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The i-STAT CG4+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of pH, partial pressure of oxygen (PO2), and partial pressure of carbon dioxide (PCO2) in arterial, venous, or capillary whole blood in point of care or clinical laboratory settings.

The i-STAT CG4+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of lactate in arterial or venous whole blood in point of care or clinical laboratory settings.

pH, PO2, and PCO2 measurements are used in the diagnosis, monitoring, and treatment of respiratory, metabolic, and acid-base disturbances.

Lactate measurements are used in (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 CG4+ cartridge is used with the i-STAT 1 analyzer as part of the i-STAT 1 System to measure pH, partial pressure of oxygen (PO2), and partial pressure of carbon dioxide (PCO2) in arterial, venous or capillary whole blood and to measure lactate (Lac) in arterial or 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 CG4+ 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 CG4+ 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 movements occur within the i STAT CG4+ cartridge. The i-STAT 1 analyzer interacts with the i-STAT CG4+ cartridge to move fluid across the sensors and generate a quantitative result. Cartridges require two to three drops of whole blood 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 analyzer functions as the main user interface and the electromechanical interface to the test cartridge. All within-cartridge fluid movements, as well as the timing and heating of the test cycle, are automated and controlled without user intervention by system software embedded within the analyzer.

Since the provided text describes a medical device (i-STAT CG4+ cartridge with the i-STAT 1 System), it is an in vitro diagnostic (IVD) device, not an AI/ML diagnostic system. Therefore, many of the typical acceptance criteria and study components for AI/ML devices (e.g., number of experts, adjudication methods, MRMC studies, training set details) are not applicable to this type of device.

This clearance is based on demonstrating substantial equivalence to a predicate device (i-STAT G3+ cartridge) through analytical performance studies, rather than a comparative effectiveness study against human readers or specific performance benchmarks tied to a disease outcome.

Here's an organized breakdown of the acceptance criteria and study information provided for the i-STAT CG4+ cartridge, focusing on what is relevant for an IVD device and clearly indicating where AI/ML-specific criteria do not apply:

Acceptance Criteria and Device Performance for i-STAT CG4+ Cartridge

The acceptance criteria for this in-vitro diagnostic device are based on demonstrating robust analytical performance and substantial equivalence to a legally marketed predicate device (i-STAT G3+ cartridge). The studies focus on precision, linearity, traceability, detection limits, and analytical specificity (interference and oxygen sensitivity), as well as method comparison with established laboratory methods.

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for an IVD device like this are generally implied by the successful demonstration of performance characteristics within clinically acceptable ranges and alignment with the predicate device. The tables below summarize the reported device performance, which implicitly met the internal acceptance criteria for substantial equivalence.

Precision/Reproducibility (Aqueous Materials - Sampled Performance Ranges)

Linearity/Assay Reportable Range (Regression Summary)

Detection Limits (LOQ and LOD)

Analytical Specificity (Interference): A substance was identified as an interferent if the difference in means (or medians) between the control and test samples was outside of the allowed error (±Ea) for the i-STAT test.

• Bromide: Interferent at 37.5 mmol/L (decreased lactate results >10.0 mmol/L).
• Glycolic Acid: Interferent at 10.0 mmol/L (increased lactate results >0.8 mmol/L).
• Other substances listed (Table 11) showed No Interference.

Altitude Study (Correlation Coefficient and Slope Acceptance)

Method Comparison (Bias at Medical Decision Levels)
Bias at medical decision levels (MDL) needs to be clinically acceptable.

• pH: Biases ranging from -0.0080 to -0.0166 at various MDLs.
• PO2: Biases ranging from -0.6 to -3.3 at various MDLs.
• PCO2: Biases ranging from 0.67 to 3.49 at various MDLs.
• Lactate: Bias of -0.140 at 5.00 mmol/L MDL.
  These biases met the implicit acceptance criteria for substantial equivalence to the comparative methods.

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

For an IVD device, there isn't a "test set" in the AI/ML sense, but rather a series of analytical performance studies using different types of samples.

• Precision (Aqueous Materials):
  • 20-Day Precision: 83-84 replicates (N) per fluid level per test.
  • Multi-site Multi-day Precision: 90-91 replicates (N) per fluid level per test across 3 point-of-care sites.
• Precision (Whole Blood):
  • Clinical Precision: N varied by sample range and test, ranging from 3 to 154 for various analytes and sample types (venous, arterial, capillary).
  • Within-Sample (Native Capillary): 60 test results (30 subjects, duplicate tests).
  • Within-Sample (Contrived Capillary): N=32 for L1 pH/PO2/PCO2, N=22 for L2 pH/PO2/PCO2 (from 27 subjects, duplicate tests).
• Linearity: Whole blood samples of varying analyte levels. Specific N not provided per sample, but regression analysis was performed.
• Detection Limit (LoQ/LoB/LoD): Whole blood samples (altered to low/blank analyte levels).
• Interference: Whole blood samples (spiked with potentially interfering substances).
• Oxygen Sensitivity: Whole blood samples (altered to 4 lactate levels).
• Altitude: Whole blood samples (relevant analyte levels).
• Method Comparison:
  • Arterial/Venous/Capillary pooled for pH, PO2, PCO2: 551-557 specimens.
  • Arterial/Venous pooled for Lactate: 345 specimens.
  • Capillary only for pH, PO2, PCO2: 184-193 specimens (native and contrived).
  • Native Capillary (Bias at MDL): 175-178 specimens.
• Matrix Equivalence: 228-289 specimens (arterial/venous whole blood, with and without anticoagulant).

Data Provenance:

• The studies were conducted by Abbott Point of Care Inc. and at "multiple point of care sites" for clinical precision and method comparison.
• The exact country of origin is not specified but implied to be across various clinical settings where the device might be used.
• The studies appear to be prospective analytical studies designed to evaluate device performance under controlled conditions, not retrospective real-world data collection.

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

Not Applicable. For an IVD device, the "ground truth" is established through the measurement by a comparative/reference method (e.g., RAPIDPoint 500/500e, or the i-STAT G3+ predicate device), not through human expert consensus or labeling. The device's performance is compared against these established analytical methods.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1) are for establishing ground truth from multiple human readers/experts, which is not relevant for calibrating the analytical performance of an IVD device.

