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The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. The Access CK-MB assay is a two-site immunoenzymatic ("sandwich") assay. Patient sample is added to a reaction vessel with mouse monoclonal anti-human CK-MB antibody-alkaline phosphatase conjugate and paramagnetic particles coated with mouse monoclonal anti-human CK-BB. Human serum CK-MB binds to the anti-CK-MB conjugate and is immobilized on the paramagnetic particle coated with anti-CK-BB. The CK-MB in the human serum or plasma binds to the immobilized anti-CK-BB on the solid phase by the sub-unit B epitope (common to CK-BB and CK-MB isoforms), while the mouse anti-CK-MB conjugate reacts specifically with the serum or the plasma CK-MB (no reaction with CK-MM or CK-BB isoforms). After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.

The provided text describes the 510(k) premarket notification for the Beckman Coulter Access CK-MB assay on the Dxl 9000 Access Immunoassay Analyzer. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Access CK-MB assay on the Access 2 Immunoassay System, K030012), rather than proving that an AI-driven device meets specific acceptance criteria.

Therefore, many of the requested details regarding AI/ML device validation (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, training set details) are not applicable to this submission content.

This submission is for an in vitro diagnostic (IVD) immunoassay, which is a chemical/biological test, not an AI or imaging device. The "device" here refers to the measurement system (the assay and the immunoassay analyzer), not an AI algorithm.

However, I can extract the acceptance criteria and performance data for the analytical performance of this IVD device as presented in the document.

Acceptance Criteria and Reported Device Performance (Access CK-MB Assay on Dxl 9000 Access Immunoassay Analyzer)

The studies presented here are analytical validation studies for an in vitro diagnostic immunoassay, not clinical validation studies for an AI/ML or imaging device. The "acceptance criteria" are based on performance claims typically established for IVD assays to demonstrate substantial equivalence to a predicate device and suitability for their intended use.

1. Table of Acceptance Criteria and Reported Device Performance

• SD ≤ 0.04 ng/mL for values ≤ 0.5 ng/mL
• CV ≤ 8.0% for values > 0.5 ng/mL | Sample 1 (Mean 0.2 ng/mL):
• Repeatability SD: 0.01, %CV: 5.2
• Between-run SD: 0.01, %CV: 3.4
• Between-day SD: 0.003, %CV: 1.9
• Within-Laboratory (Total) SD: 0.01, %CV: 6.5

Sample 2 (Mean 9.2 ng/mL):

• Within-Laboratory (Total) %CV: 3.4
  Sample 3 (Mean 54 ng/mL):
• Within-Laboratory (Total) %CV: 3.0
  Sample 4 (Mean 120 ng/mL):
• Within-Laboratory (Total) %CV: 3.0
  Sample 5 (Mean 220 ng/mL):
• Within-Laboratory (Total) %CV: 2.5 |
  | Linearity | Demonstrated linearity across the measuring interval. | Result: Assay demonstrated linearity across the measuring interval (0.2 - 300 ng/mL). |
  | Limit of Blank (LoB) | Not explicitly stated as acceptance criterion, but determined. | Result: 0.1 ng/mL |
  | Limit of Detection (LoD)| Not explicitly stated as acceptance criterion, but determined. | Result: 0.1 ng/mL |
  | Limit of Quantitation (LoQ)| LoQ ≤ 20% within-lab CV. | Result: 0.2 ng/mL (at ≤ 20% within-lab CV) |
  | Measuring Range | Comparability to predicate. | 0.2 - 300 ng/mL (Predicate: 0.1 - 300 ng/mL) |
  | Reference Interval | Updated/verified for all sample types. | Serum, Lithium heparin and EDTA plasma: 0.6 ng/ml - 6.3 ng/ml (Predicate: EDTA plasma: 0.5-5.0 ng/ml; Serum/Lithium heparin plasma: 0.6-6.3 ng/ml) |

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

• Method Comparison: N=146 samples (Concentration Range: 0.29 - 271 ng/mL).
• Imprecision: 80 replicates per sample level. Assays were run for a minimum of 20 days (2 runs per day, in duplicate).
• LoB, LoD, LoQ: "multiple reagent lots and 3 instruments over a minimum of 3 days" (LoB) or "minimum of 5 days" (LoD/LoQ).
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective), but these are typically controlled laboratory studies conducted under GLP (Good Laboratory Practice) guidelines. Given the manufacturer's location (Chaska, MN, USA), it's highly probable the studies were conducted in the US. The studies are prospective analytical validation studies specific to the device, not retrospective analysis of clinical patient data.

