Search Results

CueSee® Hypoxic is a pre-tonometered bovine hemoglobin (Hb) quality control material for professional use for monitoring blood gas analyzers' performance of Oxygen partial pressure (pO2).

CueSee® Hypoxic is prepared from a stroma-free bovine hemoglobin solution and provides the oxygen buffering characteristics of fresh whole blood. The concentrations of total hemoglobin and acid-base levels are within the normal physiological range. Tonometry with a predetermined level of oxygen balanced with nitrogen provides a distinct assay value for partial pressure of oxygen measurements. CueSee® Hypoxic contains no preservatives, viscosity adjusters or other additives that might adversely effect electrode measurements.

CueSee® Hypoxic provides one level in the critical low pO2 value range, each ampule holding 2.5 mL of solution.

CueSee® Hypoxic is packed in a carton box containing 5 ampules.

The provided text describes the 510(k) submission for the CueSee® Hypoxic device, a quality control material for blood gas analyzers. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for a diagnostic (e.g., accuracy, sensitivity, specificity for a medical condition).

Therefore, the document does not contain the information required to populate a table of acceptance criteria and device performance or describe a study for a diagnostic device in the sense of accuracy, sensitivity, or specificity. The "study" described is primarily about establishing stability and value assignment for a quality control material.

However, I can extract the relevant information regarding the product's characteristics and the tests performed to support its claims as a quality control material.

Here's what can be extracted and how it relates to the given prompt, with explanations for what is not present:

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

The document doesn't provide a typical "acceptance criteria" table for diagnostic performance (e.g., sensitivity, specificity, accuracy against a disease state). Instead, it discusses stability and value assignment as key performance aspects for a quality control material.

Notes:

• For a quality control material, the "performance" isn't about diagnosing a condition, but rather accurately reflecting a known concentration or value to allow verification of a diagnostic instrument.
• The document implies that the device "meets" its purpose by demonstrating these characteristics, which are standard for quality control materials.

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

• Sample Size: Not explicitly stated for specific tests (e.g., stability or value assignment). For value assignment, it mentions "multiple replicates of test samples" and "mean of multiple determinations performed on randomly selected samples from each lot," but no specific number.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It's implied to be internal testing by the manufacturer (Eurotrol B.V., Netherlands).

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 this document. For a quality control material, the "ground truth" (or assigned value) is established through rigorous internal testing against reference materials using validated methods, not typically by expert consensus in clinical interpretation.

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

• Not applicable as the "ground truth" for a QC material's value assignment is based on metrology and analytical chemistry, not clinical adjudication.

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

• Not applicable. This is a quality control material, not an AI-based diagnostic tool requiring human reader studies.

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

• Not applicable. This is a physical quality control material, not an algorithm. Its "standalone performance" refers to its ability to yield consistent and accurate pO2 values when measured correctly. The document describes protocols for how these values are determined (section "12. Value Assignment").

7. The type of ground truth used:

• For Value Assignment (pO2): Traceability to NIST SRM: 2658a (National Institute of Standards and Technology Standard Reference Material). This is a metrological ground truth derived from international standards, not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not applicable. This is a quality control material, not an AI model or a device that requires "training."

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

• Not applicable. As above, there's no "training set." The values of the QC material are established by direct measurement on a calibrated blood gas analyzer and traceable to a NIST Standard Reference Material.

Summary of Device and Study Focus:

The device, CueSee® Hypoxic, is a quality control material (Class I, reserved), not a diagnostic device that directly interprets patient data. Its primary purpose is to monitor the performance of blood gas analyzers for Oxygen partial pressure (pO2).

The "study" or evidence provided in the 510(k) summary focuses on demonstrating:

• Its intended use as a quality control material for pO2.
• Its composition and physical characteristics (e.g., bovine hemoglobin solution, 2.5 mL volume, liquid form).
• Its stability (31 days un-opened, 10 minutes opened).
• Its value assignment method (multiple replicates, mean determination, lot-specific values).
• Its traceability to a recognized standard (NIST SRM 2658a for pO2).
• Its substantial equivalence to a predicate device (RNA Medical® Brand QC 823 Range Blood Gas Electrolyte Metabolite Control) in terms of fundamental scientific technology, features, and characteristics, despite some differences (e.g., number of levels, analytes covered).

