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Intended Use: The CR cartridge is intended for professional use with the IRMA® Blood Analysis System for the direct measurement of creatinine, in human whole blood. The CR cartridge and the IRMA® Blood Analysis System are for in vitro diagnostic use.
Indications for Use: The measurement of creatinine aids in the diagnosis and treatment of certain renal diseases, and in monitoring renal dialysis.

The IRMA® SL Blood Analysis System CR Creatinine Cartridge is for use with the IRMA Blood Analysis System. The creatinine cartridge is a single use, disposable cartridge, for the in vitro measurement of creatinine in whole blood. Samples are introduced via syringe or capillary injections with the IRMA® Capillary Collection Device. The creatinine sensor uses an enzymatic method for measuring creatinine. The IRMA sensors are calibrated prior to each test using a calibrant packaged with the sensor. Calibration of the cartridge is completed when information determined at the factory for each lot of cartidges is combined with measurements taken during the calibration process. Factory derived calibration parameters are input into the analyzer by calibration code entry. Throughout the calibration and analysis process, signals from the sensors are analyzed. If any abnormal conditions are detected, an error message is generated and the test will be terminated. If there are no abnormal conditions, then the sample results are displayed after successful calibration and analysis. In addition, the user has the option to print a hard copy of the results.

The provided document describes the IRMA® SL Blood Analysis System CR Creatinine Cartridge, a device for in vitro measurement of creatinine in whole blood. The study presented focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria in a typical AI/ML medical device submission format.

However, based on the performance data provided, we can infer some "acceptance criteria" through comparison with the reported device performance, particularly in the context of demonstrating substantial equivalence to a predicate device.

Here's an attempt to structure the information according to your request, with a strong caveat that this is an interpretation of the provided regulatory submission format.

Acceptance Criteria and Study Details for the IRMA® SL Blood Analysis System CR Creatinine Cartridge

The provided document, a 510(k) summary, demonstrates the substantial equivalence of the IRMA® SL Blood Analysis System CR Creatinine Cartridge to a predicate device (Vitros DT60 II Chemistry System / Vitros CRSC DT Slides). The acceptance criteria are implicitly derived from the performance deemed acceptable for equivalence in the context of an in vitro diagnostic device, specifically regarding accuracy, precision, and linearity.

1. Table of Acceptance Criteria and Reported Device Performance:

Since explicit acceptance criteria are not stated as pass/fail thresholds but rather performance characteristics for substantial equivalence, the "acceptance criteria" are represented by the demonstrated performance itself, showing it is comparable to or better than the predicate device and within clinically acceptable ranges.

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

• Accuracy Test Set (Correlation Study): The number of samples for the accuracy study is ambiguously reported as 1. However, the range evaluated was 0.5 - 10.1 mg/dl, suggesting multiple samples were indeed used to calculate the slope, intercept, and correlation coefficient. The exact number of individual patient samples in the test set is not explicitly stated in the provided text.
• Precision Test Set: The number of replicates (N) for each level ranged from 12 to 60.
  • Level 1: N=12
  • Level 2: N=56
  • Level 3: N=54
  • Level 4: N=58
  • Level 5: N=60
  • Level 6: N=52
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Given the nature of a 510(k) submission for an IVD, it's typically prospective clinical laboratory testing.

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

• This device is an in vitro diagnostic (IVD) based on enzymatic methods, not an AI/ML device relying on expert image interpretation. Therefore, "experts" in the context of establishing ground truth (e.g., radiologists, pathologists) are not applicable in the same way. The ground truth (reference values) would have been established by the predicate device (Vitros DT60 II Chemistry System / Vitros CRSC DT Slides) and/or other established laboratory methods, which are inherently "expert" systems in the sense of being widely accepted and validated.

4. Adjudication Method for the Test Set:

• Not applicable as this is a biochemical measurement comparison, not a diagnostic interpretation from human readers.

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

• No, this is not an MRMC study. It is a comparison of an IVD device's performance to a predicate IVD device. The concept of "human readers improve with AI vs without AI assistance" is not relevant here.

