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The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of myoglobin levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis of heart or renal disease.

The Access Myoglobin assay is a sandwich immunoenzymatic assay. The Access Myoglobin assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access Myoglobin assay reagent pack, Access Myoglobin assay calibrators, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.

The provided text describes the Beckman Coulter Access Myoglobin assay, which is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of myoglobin levels in human serum and plasma. The K231832 submission seeks to demonstrate substantial equivalence to the predicate device (Access Myoglobin assay, K021229) when run on the Dxl 9000 Access Immunoassay Analyzer.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a separate section with pass/fail thresholds for all performance metrics. However, it presents the results of various performance studies against industry guidelines (CLSI standards), which implicitly serve as the acceptance criteria for demonstrating appropriate performance.

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

• Method Comparison: N = 155 (This refers to 155 patient samples). The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.
• Imprecision: N = 80 per sample assessed (e.g., Sample 1, Sample 2, etc.), which involved multiple samples tested in duplicate in 2 runs per day for a minimum of 20 days.
• Linearity: Sample size not explicitly stated, but typically involves a series of diluted/spiked samples.
• LoB, LoD, LoQ: Not explicitly stated as a single "sample size" but involved multiple reagent lots and 3 instruments over a minimum of 3-5 days.

The data provenance for all studies (country of origin, retrospective or prospective) is not specified in the provided document.

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

The Access Myoglobin assay is an in vitro diagnostic device for quantitative measurement of a biomarker. Its "ground truth" is established through analytical performance studies, not typically by expert review of individual cases as would be done for imaging or clinical decision support AI. Therefore, this section is not applicable in the traditional sense for this type of device. The "truth" is based on the accurate measurement of myoglobin concentration.

4. Adjudication Method for the Test Set

As this is an in vitro diagnostic quantitative assay, there is no adjudication method described or necessary in the context of expert consensus, as might be found for imaging AI. The performance is assessed against reference methods or calibrated controls.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

No MRMC comparative effectiveness study was done. This type of study is relevant for imaging or clinical decision support AI where human readers interpret results, and the AI might augment their performance. For a quantitative immunoassay, the "reader" is effectively the instrument, and the performance is evaluated on its analytical accuracy and precision.

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

Yes, the studies presented (Method Comparison, Imprecision, Linearity, LoB/LoD/LoQ) demonstrate the standalone performance of the Access Myoglobin assay on the Dxl 9000 Access Immunoassay Analyzer. These are analytical performance studies of the device itself, without human interpretation as a primary variable.

7. The Type of Ground Truth Used

The ground truth for these analytical performance studies is based on:

• Reference measurements: For method comparison, the predicate device (Access 2 Immunoassay System) served as the reference standard.
• Established concentrations/materials: For imprecision, linearity, LoB/LoD/LoQ, the ground truth is based on known concentrations of myoglobin in controls, calibrators, and spiked samples, prepared according to industry standards.
• Analytical principles: The assay measures myoglobin concentration, and the "ground truth" is the actual quantity of myoglobin present in a sample, determined through scientifically validated methods.

8. The Sample Size for the Training Set

This information is not provided in the document. For an immunoassay like this, there isn't a "training set" in the machine learning sense. The device's operational parameters and assay design are developed through extensive research and development, but this is distinct from an AI training dataset.

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

As there is no explicit "training set" in the AI sense for this immunoassay submission, this question is not directly applicable. The "ground truth" during the development and optimization of such an assay would involve internal analytical studies using characterized materials and reference methods to ensure the assay accurately measures myoglobin concentrations.

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The CKMB Test is an in vitro diagnostic assay for the quantitative determination of creatine kinase isoform MB in EDTA or lithium heparin whole-blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is intended for use as an aid in the diagnosis of myocardial infarction.

The Myo Test is an in vitro diagnostic assay for the quantitative determination of myoglobin in EDTA or lithium heparin whole-blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is intended for use as an aid in the rapid diagnosis of heart disease, for example, acute myocardial infarction.

For in vitro diagnostic use. The AQT90 FLEX analyzer is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoagulant has been added. It is intended for use in point-of-care and laboratory settings.

The AQT90 FLEX is a cartridge-based immunoassay analyzer, based on time-resolved fluorescence using a europium (Eu) chelate as the fluorescent label. The test receptacles for the assay are test cups, which contain the antibodies used for capture of the analyte, and the Eu chelate labeled antibodies used to trace the captured analyte. The sample is added to the test cup together with assay buffer. The cup is then incubated to allow formation of the immuno-complex, and subsequently washed to remove unbound antibodies and sample material. Finally, the cup is exposed to excitation light, and after a delay the emitted light generated by the fluorescent label is measured by single photon counting. The total count is then compared to an assay calibration curve to obtain a quantitative measurement of the analyte's concentration in the sample.

This technology uses dried reagents deposited in the test cups and in the calibration adjustment cups – no liquids other than the sample itself together with the assay buffer are required.

