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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 i-STAT CG8+ cartridge with the i-STAT 1 System is in the in vitro quantification of sodium and potassium in arterial or venous whole blood in point of care or clinical laboratory settings.

The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of sodium in capillary whole blood in point of care or clinical laboratory settings.

Sodium measurements are used for monitoring electrolyte imbalances.

Potassium measurements are used in the diagnosis and cinical conditions that manifest high and low potassium levels.

The i-STAT CG8+ cartridge is used with the i-STAT 1 analyzer as part of the i-STAT 1 System and contains test reagents to measure sodium (Na) in arterial, venous or capillary whole blood and to measure potassium (K) in arterial and 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 CG8+ cartridge, is designed for use by trained medical professionals in point of care or clinical laboratory settings and is for prescription use only.

The i-STAT CG8+ cartridge contains the required sensors, a fluid pack (calibrant pouch), a sample entry well and closure, fluid channels, waste chamber, and the necessary mechanical features for controlled fluid movement within cartridge. The i-STAT cartridge format allows all the tests in the cartridge to be performed simultaneously. All the test steps and fluid movement occur within the i-STAT CG8+cartridge. Cartridges require two to three drops of whole blood applied to the cartridge using a transfer device by the trained user before the cartridge is placed within the analyzer.

The i-STAT 1 analyzer is a handheld, in vitro diagnostic analytical device designed to run only i-STAT test cartridges. The instrument interacts with the i-STAT CG8+ cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).

This document describes the performance of the i-STAT CG8+ cartridge with the i-STAT 1 System for the in vitro quantification of sodium (Na) and potassium (K) in whole blood. This is a medical device, and the provided text is a 510(k) summary, which is typically submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

It's important to note that the provided text focuses on the analytical performance of a diagnostic device (measuring concentrations of substances), not an AI-assisted diagnostic device for interpreting images or other complex data. Therefore, many of the requested points regarding AI/MRMC studies, number of experts, adjudication methods, and ground truth establishment for complex AI algorithms are not applicable to this type of device and will not be found in the document.

Here's a breakdown of the requested information based on the provided text, focusing on the analytical performance validation:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a single table. Instead, it presents performance characteristic studies (precision, linearity, detection limit, interference, method comparison, and matrix equivalence) with their respective results. The success of these studies implicitly serves as the acceptance criteria for the device to be considered substantially equivalent.

Below is a summary of the reported device performance for key analytical characteristics:

• Cholesterol: Decreased Na results > 400 mg/dL
• Nithiodote (Sodium Thiosulfate): Increased Na results ≥ 2.1 mmol/L |
  | Method Comparison | | | Slope near 1, Intercept near 0, High r | Substantially equivalent to predicate device |
  | K (mmol/L) vs. Predicate (i-STAT CHEM8+) | Arterial/Venous | n=340 | Strong correlation & agreement | Slope: 1.00, Intercept: 0.00, r: 1.00. Bias at Medical Decision Levels (3.0, 5.8, 7.5): 0.00 |
  | Na (mmol/L) vs. Predicate (i-STAT CHEM8+ or epoc Blood Analysis System) | Pooled: Arterial/Venous/Capillary | n=551 (pooled), n=209 (capillary only) | Strong correlation & agreement | Pooled: Slope: 1.00, Intercept: 0.00, r: 0.99. Bias at Medical Decision Levels (115, 135, 150): 0.0. Capillary only: Slope 1.00, Intercept 0.00, r 0.98. Bias 0.0. |
  | Matrix Equivalence | | | Slope near 1, Intercept near 0, High r | Equivalence demonstrated |
  | Na (mmol/L) | Venous/Arterial non-anticoagulated vs. with anticoagulant | n=295 | Strong correlation & agreement | r: 0.99, Slope: 1.00, Intercept: 0.00 |
  | K (mmol/L) | Venous/Arterial non-anticoagulated vs. with anticoagulant | n=292 | Strong correlation & agreement | r: 0.99, Slope: 1.00, Intercept: 0.00 |

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

The "test set" in this context refers to the samples used in the analytical performance studies. The data provenance is described within each study:

