Search Results

Teco Carbon Dioxide Reagent Set is a device which is intended for measurement of Carbon Dioxide level in human serum, in vitro diagnostic use only. Test results may provide information regarding the status in the assessment of acid-base balance of metabolic alkalosis or respiratory acidosis.

Teco Carbon Dioxide Reagent Set is a single reagent kit. Reagent contains Good's buffer, phosphoenolpyruvate (PEP), phosphoenolpyruvate carboxylase (PEPC), malate dehydrogenase (MDH), magnesium ions, NADH analog, nonreactive stabilizer, preservative, and Buffer. Approximately 90% of carbon dioxide present in serum is in the form of bicarbonate. The measurement of bicarbonate is useful in the assessment of disturbances of acid-base balance resulting from metabolic or respiratory causes.

Here's a breakdown of the acceptance criteria and study information for the Teco Carbon Dioxide Reagent Set, based on the provided document:

Acceptance Criteria and Device Performance

Ask a specific question about this device

For the quantitative in vitro determination of Carbon Dioxide in serum and plasma. Carbon Dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

This in vitro diagnostic device is intended for Rx Only.

The Liquid CO2-2 (LCO2-2) kit assay consists of ready to use reagent solutions.

The provided text describes the acceptance criteria and performance of the LIQUID CO2-2 (LCO2-2) device, which is an in vitro diagnostic for quantitative determination of Carbon Dioxide in serum and plasma.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

Ask a specific question about this device

The S TEST Reagent Cartridge Carbon Dioxide (CO2) is intended for the quantitative determination of carbon dioxide concentration in serum or lithium heparin plasma using the HITACHI Clinical Analyzer E40. Carbon dioxide measurements are used in the diagnosis and treament of numerous potentially serious disorders associated with changes in body acid-base balance. The S TEST Reagent Cartridge Carbon Dioxide (CO2) is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for use in clinical laboratories or physician office laboratories. The instrument consists of a desktop analyzer unit, an operations screen that prompts the user for operation input and displays data, a printer, and a unit cover. The analyzer unit includes a single probe, an incubation rotor, carousels for sample cups and reagent cartridges, and a multi-wavelength photometer. The single-use reagent cartridges may be placed in any configuration on the carousel, allowing the user to develop any test panel where the reagent cartridges are available. The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric cuvette. The cartridges also include a dot code label that contains all chemistry parameters, calibration factors, and other production-related information, e.g., expiration dating. The dimensions of the reagent cartridges are: 13.5 mm (W) × 28 mm (D) × 20.2 mm (H). System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions, it calculates the concentration of analyte in the sample. The test system can measure analytes in serum or plasma and results are available in approximately 15 minutes per test. This submission is for Reagent Cartridge Carbon Dioxide.

The provided text describes the 510(k) summary for the Hitachi S TEST Reagent Cartridge Carbon Dioxide (CO2), a device for quantitative determination of carbon dioxide concentration in serum or lithium heparin plasma. The document focuses on demonstrating the substantial equivalence of this device to a legally marketed predicate device (Carbon Dioxide L.3K Assay, Sekisui Diagnostics, PEI, Inc., Canada- K042362) through nonclinical and clinical performance studies.

Here's an analysis of the acceptance criteria and the studies conducted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" but rather describes the performance characteristics tested and their results, often comparing them to the predicate device or established standards. I will infer acceptance criteria based on standard clinical chemistry performance requirements and the described study outcomes.

• Low (10.11 mmol/L): 1.3% (4.4%)
• Middle (19.41 mmol/L): 1.3% (3.7%)
• High (33.06 mmol/L): 1.2% (3.7%) |
  | Precision (External POL Study) | Similar to in-house, %CVs within acceptable clinical limits. | Total %CV (n=30 for each level at each site)
• Site 1: 4.1% (Low), 4.8% (Mid), 3.2% (High)
• Site 2: 6.0% (Low), 4.4% (Mid), 3.7% (High)
• Site 3: 3.1% (Low), 1.9% (Mid), 3.7% (High) |
  | Interference | Recoveries between 90% and 110% of the neat value in the presence of interferents. | No interference from Lipemia (up to 1,000 mg/dL Intralipid), Ascorbic acid (up to 50 mg/dL), Hemoglobin (up to 1,000 mg/dL), Unconjugated bilirubin (up to 19.1 mg/dL) |
  | Method Comparison (Accuracy) | Strong correlation (r > 0.95), slope close to 1, y-intercept close to 0, and agreement with predicate/reference method. | In-house (vs. standard lab system): n=96, r=0.981, Slope=1.03 (0.97-1.08), y-intercept=0.98 (-0.17-2.12)
  External POL Study (vs. comparative method):
• Site 1: n=47, r=0.984, y=0.91x+1.49 (Slope CI: 0.87-0.95, Intercept CI: 0.67-2.32)
• Site 2: n=45, r=0.970, y=0.92x+0.56 (Slope CI: 0.80-1.04, Intercept CI: -2.31-3.43)
• Site 3: n=47, r=0.982, y=0.92x+0.79 (Slope CI: 0.87-0.97, Intercept CI: -0.43-2.01) |
  | Matrix Comparison (Serum vs. Plasma) | Strong correlation between serum and plasma results (r > 0.95), slope close to 1, y-intercept close to 0. | n=50, r=0.980, Slope=1.00 (0.94-1.05), y-intercept=-0.34 (-1.97-1.30) |
  | Stability (Shelf Life) | Claimed shelf life supported by real-time stability data. | Supported shelf life of 6 months at 2-8°C (real-time testing ongoing). |
  | Reportable Range | Match clinical requirements; within demonstrated linearity. | 5.0 to 40.0 mmol/L (Predicate: 2.9 to 50.0 mmol/L) |
  | Detection Wavelength | Not an acceptance criterion for performance, but a technical specification. | 405/508 nm (Predicate: 405/415 nm) |

