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The ABL90 FLEX PLUS System is an in vitro diagnostic, portable, automated analyzer that quantitatively measures electrolytes (cK+, cNa+, cCa2+), glucose, and lactate in heparinized arterial and venous whole blood.

The ABL90 FLEX PLUS System is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient, or point-of-care setting. These tests are only performed under a physician's order.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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The ABL90 FLEX PLUS System is an in vitro diagnostic, portable, automated analyzer that quantitatively measures pH, blood gas (p02), Oximetry (s02, ctHb, FCOHb, FCOHb, FMetHb, and FHHb), in heparinized arterial and venous whole blood.

The ABL90 FLEX PLUS System is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient, or point-of-care setting. These tests are only performed under a physician's order.

pH and pO2: pH and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.

sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin plus reduced hemoglobin.

ctHb (Total Hemoglobin): Total hemoglobin measure the hemoglobin content of whole blood for the detection of anemia.

FO2Hb: Oxyhemoglobin as a fraction of total hemoglobin.

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

FMetHb: Methemoglobin as a fraction of total hemoglobin.

FHHb: Reduced hemoglobin as a fraction of total hemoglobin.

The ABL90 FLEX PLUS System consists of the ABL90 FLEX PLUS analyzer, sensor cassette and solution pack consumables, and related accessories for the analyzers. The sensor cassettes, solution packs and related accessories are compatible with both analyzers. Multiple versions of the sensor cassettes are available. The sensor cassette versions vary in the maximum number of tests and availability of sensors for use. The solution pack is available in two versions, differing in the number of activities available.

The FDA 510(k) summary for the Radiometer ABL90 FLEX PLUS System provides detailed information about the device's analytical performance testing to demonstrate its substantial equivalence to its predicate device.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the reported performance metrics (linearity, detection limits, precision, bias) and the comparison to the predicate device. The goal is to show that the ABL90 FLEX PLUS System performs comparably to the predicate (ABL90 FLEX PLUS, K160153) and adheres to recognized standards (CLSI guidelines).

The summary does not explicitly present a table of "acceptance criteria" and "reported performance" side-by-side in a single formatted table. However, the various tables throughout the "Analytical Performance Testing Summary" section serve this purpose by presenting the measured performance of the ABL90 FLEX PLUS System against unstated, but implied, acceptable ranges or a comparison to the predicate.

Here's a synthesized representation of the reported device performance for key analytical parameters, effectively serving as the "reported device performance":

Key takeaway for "Acceptance Criteria": The general acceptance criterion for this 510(k) submission is to demonstrate "substantial equivalence" to the predicate device (ABL90 FLEX PLUS, K160153). While explicit numerical acceptance criteria are not presented in this summary document, the testing aims to show that the new device's performance (linearity, detection, precision, bias, interference) is comparable to the predicate and/or meets recognized clinical and analytical standards as outlined in CLSI guidelines.

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

• Linearity Testing: Numbers of samples are not explicitly stated for linearity testing, but it was conducted "in general accordance with CLSI EP06... and EP39."
• Detection Capability (LoB, LoD, LoQ): Numbers of samples are not explicitly stated.
• Precision (using stable, aqueous ampoule-based QC material):
  • N = 243 or 244 for each QC ampoule level and parameter.
  • Data Provenance: Testing occurred at three external sites. The specific countries of origin are not mentioned, but "external sites" suggests a multi-site study. This appears to be a prospective study, as it's part of the premarket submission.
• Precision (using blood):
  • N varies by parameter and test interval, ranging from 4 to 188 samples.
  • Data Provenance: Not explicitly stated, but implies collected from blood samples (human derived). Likely prospective data collected for the study.
• Method Comparison (Bias):
  • N varies by parameter, blood type, and mode (S65/SP65), ranging from 26 to 235 samples (arterial/venous blood).
  • Data Provenance: Not explicitly stated, but implies collected from patient blood samples. This would be prospective data collected specifically for the method comparison study.

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

This device (ABL90 FLEX PLUS System) is an in vitro diagnostic (IVD) analytical instrument. The ground truth for its performance is established through reference methods, defined concentrations of analytes in quality control materials, and comparison to a legally marketed predicate device, not typically through human expert adjudication of images or clinical outcomes that require multiple medical professionals.

Therefore, the concept of "experts establishing ground truth" in the way it might apply to an AI imaging device (e.g., radiologists reviewing scans) is not directly applicable here. The "experts" would be the laboratory personnel and analytical chemists who perform the testing and ensure adherence to CLSI guidelines. Their qualifications are implicitly assumed to be appropriate for performing such technical laboratory studies.

4. Adjudication Method for the Test Set

Not applicable for an IVD analytical instrument. Ground truth is established by reference methods, certified materials, and comparison with a predicate device, not by expert adjudication.

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

Not applicable. MRMC studies are typically performed for imaging devices or diagnostic aids where human interpretation is a key component, often comparing AI-assisted vs. unassisted human performance. This device is an automated, quantitative analytical instrument.

