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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.

Study Details

Based on the provided text, the following information can be extracted regarding the studies conducted:

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

  • Precision (Aqueous Materials):
    • 20-day Multi-day Precision: N ranging from 80 to 85 (Table 2) per level for each analyte.
    • Multi-site and operator-to-operator precision: N = 90 (or 92 for one PO2 level) per level for each analyte (Table 3).
  • Precision (Whole Blood): N ranging from 1 to 137, depending on sample type and range (Table 4 & 5). Lithium heparin whole blood specimens (arterial, venous, capillary).
  • Linearity: The sample size for linearity studies is not explicitly stated in terms of 'N' values for individual tests, but it involved preparing "whole blood samples of varying analyte levels."
  • Limit of Quantitation (LoQ): Not explicitly stated, but implies sufficient samples to determine LoQ using two (2) i-STAT G3+ cartridge lots.
  • Interference: The study evaluated varying concentrations of 13 potentially interfering substances in whole blood samples. Not an 'N' count in the typical sense.
  • Altitude: Not explicitly stated, but "whole blood samples at relevant analyte levels across the reportable range for each test" were used.
  • Method Comparison:
    • Pooled Arterial, Venous, and Capillary: N = 487 for pH and PO2, N = 480 for PCO2 (Table 10).
    • Capillary only: N = 206 for pH, N = 204 for PO2, N = 199 for PCO2 (Table 11).
  • Matrix Equivalence: N = 221 (Table 13).
  • Data Provenance: The studies for performance characteristics appear to be laboratory-based (e.g., conducted at "one (1) site" for some precision, "three (3) sites" for multi-site precision, and "multiple point of care sites" for whole blood studies and method comparison). Given that it involved Abbott Point of Care Inc., it's likely a sponsored study. The document does not specify country of origin for the data, but the context of an FDA submission implies US-centric or international data acceptable to the FDA. The nature of these studies suggests prospective data collection for analytical validation.

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

  • For the analytical performance studies (precision, linearity, LoQ, interference, altitude), "ground truth" is established by reference methods or gravimetrically prepared standards, not typically by expert consensus.
  • For the Method Comparison study, the "ground truth" (or comparative method) was established by RAPIDPoint 500/500e (a predicate blood gas system), which is a device cleared for clinical use, not by human experts.
  • Therefore, no information on the number or qualifications of experts used for ground truth establishment is provided or relevant in this context.

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

  • The document does not describe any human adjudication method (e.g., 2+1 consensus) for establishing ground truth for the test sets. This is expected given the nature of in vitro diagnostic device validation, which relies on quantitative measurements against reference methods or predicate devices rather than human interpretation.

• 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:

  • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is primarily relevant for imaging diagnostics or other AI-assisted diagnostic tools where human interpretation is a core component. The i-STAT G3+ cartridge with the i-STAT 1 System is an in vitro diagnostic (IVD) device that provides direct quantitative measurements of blood gases and pH, without human interpretation as part of its primary function. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

  • Yes, the entire analytical and comparative performance evaluation of the i-STAT G3+ cartridge with the i-STAT 1 System represents a standalone performance evaluation. This device is an automated system providing quantitative results, and its performance is assessed intrinsically, without direct human intervention in the result generation or initial interpretation loop, other than operating the device. The reported performance metrics are for the device's output.

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

  • For analytical performance (precision, linearity, LoQ, interference, altitude): Ground truth is established by:
    • Aqueous materials with known concentrations.
    • Reference methods and standards: Traceability to NIST SRMs (National Institute of Standards and Technology Standard Reference Materials) for pH, PO2, and PCO2 measurements. For PO2 and PCO2, this involves certified specialty medical gas tanks and tonometered aqueous standards.
    • Whole blood samples (modified for specific tests like LoQ or collected for precision ranges).
  • For method comparison: Ground truth is established by comparison to a legally marketed predicate device, the RAPIDPoint 500/500e Blood Gas System.
  • For matrix equivalence: Ground truth is established by comparing the candidate specimen type (non-anticoagulated whole blood) against the primary specimen type (anticoagulated whole blood) on the same device or a similar system.

• 7. The sample size for the training set:

  • The document does not specify a "training set" size. The reported studies are for performance verification and validation of a diagnostic device, not for the development or training of an AI algorithm in the typical sense. While the device's internal algorithms would have been developed and optimized using data, that data is not described as a "training set" in this context.

