods, clinical outcomes where relevant). For this 510(k) submission, the ground truth for the wireless transmission involved verifying signal integrity and proper data transfer, but this is an engineering ground truth, not a diagnostic one.

8. The sample size for the training set

Not applicable. This submission does not describe a machine learning algorithm that requires a training set in the conventional sense for diagnostic performance.

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

Not applicable. (See point 8).

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The epoc Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or unanticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions.

Care-Fill Capillary Tubes are intended for use with the epoc Blood Analysis system and are used for the collection and dispensing of capillary blood samples with epoc Test Cards.

The Blood Gas Electrolyte (BGE) test card panel configuration includes sensors for Sodium -Na, Potassium - K, Calcium - iCa, pH, pCO2, pO2 and Hematocrit - Hct.

The Blood Gas Electrolyte (BGEM) test card panel configuration includes sensors for Sodium - Na, Potassium - K, Calcium - iCa, pH, pCO2, pO2, Hematocrit - Hct and Glucose -Glu.

Measurement of sodium is used in diagnosis and treatment of diseases involving electrolyte imbalance.

Measurement of potassium is used in diagnosis and treatment of diseases involving electrolyte imbalance.

Measurement of Ionized Calcium is used in diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

Measurement of pH, pCO2, pO2 (blood gases) is used in the diagnosis and treatment of lifethreatening acid-base disturbances.

Measurement of Hct distinguishes normal from abnormal states of blood volume, such as anemia and erythrocytosis.

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia, and of pancreatic islet cell tumors.

The epoc Blood Analysis System consists of three (3) components:

1. epoc Test Card: single use blood test card with sensors, fluidic channel, and on-board calibrator.
2. epoc Card Reader: raw-signal acquisition peripheral with card orifice, mechanical actuation assembly, bar code scanner, electrical contact array, thermal subsystem, and circuits for signal processing and wireless transmission.
3. epoc Host: dedicated-use Personal Digital Assistant (PDA) computing device with custom software for displaying test results.

The epoc Care-Fill Capillary Tube is intended for use only with epoc Blood Analysis System for the collection and dispensing of capillary blood samples.

Acceptance Criteria and Study Details for epoc® Blood Analysis System for Capillary Samples

The epoc® Blood Analysis System sought clearance to use capillary blood specimens and to remove the limiting labeling regarding the glucose test using neonatal samples. The acceptance criteria were implicitly established by demonstrating substantial equivalence to the predicate device, the i-STAT® Model 300 Portable Clinical Analyzer, primarily through method comparison studies and precision studies. The core of the acceptance criteria is the observed bias between the epoc system and the i-STAT system, and the precision (SD and %CV) of the epoc system.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly defined as numerical thresholds in the provided document. Instead, the study aims to demonstrate that the epoc system's performance, when using capillary blood, is "substantially equivalent" to the predicate device (i-STAT Model 300). This is assessed by comparing the biases and precision against the predicate device in clinical and non-clinical settings.

For both method comparison studies, the key performance indicator is the average(Yii-Xii), which represents the bias between the epoc system (Y) and the predicate i-STAT system (X). For precision, SD and %CV are used.

Implicit Acceptance Criteria (interpreted from "Substantially Equivalent" and comparison to predicate):

• Bias (epoc vs. i-STAT): The measured biases should be clinically acceptable and comparable to or better than previously cleared devices and clinical standards. The document presents the observed biases without stating explicit thresholds for acceptance a priori.
• Precision (epoc system): The standard deviation (SD) and coefficient of variation (%CV) for each analyte should be within clinically acceptable ranges and consistent with expected performance for point-of-care blood gas and electrolyte analyzers.

Reported Device Performance (from studies):

The following table summarizes the reported performance of the epoc system when using capillary samples, compared to the i-STAT system, and its precision.

2. Sample Sizes and Data Provenance

Equivalence of Care-Fill vs. Syringe (Non-Clinical Study):

• Sample Size: N = 42 for all analytes.
• Data Provenance: Retrospective, "in house" experiments. The origin of the blood samples (e.g., human, animal, spiked, etc.) and country are not explicitly stated, but the context implies laboratory-controlled samples, potentially modified to extend analyte ranges.