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

• Not applicable. This is an IVD assay measuring an analyte (CK-MB concentration). The "ground truth" for these analytical studies is the quantitative measurement of the CK-MB concentration by a reference method or the predicate device, not expert consensus interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

• Not applicable. See point 3.

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

• Not applicable. This is an IVD assay, not an AI/ML or imaging device. There are no "human readers" interpreting results in the way an MRMC study would apply.

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

• Not applicable. This is an IVD assay, not an AI algorithm. The performance described is the standalone analytical performance of the instrument/assay system.

7. The Type of Ground Truth Used

• For Method Comparison, the "ground truth" or reference was the predicate device (Access 2 Immunoassay System) which measured CK-MB concentrations in patient samples.
• For Imprecision, Linearity, LoB/LoD/LoQ, the "ground truth" is the true analytical concentration of the analyte in control materials or spiked samples, assessed through various statistical methods (e.g., CLSI guidelines). It's essentially the actual concentration values.

8. The Sample Size for the Training Set

• Not applicable. This device is an immunoassay, not an AI/ML algorithm that requires a "training set" in the computational learning sense. The "training" in manufacturing would relate to calibrating the instrument and assay reagents.

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

• Not applicable. See point 8. The "ground truth" for assay calibration (analogous to training) would be established by reference materials traceable to international standards, if available, or highly characterized in-house control materials with assigned values. The document mentions "Liquid calibrators prepared from buffered bovine serum albumin matrix with recombinant CK-MB at specified levels." These calibrators define the "ground truth" for the device's internal calibration.

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Rx ONLY

For in vitro diagnostic use only.

For the quantitative measurement of CK-MB in human serum and plasma (EDTA or heparin) using the VITROS 3600 Immunodiagnostic System.

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 VITROS Immunodiagnostic Products CK-MB assay is performed using the VITROS CK-MB Reagent Pack and the VITROS CK-MB Calibrators on the VITROS Systems.

The current VITROS Immunodiagnostic Products CK-MB assay is susceptible to interference from biotin. Ortho has made a modification to the manufacturing process to allow the biotinylated antibody capture conjugate to be pre-bound to the well, thus mitigating the risk of biotin interference.
The modified product utilizes all the same antibodies and raw materials with the exception of the addition of 0.7% Tween 20 and an increase in EDTA concentration from 0.001M to 0.030M, both of these modifications are to improve serum/plasma agreement which required a conversion factor in the previously cleared product.

An immunometric immunoassay technique is used, which involves the reaction of CK-MB present in the sample with a microwell coated with biotinylated Antibody (Mouse monoclonal anti-CK-BB bound to Streptavidin), and a Horseradish Peroxidase (HRP)-labeled antibody conjugate (Mouse monoclonal anti-CK-MB). Unbound (HRP)-labeled anti-CK-MB antibody conjugate is removed by washing.

The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system. The amount of CK-MB conjugate bound is directly proportional to the concentration of CK-MB present in the sample.

The provided document describes the 510(k) premarket notification for the VITROS Immunodiagnostic Products CK-MB Reagent Pack. This is an in vitro diagnostic device, not an AI/ML-based medical device. Therefore, many of the requested criteria related to AI/ML device testing (e.g., number of experts for ground truth, adjudication methods, MRMC studies, sample sizes for training sets) are not applicable to this document.

The document focuses on demonstrating the substantial equivalence of a modified CK-MB assay to a legally marketed predicate device, primarily through non-clinical performance studies.

Here's an analysis based on the provided text, addressing the applicable criteria for an in vitro diagnostic device:

1. Table of Acceptance Criteria and Reported Device Performance

For an in vitro diagnostic device like this, acceptance criteria typically revolve around analytical performance characteristics such as precision, linearity, detection limits, and method comparison to a predicate. The document doesn't explicitly state "acceptance criteria" as a pass/fail threshold, but rather presents the results of various validation studies.