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

• The performance data presented is standalone performance, as it represents the analytical performance of the IRMA® SL Blood Analysis System CR Creatinine Cartridge itself (accuracy, precision, linearity). Although it's an IVD test and operators are involved in sample handling, the "algorithm" (enzymatic method) performance is evaluated directly.

7. The Type of Ground Truth Used:

• Accuracy Study: The ground truth for the accuracy study was established by comparing the IRMA® device's results to those of the predicate device, the Vitros DT60 II Chemistry System / Vitros CRSC DT Slides.
• Precision and Linearity Studies: Ground truth (reference values) would be established using known control materials or dilutions of samples with known concentrations, or by reference methods, though specific details are not provided.

8. The Sample Size for the Training Set:

• Not applicable in the context of this device and study. This device uses an enzymatic chemical method, not a machine learning algorithm that requires a "training set" in the conventional sense. The "calibration" process mentioned (combining factory-determined information with measurements during calibration) serves a similar function to training in some ways, but it's not a data-driven training set like in AI/ML.

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

• Not applicable as there is no "training set" in the AI/ML context. Calibration for the cartridge is described as combining "information determined at the factory for each lot of cartridges" with "measurements taken during the calibration process" using a calibrant packaged with the sensor. This factory information and calibrant effectively establish the "ground truth" for the device's internal calibration.

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The lactate sensor is intended for professional and point of care use with the IRMA " Blood Analysis System for the direct measurement of lactate, in human whole blood. The Lactate Cartridge and the IRMA "Blood Analysis System are for in vitro diagnostic use.

Lactate evaluates the acid-base status and is used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

The IRMA" SL Blood Analysis System Lacrate Cartridge is for use with the IRMA "Blood Analysis System. The Lactate cartridge is a single use, disposable cartridge, for the in vitro measurement of lactate in whole blood.

Samples are introduced via syringe or capillary injections with the IRMA® Capillary Collection Device. The lactate sensor uses an amperometric electrode along with a reference electrode that measures the lactate oxidase reaction. The IRMA® sensors are calibrated prior to each test using a calibrant packaged with the sensors. Calibration of the cartidge is completed when information determined at the factory for each lot of cartridges is combined with measurements taken during the calibration process. Factory derived calibration parameters are input into the analyzer by calibration code entry.

Throughout the calibration and analysis process, signals from the sensors are analyzed. If any abnormal conditions are detected, an error message is generated and the test will be terminated. If there are no abnormal conditions, then the sample results (measured and calculated) are displayed after successful calibration and analysis. In addition, the user has the option to print a hard copy of the results.

Here's a breakdown of the acceptance criteria and study information for the Diametrics Medical IRMA® SL Blood Analysis System Lactate Cartridge, based on the provided text:

Acceptance Criteria and Device Performance

Note: The document states "The data demonstrates that the Lactate Cartridge is as safe, effective and performs as well as the legally marketed predicate device to which equivalence is claimed." This implies that the observed performance meets an unstated acceptance criterion of being comparable to the predicate device.

Study Details

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

   • Accuracy: n = 30 (Range evaluated 1 - 250 mg/dl).
   • Precision: Levels 1, 2, and 3 had n = 59 each. Level 4 had n = 58.
   • Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

2. 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 devices like this, ground truth is typically established by comparative methods using a reference laboratory instrument, not by expert consensus on imaging or clinical interpretation.

3. Adjudication method for the test set:

   • This information is not applicable/provided for this type of in vitro diagnostic device study. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology studies).

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:

   • No, an MRMC comparative effectiveness study was not done. This is an in vitro diagnostic device (IVD) for direct measurement, not an AI-assisted diagnostic tool that would involve human readers.

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

   • Yes, implicitly. The performance data (accuracy, precision, linearity) presented are the standalone performance of the IRMA® SL Blood Analysis System Lactate Cartridge itself, as an automated in vitro diagnostic device without human interpretation as part of the core measurement process. Human interaction is limited to sample collection, cartridge insertion, and reading the displayed results.

6. The type of ground truth used:

   • For accuracy, the ground truth would have been established by comparing the device's results against a reference method or a legally marketed predicate device (YSI Model 2300 Stat Plus, which is mentioned as the predicate). The "Slope," "Intercept," and "r" values indicate a regression analysis comparing the new device to a reference.
   • For precision, the ground truth is statistical, derived from repeated measurements of the same sample, indicating reproducibility.

