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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 electrolytes (cK+, cNa+, cCa2+), glucose, and lactate 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.

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

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

Calcium (cCa2+): Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

Glucose (cGlu): Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Lactate (cLac): The lactate measure the concentration of lactate. Lactate measurements are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidity of the blood).

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 ABL90 FLEX PLUS is a portable, automated system intended for in vitro testing of samples of balanced heparinized whole blood for electrolytes (cK+, cNa*, cCa²), glucose, and lactate. The ABL90 FLEX PLUS System has an automated sample inlet mechanism, which can collect blood through two different measuring modes: the S65 syringe mode and the SP65 short probe mode.

The provided text is a 510(k) Summary for the ABL90 FLEX PLUS System, an in vitro diagnostic device. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (ABL90 FLEX) rather than proving the device meets specific acceptance criteria as might be defined for a novel AI/ML device.

Therefore, much of the requested information regarding acceptance criteria for AI/ML performance, study design (test set, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set details) is not applicable to this type of device and its regulatory submission.

The document primarily proves the analytical performance of the new device is comparable to the predicate device through various analytical studies.

Here's a breakdown of the applicable information based on the provided text, and an explanation of why other requested information is not present:

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

The document does not explicitly present "acceptance criteria" in a pass/fail table for each performance metric in the way it might for a novel AI/ML device. Instead, it presents analytical performance data (linearity, precision, detection, method comparison, interference) which is implicitly compared against pre-defined internal specifications or what is considered acceptable for the similar predicate device. The goal is to show the new device performs equivalently to the predicate.

Below is a summary of the reported device performance from the tables in the document. The "Acceptance Criteria" column cannot be fully populated as precise numerical thresholds are not explicitly stated as "acceptance criteria" in this 510(k) summary, but are rather implied by the successful demonstration of performance often within CLSI guidelines and comparable to the predicate.

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

• Test Set (for performance validation):
  • Linearity: The specific number of samples tested for linearity is not explicitly stated as 'N' values in Table 1 but ranges presented (e.g., 1.896-11.146 for cCa2+) imply a sufficient number of points across the range were used.
  • Detection (LoB, LoD, LoQ): Not explicitly stated as 'N' values in Table 2.
  • Precision (using stable, aqueous ampoule-based QC material): Varies per parameter/level, but generally 243-244 replicates (N) per parameter/level.
  • Precision (using blood): Varies per parameter/mode/interval, ranging from 2 to 202 replicates (N).
  • Method Comparison:
    • Arterial blood (S65 mode): 221-225 samples (N) across parameters.
    • Arterial blood (SP65 mode): 214-218 samples (N) across parameters.
    • Venous blood (S65 mode): 231-234 samples (N) across parameters.
    • Venous blood (SP65 mode): 219-225 samples (N) across parameters.
    • Combined (S65 mode): 436-441 samples (N) for combined arterial/venous.
    • Combined (SP65 mode): 420-425 samples (N) for combined arterial/venous.
  • Interference: "Large panel of likely interferents" for paired-difference study; dose-response studies for significant interferents. Specific sample sizes for each interferent are not detailed in the summary.
• Data Provenance: The document states that precision studies using QC material were conducted at "three external sites." Method comparison and precision studies using blood were conducted using both arterial and venous blood, and in both sample collection modes. The country of origin for the data (patients or samples) is not specified in this summary. The studies are described as "analytical performance testing," implying they are prospective or controlled laboratory studies rather than retrospective analysis of existing clinical data.

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)

• Not Applicable: This device is an in vitro diagnostic (IVD) analyzer that quantitatively measures analytes. Its performance is evaluated against reference measurement procedures or highly controlled materials, not by expert interpretation of images or clinical cases requiring expert consensus or qualifications. Ground truth is established by the reference method itself or the known concentration of QC materials.