The provided text details the regulatory clearance for a quality control material, not an AI/diagnostic device that processes patient data and requires typical clinical performance metrics like sensitivity, specificity, or reader studies.

Ask a specific question about this device

This Hematocrit and Metabolite QUALICHECK solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges.

Analytes are: cGlucose, cLactate, Hct

Hematocrit and Metabolite QUALICHECK is a two-level quality control system consisting of:

• Hematocrit and Metabolite QUALICHECK, Level 1 (S7170), 944-039
• Hematocrit and Metabolite QUALICHECK, Level 2 (S7180), 944-040

The system consists of 30 ampoules per box. One ampoule contains 2 mL of solution.

The quality control solution is an aqueous solution containing an organic buffer, acid, salts, metabolites, and a preservative.

The provided text describes the Hematocrit and Metabolite QUALICHECK, a quality control system, and its substantial equivalence to a predicate device. However, the document does not contain the specific acceptance criteria, study details proving meeting these criteria, or most of the requested information about test and training sets, expert involvement, or comparative effectiveness studies.

This device is a quality control material, not a diagnostic or prognostic medical device that would typically involve AI, human-in-the-loop performance, or extensive clinical trials with patient data and expert ground truth establishment in the manner usually associated with the questions asked. The performance is assessed by comparing its measured values to established reference values and demonstrating stability.

Therefore, many of your requested points cannot be answered from the provided text. I will answer what is available and indicate when information is not present.

Acceptance Criteria and Device Performance (Limited Information Available)

The document states: "All study results met the acceptance criteria," but it does not explicitly list the acceptance criteria in a table or otherwise. It also does not report device performance data in a quantitative manner against specific criteria. The closest information available is in the "Stability" section, which mentions:

• Stability Claim: Control solutions are stable for 2 years at 2 °C to 25 °C.
• Performance against "Acceptance Criteria" (unspecified): "All study results met the acceptance criteria."

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

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

• Sample Size for Test Set:
  • Hct: For value assignment, 30 ampoules were sampled from the batch (5 from each of 6 trays) and 30 ampoules were sampled from a reference batch. Measurements were repeated 5 times per ABL555 analyzer (60 total measurements for each set of ampoules across 2+ analyzers).
  • Glucose and Lactate: Similar sampling: 30 ampoules from the batch and 30 from a reference batch. Measurements were repeated 5 times per EML105 analyzer (60 total measurements for each set of ampoules across 2+ analyzers).
• Data Provenance: Not explicitly stated, but the company (Radiometer Medical ApS) is based in Denmark. The study is part of the regulatory submission process for a medical device quality control, suggesting it is a controlled, prospective study for regulatory purposes.

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)

• Number of Experts: Not applicable or not specified. Ground truth for quality control materials for analytes like glucose, lactate, and hematocrit is established through highly calibrated reference methods and analyzers, not typically by human expert consensus or interpretation in the same way as imaging or diagnostic assessments.
• Qualifications of Experts: Not applicable/not specified. The "ground truth" (referred to as "true value" in the document) is determined by "validated ABL555" and "validated EML105" analyzers and "validated algorithms" in an Excel spreadsheet.

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

• Adjudication Method: Not applicable. The ground truth is established by instrumental measurements and calculations, not human adjudication.

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

• MRMC Study: No. This device is a quality control material for analytical instruments, not an AI-assisted diagnostic tool.

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

• Standalone Performance: Yes, in a sense. The "performance" of this device is its inherent accuracy and stability as a quality control material, which is assessed instrumentally without human in-the-loop performance altering its "reading." The device itself doesn't have an "algorithm" in the AI sense; its function is to provide known analyte concentrations.

