Search Results

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.

Ask a specific question about this device

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The document mentions several types of performance studies:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

Ask a specific question about this device

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

3

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

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

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

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

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

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

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

The document explicitly states:

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

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

Ask a specific question about this device

The Stat Profile® Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of Hematocrit, Oxygen Saturation, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin in heparinized arterial and venous whole blood.

The Stat Profile Prime Plus Analyzer System is a low cost, low maintenance analyzer for hospital laboratory and point-of-care settings. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).

The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed.

As with the predicate, the Stat Profile Prime Plus Analyzer is a blood gas, co-oximetry, electrolyte, chemistry, and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control is available, as well as an on-board Quality Management System (QMS), and an electronic monitoring approach that insures the analyzer is working properly at all times.

The Stat Profile Prime Plus Analyzer accepts samples from syringes and open tubes. The minimum sample size for analysis is 135 µL.

Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.

The provided text describes the performance validation of the Stat Profile® Prime Plus Analyzer System, specifically focusing on its point-of-care (POC) capabilities and comparability to a predicate device. This is a medical device, not an AI/ML software. Therefore, many of the requested categories related to AI/ML software development (e.g., number of experts for ground truth, adjudication method, MRMC studies, training set details) are not applicable to this document.

However, I can extract information related to the device's acceptance criteria and how its performance was proven.

Here's the breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating "substantial equivalence" to the predicate device and by meeting established criteria for method comparison and imprecision, based on CLSI guidelines. The performance data is presented as method comparison statistics (slope, intercept, r-value) and total imprecision (SD, %CV).

Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria thresholds for each parameter prior to the results. Instead, it presents the quantitative results from the study and concludes that these results "confirmed that the performance of the Stat Profile Prime Plus Analyzer System is substantially equivalent to that of the Nova Stat Profile pHOx Ultra Analyzer System (predicate device)."

Therefore, I will present the reported device performance, and the implicit acceptance can be inferred as meeting industry standards for substantial equivalence in medical devices of this type.

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Method Comparison (POC vs. Lab):
    • Hct: 417 samples
    • SO2: 398 samples
    • tHb: 416 samples
    • O2Hb: 422 samples
    • COHb: 425 samples
    • MetHb: 437 samples
    • HHb: 322 samples
  • Total Imprecision Performance: 20 runs performed on 3 analyzers, using 3 levels of quality control/linearity materials.
  • Within-Run Whole Blood Precision: Minimum of 2 operators per site across 3 POC sites (total 9 operators). Each precision run consisted of 10 replicate measurements using 7 different whole blood samples (5 native, 2 altered).
• Data Provenance: The study was conducted in the United States, across three Point-of-Care (POC) sites: a Cardiothoracic Intensive Care Unit (CTICU), an Emergency Department (ED), and a Respiratory Therapy Lab (RT). The data utilized a mix of quality control materials and discarded blood gas specimens. This suggests prospective collection of real-world samples within a clinical setting.

3. Number of Experts and Qualifications for Ground Truth

• This device is a medical diagnostic instrument, not an AI/ML algorithm. Ground truth for the method comparison study was established by laboratory measurements (presumably using the established predicate device or a gold standard lab method) which the new device's results were compared against.
• The study involved "trained Healthcare Professionals" and "POC personnel". These personnel performed the tests on the new device. Their qualifications are described as "trained, qualified staff found in typical POC sites where blood gas analyzers are utilized," including Respiratory Care, Nursing, and Exercise Physiology personnel. No "experts" in the sense of adjudicating image interpretations are mentioned, as this is not an imaging AI.

4. Adjudication Method for the Test Set

• Not applicable. This is a quantitative measurement device, not an interpretive one requiring expert adjudication. The comparison was quantitative against a reference method.

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

• Not applicable. This is a quantitative measurement device, not an AI-assisted diagnostic tool that would be evaluated for human reader improvement. The study compares the new device's performance to a predicate device and laboratory methods.