• Cefoxitin (at 521 mg/dL): -27.7% bias at 3.00 ng/mL CK-MB
• Dextran 40 (at 2400 mg/dL): -15.0% bias at 3.00 ng/mL CK-MB; -44.9% bias at 50.0 ng/mL CK-MB |
  | Cross-Reactivity | Minimal or no cross-reactivity with structurally similar substances. | CK-BB (50 µg/dL): Not Detectable
  CK-MM (4 mg/dL): Not Detectable |
  | Method Comparison to Predicate Device (Accuracy) | Strong correlation and minimal bias compared to the predicate device, with slope close to 1 and intercept close to 0. | System (3600 vs. Comparative Method):
• n: 149 patient samples
• Slope: 0.99 (95% CI: 0.9812 to 0.9950)
• Correlation Coefficient: 0.999
• Intercept: 0.112 ng/mL (95% CI: 0.05080 to 0.1723) |
  | High Dose Hook Effect | No significant hook effect within relevant supraphysiological concentrations. | No high dose hook effect up to 44,200 ng/mL (µg/L). |

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

• Precision:
  • Sample Size: 80 observations (likely meaning replicates across runs and days, as per CLSI EP05 methodology) for each of 4 patient pools.
  • Data Provenance: Not explicitly stated, but typically from internal lab testing.
• Limit of Detection/Quantitation: Not explicitly stated, but derived from experiments consistent with CLSI document EP17.
• Analytical Specificity (Interference) & Cross-Reactivity: Not explicitly stated, but involves testing at specific concentrations of CK-MB and interferents.
• Method Comparison to Predicate Device:
  • Sample Size: 149 patient (serum) samples.
  • Data Provenance: Not explicitly stated regarding country of origin, but described as "patient (serum) samples," implying collected clinical samples. The study is an analytical/non-clinical study, not a clinical trial, so it's prospective in the sense of testing the new device on these samples.

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

• Not Applicable. This is an in vitro diagnostic device measuring a biomarker concentration. The "ground truth" for method comparison is the measurement obtained by the predicate device and the analytical properties of the reference materials. Expertise is in laboratory medicine and analytical chemistry, not interpretation of images for diagnosis by human experts.

4. Adjudication Method for the Test Set

• Not Applicable. As above, no human expert adjudication is involved in establishing the "ground truth" for quantitative assay validation.

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/ML device, nor does it involve human readers interpreting images.

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

• Not Applicable. While the device operates standalone (human performs the test, the system provides a result), the concept of an "algorithm only" performance study typically refers to AI/ML models. For an IVD, the "standalone performance" is exactly what is described in the precision, linearity, and detection limit sections.

7. The Type of Ground Truth Used

• For precision, linearity, and detection limits: Analyte concentrations of reference materials or patient pools. The "truth" is established by highly controlled laboratory methods.
• For method comparison: Results obtained from the legally marketed predicate device (VITROS Immunodiagnostic CK-MB Reagent Pack, K993068). The predicate serves as the "true" or gold standard against which the modified device is compared. This is a common "ground truth" for demonstrating substantial equivalence for IVDs. While not explicitly stated, these predicate measurements would have been established through a similar robust validation process.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, so there is no "training set" in the sense of machine learning. The device's performance characteristics are inherent to its chemical and biological components and manufacturing process, validated through the non-clinical studies detailed.

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

• Not Applicable. As there is no training set for an AI/ML model, this question is not relevant. The device development involved standard IVD R&D and manufacturing, not machine learning training.

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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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AQT90 FLEX 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.

AQT90 FLEX CKMB CAL cartridge is for in vitro diagnostic use for the calibration of the CKMB Test on the AQT90 FLEX analyzer by establishing points of reference to estimate CKMB values.

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 a breakdown of the acceptance criteria and study information for the AQT90 FLEX CKMB Test Kit, CKMB CAL Cartridge, and LQC Multi-CHECK, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The study proving the device meets its acceptance criteria is a comparison study against a legally marketed predicate device, the VIDAS Creatine Kinase MB (CKMB) Assay (K962549). This is a common approach for 510(k) submissions to demonstrate substantial equivalence.