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

• Analytical Sensitivity (LoD/LoQ): 60 replicates of reagent blank and three low samples. Three low-level specimens in six runs with three instruments over three days for LoQ.
• Linearity: 10 serial dilutions plus zero standard (n=11), assayed in duplicate.
• Precision (In-house): Three levels of serum-based commercial controls, each tested in two runs, twice a day, for 20 days.
• Interference Testing: Two serum pools with approximately 17 and 30 mmol/L carbon dioxide.
• Method Comparison (In-house): 96 clinical specimens (including 3 spiked and 3 diluted samples).
• Matrix Comparison: 50 matched serum/plasma samples (including 2 spiked and 4 diluted samples).
• Precision (External POL Study): Three blinded serum samples (low, middle, high CO2 concentrations). Each sample assayed six times per day for five days, reporting 30 results per level per site.
• Method Comparison (External POL Study): 47 serum specimens (including three spiked and four diluted samples) per site (Site 2 used 45 samples due to 2 below dynamic range).

Data Provenance:

• The studies were performed by Hitachi Chemical Diagnostics, Inc. ("in-house") and at three external Physician Office Laboratory (POL)-type sites.
• Specific countries of origin for the clinical specimens are not explicitly stated, but the company address is Mountain View, CA, USA, and POL studies suggest U.S. clinical settings.
• The studies appear to be prospective for the purpose of validating the device's performance characteristics.

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

The document does not specify the number or qualifications of experts used to establish "ground truth" for the test set in the traditional sense of expert consensus for diagnostic interpretation. Instead, the ground truth is established through:

• Reference Methods/Comparative Methods: In the method comparison studies, a "standard laboratory system" or "comparative method as the reference method" was used. The qualifications of the operators of these reference methods are not provided.
• Known Concentrations: For studies like linearity, precision, and interference, known concentrations (e.g., commercial controls, spiked samples, diluted samples) are used.
• Industry Standards: Adherence to CLSI (Clinical and Laboratory Standards Institute) guidelines (e.g., CLSI EP17-A2, CLSI EP-6A, CLSI EP5-A2, CLSI EP7-A2) implies reliance on established laboratory best practices for determining analytical performance.

4. Adjudication Method for the Test Set

This type of in vitro diagnostic device (IVD) performance study (analytical and clinical chemistry accuracy/precision) typically does not involve adjudication by multiple human readers in the same way an imaging or pathology study might. Instead, the device's results are compared against:

• Reference measurements: From the predicate device or a "standard laboratory system."
• Known values: For controls, linearity standards, and spiked/diluted samples.
  The document states that method comparison samples were assayed "in singleton and in a blinded fashion" (in-house) and "assayed on the Hitachi E40 Clinical Analyzer... and a comparative method as the reference method" (external POL study), implying direct comparison without a formal adjudication panel.

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

No, an MRMC comparative effectiveness study was not done. This type of study design is typically used for diagnostic imaging or pathology devices where multiple human readers interpret cases, and the AI's impact on their performance is assessed. For an in vitro diagnostic (IVD) device like a CO2 reagent cartridge, the evaluation focuses on analytical performance characteristics (accuracy, precision, linearity, etc.) rather than human reader improvement with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop) Performance Was Done

Yes, the studies conducted are standalone performance studies. The Hitachi S TEST Reagent Cartridge Carbon Dioxide operates as an in vitro diagnostic device on an automated analyzer (Hitachi Clinical Analyzer E40). The performance results (accuracy, precision, linearity, etc.) described are the performance of the device and its associated system without direct "human-in-the-loop" interpretive input influencing the result generation. Human operators load samples and reagents and review results, but the device itself generates the quantitative CO2 concentration.

7. The Type of Ground Truth Used

The ground truth for the performance studies was established using a combination of:

• Reference Measurement/Comparative Method: For method comparison, results from a "standard laboratory system" or "comparative method" served as the reference.
• Known Values: For analytical studies like linearity, precision, LoD, and interference, commercial controls, calibrators, and spiked/diluted samples with known or traceable concentrations were used.
• Industry Standards: Adherence to CLSI guidelines ensures that the methods for establishing ground truth for these analytical parameters align with recognized best practices in laboratory medicine.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI development. This is an IVD device providing a quantitative measurement based on a chemical reaction and photometric detection. Its underlying "algorithm" is the chemistry reaction and calculation based on Beer-Lambert Law, not a learned AI model that requires a training set. Manufacturers establish internal specifications and calibration parameters based on extensive R&D and analytical validation, but this typically does not involve an external "training set" as understood in AI/ML.