The provided document is a 510(k) premarket notification from Radiometer Medical ApS for their AQT90 FLEX CKMB Test Kit, AQT90 FLEX Myo Test Kit, and the AQT90 FLEX analyzer. The submission is to seek clearance for modifications to the existing AQT90 FLEX system devices.

The document does not describe a study involving an AI model or a human-in-the-loop performance study. Instead, it describes analytical performance studies of in-vitro diagnostic assays (Myoglobin and CKMB) on a laboratory analyzer. Therefore, many of the requested elements pertaining to AI models, human experts, ground truth adjudication, MRMC studies, and training datasets are not applicable to this document.

However, I can extract information related to the acceptance criteria (implicitly, the performance metrics evaluated) and the studies conducted to prove the device meets these criteria in the context of an in-vitro diagnostic device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria (Performance Metrics) and Reported Device Performance

For an in-vitro diagnostic device, acceptance criteria are typically related to analytical performance characteristics such as linearity, limits of detection/quantitation, method comparison (agreement with a predicate), and precision. The reported device performance is the outcome of the studies conducted for these characteristics.

AQT90 FLEX Myo Test Kit

AQT90 FLEX CKMB Test Kit

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

• Linearity (Myo & CKMB): 11 sample levels for linearity series, measured with 10 replicates each. This is an in vitro analytical study, not patient data.
• LoB/LoD/LoQ (Myo & CKMB):
  • LoB: Four blank samples measured with 5 replicates on 3 days, using 2 test kit lots and 2 analyzers. Total 60 measurements per test kit lot.
  • LoD/LoQ: 10 samples per matrix (lithium heparin whole blood and plasma).
• Method Comparison (Myo & CKMB):
  • Myo: n=103 lithium heparin plasma samples.
  • CKMB: n=107 lithium heparin plasma samples.
• Matrix Comparison (Myo & CKMB):
  • Myo: n=125 for most comparisons (e.g., Liph/Pl vs Liph/WB), some n=127. Paired lithium heparin and EDTA specimens.
  • CKMB: n=106 for Liph/Pl vs Liph/WB, others n=104, 103, 101. Paired lithium heparin and EDTA specimens.
• Precision (Myo & CKMB):
  • Whole Blood: 3 lithium heparin whole blood samples, measured 5 times five replicates (total 25 measurements per sample level).
  • Plasma: 3 lithium heparin plasma pools, measured across 20 test days, twice a day with 2 replicates (total 80 measurements per sample level).

Data Provenance: The studies were conducted "at one internal test site" for method comparison and "at three hospital laboratory sites" for matrix comparison. This indicates domestic (likely Denmark, where the manufacturer is located) or potentially international clinical laboratory settings. The data are prospective in the sense that they were generated specifically for these validation studies using prepared samples (diluted native specimens, spiked specimens, blank samples). They are not patient-outcome data or retrospective chart reviews.

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

• Not Applicable. For an in-vitro diagnostic device measuring analytes (myoglobin, CK-MB), the "ground truth" isn't established by human experts in the same way as, for example, image interpretation. The ground truth for these studies is the reference measurement from the original (predicate) device or the known concentration of prepared analytical samples.

4. Adjudication Method for the Test Set:

• Not Applicable. No human interpretation or adjudication is involved in determining the concentration of analytes in a blood sample by an immunoassay method.

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

• No. This type of study is relevant for AI systems that assist human readers in tasks like image interpretation. This document describes the analytical performance of an in-vitro diagnostic device that quantitatively measures biochemical markers. There are no human readers or AI assistance involved in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

• Yes, in the context of an IVD. The performance data presented (linearity, LoD/LoQ, method comparison, precision) are all "standalone" in the sense that they demonstrate the analytical performance of the AQT90 FLEX system (analyzer and test kits) independent of human interpretation or intervention beyond proper sample handling and instrument operation. This isn't an "algorithm only" in the AI sense, but rather the performance of analytical machines.

7. The Type of Ground Truth Used:

• Reference Measurement/Known Concentration:
  • For Linearity, LoB/LoD/LoQ, and Precision: The ground truth is established by preparing samples with known or precisely characterized concentrations of the analytes (e.g., diluted native specimens, spiked specimens, blank samples).
  • For Method Comparison: The ground truth is the measurement obtained from the predicate device (the previously cleared version of the AQT90 FLEX system devices). The goal is to show agreement between the modified device and the predicate.

8. The Sample Size for the Training Set:

• Not Applicable. This document describes the validation of an in-vitro diagnostic device, not an AI model. Therefore, there's no "training set" in the machine learning sense. The device performs a chemical reaction and optical measurement based on established immunoassay principles, not a learned algorithm trained on data.

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

• Not Applicable. As there is no training set for an AI model, this question is not relevant.

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The Diazyme Myoglobin Assay is for the quantitative determination of myoglobin in human serum and plasma. Measurement of myoglobin is used as an aid in the diagnosis of acute myocardial infarction. For in vitro diagnostic use only.

The Diazyme Myoglobin Calibrator Set is intended for use in the calibration of the Diazyme Myoglobin Assay. For in vitro diagnostic use only.