• Precision/Reproducibility (Aqueous materials):
  • 20-day precision: N=80 per level (5 levels) for Na and K. Conducted at "one site."
  • Multi-site/operator precision: N=90-97 per level (5 levels) for Na and K. Conducted at "three (3) sites."
• Precision (Whole Blood):
  • N varies by analyte and sample type/range (e.g., Na venous: 17, 99, 67; Na arterial: 2, 89, 62; Na capillary: 3, 56, 95; K venous: 27, 135, 19; K arterial: 23, 124, 6).
  • Whole blood specimens collected "across multiple point of care sites." Capillary specimens involved "two individual fingersticks, collected independently by two operators."
• Linearity:
  • Whole blood samples of "varying analyte levels" were used. Specific N not provided for this study.
• Detection Limit (LoQ):
  • Whole blood that was altered to a low analyte level. Specific N not provided.
• Analytical Specificity (Interference):
  • Whole blood samples were used. Specific N not provided, but interference determined by comparing "control sample" to "test sample."
• Method Comparison:
  • K (Arterial/Venous): N=340. "Lithium heparin venous and arterial whole blood specimens collected across multiple point of care sites."
  • Na (Pooled: Arterial/Venous/Capillary): N=551. "Venous and arterial" data pooled with "capillary whole blood specimens."
  • Na (Capillary only): N=209. "Native and Contrived Capillary Specimens." Bias at Medical Decision Levels for "Native Capillary Specimens" (N=194).
• Matrix Equivalence:
  • N=295 for Na, N=292 for K. "non-anticoagulated venous and arterial whole blood specimens."

Data Provenance: The data was collected from "multiple point of care sites" in the precision and method comparison studies. The document does not specify the country of origin or whether the studies were retrospective or prospective, though typical 510(k) studies for new devices are prospective analytical performance studies.

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

This type of device (in vitro diagnostic for chemical analysis) does not typically involve expert readers or adjudication for "ground truth" in the same way an AI imaging algorithm would. The "ground truth" for analytical performance is the reference measurement provided by a comparator method (e.g., the i-STAT CHEM8+ predicate device or "comparative method" lab instrument) or gravimetric/volumetric preparation for linearity and precision studies.

Therefore, there is no mention of "experts" (e.g., radiologists) establishing ground truth, nor their qualifications or numbers.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this device does not involve human interpretation requiring adjudication. Performance is assessed by comparing quantitative results from the device against a known reference or comparative method.

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 not an AI-assisted diagnostic device, nor does it involve human readers interpreting data. It's a quantitative measurement device.

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

This is an algorithm/device-only performance study, as it's a fully automated in vitro diagnostic device. The performance data presented (precision, linearity, method comparison, etc.) reflects the standalone performance of the i-STAT CG8+ cartridge with the i-STAT 1 System. There is no human interpretation component in the measurement or output of the device.

7. The Type of Ground Truth Used

The "ground truth" in these analytical performance studies is established by:

• Reference materials/calibrators: For precision, linearity, and detection limit studies, defined aqueous or whole blood materials with known (or precisely determined) analyte concentrations are used.
• Comparator methods: For method comparison studies, the device's results are compared against a legally marketed predicate device (i-STAT CHEM8+ cartridge on the i-STAT 1 System) or another established "comparative method" (e.g., epoc Blood Analysis System) which serves as the reference, assumed to be accurate.
• Prepared samples: For linearity, samples are prepared with varying analyte levels.

8. The Sample Size for the Training Set

This document does not specify a "training set" size. For traditional in vitro diagnostic devices, there isn't a "training" phase in the machine learning sense. The device's algorithms (for sensor interpretation and calculation) are developed and validated in a more traditional engineering sense, not through iterative machine learning on a large dataset. The studies described are for validation or testing the final product's performance.

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

Not applicable, as there's no "training set" in the context of machine learning for this type of device. The ground truth for development and internal validation of such a device would likely be established through highly controlled laboratory measurements using reference methods and materials.

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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 ISE Electrodes on the RX Imola can be used for measurement of the electrolytes sodium, potassium and chloride in serum and urine and for use in diagnosis and treatment of electrolyte imbalance. For in vitro diagnostic use only.

RX imola is an automated clinical chemistry analyzer complete with dedicated analyzer software. Software functions of the analyzer include the facility to interact with a host computer for direct download of test method selection details for individual samples. A barcode system is used for the rapid identification of patient samples, reagents and QC samples, In addition, the RX imola is fitted with an Ion Selective Electrode (ISE) module that operates in conjunction with specific electrodes for the quantitative in vitro diagnostic determination of Sodium, Potassium and Chloride in serum and urine.

The provided document is a 510(k) summary for a medical device (ISE Electrodes) and outlines the performance characteristics to demonstrate substantial equivalence to a predicate device. It focuses on the analytical performance of the device rather than a clinical study involving human patients or complex AI algorithms. Therefore, many of the requested points related to multi-reader multi-case studies, expert ground truth establishment for AI, and training/test set sample sizes for AI are not applicable to this type of submission.