7. The sample size for the training set:

   • Not applicable/provided. This device is a sensor-based system, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "factory derived calibration parameters" mentioned in the device description contribute to its operational accuracy, but this is a manufacturing/calibration process, not an AI training process.

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

   • Not applicable/provided for the reason stated in point 7. The calibration of the cartridge uses "information determined at the factory for each lot of cartridges" and "measurements taken during the calibration process." This involves pre-determined factory parameters and on-site calibration measurements, not a ground truth established for a "training set" in an AI context.

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The GL Cartridge is intended for professional use with the IRMA® Blood Analysis System for the direct measurement of sodium, potassium, glucose, and chloride in human whole blood. The GL Cartridge and the IRMA® Blood Analysis System are for in vitro diagnostic use.

The electrolyte measurements (Nat, K*, Cl ) are used to assess hydrational status, aid in the diagnosis of respiratory and metabolic acid-balance, and prevention of cardiac arrhythmia. Common disease states, which use these measurements for diagnosis, are acid-base disturbances, dehydration, diarrhea, ketoacidosis, alcoholism and other toxicities.

The measurement of glucose aids in the diagnosis and treatment of diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia.

The IRMA® SL Blood Analysis System GL Cartridge is for use with the IRMA Blood Analysis System. The GL cartidge is a single use, disposable carridge, for the in vitro measurement of any of the may on the may GL cartidge comprises the analytes sodium, potassium (K945240), chloride (K981270) and glucose. Oiz currently markets cartridges with sodium, potassium, (K945240) and chloride.

Samples are introduced via syringe or capillary injections with the IRMA® Capillary Collection Device. The glucose sensor uses an amperometric electrode along with a reference electrode that measures the glucose oxidase reaction. The IRMA® sensors are calibrated prior to each test using a calibrant packaged with the sensors. Calibration of the cartridge is completed when information a canorally partil the factory for each lot of cartridges is combined with measurements taken during the calibration process. Factory derived calibration parameters are input into the analyzer by calibration code entry.

Throughout the calibration and analysis process, signals from the sensors are analyzed. If any abnormal conditions are detected, an error message is generated and the test will be terminated. If abliotinal continuent a conditions, then the sample results (measured and calculated) are displayed after successful calibration and analysis. In addition, the user has the option to print a hard copy of the results.

The provided text describes the acceptance criteria and performance of the IRMA® SL Blood Analysis System GL Cartridge, specifically focusing on its glucose measurement capabilities.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for accuracy, precision, or linearity with numerical targets. Instead, it presents the performance data of the IRMA® device and claims substantial equivalence to the predicate device, the YSI Model 2300 Stat Plus. The implied acceptance is that the performance is comparable or within an acceptable range for clinical use, particularly when compared to a legally marketed predicate device.

Based on the "Summary of Performance Data" section:

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

• Accuracy (Glucose):

  • Sample Size: n = 37
  • Data Provenance: Not explicitly stated (e.g., country of origin, prospective/retrospective). However, it's generally understood that such studies for medical devices are conducted on human samples, likely from clinical settings, and are typically prospective for regulatory submissions.

• Precision (Glucose):

  • Level 1: n = 59
  • Level 2: n = 58
  • Level 3: n = 60
  • Level 4: n = 59
  • Data Provenance: Not explicitly stated (e.g., country of origin, prospective/retrospective). These types of studies often use control materials or pooled patient samples to evaluate reproducibility.

• Linearity (Glucose):

  • Sample Size: n = 20
  • Data Provenance: Not explicitly stated. Linearity studies typically involve prepared samples with known, varying concentrations.

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

This type of information (number of experts, qualifications) is not relevant for in vitro diagnostic devices like the IRMA® SL Blood Analysis System GL Cartridge. The "ground truth" for glucose measurement is established by reference methods or a predicate device, which are assumed to be accurate based on established analytical principles and prior validation. The study compares the IRMA® device's measurements to another measurement device (likely the predicate or a laboratory reference method), not to expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. As explained above, this is for an in vitro diagnostic device measuring an analyte, not for subjective interpretation by experts. Ground truth is established by quantitative measurement, not expert consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is an automated blood analysis system, not an AI-assisted diagnostic tool that involves human readers interpreting images or data. Therefore, an MRMC study and AI assistance effect size are not relevant.

