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The Calcium2 assay is used for the quantitation of calcium in human serum, plasma, or urine on the ARCHITECT c System.

Calcium 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).

The Calcium2 assay is an automated clinical chemistry assay. Arsenazo III dye reacts with calcium in an acid solution to form a blue-purplex. The color developed is measured at 660 nm and is proportional to the calcium concentration in the sample.

Methodology: Arsenazo III

The provided text describes the performance validation of the Calcium2 assay, specifically for its use in quantitating calcium in human serum, plasma, or urine on the ARCHITECT c System. This is a Class II medical device (Calcium test system), regulated under 21 CFR 862.1145, product code CJY.

Here's an analysis based on the request:

Device: Calcium2 assay
Intended Use: Quantitation of calcium in human serum, plasma, or urine on the ARCHITECT c System. Used in the diagnosis and treatment of parathyroid disease, various bone diseases, chronic renal disease, and tetany.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly outline a pre-defined table of "acceptance criteria" against which each test result is measured, as would be common for AI/ML performance studies. Instead, it presents various performance characteristics with their measured values, often referencing CLSI guidelines for the methodology. The "acceptance" can be inferred from the reported values and the conclusion of substantial equivalence. For quantitative assays like this, performance is typically assessed against established industry standards for precision, accuracy, linearity, and interference.

However, we can infer some "acceptance criteria" implicitly from the context of "acceptable performance" and the ranges presented.

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

The provided information is for an in-vitro diagnostic (IVD) test, not an AI/ML model for image analysis. Therefore, the "test set" and "training set" terminology from an AI/ML perspective doesn't directly apply in the same way. Instead, the studies involved various types of samples (controls, panels, human serum/plasma/urine samples) tested under specific experimental designs.

• Precision Studies (Serum & Urine, 20-Day):
  • Sample Size: 80 replicates per sample type (2 controls, 3 human panels) for each of the 3 reagent lot/calibrator lot/instrument combinations in the 20-day study. (e.g., 5 samples * 80 replicates = 400 total data points per combination shown in the table).
  • Data Provenance: Not explicitly stated (e.g., country of origin). The studies are "within-laboratory" meaning they were conducted in a controlled lab setting, likely at the manufacturer's site or a designated testing facility. The nature of these samples (human serum/urine panels) suggests they are likely representative, but the specific collection method or origin (retrospective/prospective collection from patients) is not detailed.
• System Reproducibility Studies (Serum & Urine):
  • Sample Size: 90 replicates per sample type (2 controls, 3 human panels).
  • Data Provenance: Same as above, not explicitly stated.
• Accuracy Study:
  • Sample Size: Not explicitly stated for replicates, but involved 2 concentrations of NIST SRM 956d standard.
  • Data Provenance: NIST standard reference material, a highly controlled and traceable source.
• Lower Limits of Measurement Studies (Serum & Urine):
  • Sample Size: n ≥ 60 replicates for zero-analyte and low-analyte level samples for LoB, LoD, and LoQ determination.
  • Data Provenance: Not explicitly stated.
• Linearity Studies (Serum & Urine):
  • Sample Size: Not explicitly stated how many points were measured across the range, but demonstrated linearity from 2.0 to 24.0 mg/dL.
  • Data Provenance: Not explicitly stated.
• Interference Studies (Serum & Urine):
  • Sample Size: Not explicitly stated how many replicates, but each substance was tested at 2 levels of the analyte.
  • Data Provenance: Not explicitly stated.
• Method Comparison Studies (Serum & Urine):
  • Sample Size: 120 serum samples, 112 urine samples.
  • Data Provenance: Patient samples. Not explicitly stated if retrospective or prospective collection.
• Tube Type Equivalence Study (Serum):
  • Sample Size: Samples from 78 donors.
  • Data Provenance: Donor samples. Not explicitly stated if retrospective or prospective.
• Dilution Verification (Urine):
  • Sample Size: 5 samples prepared with calcium stock. Replicates for dilution recovery and imprecision were performed but the exact number isn't specified beyond "demonstrated acceptable performance."
  • Data Provenance: Prepared samples.

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

This type of IVD device (quantitative chemical assay) relies on objective measurement against a known reference (e.g., NIST standard) or internal validated methods, rather than subjective expert consensus. Therefore, "ground truth" is established through highly controlled laboratory procedures and certified reference materials, not typically through multiple human experts adjudicating results. The "experts" involved are likely laboratory scientists and metrologists operating under strict quality systems (CLSI guidelines, ISO standards).

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

Not applicable for a quantitative chemical assay. Results are objectively measured by the instrument and verified through calibration and quality control. There is no subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in-vitro diagnostic test, not an AI/ML-driven imaging or diagnostic tool that assists human readers.