The Diazyme Myoglobin Control Set is intended for use as quality controls for the Diazyme Myoglobin Assay. For in vitro diagnostic use only.

The Diazyme Myoglobin Assay is based on a latex enhanced immunoturbidimetric assay. When an antigen-antibody reaction occurs between myoglobin in a sample and anti-myoglobin antibodies which have been sensitized to latex particles, agglutination occurs. This agglutination is detected as an absorbance change (570 nm), with the magnitude of the change being proportional to the quantity of myoglobin in the sample. The actual concentration is then determined by the interpolation from a calibration curve prepared from calibrators of known concentration.

The Diazyme Myoglobin Assay's acceptance criteria and performance are detailed across sections of the provided document. The study primarily relies on method comparison and precision evaluations to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "These results meet the acceptance criteria" under the "Precision" section, implying that the reported precision values are within the pre-defined limits. The "Method Comparison" also states that the results "correlated well," implying acceptance.

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

• Test Set Sample Size:
  • Method Comparison: 66 human plasma samples.
  • Precision:
    • 3 levels of serum-based controls (N=80 for each level across 20 days, 2 runs/day, duplicates means 2022 = 80 measurements per control level).
    • 3 serum samples (N=80 for each level, calculated the same way as controls).
  • Linearity: Not specified as a number of individual samples, but prepared by mixing a low and high serum-based sample.
  • Interference: Not specified.
• Data Provenance: The document does not explicitly state the country of origin for the human plasma and serum samples. It implies prospective testing, as samples were "tested with the Diazyme Myoglobin Assay," suggesting they were collected for the purpose of this study, but this is not explicitly confirmed for all studies. The samples are described as "human plasma samples" and "serum samples", indicating clinical origin rather than synthetic.

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

Not applicable. This device is an in vitro diagnostic (IVD) assay for quantitative measurement of myoglobin. Ground truth for such assays is typically established through reference methods or highly characterized predicate devices, not expert consensus, pathology reviews, or outcome data in the same way an imaging or classification AI/CAD device would use. In this case, the ground truth for method comparison was the result obtained from the predicate device (Roche Tina-Quant Myoglobin Gen. 2 Test System).

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is an IVD assay, not a device requiring human expert adjudication for ground truth establishment. The performance is assessed against quantitative measurements from a predicate device or by statistical methods for precision and linearity.

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 assay. MRMC studies are typically performed for imaging devices or CAD systems where human readers interpret results, and the impact of AI assistance on their performance is evaluated. This device provides a quantitative measurement, not an interpretation for a human reader to improve upon.

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

Yes, the studies reported (method comparison, precision, linearity, interference) represent standalone performance of the Diazyme Myoglobin Assay. The device directly produces a quantitative result of myoglobin concentration in human serum and plasma, with no explicit human-in-the-loop component for result generation. Its performance is evaluated intrinsically through laboratory experiments.

7. The Type of Ground Truth Used

• For Method Comparison: The performance of the predicate device (Roche Tina-Quant Myoglobin Gen. 2 Test System) served as the comparator or "ground truth" to which the Diazyme Myoglobin Assay was compared.
• For Precision, Linearity, and Interference: The "ground truth" is established by the known concentrations of myoglobin in the control materials and the carefully prepared linearity and interference samples. These are quantitative studies where the expected value is either known (for controls/calibrators) or mathematically derived (for linearity/interference).

8. The Sample Size for the Training Set

Not applicable. This device is a chemical assay, not an AI/Machine Learning algorithm that requires a "training set" in the conventional sense. Its performance characteristics are inherent to the chemical reactions and detection system, and are established through analytical verification studies (like those described) rather than machine learning training.

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

Not applicable, as there is no "training set" for this type of device.

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The ADVIA® Chemistry Myoglobin assay is for in vitro diagnostic use in the quantitative measurement of myoglobin in human serum or plasma on the ADVIA® Chemistry systems. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

The ADVIA Chemistry Myoglobin calibrator is for in vitro diagnostic use in the calibration of ADVIA® Chemistry system for Myoglobin assay.

The Myoglobin reagents are ready-to-use liquid reagents packaged for use on the automated ADVIA 1650 Chemistry system. They are supplied as a 100 tests/wedge, 2 wedges/kit. ADVIA Chemistry Myoglobin calibrator is a single analyte, human serum based product containing myoglobin derived from human heart source. The kit consists of 1 vial each of 4 calibrator levels which are lyophilized. The target concentrations of these calibrators are 50, 100, 200, and 720 ng/mL. The volume per vial (after reconstitution with deionized water) is 1.0 mL. Deionized water is recommended to be used as a zero calibrator.

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes several performance characteristics and the results obtained for the ADVIA® 1650 Chemistry Myoglobin Assay. Since this is a submission for substantial equivalence to a predicate device, the "acceptance criteria" are implicitly the performance levels of the predicate device or generally accepted clinical laboratory standards as guided by CLSI documents. The reported performance of the new device is compared to these.

