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The EasyStat 300 is designed for clinical laboratory use, making quantitative measurements of pO2 (partial pressure of oxygen), pCO2 (partial pressure of carbon dioxide), and pH (hydrogen ion activity) in whole blood (arterial/venous) samples from Li-Heparinized Syringes or Capillary Tubes. This Analyzer should only be used by trained technicians in clinical laboratories to aid in the diagnosis and treatment of patients with blood gas and/or acid-base disturbances.

Blood gases (p02, pCO2) and pH measurements in blood are used in the diagnosis and treatment of life-threatening acidbase disturbances.

The EasyStat 300 is a system for use by health care professionals to rapidly analyze whole blood samples. The analyzer incorporates a Reagent Module containing the "calibrating" solutions A2, B2, and a "conditioning" solution C2, which is also use a calibrant for the Oxygen sensor. Calibrations are performed automatically or on-demand by the user to establish the "slope" of each sensor used in the calculation of the patient sample. The EasyStat 300 uses 175μL of whole blood in the "Syringe" mode and 100μL of whole blood in the "Capillary" mode to analyze patient samples. The EasyStat 300 reports results for blood Gases (PCO2, PO2), and pH. Additionally, it provides a number of calculated parameters based on the reported results and a number of input parameters as described in the Operator's Manual. The EasyStat 300 is a microprocessor-controlled device with a touch sensitive screen that guides the operator through the different menu options and proper operation. It also incorporates a thermal printer to record all reported results and patient information as described in the Operator's Manual. The device software has incorporated routines to assist the end-user with maintenance, cleaning, and troubleshooting activities also outlined in the manual. The incorporated USB port may be used to download data and also to update the software version based on detailed instructions by Medica Corporation. The blood gas and pH sensors require calibration and cleaning after a predefined number of samples are analyzed as described in the Operator's Manual. The pH and PCO2 sensors are based on potentiometric sensor design, generating a small voltage that is dependent on the concentrations of these analytes in the patient sample. The PO2 sensor is based on amperometric sensor design that generates a small current that is dependent on the concentration of oxygen in the patient sample. Medica's EasyQC materials are specifically formulated for the EasyStat 300. The EasyStat 300 may be equipped with a Medica provided barcode scanner via a USB port to automatically enter patient sample and EasyQC material info. To maintain the performance of the analyzer Medica provides a cleaning solution and a troubleshooting kit.

Here's a breakdown of the acceptance criteria and the study that proves the EasyStat 300 device meets these criteria, based on the provided FDA 510(k) summary.

Key Findings from the Document:

• Device: EasyStat 300 Blood Gas Analyzer
• Purpose: Measures pO2, pCO2, and pH in whole blood.
• Comparison: Substantially equivalent to its predicate device, the EasyStat Blood Gas Analyzer (K021515).
• Studies Conducted: Precision (Repeatability, Reproducibility), Linearity, Method Comparison, Sensitivity, and Selectivity (Interference).
• Ground Truth for Analytical Studies: Primarily based on pre-assayed whole blood samples, aqueous QC materials, and tonometered whole blood, with comparisons against results from the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a single table labeled "Acceptance Criteria," but rather presents "Performance Specs" within the precision studies and "Status" (PASS) for linearity and method comparison, indicating adherence to pre-defined criteria. The interference study uses a "Conclusion" column based on a predefined percentage change. Based on the data provided, the acceptance criteria are inferred from the "Performance Specs" headers and the overall "PASS" status for each test.

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

• Test Set Sample Sizes:

  • Precision (Repeatability):
    • Aqueous Controls (Syringe & Capillary): 3 EasyStat 300 analyzers, 3 quality control levels, analyzed for 20 days, taking duplicate readings in the morning (AM) and afternoon (PM). This means 3 analyzers * 3 levels * 20 days * 2 readings = 360 data points per analyte.
  • Precision (Reproducibility):
    • Whole Blood (Syringe & Capillary): 5 replicates of whole blood for 5 days. (Implies 25 total replicates for each analyte per mode per unit, but the exact number of units is not specified for this particular study, though the previous study used 3 units).
  • Linearity: 9 to 11 spiked and diluted whole blood specimens, tested in triplicate on 3 EasyStat 300 analyzers. (Yields approximately 27-33 data points per analyte per analyzer for a total of 81-99 data points per analyte).
  • Method Comparison: Whole blood from "more than 200 donors," plus six modified whole blood samples. All samples were tested on the predicate devices twice and on three EasyStat 300 analyzers.
    • Syringe Mode: n=272 for PO2; n=265 for PCO2; n=268 for pH.
    • Capillary Mode: n=224 for PO2; n=219 for PCO2; n=216 for pH.
  • Sensitivity: Performed on 3 ES 300 analyzers. The number of samples per analyzer is not explicitly stated but is typically multiple replicates of blank and low-concentration samples.
  • Selectivity: The number of samples is not directly stated but involved "spiked whole blood samples collected from healthy donors" for each of the 23 interferents, tested at two "Gas/pH Levels" (A and B).