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

As explained above, there is no "training set" for this type of IVD device in the AI sense. The "ground truth" for manufacturing and calibration would be established through:

• Primary Reference Materials: Traceability to primary reference standards (e.g., American Chemical Society (ACS) reagent grade sodium carbonate alkalimetric standard for CO2).
• Internal Validation: Rigorous internal testing and validation during the device's development to ensure the chemical reaction and photometric measurements yield accurate and precise results across the dynamic range.
• Quality Control: Ongoing use of quality control materials with known values to monitor performance.
  The document states, "Each lot of S TEST Reagent Cartridge Carbon Dioxide (CO2) is calibrated by the manufacturer prior to shipment using material referenced to a standard which is traceable to American Chemical Society (ACS) reagent grade sodium carbonate alkalimetric standard." This describes the process for establishing and maintaining calibration, which is akin to "ground truth" for the device's quantitative output.

Ask a specific question about this device

AU Bicarbonate reagent is intended for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.

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

For In Vitro Diagnostic Use

The AU Bicarbonate reagent kit is a liquid, ready to use and consists of four R1 reagent vials in vanous fill volumes. The calibrator is a Beckman Coulter lyophilized chemistry calibrator packaged as catalog number DR0070 and sold separately. The AU Bicarbonate reagent is an enzymatic method utilizing Bicarbonate (HCO3) and phosphoenolpyruvate (PEP), which are converted to oxaloacetate to malate with the concomitant oxidation of reduced nicotinamide adenine dinucleotide (NADH). This oxidation of NADH results in a decrease in absorbance of the reaction mixture measured bichromatically at 380/410nm proportional to the Bicarbonate content of the sample.

The AU Bicarbonate reagent is designed for optimal performance on Beckman Coulter AU analyzers.

Here's a breakdown of the acceptance criteria and study information for the AU Bicarbonate Reagent, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

All reported device performances met their respective acceptance criteria as indicated by "Pass" in the Method Comparison and Precision tables.

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

• Method Comparison Test Set: N = 133 samples.
• Precision Test Set: The document refers to "Low pool," "Med pool," and "High pool" samples. It doesn't specify an overall sample size for the precision study, but implies multiple measurements were taken for each pool (e.g., within-run and total precision across multiple runs/days).
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It is clinical laboratory data, likely gathered prospectively during validation studies.

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

• This document describes an in vitro diagnostic reagent for quantitative determination of bicarbonate, not an imaging or diagnostic device requiring expert interpretation for ground truth.
• The "ground truth" for method comparison is a reference method (Thermo Scientific, TR28321) and for precision is based on statistical measures of reproducibility. No human expert "ground truth" establishment is described for these types of studies.

4. Adjudication Method for the Test Set:

• Not applicable. This is a quantitative chemical assay, not an interpretative diagnostic task requiring adjudication. The performance is assessed against predefined statistical and analytical criteria.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically for evaluating the impact of an AI algorithm on human reader performance, which is not relevant for an in vitro diagnostic reagent.

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

• Yes, this entire study represents the standalone performance of the AU Bicarbonate Reagent on Beckman Coulter AU analyzers. There is no human-in-the-loop component in the measurement and quantification of bicarbonate by this automated system.

7. The Type of Ground Truth Used:

• Quantitative Reference Measurement: For the method comparison, the "ground truth" is a comparison against a commercially available and presumably validated reference method (Thermo Scientific TR28321).
• Statistical Definitions: For precision, the "ground truth" is based on statistical definitions of within-run and total precision, where the target values are the mean concentrations of the control pools.
• Defined Standards/Limits: For sensitivity, linearity, and interfering substances, the ground truth is established against predefined analytical limits and standards (e.g., NIST standard for calibrator traceability).

8. The Sample Size for the Training Set:

• The document does not explicitly refer to a "training set" in the context of machine learning. This is a chemical reagent and instrument system, not an AI/ML algorithm that undergoes a distinct training phase with a labeled dataset. The development and optimization of the reagent itself would involve internal R&D studies, but these are not referred to as a "training set" in this context.

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

• Not applicable, as this device does not involve a machine learning "training set." The performance characteristics are established through analytical validation studies rather than machine learning model training.

Ask a specific question about this device

The ACE Carbon Dioxide (CO2-LC) Reagent is intended for the quantitative determination of carbon dioxide concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Direct Bilirubin Reagent is intended for the quantitative determination of direct bilirubin concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Total Bilirubin Reagent is intended for the quantitative determination of total bilirubin concentration in serum and lithium heparin plasma using the ACE, ACE Alera and ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Magnesium Reagent is intended for the quantitative determination of magnesium in serum and lithium heparin plasma using the ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

In the ACE Carbon Dioxide (CO2-LC) Reagent assay, serum carbon dioxide (in the form of bicarbonate) reacts with phosphoenolpyruvate in the presence of phosphoenolpyruvate carboxylase and magnesium to yield oxaloacetic acid and phosphate. In the presence of malate dehydrogenase, the reduced cofactor is oxidized by oxaloacetic acid. The reduced cofactor absorbs strongly at 408 nm whereas its oxidized form does not. The rate of decrease in absorbance, monitored bichromatically at 408 nm/692 nm, is proportional to the carbon dioxide content of the sample.