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

No. MRMC studies are typically performed for AI/ML diagnostic aids where the AI is intended to assist a human reader, and the study measures the improvement in human reader performance (e.g., diagnostic accuracy, sensitivity, specificity) with and without AI assistance. This device is an analytical instrument for quantitative determination of blood gases and lactate, not an AI/ML diagnostic aid.

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

Yes (in principle). The listed performance studies (precision, linearity, detection limits, interference, method comparison) assessed the analytical performance of the device itself (i-STAT CG4+ cartridge with the i-STAT 1 System) independent of a human's interpretative role. The device measures and provides a numerical output for pH, PO2, PCO2, and Lactate. The "human-in-the-loop" here is the operator performing the test, not interpreting an AI-generated image or signal.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of this IVD device was established in two primary ways:

• Reference Materials: Traceability to NIST SRMs (for pH, PO2, PCO2) or a manufacturer's working calibrator (for Lactate). These are analytical standards.
• Comparative Methods: Established and legally marketed laboratory instruments (e.g., RAPIDPoint 500/500e for pH/PO2, and the i-STAT G3+ predicate device for PCO2 and the i-STAT CG4+ (K200492) for Lactate).
• Defined Concentrations: For linearity, LoQ, LoB, LoD, interference, and oxygen sensitivity studies, samples were prepared with known or targeted analyte concentrations.

This is distinct from clinical diagnostic "ground truth" which might come from pathology, long-term outcomes, or expert consensus in fields like radiology.

8. The Sample Size for the Training Set

Not Applicable. This is an IVD device that does not use AI/ML, so there is no concept of a "training set" for an algorithm. The device measures chemical analytes via established electrochemical principles.

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

Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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The i-STAT hs-Tnl cartridge with the i-STAT 1 System is in the in vitro quantification of cardiac troponin I (cTnl) in whole blood or plasma samples in point of care or clinical laboratory settings.

The i-STAT hs-Tnl cartridge with the i-STAT 1 System is intended to be used as an aid in the diagnosis of myocardial infarction (MI).

The i-STAT hs-TnI cartridge is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I (cTnI) in whole blood or plasma samples using the i-STAT 1 analyzer in point of care or clinical laboratory settings.

The i-STAT hs-TnI test uses an enzyme-linked immunosorbent assay (ELISA) method with electrochemical detection of the resulting enzyme signal. The test reports a quantitative measurement of the sample concentration of cTnI in units of ng/L in approximately 15 minutes.

The i-STAT hs-TnI immunoassay test method uses anti-cTnI antibodies for labeling and capture. The capture antibodies are coated on para-magnetic microparticles. Both label and capture antibodies are contained within the cartridge on a biosensor chip. The ELISA is initiated when the test cartridge is inserted into the analyzer. The sample is positioned over the biosensor chip to dissolve the reagents. This forms the ELISA sandwich (detection antibodylabel/antigen/capture antibody). The sample and excess antibody-conjugate are then washed off the sensors. An enzyme within the ELISA sandwich generates an electrochemically detectable product. The biosensor chip measures the enzyme product which is proportional to the concentration of cTnI within the sample.

The i-STAT hs-TnI cartridge is a single use test cartridge. The cartridge contains a biosensor chip and all reagents required to execute the test cycle. All fluid movements within the cartridge (test sample or reagent) are automatically controlled by the i-STAT 1 analyzer by electromechanical interaction with the cartridge. The analyzer executes the test cycle, acquires and processes the electrical sensor signals converting the signals into quantitative results. These functions are controlled by a microprocessor.

The i-STAT 1 System is comprised of the i-STAT 1 analyzer and accessories (i-STAT 1 Downloader/Recharger, i-STAT Electronic Simulator, i-STAT Printer and i-STAT 1 9V NiMH Rechargeable Battery).

Assay quality control materials are also available for use with the i-STAT hs-TnI cartridge and include i-STAT hs-TnI Control Level 1. i-STAT hs-TnI Control Level 2. i-STAT hs-TnI Control Level 3, and the i-STAT hs-TnI Calibration Verification Levels 1-3.

Acceptance Criteria and Device Performance for i-STAT hs-TnI Cartridge with i-STAT 1 System

This response outlines the acceptance criteria and the study that demonstrates the i-STAT hs-TnI Cartridge with the i-STAT 1 System meets these criteria, based on the provided FDA 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list "acceptance criteria" in a single, consolidated table with pass/fail remarks. Instead, it presents performance characteristics and states whether the results "met the acceptance criteria" or "demonstrated acceptable performance." Based on this, the table below synthesizes the reported performance against inferred acceptance criteria.

Table: Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size:

  • 20-Day Precision: 240 replicates per level for 6 plasma samples (total 1440 tests across 3 cartridge lots, 20 days).
  • Whole Blood and Plasma Precision: Min. 24 replicates per level (6 levels) per site (3 sites) for whole blood and plasma specimens. Total number of replicates for whole blood was 576, and for plasma was 576.
  • Precision in Control Materials: 25 replicates per level (5 levels) for control materials.
  • Multi-site Multi-Day Precision: 90 replicates per level (6 plasma samples) (total 540 tests across 3 sites, 5 days, 2 operators).
  • Linearity: Not explicitly stated as a single number but implied by samples covering the reportable range.
  • Sample Type Comparison (WB vs. Plasma): Not explicitly stated, implied by samples covering the reportable range.
  • High Dose Hook Effect: Not explicitly stated.
  • LoB/LoD: Not explicitly stated, but involved 4 healthy donors for each sample type and multiple cartridge lots.
  • LoQ: Not explicitly stated, but involved a low-level cTnI whole blood and plasma samples and 4 cartridge lots.
  • Interference: Tested at two cTnI levels using various interfering substances.
  • Cross-reactivity: Tested at three cTnI concentrations for each cross-reactive substance.
  • Hematocrit Sensitivity: Whole blood samples at two cTnI levels and seven hematocrit levels.
  • Altitude: Not explicitly stated as a single number but involved whole blood and plasma samples at relevant cTnI levels.
  • Matrix Equivalence (Non-Anticoagulated WB vs. Li-Heparin WB): 88 paired specimens (including 8 contrived).
  • Matrix Equivalence (Li-Heparin Tube with Separator Gel vs. Li-Heparin Tube): 87 paired specimens (including 8 contrived).
  • Clinical Sensitivity and Specificity: 3585 subjects presenting to the Emergency Department.