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

• Precision:
  • Serum Pool 1: 40 replicates (assayed over 5 days)
  • Control 1, Control 2, Control 3: 80 replicates each (assayed over 20 days)
  • Serum Pool 2, Serum Pool 3, Serum Pool 4: 80 replicates each (assayed over 20 days)
  • Data Provenance: Not explicitly stated, but typically these types of studies are prospective lab studies conducted internally or by contract research organizations (CROs) for the manufacturer. The document doesn't mention country of origin or if samples were from specific patient populations, implying a general laboratory setting for assay validation.
• Linearity/Assay Reportable Range: Nine intermediate levels were created from low and high serum pools, plus two additional low levels. The total number of samples is not explicitly given but would be at least 11.
  • Data Provenance: Not explicitly stated, but likely laboratory-prepared serum pools.
• Limit of Blank, Limit of Detection, Limit of Quantitation:
  • LoB: 160 replicates of "zero" serum pool.
  • LoD/LoQ: Several serum pools with myoglobin concentration up to 4 x LOD level. (Exact number not specified for these pools).
  • Data Provenance: Not explicitly stated, likely laboratory-prepared or confirmed serum pools.
• Method Comparison (Serum): 71 serum samples. One sample was removed.
  • Data Provenance: Not explicitly stated, but typically these are human patient samples. The country of origin is not specified, and it's not stated whether they were retrospective or prospectively collected for the study, but typically for method comparison, they would be prospectively selected from a relevant patient population.
• Matrix Comparison (Plasma): 64 plasma samples.
  • Data Provenance: Similar to serum comparison, likely human patient samples. Country/retrospective/prospective not specified.
• Analytical Specificity (Interference): Test samples at specific myoglobin concentrations (50, 100, 400 ng/mL) were spiked with various interferents. The number of samples for each interferent type and concentration is not explicitly given but implies multiple measurements.
  • Data Provenance: Not explicitly stated, likely laboratory-prepared spiked samples using various concentrations of human physiological interferents.

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

• This device is a quantitative immunological test system for measuring myoglobin. The "ground truth" for the test set is established by the predicate device (ADVIA Centaur Myoglobin Assay), which is itself a legally marketed device. There is no explicit mention of human experts establishing a "ground truth" for individual patient samples in the way it might be done for an imaging device (e.g., radiologists). The performance is assessed against an established analytical reference method (the predicate).

4. Adjudication Method:

• Not applicable in the typical sense for a diagnostic imaging or clinical decision support device where human experts adjudicate. For analytical assays, the "adjudication" is inherent in the analytical method comparison and statistical analysis against the predicate device.

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 diagnostic imaging or interpretation systems where human readers are making diagnoses. This device is an in vitro diagnostic (IVD) assay that provides a quantitative measurement, not an interpretation by a human reader.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes, the entire performance evaluation described (precision, linearity, LoB/LoD/LoQ, method comparison, interference) is a standalone (algorithm only) performance study. The ADVIA® 1650 Chemistry Myoglobin assay is an automated system that performs the measurement without direct human interaction in the analytical process after sample loading.

7. Type of Ground Truth Used:

• The primary "ground truth" used for evaluating the new device's performance is the results obtained from the predicate device (ADVIA Centaur Myoglobin Assay) and, for basic analytical characteristics like LoB/LoD/LoQ, established analytical methodologies and industry standards (CLSI guidelines). For interference, the ground truth is the absence of interfering substances, and deviations are measured against that.

8. Sample Size for the Training Set:

• This 510(k) summary is for an in vitro diagnostic (IVD) assay, not a machine learning or AI model in the typical sense that requires explicit "training data" in the submission. The methods (e.g., latex-particle-enhanced immunoturbidimetric) are based on established chemical and immunological principles. Therefore, there is no specific "training set" sample size mentioned or generally applicable in the context of such an IVD submission. The assay's parameters would have been optimized during its development phase, but these aren't typically documented as a "training set" in a 510(k).

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

• As there is no "training set" specified in the context of an AI/ML model for this IVD assay, this question is not applicable. The "ground truth" for developing and optimizing such an assay would be based on fundamental chemical/immunological principles and experiments to ensure accurate and precise measurement of myoglobin concentrations.

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AQT90 FLEX analyzer is for in vitro diagnostic use. The instrument is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoagulant has been added. It is intended for use in point-of-care and laboratory settings.

AQT90 FLEX Myo Test is an in vitro diagnostic assay for the quantitative determination of myoglobin in EDTA or lithium-heparin whole blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is indicated for use as an aid in the rapid diagnosis of heart disease, e.g. acute myocardial infarction.

AOT90 FLEX Myo CAL cartridge is for in vitro diagnostic use. For calibration adjustment of the Myo Test, as indicated on the cartridge, on the AQT90 FLEX analyzer.

AQT90 FLEX LQC Multi-CHECK, Levels 1-3, is for in vitro diagnostic use. For use with the AQT90 FLEX analyzer as a liquid quality control serum (LQC) to monitor the precision of laboratory testing procedures for the analytes listed on the specification insert.