• 8. How the ground truth for the training set was established:

  • As there is no "training set" described in the context of AI algorithm training, this question is not applicable. The device's underlying technology and measurement principles are based on established electrochemical and analytical methods for blood gas analysis, supported by extensive previous engineering and development rather than contemporary AI model training.

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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 <7.30 had N=20). Provenance: "data collected across multiple point of care sites." This implies prospective collection from various clinical settings.
• Linearity: Whole blood samples of varying analyte levels. Sample sizes are not explicitly stated for individual samples, but the study design evaluated the linearity of the tests using these blood samples. The regression summary provides an R² value for each analyte, indicating the strength of the linear relationship.
• Limit of Quantitation (LoQ): Whole blood altered to low concentrations. Sample size not specified, but utilized "two cartridge lots for each test."
• Limit of Blank (LoB) / Limit of Detection (LoD): Whole blood altered to "blank" and "low" lactate concentrations. Sample size not specified, but results based on the maximal value obtained for "each lot tested."
• Oxygen Sensitivity: Whole blood with high and low ranges of oxygen. Sample size not specified.
• Interference: Whole blood samples. Sample sizes not specified for individual interfering substances.
• Method Comparison:
  • pH: N=316
  • PO2: N=308
  • PCO2: N=327
  • Lactate: N=246
    Provenance: "Lithium heparin venous and arterial blood specimens were evaluated." This implies prospective collection or re-analysis of existing clinical samples. Country of origin not specified.

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

This document describes the analytical performance of an in vitro diagnostic device (blood gas and lactate analyzer). The "ground truth" for these types of studies is typically established by comparative methods using highly accurate and precise laboratory-grade instruments or reference methods. It does not involve human expert consensus in the way a medical imaging AI would for diagnosis.

For the method comparison, the comparative methods used were:

• pH, PO2, and PCO2: Radiometer ABL800 FLEX
• Lactate: epoc® Blood Analysis System

These are established clinical laboratory devices, and their measurements form the "ground truth" for comparison. The expertise lies in the certified reference materials and the robust design of these predicate devices, which are regularly calibrated and validated. No individual human experts were mentioned to establish "ground truth" for the test set in the traditional sense of consensus reading in AI studies.

4. Adjudication Method for the Test Set

Not applicable to this type of analytical performance study. Adjudication methods (like 2+1, 3+1) are typically used in studies where human interpretation (e.g., radiologist reads) needs to be reconciled to establish a ground truth for evaluating AI systems. Here, the comparison is against established analytical 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 of an in vitro diagnostic device, not a human-in-the-loop AI system for interpretation. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

This device is an analytical instrument, so its performance is inherently "standalone" in generating a numerical result. The measurements generated (pH, PO2, PCO2, Lactate) are numerical outputs. The studies described (precision, linearity, LoQ, interference, method comparison) directly assess this standalone performance against reference methods or defined standards.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation was:

• Certified Reference Materials / Aqueous Controls: For precision studies (aqueous materials).
• Measurements from Predicate Devices / Comparative Methods: For the method comparison study (Radiometer ABL800 FLEX for pH, PO2, PCO2, and epoc® Blood Analysis System for Lactate). These are considered highly accurate and serve as the clinical reference values.
• Spiked Samples / Altered Whole Blood Samples: For linearity, LoQ, LoB/LoD, and interference studies, where known concentrations or conditions are created and measured against expected values.

8. The Sample Size for the Training Set

Not applicable. This is an analytical device, not a machine learning or AI algorithm that requires a "training set" in the context of supervised learning. The device is designed based on electrochemical principles, and its performance is validated through traditional analytical studies.

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

Not applicable, as there is no "training set" for this type of device. The device's underlying principles are physics and chemistry-based rather than learned from data.

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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 ionized calcium in arterial or venous whole blood in point of care or clinical laboratory settings.

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

The i-STAT CHEM8+ test cartridge contains test reagents to analyze whole blood at the point of care or in the clinical laboratory for ionized calcium (iCa). 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 is a 510(k) summary for the i-STAT CHEM8+ cartridge with the i-STAT 1 System, specifically for the ionized calcium (iCa) test. It details various performance characteristic studies to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text. Many elements cannot be fully answered as they are not explicitly stated in this specific document, which is a summary.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the successful outcomes of the performance studies. For a clearer table, we derive the 'acceptance criteria' from the observed 'performance' meeting regulatory expectations for substantial equivalence.