• Data Provenance:

  • Analytical Performance Studies (Precision, Linearity, Hook Effect, LoB/LoD/LoQ, Interference, Cross-reactivity, Hematocrit, Altitude): These studies used a combination of frozen plasma samples, native venous whole blood and plasma specimens (prospectively collected), whole blood/plasma samples altered via spiking, control materials, and healthy donor samples. The studies were conducted at various clinical sites and internally at Abbott Point of Care.
  • Reference Interval Study: United States (US) based general population, prospectively collected venous whole blood specimens from 895 apparently healthy subjects at 8 clinical sites.
  • Matrix Equivalence Studies: Prospectively collected venous whole blood and plasma specimens from patients in point of care settings at two (2) clinical sites.
  • Clinical Sensitivity and Specificity (Pivotal Study): Prospectively collected venous whole blood and plasma specimens at 28 clinical sites in the United States. These sites were geographically diverse EDs associated with acute care hospitals, medical centers, tertiary care facilities, and primary care clinics.

3. Number of Experts and Qualifications for Ground Truth

• Clinical Sensitivity and Specificity Study (Pivotal Study):

  • Number of Experts: Not explicitly stated as a specific number, but referred to as "board-certified cardiologists and/or emergency medicine physicians."
  • Qualifications: Board-certified cardiologists and/or emergency medicine physicians. No specific years of experience are detailed.
  • Role: Adjudicated subjects based on the fourth universal definition of MI.

• Other Studies: The document does not indicate the involvement of external experts for establishing ground truth for other analytical performance or matrix equivalence studies. Ground truth for these was established through standard laboratory methods, spiked samples, and reference materials.

4. Adjudication Method for the Test Set

• Clinical Sensitivity and Specificity Study: The adjudication method for the clinical study involved "adjudication by board-certified cardiologists and/or emergency medicine physicians based on the fourth universal definition of MI." The adjudicators were blinded to the i-STAT hs-TnI test results, indicating an independent review process. The specific number of adjudicators per case (e.g., 2+1, 3+1) is not provided, but the mention of plural "physicians" suggests at least two.

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

• The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study to assess how much human readers improve with AI vs. without AI assistance. The device is an in vitro diagnostic test (IVD) for quantitative measurement of cTnI, not an imaging device or AI-powered diagnostic aide for human interpretation.

6. Standalone (Algorithm Only) Performance Study

• The performance studies described are inherently standalone for the device itself. The i-STAT hs-TnI cartridge with the i-STAT 1 System is a diagnostic test that provides a quantitative result. The clinical sensitivity and specificity are reported for the device's output (cTnI levels) as an aid in MI diagnosis, without human-in-the-loop interpretation of raw data from the device beyond reading the final numerical result.

7. Type of Ground Truth Used

• Clinical Sensitivity and Specificity Study: The ground truth for the diagnosis of MI was established by expert consensus (board-certified cardiologists and/or emergency medicine physicians) based on the fourth universal definition of MI. This is a clinical outcome/diagnostic ground truth.
• Analytical Studies:
  • Precision, Linearity, Hook Effect, LoB/LoD/LoQ, Interference, Cross-reactivity, Hematocrit, Altitude, Matrix Equivalence: Ground truth was established using a combination of:
    • Known concentrations in spiked samples.
    • Reference methods/materials (e.g., NIST SRM2921 for traceability).
    • Standard laboratory measurements and pre-defined expected values for linearity and comparison studies.
    • Clinical classification based on robust biomarker criteria (for the reference interval study of healthy subjects).

8. Sample Size for the Training Set

• The document describes performance evaluation studies and does not explicitly differentiate a "training set" for an AI/machine learning model. The i-STAT hs-TnI test is an immunoassay (ELISA method with electrochemical detection), not a device based on AI/ML. Therefore, the concept of a "training set" for an algorithm is not directly applicable in the context of this device description. The studies described are for analytical and clinical validation of the assay.

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

• As stated in point 8, the device is an immunoassay, not an AI/ML system, so there isn't a "training set" in that conventional sense. The "ground truth" for the various analytical and clinical studies (which could be considered analogous to data used for establishing performance) was established as described in point 7.

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The i-STAT CG8+ cartridge with the i-STAT 1 System is in the in vitro quantification of sodium and potassium 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 sodium in capillary whole blood in point of care or clinical laboratory settings.

Sodium measurements are used for monitoring electrolyte imbalances.

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

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 sodium (Na) in arterial, venous or capillary whole blood and to measure potassium (K) 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+cartridge. Cartridges require two to three drops of whole blood 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).

This document describes the performance of the i-STAT CG8+ cartridge with the i-STAT 1 System for the in vitro quantification of sodium (Na) and potassium (K) in whole blood. This is a medical device, and the provided text is a 510(k) summary, which is typically submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

It's important to note that the provided text focuses on the analytical performance of a diagnostic device (measuring concentrations of substances), not an AI-assisted diagnostic device for interpreting images or other complex data. Therefore, many of the requested points regarding AI/MRMC studies, number of experts, adjudication methods, and ground truth establishment for complex AI algorithms are not applicable to this type of device and will not be found in the document.

Here's a breakdown of the requested information based on the provided text, focusing on the analytical performance validation:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a single table. Instead, it presents performance characteristic studies (precision, linearity, detection limit, interference, method comparison, and matrix equivalence) with their respective results. The success of these studies implicitly serves as the acceptance criteria for the device to be considered substantially equivalent.

