The Origin™ system is comprised of the Origin™ inline device and Origin™ App. The Origin™ system is indicated for use in conjunction with a compatible drainage system by a trained healthcare professional during postoperative recovery in a hospital setting. The Origin™ inline device is placed between the surgical drainage catheter and reservoir system to continuously measure the pH of drainage fluid to provide additional information on effluent characteristics. The device is not intended to diagnose or treat any clinical condition.

Origin™ is an inline biosensor system that is integrated between an off-the-shelf drainage catheter and reservoir system and is designed to monitor real-time changes in drained effluent characteristics. Origin™ system continuously monitors the pH of wound drainage. Origin™ App is a mobile application for displaying and analyzing data from the Origin™ inline device. Origin™ App is pre-installed on an Android mobile device supplied by FluidAI. The Origin™ inline device connects to Origin™ App via Bluetooth.

The provided FDA 510(k) clearance letter and summary document for the Origin™ system primarily focus on the non-clinical performance of the device, particularly its analytical performance in measuring pH. It does not describe a study involving human readers or multi-reader multi-case (MRMC) comparative effectiveness. Therefore, some of the requested information, particularly related to clinical studies, human expert involvement in ground truth establishment for a test set, and MRMC studies, is not present in the provided text.

However, based on the analytical performance studies described, we can extract the following information:

1. Acceptance Criteria and Reported Device Performance

The document implicitly defines acceptance criteria through the results presented. The "Overall" pH range for linearity, for example, is 0.1446 pH units from 5 to 9, and 0.1 pH units from 4-10 using buffer solutions. For precision, the "Within-Laboratory" precision (total) is 0.0922 SD (1.46% CV) for sample A (pH ~6.3) and 0.1650 SD (2.10% CV) for sample B (pH ~7.85).

Since the document presents the results of studies conducted to demonstrate that the device meets some internal performance goals, we can infer that the reported values met their pre-specified acceptance criteria for analytical performance. However, the specific numerical acceptance thresholds (e.g., "Max Deviation from Linearity must be

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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, 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.

The i-STAT CG4+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of 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, metabolic, and 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+ cartridge is used with the i-STAT 1 analyzer as part of the i-STAT 1 System to measure pH, partial pressure of oxygen (PO2), and partial pressure of carbon dioxide (PCO2) in arterial, venous or capillary whole blood and to measure lactate (Lac) in arterial or 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 CG4+ 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 CG4+ 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 i STAT CG4+ cartridge. The i-STAT 1 analyzer interacts with the i-STAT CG4+ 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 functions as the main user interface and the electromechanical interface to the test cartridge. All within-cartridge fluid movements, as well as the timing and heating of the test cycle, are automated and controlled without user intervention by system software embedded within the analyzer.

Since the provided text describes a medical device (i-STAT CG4+ cartridge with the i-STAT 1 System), it is an in vitro diagnostic (IVD) device, not an AI/ML diagnostic system. Therefore, many of the typical acceptance criteria and study components for AI/ML devices (e.g., number of experts, adjudication methods, MRMC studies, training set details) are not applicable to this type of device.

This clearance is based on demonstrating substantial equivalence to a predicate device (i-STAT G3+ cartridge) through analytical performance studies, rather than a comparative effectiveness study against human readers or specific performance benchmarks tied to a disease outcome.

Here's an organized breakdown of the acceptance criteria and study information provided for the i-STAT CG4+ cartridge, focusing on what is relevant for an IVD device and clearly indicating where AI/ML-specific criteria do not apply:

Acceptance Criteria and Device Performance for i-STAT CG4+ Cartridge

The acceptance criteria for this in-vitro diagnostic device are based on demonstrating robust analytical performance and substantial equivalence to a legally marketed predicate device (i-STAT G3+ cartridge). The studies focus on precision, linearity, traceability, detection limits, and analytical specificity (interference and oxygen sensitivity), as well as method comparison with established laboratory methods.

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for an IVD device like this are generally implied by the successful demonstration of performance characteristics within clinically acceptable ranges and alignment with the predicate device. The tables below summarize the reported device performance, which implicitly met the internal acceptance criteria for substantial equivalence.

Precision/Reproducibility (Aqueous Materials - Sampled Performance Ranges)

Linearity/Assay Reportable Range (Regression Summary)

Detection Limits (LOQ and LOD)

Analytical Specificity (Interference): A substance was identified as an interferent if the difference in means (or medians) between the control and test samples was outside of the allowed error (±Ea) for the i-STAT test.

• Bromide: Interferent at 37.5 mmol/L (decreased lactate results >10.0 mmol/L).
• Glycolic Acid: Interferent at 10.0 mmol/L (increased lactate results >0.8 mmol/L).
• Other substances listed (Table 11) showed No Interference.

Altitude Study (Correlation Coefficient and Slope Acceptance)

Method Comparison (Bias at Medical Decision Levels)
Bias at medical decision levels (MDL) needs to be clinically acceptable.

• pH: Biases ranging from -0.0080 to -0.0166 at various MDLs.
• PO2: Biases ranging from -0.6 to -3.3 at various MDLs.
• PCO2: Biases ranging from 0.67 to 3.49 at various MDLs.
• Lactate: Bias of -0.140 at 5.00 mmol/L MDL.
  These biases met the implicit acceptance criteria for substantial equivalence to the comparative methods.

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

For an IVD device, there isn't a "test set" in the AI/ML sense, but rather a series of analytical performance studies using different types of samples.