In the ACE Direct Bilirubin Reagent assay, sodium nitrite added to sulfanilic acid forms diazotized sulfanilic acid. Bilirubin glucuronide in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The increase in absorbance, measured bichromatically at 554 nm/692 nm, one minute after sample addition, is directly proportional to the direct bilirubin concentration.

In the ACE Total Bilirubin Reagent assay, sodium nitrite, when added to sulfanilic acid, forms diazotized sulfanilic acid. Bilirubin in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The inclusion of dimethyl sulfoxide (DMSO) in the reagent as an accelerator causes both direct and indirect bilirubin to react rapidly. The increase in absorbance, measured bichromatically at 554 nm/692 nm, is directly proportional to the total bilirubin concentration in the sample.

Magnesium ions in serum react with Xylidyl blue-1 in an alkaline medium to produce a red complex which is measured bichromatically at 525 nm/692 nm. The intensity of color produced is directly proportional to the magnesium concentration in the sample. EGTA prevents calcium interference by preferential chelation of calcium present in the sample. A surfactant system is included to remove protein interference.

The provided text describes several in vitro diagnostic reagents (ACE Carbon Dioxide (CO2-LC) Reagent, ACE Direct Bilirubin Reagent, ACE Total Bilirubin Reagent, and ACE Magnesium Reagent) and their associated performance data. There isn't information about an AI-powered device or software. Therefore, questions related to AI aspects like multi-reader multi-case studies, effect size of AI assistance, or standalone algorithm performance are not applicable.

The acceptance criteria are not explicitly stated as clear thresholds in the provided document; rather, the document presents detailed performance data (precision, linearity, interference, and method comparison) that demonstrates the device's capability to perform as intended and to be substantially equivalent to its predicate devices. The "reported device performance" is presented directly through tables and statistical analyses for each reagent.

Here's an attempt to structure the available information based on the request, interpreting "acceptance criteria" as the performance demonstrated to support substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit "acceptance criteria" (i.e., predefined thresholds for performance metrics) are not provided in the document, the "Reported Device Performance" below represents the data presented that presumably met the internal criteria for demonstrating substantial equivalence. The document primarily focuses on precision, linearity, interference, and method comparison with predicate devices and between different systems (ACE, ACE Alera, ACE Axcel).

ACE Carbon Dioxide (CO2-LC) Reagent

ACE Direct Bilirubin Reagent

ACE Total Bilirubin Reagent

ACE Magnesium Reagent

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

The document describes several types of studies:

• In-House Precision:

  • CO2-LC: Low, Mid, High serum and plasma samples were tested (number of replicates per sample and runs is implicitly part of SD/CV calculation, but not explicitly stated).
  • Direct Bilirubin: Low, Mid, High serum and plasma samples.
  • Total Bilirubin: Low, Mid, High serum and plasma samples.
  • Magnesium: Low, Mid, High serum and plasma samples.
  • Data Provenance: In-house (Alfa Wassermann Diagnostic Technologies, LLC, West Caldwell, NJ), prospective testing.

• POL (Physician Office Laboratory) Precision: Studies conducted at 3 POL sites.

  • CO2-LC: 3 samples at each of 3 POL sites and in-house.
  • Direct Bilirubin: 3 samples at each of 3 POL sites and in-house.
  • Total Bilirubin: 3 samples at each of 3 POL sites and in-house.
  • Magnesium: 3 samples at each of 3 POL sites and in-house.
  • Data Provenance: Not explicitly stated but inferred to be from POLs in the USA (prospective testing under typical POL conditions).

• In-House Matrix Comparison (Serum vs. Plasma):

  • CO2-LC: 53-54 pairs (serum/plasma) on ACE and ACE Alera; 51 pairs on ACE Axcel.
  • Direct Bilirubin: 102 pairs on ACE; 101 pairs on ACE Alera; 56 pairs on ACE Axcel.
  • Total Bilirubin: 102 pairs on ACE and ACE Alera; 56 pairs on ACE Axcel.
  • Magnesium: 101 pairs on ACE and ACE Alera; 55 pairs on ACE Axcel.
  • Data Provenance: In-house, retrospective (presumably collected for a range of values).

• POL Method Comparison (In-House ACE vs. POL ACE/Alera):

  • CO2-LC: 45-46 samples per POL site comparison.
  • Direct Bilirubin: 49-51 samples per POL site comparison.
  • Total Bilirubin: 48-50 samples per POL site comparison.
  • Magnesium: 50-52 samples per POL site comparison.
  • Data Provenance: Not explicitly stated but inferred to be from POLs in the USA (prospective testing under typical POL conditions) compared against in-house data.

• Detection Limits (LoB, LoD, LoQ), Linearity, Interferences (ACE Alera):

  • Sample sizes for detection limits and linearity: Not explicitly stated, typically involves multiple replicates at various concentrations.
  • Sample sizes for interferences: Not explicitly stated, typically involves samples spiked with various concentrations of interferents.
  • Data Provenance: In-house.

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

This information is not provided in the document. For in vitro diagnostic assays, the "ground truth" is typically the reference method or established clinical laboratory results obtained from a highly accurate and calibrated instrument or laboratory using validated methods, rather than human expert consensus for image or clinical interpretation. The document compares performance against other (presumably established) methods and predicate devices.