Study Details:

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

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

   • Precision (Aqueous): 80-81 measurements per level (N values in Table 1). Data provenance is not specified regarding country, but it was conducted "at one site." The study design (20-day multi-day precision testing) implies a prospective collection of data for this specific study.
   • Precision (Whole Blood): 241 samples (132 venous, 109 arterial). Data collected across "three point of care sites." Data provenance regarding country or retrospective/prospective nature is not explicitly mentioned, but the context of a validation study typically implies prospective collection for this analysis.
   • Linearity: Not explicitly stated but implies multiple whole blood samples across the range (0.22 - 2.81 mmol/L).
   • LoQ/LoB/LoD: Not explicitly stated how many individual sample measurements were involved, but mentions "whole blood that was altered" and conducted over "four (4) days using two (2) cartridge lots."
   • Interference: Not explicitly stated, but each substance was evaluated by comparing a control sample to a spiked sample.
   • Method Comparison: 250 samples (N value in Table 6). Venous and arterial blood specimens were evaluated. Data provenance regarding country or retrospective/prospective nature is not explicitly mentioned.

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):

   • Not applicable for this type of device. This is an in vitro diagnostic (IVD) device for quantitative measurement. Ground truth is established by reference methods or direct measurement comparisons, not expert subjective interpretation (like radiologists for imaging). The predicate device (Epocal EPOC Blood Analysis System) served as the comparative method for the method comparison study.

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

   • Not applicable. As an IVD device measuring a quantitative analyte, there is no subjective interpretation requiring adjudication 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 not an AI-assisted diagnostic imaging device that involves human reader interpretation. It's an automated quantitative IVD system.

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

   • Yes, this is a standalone device. The performance characteristics (precision, linearity, LoQ, LoD, LoB, interference) and the method comparison against a predicate device evaluate the device itself without direct human interpretation influencing the measurement result for iCa. The system automatically performs quality checks and suppresses results if specifications are not met.

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

   • For precision studies, the 'ground truth' is the mean value derived from repeated measurements of stable materials or samples, reflecting the inherent variability.
   • For linearity studies, ground truth is established by accurately prepared samples with known concentrations.
   • For LoQ/LoB/LoD studies, ground truth is based on samples expertly prepared to very low or zero analyte concentrations.
   • For interference studies, ground truth is the expected value of the sample without the interfering substance.
   • For method comparison, the predicate device (Epocal EPOC Blood Analysis System) serves as the "ground truth" or reference for comparison.

8. The sample size for the training set:

   • Not applicable. This document describes a traditional IVD device validation, not a machine learning or AI model development that requires a "training set" in the conventional sense of AI. The device's underlying technology relies on ion-selective electrodes, not a learned model from a large dataset.

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

   • Not applicable. See point 8.

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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 glucose, and creatinine in arterial or venous 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.

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 CHEM8+ test cartridge contains test reagents to analyze whole blood at the point of care or in the clinical laboratory for glucose and creatinine. 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 the analytical performance studies for the i-STAT CHEM8+ cartridge with the i-STAT 1 System for measuring glucose and creatinine. While it details numerous performance characteristics, it does not explicitly state "acceptance criteria" for each test. However, the study design and "results met the acceptance criteria" statements imply that certain predefined thresholds were successfully achieved.

Let's break down the information available to address your request:

Acceptance Criteria and Reported Device Performance

The document doesn't provide a consolidated table of explicit acceptance criteria. Instead, it states that results "met the acceptance criteria" for linearity, and it outlines the method for identifying interference (difference between control and test samples outside of the allowed error (Ea)). For precision studies, statistical metrics like Total Standard Deviation (ST) and Coefficient of Variation (CV) are presented, and for method comparison, slope, intercept, and correlation coefficient (r) are given. The implied acceptance is that these values fall within acceptable ranges for a diagnostic device of this type.

Implied Acceptance Criteria and Reported Performance (derived from text):

Study Details:

1. Sample Size used for the Test Set and Data Provenance:

   • Precision (Aqueous): N=80 or 81 for each level of Creatinine and Glucose. Data provenance is not specified (e.g., country of origin) but implied to be laboratory-based ("one site"). It is an analytical performance study, not a clinical study on patient samples.
   • Precision (Whole Blood): Sample sizes vary per site and level (e.g., N=14 to N=21). The study used "venous whole blood (native or altered) samples." The study was conducted at "3 point of care sites."
   • Linearity: Whole blood samples of "varying analyte levels" were prepared. Specific N not provided for this particular section.
   • LoQ, LoB/LoD: Whole blood samples were "altered to low glucose" or "blank" concentrations. Specific N not provided for this section.
   • Hematocrit Sensitivity: Three hematocrit levels evaluated across four glucose levels. Specific N not provided.
   • Oxygen Sensitivity: High and low ranges of oxygen. Specific N not provided.
   • Altitude: Not explicitly stated, but results given for "average measured altitude." Specific N not provided.
   • Interference: Whole blood samples based on CLSI guidelines. Specific N not provided, but multiple substances tested.
   • Method Comparison: N=185 for Glucose, N=180 for Creatinine. Used "Venous and arterial blood specimens" for the i-STAT device and "plasma specimens" for the predicate device. Data provenance is not specified.