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Whole blood samples: n = 43 (POC Site 1), n = 46 (POC Site 2), n = 48 (POC Site 3). Total = 137 samples.
  • Plasma samples: n = 44 (POC Site 1), n = 46 (POC Site 2), n = 48 (POC Site 3). Total = 138 samples.
  • Overall total for the comparison study seems to be around 275 samples.
  • The samples used in the comparison study were in the range of 2.1 - 217 ng/mL (µg/L) for plasma and 1.5 - 277 ng/mL (µg/L) for whole blood.
• Data Provenance: Not explicitly stated regarding the country of origin. The study was performed at "POC Sites" (Point of Care Sites), suggesting it was conducted in a clinical or laboratory setting. It is a prospective study in the sense that samples were collected and tested on both the new device and the predicate for comparison.

3. Number of Experts and Qualifications for Ground Truth

This type of diagnostic test (quantitative immunoassay) relies on analytical performance rather than expert interpretation of images or clinical data for its primary ground truth establishment. Therefore, there were no "experts" in the traditional sense (e.g., radiologists) establishing ground truth for the test set. The ground truth for the comparison study is the result obtained from the predicate device (VIDAS Creatine Kinase MB (CKMB) Assay).

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is an analytical comparison with a predicate device, not a human interpretation study requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for imaging devices or devices where human interpretation directly influences the outcome and is being assisted by AI. This submission is for an in vitro diagnostic assay.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, the primary performance data presented is for the standalone algorithm/device performance in comparison to a predicate device. The results (concentration values) are generated directly by the AQT90 FLEX analyzer. There is no "human-in-the-loop" aspect to the CKMB measurement itself, and the study focuses on the analytical agreement between the new device and the predicate.

7. Type of Ground Truth Used

The ground truth used for the comparison study is the results obtained from the predicate device (VIDAS Creatine Kinase MB (CKMB) Assay). For analytical sensitivity and imprecision, the "ground truth" refers to established analytical methods and reference materials, often traceable to international standards (e.g., ERM-AD455/IFCC mentioned for traceability).

8. Sample Size for the Training Set

The provided document does not specify the sample size for a training set. This is typical for a 510(k) submission for a traditional in vitro diagnostic device, which usually involves development, verification, and validation studies but might not explicitly refer to "training sets" in the context of machine learning algorithms. The development of the assay reagents and calibration curve would have involved extensive testing, but not typically referred to as a "training set" as understood in AI/ML.

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

Since no specific "training set" is mentioned in the context of AI/ML, this question is not directly applicable. For a traditional diagnostic assay, the "ground truth" for developing the assay's performance characteristics (e.g., calibration curve, analytical sensitivity, reference ranges) is established through:

• Reference materials (e.g., ERM-AD455/IFCC mentioned for traceability).
• Known concentrations of analyte in control samples.
• Extensive laboratory testing using established analytical methods to define assay parameters.
• Clinical studies to determine reference ranges in a healthy population.

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PATHFAST CK-MB-II test is an in vitro diagnostic test for the quantitative measurement of creatine kinase-MB in heparinized or EDTA whole blood and plasma. Measurements of CK-MB are used in the aid of diagnosis of acute myocardial infarction. This method is for use in clinical laboratory or point of care (POC) settings. The kit includes the reagent cartridges and calibrators.

PATHFAST Myo-II test is an in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized or EDTA whole blood and plasma. Measurements of myoglobin are used to assist in the aid of diagnosis of myocardial infarction (MI). This method is for use in clinical laboratory or point of care (POC) settings. The kit includes the reagent cartridges and calibrators.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Mitsubishi Kagaku Iatron Inc. regarding their PATHFAST CK-MB-II and PATHFAST Myo-II diagnostic tests. It primarily addresses the regulatory approval of these devices and their intended use. It does not include information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or performance evaluation section.

Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory approval and indications for use, not on the detailed technical performance data or study methodology.

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The Stratus® CS Acute Care™ CKMB method is an in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine N-Phosphostransferase, E.C. No 2.7.3.2) in heparinized plasma. Measurements of CKMB can be used in the diagnosis and treatment of myocardial infarction and progressive, Duchenne-type muscular dystrophy. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings.

The Stratus® CS Acute Care™ CKMB Calibrator (CKMB CalPak) is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ CKMB method.

The Stratus® CS Acute Care™ CKMB Dilution Pak (CKMB DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ CKMB TestPak for the measurement of samples with elevated levels of CKMB.