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

• Ground Truth Type: "True value" established through measurements on validated reference analyzers (ABL555 for Hct, EML105 for Glucose and Lactate) and validated algorithms for calculation. This is an analytical ground truth based on reference methods.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is a quality control material, not an AI algorithm that requires a "training set." The materials are manufactured, and then their "true values" and stability are verified.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set." The "true values" for the device itself (which are the reference for other instruments using it for quality control) are established as described in point 7.

Ask a specific question about this device

This High Metabolite QUALICHECK solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges. Analytes are: pO2, ctHb, cGlucose, cLactate

High Metabolite QUALICHECK is a single level quality control system consisting of: High Metabolite QUALICHECK (S7570). The system consists of 30 ampoules per box. One ampoule contains 2 mL of solution. The quality control solution is an aqueous solution containing a biological buffer, salts, metabolites, and a preservative.

The provided documentation describes the High Metabolite QUALICHECK, a quality control system. As such, the concept of "acceptance criteria" and "device performance" is focused on its ability to serve as a reliable control for other diagnostic devices, rather than directly diagnosing a condition. The "study" described is a value assignment study to establish the accepted control ranges for the device.

Here's a breakdown of the information requested:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a quality control material are typically the established target ranges for its analytes, determined through a rigorous value assignment process. The "reported device performance" refers to the specific values found for the analytes within the control solution, which then form these target ranges.

Note: The document states "Target ranges are calculated based on the mean ±2SD" but does not explicitly list the numerical target ranges or the actual performance values. This information would typically be found in the device's insert.

Study Details

This section focuses on the value assignment study for the High Metabolite QUALICHECK.

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

   • Test Set Sample Size: 72 ampoules (12 ampoules sampled from each of 6 trays). Additionally, a "reference batch" was used, though its size is not explicitly stated in terms of ampoules. A total of 144 measurements were performed for each parameter.
   • Data Provenance: Not explicitly stated, but assumed to be generated in a controlled laboratory environment by the manufacturer (Radiometer Medical ApS, Denmark) as part of the product development and validation for regulatory submission. This is a prospective study for establishing control values.

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

   • Number of Experts: Not applicable in the traditional sense for this type of device. The "ground truth" for a quality control material is established through precise and extensive instrumental measurements on a well-characterized batch.
   • Qualifications of Experts: The measurements were performed on "a minimum of 3 validated ABL7xx series" instruments. The expertise lies in the calibration, validation, and operation of these high-precision instruments and the personnel trained to use them for quality control value assignment.

3. Adjudication method for the test set:

   • Adjudication Method: Not applicable. The "ground truth" (target ranges) is established statistically from a large number of instrumental measurements (144 measurements per parameter) from established and validated analyzers, rather than through expert consensus or adjudication of subjective interpretations.

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:

   • MRMC Study: No. This device is a quality control material for in vitro diagnostic instruments, not an AI-powered diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant.

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

   • Standalone Performance: Not applicable. This is a physical quality control solution, not an algorithm. Its "performance" is its ability to provide stable and accurate reference values when measured by compatible analyzers. The value assignment study itself is a standalone evaluation of the control solution's inherent characteristics.

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

   • Type of Ground Truth: The ground truth is established through reference method measurements or highly precise, validated instrumental measurements on a large, representative sample of the quality control material. Specifically, it's based on the statistical analysis (mean ± 2SD) of 144 measurements from validated ABL7xx series analyzers.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable. This is not an AI/machine learning device that requires a training set. The "training" in this context refers to the initial production of the control material according to specifications.

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

   • Ground Truth for Training Set: Not applicable. There is no training set for this type of device in the machine learning sense. The "ground truth" (i.e., the target values) for the product is established through the value assignment process described in point 6 above for the manufactured batches.

Ask a specific question about this device

For In Vitro Diagnostic Use. This Range+ QUALICHECK solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges.

Range+ QUALICHECK is a three level quality control system consisting of:

• Range+ QUALICHECK, LEVEL 1 (S7930) .
• Range+ QUALICHECK, LEVEL 2 (S7940) .
• Range+ QUALICHECK, LEVEL 3 (S7950) .

Each level consists of 30 ampoules per box. One ampoule contains 2 mL of solution.