6. Standalone Performance

• Yes, effectively. The "Stat Profile® Prime Plus Analyzer System" provides quantitative measurements. The performance data presented (Method Comparison, Total Imprecision, Within-Run Whole Blood Precision) represents the standalone performance of the device in generating these measurements, compared against established laboratory methods or statistical precision targets. There is no "human-in-the-loop" performance as the human simply operates the device to obtain the measurement.

7. Type of Ground Truth Used

• Comparative ("Reference") Method: For the method comparison study, the ground truth was the results obtained from analyses performed by "Lab" (laboratory reference methods, presumably the predicate device or another validated laboratory analyzer). This is a comparative ground truth against an established standard.
• Statistical Targets: For precision studies, the ground truth is implicitly defined by the acceptable statistical variance and bias from the mean of repeated measurements, often against known control material values.

8. Sample Size for the Training Set

• Not applicable. This is a physical, chemical, and optical measurement device, not a machine learning model that requires a "training set" in the computational sense. The device's measurement algorithms are fixed based on spectrophotometric and impedance principles.

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

• Not applicable, as there is no "training set" for an AI/ML model for this device. The principles of measurement are based on established scientific methods (e.g., spectrophotometry and impedance) and not trained on data in the AI/ML sense.

Ask a specific question about this device

The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings for quantitative determination of Hematocrit, Oxygen Saturation, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin, in heparinized arterial and venous whole blood.

The Stat Profile Prime Plus Analyzer System is designed to be a low cost, low maintenance analyzer for the hospital laboratory setting. It consists of the analyzer, sensor cartridges, calibrator packs, auto-cartridge quality control packs (internal controls), ampuled quality control materials (external controls) and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).

The system architecture and user interface for this proposed device is based on the previously cleared Stat Profile Prime CCS Analyzer System (K131703). The predicate for this proposed device is the Stat Profile pHOx Ultra Analyzer System (K110648).

The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed. The reporting of CO-Oximeter parameters (or not reporting them) will also be determined by the selection of the Sensor Cards.

Similar to the predicate device, the Stat Profile Prime Plus Analyzer is a blood gas/cooximetry/electrolyte/chemistry and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control will be used, as well as an on-board Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly at all times.

The Stat Profile Prime Plus Analyzer accepts samples from syringes, and small cups. The minimum sample size for analysis is 135 µL.

Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.

The provided text describes the Nova Stat Profile Prime Plus Analyzer System, an in vitro diagnostic device. This document is a 510(k) summary submitted to the FDA, detailing the device's substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The general acceptance criteria for "Method Comparison Studies" is that "The blood comparison data for Hematocrit, Oxygen Saturation, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin for the Stat Profile Prime Plus analyzers meet the acceptance criteria." Specific numerical acceptance criteria are not explicitly detailed in the provided text, but the study concluded that the device did meet them.

Similarly, for "Precision/Reproducibility," the text states: "The precision data for all parameters meet the within run imprecision specifications for the Stat Profile Prime Plus analyzers." and "The precision data for all parameters meet the between analyzer run to run imprecision specifications for the Stat Profile Prime Plus analyzers." No specific numerical targets for imprecision are given.

For "Linearity Testing", the conclusion is: "The linearity comparison data for all parameters for the Stat Profile Prime Plus analyzers shows good correlation and linearity to the reference analyzers across the claimed measurement range for all parameters and met the acceptance criteria."

The table below summarizes the claimed measurement ranges, which serve as a form of acceptance criteria for the operational limits of the device. The reported performance is a general statement that the device meets "the acceptance criteria."

Note on "Reported Device Performance": The document states that the studies "meet the acceptance criteria." It does not provide specific numerical results or performance metrics (e.g., bias, CV%) for the Nova Stat Profile Prime Plus Analyzer System itself, but rather confirms that its performance is equivalent to the predicate and within acceptable ranges.