The Stratus® CS Acute Care™ Troponin I method (cTnl) is an in vitro diagnostic assay for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI). Cardiac troponin I can also be used as aid in the risk stratification of patients with acute coronary syndromes (ACS) with respect to their relative risk of mortality. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings.

The Stratus® CS Acute Care™ Troponin I Calibrator (cTnI CalPak) is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ Troponin I method.

The Stratus® CS Acute Care™ Troponin I Dilution Pak (cTnI DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ cTnI TestPak for the measurement of samples with elevated levels of cardiac Troponin I.

The Stratus® CS Acute Care™ Myoglobin method (MYO) is an in vitro diagnostic assay for the measurement of myoglobin in heparinized plasma. Measurements of myoglobin aid in the rapid diagnosis of renal or heart disease, e.g. myocardial infarction. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings.

The Stratus® CS Acute Care™ Myoglobin Calibrator (MYO CalPak) is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ myoglobin method.

The Stratus® CS Acute Care™ Myoglobin Dilution Pak (MYO DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ MYO TestPak for the measurement of samples with elevated Myoglobin levels.

The Stratus® CS Acute Care™ CKMB method is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. In this procedure, dendrimer linked monoclonal antibody is added to the center portion of a square piece of glass fiber paper in the CKMB TestPak. Sample is then added onto the paper where it reacts with the immobilized antibody. After a short incubation, a conjugate consisting of enzyme-labeled monoclonal antibody directed against a distinct antigenic site on the B subunit of the CKMB molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzyme-labeled antibody reacts with the bound CKMB, forming an antibody-antigen-labeled antibody sandwich. The unbound labeled antibody is later eluted from the field of view of the Stratus® CS analyzer by applying a substrate wash solution to the center of the reaction zone. By including substrate for the enzyme within the wash solution, initiation of enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of CKMB in the sample. The reaction rate is measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer.

The Stratus® CS Acute Care CKMB calibrator (CKMB CalPak) is a refrigerated liquid product containing human heart CKMB in a buffered bovine protein matrix with stabilizers and preservative. The kit consists of five CalPaks at a single calibrator level. Each CalPak contains calibrator reagent in three wells.

The Stratus® CS Acute Care CKMB Diluent (CKMB DilPak) is a refrigerated liquid product containing buffered human protein matrix with stabilizers and 0.2% sodium azide. The kit consists of 5 DilPaks with diluent in one well.

The Stratus® CS Acute Care™ Troponin I method is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. In this procedure, dendrimer linked monoclonal antibody is added to the center portion of a square piece of glass fiber paper in the c TnI TestPak. This antibody recognizes a distinct antigenic site on the cardiac troponin I molecule. Sample is then added onto the paper where it reacts with the immobilized antibody. After a short incubation, a conjugate consisting of enzyme-labeled monoclonal antibody directed against a second distinct antigenic site on the cardiac troponin I molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzyme-labeled antibody reacts with the bound cardiac troponin I, forming an antibody-antigen-labeled antibody sandwich. The unbound labeled antibody is later eluted from the field of view of the Stratus® CS analyzer by applying a substrate wash solution to the center of the reaction zone. By including substrate for the enzyme within the wash solution, initiation of enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of cardiac troponin I in the sample. The reaction rate can then be measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer.

The Stratus® CS Acute Care Troponin I calibrator (cTnI CalPak) is a frozen liquid product containing native, human troponin complex, in a human serum base with less than 0.1% sodium azide. The kit consists of five CalPaks at a single calibrator level. Each CalPak contains calibrator reagent in three wells.

The Stratus® CS Acute Care Troponin I Diluent (cTnI DilPak) is a refrigerated liquid product containing a buffered human protein matrix with stabilizers and less than 0.1% sodium azide. The kit consists of 5 DilPaks with diluent in one well.

The Stratus® CS Acute Care™ MYO method is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. In this procedure, dendrimer linked monoclonal myoglobin antibody is added to the center portion of a square piece of glass fiber paper in the MYO TestPak. This antibody recognizes a distinct antigenic site on the myoglobin molecule. Sample is then added onto the paper where it reacts with the immobilized antibody. After a short incubation, a conjugate consisting of enzyme-labeled monoclonal antibody directed against a second distinct antigenic site on the myoglobin molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzyme-labeled antibody reacts with the bound myoglobin, forming an antibody-antigen-labeled antibody sandwich. The unbound labeled antibody is later eluted from the field of view of the Stratus® CS analyzer by applying a substrate wash solution to the center of the reaction zone. By including substrate for the enzyme within the wash solution, initiation of enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of myoglobin in the sample. The reaction rate can then be measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer.