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

• Not Applicable: As this is an IVD device measuring quantitative analytes, there is no expert adjudication process in this context, unlike an AI/ML device interpreting medical images. Performance is determined by comparison to reference methods or statistical analysis against known values.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable: This is an IVD analyzer, not an AI/ML device that assists human readers. Therefore, an MRMC study is not relevant to its regulatory approval process.

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

• Partially Applicable (in a different sense): The ABL90 FLEX PLUS System is a standalone automated analyzer. Its performance is measured directly (algorithm only, if you consider the device's internal measurement algorithm) against reference methods or known concentrations, without a human-in-the-loop interpretation being the primary output that's being evaluated for accuracy. The results presented (linearity, precision, method comparison) are representative of its standalone performance.

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

• Quantitative Reference Methods / Known Concentrations:
  • Linearity/Detection: Ground truth is established by preparing samples with known, precise concentrations across the measurement range, or by the inherent properties of the measurement system for LoB/LoD/LoQ.
  • Precision: Ground truth is the expected value of the quality control (QC) materials or the prepared blood samples, or simply the reproducibility of measurements on the same sample.
  • Method Comparison: Ground truth is the measurement from the legally marketed predicate device (ABL90 FLEX, specifically "ABL90 FLEX PLUS analyzer as it was designed at the time of the clearance of K160153") that the new device is being compared against. This device itself serves as the "reference method" for substantial equivalence.
  • Interference: Ground truth is the expected measurement of known samples, with and without the interferent, using a reference method, to identify if the interferent causes a clinically significant deviation.

8. The sample size for the training set

• Not Applicable (in the AI/ML sense): This document describes the analytical validation of a traditional IVD device, not an AI/ML algorithm. There is no "training set" in the machine learning sense for this type of submission. The device is a physical instrument with established chemical/electrochemical measurement principles.

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

• Not Applicable: As there is no "training set" in the AI/ML context, this question is not relevant. The device's internal parameters and calibration would be established through a manufacturing and calibration process, not through a "training" phase with a ground truth dataset in the way an AI model is trained.

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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 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 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.

3

· 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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The OPTI® B-Lac cassette is intended to be used for the in vitro measurement of pH, PO2, total hemoglobin (tHb), and % Saturated O2 in sodium heparinized venous blood samples on the OPTI CCA-TS and OPTI CCA-TS2 platform in a clinical laboratory location.
· Measurements of blood gases (pCO2, pO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

• · Total hemoglobin (tHb) measurement is used to determine the hemoglobin content of human blood.
  · Oxygen saturation (SO2) measurement is used to determine the oxygen capacity of the hemoglobin.

The OPTI CCA-TS/TS2 are portable devices, microprocessor-based instrument using optical fluorescence for the measurement blood gases, electrolytes and enzymes. The OPTI CCA-TS/TS2 utilize a color, graphical touch screen user interface. A disposable, single-use cassette contains all of the elements needed for calibration, sample measurement, and waste containment. Specific calibration from the cassette is scanned into the analyzer by holding the cassette package in front of the bar code scanner. The cassette is then placed into the measurement chamber. The analyzer warms the cassette to 37.0±0.1°C and performs a calibration verification. When calibration is verified, the analyzer aspirates the blood sample into the cassette and across the optode sensors. Fluorescence emission is then measured after equilibrating with the blood sample. After a single measurement, the cassette containing the blood sample is removed from the analyzer and discarded. The analyzer contains no reagents, blood, or waste. The B-Lac cassette is a disposable, single use cassette that contains four (4) sensors for in vitro quantitative measurements of PO2, PCO2, pH. There is an additional laser based measurement of total hemoglobin (tHb) and SO2. The B-Lac cassette is sealed in a foil pouch along with a desiccant and is marked with a barcode label that includes a lot identification number, calibration information, and expiration date.

The provided document describes the OPTI® B-Lac Cassette for in vitro measurement of blood gases and related parameters. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the performance of the redesigned B-Lac cassette was determined to meet the performance claims made in the original B-Lac cassette submission (K093280) for all analytes. However, the specific quantitative acceptance criteria from K093280 are not detailed in this document. The reported device performance is indicated by the statement that the device "meets the performance claims" or "was demonstrated to meet the performance claims."