Study Information:

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

   • Method Comparison Studies: The study compared the Stat Profile Prime Plus to the Nova Stat Profile pHOx Ultra analyzer using an unspecified number of "heparinized whole blood" samples. The provenance of this blood data (country, retrospective/prospective) is not specified.
   • Precision/Reproducibility - Within Run and Run to Run Studies:
     • Within Run Precision: "one run of each of the following sample types and levels was performed, 20 replicates per run." Sample types included: Stat Profile Prime Plus Internal Controls (Levels 1-5), Stat Profile Prime Plus Ampuled Controls (Levels 1-5), and "Two whole bloods, sampled from syringes."
     • Run to Run Precision: "triplicate analyses were performed on a single whole blood sample in ten separate runs during a single day."
     • The provenance of these whole blood samples (country, retrospective/prospective) is not specified.
   • Linearity Testing: Used "whole blood" to establish/verify the Analytical Measurement Range (AMR). The number of samples is not specified. Provenance is not specified.
   • Specificity / Interference Testing: "whole blood collected in lithium heparin vacutainers." The number of samples for screening or dose-response is not specified. Provenance is not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is an in vitro diagnostic analyzer that measures objective chemical and physiological parameters in blood samples, not image interpretation or diagnosis by experts. The "ground truth" for the performance studies would be established by the reference methods (e.g., the predicate device or other highly accurate laboratory methods) against which the new device's measurements are compared.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used in studies involving subjective interpretation (e.g., by experts) to reach a consensus for ground truth. This is a device measuring objective parameters.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device requiring human interpretation; it directly measures parameters.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The studies described (Method Comparison, Precision, Linearity, Interference) assess the standalone performance of the device's measurement capabilities. The device is designed to provide quantitative measurements and does not involve a human-in-the-loop for interpreting its direct output in the way an AI diagnostic tool might.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance studies appears to be:

   • Method Comparison: Measurements from the legally marketed predicate device (Stat Profile pHOx Ultra analyzer) served as the reference.
   • Precision: Internal controls, ampuled controls, and whole blood samples with expected values.
   • Linearity: Comparison against a "reference analyzer and/or the product specifications."
   • Specificity/Interference: Comparison of measurements with and without potential interfering substances.

7. The sample size for the training set: Not applicable. This device does not appear to employ machine learning algorithms that require a separate "training set" in the conventional sense. Its principles of measurement are based on established spectrophotometric and impedance sensor technologies.

8. How the ground truth for the training set was established: Not applicable, as there is no mention of a machine learning training set. The device's underlying principles are based on known physical and chemical measurement techniques.

Ask a specific question about this device

The GEM Premier 5000 is a portable critical care system for use by health care professionals to rapidly analyze heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of Hematocrit and Total Hemoglobin from venous and arterial heparinized whole blood, as well as quantitative measurements of O2Hb. COHb. MetHb. HHb. sO2 from venous, arterial and capillary heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's oxygen delivery capacity.

• Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).
• Total Hemoglobin (tHb): Total hemoglobin measure the hemoglobin content of whole blood for the detection of anemia.
• · COHb: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.
• · MetHb: Methemoglobin measurements are used to determine different conditions of methemoglobinemia.

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

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

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

The GEM Premier 5000 system provides health care professionals in central laboratory or point-of-care clinical settings with fast, accurate, quantitative measurements of Hematocrit and Total Hemoglobin from venous and arterial heparinized whole blood, as well as quantitative measurements of O₂Hb, COHb, MetHb, HHb, sO2 from venous, arterial and capillary heparinized whole blood.

Key Components:
Analyzer: Employs a unique color touch screen and a simple set of menus and buttons for user interaction. The analyzer guides operators through the sampling process with simple, clear messages and prompts.
GEM Premier 5000 PAK (disposable, multi-use GEM PAK): Houses all required components necessary to operate the instrument once the cartridge is validated. These components include the sensors, CO-Ox optical cell, Process Control (PC) Solutions, sampler, pump tubing, distribution valve and waste bag. The GEM PAK has flexible menus and test volume options to assist facilities in maximizing efficiency. NOTE: The EEPROM on the GEM PAK includes all solution values and controls the analyte menu and number of tests.
Intelligent Quality Management 2 (iQM2): iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions. iQM2 is a statistical process control system that performs 5 types of continuous, quality checks to monitor the performance of the GEM PAK, sensors, CO-Ox, and reagents. These checks include System.