Below is a summary of the reported device performance for key analytical characteristics:

• Cholesterol: Decreased Na results > 400 mg/dL
• Nithiodote (Sodium Thiosulfate): Increased Na results ≥ 2.1 mmol/L |
  | Method Comparison | | | Slope near 1, Intercept near 0, High r | Substantially equivalent to predicate device |
  | K (mmol/L) vs. Predicate (i-STAT CHEM8+) | Arterial/Venous | n=340 | Strong correlation & agreement | Slope: 1.00, Intercept: 0.00, r: 1.00. Bias at Medical Decision Levels (3.0, 5.8, 7.5): 0.00 |
  | Na (mmol/L) vs. Predicate (i-STAT CHEM8+ or epoc Blood Analysis System) | Pooled: Arterial/Venous/Capillary | n=551 (pooled), n=209 (capillary only) | Strong correlation & agreement | Pooled: Slope: 1.00, Intercept: 0.00, r: 0.99. Bias at Medical Decision Levels (115, 135, 150): 0.0. Capillary only: Slope 1.00, Intercept 0.00, r 0.98. Bias 0.0. |
  | Matrix Equivalence | | | Slope near 1, Intercept near 0, High r | Equivalence demonstrated |
  | Na (mmol/L) | Venous/Arterial non-anticoagulated vs. with anticoagulant | n=295 | Strong correlation & agreement | r: 0.99, Slope: 1.00, Intercept: 0.00 |
  | K (mmol/L) | Venous/Arterial non-anticoagulated vs. with anticoagulant | n=292 | Strong correlation & agreement | r: 0.99, Slope: 1.00, Intercept: 0.00 |

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

The "test set" in this context refers to the samples used in the analytical performance studies. The data provenance is described within each study:

• Precision/Reproducibility (Aqueous materials):
  • 20-day precision: N=80 per level (5 levels) for Na and K. Conducted at "one site."
  • Multi-site/operator precision: N=90-97 per level (5 levels) for Na and K. Conducted at "three (3) sites."
• Precision (Whole Blood):
  • N varies by analyte and sample type/range (e.g., Na venous: 17, 99, 67; Na arterial: 2, 89, 62; Na capillary: 3, 56, 95; K venous: 27, 135, 19; K arterial: 23, 124, 6).
  • Whole blood specimens collected "across multiple point of care sites." Capillary specimens involved "two individual fingersticks, collected independently by two operators."
• Linearity:
  • Whole blood samples of "varying analyte levels" were used. Specific N not provided for this study.
• Detection Limit (LoQ):
  • Whole blood that was altered to a low analyte level. Specific N not provided.
• Analytical Specificity (Interference):
  • Whole blood samples were used. Specific N not provided, but interference determined by comparing "control sample" to "test sample."
• Method Comparison:
  • K (Arterial/Venous): N=340. "Lithium heparin venous and arterial whole blood specimens collected across multiple point of care sites."
  • Na (Pooled: Arterial/Venous/Capillary): N=551. "Venous and arterial" data pooled with "capillary whole blood specimens."
  • Na (Capillary only): N=209. "Native and Contrived Capillary Specimens." Bias at Medical Decision Levels for "Native Capillary Specimens" (N=194).
• Matrix Equivalence:
  • N=295 for Na, N=292 for K. "non-anticoagulated venous and arterial whole blood specimens."

Data Provenance: The data was collected from "multiple point of care sites" in the precision and method comparison studies. The document does not specify the country of origin or whether the studies were retrospective or prospective, though typical 510(k) studies for new devices are prospective analytical performance studies.

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

This type of device (in vitro diagnostic for chemical analysis) does not typically involve expert readers or adjudication for "ground truth" in the same way an AI imaging algorithm would. The "ground truth" for analytical performance is the reference measurement provided by a comparator method (e.g., the i-STAT CHEM8+ predicate device or "comparative method" lab instrument) or gravimetric/volumetric preparation for linearity and precision studies.

Therefore, there is no mention of "experts" (e.g., radiologists) establishing ground truth, nor their qualifications or numbers.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this device does not involve human interpretation requiring adjudication. Performance is assessed by comparing quantitative results from the device against a known reference or comparative method.

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, nor does it involve human readers interpreting data. It's a quantitative measurement device.

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

This is an algorithm/device-only performance study, as it's a fully automated in vitro diagnostic device. The performance data presented (precision, linearity, method comparison, etc.) reflects the standalone performance of the i-STAT CG8+ cartridge with the i-STAT 1 System. There is no human interpretation component in the measurement or output of the device.

7. The Type of Ground Truth Used

The "ground truth" in these analytical performance studies is established by:

• Reference materials/calibrators: For precision, linearity, and detection limit studies, defined aqueous or whole blood materials with known (or precisely determined) analyte concentrations are used.
• Comparator methods: For method comparison studies, the device's results are compared against a legally marketed predicate device (i-STAT CHEM8+ cartridge on the i-STAT 1 System) or another established "comparative method" (e.g., epoc Blood Analysis System) which serves as the reference, assumed to be accurate.
• Prepared samples: For linearity, samples are prepared with varying analyte levels.

8. The Sample Size for the Training Set

This document does not specify a "training set" size. For traditional in vitro diagnostic devices, there isn't a "training" phase in the machine learning sense. The device's algorithms (for sensor interpretation and calculation) are developed and validated in a more traditional engineering sense, not through iterative machine learning on a large dataset. The studies described are for validation or testing the final product's performance.

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

Not applicable, as there's no "training set" in the context of machine learning for this type of device. The ground truth for development and internal validation of such a device would likely be established through highly controlled laboratory measurements using reference methods and materials.

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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 H, partial pressure of oxygen (PO2), and partial pressure of carbon dioxide (PCO2) in arterial, venous, or capillary whole blood in point of care or clinical laboratory settings.

pH, PO2, and PCO2 measurements are used in the diagnosis, monitoring, and treatment of respiratory, metabolic and acid-base disturbances.

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 pH, partial pressure of oxygen (PO2), and partial pressure of carbon dioxide (PCO2) in arterial, venous or capillary 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 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 and comparison studies for the Abbott i-STAT CG8+ cartridge with the i-STAT 1 System, specifically for pH, PO2, and PCO2 measurements. It does not contain information about the establishment of ground truth by expert readers, multi-reader multi-case (MRMC) studies, or the training set for an AI/ML device. This document is a 510(k) summary for an in vitro diagnostic device, not an AI/ML-driven device.

Therefore, the following information cannot be extracted from the given text:

• Number of experts used to establish the ground truth.
• Qualifications of those experts.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, effect size of human readers improving with AI vs without AI assistance.
• Standalone (algorithm only without human-in-the-loop performance) study.
• Type of ground truth (expert consensus, pathology, outcomes data, etc.) as the ground truth is established by a comparative method (predicate device or standard laboratory methods) for analytical performance.
• Sample size for the training set.
• How ground truth for the training set was established.