   Overall Provenance: The studies are "analytical performance" studies, primarily laboratory-based and conducted on various prepared or native samples. There is no indication of geographic origin or whether samples were retrospective or prospective, though for analytical performance, prospective collection for the purpose of the study is common.

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

   • This is an in vitro diagnostic (IVD) device. The "ground truth" for analytical performance studies is established by reference methods or highly accurate laboratory analyzers (the "comparative method"), not by human experts interpreting images or clinical outcomes. In this case, "ground truth" (or comparative method) for the method comparison study was the Beckman DxC, a laboratory analyzer.

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

   • Not applicable. This is an IVD device measuring analytes, not interpretations of images or clinical assessments requiring human adjudication.

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 an IVD device for measuring chemical analytes in blood, not an imaging device assisted by AI to be read by human experts.

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

   • The i-STAT device functions as a standalone analyzer that quantifies glucose and creatinine. The performance studies described (precision, linearity, LoQ, LoD, interference, method comparison) are standalone performance studies of the device's ability to measure these analytes. While a human initiates the test and interprets the quantitative result, the measurement process itself is automated (algorithm only).

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • For the method comparison study, the ground truth was essentially the measurements from a legally marketed predicate device (Beckman DxC), which serves as the comparative method in analytical validation. For other analytical performance studies (precision, linearity, LoQ/LoD), the "ground truth" is based on the known concentrations of prepared reference materials or controls, or the statistical evaluation of repeated measurements of samples.

7. The sample size for the training set:

   • The documentation does not discuss a "training set" in the context of machine learning or AI models, as this is a traditional IVD device based on electrochemical principles, not an AI/ML device. Therefore, no separate training set is mentioned or applicable in the way it would be for an AI-powered diagnostic.

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

   • Not applicable, as there is no explicitly mentioned "training set" in the context of an AI/ML model for this traditional IVD device.

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

Sodium measurements are used for monitoring electrolyte imbalances.

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

Interference:

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

Limit of Quantitation (LoQ):

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

2. Sample Sizes and Data Provenance

• Precision (Aqueous Materials):

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

• Precision (Whole Blood):

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

• Linearity:

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

• Limit of Quantitation (LoQ):

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

• Interference:

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

• Method Comparison:

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

3. Number of Experts and Qualifications for Ground Truth

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

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

8. The Sample Size for the Training Set

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

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

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

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The i-STAT Alinity System with i-STAT Glucose test is intended for use or clinical laboratory settings. The i-STAT Alinity System with Glucose test is intended for the quantitative measurement of glucose in arterial and venous whole blood.

Glucose measurements are used in the diagnosis, monitoring, and treatment of carbohydrate metabolism disorders including, but not limited to, diabetes mellitus, idiopathic hypoglycemia, and pancreatic islet cell carcinoma. The i-STAT Glucose test with the i-STAT Alinity System has not been evaluated in neonates.

For in vitro diagnostic use.

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

The i-STAT 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 test reagents which are located on the sensors. 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.

Here's a breakdown of the acceptance criteria and the study used to prove the device meets them, based on the provided text:

Device: i-STAT Alinity System with i-STAT Glucose test

Intended Use: Quantitative measurement of glucose in arterial and venous whole blood for diagnosis, monitoring, and treatment of carbohydrate metabolism disorders.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" vs. "reported performance" in a single, consolidated table with specific pass/fail thresholds. Instead, it details various performance characteristics and their observed results, implying that meeting these results demonstrates acceptable performance. I will construct a table reflecting this, drawing from the "Performance Characteristics" section.

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

This section generally refers to the performance studies.