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

Yes, the performance data presented (accuracy, precision, linearity) reflects the standalone performance of the IRMA® SL Blood Analysis System GL Cartridge for glucose measurement. It is an automated system designed for direct measurement.

7. The Type of Ground Truth Used

The ground truth for the glucose measurements in the performance study would have been established by a reference method or a legally marketed predicate device (YSI Model 2300 Stat Plus, mentioned as the predicate in the substantial equivalence claim). This means the measurements from the IRMA® device were compared against measurements from a highly accurate and validated method or device.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" for the glucose measurement. In the context of this type of in vitro diagnostic device, the "training" for the device's internal algorithms and calibration parameters happens internally at the factory and during the initial calibration process described (using factory-derived parameters combined with measurements during daily calibration). There isn't typically a large external "training set" of patient data in the same way an AI/ML algorithm might have for image classification.

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

Given the explanation in point 8, the concept of "ground truth for the training set" as it applies to AI/ML is not directly applicable here. However, the accuracy of the device's measurements (and thus its "training" or calibration parameters) relies on the use of calibrants and control materials with known, highly accurate concentrations, which themselves are verified against reference methods. The device states: "The IRMA® sensors are calibrated prior to each test using a calibrant packaged with the sensors. Calibration of the cartridge is completed when information a canorally partil the factory for each lot of cartridges is combined with measurements taken during the calibration process. Factory derived calibration parameters are input into the analyzer by calibration code entry." This suggests the "ground truth" for its internal calibration is established through a combination of factory-set parameters and on-board calibration using precise, standardized solutions.

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The IRMA Blood Analysis System is intended for professional use in those settings where direct measurement of blood such as blood gases (pCO2 and pO2), pH, Na , K , iCa BUN. CI'. and Hct. in whole blood are performed such as the clinical laboratory or the patient bedside.

The pH, pCO2, pO2 measurements, and their associated calculated values are used to assess acid-base status and state of oxygenation. Common causes of acid-base disturbances include: cardiopulmonary disease, metabolic abnormalities, drugs and poisons, and fluid imbalance.

The electrolyte measurements (Na . K . Cl) are used to assess hydrational status, aid in the diagnosis of respiratory and metabolic acid-balance, and prevention of cardiac arrhythmia. Common disease states which utilize these measurements for diagnosis are acid-base disturbances, dehydration, diarrhea, ketoacidosis, alcoholism and other toxicities.

The measurement of ionized calcium is used to assess disease states such as thyroid abnormalities, renal failure or transplant, and to monitor dialysis patients.

The measurement of blood urea nitrogen is used to monitor renal disease, dialysis --patients, and hyperalimentation.

The measurement of hematocrit is used to assess anemia, blood loss such as in an accident or during surgical procedures, and polycythemia.

With the addition of BUN and Cr, the IRMA Blood Analysis System will measure: blood gases (pCO2 and pO2), pH, sodium, potassium, ionized calcium, blood urea nitrogen, chloride, and hematocrit. The sensor arravs of the cartridge will also be packaged in various combinations.

The current IRMA Blood Analysis System comprises a system of an electronic instrument and disposable cartridges (single-use or multi-use) intended for the measurement of blood gases (pCO2 and pO2), pH, potassium, sodium, ionized calcium, and hematocrit in blood.

The new system will measure the above mentioned analytes plus blood urea nitrogen (BUN) and chloride (Cl) in blood on the single-use cartridge. Except for the addition of these two analytes and their associated changes, the system will remain the same as the current system.

The IRMA analyzer can use either battery or AC power. The system's operation utilizes a microprocessor which is controlled by internal electronics and diagnostics. The microprocessor controls the touch screen, analog electronics which collect the digital signals from the sensors and the controls the printer. The printer provides a hard copy of the measured and calculated values.

Samples are introduced via syringe or capillary injections with the IRMA Capillary Collection Device. The minimum sample volumes are 200uL from a syringe injection and 125uL from a Capillary Collection Device injection. Other capillary collection devices which require aspiration are not compatible with the system.