• Precision (Aqueous Materials):
  • 20-Day Precision: 83-84 replicates (N) per fluid level per test.
  • Multi-site Multi-day Precision: 90-91 replicates (N) per fluid level per test across 3 point-of-care sites.
• Precision (Whole Blood):
  • Clinical Precision: N varied by sample range and test, ranging from 3 to 154 for various analytes and sample types (venous, arterial, capillary).
  • Within-Sample (Native Capillary): 60 test results (30 subjects, duplicate tests).
  • Within-Sample (Contrived Capillary): N=32 for L1 pH/PO2/PCO2, N=22 for L2 pH/PO2/PCO2 (from 27 subjects, duplicate tests).
• Linearity: Whole blood samples of varying analyte levels. Specific N not provided per sample, but regression analysis was performed.
• Detection Limit (LoQ/LoB/LoD): Whole blood samples (altered to low/blank analyte levels).
• Interference: Whole blood samples (spiked with potentially interfering substances).
• Oxygen Sensitivity: Whole blood samples (altered to 4 lactate levels).
• Altitude: Whole blood samples (relevant analyte levels).
• Method Comparison:
  • Arterial/Venous/Capillary pooled for pH, PO2, PCO2: 551-557 specimens.
  • Arterial/Venous pooled for Lactate: 345 specimens.
  • Capillary only for pH, PO2, PCO2: 184-193 specimens (native and contrived).
  • Native Capillary (Bias at MDL): 175-178 specimens.
• Matrix Equivalence: 228-289 specimens (arterial/venous whole blood, with and without anticoagulant).

Data Provenance:

• The studies were conducted by Abbott Point of Care Inc. and at "multiple point of care sites" for clinical precision and method comparison.
• The exact country of origin is not specified but implied to be across various clinical settings where the device might be used.
• The studies appear to be prospective analytical studies designed to evaluate device performance under controlled conditions, not retrospective real-world data collection.

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

Not Applicable. For an IVD device, the "ground truth" is established through the measurement by a comparative/reference method (e.g., RAPIDPoint 500/500e, or the i-STAT G3+ predicate device), not through human expert consensus or labeling. The device's performance is compared against these established analytical methods.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1) are for establishing ground truth from multiple human readers/experts, which is not relevant for calibrating the analytical performance of an IVD device.

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

No. MRMC studies are typically performed for AI/ML diagnostic aids where the AI is intended to assist a human reader, and the study measures the improvement in human reader performance (e.g., diagnostic accuracy, sensitivity, specificity) with and without AI assistance. This device is an analytical instrument for quantitative determination of blood gases and lactate, not an AI/ML diagnostic aid.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes (in principle). The listed performance studies (precision, linearity, detection limits, interference, method comparison) assessed the analytical performance of the device itself (i-STAT CG4+ cartridge with the i-STAT 1 System) independent of a human's interpretative role. The device measures and provides a numerical output for pH, PO2, PCO2, and Lactate. The "human-in-the-loop" here is the operator performing the test, not interpreting an AI-generated image or signal.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of this IVD device was established in two primary ways:

• Reference Materials: Traceability to NIST SRMs (for pH, PO2, PCO2) or a manufacturer's working calibrator (for Lactate). These are analytical standards.
• Comparative Methods: Established and legally marketed laboratory instruments (e.g., RAPIDPoint 500/500e for pH/PO2, and the i-STAT G3+ predicate device for PCO2 and the i-STAT CG4+ (K200492) for Lactate).
• Defined Concentrations: For linearity, LoQ, LoB, LoD, interference, and oxygen sensitivity studies, samples were prepared with known or targeted analyte concentrations.

This is distinct from clinical diagnostic "ground truth" which might come from pathology, long-term outcomes, or expert consensus in fields like radiology.

8. The Sample Size for the Training Set

Not Applicable. This is an IVD device that does not use AI/ML, so there is no concept of a "training set" for an algorithm. The device measures chemical analytes via established electrochemical principles.

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

Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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The ABL90 FLEX PLUS System is an in vitro diagnostic, portable, automated analyzer that quantitatively measures pH, blood gas (p02), Oximetry (s02, ctHb, FCOHb, FCOHb, FMetHb, and FHHb), in heparinized arterial and venous whole blood.

The ABL90 FLEX PLUS System is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient, or point-of-care setting. These tests are only performed under a physician's order.

pH and pO2: pH and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.

sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin plus reduced hemoglobin.

ctHb (Total Hemoglobin): Total hemoglobin measure the hemoglobin content of whole blood for the detection of anemia.

FO2Hb: Oxyhemoglobin as a fraction of total hemoglobin.

FCOHb: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.

FMetHb: Methemoglobin as a fraction of total hemoglobin.

FHHb: Reduced hemoglobin as a fraction of total hemoglobin.

The ABL90 FLEX PLUS System consists of the ABL90 FLEX PLUS analyzer, sensor cassette and solution pack consumables, and related accessories for the analyzers. The sensor cassettes, solution packs and related accessories are compatible with both analyzers. Multiple versions of the sensor cassettes are available. The sensor cassette versions vary in the maximum number of tests and availability of sensors for use. The solution pack is available in two versions, differing in the number of activities available.

The FDA 510(k) summary for the Radiometer ABL90 FLEX PLUS System provides detailed information about the device's analytical performance testing to demonstrate its substantial equivalence to its predicate device.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the reported performance metrics (linearity, detection limits, precision, bias) and the comparison to the predicate device. The goal is to show that the ABL90 FLEX PLUS System performs comparably to the predicate (ABL90 FLEX PLUS, K160153) and adheres to recognized standards (CLSI guidelines).

