Search Results

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.

Ask a specific question about this device