The AOT90 FLEX is a cartridge-based immunoassay, based on time-resolved fluorescence using a europium (Eu) chelate as the fluorescent label. The test receptacles for the assay are 300 µL test cups, which contain the antibodies used for capture of the analyte, and the Eu chelate labeled antibodies used to trace the captured analyte. The sample is added to the test cup together with assay buffer. The cup is then incubated to allow formation of the immuno-complex, and subsequently washed to remove unbound antibodies and sample material. Finally, the cup is exposed to excitation light, and after a delay the emitted light generated by the fluorescent label is measured by single photon counting; this measurement cycle is repeated up to 3,300 times. The total count is then compared to an assay calibration curve to obtain a quantitative measurement of the analyte's concentration in the sample.

This technology uses dried reagents deposited in the test cups and in the calibration adjustment cups - no liquids other than the sample itself together with the assay buffer are required. Total assay time is less than 20 minutes.

Here's an analysis of the provided text regarding the AQT90 FLEX Myo Test, Myo CAL cartridge, and LQC Multi-CHECK, detailing the acceptance criteria and study information:

Acceptance Criteria and Device Performance

The provided document describes the AQT90 FLEX Myo Test being compared to a predicate device, the ARCHITECT STAT Myoglobin. The acceptance criteria are implicitly based on demonstrating substantial equivalence to the predicate device, particularly in terms of analytical performance.

A key performance metric presented is the correlation between the new device and the predicate device for Myoglobin measurements.

Table of Acceptance Criteria and Reported Device Performance

Study Details

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

   • Whole Blood Samples: 157 samples
   • Plasma Samples: 165 samples
   • Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective, using existing samples to compare performance against a predicate device.

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

   • Not Applicable. This study is a comparative method study for an in vitro diagnostic device, comparing its quantitative measurements against a previously cleared predicate device. "Ground truth" in this context is the quantitative measurement provided by the predicate device, not expert interpretation of images or clinical outcomes.

3. Adjudication method for the test set:

   • Not Applicable. As mentioned above, this is a quantitative comparison, not a study requiring adjudication of expert 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:

   • Not Applicable. This document describes an in vitro diagnostic device for quantitative measurement of myoglobin, not an AI-assisted diagnostic imaging device that involves human readers.

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

   • Yes. The study presents the performance of the AQT90 FLEX Myo assay (the algorithm/device only) in measuring myoglobin concentrations and comparing these measurements directly to those obtained from the predicate device. There is no human-in-the-loop component in the measurement process itself.

6. The type of ground truth used:

   • The "ground truth" for comparison was the measurements obtained from the predicate device: ARCHITECT STAT Myoglobin assay. This is considered a "reference standard" or "comparator method" for demonstrating substantial equivalence.

7. The sample size for the training set:

   • Not explicitly stated in the provided text. The document describes a "comparison" study. For quantitative IVD devices, a "training set" in the machine learning sense is not typically discussed in 510(k) summaries as the device calibration and analytical method development process usually involves proprietary internal development and validation, separate from the clinical performance comparison against a predicate.

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

   • Not explicitly stated. As noted above, typical IVD development involves extensive analytical validation. The "ground truth" for establishing the device's accuracy and precision during its development (analogous to a training phase) would involve reference materials, spiked samples, and potentially calibrators whose concentrations are established using highly accurate reference methods or certified reference materials. The provided document focuses on the comparison to the predicate device for regulatory submission.

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Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.

Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin STAT assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.

The Elecsys Myoglobin Immunoassay includes two applications of the same reagents with different incubation times of 18 minutes (Myoglobin assay) and 9 minutes (Myoglobin STAT assay). The assay is a two-step sandwich immunoassay, using two different monoclonal antibodies directed against human Myoglobin, with streptavidin microparticles, and electrochemiluminescence detection. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode.

The acceptance criteria for the Elecsys Myoglobin Immunoassay and Elecsys Myoglobin STAT Immunoassay, along with the reported device performance, are detailed below. The study proves the device's substantial equivalence to a predicate device (Elecsys Myoglobin STAT assay K983176), rather than establishing new clinical effectiveness. Therefore, the information regarding multi-reader multi-case studies, expert adjudication, and detailed ground truth establishment for novel device performance is not fully applicable in the context of a 510(k) submission for substantial equivalence based on performance characteristics.

1. Table of Acceptance Criteria and the Reported Device Performance

Note: For the purpose of substantial equivalence, the reported device performance of the new assays is compared to the performance characteristics of the predicate device. Where specific acceptance criteria are not explicitly stated, the presented predicate device's performance often implicitly serves as the benchmark for demonstrating comparable characteristics.

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

• Method Comparison (Myoglobin assay): N = 129 samples were used for the test set.
• Method Comparison (Myoglobin STAT assay): N = 139 samples were used for the test set.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, given it's a submission for an IVD device, the data for performance characteristics would typically be generated in controlled laboratory settings through prospective testing of manufactured lots and clinical sample comparisons.