Here's a table based on the information provided, noting where specific numerical criteria are not available in this document:

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

• 20-Day Precision:

  • Sample Size: Paired samples run twice daily over 20 days. Three lots of B-Lac cassettes were used, and three levels of aqueous quality control solution.
  • Data Provenance: In-house (presumably US-based, as the company is in Georgia, USA). Retrospective data analysis of prospective testing.

• Within-Run Precision:

  • Sample Size: Multiple repeats using three lots of B-Lac cassettes, three levels of aqueous quality controls, and whole blood manipulated to 3 different levels.
  • Data Provenance: In-house. Retrospective data analysis of prospective testing.

• Method Comparison (in-house):

  • Sample Size: Whole blood samples tonometered to different levels using different O2/CO2 gas mixtures to generate test levels for pH, PCO2, PO2, and SO2. Samples manipulated for tHb. The exact numerical count of samples or measurements is not specified.
  • Data Provenance: In-house. Retrospective data analysis of prospective testing.

• Method Comparison (Altitude):

  • Sample Size: Whole blood samples were tonometered to obtain samples that span the range for PCO2, PO2, and pH, and spiked or diluted for tHb. Aqueous solutions were measured. Number of samples/measurements not specified, but done at 4 distinct altitude sites (75 ft, 1080 ft, 5560 ft, 10151 ft).
  • Data Provenance: Conducted in the USA (Maine, Georgia, North Carolina, Colorado). Retrospective data analysis of prospective testing.

• Interference Testing:

  • Sample Size: 16 interferents tested for each analyte (PCO2, PO2, pH, tHb, SO2). The number of samples per interferent is not specified.
  • Data Provenance: In-house. Retrospective data analysis of prospective testing.

• Stability Testing:

  • Sample Size: Three lots of B-Lac cassettes were tested. One lot was subjected to two cycles of elevated and frozen temperatures.
  • Data Provenance: In-house. Retrospective data analysis of prospective testing for the initial 6 months, with real-time testing ongoing.

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

This document describes a medical device for in vitro diagnostic measurements. The "ground truth" for the test set is established by:

• Reference Methods/Predicate Devices:

  • Gravimetric target for PCO2 and PO2 (based on gas concentration).
  • Predicate device ABL90 Flex for pH, PCO2, PO2, and tHb.
  • E series cassettes on the OPTI CCA-TS/TS2 for SO2.

• No human "experts" (e.g., radiologists) were involved in establishing the ground truth in the way
  this question implies for imaging or subjective interpretation devices. The ground truth is
  based on established analytical methods and reference instruments.

4. Adjudication Method for the Test Set

Not applicable. This device provides quantitative measurements, and ground truth is established by reference methods/instruments, not through expert consensus requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document does not mention any MRMC comparative effectiveness study where human readers improve with or without AI assistance. This device is an in vitro diagnostic instrument, not an AI-assisted diagnostic tool for human interpretation.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Yes, the studies described are of standalone performance of the device (OPTI® B-Lac Cassette on OPTI CCA-TS/TS2 platforms). The measurements are performed automatically by the instrument and its embedded algorithms. There is no human-in-the-loop performance described or implied for the measurement process itself, although clinical interpretation of the results by healthcare professionals would follow.

7. Type of Ground Truth Used

The ground truth used for performance evaluation includes:

• Gravimetric targets: For PCO2 and PO2 (based on gas concentration for tonometered samples).
• Predicate device measurements: Measurements from the Radiometer ABL90 Flex for pH, PCO2, PO2, tHb, and from the OPTI CCA TS2 E-Series Cassettes for SO2.
• Aqueous quality control solutions and manipulated whole blood samples: Used for precision and linearity studies, where the expected values are known or derived from previous characterization.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. The device utilizes "new algorithms utilized to calculate concentrations for these sensors" (specifically for PCO2) and has updated software. However, the data sets described are for performance verification and validation, not for training a new algorithm from scratch in the classical AI sense. If there was an internal dataset used for algorithm development or "training" (e.g., to derive calibration curves or correction factors), that information is not provided. The described studies are primarily for demonstrating post-development performance.