However, I can extract information related to acceptance criteria (implied by the study results meeting certain performance metrics) and the study that proves the device meets those criteria for the i-STAT CG8+ cartridge.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a separate table for each test, but rather presents performance data (precision, linearity, detection limits, interference, method comparison) which are implicitly compared against pre-defined acceptance criteria (not explicitly listed but implied by the "met acceptance criteria" statements in the Altitude study and the overall conclusion of substantial equivalence).

Based on the provided data, here's a representation for the key performance metrics.
The acceptance criteria are implicitly met if the reported performance supports substantial equivalence.

• pH: Within-Laboratory SD up to 0.00482 pH units (0.07% CV).
• PO2: Within-Laboratory SD up to 10.80 mmHg (2.91% CV).
• PCO2: Within-Laboratory SD up to 1.307 mmHg (1.48% CV).
  Multi-Site/Operator (Table 3):
• pH: Overall SD up to 0.00579 pH units (0.09% CV).
• PO2: Overall SD up to 12.24 mmHg (4.07% CV).
• PCO2: Overall SD up to 1.489 mmHg (3.63% CV). |
  | Precision (Whole Blood)| Demonstrate consistent reproducibility across different blood sample types (venous, arterial, capillary). | Whole Blood Precision (Table 4):
• pH: %CV from 0.04% to 0.08% for venous/arterial, up to 0.34% for capillary.
• PO2: %CV from 0.97% to 4.18% for venous/arterial/capillary (excluding N/A ranges). Capillary PO2 up to 10.65% CV.
• PCO2: %CV from 0.65% to 2.85% for venous/arterial, up to 6.56% for capillary. |
  | Linearity | Demonstrate linearity over the specified reportable range. | Regression Summary (Table 5):
• pH: Slope 1.011, Intercept -0.098, R² 0.9994 (Range Tested: 6.4290 – 7.8522 pH units).
• PO2: Slope 0.977, Intercept 1.062, R² 0.9956 (Range Tested: 4.4 – 700.0 mmHg).
• PCO2: Slope 1.029, Intercept -1.144, R² 0.9991 (Range Tested: 2.40 – 148.38 mmHg).
  "demonstrated linearity over the reportable range for each i-STAT test." |
  | Limit of Quantitation (LoQ)| LoQ to be at or below the lower limit of the reportable range. | Summary of LoQ Results (Table 6):
• pH: Lower limit 6.500, Determined LoQ 6.464.
• PO2: Lower limit 5, Determined LoQ 5.
• PCO2: Lower limit 5.0, Determined LoQ 3.2. |
  | Analytical Specificity (Interference) | No significant interference from specified substances at toxic/pathological concentrations. | Potentially Interfering Substances (Table 7):
  No interference identified for pH, PO2, and PCO2 from Acetaminophen, Atracurium, Bilirubin, Calcium, Ethanol, Hemoglobin, Ibuprofen, Intralipid 20%, Morphine, Potassium, Sodium, Thiopental, Triglyceride at specified concentrations. |
  | Altitude Performance | Equivalent performance between candidate and comparator conditions at approximately 10,000 feet above sea level. | Summary of Altitude Study Results (Table 8):
• pH: r=1.00, Slope=0.99 (95% CI 0.984 to 0.998).
• PO2: r=1.00, Slope=1.02 (95% CI 1.000 to 1.037).
• PCO2: r=1.00, Slope=0.98 (95% CI 0.969 to 0.989).
  "met acceptance criteria and demonstrated equivalent performance". |
  | Method Comparison (vs. Predicate) | High correlation (r) and acceptable bias at medical decision levels when compared to the predicate device. | Pooled Data (Table 9):
• pH: N=468, r=0.99, Slope=1.00, Intercept=0.00. Bias at MDLs: -0.0040.
• PO2: N=461, r=0.99, Slope=1.03, Intercept=-0.72. Bias at MDLs: 0.1 to 0.9.
• PCO2: N=465, r=0.97, Slope=1.08, Intercept=-1.13. Bias at MDLs: 1.79 to 4.71.
  Capillary Only (Table 10 & 11):
• pH: N=195, r=0.98, Slope=1.02, Intercept=-0.11. Bias at MDLs: -0.0160 to -0.0041 (native N=179).
• PO2: N=190, r=0.99, Slope=1.02, Intercept=-1.75. Bias at MDLs: -1.8 to -0.7 (native N=175).
• PCO2: N=189, r=0.97, Slope=1.09, Intercept=-1.90. Bias at MDLs: 1.17 to 3.36 (native N=179). |
  | Matrix Equivalence | Demonstrate acceptable equivalence between anticoagulated and non-anticoagulated specimens. | Matrix Equivalence (Table 12):
• pH: N=241, r=0.98, Slope=0.97, Intercept=0.19.
• PO2: N=241, r=0.98, Slope=0.94, Intercept=1.28.
• PCO2: N=241, r=0.96, Slope=1.02, Intercept=-0.23. |

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

• Precision Studies (Aqueous):
  • 20-day precision: N=80 for each fluid level (5 levels per analyte). Provenance not explicitly stated, but typically conducted in-house by the manufacturer.
  • Multi-site/Operator precision: N=90 or N=96 for each fluid level (5 levels per analyte). Conducted at three (3) sites. Provenance not explicitly stated (e.g., country of origin), assumed to be domestic (US) unless otherwise specified.
• Precision Study (Whole Blood): Sample sizes vary by analyte and sample type/range, ranging from N=0 (N/A) to N=108. Collected across multiple point-of-care sites. Provenance not explicitly stated. These are retrospective or newly collected clinical samples used for analytical testing.
• Linearity Study: "whole blood samples of varying analyte levels for each i-STAT test." Specific N not provided for linearity, but likely a smaller set sufficient to cover the range.
• Detection Limit (LoQ) Study: "two (2) i-STAT CG8+ cartridge lots and whole blood that was altered to a low analyte level". Specific N not provided, but typically involves repeat measurements.
• Interference Study: "whole blood samples." Specific N not provided for interference testing.
• Altitude Study: "whole blood samples at relevant analyte levels across the reportable range for each test." Specific N not provided for altitude study.
• Method Comparison Study:
  • Pooled (Arterial/Venous/Capillary): N=468 (pH), 461 (PO2), 465 (PCO2). Specimens collected across multiple point-of-care sites.
  • Capillary only: N=195 (pH), 190 (PO2), 189 (PCO2). This set includes native and contrived samples.
  • Native Capillary only bias: N=179 (pH), 175 (PO2), 179 (PCO2). Specimens collected from skin puncture.
  • Data provenance: "collected across multiple point of care sites," implying prospective collection of patient samples for these comparison studies. Country of origin not specified, but usually US for FDA submissions. The studies reference CLSI guidance documents.
• Matrix Equivalence Study: N=241. "non-anticoagulated venous and arterial whole blood specimens."