The summary does not explicitly present a table of "acceptance criteria" and "reported performance" side-by-side in a single formatted table. However, the various tables throughout the "Analytical Performance Testing Summary" section serve this purpose by presenting the measured performance of the ABL90 FLEX PLUS System against unstated, but implied, acceptable ranges or a comparison to the predicate.

Here's a synthesized representation of the reported device performance for key analytical parameters, effectively serving as the "reported device performance":

Key takeaway for "Acceptance Criteria": The general acceptance criterion for this 510(k) submission is to demonstrate "substantial equivalence" to the predicate device (ABL90 FLEX PLUS, K160153). While explicit numerical acceptance criteria are not presented in this summary document, the testing aims to show that the new device's performance (linearity, detection, precision, bias, interference) is comparable to the predicate and/or meets recognized clinical and analytical standards as outlined in CLSI guidelines.

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

• Linearity Testing: Numbers of samples are not explicitly stated for linearity testing, but it was conducted "in general accordance with CLSI EP06... and EP39."
• Detection Capability (LoB, LoD, LoQ): Numbers of samples are not explicitly stated.
• Precision (using stable, aqueous ampoule-based QC material):
  • N = 243 or 244 for each QC ampoule level and parameter.
  • Data Provenance: Testing occurred at three external sites. The specific countries of origin are not mentioned, but "external sites" suggests a multi-site study. This appears to be a prospective study, as it's part of the premarket submission.
• Precision (using blood):
  • N varies by parameter and test interval, ranging from 4 to 188 samples.
  • Data Provenance: Not explicitly stated, but implies collected from blood samples (human derived). Likely prospective data collected for the study.
• Method Comparison (Bias):
  • N varies by parameter, blood type, and mode (S65/SP65), ranging from 26 to 235 samples (arterial/venous blood).
  • Data Provenance: Not explicitly stated, but implies collected from patient blood samples. This would be prospective data collected specifically for the method comparison study.

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

This device (ABL90 FLEX PLUS System) is an in vitro diagnostic (IVD) analytical instrument. The ground truth for its performance is established through reference methods, defined concentrations of analytes in quality control materials, and comparison to a legally marketed predicate device, not typically through human expert adjudication of images or clinical outcomes that require multiple medical professionals.

Therefore, the concept of "experts establishing ground truth" in the way it might apply to an AI imaging device (e.g., radiologists reviewing scans) is not directly applicable here. The "experts" would be the laboratory personnel and analytical chemists who perform the testing and ensure adherence to CLSI guidelines. Their qualifications are implicitly assumed to be appropriate for performing such technical laboratory studies.

4. Adjudication Method for the Test Set

Not applicable for an IVD analytical instrument. Ground truth is established by reference methods, certified materials, and comparison with a predicate device, not by expert adjudication.

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

Not applicable. MRMC studies are typically performed for imaging devices or diagnostic aids where human interpretation is a key component, often comparing AI-assisted vs. unassisted human performance. This device is an automated, quantitative analytical instrument.

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

Yes, the performance data presented (linearity, detection/quantitation, precision, bias, interference) are all measures of the standalone analytical performance of the ABL90 FLEX PLUS System. The device provides quantitative measurements autonomously without continuous human interpretation required for each result.

7. The Type of Ground Truth Used

The ground truth used for this device's analytical performance studies are:

• Reference materials/Certified Analytes: For linearity, detection, and precision testing. These are materials with known, precisely measured concentrations of the analytes (pH, pO2, ctHb, sO2, etc.).
• Predicate Device Measurements: For method comparison/bias studies, the measurements from the legally marketed ABL90 FLEX PLUS (K160153) served as the comparator (or "ground truth" to determine bias relative to the predicate).
• CLSI Guidelines: The studies adhere to relevant Clinical and Laboratory Standards Institute (CLSI) guidelines (e.g., EP06, EP39, EP17-A2, EP05-A3, EP09c, EP07, EP37), which define accepted methodologies and performance characteristics for IVD devices.

8. The Sample Size for the Training Set

Not applicable. This document describes the performance testing for a finished IVD product, not the development or training of a machine learning model. IVD devices like the ABL90 FLEX PLUS System are based on established analytical principles (potentiometry, optical, spectrophotometry) and calibrated using defined reference materials, not "trained" on a dataset in the AI sense.

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

Not applicable, as there is no "training set" in the context of this device's analytical principles. Ground truth for calibration and development of such instruments is established through rigorous analytical chemistry methods using highly purified and characterized reference standards.

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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 Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of pH, Partial Pressure of Carbon Dioxide (pCO2), Partial Pressure of Oxygen (pO2), Hematocrit, Sodium, Chloride, Ionized Calcium, Ionized Magnesium, Gucose, and Lactate in heparinized capillary whole blood.

Indication for Use: pH, pCO2, pO2 measurements are used in the diagnosis and treatment of life-threatening acid base disturbances.

Hematocrit (Hct) measurements of the packed red blood cell volume are used to distinguish normal states, such as anemia and erythrocytosis.

Glucose (Glu) measurement is used in the diagnosis and treatment of carbohydrate metabolism distuding diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Lactate (lactic acid) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis.

Sodium (Na) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance.

Potassium (K) measurements are used in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.

Chloride (Cl) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Ionized Calcium (iCa) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Ionized Magnesium (iMg) measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).

The Stat Profile Prime Plus Analyzer System is an analyzer for use in hospital laboratory and point-of-care settings. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).

The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed.