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

As no specific "training set" is described for algorithm development, the method of establishing ground truth for such a set is not provided. The document focuses on the verification and validation of the device's performance against established clinical and analytical standards.

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The epoc® Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous, or capillary whole blood in the laboratory or at the point of care.
The Blood Gas Electrolyte and Metabolite (BGEM) Test Card panel configuration includes sensors that quantitate pH, pCO2, oO2, Sodium, Potassium, Ionized Calcium, Chloride, Total Carbon Dioxide, Glucose, Lactate, Blood Urea Nitrogen, Creatinine, and Hematocrit.
pH, pCO2, pO2 (blood gases) measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of lifethreatening acid-base disturbances.
Sodium and Potassium measurements from the epoc Blood Analysis System are treatment of diseases involving electrolyte imbalance.
lonized Calcium measurements from the epoc Blood Analysis System are treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
Chloride measurements from the epoc Blood Analysis System are used in the treatment of electrolyte and metabolic disorders.
Total Carbon Dioxide measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of disorders associated with changes in body acid-base balance.
Glucose measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of carbolism disorders, including diabetes mellitus and idiopathic hypodycemia, and of pancreatic islet cell tumors.
Lactate measurements from the epoc Blood Analysis System are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood),
Blood Urea Nitrogen measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of certain renal and metabolic diseases.
Creatinine measurements from the epoc Blood Analysis System are used in the diagnosis and treatment diseases and in monitoring renal dialysis.
Hematocrit measurements from the epoc Blood Analysis System are used to distinguish normal states of blood volume, such as anemia and erythrocytosis.

The epoc® Blood Analysis System is an in vitro diagnostic device system for the quantitative testing of blood gases, electrolytes, and metabolites in venous, arterial, and capillary whole blood samples. The epoc® System is comprised of three (3) major subsystems: epoc® Host, epoc® Reader and epoc® BGEM Test Card.

• epoc® Blood Gas Electrolyte Metabolite (BGEM) Test Card: single-use, device with . port for blood sample introduction which contains the sensor configurations for testing Sodium (Na+), Potassium (K+), Calcium (Ca++), Chloride (C)I-, pH, partial pressure of carbon dioxide (pCO2), partial pressure of oxygen (pO2), Glucose (Glu), Lactate (Lact), Creatinine (Crea), Hematocrit (Hct), Blood Urea Nitrogen (BUN) and Total Carbon Dioxide (TCO2).
• . epoc® Reader: portable, battery-powered device component that measures electrical signals from the test card sensors during blood testing and transmits this sensor data wirelessly via Bluetooth to the epoc Host.
• . epoc® Host: mobile computer-based device component for calculating test results from the sensor data sent by the epoc Reader and displaying these results on the graphical user interface. The epoc Host component can be physically connected to the Reader by a cradle component. The epoc Host also incorporates an internal laser barcode scanner for scanning patient and operator IDs. The epoc Host component currently runs on Microsoft® Windows Mobile 6.5 Operating System (OS).

Based on the provided text, the "epoc® Blood Analysis System with NXS Host" is being submitted as a modified device, and the submission primarily focuses on hardware and software updates to the epoc Host component. The document explicitly states that "No performance data was required to evaluate the changes introduced with the alternate epoc Host component" and that there is "no change to labeled performance claims." Therefore, there isn't a comprehensive study proving the device meets new acceptance criteria. Instead, the submission argues for substantial equivalence to a previously cleared predicate device by demonstrating that the modifications do not negatively impact safety and effectiveness.