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

Yes, the performance data presented (linearity, detection/quantitation, precision, bias, interference) are all measures of the standalone analytical performance of the ABL90 FLEX PLUS System. The device provides quantitative measurements autonomously without continuous human interpretation required for each result.

7. The Type of Ground Truth Used

The ground truth used for this device's analytical performance studies are:

• Reference materials/Certified Analytes: For linearity, detection, and precision testing. These are materials with known, precisely measured concentrations of the analytes (pH, pO2, ctHb, sO2, etc.).
• Predicate Device Measurements: For method comparison/bias studies, the measurements from the legally marketed ABL90 FLEX PLUS (K160153) served as the comparator (or "ground truth" to determine bias relative to the predicate).
• CLSI Guidelines: The studies adhere to relevant Clinical and Laboratory Standards Institute (CLSI) guidelines (e.g., EP06, EP39, EP17-A2, EP05-A3, EP09c, EP07, EP37), which define accepted methodologies and performance characteristics for IVD devices.

8. The Sample Size for the Training Set

Not applicable. This document describes the performance testing for a finished IVD product, not the development or training of a machine learning model. IVD devices like the ABL90 FLEX PLUS System are based on established analytical principles (potentiometry, optical, spectrophotometry) and calibrated using defined reference materials, not "trained" on a dataset in the AI sense.

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's analytical principles. Ground truth for calibration and development of such instruments is established through rigorous analytical chemistry methods using highly purified and characterized reference standards.

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The ABL90 FLEX analyzer is an in vitro diagnostic, portable, automated analyzer that quantitatively measures neonatal bilirubin in heparinized capillary, venous and arterial whole blood.
The ABL90 FLEX analyzer is intended for use by trained technologists, nurses, physicians and therapists.
It is intended for use in a laboratory environment, near patient or point-of-care setting.
These tests are only performed under a physician's order.
Bilirubin measurements on the ABL90 FLEX analyzer are intended to aid in assessing the risk of kernicterus in neonates.

ABL90 FLEX PLUS:
The ABL90 FLEX PLUS analyzer is an in vitro diagnostic, portable, automated analyzer that quantitatively measures neonatal bilirubin in heparinized capillary, venous and arterial whole blood.
The ABL90 FLEX PLUS analyzer is intended for use by trained technologists, nurses, physicians and therapists.
It is intended for use in a laboratory environment, near patient or point-of-care setting.
These tests are only performed under a physician's order.
Bilirubin measurements on the ABL90 FLEX PLUS analyzer are intended to aid in assessing the risk of kernicterus in neonates.

The ABL90 FLEX and ABL90 FLEX PLUS analyzers are two models of the same portable, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO-, pCO3, potassium, sodium, calcium, chloride, glucose, lactate, neonatal bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO-Hb, FCOHb, FMetHb, FHHb and FHbF).
The manufacturer of the ABL90 FLEX and ABL90 FLEX PLUS is Radiometer Medical ApS.
The ABL90 FLEX and ABL90 FLEX PLUS consist of an instrument with a sensor cassette and a solution pack as the main accessories. Multiple models of sensor cassettes are available.
The various sensor cassette models for different parameter combinations. For each parameter combination, models allowing for different test load are available.
The solution pack is available in two models differing in the number of tests available.
Technology:
The ABL 90 FLEX and ABL90 FLEX PLUS electrochemical sensors are miniaturized, manufactured by film technology and integrated in a common sensor cassette. Likewise, the ABL90 FLEX and ABL90 FLEX PLUS optical oxygen sensor is integrated in the sensor cassette. A 256-pixel array spectrophotometer is used for the co-oximetry parameters and bilirubin.
Clinical Utility ctBil:
For newborns up to an age of one month the method's reportable range covers the entire reference range. Neonatal Bilirubin test is intended for use to aid in assessing the risk of kernicterus in newborns.

The provided document is a 510(k) Premarket Notification from the FDA regarding the ABL90 FLEX and ABL90 FLEX PLUS devices for measuring neonatal bilirubin. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria as typically done for novel AI/ML medical devices.

Therefore, many of the requested points related to acceptance criteria, ground truth establishment, expert consensus, MRMC studies, and training sets are not applicable to this type of submission. This 510(k) is for an in-vitro diagnostic device that measures a chemical parameter (bilirubin) using established spectrophotometric technology, not an AI/ML-driven diagnostic or image analysis tool. The "performance" being evaluated is the analytical performance (accuracy, precision, linearity) of the device against a known predicate and reference methods, not the diagnostic performance of an algorithm.

However, I can extract the relevant information from the document that pertains to its performance evaluation.

Overview of Device Performance Evaluation (Not AI/ML focused)

The ABL90 FLEX and ABL90 FLEX PLUS analyzers are in vitro diagnostic devices designed to quantitatively measure neonatal bilirubin in heparinized capillary, venous, and arterial whole blood. The submission aims to extend the indicated sample types for neonatal bilirubin measurement to include arterial and venous whole blood, leveraging performance data already established for capillary whole blood in a previous 510(k) (K132691).