All studies appear to be prospective data collection or laboratory studies designed for validation, based on the testing methodologies described (e.g., CLSI guidelines, collection of new samples).

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

Not applicable. This is an in vitro diagnostic device measuring objective physiological parameters (pH, PO2, PCO2). The "ground truth" or comparative value for these measurements is established by a "comparative method" (RAPIDPoint 500/500e, which is another blood gas analyzer) or by standard reference methods/materials (e.g., NIST SRMs, tonometered aqueous standards). There is no human interpretation or expert consensus involved in determining the "truth" for these quantitative chemical measurements.

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

Not applicable, as ground truth is not established by human readers 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 not an AI/ML device that assists human readers. It is an IVD for direct measurement of blood gas parameters.

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

Not applicable. This device is a measurement system; its performance is inherently "standalone" in that it produces a quantitative result without human-in-the-loop interpretation of images or complex data patterns. It outputs a direct measurement.

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

The "ground truth" for the device's measurements (pH, PO2, PCO2) is established by:

• Reference materials/standards: NIST SRMs and certified specialty medical gas tanks for traceability and calibration (Section VI, Traceability).
• Comparative method: The predicate device, the Siemens RAPIDPoint 500e Blood Gas System, or the RAPIDPoint 500/500e in general, for method comparison studies (Section VII.B.a). This is considered a highly accurate and established method for these analytes.
• Internal reference: For "other sensitivity studies" like Altitude, the i-STAT CG4+ (blue) cartridges on the i-STAT 1 analyzer served as a comparator device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set" in the machine learning sense. The device is based on established electrochemical principles, and its performance is validated through analytical studies.

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

Not applicable, as there is no "training set." The device is calibrated using reagents contained within the cartridge, traceable to known standards (NIST SRMs).

Ask a specific question about this device

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 i-STAT G3+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of pH, partial pressure of oxygen (PO2), and partial pressure of carbon dioxide (PCO2) in arterial, venous, or capillary whole blood in point of care or clinical laboratory settings.

pH, PO2, and PCO2 measurements are used in the diagnosis, monitoring, and treatment of respiratory, metabolic, and acid-base disturbances.

The i-STAT G3+ cartridge is used with the i-STAT 1 analyzer as part of the i-STAT 1 Sustem to measure pH, partial pressure of oxygen (PO2), and partial pressure of carbon dioxide (PCO2) in arterial, venous or capillary 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 G3+ 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 G3+ 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 movements occur within the -STAT G3+ cartridge. The i-STAT 1 analyzer interacts with the i-STAT G3+ cartridge to move fluid across the sensors and generate a quantitative result. Cartridges require two to three drops of whole blood 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 analyzer interacts with the cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).

Here's a breakdown of the acceptance criteria and the studies that demonstrate the Abbott i-STAT G3+ cartridge with the i-STAT 1 System meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as a separate table within the document. However, they are implied by the performance characteristics demonstrated in the analytical and comparison studies. The performance reported in these studies indicates the criteria that the device successfully met for precision, linearity, detection limits, analytical specificity (interference), altitude stability, and method comparison.

Based on the provided text, the device's performance is demonstrated against these implied criteria.

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The i-STAT G cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of glucose in arterial. venous or capillary whole blood in point of care or clinical laboratory settings.

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

The i-STAT G cartridge is used with the i-STAT 1 analyzer as part of the i-STAT 1 System to measure glucose in arterial, venous, or capillary whole blood for the diagnosis, monitoring, and treatment of metabolism disorders including, but not limited to, diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

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 Sustem, including the i-STAT G 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 G cartridge contains the required sensors and 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 the cartridge. The test is contained in a single-use, disposable cartridge. All the test steps and fluid movements occur within the i-STAT G cartridge. Cartridges require two to three drops of whole blood 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 analyzer interacts with the cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).

Here's a breakdown of the acceptance criteria and the study details for the i-STAT G cartridge with the i-STAT 1 System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for each performance characteristic in a summarized table within the 510(k) summary. However, it indicates that the studies "met acceptance criteria" or "demonstrated equivalency" to a predicate device or allowable error.
For several tests (e.g., precision, linearity), the results are presented, and the implicit acceptance criterion is that these results fall within acceptable clinical or statistical limits, or demonstrate substantial equivalence to the predicate device.
For the purpose of this response, I will infer the acceptance criteria from the context of how the results are presented and the FDA's ultimate determination of "substantially equivalent."

• Arterial vs. i-STAT CHEM8+: N=173, Slope 1.00, Intercept 1.00, r 1.00
• Venous vs. i-STAT CHEM8+: N=164, Slope 1.00, Intercept 1.50, r 1.00
• Capillary vs. epoc Blood Analysis System: N=234, Slope 1.00, Intercept 2.00, r 1.00 (Table 10) |
  | Matrix Equivalence: Passing-Bablok regression (non-anticoagulated vs. heparinized) with slope ~1, intercept ~0, and high correlation (r ~1). | N=158, r 1.00, Slope 1.00, Intercept 0.00 (Table 11). |
  | EDTA Matrix Equivalence: Passing-Bablok regression (K2EDTA/K3EDTA vs. lithium heparin) with slope ~1, intercept ~0, and high correlation (r ~1). | K2EDTA vs. LiHep: N=43, r 1.00, Slope 1.03, Intercept -1.037 (Table 12)
  K3EDTA vs. LiHep: N=43, r 1.00, Slope 1.03, Intercept 0.015 (Table 13) |