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

This is a standalone quantitative assay. The Calcium2 device automatically measures calcium concentration. Human involvement is in sample preparation, loading, and interpreting the numerical output. Its performance is evaluated entirely as an automated system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this device's performance validation is established primarily through:

• Reference Materials: For accuracy (e.g., NIST SRM 956d for bias estimation).
• Known Concentrations: For linearity, lower limits of measurement, and dilution verification, samples are prepared with known concentrations of calcium or spiked with calcium.
• Comparative Methods: For method comparisons, the "ground truth" is implicitly the performance of the legally marketed predicate device (Abbott Clinical Chemistry Architect/Aeroset Calcium, K062855), which serves as the comparator.
• Statistical Models/Guidelines: CLSI guidelines (EP05-A3, EP09c, EP17-A2, EP06, EP07, EP34) provide the statistical framework and methodology for validating performance characteristics like precision, linearity, and interference.

8. The Sample Size for the Training Set

Not applicable in the typical AI/ML sense. This is a chemistry assay, not a machine learning model that undergoes a "training" phase with a large dataset. The "training" for such a device involves rigorous engineering, chemical formulation, and calibration development, rather than data-driven model training.

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

As above, "training set" is not a concept for this type of device. The accuracy and reliability of the assay are built into its chemical design, reagent formulation, and instrument calibration process. These processes rely on highly accurate reference standards (like NIST) and established analytical chemistry principles to ensure the device measures calcium correctly across its analytical range.

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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 intended for use in the in vitro quantification of ionized calcium and hematocrit 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 hematocrit in capillary whole blood in point of care or clinical laboratory settings.

Ionized calcium measurements are used in the diagnosis, monitoring, and treatment of conditions including, but not limited to, parathyroid disease, a variety of bone disease, chronic renal disease, tetany, and disturbances related to surgical and intensive care.

Hematocrit measurements can aid in the determination of normal or abnormal total red cell volume status that can be associated with conditions including anemia, erythrocytosis, and blood loss related to trauma and surgery.

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 hematocrit (Hct) in arterial, venous or capillary whole blood and to measure ionized calcium (iCa) 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+ cartridges require two to three drops of whole blood which are applied to the cartridge using a transfer device by the trained user before the cartridge is placed within the analyzer.

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

The provided text describes the analytical performance studies for the i-STAT CG8+ cartridge with the i-STAT 1 System, a device for in vitro quantification of ionized calcium (iCa) and hematocrit (Hct). This submission sought to demonstrate substantial equivalence to a predicate device (i-STAT CHEM8+ cartridge with the i-STAT 1 System, K191360).

Here's an analysis of the acceptance criteria and study details based on the provided information:

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

The document does not explicitly state pre-defined acceptance criteria (e.g., target ranges for precision, linearity, or bias). Instead, it presents the results of various analytical performance studies. The conclusion states that the studies demonstrate substantial equivalence to the predicate device, implying that the reported performance metrics met the internal or regulatory thresholds for such a claim.

However, we can infer performance targets for some aspects by comparing the reported results to general expectations for such devices or by looking at the predicate device's characteristics mentioned (though the predicate's detailed performance is not provided in this document).

For the purpose of this request, I will present the reported performance values. The "Acceptance Criteria" column will reflect the general expectation of "demonstrating substantial equivalence" or meeting regulatory standards for the tested parameter, as specific numerical acceptance criteria are not provided in the document.

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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 EasyStat 300 is designed for clinical laboratory use, making quantitative measurements of potassium (K+), ionized calcium (Ca++), and chloride (Cl-) in whole blood (arterial/venous) samples from Li-Heparinized Syringes. This Analyzer should only be used by trained technical laboratories to aid in the dagnosis and treatment of patients with electrolyte and/or acid-base disturbances.

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

Calcium (Ca++) (ionized) 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).

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

The EasyStat 300 is a system for use by health care professionalsto rapidly analyze venous and arterial whole blood samples in a clinical laboratory setting. The analyzer incorporates a Reagent Module containing the "calibrating" solutions A2, B2, and a "conditioning" solution C2. Calibrations are performed automatically or on-demand by the user to establish the "slope" of each sensor, used in the calculation of the patient sample.

The analyzer employs "Ion Selective Electrode" (ISE) sensors for K*, Ca**, Cl¯.

The EasyStat 300 uses 175µL of whole blood in the "Syringe" mode to analyze patient samples. The EasyStat 300 reports results for Potassium (K+), Calcium (Ca++), Chloride (Cl-). Additionally, it provides a number of calculated parameters based on the reported results and a number of input parameters as described in the Operator's Manual.

Medica's EasyQC materials (REF 8315/8316/8317) are specifically formulated for the EasyStat 300. Medica requires the use of quality controls every day patient samples are analyzed and after any troubleshooting is performed, as instructed in the Operator's Manual, to validate the performance of the analyzer. The analyzer stores QC results and provides a statistical analysis of its performance using Levey-Jennings plots for the last 30 consecutive days.