Primary Sensor Card Port:
There are two options for the primary sensor card:

• Primary Sensor Card 1 shall enable and report the following listed analytes: .
  • PO2, PCO2, pH, Hct, tHb, SO2, O2Hb, COHb, MetHb, HHb, Glu, Lactate, Sodium, o Potassium, Chloride, Calcium, Ionized Magnesium
• Primary Sensor Card 2 shall enable and report the following listed analytes: .
  • PO2, PCO2, pH, Hct, tHb, SO2, Glu, Lactate, Sodium, Chloride, Calcium, Ionized o Magnesium

Auxiliarv Sensor Card Port:
The reporting of Creatinine and BUN parameters (or not reporting them) shall be determined by the selection of the Auxiliary Sensor Card

• . Auxiliary Sensor Card 1 shall enable the Creatinine and BUN parameters
• Auxiliary Sensor Card 2 shall be a "dummy" sensor card and will not report any parameters. .

As with the predicate, the Stat Profile Prime Plus Analyzer is a blood gas, co-oximetry, electrolyte, chemistry, and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control is available, as well as an on-board Quality Management System (QMS), and an electronic monitoring approach that ensures the analyzer is working properly.

The Stat Profile Prime Plus Analyzer accepts samples from syringes, open tubes, and capillary tubes. The sample size for analysis is 135 µL for the complete test panel or 90 µL for the capillary panel.

Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.

Stat Profile Prime Plus Analyzer System Components:
The Stat Profile Prime Plus Analyzer System is comprised of the following components.

• . Stat Profile Prime Plus Analyzer System
• Primary Sensor Cartridge .
• Auxiliary Sensor Cartridge .
• Stat Profile Prime Plus Auto-Cartridge Quality Control Pack
• Stat Profile Prime Plus Calibrator Cartridge
• Stat Profile Prime Plus External Ampule Control
• . IFU/Labeling

Sample Types:
The Stat Profile Prime Plus Analyzer System accepts lithium heparinized arterial, venous, and capillary whole blood.

Measured Parameters:
The Stat Profile Prime Plus Analyzer measures:

• . pH
• . Partial Pressure of Carbon Dioxide (pCO2)
• Partial Pressure of Oxygen (pO2) ●
• Hematocrit (Hct) ●
• . Glucose (Glu)
• . Lactate (Lac)
• Sodium (Na) ●
• Potassium (K)
• Chloride (CI)
• . Ionized Calcium (iCa)
• . lonized Magnesium (iMg)

The Nova Biomedical Stat Profile Prime Plus Analyzer System is undergoing a 510(k) premarket notification to expand its indications for use to include capillary whole blood specimen testing for pH, pCO2, pO2, Sodium (Na+), Potassium (K+), Chloride (Cl-), Ionized Calcium (Ca2+), Ionized Magnesium (Mg2+), Glucose, Lactate, and Hematocrit. The study described focuses on demonstrating the substantial equivalence of the Stat Profile Prime Plus Analyzer system to its predicate device, the Nova Biomedical Stat Profile pHOx Ultra Analyzer, specifically for capillary whole blood samples.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are primarily demonstrated through method comparison and precision studies. While explicit numerical acceptance criteria for each parameter (e.g., specific ranges for slope, intercept, r-value in method comparison, or max SD/CV% for precision) are not directly stated in the provided text as a standalone table, the conclusion sections for each study indicate that the device "met the clinical accuracy acceptance criteria" or "met the performance criteria for precision." The reported performance is shown in the tables below, which are the primary evidence for meeting the implicit acceptance criteria.

Method Comparison (Clinical Accuracy - Comparison to Predicate Device)

Precision (Laboratory and Point-of-Care Settings)

The precision data is presented across multiple tables (Tables 4, 5, 6, 7, 8, 9, 10). Rather than reiterating all data here, the text explicitly states:

• "The precision data for all samples in capillary mode met the within run and between analyzer imprecision specifications for the Prime Plus analyzers." (Summary of Capillary Mode Within Sample Precision)
• "This study demonstrates the Stat Profile Prime Plus analyzer exhibits clinically acceptable imprecision specifications for pH, pCO2, pO2, sodium (Na+), chloride (C1-), potassium (K+), ionized calcium (Ca2+), ionized magnesium (Mg2+), glucose, lactate, and hematocrit measured by the Stat Profile Prime Plus Analyzer System in Capillary mode." (Conclusion of Within-Run Imprecision - Capillary Mode Fingerstick (External POC))
• "The analyzer used for this evaluation met the performance criteria for within sample precision on capillary fingerstick specimens run by POC operators." (Conclusion of Within-Sample Imprecision - Capillary Mode Fingerstick (Internal POC))
• "The Stat Profile Prime Plus analyzers provided consistently reliable performance throughout the evaluation study. The analyzers used for this evaluation met the acceptance criteria for precision." (Conclusion of Within-Run Imprecision - Capillary Mode)

The acceptance criteria are therefore implicitly met by the reported r-values nearing 1.0 and slopes nearing 1.0 with intercepts near 0 for method comparison, and the CV% and SD values falling within acceptable limits (though the limits themselves are not numerically specified in the provided text).

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

• Method Comparison Test Set (Capillary Mode):

  • For each measured parameter, the sample size (N) ranged from 118 to 123 at the ER site and 123 to 128 at the Hemodialysis site. The combined sample size (N) for each parameter ranged from 241 to 251.
  • Provenance: This was a prospective clinical study conducted at two external Point-of-Care (POC) sites within the United States (an Emergency Room and a Hemodialysis Unit). Some samples (less than 10%, indicating "Altered Samples" ranging from 5 to 10 for each site) were altered to cover the full dynamic range. These were "de-identified and discarded arterial blood specimens" for the external precision study (implicitly reflecting human samples, though the exact origin beyond "external POC site" is not specified beyond being collected from patients).