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

• Precision (20-day, aqueous materials): N=80 for each of 5 fluid levels.
• Precision (Multi-site and operator-to-operator, aqueous materials): N=89-90 for each of 5 fluid levels.
• Precision (whole blood):
  • Venous whole blood: N=38 (20-90 mg/dL), N=67 (>90-150 mg/dL), N=32 (>150-250 mg/dL), N=15 (>250-400 mg/dL), N=12 (>400-700 mg/dL).
  • Arterial whole blood: N=9 (20-90 mg/dL), N=94 (>90-150 mg/dL), N=64 (>150-250 mg/dL), N=6 (>250-700 mg/dL).
  • Capillary whole blood: N=33 (20-90 mg/dL), N=53 (>90-150 mg/dL), N=37 (>150-250 mg/dL), N=16 (>250-700 mg/dL).
• Linearity: Whole blood samples of varying glucose levels across the reportable range.
• Limit of Quantitation (LoQ): Whole blood "altered to a low glucose level."
• Limit of Blank/Detection (LoB/LoD): Whole blood "altered to a blank glucose level" and "two (2) low glucose levels."
• Interference: Whole blood samples at low and high glucose levels.
• Oxygen Sensitivity: Whole blood samples "altered to four (4) glucose levels."
• Hematocrit Sensitivity: Whole blood samples at "three (3) hematocrit levels...at four (4) glucose levels."
• Altitude: Whole blood samples "across the reportable range."
• Method Comparison:

  • Arterial/Venous: N=571 (pooled data for i-STAT CHEM8+ comparison)

  • Arterial: N=173 (vs. i-STAT CHEM8+)

  • Venous: N=164 (vs. i-STAT CHEM8+)

  • Capillary: N=234 (vs. epoc Blood Analysis System)

• Matrix Equivalence (non-anticoagulated vs. heparinized): N=158
• EDTA Matrix Equivalence: N=43 for K2EDTA vs LiHep, N=43 for K3EDTA vs LiHep.

Data Provenance:

• Retrospective/Prospective: Primarily involves prospective testing of samples (aqueous materials, whole blood) under controlled conditions, or collection of patient samples for method comparisons.
• Country of Origin: Not specified in the provided text, but implied to be within the scope of where Abbott Point of Care (US company) conducts its clinical evaluations, likely the US or other regions following CLSI guidelines.

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

This information is not detailed in the provided document. The ground truth for analytical performance studies on diagnostic devices like this often relies on:

• Reference methods using highly accurate laboratory analyzers.
• Certified reference materials (like NIST SRM 965 mentioned for traceability).
• Clinically established ranges and allowable errors.
• The "experts" are primarily the laboratory scientists and statisticians who conduct and analyze the studies according to CLSI guidelines.

For method comparison studies, the "ground truth" is typically the result from a legally marketed predicate device (i-STAT CHEM8+ cartridge) or a well-established laboratory reference method (epoc Blood Analysis System). The document does not mention human expert annotation of samples for establishing ground truth, as it's an in-vitro diagnostic device not directly involving image interpretation or clinical decision-making by human experts for the output itself.

4. Adjudication Method for the Test Set

This information is not applicable in the traditional sense for an in-vitro diagnostic glucose test. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where human readers or interpreters make subjective assessments that might differ, and a consensus or adjudication process is needed to establish a definitive ground truth. For quantitative measurements like glucose, the "adjudication" is inherent in the analytical process:

• Reference methods provide the comparative "true" value.
• Statistical analyses (e.g., Passing-Bablok regression, precision calculations) determine if the device's results are sufficiently close to this reference or internally consistent.
• Discrepancies would be investigated through quality control and root cause analysis, not expert adjudication of contradictory readings from the device itself.

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

No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance on multiple cases) is relevant for AI-powered diagnostic imaging devices where human interpretation is a key component. The i-STAT G cartridge is an in-vitro diagnostic device that directly measures glucose levels, not an AI assistance tool for human interpretation.

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

Yes, the studies presented are essentially "standalone" performance evaluations. The i-STAT G cartridge with the i-STAT 1 System functions as an automated system for quantifying glucose. The performance data presented (precision, linearity, LoQ, LoB/LoD, interference, sensitivity, altitude, method comparison, and matrix equivalence) are all evaluations of the device's analytical performance on its own, without direct real-time human interpretation of the glucose value itself as the primary output to be compared. Human involvement is for sample collection, device operation, and quality control, but the reported glucose value is generated by the "algorithm" (the device's embedded processes).

7. The Type of Ground Truth Used

The ground truth used for performance validation includes:

• Reference methods: For method comparison studies, the i-STAT CHEM8+ cartridge on the i-STAT 1 System (predicate device) and the epoc Blood Analysis System served as comparative methods to establish ground truth or reference values.
• Certified reference materials/Calibrators: Mention of NIST SRM 965 for traceability and "i-STAT Calibration Verification set" for precision studies indicates the use of highly accurate, traceable materials.
• Spiked samples: For linearity, LoQ, LoB/LoD, and interference studies, samples were "altered" or "spiked" to known concentrations of glucose or interfering substances.
• Statistical models and clinical thresholds: The "allowable error (±Ea)" indicates that performance is judged against pre-defined clinical or statistical acceptance limits.

8. The Sample Size for the Training Set

This information is not provided in the document. The document describes performance validation studies (test sets). For an IVD device like this, the "training set" would refer to data used during the development and optimization phases before the formal validation for regulatory submission. Details on development-stage datasets are generally not included in 510(k) summaries.

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

This information is not provided for the same reasons as point 8.

Ask a specific question about this device

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

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

The i-STAT 1 Analyzer is intended for use in the in vitro quantification of various analytes in whole blood or plasma in point of care or clinical laboratory settings. Analyzers and cartridges should be used by healthcare professionals trained and certified to use the system and should be used according to the facility's policies and procedures.

The i-STAT System is for in vitro diagnostics use. Caution: Federal law restricts this device to sale by or on the order of a licensed practitioner.

The i-STAT CG8+ cartridge is used with the i-STAT 1 analyzer as part of the i-STAT 1 System to measure glucose (Glu) in arterial, venous or capillary 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+ cartridge. Cartridges require two to three drops of whole blood, which are typically 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 acceptance criteria and study proving the device meets those criteria are detailed below, based on the provided FDA 510(k) summary for the i-STAT CG8+ cartridge with the i-STAT 1 System.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a single table with corresponding performance values in the provided document. Instead, performance expectations are implied through the comparison to the predicate device and the presentation of various study results (precision, linearity, detection limits, interference, sensitivity, and method comparison) against established CLSI guidelines or internal thresholds.