The Reagent Module (REF 8101) has a twelve-month shelf-life when stored at 4º-25ºC.

The electrolyte sensors (K, Ca, Cl) have one-year shelf-life when stored at 4º-25ºC. Use-Life of the sensors is determined from their calibration profiles and from the reported results during the EasyQC analysis. Sensors are replaced by the operator as described in the Operator's Manual. An automatic calibration is performed after installation to qualify the new sensor(s) and the operator is instructed to use the EasyQC multi-level QC materials to validate the EasyStat 300 performance.

The EasyStat 300 may be equipped with a Medica provided barcode scanner (REF 8420) via a USB port to automatically enter patient sample and EasyQC material information. Details are provided in the operator's Manual.

To maintain the performance of the analyzer Medica provides a cleaning solution (REF 8305) and a troubleshooting kit (REF 8250). Their proper uses are described also in the operator's Manual.

Here's an analysis of the provided text to extract the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details various performance studies (Precision, Linearity, Method Comparison, Sensitivity, Selectivity) and lists specifications or desired outcomes that serve as acceptance criteria. The actual performance is described within each study's results.

Note: The document does not explicitly present a "table of acceptance criteria and reported device performance" as a single, consolidated table. I will construct it based on the details provided in different sections.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The document mentions several types of performance studies:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

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

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

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

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

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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Medicon Hellas Albumin: Reagent for the quantitative measurement of albumin in serum. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Medicon Hellas Calcium: Reagent for the quantitative measurement of calcium in serum or urine. Calcium 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).

Medicon Hellas Creatinine: Reagent for the quantitative measurement of creatinine in serum and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

Medicon Hellas Glucose: Reagent for the quantitative measurement of glucose in serum and urine. 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.

Medicon Hellas Direct Bilirubin; Reagent for the quantitative measurement of direct bilirubin (conjugated) in serum. Measurements of the level of direct bilirubin is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall blader block.

Medicon Hellas Total Bilirubin: Reagent for the quantitative measurements of total bilirubin in serum. Measurements of the levels of total bilirubin is used in the diagnosis and treatment of liver. hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Medicon Hellas Urea Nitrogen: Reagent is for the quantitative measurement of urea nitrogen in serum and urine. Measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

The Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Glucose, Medicon Hellas Direct Bilirubin, Medicon Hellas Total Bilirubin, and Medicon Hellas Urea Nitrogen are reagents for use with Diatron Pictus 500 Clinical Chemistry Analyzers. They are test systems for the quantitative measurement of albumin, calcium, creatinine, glucose, direct and total bilirubin, and urea nitrogen in human serum and urine where clinically applicable. The methods employed are photometric, utilizing reactions between the sample and reagents to produce a colored chromophore or a change in absorbance that is proportional to the concentration of the analyte. The analyzer photometer reads the absorbances at time intervals dictated by the method application stored in the analyzer memory, and the change in absorbance is calculated automatically.

The provided text describes the performance of several Medicon Hellas assays (Albumin, Calcium, Creatinine, Glucose, Direct Bilirubin, Total Bilirubin, and Urea Nitrogen) when run on the Diatron Pictus 500 Clinical Chemistry Analyzer, demonstrating their substantial equivalence to predicate devices (Beckman Coulter AU reagents on AU2700 analyzer, and Abbott Architect Direct Bilirubin on Architect c8000 analyzer).

Here's an analysis of the provided information, structured to address your specific points regarding acceptance criteria and study details:

1. A Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a single, overarching table with pass/fail remarks. Instead, it describes each performance characteristic and then presents the results. The "Summary" sections for each study type imply that the results met the pre-defined acceptance criteria for demonstrating substantial equivalence. For instance, for accuracy, it states "Accuracy studies completed on at least three lots of each candidate reagent confirm that Medicon albumin... are substantially equivalent to the related predicate devices." This implies that the statistical analyses (Deming regression, R2, slope, intercept) fell within acceptable ranges. Similarly, for precision, it states "All lots passed acceptance criteria for each applicable sample type at each level."

Since explicit acceptance criteria are not presented, they are inferred from the demonstrated performance and the statement that the devices "passed acceptance criteria" or "met statistical acceptance criteria." Below is a table summarizing the reported device performance for each analyte. The "Acceptance Criteria" column will reflect the general statements of success or the implied ranges from the results themselves, as explicit numerical targets for individual tests are not given.

Implied Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

3

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

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

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

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

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

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

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

The document explicitly states:

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

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

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The i-STAT CHEM8+ cartridge with the i-STAT 1 System is in the in vitro quantification of sodium, potassium, chloride, ionized calcium, glucose, blood urea nitrogen, creatinine, hematocrit, and total carbon dioxide in arterial or venous 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 clinical conditions that manifest high and low potassium levels.