In-house Method Comparison (Capillary samples, epoc vs. i-STAT):

• Sample Size: N = 51 for pH/pCO2, N = 52 for pO2/Na/K/Ca/Glu/Hct.
• Data Provenance: Retrospective, "in-house" study using capillary blood samples. Origin and country are not specified.

Clinical Precision Study (Care-Fill capillary tubes):

• Sample Size: N = 10 replicates per study, across 6 precision studies (3 pools of blood, 2 POC locations, 6 different operators). So, 60 measurements per analyte in total, distributed.
• Data Provenance: Prospective, patient samples, collected at "2 POC locations" (Nursery and NICU), implying a hospital setting. Country not explicitly stated but implied to be where epoc is manufactured/marketed (Canada/USA).

Clinical Method Comparison (Capillary samples, epoc vs. i-STAT):

• Sample Size: N = 47 for pH/iCa/Hct, N = 48 for pCO2/pO2/Na/K/Glu. For neonatal glucose specifically, N = 36.
• Data Provenance: Prospective, patient samples of whole blood (12 adult capillary, 36 neonatal capillary). Performed "at a hospital" in "four (4) locations: NICU, Wellbaby Nursery and two (2) different outpatient drawing areas." Country not explicitly stated, but implied as per above.

3. Number of Experts and Qualifications for Ground Truth

The concept of "experts" and "ground truth" as typically used in AI/image analysis studies (e.g., radiologists interpreting images) is not directly applicable here. This submission is for a medical device that measures physiological parameters.

• Ground Truth Establishment: The ground truth or reference standard for comparison in these studies is the predicate device, the i-STAT Model 300 Portable Clinical Analyzer. The i-STAT system itself is a cleared device already accepted as an accurate measurement tool for these parameters. There is no mention of human experts establishing a separate "ground truth" or reference, beyond the inherent accuracy of the predicate device.

4. Adjudication Method

Not applicable. As explained in point 3, the ground truth is established by the predicate device, not by human interpretation or consensus that would require an adjudication method.

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

Not applicable. This is not a study involving human readers interpreting cases (e.g., medical images) with and without AI assistance. It is a device performance study comparing a new device (epoc) to a predicate device (i-STAT) for quantitative measurements. Therefore, there is no "effect size of how much human readers improve with AI vs without AI assistance."

6. Standalone Performance Study

Yes, a standalone performance study was conducted.

• Equivalence of Care-Fill vs. Syringe (Non-Clinical Study): This study directly compared two delivery methods on the epoc system, not against an external reference, to ensure the new capillary tube delivery method did not alter results.
• Clinical Precision Study: This study evaluated the precision (repeatability) of the epoc system itself when using capillary samples collected via the Care-Fill tubes, without direct comparison to a predicate device for each measurement. It assessed the algorithm's consistency and reliability in real-world use.

7. Type of Ground Truth Used

The ground truth used for the comparative studies (method comparison) was the measurements obtained from the predicate device, the i-STAT Model 300 Portable Clinical Analyzer. This is considered "reference method" ground truth, where a previously validated and cleared device serves as the standard.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" as would be typical for machine learning algorithms. The epoc system is described as having "on-board calibrator" and "custom software that displays the test results" and "software to control the test and calculate analytical values from raw sensor signals." This implies a rule-based or empirically calibrated system rather than a machine learning model that requires a distinct training phase with a labeled dataset in the contemporary sense. The calibration and development likely involved extensive in-house testing and engineering, but these are not referred to as a "training set."

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

Given that a distinct "training set" in the context of machine learning is not mentioned (see point 8), the concept of establishing ground truth for it also does not directly apply. The calibration and performance optimization of the epoc system's algorithms/software would have been established through a combination of:

• Reference materials/standards: Calibrators are mentioned as "on-board" the test card.
• Extensive laboratory testing: Comparison against established laboratory methods and reference analyzers during the development and validation phases.
• Empirical data collection: Using various blood samples (e.g., with known concentrations, or compared to highly accurate laboratory instruments) to optimize the sensor responses and calculation algorithms.

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