• Data Provenance:

  • The document states, "All tests on the following sections are non-clinical bench tests except for Method Comparison, which was performed on a clinical laboratory using actual venous and arterial blood."
  • The non-clinical tests used "contrived venous blood of aqueous QC materials" and "tonometered w. Blood."
  • Country of Origin: Not explicitly stated, but Medica Corporation is located in Bedford, MA, which suggests US origin for the company, implying the studies were likely conducted within the US or under US regulatory standards.
  • Retrospective or Prospective: All studies described appear to be prospective analytical studies conducted specifically for this 510(k) submission.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
• How Ground Truth Was Established (for analytical studies): The ground truth for the test sets in these analytical studies was primarily established by:
  • Reference Methods/Predicate Device: For the method comparison study, samples were run on the predicate device (EasyStat analyzer) to serve as the reference.
  • Pre-assayed Materials: Linearity studies used "pre-assayed whole blood samples."
  • Aqueous QC Materials: Precision studies extensively used "EasyQC tri-level aqueous material" provided by Medica itself.
  • Spiking/Dilution/Tonometry: Samples were manipulated (spiked, diluted, tonometered) to cover the analytical measurement range and introduce interferents, providing a controlled "ground truth" for those specific tests.
  • Known Concentrations: Sensitivity studies used the known concentrations of buffered saline or tonometered blood to determine detection limits.

These are analytical performance studies, not clinical studies involving expert interpretation of images or clinical outcomes. Therefore, the concept of "experts establishing ground truth" in the diagnostic interpretation sense (e.g., radiologists for imaging) does not directly apply here. The ground truth is laboratory-based and instrument-based.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable.
  • These are analytical performance studies of a laboratory device designed to measure specific blood gas and pH values. The "test set" in this context refers to the samples run on the device, not a set of cases requiring human interpretation and multi-expert adjudication.
  • The "ground truth" is established by reference methods or known concentrations, not by consensus of human experts adjudicating a clinical finding.

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

• MRMC Study: Not applicable.
  • The EasyStat 300 is a blood gas analyzer, an in-vitro diagnostic (IVD) device that directly measures chemical parameters in blood. It is not an AI-assisted diagnostic imaging device or a system that requires human interpretation of complex data for diagnosis. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are not relevant to this device.

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

• Standalone Performance: Yes, the entire performance evaluation described in the summary is effectively a "standalone" assessment of the EasyStat 300's analytical performance capabilities. The device processes samples and generates numerical results for pO2, pCO2, and pH without human intervention in the measurement process itself, beyond sample loading and initiation. The studies evaluate the device's accuracy, precision, linearity, sensitivity, and selectivity in producing these measurements.

7. The Type of Ground Truth Used

The ground truth used for these studies includes:

• Predicate Device Measurements: For method comparison, the results from the legally marketed predicate device (EasyStat Blood Gas Analyzer) served as the reference standard.
• Pre-assayed Whole Blood Samples: Used in linearity studies, where the expected values were established prior to testing.
• Aqueous Quality Control Materials (EasyQC): Used extensively in precision studies, these materials have known target concentrations.
• Tonometered Whole Blood: Used in sensitivity studies and for modifying samples for method comparison/linearity. Gas tonometry allows for precise control of pO2 and pCO2 levels in blood.
• Buffered Saline: Used in pH sensitivity studies as a sample with a known pH.
• Spiked and Diluted Whole Blood Samples: Used to create samples with varying known concentrations or to introduce interferents for linearity and selectivity studies.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable / Not explicitly provided for algorithm training.
  • The EasyStat 300 is an IVD device based on established potentiometric and amperometric sensor technology, not a machine learning or AI-based device that typically undergoes "training" on large datasets. Its function relies on electrochemical principles and calibration, not a trained algorithm that learns from data. Therefore, the concept of a "training set" in the machine learning sense does not apply here. The device is calibrated and validated through the analytical studies described.

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

• Ground Truth for Training Set: Not applicable.
  • As explained above, this device does not utilize an AI/ML algorithm that requires a "training set" with established ground truth in the way medical imaging AI models do. Its "training" involves chemical and electrical calibration procedures as part of its normal operation, based on known physical and chemical principles documented in the operator's manual. The validation of its performance relies on the analytical studies against predicate devices, reference materials, and controlled samples.

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