The Stratus® CS Acute Care MYO calibrator (MYO CalPak) is a refrigerated liquid product containing human heart myoglobin in a bovine albumin matrix with stabilizers and less than 0.1 % sodium azide. The kit consists of five CalPaks at a single calibrator level. Each CalPak contains calibrator reagent in three wells.

The Stratus® CS Acute Care MYO Diluent (MYO DilPak) is a refrigerated liquid product containing a buffered bovine protein matrix with stabilizers and 0.2 % sodium azide. The kit consists of 5 DilPaks with diluent in one well.

The provided text describes a 510(k) premarket notification for Dade Behring's Stratus® CS Acute Care™ assays (CKMB, Troponin I, and Myoglobin), along with their associated calibrators and diluents. The core of this submission is to achieve substantial equivalence for these products to allow their use in Point-of-Care (POC) settings in addition to the clinical laboratory.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria (e.g., specific thresholds for precision or accuracy). Instead, it relies on demonstrating substantial equivalence to predicate devices and showing that performance in "non-laboratory" (POC) settings is comparable to that in "laboratory" settings.

The key performance metric reported, implicitly serving as the acceptance criterion, is the comparability of precision and accuracy data generated by "non-laboratory" personnel (POC) to that generated by "laboratory" personnel.

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

• Sample Size for Test Set: The document explicitly states: "Method comparison and precision analysis were performed at three different locations (clinical laboratory (LAB), Emergency Department (ED) and Cardiac Care Unit (CCU) within each of two hospitals (2))."
  • It does not provide a specific number of samples or patients included in these method comparison and precision analyses. It only mentions where the testing was conducted.
• Data Provenance: The locations are described as "three different locations (clinical laboratory (LAB), Emergency Department (ED) and Cardiac Care Unit (CCU) within each of two hospitals (2))". This suggests a prospective study design as data was generated at these sites for the purpose of the submission. The country of origin is not explicitly stated, but given the submitter's address (Newark, DE, USA), it's highly likely the study was conducted in the USA.

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

• The document does not mention the use of experts to establish ground truth in the context of diagnostic interpretation for the test set. This type of submission is for in vitro diagnostic (IVD) assays, where the "ground truth" for evaluating performance is typically established by reference methods or clinical diagnosis (e.g., confirmed myocardial infarction) against which the assay results are compared.
• The text focuses on the performance of the assay itself (precision, accuracy) when operated by different personnel. It states: "This data and a summary of information on the operators and their training, from either the ED or CCU, i.e. "non-lab" operators, is also included in the original 510(k)'s." This implies the operators were "trained health care professionals" (as per the intended use), but not necessarily "experts" establishing ground truth in a diagnostic sense for the comparative study.

4. Adjudication Method for the Test Set

• No adjudication method is described in the provided text. The study focuses on comparing quantitative assay results between different operational settings (lab vs. POC) rather than on diagnostic interpretations that would require adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is more common for imaging devices or algorithms that directly assist human interpretation in making a diagnosis where multiple readers evaluate cases.
• This submission is for an in vitro diagnostic (IVD) assay that measures biomarkers. The comparison is between the assay's performance (precision and accuracy) when operated by "laboratory" personnel versus "non-laboratory" personnel, not improving human readers' diagnostic accuracy with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• This question is not directly applicable as the device is an in vitro diagnostic assay (a chemical test), not an AI algorithm. Its performance is inherent to the assay and analyzer, regardless of the operator, though operator technique can influence results.
• The study did evaluate the assay's performance in a standalone manner, meaning the assay itself produced results, and these results were then assessed for precision and accuracy when executed by different types of operators (laboratory vs. "non-lab" or POC). There isn't an "algorithm-only" concept here in the sense of AI.