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

This information is not applicable and not provided in the document. For an in vitro diagnostic (IVD) immunoassay, "ground truth" is typically established by reference methods, comparison with a predicate device, or established scientific principles and accepted standards for analyte detection and quantification, rather than expert human interpretation of imaging or clinical data. The study primarily compares the performance of the new device to a predicate device.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation (e.g., radiology images) where human readers may disagree. For an immunoassay, the "ground truth" for comparison is based on quantitative measurements from established methods or the predicate device, not human interpretation 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

This information is not applicable. The device is an immunoassay for quantitative determination of myoglobin, not an AI-assisted diagnostic tool for human readers interpreting cases. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

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

Yes, the studies presented are for the standalone performance of the Elecsys Myoglobin Immunoassay and Elecsys Myoglobin STAT Immunoassay systems. The reported results (e.g., precision, method comparison, limit of detection) reflect the performance of the assay and analyzer without human interpretation of the final quantitative result. Humans are involved in operating the analyzer and interpreting the numerical output, but the "performance" described is the analytical performance of the device itself.

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

The "ground truth" for the performance characteristics presented is primarily based on:

• Comparison to a predicate device: The Elecsys Myoglobin STAT assay (K983176) serves as the primary comparator.
• Internal reference preparations/standards: The Myoglobin STAT assay traceability is against an in-house reference preparation.
• Calibrated methods: The predicate device was calibrated against Tina-quant Myoglobin, which in turn was calibrated against a nephelometric method.
• Defined analytical methods: E.g., for precision, the coefficient of variation (CV) is calculated based on repeated measurements of control samples or patient samples. For method comparison, it refers to the correlation and agreement with the predicate device's quantitative measurements.

8. The sample size for the training set

This document does not specify a "training set" in the context of machine learning or AI algorithms. For an immunoassay, the development involves optimization of reagents, antibodies, and protocols, often using a large number of samples for validation and calibration curve generation. The provided sample sizes relate to the evaluation of performance characteristics (e.g., N=129 and N=139 for method comparison studies) and are equivalent to "test sets" for analytical validation.

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

As there is no "training set" in the AI/ML sense, this question is not directly applicable. For the development and calibration of the immunoassay, the "ground truth" for defining the calibration curve and ensuring accurate quantification would be established through a rigorous process involving:

• Certified reference materials or secondary reference materials traceable to international standards (if available).
• Serial dilutions of known concentrations of myoglobin.
• Comparison with established methodologies (e.g., gravimetric, spectrophotometric, or other widely accepted quantitative techniques).
• Manufacturer's in-house reference preparations that are carefully characterized and validated.

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Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of myoglobin levels in human serum and plasma using the Access Immunoassay Systems. Measurement of myoglobin aids in the rapid diagnosis of heart and renal diseases.

The Access Myoglobin reagent and calibrators, the Access Immunoassay Analyzers comprise the Access Immunoassay Systems for the quantitative determination of cardiac Myoglobin in human serum and plasma.

The provided 510(k) summary focuses on a single performance characteristic: imprecision. The submission is for a modified version of an already cleared device, and the only change noted is to the acceptable imprecision range in the Instructions For Use (IFU).

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The reported device performance (7.32% CV to 9.25% CV) falls within the updated acceptance criteria (≤ 10% CV).

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

• Sample Size: Not explicitly stated. The summary mentions "concentrations from approximately 79 to 2405 ng/mL" for imprecision testing, but not the number of individual samples or replicates used.
• Data Provenance: Not explicitly stated. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.

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

This information is not applicable to this type of submission. The device is an immunoassay for quantitative determination of myoglobin, and the "ground truth" for evaluating imprecision is determined by statistical analysis of repeat measurements, not by expert interpretation of samples.

4. Adjudication Method for the Test Set

This information is not applicable as it relates to expert consensus for ground truth, which is not relevant for imprecision studies of an immunoassay.

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 information is not applicable. This submission is for an immunoassay for myoglobin, not an AI-assisted diagnostic imaging device that involves human readers.

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

This information is not applicable. This is a laboratory immunoassay device, not an algorithm, and does not involve human-in-the-loop performance in the same way as an AI-driven image analysis tool. The performance described (imprecision) is inherently "standalone" in the sense that it measures the inherent variability of the assay itself.

7. The Type of Ground Truth Used

The ground truth for imprecision studies is the measured value itself and its statistical distribution. Repeated measurements of the same sample are used to assess the variability (imprecision) of the assay. There isn't an external "truth" in the way there would be for disease diagnosis (e.g., pathology).

8. The Sample Size for the Training Set

This information is not applicable. This device is a biochemical assay and does not involve machine learning models that require a "training set."

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

This information is not applicable as there is no training set for this type of device.

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The Triage® CardioProfilER® Panel is a fluorescence immunoassay to be used with the Triage Meters for the quantitative determination of Creatine Kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure), an aid in the risk stratification of patients with heart failure, and an aid in the risk stratification of patients with acute coronary syndromes.

The Triage® Profiler S.O.B.TM (Shortness of Breath) Panel is a fluorescence immunoassay to be used with the Triage Meters for the quantitative determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peotide, and cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the risk stratification of patients with heart failure, an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism and an aid in the risk stratification of patients with acute coronary syndromes.