Here's an analysis based on the provided information, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not detail specific acceptance criteria for new performance claims or provide a table of performance data because the submission states "No performance data was required to evaluate the changes introduced with the alternate epoc Host component." The device is intended to meet the same performance specifications as the predicate device. The change is in the host component (hardware and OS), not the core measurement technology or labeled performance.

The submission is essentially asserting that the "epoc® Blood Analysis System with NXS Host" (Modified Device) is substantially equivalent to the "epoc® Blood Analysis System" (Predicate Device) and thus relies on the predicate device's existing performance data and acceptance criteria.

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

Not applicable. No new clinical performance or analytical performance study with a test set is described. The submission focuses on verification and validation activities for hardware, software, and usability to support substantial equivalence due to a change in the host component.

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

Not applicable. As no new performance study is described, there's no mention of experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. No new performance study is described.

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

No. This device is an in vitro diagnostic system for quantitative testing of blood parameters, not an imaging AI device that would typically involve a multi-reader multi-case study with human readers.

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

The device is an analytical instrument. Its performance is inherent to the system (sensors, reader, software). While the software is a key component, the "standalone" concept as typically applied to AI in imaging doesn't directly map. However, the document states: "No performance data was required to evaluate the changes introduced with the alternate epoc Host component." This implies that the core analytical performance (algorithm) is considered unchanged from the predicate device and its previous clearances. Verification and validation activities were done on the new host component, but not necessarily a "standalone" re-evaluation of the core measurement algorithm's performance on a new dataset.

7. The Type of Ground Truth Used

Not applicable for new performance data. The device measures objective chemical and physical properties of blood samples. The ground truth for such devices is typically established through reference methods and calibrated controls, not expert consensus or pathology in the same way as an imaging AI. The submission relies on the established ground truth methodologies for the predicate device.

8. Sample Size for the Training Set

Not applicable. This document describes a modification to an existing IVD device (updating hardware and operating system for the host component). It does not describe the development of a new AI algorithm or machine learning model that would involve a "training set" in the conventional sense. The "epoc Host Application Software has been modified to support the Android-based Operating System" but this is a software porting/adaptation, not a new algorithm being trained on data.

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

Not applicable, as there is no mention of a training set for a new AI algorithm.

Summary of the Study and Why it Meets (Implied) Acceptance Criteria:

The study detailed in this 510(k) submission is not a clinical performance study generating new acceptance criteria or performance data for the analytes measured. Instead, it is a Special 510(k) submission designed to demonstrate that hardware and software updates to the epoc Host component of the epoc® Blood Analysis System do not alter the safety or effectiveness of the device and thus maintain substantial equivalence to the previously cleared predicate device.

The "study" or evidence provided to meet acceptance criteria consists of:

• Verification and Validation Activities: "All software, hardware and usability verification and validation activities were performed in accordance to relevant standards, established plans and protocols and Design Control procedures."
• Meeting Acceptance Criteria: "Testing verified all acceptance criteria were met." (These are acceptance criteria related to software, hardware function, and usability for the new host component, ensuring it performs its intended role without impacting the core analytical performance).
• Risk Management: A risk management process compliant with EN ISO 14971:2012 and ISO 14971:2007 was performed, concluding that "the overall residual risk of the epoc System with the epoc NXS host is acceptable."
• Cybersecurity Information: Cybersecurity design inputs were established, risks assessed, and controls designed within the software.

The core argument for meeting acceptance criteria (by proving substantial equivalence) is that:

• There is no change to the intended use or indications for use.
• There is no change to the fundamental scientific technology (the epoc Reader and Test Card, which contain the sensors, remain unchanged).
• There is no change to labeled performance claims.
• There is no change to the principle of operation.
• There is no change to cartridge (test card) calibrator formulation and technology.

Therefore, the "acceptance criteria" here are implicitly that the new epoc NXS Host component, through its verification and validation, functions correctly, safely, and does not introduce new risks, thereby maintaining the established performance and safety profile of the predicate device.