The provided text describes the GEM Premier 5000, a portable critical care system for analyzing heparinized whole blood samples. It focuses on the device's technical specifications and performance studies to demonstrate substantial equivalence to a predicate device (GEM Premier 4000) for Hematocrit and CO-Oximetry measurements.

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

The document does not explicitly state "acceptance criteria" for precision or method comparison studies in a single table with target values. Instead, it presents the "Within Analyzer SD/CV" and "Total SD/CV" or "Bias" for various analytes and compares them to specifications which are indirectly implied to be the acceptance criteria. For the purpose of this response, I will interpret "SD/CV Spec" as the acceptance criteria for reproducibility and "Medical Decision Levels" with a calculated "Total Error Observed" compared to an unstated "GEM Premier 5000 Total Error Specifications" as acceptance criteria for accuracy.

Here's a table summarizing the reported device performance based on the precision and method comparison studies:

Table 1: Summary of Device Performance against Implicit Criteria

Note: For the Total Error Observed, the document states these were compared to "GEM Premier 5000 Total Error Specifications," but these specifications are not explicitly provided in the text for all analytes. However, for capillary clinical testing, specific TEa values are given for some analytes, which are used here as proxies for acceptance criteria where available.

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

• Internal Precision Study (Aqueous Controls):
  • Sample Size: 120 per analyte/level (3 analyzers, 20 days, 2 runs/day, 1 replicate/run).
  • Data Provenance: Internal study (Instrumentation Laboratory Co.), prospective.
• Internal Precision Study (GEM PAK Process Control Solutions):
  • Sample Size: 120 per analyte/level (3 analyzers, 20 days, 2 runs/day, 1 replicate/run).
  • Data Provenance: Internal study (Instrumentation Laboratory Co.), prospective.
• Internal Precision Study (Whole Blood):
  • Sample Size: 120 per analyte/sample mode (3 analyzers, 5 days, 1 run/day, 8 replicates/run).
  • Data Provenance: Internal study (Instrumentation Laboratory Co.), prospective. Origin of whole blood samples likely internal or procured, not specified by country.
• Reproducibility Study (Aqueous Controls – Point-of-Care (POC) Setting):
  • Sample Size: 90 per analyte/level (3 external POC sites, 3 different GEM Premier 5000 instruments, triplicate measurements, twice a day, total 30 replicates per level, pooled).
  • Data Provenance: External clinical POC settings, prospective. Country of origin not specified, but likely USA based on the FDA submission.
• External Precision (Whole Blood - Central Lab and POC settings):
  • Sample Size: Varies by analyte and site (e.g., Hct Normal Mode POC-All N=126, CSL N=36, Lab1 N=30, Lab2 N=30). The overall study involved multiple whole blood specimens (at least two per day) analyzed in triplicate daily for 5 days.
  • Data Provenance: 2 external central laboratories, 1 internal Customer Simulation Laboratory (CSL), and 3 external POC locations. Prospective, "contrived whole blood specimens were analyzed in addition to native specimens" in the CSL. Country of origin not specified, but likely USA based on the FDA submission.
• Analytical Specificity (Interference Study):
  • Sample Size: Not explicitly stated as a single "test set" size for all substances, but experiments were conducted with various concentrations of interfering substances.
  • Data Provenance: Internal study (Instrumentation Laboratory Co.), prospective.
• Internal Method Comparison (Clinical Samples):
  • Sample Size: Varies by analyte (N=376 for Hct, N=373 for O2Hb, etc.).
  • Data Provenance: Clinical samples (heparinized whole blood) altered as needed to cover medical decision levels. Internal study, retrospective/prospective hybrid (samples altered to cover ranges).
• Clinical Testing (Point-of-Care Setting - Normal Mode):
  • Sample Size: Varies by analyte (e.g., N=490 for Hct, N=485 for COHb).
  • Data Provenance: Three (3) external point-of-care (POC) sites and one (1) internal Customer Simulation Laboratory (CSL) at IL. Heparinized whole blood patient samples from the intended use population. Samples spiked in CSL to cover reportable ranges. Provenance likely USA, prospective.
• Clinical Testing (Capillary Samples):
  • Sample Size: Native capillary samples: N=52 (external POC), N=100 (IL CSL) for a total of 152 native samples for O2Hb, HHb, sO2. Total N becomes 180-182 when pooled with additional internally prepared contrived capillary samples for specific analytes (pages 29-30).
  • Data Provenance: One external POC site and the IL internal Customer Simulation Laboratory (CSL). Native finger-stick samples and contrived capillary samples. Provenance likely USA, prospective.