The Triage CardioProfilER Panel is a single-use device containing murine monoclonal and polyclonal antibodies against CK-MB, murine monoclonal and polyclonal antibodies against myoglobin, murine monoclonal and goat polyclonal antibodies against troponin I and murine monoclonal and polyclonal antibodies against BNP labeled with a fluorescent dye and immobilized on the solid phase, and stabilizers. Additionally, there are builtin control features that ensure that the test was performed properly and the reagents were functionally active.

The Triage Profiler S.O.B. Panel is a single-use device containing murine monoclonal and polyclonal antibodies against CK-MB, murine monoclonal and polyclonal antibodies against myodlobin, murine monoclonal and qoat polyclonal antibodies against troponin I, murine monoclonal antibodies against D-dimer, and murine monoclonal and polyclonal antibodies against BNP labeled with a fluorescent dye and immobilized on the solid phase, and stabilizers. Additionally, there are built-in control features that the test was performed properly and the reagents were functionally active.

The Test Cartridges are inserted into the Triage Meter and results for each analyte are measured and displayed on the display screen or printout. Internal assay controls (positive and negative controls) and automatic endpoint detection technology is used to indicate assay completion.

This 510(k) summary (K080269) describes the Triage CardioProfilER Panel and the Triage Profiler S.O.B. Panel, which are fluorescence immunoassays used with Triage Meters for the quantitative determination of various cardiac and circulatory markers in EDTA whole blood and plasma specimens.

The submission focuses on establishing substantial equivalence to a predicate device, the Biosite Triage BNP Test (K051787), particularly for the use of BNP in risk stratification of heart failure patients.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain specific quantitative acceptance criteria or detailed device performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard) for the Triage CardioProfilER Panel or the Triage Profiler S.O.B. Panel.

Instead, the submission states that:

• "The devices and test methods described in this Premarket Notification for the Triage CardioProfilER Panel and the Profiler S.O.B. Panel are identical in principle, reagents and procedure to their predecessors."
• "More specifically, the BNP assays included in these panels are identical to the BNP assay used in the Triage BNP Test (K051787)."
• "Therefore, the use of the Triage CardioProfilER and the Profiler S.O.B. Panels as an aid in the risk stratification of patients with heart failure is substantially equivalent to the predicate method."

This indicates that the acceptance criteria for these devices are primarily based on demonstrating substantial equivalence to the previously cleared predicate device (K051787) through comparison of their identical principles, reagents, and procedures, rather than presenting new performance data against specific numerical targets.

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

The document does not specify any sample sizes used for a test set or data provenance for a study proving device performance. The submission relies on the substantial equivalence of the new devices to the predicate.

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

Not applicable. No de novo study featuring a test set with ground truth established by experts is described in the provided document.

4. Adjudication Method for the Test Set

Not applicable. No de novo study featuring a test set with adjudication is described in the provided document.

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

No. The document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The devices are diagnostic assays, not AI-assisted interpretation tools for image analysis.

6. If a Standalone (Algorithm Only) Performance Study Was Done

The document does not describe a standalone performance study in the sense of an independent algorithm's performance. The devices are immunoassay panels that produce quantitative measurements. Their performance is indirectly addressed by claiming identity to previously-cleared assays within the predicate device.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for performance evaluation of the new devices, as it primarily relies on substantial equivalence. For the predicate device's clearance (K051787), it would have been expected that clinical diagnosis, pathology, or patient outcomes data were used as ground truth for establishing the performance characteristics of the individual assays (CK-MB, myoglobin, troponin I, BNP, D-dimer).

8. The Sample Size for the Training Set

Not applicable. The document does not describe an AI or machine learning model that would require a "training set" in the context of typical AI device submissions. These are immunoassay panels.

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

Not applicable. As above, there is no mention of a training set or its associated ground truth establishment methods for these immunoassay panels.

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ARCHITECT STAT Troponin-I is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of cardiac troponin-I in human serum or plasma on the ARCHITECT i 2000SR System. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI).

ARCHITECT STAT Myoglobin is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of myoglobin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. Myoglobin values are used to assist in the diagnosis of myocardial infarction (MI).

Not Found

This is an FDA Premarket Notification (510(k)) letter for the ARCHITECT STAT Troponin-I Immunoassay and ARCHITECT STAT Myoglobin Immunoassay. It confirms that the devices are substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, or MRMC studies.

This type of FDA letter is an approval document, not a study report. To find the information you're looking for, you would typically need to consult:

• The original 510(k) submission document itself (which includes the detailed performance data).
• The device's Instructions for Use (IFU) or package insert, which often summarizes performance characteristics.
• Clinical studies or validation reports associated with the device, usually referenced or summarized in the 510(k) submission.

Since the provided text does not contain the requested information, I cannot complete the table or answer the specific questions about the study design, sample sizes, or ground truth.

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Cardiac Markers reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure cardiac marker analytes.