4. Adjudication Method for the Test Set

This concept (e.g., 2+1, 3+1 for resolving discrepancies) is not applicable to these types of in vitro diagnostic device studies. Performance is measured numerically and objectively.

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

No. This is an in vitro diagnostic assay, not an AI-powered diagnostic imaging device.

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

Not applicable. This is not an AI algorithm. The performance data presented are for the reagent and instrument system.

7. The Type of Ground Truth Used

For precision studies, the "ground truth" is the true concentration of the analyte in the control material or patient sample, which is established by reference methods or manufacturing specifications of the control materials. For method comparison studies, the predicate device's results or an established in-house method are used as the comparative reference. The document states the intended use is for "quantitative determination" of analytes, implying comparison to a quantitative gold standard.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning device and therefore does not have a "training set" in that context. The development of reagents and the establishment of their performance characteristics do not involve machine learning training sets.

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

Not applicable, as there is no "training set" for these reagents in the context of AI/ML.

Ask a specific question about this device

For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

The VITROS ECO2 assay is performed using the VITROS Chemistry Products ECO2 Slides and the VITROS Chemistry Products Calibrator Kit 2 on the VITROS Chemistry Systems. The VITROS ECO2 Slide is a multi-layered, analytical element coated on a polyester support. The method is based on an enzymatic detection. All reactions necessary for a single quantitative measurement of CO2 take place within the multi-layered analytical element of a VITROS Chemistry Products ECO2 Slide. A drop of sample fluid is metered onto the slide and a reaction occurs which ultimately results in a reduction of NADH. The concentration of CO2 in the sample is determined by measuring the absorbance of the unreacted NADH by reflectance spectrophotometry.

Here's a breakdown of the acceptance criteria and study details for the VITROS Chemistry Products ECO2 Slides, based on the provided 510(k) summary (K120763):

Device Overview:

This 510(k) submission is for a modified version of the VITROS Chemistry Products ECO2 Slides. The primary modification is a change in the biological source of Phosphoenolpyruvate carboxylase (PEPC) from wheat germ to a microorganism, aiming to improve enzyme solution stability during manufacturing. The device measures total carbon dioxide (CO2) concentration in serum and plasma using various VITROS Chemistry Systems.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly detailed as numerical ranges in the provided text, but rather described through the types of performance characteristics evaluated and the overarching conclusion that the modified device "met the pre-determined acceptance criteria for all the performance testing."

The performance characteristics considered for potential hazards and subsequently validated are:

Overall Conclusion regarding Acceptance Criteria: The document states, "Validation and verification testing were conducted and the modified device met the pre-determined acceptance criteria for all the performance testing. The modification does not negatively impact the performance of the device or the safety and effectiveness of the device."

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

• Sample Size for Test Set: The document does not specify the exact sample sizes used for the validation and verification testing (test set). It only states that "Validation and verification testing were conducted."
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that this is a 510(k) summary for a diagnostic device, it is typically expected that studies would be conducted in a controlled laboratory setting, likely in the country of the manufacturer (USA, as inferred from the Rochester, NY address).

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

This information is not applicable to this type of medical device submission. This device is an in vitro diagnostic (IVD) chemistry product, not an imaging or AI-based diagnostic tool requiring expert interpretation of results. The "ground truth" for a CO2 measurement device is established through reference methods and calibrated instruments, not subjective expert consensus.

4. Adjudication Method for the Test Set

This is not applicable as it's an IVD chemistry product, not an imaging or qualitative diagnostic requiring adjudication of human interpretations. The "adjudication" is inherent in the analytical methods and instrument calibration.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered devices where human readers' performance with and without AI assistance is being evaluated. This 510(k) is for a modification to a chemistry diagnostic slide.

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

N/A (Not Applicable in the traditional sense of an "algorithm"). This is a chemical assay, not a standalone algorithm. The "performance" is the analytical performance of the device itself (slide and chemistry system) in measuring CO2 concentrations accurately and precisely. The studies conducted (accuracy, precision, linearity, etc.) assess the standalone analytical performance of the modified product.

7. The Type of Ground Truth Used

The ground truth for this device would be established through:

• Reference Methods: Highly accurate and precise analytical methods for CO2 measurement, often traceable to international standards.
• Calibrated Materials: Certified reference materials or calibrators with known CO2 concentrations.
• Comparison to Predicate Device: A key aspect of a Special 510(k) is demonstrating substantial equivalence to a legally marketed predicate device. This implies that the performance of the modified device is compared against the established performance of the predicate.

The document states, "The information presented in the premarket notification provides a reasonable assurance that the VITROS Chemistry Products ECO₂ Slides (modified)... is substantially equivalent to the predicate (unmodified VITROS ECO2 Slide) and is safe and effective for the stated intended use."

8. The Sample Size for the Training Set

This is not applicable to this type of device. The VITROS Chemistry Products ECO2 Slides utilize enzymatic reactions for detection, not a machine learning model that requires a "training set" in the computational sense. The "training" for such a product involves optimizing the chemical formulation and manufacturing process, which is distinct from data-driven AI model training.

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

Not applicable for the same reasons as #8. The "ground truth" for developing this chemical assay would be based on fundamental chemistry principles, enzyme kinetics, and analytical performance characteristics measured through laboratory experiments, not a data-labeling process for a training set.