The core of the performance study for this specific submission is demonstrating method comparison (correlation) against a predicate device (ABL800 FLEX or ABL835 FLEX, which is part of the ABL800 FLEX family) for the new sample types.

Relevant Performance Information and Analysis (from the provided document):

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

   • Acceptance Criteria: Not explicitly stated as pass/fail thresholds in this document for the method comparison study. The goal is to demonstrate "substantial equivalence" based on the correlation characteristics (slope, intercept, R-squared) to the predicate device. The implicit acceptance is that the correlation is strong (R-squared close to 1) and the linear relationship is close to y=x (slope close to 1, intercept close to 0), indicating comparable performance to the predicate. The FDA's determination of substantial equivalence implies these criteria were met.

   • Reported Device Performance (from Table 1: Neonatal bilirubin linear regression data for ABL90 FLEX measurements compared to ABL835 FLEX measurements):

     Parameter	Units	Slope	Intercept (mg/dL)	R²	Sy.x (mg/dL)
     ctBil All (combined samples)	mg/dL	0.97	-0.38	1.00	0.60
     ctBil Arterial All	mg/dL	0.98	-0.54	0.97	0.53
     ctBil Venous All	mg/dL	0.98	-0.32	0.98	0.62
     ctBil site 1	mg/dL	0.96	-0.18	1.00	0.57
     ctBil site 2	mg/dL	0.98	-0.71	1.00	0.58

   Interpretation: The R-squared values are very high (0.97 to 1.00), indicating a very strong linear correlation between the ABL90 FLEX and the predicate ABL835 FLEX. The slopes are close to 1 (0.96-0.98) and intercepts are close to 0 (-0.18 to -0.71 mg/dL), suggesting good agreement (i.e., minimal proportional or constant bias) between the new device and the predicate.

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

   • Test Set Sample Sizes:
     • 44 arterial blood samples
     • 42 venous blood samples
     • 17 spiked cord blood samples
     • Total N = 103 samples (44 arterial + 42 venous + 17 spiked)
   • Data Provenance: The study was conducted at "two point-of-care sites." The document does not specify the country of origin of the data. It is a prospective method comparison study where new measurements were taken for the purpose of this submission.

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

   • Not applicable in the context of an AI/ML algorithm. For this in vitro diagnostic device, the "ground truth" for the method comparison is the measurement obtained from the predicate device (ABL835 FLEX), which is itself a validated diagnostic instrument. This is an analytical performance study, not a diagnostic performance study relying on expert interpretation.

4. Adjudication method for the test set:

   • Not applicable. This study involves direct quantitative measurements of a chemical analyte, not qualitative assessments or interpretations that would require adjudication.

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

   • Not applicable. This is an in vitro diagnostic device measuring a chemical substance, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data.

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

   • This is inherently a "standalone" device in its measurement function. The device itself performs the measurement and provides a numerical output. Human involvement is in operating the device and interpreting the numerical result in a clinical context, but not in assisting an algorithm to produce the measurement.

7. The type of ground truth used:

   • The "ground truth" (or reference method for comparison) was measurements obtained from another legally marketed device (predicate device, ABL835 FLEX), which is widely considered a reliable method for bilirubin measurement. For in vitro diagnostics, this is a standard approach to demonstrating substantial equivalence – showing comparable performance to an established method.

8. The sample size for the training set:

   • Not applicable. This device uses established spectrophotometric technology and is not an AI/ML device that requires a training set in the conventional sense. The "training" here would be the design and calibration of the instrument based on chemical and optical principles.

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

   • Not applicable. As above, no training set in the AI/ML sense.

Ask a specific question about this device

The ABL90 FLEX PLUS analyzer is an in vitro diagnostic, portable, automated analyser that quantitatively measures, pH, blood gases, electrolytes, glucose, lactate and oximetry in heparinized whole blood, and neonatal bilirubin in heparinized capillary whole blood.

The ABL90 FLEX PLUS analyzer is intended for use by trained technologists, nurses, physicians and therapists.

It is intended for use in a laboratory environment, near patient or point-of-care setting.

These tests are only performed under a physician's order.

Bilirubin measurements on the ABL90 FLEX PLUS analyzer are intended to aid in assessing the risk of kernicterus in neonates.

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

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

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

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

Chloride (cCl-): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.

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

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

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

sO2: oxygen saturation, more specifically the ratio between the concentration of oxyhemoqlobin and oxyhemoglobin plus reduced hemoqlobin.

FO2Hb: oxyhemoqlobin as a fraction of total hemoqlobin.

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

FMetHb: methemoglobin as a fraction of total hemoglobin.

FHHb: reduced hemoqlobin as a fraction of total hemoglobin.

Fraction of Fetal Hemoglobin (FHbF): FHbF indicates the amount of fetal hemoglobin. FHbF is seldom used clinically.

The ABL90 FLEX PLUS is a portable, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, chloride, glucose, lactate, neonatal bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO-Hb, FCOHb, FMetHb, FHHb and FHbF).