ABX PENTRA CK-NAC CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the total creatine kinase in human serum and plasma based on an optimized UV test.

Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive. Duchenne-type muscular dystrophy.

The ABX PENTRA CK Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CK-MB RTU and ABX PENTRA CK-NAC methods.

ABX PENTRA Myoglobin CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of myoqlobin (an oxygen storage protein found in muscle) in human serum and plasma based on a latex-enhanced immunoturbidimetric assay.

Measurements of myoglobin aids in the rapid diagnosis of heart or renal disease.

The ABX PENTRA Myoglobin Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Myoglobin CP method on Horiba ABX clinical chemistry analyzers.

The ABX PENTRA Immuno II Control L/H is for use in quality control by monitoring accuracy and precision.

The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers.

The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.

The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.

All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.

The ABX PENTRA CK NAC CP is an in vitro diagnostic assay for the quantitative determination of total creatine kinase in human serum and plasma based on an optimized UV test. The assay is composed of a bi-reagent cassette, with 26 ml and 6.5 ml compartments. Reagents are chemical solutions with additives.

The ABX PENTRA Myoglobin CP is an in vitro diagnostic assay for the quantitative determination of myoglobin in human serum and plasma based on a latex-enhanced immunoturbidimetric test. The assay is composed of a bi-reagent cassette, with 15 ml and 9.5 ml compartments. Reagents are chemical solutions with chemical additives and substances of animal origin.

The ABX PENTRA Myoglobin Cal is a liquid calibrator prepared from a dilution of purified myoglobin positive human sera. It is used for the calibration of the myoglobin assay. The assigned values are given on the vials. This calibrator is provided in five vials of 1 ml.

The ABX PENTRA CK Control is a lyophilized assayed control prepared from a bovine serum albumin with chemical additives and material of biological origin. It has to be used for the quality control of the creatine kinase assay. The assigned values are given in the enclosed annex. This calibrator is provided in 4 vials of 3 ml.

The ABX PENTRA Immuno II Control L/H is a lyophilized assayed control prepared from a stabilized pool of human sera. It has 2 levels (Low and High) to be used for the quality control of the myoglobin assay. The assigned values are given in the enclosed annex. Each level of this control is provided in one vial of 3 ml.

The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. This calibrator is provided in ten vials of 3 ml.

The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annexes, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.

This submission describes various reagents, controls, and calibrators for in vitro diagnostic use with the Horiba ABX Pentra 400 clinical chemistry analyzer. The performance data focuses on establishing substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are primarily performance characteristics of the various reagents, controls, and calibrators.

ABX PENTRA CK NAC CP (Reagent for Total Creatine Kinase)

ABX PENTRA Myoglobin CP (Reagent for Myoglobin)

ABX PENTRA Myoglobin Cal (Calibrator)

ABX PENTRA Multical (Calibrator)

ABX PENTRA CK Control (Control)

ABX PENTRA Immuno II Control L/H (Control)

ABX PENTRA N Control and ABX PENTRA P Control (Controls)

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

• ABX PENTRA CK NAC CP: Correlation study used n=350 samples.
• ABX PENTRA Myoglobin CP: Correlation study used n=180 samples.
• Data Provenance: Not explicitly stated, but the submission is from Horiba ABX, France. Given the nature of in vitro diagnostic device submissions for a global market, it is common for such studies to be conducted internally or at contract research organizations, potentially in the country of origin (France) or other locations. The document does not specify if the data is retrospective or prospective, but performance data for new IVD products is typically generated prospectively, though some method comparison might involve retrospective samples.

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

Not applicable. As an in vitro diagnostic device for quantitative determination of analytes, "ground truth" is typically established by reference methods or predicate devices, not by expert interpretation of images or clinical cases. The "experts" in this context would be the laboratory personnel performing the reference method assays or clinical chemists validating the results. Their qualifications are not detailed in this submission.

4. Adjudication Method for the Test Set

Not applicable. This is for an in vitro diagnostic assay, not a medical imaging or diagnostic interpretation device requiring adjudication of expert opinions. Performance is assessed through quantitative measurements, precision, accuracy, linearity, and correlation with predicate devices.

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

Not applicable. This is not an AI-assisted diagnostic device. It's a collection of reagents, controls, and calibrators for a chemistry analyzer.

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

Not applicable for an IVD reagent/calibrator/control submission. The device performs a quantitative measurement on an automated analyzer. Its performance is inherently "standalone" in the sense that the analyzer and reagents perform the test without human interpretive input for the result itself. Human involvement is in sample handling, loading, running, and interpreting the numerical result in a clinical context.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the performance studies (accuracy, correlation), the "ground truth" is established by comparison to results obtained from predicate devices (as detailed in the substantial equivalence table) or established reference methods. For example, the correlation studies show the device's results (Y) compared to a reference method or predicate device's results (x). Precision and linearity are evaluated against expected analytical performance criteria.

8. The Sample Size for the Training Set

Not applicable. These are chemical reagents, controls, and calibrators for an in vitro diagnostic assay, not an AI or machine learning algorithm that requires a "training set."

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

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

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