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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).

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

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

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

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

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

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

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

The i-STAT 1 analyzer is a handheld, in vitro diagnostic analytical device designed to run only i-STAT test cartridges. The instrument interacts with the i-STAT CG8+ cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).

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

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

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

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

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

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

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The 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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