However, based on the provided information, a summary of key performance characteristics and their reported values can be presented as follows:

1. Table of Acceptance Criteria and Reported Device Performance (Implied from Study Results)

Note: The acceptance criteria are largely implied by the successful completion and positive results of studies designed according to CLSI (Clinical and Laboratory Standards Institute) guidelines, such as EP05-A3, EP06-Ed2, EP17-A2, EP07-ED3, EP37-ED1, EP09c-ED3, and EP35. Meeting the statistical benchmarks (e.g., specific SD, %CV, R², slope, intercept ranges, or being within "allowable error") for these guidelines indicates that the device's performance is acceptable for its intended use.

Study Details

Here's a breakdown of the study details based on the provided document:

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

• Precision Studies:

  • 20-day Precision (Aqueous): N=80 samples per level.
  • Multi-site/Operator Precision (Aqueous): N=90-96 samples per level (across 3 sites).
  • Whole Blood Precision: Venous (N=29-102 per range), Arterial (N=5-105 per range), Capillary (N=15-107 per range).

• Linearity: Whole blood samples of varying glucose levels. Specific N not provided for this section, but typically multiple points across the range are tested.

• Detection Limits (LoQ, LoB, LoD): Whole blood samples (altered to low/blank glucose levels). Specific N not provided.

• Analytical Specificity (Interference): Whole blood samples. Specific N for each substance not provided, but the study was extensive (Table 8 lists many substances).

• Other Sensitivity Studies:

  • Oxygen Sensitivity: Whole blood samples.
  • Hematocrit Sensitivity: Whole blood samples (at low, mid, high hematocrit levels).
  • Altitude: Whole blood samples.

• Method Comparison (with predicate device):

  • N = 547 (pooled data from arterial, venous, and capillary whole blood specimens).

• Matrix Equivalence:

  • N = 297 (venous and arterial whole blood specimens).

• Data Provenance:

  • The document states "collected across multiple point of care sites" for whole blood precision and method comparison studies. It also mentions "at one site" for the 20-day precision study and "at three (3) sites" for the multi-site precision study.
  • The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. However, clinical studies for 510(k) submissions are typically prospective, especially those involving patient samples collected concurrently with the study.

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

• For this type of in vitro diagnostic device (quantitative glucose measurement), the "ground truth" for the test set is established by comparative reference methods, not by expert consensus or interpretations of images by radiologists.
• The document mentions "a comparative method" (i-STAT CHEM8+ and epoc Blood Analysis System for glucose) for the method comparison study. These are legally marketed, validated laboratory or point-of-care devices that serve as the reference standard for measuring glucose.
• No human experts (like radiologists in an imaging study) are used to establish "ground truth" for quantitative lab tests in this context. Their role might be in collecting samples by healthcare professionals, but not in determining the true value of the analyte.

4. Adjudication Method for the Test Set

• Adjudication methods (e.g., 2+1, 3+1) are primarily relevant for imaging studies where human readers interpret data, and discrepancies need to be resolved.
• For quantitative in vitro diagnostic tests like glucose measurement, adjudication of results in the traditional sense is not applicable. The "ground truth" is determined by the output of a reference instrument or method, and performance is assessed by statistical agreement between the new device and the reference.

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

• No, an MRMC comparative effectiveness study was not done.
• This device is an in vitro diagnostic for quantitative measurement of glucose, not an AI-based imaging or diagnostic device that assists human readers. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

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

• Yes, the performance characteristics described (precision, linearity, detection limits, interference, sensitivity) represent the standalone performance of the device (i-STAT CG8+ cartridge with i-STAT 1 System).
• The method comparison study also evaluates the device's performance against a reference method independently. Human involvement is primarily in operating the device and collecting samples, not in interpreting or enhancing the device's quantitative output.

7. The Type of Ground Truth Used

• The ground truth for the device's performance evaluation was established using comparative reference methods (e.g., i-STAT CHEM8+ glucose test, epoc Blood Analysis System) which are considered established and validated methods for glucose quantification.
• This is akin to using a gold standard laboratory test result for comparison.

8. The Sample Size for the Training Set

• The provided document is a 510(k) summary for a point-of-care in vitro diagnostic device, not an AI/Machine Learning device.
• Therefore, there is no "training set" in the context of machine learning model development. The device relies on electrochemical detection mechanisms and pre-calibrated algorithms, not on statistical models trained on large datasets in the way AI applications do.
• The studies described are for validation (test set), not training.

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

• As explained in point 8, there is no "training set" for this device in the machine learning sense.
• The fundamental principles and calibration of the glucose sensor (glucose oxidase-based amperometric peroxide detection) are based on established chemical and electrochemical principles in analytical chemistry, refined and validated during product development.

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

Sodium measurements are used for monitoring electrolyte imbalances.

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

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

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

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

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

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

4. Adjudication Method for the Test Set

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

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

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

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

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

8. The Sample Size for the Training Set

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

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

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

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The i-STAT CG4+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of pH, PO2, PCO2, and lactate in arterial or venous whole blood in point of care or clinical laboratory settings.

pH, PO2, and PCO2 measurements are used in the diagnosis, monitoring, and treatment of respiratory disturbances and metabolic and respiratory-based acid-base disturbances.

Lactate measurements are used in (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 CG4+ test cartridge contains test reagents to analyze whole blood at the point of care or in the clinical laboratory for pH. PO2 (partial pressure of oxygen), PCO2 (partial pressure of carbon dioxide), and lactate. 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.

Here's a summary of the acceptance criteria and study information for the i-STAT CG4+ Cartridge with the i-STAT 1 System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for each performance characteristic in a pass/fail format. Instead, it presents study results and concludes that the device is "substantially equivalent" to predicate devices. However, we can infer some criteria from the reported performance, especially in precision and linearity compared to typical clinical expectations.

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

• Precision (Aqueous Materials): The "test set" for this was aqueous materials. N values for each level were 80 or 81. Provenance is not explicitly stated beyond "at one site." It's an analytical performance study, not involving human subjects directly.
• Precision (Whole Blood): The "test set" for this involved whole blood venous and arterial specimens. Sample sizes (N) varied by sample type and range for each analyte (e.g., pH venous

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