The document details the acceptance criteria and the study that proves the device meets those criteria for analytical performance.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (Ion Selective Electrodes for measuring common electrolytes), the "acceptance criteria" are typically defined by demonstrating that the new modified device performs equivalently to the existing cleared predicate device and meets established analytical performance guidelines (e.g., CLSI standards for precision, linearity, and interference). The document implicitly defines acceptance by stating "The acceptance criteria ... was met" or "The results... support the claimed measuring ranges."

Here's a summary of the performance demonstrated based on the provided text:

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

The "test set" in this context refers to the samples used for analytical validation studies.

• Precision Studies:
  • Serum: Two levels of control material and at least five human serum samples for each analyte (Sodium, Potassium, Chloride). Tested twice per day for 20 non-consecutive days, two replicates per run. This totals 80 data points per measured sample/control (20 days * 2 runs/day * 2 replicates/run).
  • Urine: Two levels of urine controls and at least five urine patient pools for each analyte. Tested twice per day for 20 non-consecutive days, two replicates per run. This totals 80 data points per measured sample/control.
• Linearity Studies: 9 levels of samples used for each analyte and specimen type.
• Method Comparison (Correlation):
  • Serum: 105 patient serum samples for Sodium, 109 for Potassium, 104 for Chloride.
  • Urine: 72 patient urine samples for Sodium, 84 for Potassium, 90 for Chloride.
• Data Provenance: The document does not explicitly state the country of origin for the patient samples. The studies were conducted in-house by Randox Laboratories Limited, which is based in the United Kingdom. The studies were retrospective in the sense that they used collected samples to validate the device's performance, not in the sense of analyzing pre-existing patient data outside a controlled study.

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

• N/A. This is an in vitro diagnostic (IVD) device for measuring electrolyte concentrations using Ion Selective Electrodes. The "ground truth" for analytical performance studies is established by quantitative measurements using reference methods or by the known concentrations of controls/calibrators, not by human expert interpretation like radiologists.

4. Adjudication Method for the Test Set

• N/A. As this is an analytical performance study for an IVD device, there is no human adjudication method required. Performance is based on quantitative measurements.

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

• N/A. This is not an AI-based device, nor is it a device that involves human "readers" interpreting images or clinical data. Therefore, an MRMC study is not relevant.

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

• Partially Applicable / Context Dependent. The device (ISE Electrodes on the RX Imola) performs measurements automatically. The performance data presented (precision, linearity, interference, method comparison) is the "standalone" performance of the device as it directly measures the analytes, without requiring human "interpretation" of the analytical result itself beyond standard lab procedures. There is no separate algorithm being tested in the AI sense.

7. The Type of Ground Truth Used

• Reference Method / Known Concentration:
  • For precision and linearity studies, ground truth is established by using control materials and prepared linearity samples with known, validated concentrations or statistically derived consensus values from repeated measurements.
  • For method comparison, the "ground truth" is effectively the measurements obtained from the predicate device (the RX imola with the previous ISE unit, K052914), against which the new device (RX imola with new ISE electrodes, K230890) is correlated to demonstrate equivalence.
  • For interference studies, known interfering substances are added at specific concentrations to samples to evaluate their effect on the measurement.

8. The Sample Size for the Training Set

• N/A (in the AI/machine learning sense). This device does not involve a "training set" in the context of machine learning. It's a chemical measurement system with established electrochemical principles. Standard calibration and quality control procedures are part of its normal operation, but these are not "training sets" in the AI development sense.

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

• N/A (in the AI/machine learning sense). As there is no AI training set, this question is not applicable. The device's operational "knowledge" comes from its manufacturing specifications, calibration protocols using reference materials, and the underlying physical and chemical principles of ion-selective electrodes.

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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 A-LYTE® Integrated Multisensor (IMT Na K Cl) is for in vitro diagnostic use in the quantitative determination of sodium, potassium, and chloride (Na, K, Cl) in human serum, plasma (lithium heparin) and urine using the Atellica® Cl Analyzer. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of arge amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The A-LYTE Na, K, and Cl assays use indirect Integrated Multisensor Technology (IMT). There are four electrodes used to measure electrolytes. Three of these electrodes are ionselective for sodium, potassium and chloride. A reference is also incorporated in the multisensor.