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)

The document relates to an in-vitro diagnostic device measuring blood parameters. Ground truth in this context is typically established by comparative measurements against a recognized reference method or a predicate device, not by expert consensus in the same way an imaging AI would use expert radiologist reads.

For the Internal Method Comparison and Clinical Testing studies, the GEM Premier 5000 was compared to the predicate device, the GEM Premier 4000. The predicate device itself serves as the "reference standard" or "ground truth" for demonstrating substantial equivalence. The document does not specify human experts establishing ground truth for the test set; rather, the predicate device and established analytical methods (e.g., CNMetHb procedure - CLSI H15-A3 for tHb) are used as comparators.

The Linearity study also mentions comparing results to "reference analyzers or standard reference procedures (i.e. CNMetHb procedure - CLSI H15-A3 for tHb)".

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

Not applicable for this type of in-vitro diagnostic device. "Adjudication" typically refers to the process of resolving discrepancies between human readers or between human readers and an AI output, especially in imaging studies where subjective interpretation is involved. For this device, ground truth is established through quantitative comparisons against established reference methods or a predicate device.

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 that provides quantitative measurements of blood parameters, not an AI-based imaging or diagnostic aid that assists human readers/clinicians in interpretation. Therefore, no MRMC study or assessment of human reader improvement with/without AI assistance was conducted or would be relevant.

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

Yes, the studies presented evaluate the performance of the device itself in a standalone capacity. The GEM Premier 5000 provides quantitative measurements directly. Operators interact with the device to load samples and retrieve results, but the analytical process and result generation are entirely performed by the instrument's internal "algorithm" (i.e., its measurement and data processing capabilities).

The device description on page 5 highlights its autonomy:

• "The analyzer guides operators through the sampling process with simple, clear messages and prompts."
• "After inserting the GEM PAK, the instrument will perform an automated PAK warm-up..."
• "Auto PAK Validation (APV) process is automatically completed..."
• "iQM2 manages the quality control process, replacing external quality controls."

This indicates that the device operates autonomously for its core measurements, with human intervention for sample loading and result review, but not for interpreting the raw measurement signals.

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

The ground truth for the performance studies was established through:

• Comparison to a Legally Marketed Predicate Device: The GEM Premier 4000 served as the primary comparator for method comparison studies, demonstrating substantial equivalence.
• Standard Reference Procedures/Analyzers: For linearity studies and potentially for other analytical performance aspects, comparison to "reference analyzers or standard reference procedures (i.e. CNMetHb procedure - CLSI H15-A3 for tHb)" was used.
• Certified Control Materials: Aqueous controls and GEM PAK Process Control Solutions that are "traceable to NIST standards, CLSI procedures or internal standards" were used for precision and reproducibility studies. These materials have known, certified values which serve as ground truth for assessing device accuracy and precision.

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of machine learning or AI algorithms as the primary focus is on proving the analytical performance of an in-vitro diagnostic instrument through traditional analytical validation studies (precision, linearity, method comparison, etc.).

However, the device incorporates "Intelligent Quality Management 2 (iQM2)" which is described as "an active quality process control program designed to provide continuous monitoring of the analytical process... with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions." While iQM2 itself would have been developed and "trained" or calibrated using extensive internal data during the device's R&D phase, the public 510(k) summary does not provide details on a specific training set size for the iQM2 component. The studies presented are for the validation of the final device's performance, not the internal development of iQM2.

The "internal precision study" and "internal method comparison" are validation studies of the final device. The data shown in these tables is for testing the device's performance, not training it.