Chloride measurements are primarily used in the diagnosis, monitoring, and treatment of electrolyte and metabolic disorders including, but not limited to, cystic fibrosis, diabetic acidosis, and hydration disorders.

Ionized calcium measurements are used in the diagnosis and treatment of parathyroid disease, chronic renal disease and tetany.

Glucose measurements are used in the diagnosis, monitoring, and treatment of carbohydrate metabolism disorders including, but not limited to, diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma.

Blood urea nitrogen measurements are used for the diagnosis, and treatment of certain renal and metabolic diseases.

Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Hematoorit measurements can aid in the determination and monitoring of normal total red cell volume status that can be associated with conditions including anemia and erythrocytosis. The i-STAT Hematocrit test has not been evaluated in neonates.

Carbon dioxide measurements are used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

The i-STAT CHEM8+ test cartridge contains test reagents to analyze whole blood at the point of care or in the clinical laboratory for sodium (Na), potassium (K), chloride (CI), ionized calcium (iCa), glucose (Glu), blood urea nitrogen (BUN), creatinine (Crea), hematocrit (Hct), and total carbon dioxide (TCO2). The test is contained in a single-use, disposable cartridge. Cartridges require two to three drops of whole blood which are typically applied to the cartridge using a transfer device.

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

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

The provided text describes a 510(k) premarket notification for the i-STAT CHEM8+ cartridge with the i-STAT 1 System, specifically addressing the addition of an anticoagulant-free whole blood matrix. The document references several previous 510(k) clearances for various analytical performance characteristics and presents a new "Matrix Equivalence" study for the anticoagulant-free whole blood.

Here's an analysis of the acceptance criteria and study information provided, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for the "Matrix Equivalence" study in a tabulated format. However, it implicitly uses a Passing-Bablok linear regression analysis to demonstrate equivalence. The reported device performance is presented as the results of this regression analysis. We can infer the expected performance from general expectations for method comparisons in analytical chemistry, where a slope close to 1, an intercept close to 0, and a high correlation coefficient (r) indicate good agreement.

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

• Sample Size (Test Set for Matrix Equivalence): The sample sizes vary slightly per analyte:
  • Na, Cl, iCa: 314
  • K, Glu: 313
  • BUN: 310
  • Crea: 312
  • Hct: 311
  • TCO2: 273
• Data Provenance: The study was conducted at "three (3) point of care sites." The document does not specify the country of origin, but given the FDA submission, it is likely the US or a region with equivalent regulatory standards. The data is prospective in nature, as it involved collecting samples (both anticoagulant-free and anticoagulated) for direct comparison.

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

This type of study (matrix equivalence for IVD devices) does not typically involve human experts establishing "ground truth" in the way a diagnostic imaging study would. The ground truth (or reference method) for comparison is the measurement obtained from the previously cleared device using anticoagulated samples. The expertise lies in the calibration of the reference method and the design and execution of the analytical study, not in human interpretation of results.

4. Adjudication Method for the Test Set

Not applicable for this type of analytical method comparison study. Adjudication is relevant for subjective assessments, typically in diagnostic imaging or clinical outcomes, to resolve discrepancies among human readers or between AI and human readers. Here, the comparison is between two quantitative measurement methods.

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 analytical performance study for an in vitro diagnostic device, not a diagnostic imaging or clinical decision support AI.

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

Yes, the analytical performance (precision, linearity, LoQ, LoB/LoD, interference, and method comparison) of the i-STAT CHEM8+ cartridge with the i-STAT 1 System, and its equivalence between different sample matrices, primarily represents standalone performance of the device without human intervention beyond sample collection and device operation. The "Matrix Equivalence" study directly compares the results of the device using two different sample types.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the "Matrix Equivalence" study was established by the mean result from the primary sample, which refers to measurements obtained from whole blood samples collected with balanced heparin or lithium heparin anticoagulant using the previously cleared i-STAT CHEM8+ system. This acts as the "reference method" for comparison to the anticoagulant-free samples.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the purpose of the Matrix Equivalence study. This study is a validation study demonstrating that a new sample matrix (anticoagulant-free whole blood) yields equivalent results to the established (anticoagulated) sample matrix. The device itself (i-STAT CHEM8+ with i-STAT 1 System) would have undergone extensive development and internal testing (which could be considered a form of "training") prior to its initial clearances (K183678, K183680, K183688, K191298, K191360). The current submission focuses on extending the indications for use.

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

As no explicit "training set" is mentioned for this specific submission's study, this question is not directly answerable from the provided text. The "ground truth" for the reference method within the Matrix Equivalence study, as stated above, derives from the previously cleared performance of the i-STAT CHEM8+ system using anticoagulated samples, which would have been established through robust analytical validation studies (e.g., comparison to laboratory reference methods).

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