The cartridges utilize microelectrode technology for the measurement of the following blood analytes: pH, pCO2, pO2, sodium, potassium, ionized calcium, blood urea nitrogen, chloride, and hematocrit.

The principles of measurement are similar to traditional electrode methodologies for blood gas and electrolyte measurements. The pH, pCO2, Na*, K*, iCa**, BUN, and Cli utilize ion-selective potentiometric electrodes including a reference electrode. The pO2 electrode is an amperometric Clark electrode. The hematocrit sensor utilizes a conductivity electrode.

Here's a breakdown of the acceptance criteria and study information for the IRMA Blood Analysis System's BUN and Chloride sensors, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are "not explicitly stated" in numerical form within the provided text. They are implied by the statement "indicate substantial equivalence between Cl- and BUN sensors on the IRMA Blood Analysis System and the predicate devices" and the presentation of strong correlation coefficients.

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

• Chloride (Cl-) Test Set Sample Size: n = 99
• BUN Test Set Sample Size: n = 97
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the submission is to the US FDA and the company is based in Roseville, MN, USA.
  • Retrospective or Prospective: Not explicitly stated, but the description "split sample studies were conducted using whole blood samples measured by both the IRMA system and a reference method" and "heparinized whole blood samples were prepared by spiking with varying concentrations of electrolytes to allow testing throughout the reportable range" suggests a prospective study where samples were prepared and then tested on both systems.

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

• Number of Experts: The text states, "Testing was conducted by three laboratory personnel."
• Qualifications of Experts: Not explicitly stated beyond "laboratory personnel." No specific professional certifications (e.g., medical technologist) or years of experience are mentioned. The document notes that the IRMA system was previously cleared for use by non-laboratory personnel, and this submission's data does not include such personnel.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly described. The study appears to rely on direct comparison of the IRMA system's results against a reference method, rather than an adjudication process between multiple readers/interpretations. "The method of least squares was used to determine the best fit line."

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

• MRMC Study Done?: No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical accuracy and precision of a diagnostic device (blood analyzer) compared to reference methods, not on human reader performance with or without AI assistance.

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

• Standalone Performance Done?: Yes, the accuracy and precision data presented for Chloride and BUN represent the standalone performance of the IRMA Blood Analysis System's sensors, measuring the analytes in blood and aqueous samples. It's an instrument-based measurement, not an AI or human interpretation task.

7. The Type of Ground Truth Used

• Type of Ground Truth: Reference methods, specifically a Vitros Chemistry System DT6011 (for BUN) and a Buchler Digital Chloridometer (for Chloride) for accuracy studies. For precision, aqueous standards and control materials with known concentrations were used.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. The IRMA Blood Analysis System is a medical device based on established electrochemical and enzymatic methodologies, not a machine learning or AI model that requires a "training set" in the traditional sense. Its "training" is in its engineering design, calibration, and manufacturing process.

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

• How Ground Truth for Training Set Was Established: Not applicable, as this is not a machine learning device. The "ground truth" for its operation is inherent in the design and calibration using NIST traceable gases and salt standards, as described in the "Calibration" section.

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The IRMA Blood Analysis System is intended for professional use in those settings where blood analysis of blood gases (pCO2 and pO2), pH, Na+, K+, iCa++ and Hct in whole blood are performed such as the clinical laboratory or the patient bedside. The system may utilize either a single-use or a multi-use cartridge for these measurements.

The pH, pCO2, pO2 measurements, and their associated calculated values are used to assess acid-base status and state of oxygenation. Common causes of acid-base abnormalities, drugs and poisons, and fluid imbalance.

The electrolyte measurements (Na+, K+) are used to assess hydrational status, aid in the diagnosis of respiratory and metabolic acid-balance, and prevention of cardiac arrhythmia. Conditions which utilize these measurements for diagnosis are malnutrition, diarrhea, ketoacidosis, alcoholism and other toxicities.

The measurement of ionized calcium is used to assess disease states such as thyroid abnormalities, renal failure or transplant, and to monitor dialysis patients.