7. The Type of Ground Truth Used

• For precision, the ground truth is the reproducibility of the assay itself, ideally measured against itself or reference materials.
• For accuracy, the ground truth would typically be established by reference methods for CKMB, Troponin I, and Myoglobin, or clinical diagnosis of the conditions they aid in diagnosing (e.g., acute myocardial infarction).
• However, the text strongly emphasizes substantial equivalence to existing predicate devices. This means the "ground truth" for the new intended use (POC) largely hinges on demonstrating that the results produced by the new method (in POC settings) are comparable to those produced by the predicate devices (which are already accepted) and the same device in traditional lab settings.

8. The Sample Size for the Training Set

• The text does not mention a training set sample size. This is expected because the submission is for an IVD assay, not an AI or machine learning model that typically requires a distinct training phase. The assays' underlying chemistry and calibration are established through development, not a "training set" in the AI sense.

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

• As there is no "training set" in the context of an AI model, this question is not applicable. The development and initial validation of these assays would have followed standard IVD development procedures, establishing analytical performance characteristics (like linearity, limits of detection, interference, etc.) using reference materials and clinical samples. The current submission is primarily about demonstrating equivalent performance for an extended intended use (POC).

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

The ARCHITECT STAT CK-MB assay is a two-step assay to determine the presence of the MB isoenzyme of creatine kinase (CK-MB) in human serum and plasma using CMA technology with flexible assay protocols, referred to as Chemiflex®. In the first step, sample and anti-CK-MB coated paramagnetic microparticles are combined. After incubation and washing, anti-CK-MB acridinium conjugate is added in the second step. Following another incubation and wash, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of CK-MB in the sample and the RLUs detected by the ARCHITECT i* optical system.

Here's a breakdown of the acceptance criteria and study information for the ARCHITECT® STAT CK-MB immunoassay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not explicitly state the exact sample size for the test set used in the clinical performance study. It mentions a "sample stability study" and a "method comparison using the NCCLS Bias Estimation Standard (EP-9A)" which imply a test set was used, but the number of samples is not provided.
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the data 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 provided in the document. The study involved a comparison against a predicate device (AxSYM® CK-MB assay), and the "ground truth" for the test samples would have been the results obtained from the predicate device or a clinical outcome implicitly associated with CK-MB levels. There's no mention of a ground truth established by external experts.

4. Adjudication Method for the Test Set

• This information is not provided in the document. Since the "ground truth" was based on comparison to a predicate device, an explicit expert adjudication method for the test set is unlikely to have been employed in the traditional sense (e.g., multiple experts reviewing and reaching consensus).

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

• No, an MRMC comparative effectiveness study was not done. This device is an immunoassay (a lab test), not an AI-assisted diagnostic imaging device or an AI system designed to aid human readers. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply here.

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

• This is a standalone diagnostic test. The ARCHITECT® STAT CK-MB immunoassay is a device that itself performs the quantitative determination of CK-MB from a sample. It generates a numerical result, which is then interpreted by clinicians. It does not involve a human-in-the-loop performance analysis in the context of an algorithm. Its performance is evaluated compared to a predicate device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• The primary "ground truth" used for evaluating the ARCHITECT® STAT CK-MB assay was the results obtained from the predicate device, the Abbott AxSYM® CK-MB Assay. The study aimed to demonstrate substantial equivalence, meaning the new device's measurements correlated well with the established predicate. The clinical utility of CK-MB values (used to assist in the diagnosis of MI) represents the broader clinical "ground truth" for both devices.

8. The Sample Size for the Training Set

• This information is not applicable/provided in the context of this device's development. Immunoassays are not "trained" in the same way machine learning models are. Their performance is established through rigorous analytical and clinical validation studies using samples, not through a "training set" for an algorithm.

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

• This information is not applicable as there is no "training set" in the context of an immunoassay. The development and validation of an immunoassay rely on established chemical reactions, antibodies, and measurement principles, with performance characterized through analytical studies and comparison to established methods.

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The RAMP CK-MB Assay is a quantitative immunochromatographic test indicated for use as an in vitro diagnostic product used with the RAMP Clinical Reader to measure CK-MB levels in EDTA whole blood. Measurement of CK-MB aids in the rapid diagnosis of acute myocardial infarction (AMI). The RAMP CK-MB Assay is not intended to monitor reperfusion patients. The RAMP CK-MB Assay is intended to be used only to prioritize patient management for those suspected of AMI.

