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The Stat Profile® Prime ABG Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of pH, PCO2, and PO2 in heparinized whole blood.

pH, PCO2, PO2: Whole blood measurement of blood gases is used in the diagnosis and treatment of life-threatening acid-base disturbances.

The Stat Profile Prime Auto QC Cartridge ABG is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of the Stat Profile Prime ABG Analyzer.

The Stat Profile Prime Ampuled Control ABG/CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Stat Profile Prime ABG Analyzer.

The Stat Profile Prime Calibrator Cartridge ABG is intended for the calibration of pH, PCO₂, and PO₂ using the Stat Profile Prime ABG Analyzer.

The Stat Profile® Prime ABG Analyzer System is a small, low cost blood gas analyzer for laboratory use. The sensors and flow path have been integrated into one replaceable microsensor card, which is replaced periodically according to usage. The product, consumables, installation instructions and packaging are designed for easy customer installation. The Stat Profile® Prime ABG Analyzer System is not intended for Point of Care Use.

Whole blood specimens are aspirated into the analyzer's microsensor card from syringes, tubes, or capillary blood collection devices using a peristaltic pump and a sampling probe. The disposable microsensor card contains the analytical flow path and the measurement sensors (PCO2, PO2, and pH). Once the analysis measurement is complete, the whole blood specimen is automatically flushed out of the microsensor card flow path and into a self-contained waste collection bag contained within the disposable calibrator cartridge.

As in the predicate Stat Profile® Prime CCS Analyzer System (K131703), the Stat Profile Prime ABG Analyzer will have an enhanced test menu and multiple quality control options. Both traditional Internal and External liquid QC shall be offered, as well as an on-board Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly.

As with the predicate, the Stat Profile Prime ABG Analyzer is microprocessor-based and incorporates:

• traditional sensor technology to measure blood pO₂
• . ion selective electrode technology to measure PCO2 and, pH

Liquid quality control materials are available as internal auto-cartridge quality control packs and as external ampules. The sampling, calibration and quality control functions are fully automated.

Internal Calibration standards with dissolved gases are provided in sealed pouches eliminating the need for users to calibrate the blood gas electrodes using external compressed gas cylinders. The Calibration Cartridges contain aqueous solutions within individual flexible bags housed in a cardboard box and a flexible waste bag. Each bag includes a fitment with a septa that is pierced during the insertion of the cartridge into the analyzer.

The external glass ampule controls contain a buffered bicarbonate solution with a known pH level. The solutions are equilibrated with known levels of O2, CO2, and N2. Each ampule contains 1.7 ml volume.

The internal auto QC cartridge consists of 3 flexible bags within a cardboard carton. Each bag contains an aqueous quality control material for monitoring the measurement of pH, PCO2 and PO2. The aqueous quality control materials are composed of a buffered bicarbonate solution, with a known pH. Solutions are equilibrated with known levels of O2, CO2, and N2. Each bag contains a minimum volume of 100 mL.

The Stat Profile Prime ABG Analyzer accepts Lithium heparin whole blood sample from syringes, open tubes, small cups, and capillary tubes. The minimum sample size for both syringe and capillary samples analysis is 50 µL.

Measured Parameters:
The Stat Profile Prime ABG Analyzer measures pH. PCO2, and PO2.

Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Stat Profile® Prime ABG Analyzer System, Stat Profile Prime Auto QC Cartridge ABG, Stat Profile Prime Ampuled Control ABG/CCS, Stat Profile Prime Calibrator Cartridge ABG

Indications for Use: The Stat Profile Prime ABG Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of pH, PCO2, and PO2 in heparinized whole blood. (Similar indications are provided for the QC and Calibrator cartridges, intended for monitoring performance and calibration, respectively).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria values for bias, precision, or linearity. Instead, it presents the study results for these performance metrics and implies their acceptability by concluding the device is "substantially equivalent" to predicate devices. For the purpose of this table, "Reported Device Performance" will reflect the ranges found in the study results. The ranges provided are from the various analyzers tested (Analyzer #1, #2, #3).

Note: The document explicitly states "Bench testing was completed to demonstrate that the Stat Profile Prime ABG Analyzer is substantially equivalent in performance, safety and efficacy to the Stat Profile Prime CCS Analyzer System." and "The comparison data for all parameters for the Stat Profile Prime analyzers shows good correlation with the reference analyzer across the claimed measurement range for all parameters." indicating that the reported performance met the unstated acceptance criteria for substantial equivalence.