The quality control solution is an aqueous solution containing a biological buffer, salts, glucose, lactate, dyes and a preservative, and it is equilibrated with carbon dioxide and oxygen.

The provided text describes a 510(k) submission for a quality control system, Range+ QUALICHECK, used to evaluate the accuracy and precision of various analytes in blood gas, oximetry, electrolyte, and metabolite measurements. The study presented here is focused on establishing the value assignments and control ranges for the device, rather than proving its acceptance against specific performance criteria in the way one might for a diagnostic test with sensitivity/specificity targets.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a quality control system, so the "performance" here relates to the establishment of its control ranges. The acceptance criteria for the value assignment process are implicitly defined by the methodology used to calculate the target ranges.

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

• Sample Size for Test Set: For value assignment, 72 ampoules from the Range+ QUALICHECK batch and 72 ampoules from a reference batch were used. Each parameter was measured 12 times on a minimum of 3 devices, leading to at least 144 measurements per parameter. (Calculated as 12 repetitions x 3 devices x 4 ampoules, assuming at least 4 ampoules are measured on each device in an alternating fashion, though the text states "12 times on each ABL7xx for a total of 144 measurements" which suggests 12 measurements per ampoule * 3 devices * 4 ampoules? Or 12 measurements per device for a specific ampoule for a total of 144, if there are 12 different ampoules per device). The more direct reading is 12 repetitions * 3 devices = 36 measurements per ampoule * 4 ampoules measured per device, so 12 * 3 * 4 = 144. However, the text says 12 times on each ABL7xx for a total of 144 measurements so this means that 12 sample ampoules are measure 12 times on each ABL7xx? The interpretation of 12 times on each ABL7xx for a total of 144 measurements as meaning 12 individual tests per ABL7xx * 3 ABL7xx devices * some number of distinct ampoules leading to 144 total measurements is uncertain. A more direct reading could be 12 individual measurements per ampoule * 12 ampoules = 144, if using only one ABL7xx device? The text could be clearer here.
• Data Provenance: The document does not explicitly state the country of origin of the data. Given the submitter's address (Aakandevej 21, 2700 Broenshoej, Denmark), it is strongly implied that the studies were conducted in Denmark or by the submitting company. The study is prospective as it involves controlled measurements to establish values for the new device.

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

The ground truth for this device is the assigned value and control range for each analyte. This is established through a rigorous measurement process rather than expert consensus on subjective interpretations (like radiology images).

• Number of Experts: Not applicable in the traditional sense of medical expert reviewers. The "ground truth" (assigned values) is determined by the analytical performance of validated ABL7xx series devices and a statistical calculation (mean ±2SD).
• Qualifications of Experts: Not applicable. The "expertise" lies in the validation of the ABL7xx devices and the adherence to the described measurement protocol.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring human adjudication of subjective assessments. The results are quantitative measurements. The "adjudication" is inherent in the statistical calculation of the mean and standard deviation from repeated measurements.

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

No. An MRMC study is typically performed for diagnostic devices where human readers interpret medical cases. This device is an in-vitro diagnostic quality control material, and its performance is evaluated through analytical measurements and statistical determination of control ranges, not human interpretation.

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

Yes, in a sense relevant to a QC material. The performance described (value assignment and stability) represents the standalone performance of the Range+ QUALICHECK material when analyzed on compatible devices (ABL7xx series). There is no "human-in-the-loop" component for the performance of the QC material itself; it's about the inherent properties and measured values of the solution.

7. The Type of Ground Truth Used

The ground truth used is the assigned values and control ranges derived from repeated analytical measurements on validated laboratory instruments (ABL7xx series devices) using a specified protocol. This is essentially an instrument-derived quantitative ground truth.

8. The Sample Size for the Training Set

The provided text describes the process for value assignment which serves as the "ground truth" or reference for the quality control material. It doesn't explicitly refer to a "training set" in the context of an algorithm or AI model development. The data used for determining the assigned values and control ranges is:

• 72 ampoules from the Range+ QUALICHECK batch.
• 72 ampoules from a reference batch.
• For each parameter, a minimum of 144 measurements (12 repetitions on each of at least 3 validated ABL7xx series devices).