The manufacturer of the ABL90 FLEX PLUS is Radiometer Medical ApS.

The ABL90 FLEX PLUS consists of an instrument with a sensor cassette and a solution pack as the main accessories. Multiple models of sensor cassettes are available.

The various sensor cassette models for different parameter combinations. For each parameter combination, models allowing for different test load are available. The solution pack is available in two models differing in the number of tests available.

The provided text describes the ABL90 FLEX PLUS analyzer, an in vitro diagnostic device. The submission is for a design change to an existing device, the ABL90 FLEX, with the introduction of the ABL90 FLEX PLUS which includes a mechanized inlet module (AutoInlet) and a Short Probe Mode.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The core of the performance evaluation is a "Method comparison of ABL90 FLEX PLUS Short Probe mode versus ABL90 FLEX syringe mode with inlet clip" and "Imprecision" studies. The reported device performance is that all acceptance criteria were met.

Method Comparison Acceptance Criteria & Performance:

Imprecision Acceptance Criteria & Performance:

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

• Method Comparison Test Set: "more than 40 samples (N) per parameter"
• Data Provenance: Samples were "heparinized, leftover whole blood samples (analyzed 2-3 hours post draw)." The specific country of origin is not explicitly stated, but the submission is from Radiometer Medical ApS in Denmark, suggesting the study likely occurred in a European context or by their internal methods. The study is retrospective as it uses "leftover whole blood samples".

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

Not applicable to this type of in vitro diagnostic device and study. The ground truth for this device is based on measurements from a predicate device (ABL90 FLEX) or a reference instrument, not expert consensus.

4. Adjudication method for the test set

Not applicable. The study compares quantitative measurements between two devices, not subjective interpretations requiring adjudication.

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

Not applicable. This is an in vitro diagnostic device for quantitative measurements, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.

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

Yes, the performance studies described (Method Comparison and Imprecision) evaluate the standalone analytical performance of the ABL90 FLEX PLUS device (ABL90 FLEX PLUS Short Probe mode and ABL90 FLEX PLUS for imprecision). The comparisons are against a predicate device or reference instrument, not involving human interpretation.

7. The type of ground truth used

• Method Comparison: The predicate device, ABL90 FLEX syringe mode with inlet clip, served as the comparative "truth". The study assessed if the new ABL90 FLEX PLUS Short Probe mode yields equivalent results to this established method.
• Imprecision: "The total imprecision for all parameters except neonatal bilirubin was calculated as the imprecision of the bias towards a reference value determined for each sample on an ABL90 FLEX reference instrument." For neonatal bilirubin, the ground truth source is not explicitly defined beyond "aqueous solutions," but implies a known concentration.

8. The sample size for the training set

Not explicitly stated. For in vitro diagnostic devices, "training set" is not a standard term as it is in machine learning. The studies described are performance verification studies for a medical device. If there was an internal development phase for calibration or algorithm adjustment, that data is not detailed here.

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

Not applicable directly as this is not an ML/AI model with a "training set" in the conventional sense. For the performance studies, ground truth (or reference values) for comparison were established by:

• Method Comparison: Measurements from the predicate device (ABL90 FLEX syringe mode with inlet clip).
• Imprecision: Measurements on an "ABL90 FLEX reference instrument" for most parameters, and "aqueous solutions" for neonatal bilirubin (implying known concentrations).

Ask a specific question about this device

The ABL90 FLEX analyzer is an in vitro diagnostic, portable, automated analyzer that quantitatively measures neonatal bilirubin in heparinised capillary whole blood. The ABL90 FLEX analyzer is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order. Bilirubin measurements on the ABL90 FLEX analyzer are intended to aid in assessing the risk of kernicterus in neonates.

The ABL90 FLEX is a portable, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, chloride, glucose, lactate, neonatal bilirubin and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF). The ABL90 FLEX consists of an instrument with a sensor cassette and a solution pack as the main accessories. Multiple models of sensor cassettes are available. The various sensor cassette models for different parameter combinations. For each parameter combination, models allowing for different test load are available. The solution pack is available in one model. The ABL 90 FLEX electrochemical sensors are miniaturized, manufactured by film technology and integrated in a common sensor cassette. Likewise, the ABL90 FLEX optical oxygen sensor is integrated in the sensor cassette. A 256-pixel array spectrophotometer is used for the co-oximetry parameters and bilirubin.