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

As noted in point 8, a "training set" in the context of typical AI/ML models is not explicitly described or relevant for the approval justification in this 510(k) summary. The document validates the measurement accuracy and precision of the device against predicate devices and reference methods, not an AI model that learns from data in the field.

If "training set" refers to the data used to initially calibrate the instrument's sensors and algorithms during development, this ground truth would have been established through:

• Primary Reference Methods: Employing highly accurate and precise laboratory methods (e.g., gas chromatography, certified spectrophotometric methods, gravimetric/volumetric methods) to determine the true concentration of analytes in reference materials and clinical samples.
• Reference Materials/Standards: Calibrating the device using NIST-traceable standards and other certified reference materials with known analyte concentrations.
• Extensive Internal Testing and Optimization: Using a large array of characterized samples (e.g., blood samples with varying analyte concentrations, interfering substances) to optimize the device's measurement algorithms and ensure accurate performance across its claimed reportable range.

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 GEM® Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCQ2, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb. OHb. COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions. Iiver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates. the level of total bilirubin is used to aid in assessing the risk of kernicterus.

Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier 4000 system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls. Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed.

As part of this program, GEM CVP (Calibration Valuation Product) with CO-Ox, GEM CVP tBili and GEM CVP Hematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration following warm-up. The reported values for GEM CVP (two levels for pH, blood gases, electrolytes, total bilirubin, CO-Oximetry and hematocrit) must meet IL's specifications before the iQM cartridge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iQM program monitors the status of the system during the cartridge use life.

The GEM® Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCQ2, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb. OHb. COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions. Iiver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates. the level of total bilirubin is used to aid in assessing the risk of kernicterus.

Software V3.0.0 introduces the following new functionality to further improve the service and support of the GEM® Premier 4000: Remote desktop sharing, Remote software upgrades, Remote diagnostics, Remote LIS tracing, Remote cartridge data (Copy IL Data) transfer.

Here's an analysis of the provided text regarding the GEM® Premier 4000 device, focusing on the acceptance criteria and study information:

Key Finding: This submission (K133407) is a Special 510(k) for a software modification only. It asserts that the modifications have no impact on the performance of the device and therefore, the performance data from the predicate device (K112995) still applies. As such, the document does not contain new acceptance criteria or new study data to demonstrate the device meets acceptance criteria for its analytical performance. It focuses on the verification and validation of the new software features.

Given this, I will extract information related to the device's original performance as described, but it's important to note that this document doesn't provide new studies for analytical performance.

Acceptance Criteria and Device Performance (Based on Predicate Device K112995)

Since this K133407 submission is a modification of a previously cleared device (K112995) and claims "Identical Performance Characteristics" and that the software changes "have no impact to the performance," the acceptance criteria and reported device performance are implicitly those established and accepted for the predicate device. However, this document does not explicitly list performance acceptance criteria or detailed performance reports for the analytes.

The document states:

• "The reported values for GEM CVP (two levels for pH, blood gases, electrolytes, total bilirubin, CO-Oximetry and hematocrit) must meet IL's specifications before the iQM cartridge can be used for patient sample measurements." This indicates that IL (Instrumentation Laboratory) has internal specifications that must be met for quality control (GEM CVP) to ensure accuracy.

Therefore, a table of acceptance criteria and reported device performance for the analytes cannot be fully created from this document. The document specifically states that "the performance data on record for the predicate device (K112995) still apply." To find the detailed acceptance criteria and performance, one would need to refer to the K112995 submission.

Study Details (for the K133407 Software Modification)

This special 510(k) focuses on the software modification and its impact, not on the analytical performance of the device.

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

   • Test set for analytical performance: Not applicable for this submission, as full analytical performance studies were not conducted. The submission states that the software changes have no impact on analytical performance, so the performance data of the predicate device (K112995) is referenced.
   • Test set for software verification/validation: The document mentions "design control principles (risk management, verification and validation) have been applied," but it does not specify sample sizes or data provenance for the software testing.

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

   • Not applicable for a software modification submission. No human expert "ground truth" was established for analytical performance in this specific document.

3. Adjudication method for the test set:

   • Not applicable.