A diluted sample (1:10 with A-LYTE IMT Diluent)) is positioned in the sensor and Na+. K+ or Cl- ions establish equilibrium with the electrode surface. A potential is generated proportional to the logarithm of the analyte activity in the sample. The electrical potential generated on a sample is compared to the electrical potential generated on a standard solution, and the concentration of the desired ions is calculated by use of the Nernst equation.

This document describes the performance characteristics of the A-LYTE® Integrated Multisensor (IMT Na K Cl) device, which is used for the quantitative determination of sodium, potassium, and chloride in human serum, plasma, and urine. The information provided outlines the acceptance criteria for various performance metrics and the study results demonstrating that the device meets these criteria.

Here's a breakdown of the requested information:

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

The document doesn't explicitly list "acceptance criteria" in a separate table, but rather describes the design goals or target performance for each characteristic, followed by the obtained results. I will present these as acceptance criteria and reported performance.

Table 1: Acceptance Criteria and Reported Device Performance

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 Sample Sizes:

  • Detection Capability (LoQ): 180 determinations for each analyte (Na, K, Cl) in both serum/plasma and urine.
  • Linearity: 5 replicates per level for at least nine levels, implying a minimum of 45 measurements per analyte and sample type.
  • Precision: N ≥ 80 for each sample type (serum and urine) for each analyte (Na, K, Cl).
  • Assay Comparison:
    • Na (Serum): 123 samples
    • Na (Urine): 117 samples
    • K (Serum): 119 samples
    • K (Urine): 117 samples
    • Cl (Serum): 123 samples
    • Cl (Urine): 127 samples
  • Reproducibility: N=225 results for each sample type (serum QC, human serum, human urine) per analyte (Na, K, Cl), with n=5 assays in 1 run for 5 days using 3 instruments and 3 sensor lots.
  • Specimen Equivalency:
    • Na (Lithium heparin plasma vs Serum): 138 samples
    • K (Lithium heparin plasma vs Serum): 56 samples
    • Cl (Lithium heparin plasma vs Serum): 136 samples
  • Interferences: Not explicitly stated as a single "sample size," but implied from the number of test concentrations and conditions evaluated (e.g., specific concentrations of hemoglobin, bilirubin, lipemia).
  • Non-Interfering Substances: Not explicitly stated as a single "sample size," but implied from the number of test concentrations and conditions evaluated.

• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission for an in vitro diagnostic device, these studies are typically prospective validation studies conducted at the manufacturer's R&D facilities or contracted labs, adhering to CLSI guidelines.

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

This device is an in vitro diagnostic (IVD) for quantitative determination of electrolytes. The "ground truth" (or reference values) for these types of devices is established through:

• Reference Methods: Comparison against established, well-characterized reference methods or instruments (e.g., the predicate device in the assay comparison, or other highly accurate laboratory methods). In this case, "Atellica CH Na/K/Cl on Atellica CH Analyzer" served as the comparative assay, which itself would have been validated against reference standards.
• Certified Reference Materials: Use of calibrated standards and controls with known analyte concentrations derived from definitive methods.

Therefore, the concept of "experts" (like radiologists interpreting images) establishing ground truth does not directly apply here. Instead, ground truth is based on physical/chemical measurements and their traceability to metrological standards. There are no human experts involved in adjudicating the "truth" of an electrolyte concentration in a sample as there would be in image interpretation.

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

Not applicable. As explained in point 3, the ground truth for this type of quantitative IVD assay is established through comparison to reference methods, not human adjudication of a qualitative or semi-quantitative outcome.

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 automated laboratory analyzer, specifically an Integrated Multisensor for electrolyte measurement. It is not an imaging AI device that assists human readers.

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

Yes, the performance data presented (Detection Capability, Linearity, Precision, Reproducibility, Interferences) represent the standalone performance of the A-LYTE® Integrated Multisensor (IMT Na K Cl) on the Atellica® CI Analyzer. These are direct measurements of the device's analytical precision, accuracy, and interference profiles under controlled laboratory conditions, without human interpretation influencing the quantitative results. The Assay Comparison also represents the device's performance against another automated laboratory system (the predicate device).

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

The ground truth for this device's performance studies is based on:

• Reference Standards/Methods: Calibrated reference materials and comparison to a legally marketed predicate device (TD-LYTE Integrated Multisensor on Trinidad CH System, now Atellica CH System). This ensures that the measured concentrations are accurately determined against established analytical benchmarks.
• Known Concentrations: For linearity, precision, and interference studies, samples are often spiked or diluted to known concentrations, or quality control materials with certified values are used.