Here's a breakdown of the acceptance criteria and study information for the ABL90 FLEX device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

• Capillary mode: Total %CV from 1.4% to 3.8%
• Syringe mode: Total %CV from 1.3% to 4.6%
  Spiked Adult Whole Blood (1-day pooled):
• Capillary mode: Total %CV from 1.6% to 14.0%
• Syringe mode: Total %CV from 1.0% to 8.7%
  Spiked Adult Whole Blood & Cord Blood (1-day lab):
• Capillary mode: Total %CV from 1.1% to 7.7% for adult, 0.9% to 7.4% for cord. |
  | Method Comparison (vs. Predicate ABL800 FLEX) | Good correlation with the predicate device and very good agreement between the two modes. | Syringe mode (pooled): Slope = 0.9903 (95% CI: 0.975-1.005), Intercept = 0.6574, R² = 0.9878
  Capillary mode (pooled): Slope = 0.9760 (95% CI: 0.961-0.991), Intercept = 0.7741, R² = 0.9861 |
  | Linearity | Linear over the entire measuring range and fulfills requirements for allowable error due to non-linearity. | Linear (first order) over the entire measuring range. R² = 0.9996 for Bilirubin: ABL90 vs. Sample Conc. |
  | Interference (Non-Significant) |

Ask a specific question about this device

The ABL90 FLEX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, and oximetry in heparinised whole blood. The ABL90 FLEX analyzer is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order.

Indications for use:

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

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

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

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

Chloride (cCl¯): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.

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

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

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

sO2: oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoqlobin plus reduced hemoglobin.

FO2Hb: oxyhemoqlobin as a fraction of total hemoglobin.

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

FMetHb: methemoqlobin as a fraction of total hemoglobin.

FHHb: reduced hemoglobin as a fraction of total hemoglobin.

Fraction of Fetal Hemoglobin (FHbF): FHbF indicates the amount of fetal hemoglobin. FHbF is seldom used clinically.

The ABL90 FLEX is a portable, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, chloride, glucose, lactate, and co-oximetry parameters (total hemoqlobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF).

This document describes modifications to the ABL90 FLEX device, specifically software changes to suppress glucose results under certain low pO2 conditions. The following is a summary of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The results are valid under the conditions that:

• all glucose results are suppressed when the pO2 level of the sample is below 10 mmHg.
• all glucose results are suppressed when pO2 level of the sample is between 10 mmHg and 25 mmHg and the glucose level is above 270 mg/dL.
  All acceptance criteria are met: Bias 90 mmHg | 18.1 | 0.1 | 0.7 | 4.1 | 240 |
  | Glu Mid $98.7 \pm 9 mg/dL$ | 10 mmHg | 101.7 | 1.1 | 3.8 | 3.7 | 240 |
  | | 30 mmHg | 101.0 | 0.7 | 3.3 | 3.3 | 240 |
  | | >90 mmHg | 101.2 | 0.5 | 3.3 | 3.2 | 240 |
  | Glu High $270 \pm 6 mg/dL$ | 10 mmHg | 254.1 | 1.6 | 10.8 | 4.2 | 240 |
  | | 30 mmHg | 262.3 | 1.1 | 8.8 | 3.4 | 240 |
  | | >90 mmHg | 271.9 | 1.7 | 7.4 | 2.7 | 240 | | Passed |
  | 48/Unacceptable bias on Glucose results obtained from samples with pO2 levels above 25 mmHg | (Covered by Interference Study) | (Covered by Interference Study) | (Covered by Interference Study) | Passed |
  | (General Performance) Method Comparison | Method comparison study versus a comparative analyzer (ABL735). | Slope: 0.9 - 1.1
  Intercept: 0
  Correlation Coefficient: ≥ 0.95 | Linear regression of the pooled data gives a slope of 0.9206, intercept of 0.084 and an R² ≥ 0.95. | Passed |

2. Sample Sizes and Data Provenance

Interference Study (Test Set):

• Sample Size:
  • 6 different pO2 levels (including a control at ≥90 mmHg)
  • 7 different glucose levels
  • 3 analyzers
  • 6 tests of each sample on each analyzer
  • 2 runs
  • Total: 1512 measurements
• Data Provenance: Fresh heparinized whole blood samples. The document does not specify the country of origin but implies an in-house study ("Radiometer Medical ApS"). The samples are likely prospective as they are "fresh heparinized whole blood samples" and "untreated donor samples in combination with spiked donor blood."

Precision Study (Test Set):

• Sample Size:
  • 20 days
  • 3 different pO2 levels
  • 3 different glucose levels
  • 2 tests of each sample each day
  • 2 runs
  • Total: 2160 measurements
• Data Provenance: Serum pool sample of glucose. The document does not specify the country of origin but implies an in-house study ("Radiometer Medical ApS"). likely prospective.

Method Comparison Study:

• Sample Size: A total of 52 different donors and approximately 500 samples.
• Data Provenance: In-house study using untreated donor samples in combination with spiked donor blood where necessary. Likely prospective.

3. Number of Experts and Qualifications for Ground Truth

The studies described are for an in vitro diagnostic device measuring blood analytes. The ground truth for such devices is typically established through a reference method or comparator device, not clinical expert consensus in the way image analysis or clinical diagnosis algorithms would.

• Interference Study: The ground truth for bias calculation was established by comparing results to a "control" pO2 level (≥90 mmHg). This relies on the established accuracy of the glucose measurement at optimal pO2.
• Precision Study: The ground truth is inherent in the known concentrations of glucose levels in the serum pool samples used.
• Method Comparison Study: The ground truth was established by comparison to results from a "comparative analyzer (ABL735)," which is a predicate device.

Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth in the context of clinical interpretation (e.g., radiologists for images) is not applicable here. The ground truth is based on laboratory-defined reference measurements or a well-established predicate device.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used for subjective assessments where multiple human readers disagree (e.g., interpreting medical images or clinical notes). This document describes performance studies for an in vitro diagnostic device, where results are quantitative measurements. Discrepancies would be resolved through re-testing, calibration, or investigation of instrument malfunction, not clinical adjudication by experts. Therefore, no formal adjudication method of this type is mentioned or expected.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for assessing the impact of AI on human reader performance, typically in diagnostic imaging or similar fields where human interpretation is central. This document focuses on the analytical performance of an in vitro diagnostic device, specifically the impact of a software modification on glucose measurement accuracy under certain pO2 conditions. The comparisons are between the device's results and reference methods/predicate devices, not between human readers with and without AI.

6. Standalone Performance

Yes, standalone performance was done. The entire submission describes the standalone analytical performance of the ABL90 FLEX device, particularly its glucose measurement under varying pO2 conditions, after the proposed software modification. The studies (Interference, Precision, Method Comparison) evaluate the device's inherent measurement capabilities and the impact of the software suppression logic without human intervention in the continuous measurement process. The modification itself involves the device automatically suppressing results based on pO2 and glucose levels.

7. Type of Ground Truth Used

• Interference Study: The ground truth for bias calculation was primarily reference measurements at optimal pO2 (≥90 mmHg) and the known concentrations of spiked glucose.
• Precision Study: The ground truth was based on the known concentrations of glucose in the serum pool samples used.
• Method Comparison Study: The ground truth was established through comparison with a predicate device (ABL735) and likely involved reference methods for its initial validation.

In essence, the ground truth for these analytical performance studies is rooted in established reference values, comparator devices, and controlled experimental conditions where "true" concentrations or performance characteristics are either known or determined by a validated reference standard.

8. Sample Size for the Training Set

The document does not explicitly state a separate "training set" sample size. This is common for analytical performance studies of this nature, especially when the modification is primarily a software rule change based on understanding of the underlying chemistry (glucose oxidase co-reaction with oxygen). The "training" in such cases might involve development and initial testing against known samples to define the suppression rules, which is not typically formalized as a distinct "training set" in the context of a 510(k) submission for IVDs. The "test set" described above (1512 measurements for interference, 2160 for precision) serves as the primary validation data.

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

As noted above, a formal "training set" with ground truth establishment in the machine learning sense is not explicitly described or necessarily applicable here. The software modification (suppression rules) likely emerged from:

• Understanding of the underlying scientific principle: The document states, "The linearity of the glucose is dependent on the oxygen tension of the sample. This dependence is due to the co-reaction of glucose and oxygen by the enzyme glucose oxidase." This foundational knowledge guides the need for suppression.
• Prior internal R&D data/experiments: Radiometer would have conducted extensive internal studies to characterize the glucose sensor's performance across various pO2 and glucose concentrations to determine the thresholds (e.g., 270 mg/dL) at which accuracy is compromised. This data, if it exists, would have informed the development of the suppression logic.

Therefore, the "ground truth" for developing these rules would be based on analytical measurements from controlled experiments using samples with known glucose and pO2 concentrations, helping to define the performance boundaries.

Ask a specific question about this device

The ABL90 FLEX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, and oximetry in heparinised whole blood. The ABL90 FLEX analyzer is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order.

Indications for use:
pH, pO2 and pCO2: pH, pCO2 and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Potassium (cK+): potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
Sodium (cNa+): sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
Calcium (cCa2+): calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
Chloride (cCl-): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.
Glucose (cGlu): glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Lactate (cLac): The lactate measurements measure the concentration of lactate in plasma. Lactate measurements are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood.)
Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.
sO2: oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoglobin.
FO2Hb: oxyhemoglobin as a fraction of total hemoglobin.
FCOHb: carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.
FMetHb: methemoglobin as a fraction of total hemoglobin.
FHHb: reduced hemoglobin as a fraction of total hemoglobin.
Fraction of Fetal Hemoglobin (FHbF): FHbF indicates the amount of fetal hemoglobin. FHbF is seldom used clinically.

The ABL90 FLEX is a portable, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2 , pCO2, potassium, sodium, chloride, glucose, lactate, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, F MetHb, FHHb and FHbF).
The modification consists of Data Management software called AQURE system. The software enables display of test results, receivable of data from connected devices at the point-of-care or laboratory, transfer of test results to the HIS/LIS and initiation of device actions.

This document describes the software modification (AQURE system) for the ABL90 FLEX device, rather than a new device or a clinical study evaluating its performance. The bulk of the text focuses on demonstrating substantial equivalence to previously cleared devices.

Therefore, the requested information regarding acceptance criteria, sample sizes, expert involvement, and comparative effectiveness studies is not available in the provided text. The document explicitly states:

"No performance characteristics are affected by the change. The performance data submitted in the original submission (K092686) still apply."