• Precision Test Set (Capillary Mode):

  • Within Run Precision (Internal Lab): 20 replicates for each parameter, tested on two Prime Plus analyzers from venous blood transferred to capillary tubes. This appears to be lab-based, controlled samples.
  • Within Sample Precision (Internal Lab): 2 replicates from 30 different donors (Total N=60 for each analyte) of capillary whole blood. This implies human subjects.
  • Within-Run Imprecision (External POC): Sample analysis involved transferring discarded arterial blood specimens from a lithium heparin syringe to three balanced heparin capillary tubes. The number of unique discarded specimens is not explicitly stated but "each whole blood specimen" suggests multiple, distinct specimens were used.
  • Within-Sample Imprecision (Internal POC - Fingerstick): Capillary whole blood was collected via fingerstick puncture from individuals, with 2 replicates for each. N=60 for all sample pairs. This explicitly involves human subjects/donors.
  • Within-Run Imprecision (Internal Study - Lab): 5 different concentrations of deidentified venous whole blood specimens per analyte. Each concentration was run on 3 Prime Plus analyzers, 5 days, 1 run/day, 8 replicates/run/level. This totals 120 (5 concentrations * 3 analyzers * 5 days * 8 replicates) data points per analyte for the "N" value in Table 10. These are likely controlled lab samples simulating human blood.

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

The provided text does not explicitly state the number of experts used or their specific qualifications for establishing ground truth.

• For the method comparison study, the predicate device (Nova Stat Profile pHOx Ultra Analyzer) serves as the "ground truth" or reference method for comparison. The performance of this predicate device itself is assumed to be established and accepted.
• For the precision studies, the intrinsic analytical performance of the device is assessed, rather than against a human expert's interpretation.

4. Adjudication Method for the Test Set

This information is not applicable as the device measures objective chemical and physical parameters rather than interpreting images or clinical signs that would require human adjudication. The "ground truth" is the measurement from the predicate device or the inherent value in the sample for precision studies.

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

This information is not applicable as the device is an in-vitro diagnostic (IVD) analyzer for quantitative measurements, not an AI imaging or diagnostic algorithm requiring human reader performance studies. The study focuses on instrument performance and equivalence rather than human reader improvement with AI assistance.

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

Yes, the studies conducted (method comparison and precision) are standalone performance evaluations of the device's accuracy and precision in measuring the analytes. There is no "human-in-the-loop" aspect to the analytical performance being evaluated; the device provides direct quantitative measurements.

7. The Type of Ground Truth Used

• Method Comparison: The "ground truth" or reference standard for comparison was the predicate device, the Nova Stat Profile pHOx Ultra Analyzer. This is a comparative method where the new device's performance is assessed against an already legally marketed and accepted device.
• Precision Studies: The "ground truth" for precision is the measured value itself and its statistical variation across multiple runs or samples. It's an assessment of the device's inherent reproducibility and repeatability, not against an external truth source like pathology or outcomes data. Human samples (venous and capillary whole blood) were used to test performance under realistic conditions.

8. The Sample Size for the Training Set

The provided text does not mention a training set as this is not a machine learning or AI-driven device in the sense of requiring an explicit training phase with labeled data in the way an imaging algorithm would. This is an analytical instrument based on established sensor technology and algorithms. Therefore, discussions of training sets and their sample sizes are typically not relevant for this type of device submission. The device uses "the same sensor technology, measurement algorithms, formulations of the internal and external controls, and calibrator cartridge" as its predicate, implying a well-established design.

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

As no training set is discussed or implied to be applicable for this type of analytical device in the provided context, this question is not applicable.

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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.

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The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin, and CO-Oximetry (tHb, O2Hb, MetHb, HHb, sO2*) parameters from arterial, venous, or capillary lithium heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity.

*s02 = ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin.

• · pH, pCO2, and pO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid- base disturbances.
• · Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes:
• Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insividus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
• Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment
• of disease conditions characterized by low or high blood potassium levels.
• Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany.
• Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders, such as cystic fibrosis and diabetic acidosis.
• · Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).
• · Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism
• disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
• · Lactate (Lac) measurement is used:
• to evaluate the acid-base status of patients suspected of having lactic acidosis;
• to monitor tissue hypoxia and strenuous physical exertion;
• in the diagnosis of hyperlactatemia.
• · Total Bilirubin (tBili) measurement is used to aid in assessing the risk of kernicterus and hyperbilirubinemia in neonates.

• CO-Oximetry (tHb, COHb, MetHb, O2Hb, HHb, and sO2) evaluates the ability of the blood to carry oxygen by measuring total hemoglobin and determining the percentage of functional and dysfunctional hemoglobin species.

– Total Hemoglobin (tHb): Total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.

• COHo: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.

• MetHb: Methemoglobin measurements are used to determine different conditions of methemoglobinemia.

• HHb: Deoxyhemoglobin, as a fraction of total hemoglobin, is used in combination with oxyhemoglobin to measure oxygen status.

• O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with deoxyhemoglobin to measure oxygen status.

• sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin, is used to measure oxygen status.

The GEM Premier 7000 with iQMs system provides health care professionals with quantitative measurements of lithium heparinized whole blood pH, pCO2, pO2, Na*, K*, Ch, Ca**, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO₂*) from arterial, venous or capillary samples at the point of health care delivery in a clinical setting and in a central laboratory.