8. The sample size for the training set:

Not applicable. This device is a measurement instrument based on established potentiometric technology (Ion-Selective Electrodes). It does not employ machine learning or AI models that require a separate "training set" in the conventional sense. The development and calibration of such devices rely on comprehensive analytical chemistry and engineering principles, using calibration standards, quality control materials, and extensive internal testing during the development phase. The data presented here are for the validation of the finalized device, not for its iterative training.

9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" for an AI model. For the development and calibration of the IMT, the ground truth would be established through a combination of:

• Primary Reference Materials: Use of highly pure chemical standards with accurately known concentrations.
• Secondary Reference Standards: Calibrated solutions traceable to primary standards.
• Reference Measurement Procedures: Highly accurate and precise analytical methods (e.g., flame photometry, coulometry, or isotope dilution mass spectrometry for elemental analysis) used to assign values to control materials and calibrators.
• Internal R&D and Optimization: Extensive testing and refinement of the sensor and instrument performance using these traceable standards during the development process.

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The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

The Glucose test system is for the quantitative measurement of glucose in human serum, plasma, urine and cerebrospinal fluid on Beckman Coulter AU/DxC AU analyzers. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and of pancreatic islet cell carcinoma.

System reagent for the quantitative determination of C-Reactive Protein in human serum and plasma on Beckman Coulter AU/DxC AU Analyzers. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Measurements may also be useful as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes. Reagents for the quantitative determination of Sodium, Potassium and Chloride concentrations in human serum, plasma and urine on the Beckman Coulter ISE modules.

The sodium test system is intended for the quantitative measurement of sodium in serum, plasma, and urine.

Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

The potassium test system is intended for the quantitative measurement of potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

The chloride test system is intended for the quantitative measurement of the level of chloride in plasma, serum, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer carries out automated analysis of serum, plasma, urine samples and other body fluids and automatically generates results. The device is an automated photometric clinical analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Electrolyte measurement is performed using a single cell lon Selective Electrode (ISE) which is also common among the other members of the AU family.

The ISE module for Na+, K+, and Cl- employs crown ether membrane electrodes for sodium and potassium and a molecular oriented PVC membrane for chloride that are specific for each ion of interest in the sample. An electrical potential is developed according to the Nernst Equation for a specific ion. When compared to the Internal Reference Solution, this electrical potential is translated into voltage and then into the ion concentration of the sample.

In this Beckman Coulter procedure, glucose is phosphorylated by hexokinase (HK) in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6phosphate dehydrogenase (G6P-DH) specifically oxidizes G-6-P to 6phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide (NAD+) to nicotinamide adenine dinucleotide, reduced (NADH). The change in absorbance at 340/660 nm is proportional to the amount of glucose present in the sample.

The CRP Latex reagent is an in vitro diagnostic device that consists of ready to use buffer and latex particles coated with rabbit anti-CRP antibodies. In this procedure, the measurement of the rate of decrease in light intensity transmitted through particles suspended in solution is the result of complexes formed during the immunological reaction between the CRP of the patient serum and rabbit anti-CRPantibodies coated on latex particles. Two measuring range settings are available: Normal application (CRP Concentrations ranging between 5.0-480 mg/L) and Highly Sensitive (Cardiac) Application- (CRP concentrations ranging between 0.2-80mg/L).

This document describes the acceptance criteria and supporting study for the Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer and its associated reagents (Glucose, CRP Latex, ISE Reagents for Sodium, Potassium, and Chloride).

1. Table of Acceptance Criteria and Reported Device Performance

The device performance was evaluated across several metrics. The table below summarizes the acceptance criteria (often implied by the "Pass" result and the specific targets within the CLSI guidelines references) and the reported performance for key tests:

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The Alinity ci-series is intended for in vitro diagnostic use only.

The Alinity ci-series is a System comprised of inity i or Alinity c analyzers/processing modules that may be arranged into individual or multimodule configurations including up to four Alinity i processing modules, up to four Alinity c processing modules, or a combination of up to four of Alinity i and Alinity c processing modules with a shared system control module to form a single workstation.

The Alinity c System is a fully automated, random/continuous access, clinical chemistry analyzer intended for the in vitro determination of analytes in body fluids.

The Alinity i System is a fully automated analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology is used to determine the presence of antigens, antibodies, and analytes in samples.

The Alinity c ICT (Integrated Chip Technology) is used for the quantitation of sodium, and chloride in human serum, plasma, or urine on the Alinity c analyzer.

Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension. Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

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

The Alinity c Glucose Reagent Kit is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the Alinity c analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The Alinity i Total B-hCG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative and qualitative determination of beta-human chorionic gonadotropin (B-hCG) in human serum and plasma for the early detection of pregnancy on the Alinity i analyzer.

The Alinity ci-series is comprised of individual Alinity i or Alinity c analyzers/processing modules that may be arranged into individual or multimodule configurations which include either multiple Alinity i processing modules, multiple Alinity c processing modules, or a combination of up to four of both Alinity i and Alinity c processing modules with a shared system control module (SCM). The SCM includes the reagent and sample manager (RSM). The multimodule configurations do not have a separate device label or list number. In a multimodule configuration, each processing module retains its original unique identification label.

The document describes the non-clinical performance evaluation of the Alinity ci-series system, Alinity i Total ß-hCG Reagent Kit, Alinity c Glucose Reagent Kit, and Alinity c ICT Sample Diluent. The study focuses on demonstrating equivalent performance between the original single-module configurations and the new multi-module configurations.

Here's an breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on demonstrating "equivalent performance" between the investigational multimodule system and the previously cleared single-module predicate devices. The reported performance metrics are precision (%CV) and method comparison parameters (slope and correlation coefficient). The document doesn't explicitly state numerical acceptance criteria thresholds, but rather implies that the observed results were within an acceptable range for "equivalent performance."

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

The document does not explicitly state the exact sample sizes (number of patient samples) for the precision and method comparison studies. It provides ranges of analyte concentrations, implying that multiple samples spanning these ranges were tested.

• Precision Studies: Samples across various concentration ranges (e.g., 5.25 to 12,850 mIU/mL for ß-hCG, 7 to 688 mg/dL for glucose serum, etc.) were used. The term "5-day precision" suggests a study design where samples are run over 5 days to assess within-laboratory variability.
• Method Comparison Studies: Samples across various concentration ranges were used (e.g., 2.74 to 14,998.60 mIU/mL for ß-hCG, 14 to 659 mg/dL for glucose serum, etc.).

Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that it's a pre-market submission to the FDA, the studies are typically prospective and conducted by the manufacturer, often at their own facilities or clinical study sites.

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

Not applicable for this type of device. The ground truth for quantitative laboratory assays is typically established by reference methods or the performance of a cleared predicate device, not by expert consensus or physician review in the way it would be for imaging diagnostics. The "ground truth" here is the measurement obtained from the previously cleared single-module systems.

4. Adjudication method for the test set

Not applicable for this type of device. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation (e.g., radiology reads) to resolve discrepancies among multiple expert reviewers. Here, the comparison is against quantitative measurements from a reference or predicate system.

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 submission is for an in vitro diagnostic (IVD) system that performs automated quantitative measurements, not an AI-assisted diagnostic imaging device that involves human readers.

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

This refers to the performance of the automated Alinity ci-series system. The studies described (precision and method comparison) are essentially standalone performance evaluations comparing the new multimodule system to the existing single-module systems. There is no "human-in-the-loop" component in the sense of an operator making diagnostic interpretations based on the output. Operators load samples and reagents and manage the system, but the analytical measurement itself is automated.

7. The type of ground truth used

The ground truth used for comparison in these non-clinical studies is the performance of the predicate devices (Alinity i System for Alinity i Total ß-hCG, and Alinity c System for Alinity c Glucose and ICT assays) in their single-module configurations. The goal was to demonstrate "equivalent performance" of the new multimodule configurations to these already cleared systems. This is a form of comparative effectiveness against a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This document describes the validation of a laboratory instrument system and reagent kits through non-clinical performance studies (precision, method comparison), not an AI/machine learning model that requires a distinct "training set." The methodology involves biochemical reactions and optical/potentiometric detection, which are established principles, not learned from a dataset.

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

Not applicable, as there is no "training set" in the context of an AI/ML model for this device.

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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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cobas pure integrated solutions is an automated analyzer, intended for running qualitative, semiguantitative and quantitative clinical chemistry and immunochemistry assays as well as ion selective measurements.

Glucose HK Gen.3 is an in vitro test for the quantitative determination of glucose in human serum, plasma, urine and CSF on Roche/Hitachi cobas c systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoqlycemia, idiopathic hypoglycemia and pancreatic islet cell tumors.

The ISE analytical unit of the Roche/Hitachi cobas c systems is intended for the quantitative determination of sodium in serum, plasma or urine using ion-selective electrodes. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Methadone II (MDN2) is an in vitro diagnostic test for the qualitative and semiquantitative detection of methadone in human urine on Roche/Hitachi cobas c systems at a cutoff concentration of 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Semiquantitative assays are intended to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/mass spectrometry (GC-MS).