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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, PO2, PCO2, and 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 disturbances and metabolic and respiratory-based 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+ test cartridge contains test reagents to analyze whole blood at the point of care or in the clinical laboratory for pH. PO2 (partial pressure of oxygen), PCO2 (partial pressure of carbon dioxide), and lactate. The test is contained in a single-use, disposable cartridge. Cartridges require two to three drops of whole blood which are typically applied to the cartridge using a transfer device.

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 cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).

The i-STAT 1 System is comprised of the i-STAT 1 analyzer, the i-STAT test cartridges and accessories (i-STAT 1 Downloader/Recharger, electronic simulator and portable printer). The system is designed for use by trained medical professionals at the patient point of care or in the clinical laboratory and is for prescription use only.

Here's a summary of the acceptance criteria and study information for the i-STAT CG4+ Cartridge with the i-STAT 1 System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for each performance characteristic in a pass/fail format. Instead, it presents study results and concludes that the device is "substantially equivalent" to predicate devices. However, we can infer some criteria from the reported performance, especially in precision and linearity compared to typical clinical expectations.

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

• Precision (Aqueous Materials): The "test set" for this was aqueous materials. N values for each level were 80 or 81. Provenance is not explicitly stated beyond "at one site." It's an analytical performance study, not involving human subjects directly.
• Precision (Whole Blood): The "test set" for this involved whole blood venous and arterial specimens. Sample sizes (N) varied by sample type and range for each analyte (e.g., pH venous

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The RAPIDPoint® 500e Blood Gas System is in vitro diagnostic use and is designed to provide the determination in whole blood for the following parameters:

• Partial pressure of carbon dioxide ●
• Partial pressure of oxygen
• pH
• Sodium ●
• Potassium
• lonized Calcium ●
• Chloride .
• Glucose ●
• . Lactate
• . Total Hemoglobin and fractions: FO2Hb, FCOHb, FMetHb, FHHb
• . Neonatal Bilirubin

The RAPIDPoint 500e Blood Gas System is also intended for in vitro testing of pleural fluid samples for the pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions.

The following critical value applies to pleural fluid pH > 7.3 is measured in uncomplicated parapneumonic effusions. All pleural fluids with a pH measurement

The RAPIDPoint 500e Blood Gas System is a compact, bench-top analyzer designed for in vitro diagnostic testing and is suitable for professional use in a point-of-care or central laboratory environment. This system measures the following: blood gases, electrolytes, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. Additionally, the RAPIDPoint 500e Blood Gas System measures pH in pleural fluid.

The RAPIDPoint 500e Blood Gas System incorporates a cartridge-based design with no external reagent bottles or gas tanks. The system uses self-contained measurement and wash/waste cartridges that are replaced when depleted. The system automatically calibrates the measurement sensors and reports results within 60 seconds for display on a color touch screen for easy viewing.

The provided text concerns the FDA 510(k) summary for the RAPIDPoint® 500e Blood Gas System. This document describes a modification to an existing device (RAPIDPoint 500 System) and asserts its substantial equivalence for FDA clearance. Therefore, a study to prove the device meets specific acceptance criteria for a new clinical claim (such as disease diagnosis accuracy based on images) is not applicable here.

The submission is a Special 510(k), meaning the changes are minor and do not alter the intended use, fundamental scientific technology, labeling, or principle of operation. The primary changes are an operating system update and minor hardware/software enhancements.

Key points from the document regarding "acceptance criteria" and "study:

• No new performance claims: The document explicitly states: "There is no change to labeled performance claims." This implies that the performance criteria previously established for the predicate device (RAPIDPoint 500 System) are still considered valid and met by the modified device.
• Verification and validation activities: The document states: "All verification and validation activities were performed in accordance to relevant standards, established plans and protocols and Siemens Design Control procedures. Testing verified all acceptance criteria were met." This refers to internal engineering and design control testing to ensure the modifications haven't negatively impacted the known performance characteristics of the device.