This means that a new study to prove the device meets acceptance criteria for its clinical performance was not conducted, as the modification was to the data management software and not the core measurement capabilities of the ABL90 FLEX analyzer. The submission relies on the performance data of the predicate devices.

Ask a specific question about this device

The ABL90 FLEX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, and oximetry in heparinised whole blood. The ABL90 FLEX analyzer is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order.

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

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

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

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

Chloride (cCI): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.

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

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

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

sO2: oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoglobin.

FO2Hb: oxyhemoglobin as a fraction of total hemoglobin.

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

FMetHb: methemoglobin as a fraction of total hemoglobin.

FHHb: reduced hemoglobin as a fraction of total hemoglobin.

Fraction of Fetal Hemoglobin (FHbF): FHbF indicates the amount of fetal hemoglobin. FHbF is seldom used clinically.

The ABL90 FLEX is a portable, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2 , pCO2, potassium, sodium, calcium, chloride, glucose, lactate, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF).

The change consists of an update to the Intralipid correction algorithm for Oxi parameters. The purpose of this update is to improve the suppression of Intralipid interference.

Here's a breakdown of the acceptance criteria and the study details for the ABL90 Flex with the improved Intralipid correction algorithm, extracted from the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Test Set Size: "between 76 and 282 samples per parameter spanning the measuring range."
   • Data Provenance: "In-house method comparison study" and "existing performance verification data obtained in-house." This suggests the data was generated internally by Radiometer Medical ApS, likely in Denmark. The data is prospective in nature as it's a verification study against a new algorithm.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications: Not explicitly stated. The study references "medical decision points" and "existing claims" but does not detail the involvement or qualifications of experts in establishing the ground truth for these.

3. Adjudication Method for the Test Set: Not explicitly stated. Given that the study compared the "new algorithm" against the "previous algorithm" and "existing claims," it implies a comparison to a established reference, but the method of adjudication (e.g., expert consensus) for that reference is not detailed.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. The study focuses on the analytical performance of the device's algorithm.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study: Yes, this appears to be a standalone (algorithm only) performance study. The focus is on the performance of the "Improved Intralipid correction algorithm for Oxi parameters" and its impact on measurements, without human interaction with the algorithm's output as part of the primary evaluation.

6. Type of Ground Truth Used: The ground truth used for performance evaluation was based on the "previous algorithm" (predicate device's algorithm) and "existing claims" for analytical performance (bias, imprecision, linearity, LOQ). This can be categorized as a comparative analytical truth against a previously validated method, rather than a clinical ground truth like pathology or patient outcomes.

7. Sample Size for the Training Set: Not explicitly stated. The document describes a "new correction" and an "improved Intralipid correction algorithm," implying development and training, but the sample size used for this training is not provided in this 510(k) summary.

8. How the Ground Truth for the Training Set Was Established: Not explicitly stated. The document describes the verification of the new algorithm against the old one and existing claims, but it does not detail how the ground truth was established for the training of the new algorithm itself.

Ask a specific question about this device

The ABL90 FLEX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, and oximetry in heparinised whole blood. The ABL90 FLEX analyzer is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order.

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

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

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

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

Chloride (cCl¯): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.

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

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

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

sO2: oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoglobin.

FO2Hb: oxyhemoglobin as a fraction of total hemoglobin.

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

FMetHb: methemoglobin as a fraction of total hemoglobin.

FHHb: reduced hemoglobin as a fraction of total hemoglobin.

Fraction of Fetal Hemoglobin (FHbF): FHbF indicates the amount of fetal hemoglobin. FHbF is seldom used clinically.

The ABL90 FLEX is a portable, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2 , pCO2, potassium, sodium, calcium, chloride, glucose, lactate, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, F MetHb, FHHb and FHbF).

The labelling and the software has been modified to assure that the Operator does not use qlucose results obtained from samples with a pO2 level below 25 mmHg.

This document describes a Special 510(k) submission for a device modification to the ABL90 Flex, specifically related to the suppression of cGlu (glucose) results when pO2 levels are below 25 mmHg.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The table provided in the input shows specific bias percentages for different cGlu and pO2 levels in a separate "Testing results summary" section. I have extracted the overall "Meet the acceptance criteria or not?" statement for the acceptance table as it represents the final determination.

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

• Sample Size: The interference study involved:
  • 5-7 different pO2 levels
  • 5 different glucose levels
  • 10 analyzers
  • 5 tests of each sample on each analyzer
  • 3 runs
  • Total of 3150 measurements.
• Data Provenance: The study used "fresh heparinized samples." The document does not specify the country of origin of the data, but the submitter is Radiometer Medical ApS, located in Denmark. It is a prospective study as it describes validations and verifications activities, including an "Interference study."

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

Not applicable. This study does not involve human readers or experts establishing ground truth in the traditional sense of medical image analysis. The ground truth for the glucose measurements is established by a "reference method" as indicated by the acceptance criteria "compared to the reference method." The qualifications of those performing the reference method measurements are not specified.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers with potential disagreements requiring adjudication. The direct comparison is between the device's measurement and a reference method.