*sO₂ = Ratio between the concentration of oxyhemoglobin plus deoxyhemoglobin plus deoxyhemoglobin.

Key Components:
Instrument: It employs a unique touch-sensitive color screen and a simple set of menus and buttons for user interaction. The analyzer guides operators through the sampling process with simple, clear messages and prompts.
PAK (Cartridge): All required components for sample analysis are contained in the GEM PAK, including sensors, optical cell for CO-Oximetry and total bilirubin, sampler, pump tubing, distribution valve, waste container and Process Control Solutions. The GEM PAK is an entirely closed analytical system. The operator cannot introduce changes to the analytical process before or during the GEM PAK's use-life on board the instrument. The GEM PAK has flexible menus and test volume options to assist facilities in maximizing efficiency. The EEPROM on the GEM PAK includes all solution values and controls the analyte menu and number of tests. The setup of the instrument consists of inserting the GEM PAK into the instrument. The instrument will perform an automated GEM PAK start-up during which the following is performed: warm-up (15 minutes), sensor conditioning (10 minutes), Process Control Solution (PCS) performance (15 minutes), all of which take about 40 minutes. After GEM PAK start-up, Auto PAK Validation (APV) process is automatically completed: two completely independent solutions traceable to NIST standards, CLSI procedures or internal standards, containing two levels of concentration for each analyte (PC Solution D and E), are run by the analyzer to validate the integrity of the PC Solutions and the overall performance of the analytical system. Note: GEM PAKs that include tBili analyte will require the successful performance of CVP 5 tBili. Includes all necessary components for hemolysis detection, such as an acoustofluidic flow cell, an LED light source and an optical detector, for appropriate flagging of potassium measurements in whole blood samples without additional sample volume or sample processing steps.
Intelligent Quality Management (iQM3): iQM3 is used as the quality control and assessment system for the GEM Premier 7000 system. iQM3 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external QC. iQM3 introduces hemolysis detection in whole blood samples, enhancing quality assessment in the pre-analytical phase of testing.

Based on the provided text, the device in question is the GEM Premier 7000 with iQM3, which is a portable critical care system for analyzing blood samples. The document describes its comparison to a predicate device, the GEM Premier 5000, and discusses its performance studies.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

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

The document does not provide a direct table of specific numerical acceptance criteria for each analyte's performance (e.g., pH, pCO2, Na+, etc.) nor does it list the reported device performance in those exact terms. Instead, it states that "All verification activities were performed in accordance to established plans and protocols and design control procedures. Testing verified that all acceptance criteria were met."

The "Performance Summary" section lists the types of studies conducted to demonstrate that the modifications (specifically the new iQM quality check/Hemolysis detection module) do not impact the performance data represented in the Operators Manual, aligning with recognized guidelines. This implies the acceptance criteria are tied to maintaining performance comparable to the predicate device and being within acceptable ranges as defined by the mentioned CLSI guidelines.

Therefore, a table of explicit numerical acceptance criteria and reported performance values for each analyte is NOT AVAILABLE in the provided text. The document broadly states that the device met its acceptance criteria.

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

The document mentions several types of performance studies:

• Verification (Internal Method Comparison, Internal Whole Blood Precision, Hemolysis Interference on Potassium, Hemolysis Verification)
• Shelf-life and Use-life studies

However, the specific sample sizes used for these test sets are NOT provided in the text. There is also no information about the data provenance (e.g., country of origin of the data, retrospective or prospective).

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

This information is NOT available in the provided text. The device is an in-vitro diagnostic (IVD) instrument that provides quantitative measurements of various blood parameters. The "ground truth" for such devices typically comes from reference methods, calibrated standards, or comparative analyses with established, highly accurate laboratory instruments, rather than human expert consensus on interpretations like with imaging.

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

Given that this is an IVD device for quantitative measurements of blood parameters, the concept of "adjudication" by multiple human readers (like in imaging studies) does not directly apply. Performance is assessed through analytical accuracy, precision, and interference studies against known standards or reference methods. Therefore, no adjudication method in the sense of expert consensus on interpretations is described or implied.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. This type of study is relevant for AI-assisted diagnostic tools where human interpretation is part of the workflow. The GEM Premier 7000 with iQM3 is described as an analytical instrument providing direct quantitative measurements, not an AI system assisting human readers with interpretation. The "iQM3" refers to Intelligent Quality Management, which is an automated quality control system for the instrument itself, not an AI for human diagnostic assistance.

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

The device itself is a standalone analytical instrument. The performance studies described (Internal Method Comparison, Internal Whole Blood Precision, Hemolysis Verification, etc.) essentially represent "standalone" performance, as they evaluate the accuracy and precision of the instrument's measurements directly. The iQM3 system is an internal quality control mechanism for the device's measurements. Therefore, yes, a standalone performance evaluation of the device's analytical capabilities was implicitly done.

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

For a device that provides quantitative measurements of blood parameters, the "ground truth" for the test set would typically be established using:

• Reference methods: Highly accurate and precise laboratory methods for measuring each analyte.
• Calibrated standards: Solutions with precisely known concentrations of the target analytes.
• Comparison to predicate device: As this is a 510(k) submission, a primary method of establishing "ground truth" performance for the new device is by comparing its measurements against those of a legally marketed predicate device (GEM Premier 5000), which itself would have been validated against reference methods and standards.

The text mentions "two completely independent solutions traceable to NIST standards, CLSI procedures or internal standards" for "Auto PAK Validation (APV)". This strongly suggests that traceable standards and potentially CLSI-defined reference methods were used to establish the ground truth for performance evaluation.