Elecsys TSH is an immunoassay for the in vitro quantitative determination of thyrotropin in human serum and plasma. Measurements of TSH are used in the diagnosis of thyroid and pituitary disorders. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.

The cobas pure integrated solutions is a fully automated, random-access, software controlled system intended for in vitro quantitative and qualitative analysis of analytes in body fluids. It will typically be used in low to mid throughput clinical laboratories. The system consolidates clinical chemistry, homogenous immunoassays as well as electrolyte testing within one workplace. The cobas pure integrated solutions consists of a clinical chemistry analytical unit (cobas c 303) with an integrated ISE analytical unit, an immunoassay analytical unit (cobas e 402) and a core unit.

Glucose is phosphorylated by hexokinase (HK) in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G-6-PDH) specifically oxidizes G-6-P to 6-phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide (NAD) to nicotinamide adenine dinucleotide reduced (NADH). One micromole of NADH is produced for each micromole of glucose consumed. The NADH produced absorbs light at 340 nm and can be detected spectrophotometrically as an increased absorbance.

The ISE analytical unit for Na+ employs ion-selective membrane to develop an electrical potential (electromotive force, EMF) for the measurements of ions in solution. Selective membrane is in contact with both the test solution and an internal filling solution. Due to the selectivity of the membrane, only the ions to be EMF. The membrane EMF is determined by the difference in concentration of the test ion in the test solution and the internal filling solution.

The ISE analytical unit of the Roche/Hitachi cobas c systems is intended for the quantitative determination of sodium in serum, plasma or urine using ion-selective electrodes. Sodium is the major extracellular cation and functions to maintain fluid distribution and osmotic pressure. Some causes of decreased levels of sodium include prolonged vomiting or diarrhed reabsorption in the kidney and excessive fluid retention. Common causes of include excessive fluid loss, high salt intake and increased kidney reabsorption.

The Methadone assay is based on the kinetic interaction of microparticles in a solution (KIMS) as measured by changes in light transmission. In the absence of sample drug conjugates bind to antibody-bound microparticles, causing the formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases.

When a urine sample contains the drug in question, this drug derivative conjugate for microparticle-bound antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. The presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.

The Elecsys TSH immunoassay makes use of a sandwich test principle using monoclonal antibodies specifically directed against human TSH. The antibodies labeled with ruthenium complex) construct from human and mouse specific components. Elecsys TSH immunoassay is intended for the in vitro quantitative determination of thyrotropin in human serum and plasma. Measurements of TSH are used in the diagnosis of thyroid and pituitary disorders. It is intended for use on the cobas e immunoassay analyzers.

The provided text describes several in vitro diagnostic (IVD) devices and their performance characteristics. It outlines how Roche Diagnostics established the substantial equivalence of these devices (Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH, and the cobas pure integrated solutions analyzer) to their predicate devices through various non-clinical tests.

However, the document does not provide a table of acceptance criteria and reported device performance in a format that easily allows for direct comparison against specific numeric targets. Instead, it describes general study types and states that the "analytical performance data for all representative assays meet specifications and support the substantial equivalence."

Furthermore, it does not explicitly detail the following requested information:

• Sample sizes used for the test set and data provenance: The document mentions "human serum, plasma, urine and CSF" as sample types but not explicit test set sample numbers or their country of origin for most tests. It generally refers to "human samples" or "pooled human plasma and serum samples."
• Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present for any of the described tests. The ground truth for these IVDs is typically established through reference methods or established control materials, not expert consensus on individual cases.
• Adjudication method: Not applicable/provided as the tests are analytical and do not involve human interpretation requiring adjudication.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable, as these are IVD assays, not AI-assisted reader studies.
• Standalone performance: The entire document describes the standalone performance of the algorithms/assays.
• Type of ground truth used: For quantitative assays (Glucose, Sodium, TSH), the ground truth is implicitly based on established reference methods or known concentrations in control materials. For qualitative/semi-quantitative assays like Methadone, it's based on known concentrations relative to a cutoff or confirmed by methods like GC-MS.
• Sample size for the training set: Not explicitly stated, as these are typically not machine learning models in the sense of needing a distinct "training set" for classification, but rather reagents and analytical systems whose performance is validated. The mentioned "study" refers to validation studies, not AI model training.
• How the ground truth for the training set was established: Not applicable, as explained above.