Given this context, I cannot generate a table of acceptance criteria and reported device performance in the typical sense of a clinical diagnostic study with new performance endpoints. The "acceptance criteria" here refers to demonstrating that the modified device performs comparably to the predicate for all existing measurements and that the new software/hardware features function as intended without compromising safety or effectiveness.

Therefore, the requested information elements cannot be fully addressed in the way they would for a device making new diagnostic claims based on a primary clinical study.

Here's an attempt to answer the questions based on the available information, noting where specific details are not provided:

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

   As this is a Special 510(k) for a modified device with "no change to labeled performance claims" and "no change to principle of operation," there isn't a new set of clinical performance acceptance criteria and reported performance figures presented in this summary document. The acceptance criteria implicitly refer to demonstrating that the modified device's performance is substantially equivalent to the predicate device across all analytes and clinical uses, meaning it continues to meet the predicate's established performance specifications. The document states: "Performance testing results were also comparable."

   Inferred Acceptance Criteria (based on substantial equivalence to predicate):
   The modified device (RAPIDPoint 500e Blood Gas System) must demonstrate performance comparable to the legally marketed predicate device (RAPIDPoint 500 System) for all measured analytes (pCO2, pO2, pH, Sodium, Potassium, Ionized Calcium, Chloride, Glucose, Lactate, Total Hemoglobin and fractions, Neonatal Bilirubin) in whole blood and pH in pleural fluid. This comparability would typically be assessed by demonstrating agreement (e.g., bias, precision, linearity) within acceptable limits as defined for the predicate device.

   Reported Device Performance:
   The document states: "Performance testing results were also comparable." Specific numerical performance data (e.g., accuracy, precision) for each analyte for the modified device are not provided in this 510(k) summary, as the submission focuses on substantial equivalence of the modified device to the predicate, rather than establishing new performance specifications.

2. Sample size used for the test set and the data provenance

   Not explicitly stated in the provided document. The document refers to "verification and validation activities" and "performance testing results," but does not detail the sample sizes or the provenance (e.g., country of origin, retrospective/prospective) of the data used for establishing "comparable" performance. Given it's a diagnostic device for blood analysis, samples would typically be human blood and pleural fluid.

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

   Not applicable or not specified. For laboratory diagnostic devices like blood gas analyzers, "ground truth" is typically established by reference methods or highly accurate laboratory instruments, not by a panel of human experts interpreting data.

4. Adjudication method for the test set

   Not applicable or not specified. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies for endpoint determination (e.g., presence of disease from images) based on multiple expert opinions. For a blood gas system, the performance is evaluated by comparing measurements against reference methods, not subjective 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 an in vitro diagnostic (IVD) blood gas system, not an AI-assisted diagnostic imaging or interpretation device that involves human "readers."

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

   This device is an automated in vitro diagnostic system. Its "standalone" performance means the accuracy and reliability of its measurements of various blood parameters. While the document mentions software changes and cybersecurity enhancements, it is not an algorithm that interprets human-generated data or makes a diagnosis. Its performance is inherent to its measurement capabilities. The 510(k) summary asserts that its performance is "substantially equivalent" to the predicate, implying successful internal testing to confirm this.

7. The type of ground truth used

   For IVD devices measuring physiological parameters, "ground truth" is typically established by:

   • Reference methods: Highly accurate and validated analytical methods (e.g., gas chromatography for blood gases, gravimetric methods for electrolytes) or
   • Comparison to predicate/established devices: Comparing measurements from the device under evaluation to a legally marketed and well-characterized predicate device or other established clinical laboratory instruments.

   This document explicitly states the modified device is "substantially equivalent to the comparative method" (referring to the predicate device).

8. The sample size for the training set

   Not applicable or not specified. This is a measurement device for chemical and physiological parameters, not a machine learning model that requires a distinct "training set" of clinical data in the typical sense. Any internal developmental data would be for engineering optimization rather than model training.

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

   Not applicable (as it's not an AI/ML device requiring a training set in that context).

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