The measurement of hematocrit is used to assess anemia, blood loss such as in an accident or during surgical procedures, and polycythemia.

These indications for use of the IRMA Blood Analysis System which utilizes the multiuse cartridge are identical to those of the IRMA Blood Analysis System which utilizes the single-use cartridge. The System will now offer the user an option to choose which cartridge platform best fits their needs either the single-use or multi-use cartridge. Both platforms offer the following sensors: blood gases (pCO2 and pO2), pH, sodium, potassium, ionized calcium, and hematocrit. Similar to the single-use cartridge, the sensor arrays of the multi-use cartridge will also be packaged in various combinations.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the IRMA® Blood Analysis System with an Optional Multi-Use Cartridge. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document does NOT contain information about:

• Specific acceptance criteria metrics (e.g., sensitivity, specificity, accuracy targets).
• Any study that proves the device meets acceptance criteria.
• Sample sizes for test sets or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• The type of ground truth used (e.g., pathology, outcomes data).

The document is purely a regulatory clearance notice and details the device's intended use and indications for use. It states that the system measures blood gases (pCO2 and pO2), pH, Na+, K+, iCa++, and Hct in whole blood, either with a single-use or multi-use cartridge, in settings such as clinical laboratories or patient bedsides. The indications for use are for assessing acid-base status, hydration, electrolyte balance, cardiac arrhythmias, disease states related to calcium, anemia, and blood loss.

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The IRMA® Blood Analysis System is intended for professional use in those settings where direct measurement of blood such as blood gases (pCO2 and pO2), pH, Na+, K+, iCa++ and Hct in whole blood are performed such as the clinical laboratory or patient bedside, and The IRMA/Lifescan SureStep®Pro glucose module is intended for quantitative measurement of glucose in a sample of whole blood. It can be used in a clinical setting to measure glucose in arterial, venous, and capillary samples in both adults and neonates. It can also be used by lay persons for capillary blood glucose monitoring in the home.

Indications for Use:
The pH, pCO2, pO2 measurements, and their associated calculated values are used to assess acid-base status and state of oxygenation. Common causes of acid-base disturbances include cardiopulmonary disease, metabolic abnormalities, drugs and poisons, and fluid imbalance.

The electrolyte measurements (Na+ K+)are used to assess hydrational status, aid in the diagnosis of respiratory and metabolic acid-balance, and prevention of cardiac armythmia. Common disease states which utilize these measurements are acid-base disturbances, dehydration, diarrhea, ketoacidosis, alcoholism and other toxicities.

The measurement of ionized calcium is used to assess disease states such as thyroid abnormalities, renal failure or transplant, and to monitor dialysis patients.

The measurement of hematocrit is used to assess anemia, blood loss such as in an accident or during surgical procedures, and polycythemia.

The measurement of glucose on the module is used to monitor glucose levels in diabetic patients. It is not intended to be used for the diagnosis of diabetes.

These indications for use are identical to the predicate devices since the new system consists of an integration of the two predicate devices.

Not Found

This document is a 510(k) clearance letter for the Diametrics Medical IRMA Blood Analysis System, dated December 18, 1997. It primarily focuses on the regulatory approval and intended use of the device, rather than detailed performance study results or acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a device study is not present in the provided text.

The document states:

• Device Name: IRMA Blood Analysis System with Optional Lifescan SureStep®Pro Blood Glucose Module
• Intended Use: For professional use to directly measure blood gases (pCO2, pO2), pH, Na+, K+, iCa++, and Hct in whole blood in clinical laboratory or patient bedside settings. The glucose module is for quantitative measurement of glucose in whole blood for adults and neonates in clinical settings, and by laypersons for capillary blood glucose monitoring at home.
• Indications for Use: Details the clinical applications of the pH, pCO2, pO2, Na+, K+, ionized calcium, hematocrit, and glucose measurements.
• Substantial Equivalence: The FDA determined the device is substantially equivalent to predicate devices, indicating that the new system integrates two predicate devices with identical indications for use.

To answer your specific questions, a different type of document, such as a summary of safety and effectiveness, clinical study report, or internal validation report, would be required. This 510(k) clearance letter confirms regulatory approval based on equivalence but does not provide the detailed performance study data you're asking for.

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