Given the nature of the document, which focuses on device-specific analytical performance claims rather than AI model validation, several of the requested categories are not directly addressed or are not relevant.

Below is an attempt to structure the available information, noting the limitations.

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria (e.g., "sensitivity ≥ 95%") are not explicitly provided in the text, this table will summarize what types of performance were evaluated and that they met specifications as stated in the document.

Overall Conclusion for all devices: "The analytical performance data for all representative assays meet specifications and support the substantial equivalence...to the predicate devices."

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

• Glucose HK Gen.3:
  • Precision studies: "Two aliquots per run, two runs per day for ≥ 21 days". Types of samples (e.g., patient, control) not specified, but typically human-derived.
  • Linearity, LoB, LoD, LoQ, Interference, Matrix Comparison, Post Dilution Check, Recovery in Controls: Sample numbers or types of samples for these specific studies are not detailed.
  • Method Comparison: "all sample types" (e.g., human serum, plasma, urine, CSF) tested between cobas c 303 and cobas c 503.
  • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
• ISE indirect Na for Gen.2:
  • Precision studies: "One run per day for ≥ 21 days with two parts, two aliquots per part". Typically human-derived samples.
  • Endogenous Interference: "pooled human plasma and serum samples spiked with varying levels of interferent."
  • Linearity, LoB, LoD, LoQ, Drug Interference, Calibration Frequency, Post Dilution Check, Recovery in Controls: Sample numbers or specific types of samples not detailed.
  • Method Comparison: "all sample types" (e.g., human serum, plasma, urine) tested.
  • Data Provenance: Not specified.
• ONLINE DAT Methadone II:
  • Precision: "human samples and controls" (n=84 for repeatability, with 2 aliquots per run, 2 runs per day, 21 days for intermediate precision).
  • Endogenous Interference: "urine containing methadone" and "pooled human urine".
  • Drug Interference: "human urine containing methadone".
  • Cross Reactivity: Details not given, but likely spiked drug solutions into human urine.
  • Method Comparison: Urine samples compared against GC-MS and cobas c 503.
  • Data Provenance: Not specified.
• Elecsys TSH:
  • Precision: Likely control materials and potentially patient samples.
  • Endogenous Interfering Substances: "human serum samples (native serum pools)".
  • Cross-reacting Compounds: "native human serum sample pool".
  • Anticoagulants Effect: "native human serum samples, single donors as well as pools" drawn into various tubes.
  • Linearity, LoB, LoD, LoQ, Drug Interference, On-board Reagent Stability, High-dose Hook Effect: Sample numbers or types not specified.
  • Method Comparison: Human serum and plasma samples compared between cobas e 402 and cobas e 801.
  • Data Provenance: Not specified.

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

Not applicable. For in vitro diagnostic assays, "ground truth" is established through analytical reference methods, defined concentrations of calibrators/standards, or confirmed by other laboratory methods (e.g., GC-MS for Methadone) rather than expert human interpretation of results.

4. Adjudication method

Not applicable. These are analytical tests performed by automated systems; there is no human interpretation or adjudication involved in generating the primary test result.

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 for in vitro diagnostic assays on automated analyzers, not AI-assisted human reader studies. The "AI" would refer to the algorithms within the analytical unit, not a system designed to assist human readers.

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

Yes, the entire document focuses on the standalone performance of the analytical systems and assays. The results are generated directly by the device/analyzer without human intervention for interpretation beyond loading samples and performing quality control.

7. The type of ground truth used

• For Glucose, Sodium, TSH (Quantitative assays): The ground truth for these quantitative measurements is based on reference methods, known concentrations in calibrators and controls, or comparative methods (e.g., flame photometry for sodium, or existing cleared assays on predicate devices).
• For Methadone (Qualitative/Semi-quantitative assay): Ground truth is established by known concentrations relative to a cutoff (e.g., 225 ng/mL for negative control, 375 ng/mL for positive control) and confirmed by a "confirmatory method such as gas chromatography/mass spectrometry (GC-MS)".

8. The sample size for the training set

Not explicitly specified. These are not AI/ML models in the typical sense that require a distinct "training set." The development of reagents and analytical platforms involves extensive R&D and optimization, but the validation studies described here are for demonstrating performance and equivalence, not for "training" an algorithm in a machine learning context.

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

Not applicable, as a distinct "training set" with established ground truth in the context of machine learning model development is not typically associated with the development and validation of these types of in vitro diagnostic reagents and analyzers. The principles are generally based on established biochemical reactions, electrochemical measurements, or immunoassays.

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