8. The sample size for the training set

The document describes the GEM Premier 7000 with iQM3 as a medical device for quantitative measurements, not explicitly as a machine learning/AI model that requires a "training set" in the conventional sense (i.e., for supervised learning). The iQM3 is an "active quality process control program" with "Pattern Recognition (PR) software." While pattern recognition might involve some form of "training" or calibration, the document does not specify a separate "training set" in terms of data volume for such a process. It focuses on the validation of the device's analytical performance. Therefore, the concept of a "training set" sample size as applicable to AI/ML devices is not explicitly discussed or provided.

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

As noted above, the primary function of GEM Premier 7000 with iQM3 is quantitative measurement. If the "iQM3" component involved training for its "Pattern Recognition (PR) software," the document does not detail how a specific ground truth for such training was established. It primarily discusses the use of "Process Control Solutions (PCS)" and "Calibration Valuation Product (CVP 5)" for system checks and validation ("Auto PAK Validation (APV) process"). These solutions, traceable to NIST or CLSI standards, function as internal reference points for the device's operational checks and quality control, which could be considered an ongoing form of "ground truth" to maintain analytical performance, rather than a one-time "training set" for model development.

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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.

• System 1 PO2 Level 1: 1.39 SD (vs 2.5 SD)
• System 1 PCO2 Level 1: 0.9 CV (vs 5.0% CV)
• System 1 pH Level 1: 0.002 SD (vs 0.020 SD)

Aqueous Controls (Capillary Mode): All results "within specification." Examples:

• Unit 1 PO2 Level 1: 2.70 SD (vs 3 SD)
• Unit 1 PCO2 Level 1: 1.5 CV (vs 5.0% CV)
• Unit 1 pH Level 1: 0.004 SD (vs 0.020 SD) |
  | Reproducibility | pO2: Level 1: 2.5mmHg; Level 2: 2.5mmHg; Level 3: 3.0% CV | 5-day w. Blood Study (Syringe Mode): All results "within specification." Examples:
• PO2 Level 1: 0.6 SD (vs 2.5mmHg)
• PCO2 Level 1: 0.5 SD (vs 2.0% CV, implied from table structure)
• pH Level 1: 0.007 SD (vs 0.015 units)

5-day w. Blood Study (Capillary Mode): All results "within specification." Examples:

• PO2 Level 1: 0.9 SD (vs 2.4mmHg)
• PCO2 Level 1: 2.5 CV (vs 4.0% CV)
• pH Level 1: 0.008 SD (vs 0.015 units) |
  | Linearity | "met all device specifications" (implied criteria typically high R^2 values, slope ~1) | Data shown (e.g., for ES300-P7):
• PO2 (Syringe): R² 0.999, Slope 1.016 (PASS)
• PCO2 (Syringe): R² 0.999, Slope 1.066 (PASS)
• pH (Syringe): R² 0.996, Slope 1.008 (PASS)
  Conclusion: "all analytes... are linear within the advertised reportable range." |
  | Method Comparison | "linear regression slope, the coefficient of variation, and the calculated predicted bias at the decision levels for each analyte were within specifications." (implied) | Exemplified by PO2 Syringe Mode:
• n=272, Slope=1.001, R²=0.999
• Predicted Bias for PO2 (30.0, 45.0, 60.0): All PASS ("within specifications," typically close to 0 bias and CI within allowable error).
  Conclusion: "all analytes... are favorably correlated to the predicate/reference device... within specifications." |
  | Sensitivity | LoQ

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The GEM Premier ChemSTAT is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of sodium (Na+), Potassium (K+), Ionized Calcium (Ca++), Chloride (Cl-), Glucose (Glu), Lactate (Lac), Hematocrit (Hct), Creatinine (Crea), Blood Urea Nitrogen (BUN), Total Carbon Dioxide (tCO2), pH, and partial pressure of carbon dioxide (pCO2) from arterial and venous heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance.

Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes:

· Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.

· Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

· Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. · Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders, such as cystic fibrosis and diabetic acidosis.

· Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

· Lactate (Lac) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis, to monitor tissue hypoxia and strenuous physical exertion, and in the diagnosis of hyperlactatemia.

· Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).

· Creatinine (Crea) measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

· Blood Urea Nitrogen (BUN) or urea measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases.

· Total carbon dioxide/tCO2 (also referred to as bicarbonate/HCO3-) is used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

· pH and pCO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid-base disturbances.

The GEM Premier ChemSTAT system provides fast, accurate, quantitative measurements of Sodium (Na"), Potassium (K*), Ionized Calcium (Ca*), Chloride (Cl·), Glucose (Glu), Lactate (Lac), Hematocrit (Hct), Creatinine (Crea), Blood Urea Nitrogen (BUN), Total Carbon Dioxide (tCO2), pH, and partial pressure of carbon dioxide (pCO2) from arterial and venous lithium heparinized whole blood.

The provided text describes a Special 510(k) submission for an upgrade to the operating system of the GEM Premier ChemSTAT device. The device itself is an in vitro diagnostic (IVD) system for quantitative measurements of various blood parameters. The submission focuses on the software upgrade rather than a change in the device's fundamental function or performance.

Therefore, the "acceptance criteria" and "reported device performance" in this context refer to the successful verification and validation of the software upgrade and the continued adherence to the established performance of the unmodified device, as the indications for use and performance claims remain unchanged. The study proving this essentially consists of the software verification and validation activities.

Here's the information extracted from the document, tailored to the context of a software upgrade:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a software upgrade with no changes to the performance claims of the device, the general acceptance criteria are that the upgraded software performs as intended without adversely affecting the device's established performance specifications. The reported device performance is that these criteria were met.