Ask a specific question about this device

The ACE Axcel Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative determination of constituents in blood and other fluids.

The ACE Carbon Dioxide (CO2-LC) Reagent is intended for the quantitative determination of carbon dioxide concentration in serum using the ACE Axcel Clinical Chemistry System. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Direct Bilirubin Reagent is intended for the quantitative determination of direct bilirubin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Total Bilirubin Reagent is intended for the quantitative determination of total bilirubin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Magnesium Reagent is intended for the quantitative determination of magnesium concentration in serum using the ACE Axcel Clinical Chemistry System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low serum levels of magnesium) and hypermagnesemia (abnormally high serum levels of magnesium). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Axcel Clinical Chemistry System consists of two major components, the chemistry instrument and an integrated Panel PC. The instrument accepts the physical patient samples, performs the appropriate optical or potentiometric measurements on those samples and communicates that data to an integral Panel PC. The Panel PC uses keyboard or touch screen input to manually enter a variety of data, control and accept data from the instrument, manage and maintain system information and generate reports relative to patient status and instrument performance. The Panel PC also allows remote download of patient requisitions and upload of patient results via a standard interface.

In the ACE Carbon Dioxide (CO2-LC) Reagent assay, serum carbon dioxide (in the form of bicarbonate) reacts with phosphoenolpyruvate in the presence of phosphoenolpyruvate carboxylase and magnesium to yield oxaloacetic acid and phosphate. In the presence of malate dehydrogenase, the reduced cofactor is oxidized by oxaloacetic acid. The reduced cofactor absorbs strongly at 408 nm whereas its oxidized form does not. The rate of decrease in absorbance, monitored bichromatically at 408 nm/692 nm, is proportional to the carbon dioxide content of the sample.

In the ACE Direct Bilirubin Reagent assay, sodium nitrite added to sulfanilic acid forms diazotized sulfanilic acid. Bilirubin glucuronide in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The increase in absorbance, measured bichromatically at 554 nm/692 nm, one minute after sample addition, is directly proportional to the direct bilirubin concentration.

In the ACE Total Bilirubin Reagent assay, sodium nitrite, when added to sulfanilic acid. forms diazotized sulfanilic acid. Bilirubin in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The inclusion of dimethyl sulfoxide (DMSO) in the reagent as an accelerator causes both direct and indirect bilirubin to react rapidly. The increase in absorbance, measured bichromatically at 554 nm/692 nm, is directly proportional to the total bilirubin concentration in the sample.

Magnesium ions in serum react with Xylidyl blue-1 in an alkaline medium to produce a red complex which is measured bichromatically at 525 nm/692 nm. The intensity of color produced is directly proportional to the magnesium concentration in the sample. EGTA prevents calcium interference by preferential chelation of calcium present in the sample.

This document describes the performance of the ACE Carbon Dioxide (CO2-LC) Reagent, ACE Direct Bilirubin Reagent, ACE Total Bilirubin Reagent, and ACE Magnesium Reagent when used with the ACE Axcel Clinical Chemistry System. The study aims to demonstrate substantial equivalence to the predicate device, the Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K931786).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided in the document are implicitly established by demonstrating comparability to the predicate device. The performance data presented are the results obtained for the current device and reagents.

The study demonstrates that the ACE Axcel Clinical Chemistry System with the listed reagents achieves precision and accuracy comparable to the predicate device, supporting substantial equivalence.

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

The studies conducted are primarily accuracy (correlation) and precision studies.

• ACE Carbon Dioxide (CO2-LC) Reagent:
  • Accuracy (correlation study): 120 samples.
  • Accuracy (patient correlation studies): Conducted at three separate Physician Office Laboratory (POL) sites; the number of samples per POL site is not specified, but the total across all sites for CO2 values ranged from 3.2 to 47.6 mEq/L.
  • Precision: Four CO2 levels tested for 22 days; three separate POL sites tested for 5 days.
• ACE Direct Bilirubin Reagent:
  • Accuracy (correlation study): 116 samples.
  • Accuracy (patient correlation studies): Conducted at three separate POL sites; the number of samples per POL site is not specified, but the total across all sites for Direct Bilirubin values ranged from 0.2 to 12.5 mg/dL.
  • Precision: Four direct bilirubin levels tested for 22 days; three separate POL sites tested for 5 days.
• ACE Total Bilirubin Reagent:
  • Accuracy (correlation study): 117 samples.
  • Accuracy (patient correlation studies): Conducted at three separate POL sites; the number of samples per POL site is not specified, but the total across all sites for Total Bilirubin values ranged from 0.2 to 34.8 mg/dL.
  • Precision: Four total bilirubin levels tested for 22 days; three separate POL sites tested for 5 days.
• ACE Magnesium Reagent:
  • Accuracy (correlation study): 108 samples.
  • Accuracy (patient correlation studies): Conducted at three separate POL sites; the number of samples per POL site is not specified, but the total across all sites for Magnesium values ranged from 0.6 to 5.5 mg/dL.
  • Precision: Four magnesium levels tested for 22 days; three separate POL sites tested for 5 days.

Data Provenance: The document does not explicitly state the country of origin for the data. The "POL sites" (Physician Office Laboratory sites) suggest these are real-world clinical samples, likely from within the United States given the 510(k) submission. The data appears to be prospective in nature, as indicated by the description of testing conducted over 22 days and 5 days at different sites for precision and the collection of samples for correlation studies.