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

As explained in points 3 and 7, the "ground truth" (assigned values and control ranges) is established through a precise and controlled measurement protocol:

• Multiple ampoules (72 from the new batch, 72 from a reference batch) are prepared by conditioning at 25°C for 6 hours.
• Measurements are performed on a minimum of 3 validated ABL7xx series devices.
• For each parameter, 12 alternating measurements (between sample and reference ampoules) are taken on each ABL7xx device, totaling at least 144 measurements per parameter.
• The target ranges are then calculated as the mean ±2 standard deviations of these collected measurements.

Ask a specific question about this device

Mission Controls are used for pH/Blood Gas and Electrolyte Analyzers to estimate test imprecision and to detect systematic deviations that may occur because of instrument or reagent variation.
There are 4 levels of QC encompassed in this request. Levels 1,2,3 cover the Low Mid High of the clinical range for the analytes included in the QC. Level 4 is to check at High O2 level.
Mission Controls are intended for six systems: AVL Scientific, Ciba-Coming/Bayer, IL, NOVA, Radiometer, Medica, Shapparelli, Medarini.
The products encompassed by this request are intended for in-vitro diagnostics use and are intended for pH/Blood Gas = (pr). pCO2, pO2), and Licolorito - (No, N, Ol, St, L. ( St, S.) = S. ( = ) = ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Analyzers to estimate test imprecision and to detect systematic deviations that may occur because of instrument or reagent variation.

Mission Controls are used for pH/Blood Gas and Electrolyte Analyzers to estimate test . imprecision and to detect systematic deviations that may occur because of instrument or reagent variation.
Mission Controls are aqueous based tonometered controls .
Mission uses a similar composition, description and packaging as that used by the predicate Mission uses a similar oompoomon, assistion of this submission.

The provided text describes a 510(k) submission for "Mission Diagnostic Reagents on pH/Blood Gas &/or Electrolyte Analyzers" (Mission Controls™). Here's an analysis of the acceptance criteria and study information contained within the submission:

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

The submission mentions "Stability studies were done per SOP23-01-03" and "Stabilities studies support a 3 year shelf life." However, specific quantitative acceptance criteria for performance parameters (e.g., accuracy, precision, bias, stability limits) and the reported numerical device performance results are not provided in the excerpt. The submission focuses on substantial equivalence to a predicate device.

The intended use of the Mission Controls is to "estimate test imprecision and to detect systematic deviations that may occur because of instrument or reagent variation" on pH/Blood Gas and Electrolyte Analyzers. The acceptance criteria would likely be related to the ability of the controls to maintain their specified values within certain limits over their shelf-life and under various storage/use conditions, and to perform comparably to the predicate device.

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

This information is not explicitly provided in the excerpt. The statement "Stability studies were done per SOP23-01-03" indicates that a study was conducted, but details about the sample size (e.g., number of control lots tested, number of replicates, duration of testing points), data provenance (e.g., where the study was performed), or whether it was retrospective or prospective are absent.

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

This is not applicable as the device is a quality control material for analytical instruments, not a diagnostic device requiring expert interpretation of results to establish "ground truth" in the clinical sense. The "ground truth" for a quality control material is its assigned value, which is determined through a rigorous analytical process, typically by the manufacturer, rather than by human experts in the context of interpretation.

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

This is not applicable for a quality control material for analytical instruments. Adjudication methods are typically used in clinical studies where human interpretation of medical images or data is involved and discrepancies need to be resolved.

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

This is not applicable as the device is a quality control material, not an AI-powered diagnostic tool requiring human-in-the-loop assessment or human reader improvement studies.

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

This is not applicable as the device is a quality control material, not an algorithm.