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

Not applicable. This is not an MRMC comparative effectiveness study and does not involve AI assistance for human readers. The modification is a software change to suppress glucose results under certain conditions to ensure accuracy.

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

Yes, a standalone study (interference study) was done to evaluate the performance of the device's glucose measurement algorithm under varying pO2 and glucose levels. The software modification itself (suppression of results) is an algorithm-only function.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device's performance was a reference method for glucose measurement. The specific nature of this reference method (e.g., a laboratory gold standard instrument) is not detailed in the provided text.

8. The Sample Size for the Training Set

Not applicable. This document describes a modification to an existing device and its verification, not the development or training of a new algorithm. The term "training set" is usually associated with machine learning models. The study described here is an interference study to validate a device modification.

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

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

Ask a specific question about this device

The ABL90 FLEX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, and oximetry in heparinised whole blood. The ABL90 FLEX analyzer is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order.

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

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

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

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

Chloride (cCI¯): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.

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

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

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

sO2: oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoqlobin.

FO2Hb: oxyhemoglobin as a fraction of total hemoglobin.

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

FMetHb: methemoglobin as a fraction of total hemoglobin.

FHHb: reduced hemoglobin as a fraction of total hemoglobin.

Fraction of Fetal Hemoglobin (FHbF): FHbF indicates the amount of fetal hemoglobin. FHbF is seldom used clinically.

The ABL90 FLEX is a portable, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2 , pCO2, potassium, sodium, chloride, glucose, lactate, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, F MetHb, FHHb and FHbF).

The implementation of the WiFi option allows wireless functionality for establishing network connectivity; all of which is supported by wired LAN connection in the existing application.

Here's an analysis of the provided text regarding the ABL90 Flex device modification for WiFi, structured to address your specific questions.

Acceptance Criteria and Study for ABL90 Flex - WiFi Modification

The submission pertains to a Special 510(k) for a device modification, specifically adding WiFi functionality to the existing ABL90 Flex. A key assertion in such submissions is that the modification does not affect the core performance characteristics of the previously cleared device. Therefore, the "acceptance criteria" and "device performance" in this context refer to the performance characteristics of the original ABL90 Flex, which the modified device is claimed to still meet.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a special 510(k) for a modification (WiFi functionality), the acceptance criteria are implicitly that the addition of WiFi does not degrade or alter the performance characteristics of the existing device's measurements. The reported device performance is that these performance characteristics remain unchanged.

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

The document explicitly states: "No performance characteristics are affected by the change. The performance data submitted in the original submission (K092686) still apply."

This indicates that no new performance studies were conducted specifically for the WiFi modification to generate a new "test set" for measurement performance. The evidence relies on the existing performance data of the predicate device (K092686).

• Sample Size for Test Set: Not applicable for new performance data related to the WiFi modification, as existing data is referenced. The sample size for the original ABL90 Flex (K092686) performance studies would be relevant but is not provided in this submission summary.
• Data Provenance: Not applicable for new performance data related to the WiFi modification. The provenance for the original ABL90 Flex performance data (K092686) is not detailed in this submission summary.

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

Again, because no new performance studies are detailed for the WiFi modification, this information is not provided in the submission. The ground truth for the original ABL90 Flex (K092686) performance studies would have been established, but details are not present here.

4. Adjudication Method for the Test Set

Not applicable, as no new performance studies with specific test sets requiring adjudication were conducted for the WiFi modification.

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

No. This type of study is typically performed for diagnostic imaging devices where human interpretation plays a significant role. The ABL90 Flex is an automated analytical instrument where the output is numerical measurements, not subjective human interpretation.

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

Yes, in essence. The ABL90 Flex is an automated analytical device. Its performance, as referenced from the original 510(k) (K092686), is inherently "standalone" in that it performs measurements without real-time human intervention affecting the measurement process itself. The modification (WiFi) is a connectivity feature and does not alter the core analytical algorithm or measurement capabilities.

7. The type of Ground Truth Used

For the core analytical measurements of the ABL90 Flex (pH, pO₂, electrolytes, glucose, etc.), the ground truth would typically be established through:

• Reference Methods: Highly accurate and precise laboratory methods considered the "gold standard" for specific analytes.
• Calibrated Reference Materials: Using certified reference materials or calibrators with known concentrations.
• Interlaboratory Comparison: Comparing results against other established and validated analytical devices or laboratories.

However, the specific details for the original ABL90 Flex (K092686) are not provided in this document.

8. The Sample Size for the Training Set

Not applicable. The ABL90 Flex is a chemical analyzer, not a machine learning or AI-based device that requires a "training set" in the conventional sense. Its "training" or calibration involves using specific calibrant solutions according to established protocols.

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

Not applicable, as there is no "training set" in the context of machine learning for this device. The calibration process involves using commercially available or internally prepared calibrants with known, traceable values (ground truth) to adjust the instrument's response.

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