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

This is a clinical chemistry device for quantitative determination. The ground truth is established by comparing the device's measurements against a predicate device (Alfa Wassermann ACE Clinical Chemistry System). Therefore, no human experts are explicitly mentioned as establishing a "ground truth" in the diagnostic interpretation sense. The predicate device itself serves as the reference standard.

4. Adjudication method for the test set

Not applicable. This study involves quantitative measurements by a device and comparison to a predicate device, not qualitative interpretations requiring human 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 a clinical chemistry analyzer and reagent system, not an AI-assisted diagnostic imaging or interpretation system involving human readers.

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

Yes, the performance data presented are for the standalone algorithm/device (ACE Axcel Clinical Chemistry System with the specified reagents) measuring analytes in samples, compared directly against a predicate device. There is no human-in-the-loop component mentioned in the context of the reported performance data.

7. The type of ground truth used

The type of ground truth used is comparison to a legally marketed predicate device. The ACE Axcel Clinical Chemistry System and its reagents were compared to the Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K931786). The predicate device's measurements serve as the reference for established accuracy.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that typically involves a distinct "training set." The device's performance is based on established chemical reactions and detection methods. The studies described are for validation/testing of the device's performance against a predicate, not for training an algorithm.

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

Not applicable, as there is no training set in the context of this device.

Ask a specific question about this device

The Total CO2 electrode for the ELITech Clinical Systems Selectra ProM is intended for the quantitative determination of carbon dioxide in serum and plasma. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
ELITech Clinical Systems ISE Calibrators are used for the calibration of sodium (Na+), potassium (K+), chloride (Cl-) and carbon dioxide (Total CO2) on ELITech Clinical Systems Selectra ProM analyzer equipped with ISE module.

The ELITech Clinical Systems ISE Total CO2 Electrode system is comprised of the electrodes plus ISE Reference Solution, ISE Diluent, ISE Calibrators.

Here's a breakdown of the acceptance criteria and study information for the ELITech Clinical Systems ISE TotalCO2 Electrode and ISE Calibrators, based on the provided text:

Key Takeaway: This document is a 510(k) summary for a medical device (Total CO2 electrode and calibrators). It focuses on demonstrating substantial equivalence to a previously approved predicate device, not on validating novel performance claims. As such, the "acceptance criteria" and "study" described are primarily for demonstrating equivalence, especially concerning analytical performance (precision and method comparison). Given this is a 510(k), it is an analytical study, not a clinical study to diagnose disease.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the comparison to the predicate device, aiming to show performance that is either equivalent or better. Specific acceptance criteria are not explicitly stated in a quantitative form, but rather the performance data is presented for comparison.

Study Information

1. Sample Size used for the test set and the data provenance:

   • Total CO2 Method Comparison: The range for the method comparison was 9.7 to 44.9 mEq/L. The document does not explicitly state the number of samples used for the method comparison study.
   • Precision Study: For the precision study, results are reported for multiple "levels" (12.1 mEq/L, 19.9 mEq/L, 27.5 mEq/L). The number of replicates at each level is not specified, but typically "within-run" and "total" precision studies involve multiple measurements over several days.
   • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) submission, these are typically prospective analytical studies performed by the manufacturer, but this is not explicitly confirmed.

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

   • This is an analytical performance study for an in vitro diagnostic device, not a clinical diagnostic study involving image interpretation or expert consensus. Therefore, there were no "experts" in the sense of clinical specialists establishing a ground truth for diagnostically challenging cases.
   • The "ground truth" or reference values for method comparison would have been established by the predicate device (Roche Bicarbonate liquid) or a recognized reference method commonly used in clinical chemistry labs. The comparison data shows a linear regression against the predicate, implying the predicate served as the reference for comparative analysis.

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

   • Not applicable. As noted above, this is an analytical performance study, not a clinical study requiring adjudication of diagnostic outcomes.

4. 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/imaging device and does not involve human readers for interpretation.

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

   • Yes, the performance characteristics (precision, method comparison, measuring range, interferences) are all for the standalone device (ELITech Clinical Systems ISE Total CO2 Electrode) without human intervention in the result generation process, beyond operating the instrument.

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

   • The "ground truth" in this context is the results obtained from the legally marketed predicate device (Roche Diagnostics COBAS Integra Bicarbonate liquid) or a recognized clinical chemistry reference method, against which the new device's measurements are compared. The calibrators are traceable to NIST SRM (National Institute of Standards and Technology Standard Reference Materials), which serves as a metrological ground truth for concentration.

7. The sample size for the training set:

   • This document describes performance validation studies, not product development or machine learning training. There is no mention of a "training set" in the context of machine learning model development. This is a traditional IVD device.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for a machine learning model.

Ask a specific question about this device

The Eon 100 is a discrete photometric chemistry analyzer for clinical use. It is a device intended for the in-vitro, spectrophotometric determination of general chemistry assays. The Eon 100 has replaceable parts, automated maintenance monitoring and backup of both patient and system data.

The Eon 100 Chemistry Analyzer is intended to be used to assist the clinician with the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease.

The Eon 100 includes an optional Ion Selective Electrodes (ISE) module for the measurement of sodium, potassium and chloride in serum and plasma.