• Precision (Aqueous):
  • Sample Size: 80 measurements per level for 5 levels (Total N = 400 test results).
  • Data Provenance: Not explicitly stated, but typically performed in a controlled laboratory setting (likely within the US, given the FDA submission). Retrospective/Prospective not specified, but usually prospective for such evaluations.
• Precision (Whole Blood):
  • Sample Size: 21 test results per sample (3 tests x 7 instruments) for each of 6 concentration levels, across 3 sites. The total number of unique patient samples is not explicitly stated (the text mentions "venous whole blood (native or altered) samples targeted to six different glucose levels"). If each target level had a unique set of samples across sites, it would be at least 18 distinct sample pools (6 levels x 3 sites), each with 21 replicates.
  • Data Provenance: Performed at 3 point-of-care sites. Likely prospective, collecting fresh whole blood samples. Country of origin not specified, but likely US.
• Linearity:
  • Sample Size: Not explicitly stated as a number of patient samples. It evaluated a "series of glucose concentration levels in whole blood."
  • Data Provenance: Not specified.
• Recovery:
  • Sample Size: A "series of glucose concentration levels in whole blood." Not a specific count.
  • Data Provenance: Not specified.
• Limit of Quantitation (LoQ):
  • Sample Size: Not explicitly stated, involved "whole blood that was altered to low glucose concentrations (< 20 mg/dL)."
  • Data Provenance: Not specified.
• Interference:
  • Sample Size: Evaluated "whole blood test samples based on CLSI EP07-A2." Not a specific count of unique samples, but rather a set of samples spiked with various compounds.
  • Data Provenance: Not specified.
• Anticoagulant Study:
  • Sample Size: 40 blood samples.
  • Data Provenance: Not specified.
• Altitude Study:
  • Sample Size: Not a count of patient samples, but evaluated against "commercially available i-STAT Glucose control materials that represented 3 Glucose levels."
  • Data Provenance: Not specified, likely laboratory simulation.
• Oxygen Study:
  • Sample Size: "whole blood samples... at four glucose levels." Not a specific count.
  • Data Provenance: Not specified, likely laboratory simulation.
• Method Comparison with Predicate Device:
  • Sample Size: 237 subjects.
  • Data Provenance: Conducted across 3 point-of-care sites. Likely prospective collection of fresh venous or arterial whole blood samples. Country of origin not specified, but again, likely US.

3. 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 (IVD) device for quantitative measurement of glucose. The "ground truth" or reference values are established by laboratory methods, typically using a validated reference method (like hexokinase method on a central lab analyzer) or traceable reference materials, not expert human interpretation. The clinical method comparison is against a legally marketed predicate device, not against expert consensus.

4. Adjudication method for the test set

Not applicable. This device provides a quantitative measurement of a biomarker. "Adjudication" typically refers to resolving discrepancies in human interpretation or classification, which isn't the primary mechanism for establishing ground truth for a glucose measurement device. The "ground truth" for the device's accuracy would be established by comparison to a traceable reference 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 an in vitro diagnostic device for quantitative chemical measurement, not an AI-assisted diagnostic imaging or interpretation device that would involve human "readers" or "AI assistance."

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

Yes. All performance characteristics listed (Precision, Linearity, Recovery, LoQ, Interference, Anticoagulant, Altitude, Oxygen studies) represent the standalone performance of the i-STAT Alinity System with the i-STAT Glucose test. The "Method Comparison with Predicate Device" also evaluates the standalone performance of the new device against another standalone device. There is no AI component or human-in-the-loop aspect described for the glucose measurement itself; the device provides a direct quantitative result.

7. The type of ground truth used

The type of ground truth used for the analytical performance studies (Precision, Linearity, Recovery, LoQ, Interference) would typically be:

• For Precision (Aqueous) and Linearity: Certified reference materials (e.g., NIST SRM965 is mentioned for test traceability) or highly characterized control materials with assigned values. For linearity, serially diluted or spiked samples measured against a reference method.
• For Precision (Whole Blood) and Method Comparison: Typically, a validated and highly accurate laboratory reference method for glucose measurement (e.g., spectrophotometric hexokinase method) performed on a central laboratory analyzer would serve as the "ground truth" or comparator for blood samples. The document states a comparison to the predicate device (i-STAT 1 Wireless Analyzer) for method comparison, which itself would have been validated against such a reference.
• For Recovery, LoQ, Interference, Anticoagulant, Altitude, Oxygen Studies: These studies involve specific sample preparations (e.g., spiked samples, altered concentrations, different oxygen levels) and the "ground truth" would be either the known prepared concentration or the measurement by a trusted reference method.

8. The sample size for the training set

Not applicable. This is a traditional in vitro diagnostic device, not an AI/Machine Learning device that requires a "training set." Its operation is based on established electrochemical principles, not on learning from data.

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

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

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