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

• Method Comparison (Whole Blood Patient Specimens):
  • Sample Size: A minimum of 150 whole blood specimens were analyzed for each parameter (pH, pCO2, pO2). The exact 'N' values vary slightly for each parameter and analyzer combination (e.g., pH: 170-187, pCO2: 161-168, pO2: 153-165).
    • Additionally, "altered samples" were included: pH (14-18), pCO2 (10-16), pO2 (9-11).
  • Data Provenance: Retrospective, from hospital patients ("Discarded heparinized arterial whole blood specimens from hospital patients"). Some samples were also prospectively collected and altered ("venous whole blood from male and female donors was tonometered to cover the analytical measurement range"). The country of origin of the data is not specified but is implied to be from the USA given the FDA submission.
• Precision/Reproducibility Studies:
  • Run-to-Run Precision (Whole Blood): Single whole blood sample analyzed in triplicate over 10 separate runs (N=30 per analyzer for each parameter).
  • Run-to-Run Precision (Control Solutions): Quality Control solutions (3 levels) analyzed in duplicate, two runs per day for a total of 40 runs (N=240 per parameter/level).
  • Within-Run Precision (Whole Blood & Control Solutions): One run of 20 replicates (N=20 per analyzer for each parameter/level).
  • Data Provenance: Not explicitly stated, but clinical laboratory settings are mentioned for the device's intended use, suggesting an internal lab setting for these studies.
• Linearity Testing:
  • Sample Size: 10-14 levels were prepared for each parameter. Each level was analyzed in duplicate on each of the three test analyzers.
  • Data Provenance: Not explicitly stated, but implied to be from an internal lab setting.

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

The document describes performance testing against a "reference analyzer" (Stat Profile Prime CCS Comp analyzers) for method comparison and linearity studies.

• Method Comparison and Linearity: The ground truth was established by the Stat Profile Prime CCS Comp analyzers. These are other devices from the same manufacturer, acting as the reference method.
• Precision Studies: The ground truth for precision studies is the measurement itself, demonstrating the device's consistency, not comparison to an expert.

No human experts were used to establish the ground truth for the test set. The comparative method was another medical device.

4. Adjudication Method for the Test Set

Since the ground truth was established by a reference medical device (Stat Profile Prime CCS Comp analyzers), no human adjudication method was employed. The quantitative measurements from the test device were compared directly to the quantitative measurements from the reference device.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document pertains to an in vitro diagnostic (IVD) device for quantitative biochemical measurements, not an image-based diagnostic or AI-assisted diagnostic device where human reader performance is typically assessed.

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

Yes, the studies described are standalone performance evaluations of the device (analyzer and its consumables/controls). The method comparison, precision, and linearity studies directly assess the device's analytical performance without human intervention in the measurement process itself or its interpretation for the purpose of the study. The device is intended for use by healthcare professionals in clinical laboratory settings, implying that human professionals operate the device and interpret its results within a clinical context. However, the performance studies outlined here are standalone in terms of the device's measurement accuracy and precision.

7. The Type of Ground Truth Used

• Method Comparison and Linearity: The ground truth was established by comparison to a legally marketed predicate device (Stat Profile® Prime CCS Analyzer System) acting as the reference method. The document states: "The Prime CCS Comp analyzers were used to establish the target value of each blood level for each parameter."
• Precision/Reproducibility: The ground truth for these studies is the measured value itself, with the goal of demonstrating consistency and repeatability, rather than accuracy against an external standard. For control solutions, the "Target Range" acts as a reference for expected values.
• Traceability: For pH, pCO2, and pO2, the standards and reagents are traceable to NIST (National Institute of Standards and Technology) primary reference materials. This establishes a higher-level metrological ground truth for calibration.

8. The Sample Size for the Training Set

This document describes the regulatory submission for a medical device (a blood gas analyzer). It does not discuss a "training set" in the context of an AI/machine learning model. The device uses traditional sensor technology and algorithms, not machine learning that would require a separate training phase with a distinct dataset.

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

As mentioned above, there is no "training set" in the context of AI/ML for this device. The device relies on established electrochemical and optical principles for measurement. Its calibration system for the training set (if we interpret "training set" loosely as the data used to fine-tune the device's internal calibration parameters during development) would have been established using reference materials traceable to NIST standards. However, this is part of standard IVD development and not ML training.

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