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

The document does not specify a "test set sample size" or "data provenance" in the traditional sense for evaluating diagnostic performance. The focus is on software verification and validation. Therefore, the "sample" for testing the software functionality would be the various test cases and scenarios designed to validate the operating system upgrade and its interaction with the GEM Premier ChemSTAT application software.

The document states: "Performance data is limited to Software Verification and Validation as the scope of this Special 510(k) is specific to an operating system upgrade from Fedora 17 Linux to WindRiver LTS 18 Linux."

Further details on the specific number of test cases, the nature of the data (e.g., simulated, actual runs on the device), or its origin are not provided in this summary.

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)

This information is not applicable to a software operating system upgrade as described. "Ground truth" in the context of expert consensus is typically relevant for diagnostic performance studies where human interpretation or a gold standard reference is needed (e.g., pathology for an imaging device). Here, the "ground truth" is the proper functioning of the software and its integration with the hardware, which is evaluated through engineering and software testing.

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

This information is not applicable for a software operating system upgrade. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies in expert interpretation of diagnostic results. Software verification and validation typically rely on predefined test outcomes and engineering assessments.

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

This information is not applicable. An MRMC comparative effectiveness study is used to evaluate the impact of an AI algorithm on human reader performance, usually for diagnostic tasks. This submission is for a software operating system upgrade for an existing IVD device, not for a new AI algorithm.

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

The concept of "standalone performance" in the context of an algorithm's diagnostic capability (like an AI algorithm) is not directly applicable here. The device itself (GEM Premier ChemSTAT) operates to provide quantitative measurements. The software upgrade ensures the continued, correct operation of the device. The verification and validation activities demonstrate that the upgraded software performs its functions correctly as part of the overall device system.

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

For this software upgrade, the "ground truth" is the expected behavior and functionality of the software and the device. This is established through:

• Functional specifications: The software is expected to perform according to its design specifications.
• Risk analysis: The software should not introduce new risks or fail to mitigate existing ones.
• Cybersecurity standards: The software should meet cybersecurity requirements.
• Established device performance: The software upgrade should not negatively impact the established analytical and clinical performance of the GEM Premier ChemSTAT device (which relies on the physical and chemical principles of its measurements).

The document explicitly states that the changes "do not introduce...changes to labeled performance claims." This implies that the performance of the device (e.g., accuracy, precision of Na+, K+, Glu measurements) remains the same as previously cleared, and the software upgrade was validated not to alter these.

8. The sample size for the training set

This information is not applicable. Training sets are used for machine learning models. This submission describes a conventional software operating system upgrade (Fedora 17 Linux to WindRiver LTS 18 Linux) for an existing IVD device, not the development or retraining of a machine learning algorithm.

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

This information is not applicable, as there is no training set for a machine learning model; it is a software operating system upgrade.

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The GEM Premier 5000 is a portable critical care system for use by health care professionals to rapidly analyze heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCO2, pO2, sodium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MHb, sO2*) parameters from arterial, venous or capillary heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity.

*sO2 = ratio between the concentration of oxyhemoglobin plus deoxyhemoglobin plus deoxyhemoglobin.

· pH, pCO2, and pO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid-base disturbances.

· Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes:

· Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.

· Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

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

· Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders, such as cystic fibrosis and diabetic acidosis.

· Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).

· Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

• · Lactate (Lac) measurement is used:
• · to evaluate the acid-base status of patients suspected of having lactic acidosis;
• · to monitor tissue hypoxia and strenuous physical exertion;
• in the diagnosis of hyperlactatemia.

· Total Bilirubin (tBili) measurement is used to aid in assessing the risk of kernicterus and hyperbilirubinemia in neonates.

· CO-Oximetry (tHb, COHb, MetHb, O2Hb. HHb, and sO2) evaluates the ability of the blood to carry oxygen by measuring total hemoglobin and determining the percentage of functional hemoglobin species.

• Total Hemoglobin (tHb): Total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.

· COHb: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.

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· MetHb: Methemoglobin measurements are used to determine different conditions of methemoglobinemia.

· HHb: Deoxyhemoglobin, as a fraction of total hemoglobin, is used in combination with oxyhemoglobin to measure oxygen status.

· O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with deoxyhemoglobin to measure oxygen status.

• sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin, is used to measure oxygen status.

The GEM Premier 5000 system provides fast, accurate, quantitative measurements of heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2) from arterial, venous or capillary samples.

The provided text is a 510(k) summary for the GEM Premier 5000 device, detailing an operating system upgrade. This document is a regulatory submission for a device change and does not contain the information requested regarding acceptance criteria, device performance tables, study specifics (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), or ground truth establishment.

The submission is a Special 510(k), which indicates a modification to an already cleared device, not a de novo clearance requiring extensive clinical performance studies. The core of this submission is a software update (operating system change from Fedora 17 Linux to WindRiver LTS 18 Linux) with the stated reason to "accommodate long-term support of resolutions for common vulnerability exposures."

The document explicitly states:

• "Performance data is limited to Software Verification as the scope of this Special 510(k) is specific to an operating system upgrade..."
• "The changes in this submission do not introduce: Changes to indications for use or intended use, Changes to the fundamental scientific technology, Changes to operating principle, Changes to labeled performance claims."

Therefore, the requested information, which typically pertains to the establishment of initial clinical performance and effectiveness, is not present in this regulatory document for this specific submission. The focus here is on ensuring the device continues to meet its previously established performance claims after a technical software upgrade, rather than demonstrating new performance capabilities.

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