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

For quality control materials, the "ground truth" is typically established through:

• Assigned Values: These are the expected values of the analytes within the control materials. These values are determined by the manufacturer using highly accurate and precise reference methods, often traceable to international standards, and verified through multiple measurements on various accredited instruments.
• Statistical Analysis: A comprehensive statistical analysis of multiple measurements across different instruments and laboratories is used to establish the mean and range for each analyte within the control. This forms the basis for the control's expected performance and the limits for acceptable variation.

The document implicitly refers to this type of ground truth by stating the controls are used to "estimate test imprecision and to detect systematic deviations." The controls themselves have pre-defined "true" values that analytical instruments are expected to measure within a certain range.

8. The sample size for the training set

This is not applicable. Quality control materials like Mission Controls™ do not involve training sets in the machine learning sense. Their performance is established through analytical validation and stability studies.

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

This is not applicable for the reasons stated above.

Ask a specific question about this device

Liquichek™ Blood Gas Plus Co-Oximeter Control (Radiometer 700 Series) is an assayed quality control intended for use in monitoring the precision of an individual laboratory's measurement of pH, pCO2, pO2, electrolytes, glucose, lactate (lactic acid), total hemoglobin, and hemoglobin fractions by blood gas, ion selective electrode (ISE), biosensor and Radiometer 700 Series CO-Oximetry instrumentation.

Liquichek™ Blood Gas Plus CO-Oximeter Control (Radiometer 700 Series) is a dye based, buffered bicarbonate and electrolyte solution in equilibrium with pre-determined levels of oxygen, carbon dioxide, nitrogen, glucose and lactate (lactic acid).

Here's an analysis of the provided text regarding the Bio-Rad Laboratories Premarket Notification Section 510(k) for Liquichek Blood Gas Plus CO-Oximeter 700 Series.

It's important to note that this document is a 510(k) premarket notification for a quality control material, not a medical device in the sense of an algorithm or diagnostic tool that directly analyzes patient data. Therefore, the questions related to AI, human readers, ground truth establishment for AI, and similar concepts are not directly applicable. I will address the relevant points based on the nature of the device.

Acceptance Criteria and Device Performance for Liquichek Blood Gas Plus CO-Oximeter Control (Radiometer 700 Series)

1. Table of Acceptance Criteria and Reported Device Performance

The core "performance" of a quality control material is its stability and its ability to monitor the precision of an instrument. The acceptance criteria are typically related to maintaining target values and stability over time under specified storage conditions. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through stability studies.

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

• Test Set Sample Size: The document does not specify a numerical "sample size" in terms of how many individual tests or vials were used for the stability studies. For a quality control product, this would typically involve multiple lots or batches tested over time at various intervals. The document states "Stability studies have been performed..." without quantitative details.
• Data Provenance: The studies were performed by Bio-Rad Laboratories. The country of origin is implicitly the USA (Bio-Rad Laboratories is based in Irvine, California). The studies described are prospective in nature, as they are "stability studies" performed to determine shelf life and open vial stability for the new device prior to its market release.

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

Not applicable. For a quality control material, "ground truth" isn't established by human experts in a diagnostic sense. Instead, the "ground truth" or reference values for the control material's analytes (e.g., pH, pCO2, glucose levels) are established through manufacturing processes, assaying against known standards, and rigorous internal quality control procedures to ensure homogeneity and accurate assigned values for each level of the control. The document refers to the product as an "assayed quality control," meaning it has assigned values.

4. Adjudication Method for the Test Set

Not applicable. There's no "adjudication" in the context of a quality control material's stability testing. The assessment is based on objective analytical measurements and pre-defined acceptance limits for stability.

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

Not applicable. This is a quality control material, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical, chemical quality control product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this type of product refers to the assigned values of the analytes (pH, pCO2, pO2, electrolytes, glucose, lactate, total hemoglobin, and hemoglobin fractions) within each level of the control material. These values are established by the manufacturer (Bio-Rad) through:

• Rigorous analytical testing using reference methods and calibrated instruments.
• Ensuring batch-to-batch consistency.
• Determining the target range for each analyte for each level of the control.

The purpose of the control is then for laboratories to monitor their own instrument's precision against these known assigned values.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As noted above, this device does not utilize a "training set." The "ground truth" for the control material itself (i.e., its assigned values) is established through the described manufacturing and analytical processes.