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

   • Not applicable. This device is an automated in vitro diagnostic analyzer, not an AI-assisted diagnostic imaging or interpretation tool for human readers.

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

   • The "standalone" performance of the analytical functions refers to the predicate device K112995. This submission K133407 focuses on software features (remote desktop sharing, remote upgrades, remote diagnostics, remote LIS tracing, remote cartridge data transfer) that improve service and support, not the core analytical algorithm's standalone performance.

6. The type of ground truth used:

   • For the analytical performance (referenced from K112995), the ground truth for blood gas, electrolyte, and metabolite measurements in IVDs typically involves reference methods, calibrated standards, or comparative studies against established laboratory instruments using patient samples. This document does not specify the type of ground truth used for the original analytical performance.
   • For the software modifications in this K133407, the ground truth would be adherence to functional and non-functional requirements established during the software development and verification process.

7. The sample size for the training set:

   • Not applicable. This is an IVD device, not a machine learning model that requires a training set in the AI sense.

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

   • Not applicable.

Summary of what's provided for K133407:

This document is a "Special 510(k)" for a software update (V3.0.0) to the GEM® Premier 4000. The primary claim is that the software changes (remote desktop sharing, remote upgrades, remote diagnostics, remote LIS tracing, remote cartridge data transfer) do not impact the fundamental scientific technology or performance characteristics of the device. Therefore, no new analytical performance studies were conducted, and the previous performance data (from K112995) still applies. The document emphasizes that "design control principles (risk management, verification and validation)" were applied to ensure the software release's safety and effectiveness, but it does not provide details on the specific testing performed for these software features (e.g., sample sizes of test cases, specific test protocols, or acceptance criteria for the software functions themselves).

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 cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+, K+, iCa2+ (ISE), hematocrit (Hct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COHb, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory. The integrated AutoQC module and the oximeter module are available as an option.

The cobas b 123 POC system consists of a modular analyzer incorporating a Linux-based graphical user interface with a large color touch screen interfacing the analyzer electronic, sensor, fluidic and AutoQC modules. The user interface module contains the analyzer CPU and all required electronic interfaces for external communication, data storage and data transfer. A single electrochemical sensor system independent of the reagent delivery system that utilizes Roche thick film technology consolidates the following analytes: pCO2, pH, calcium, potassium and sodium (potentiometric measurement); pO2 (amperometric measurement); Hct (conductivity measurement); Glucose and Lactate enzyme reaction (amperometric measurement). An optionally integrated oximeter module consisting of a spectrometer, measurement and calibration light source, respectively, an ultrasonic hemolyzer and thermostatic components measure SO2, tHb, O2Hb, HHb, COHb, and MetHb. A disposable, self-contained sample and reagent delivery system contains: Liquid reagents, calibrators and waste container, stable for 42 days on-board; Built-in safety shielded sample port; Built-in oximeter cuvette; Two peristaltic pump fluidics system; Built-in air filter. The system also includes an optional integrated AutoQC module which utilizes a disposable cassette containing three levels of quality control material. A smart memory chip is incorporated into each biosensor, reagent pack (sample and reagent delivery system) and AutoQC cassette providing the lot number, expiration date and value assignments (for QC and CVC materials). The chip also tracks and monitors sensor, reagent pack, AutoQC and AutoCVC cassette usage.

This is a 510(k) Summary for a medical device and therefore does not contain details about acceptance criteria, study methodologies, or performance against specific metrics as these are typically found in the full 510(k) submission. Acceptance criteria and detailed study information are usually proprietary data submitted to the FDA and are not part of the publicly available 510(k) Summary.

This document focuses on establishing substantial equivalence by comparing the cobas b 123 POC System and its associated control packs to previously cleared predicate devices. It lists the intended use, device descriptions, and similarities and differences between the new device and the predicate devices for various analytes.

Therefore, the requested information (table of acceptance criteria and reported device performance, sample sizes, data provenance, number of experts, adjudication method, MRMC study details, standalone performance, training set sample size, and ground truth establishment) cannot be extracted from the provided text.

Ask a specific question about this device