The Eon 100 is for in vitro diagnostic use only.

The Eon 100 is a discrete photometric chemistry analyzer for clinical use. It is a device intended for the in-vitro, spectrophotometric determination of general chemistry assays. The Eon 100 has replaceable parts, automated maintenance monitoring and backup of both patient and system data. The Eon 100 includes an optional Ion Selective Electrodes (ISE) module for the measurement of sodium, potassium and chloride in serum and plasma.

I am sorry, but the provided text from the FDA 510(k) summary for the EON 100 Chemistry Analyzer does not contain detailed information regarding the specific acceptance criteria, study design, or the performance data in the format you requested for a software or AI device.

The document primarily focuses on the regulatory clearance for various reagents and the analyzer itself as "substantially equivalent" to legally marketed predicate devices. It lists the indications for use for each component, but it does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or details about training sets.
• Information about expert involvement for ground truth, adjudication methods, or MRMC studies.
• Details on standalone algorithm performance or the type of ground truth used.

This type of detailed performance data and study design is typically found in the full 510(k) submission, which is not fully provided here, or in associated scientific publications or clinical study reports. The FDA 510(k) summary is generally a high-level document confirming substantial equivalence based on information submitted by the manufacturer.

Ask a specific question about this device

For in vitro diagnostic use in the quantitative determination of carbon dioxide in human serum and plasma on ADVIA Chemistry Systems. Such measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

The ADVIA Chemistry Carbon Dioxide reagent is a solution containing buffer (pH 7.6 at 25°C), 12.5 mmol/L PEP, ≥ 400 U/L PEPC (microbial), ≥ 4100 U/L malate dehydrogenase (mammalian), 0.6 mmol/L NADH analog, activators, stabilizers, a surfactant, and a preservative.

The provided text describes a 510(k) summary for the ADVIA® Chemistry Carbon Dioxide Liquid (CO2 L) Reagent, demonstrating its substantial equivalence to a predicate device. The information focuses on the device's performance characteristics.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:

Preamble: This document does not describe an AI/ML powered device, therefore some of the requested information (like MRMC study, AI assistance, training set details) is not applicable. The device is an in-vitro diagnostic reagent and its acceptance criteria are based on analytical performance compared to a predicate device, not on diagnostic accuracy involving human interpretation.

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

The document does not explicitly state pre-defined acceptance criteria in numerical terms for each performance characteristic. Instead, it states that "All of the evaluation studies gave acceptable results compared to the predicate device" and concludes with a "substantial equivalence" claim. However, we can infer the performance metrics reported.

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

• Imprecision: Assayed two control sera. Each sample was assayed 2 times per run, 2 runs per day, for at least 10 days. The 'N' column in the table refers to the number of replicates (40 for each level). This is a prospective lab-based study using control materials.
• Linearity/Assay Reportable Range: Established based on calculations from the limit of detection and linearity studies. No specific sample size of patient samples is given for the linearity study itself.
• Limit of Detection: 40 replicates of 0.9% saline and 40 replicates of a Low Sample, using one lot of reagent. Data obtained from a 10-day precision study. This is a prospective lab-based study.
• Method Comparison: Sixty-two (62) serum samples. The provenance (country of origin, retrospective/prospective) is not specified, but it's implied to be a prospective comparison of the new and predicate methods.
• Analytical Specificity: Interference studies used samples spiked with interferents (Intralipid, unconjugated bilirubin, hemoglobin). Specific sample sizes for each interference study are not given, but they refer to specific CO2 sample concentrations (e.g., 22.2 mmol/L CO2 sample). This is a controlled lab-based study using spiked samples.

Data Provenance (General): Not explicitly stated, but these are typical studies performed in a lab setting, likely in the US, during product development.

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 is not applicable to an in-vitro diagnostic assay. The "ground truth" for this type of device is established by the analytical reference methods or reference materials themselves, or by comparison to a legally marketed predicate device which serves as the comparative standard. There are no human experts "reading" or interpreting the results in a diagnostic imaging sense.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human experts interpret data (e.g., radiology images) and a consensus is needed to establish ground truth or resolve discrepancies. For an in-vitro diagnostic, the measurements are quantitative chemical analyses, not subjective interpretations.

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 is not applicable. The device is a laboratory reagent, not an AI-powered diagnostic tool that assists human readers.

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

The device itself is a "standalone" analytical system in that it chemically quantifies CO2. Its performance is entirely "algorithm only" in the sense of the chemical reactions and spectrophotometric measurements. There is no human interpretation of an image or signal that the device is intending to aid or replace.

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

The "ground truth" for this type of device is established by:

• Reference Methods/Materials: For imprecision, linearity, and LoD, the device measures against established control materials or standard concentrations.
• Predicate Device: For method comparison, the Genzyme Carbon Dioxide L3K® Assay (K042362) serves as the "ground truth" or reference for comparison, based on its established performance and market history. The goal is to show agreement with this predicate.

8. The sample size for the training set

This is not applicable. This is an IVD reagent developed through chemical and assay optimization, not a machine learning model that requires a "training set" in the context of AI.

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

This is not applicable as there is no training set for an AI model. The development of the reagent involves standard chemical and analytical validation processes.

Ask a specific question about this device