Ask a specific question about this device

Liquichek™ Blood Gas Plus Co-Oximeter Control (IL Synthesis Series) is an assayed quality control intended for use in monitoring the precision of an individual laboratory's measurement of pH, pCO2, pO2, electrolytes, glucose, total hemoglobin, and hemoglobin fractions by blood gas, ion selective electrode (ISE), biosensor and IL Synthesis Co-Oximetry instrumentation.

Liquichek™ Blood Gas Plus CO-Oximeter Control (IL Synthesis Series) is a dye based, buffered bicarbonate and electrolyte solution in equilibrium with pre-determined levels of oxygen, carbon dioxide, nitrogen and glucose.

This document describes the safety and effectiveness of the "Liquichek™ Blood Gas Plus CO-Oximeter Control (IL Synthesis Series)" and seeks to establish its substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the comparison to the predicate device and the stability studies conducted. The goal is to demonstrate that the new device performs similarly to the predicate device and meets its stated stability claims.

2. Sample Size and Data Provenance (for test set)

The document states that "Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Blood Gas Plus CO-Oximeter Control (IL Synthesis Series)." It also mentions that "All supporting data is retained on file at Bio-Rad Laboratories."

• Sample Size: The specific sample sizes (number of vials, replicates, lots, or dates during stability studies) used for the stability testing (which serve as the "test set" for the performance claims) are not explicitly stated in the provided text.
• Data Provenance: The data provenance is from Bio-Rad Laboratories, the submitter of the device. The study is a prospective stability study conducted on the new device, designed to support its stated claims. The country of origin for the data is implicitly the United States, as Bio-Rad Laboratories is based in Irvine, California, and the submission is to the FDA.

3. Number of Experts and Qualifications (for ground truth of test set)

This device is an assayed quality control material for laboratory instruments. The "ground truth" for its performance is typically established through analytical methods and instrument readings, not expert human interpretation. Therefore, the concept of "experts" in the traditional sense (e.g., radiologists) for establishing ground truth is not applicable here.

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication Method (for test set)

Since the ground truth is established through analytical measurements and a comparison to predefined stability limits and performance metrics, an adjudication method for human interpretation is not applicable. The performance is assessed against established measurement procedures and statistical analysis of the stability data.

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

• Was an MRMC study done? No.
• Effect Size: Not applicable, as this is an in-vitro diagnostic control material, not a diagnostic imaging aid for human readers.

6. Standalone Performance Study (Algorithm Only)

• Was a standalone study done? Yes, to the extent that "standalone" refers to the device itself being tested independently to determine its inherent performance characteristics (stability, analyte values on compatible instruments). The stability studies are effectively a standalone performance assessment of the control material's behavior over time and under different conditions. The "Summary of Performance Data" directly reports on the outcomes of these studies.

7. Type of Ground Truth Used

The ground truth used for this device is based on:

• Analytical Measurements/Instrument Readings: The stability studies involve repeatedly measuring the analytes (pH, pCO2, pO2, electrolytes, glucose, total hemoglobin, and hemoglobin fractions) in the control material using specified instrumentation (IL Synthesis CO-Oximetry instrumentation) over time and under various storage conditions.
• Defined Chemical/Physical Properties: The control material is designed with predetermined levels of oxygen, carbon dioxide, nitrogen, and glucose, and its matrix is a buffered bicarbonate and electrolyte solution. The expected values for the analytes are what the device is "controlling" against.
• Comparison to Predicate Device: Substantial equivalence claims heavily rely on demonstrating that the new device's performance is comparable to the legally marketed predicate device, implying that the predicate's established performance serves as a reference point for acceptable ground truth.

8. Sample Size for the Training Set

This device is a quality control material, not an AI/ML algorithm that requires a "training set" in the conventional sense. Therefore, the concept of a training set sample size is not applicable. The manufacturing process for the control material involves precise formulation and quality checks, but not algorithmic training.

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

As there is no "training set" for this type of device, this question is not applicable.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device