The RAMP CK-MB Assay is a quantitative immunochromatographic test for the determination of CK-MB levels in EDTA whole blood. Diluted EDTA whole blood is added to the sample well of the Test Cartridge which houses the immunochromatographic test strip. The red blood cells are retained in the sample pad, and the separated plasma migrates along the strip. Fluorescent-dyed latex particles coated with anti-CK-MB antibodies bind to CK-MB, if present in the sample. As the sample migrates along the strip, CK-MB bound particles are immobilized at the detection zone, and additional particles are immobilized at the internal control zone. The RAMP Reader then measures the amount of fluorescence emitted by the complexes bound at the detection zone and at the internal control zone. Using a ratio between the two fluorescence values, a quantitative reading is calculated.

Here's an analysis of the acceptance criteria and study proving device performance for the Response Biomedical Corp. RAMP CK-MB Premarket Notification (K033747) based on the provided text:

Important Note: The provided text is a 510(k) summary, which is a regulatory document. It describes the studies performed to demonstrate substantial equivalence to a predicate device, not necessarily pre-defined "acceptance criteria" in the rigorous sense of a clinical trial primary endpoint. Therefore, I will interpret "acceptance criteria" as the performance characteristics and comparative metrics targeted to establish substantial equivalence.

Acceptance Criteria and Reported Device Performance

• 7.7% at 7.19 ng/mL
• 7.8% at 14.29 ng/mL
• 4.8% at 25.06 ng/mL
  Total Precision (%CV):
• 8.6% at 7.19 ng/mL
• 8.5% at 14.29 ng/mL
• 6.9% at 25.06 ng/mL |
  | Linearity (R-value & Slope) | R = 0.999 for actual vs. expected CK-MB concentration
  Slope = 1.05
  Offset = 0.098 |
  | Percent Recovery | Ranged from 99% to 111% (average 106%) for spiked CK-MB antigen (at 2.5, 5.0, 10.0, 20.0, 40.0, and 60.0 ng/mL concentrations) |
  | Hook Effect | No high dose hook effect up to 1000 ng/mL CK-MB |
  | Analytical Sensitivity (Lower Limit of Detection - LLD) | LLD = 0.32 ng/mL CK-MB |
  | Analytical Specificity (Cross-reactivity) | CK-MM and CK-BB: No significant cross-reactivity
  HAMA, HAGA, HARA, RhF: Limited cross-reactivity |
  | Interference | No evidence of cross-reactivity or interference observed for hemoglobin (up to 2000 mg/dL), triglyceride (up to 3000 mg/dL), bilirubin (up to 80 mg/dL), cholesterol, or heparin (up to 104 IU/mL). No trend observed with increasing interferent concentration. |
  | Normal Range | 0.00 to 3.74 ng/mL in a study of 180 healthy individuals (5th to 95th percentile).
  (Compared favorably to Triage: 0.80-4.94 ng/mL and Dimension: 0.10-3.11 ng/mL, and their package inserts). |
  | Precision (Replicate Correlation) | Combined Populations: R=0.993, R²=0.988 (n=183)
  Suspect AMI Patients: R=0.993, R²=0.986 (n=128)
  Normal Individuals: R=0.959, R²=0.920 (n=55) |
  | Method Comparison (Correlation with Predicate Device - Dimension CK-MB Assay) | RAMP CK-MB vs. Dimension:
• Combined Normal and Suspect AMI: R=0.986, R²=0.972 (n=363)
• Suspect AMI: R=0.984, R²=0.967 (n=183)
• Normal: R=0.882, R²=0.779 (n=180) |
  | Method Comparison (Correlation with Predicate Device - Triage CK-MB Assay) | Triage CK-MB vs. Dimension (for context/comparison):
• Combined Populations: R=0.981, R²=0.962 (n=363)
• Suspect AMI: R=0.981, R²=0.963 (n=183)
• Normal: R=0.457, R²=0.209 (n=180) |

Study Details:

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

   • Precision Study: 184 subjects (55 normal, 129 suspected AMI). Data provenance is from "individual hospital criteria," suggesting it might be from sites within Canada or the US, but the specific country is not explicitly stated. The samples were taken and stored refrigerated for up to one day between analyses, implying a prospective or recently collected retrospective setup.
   • Method Comparison Study: 365 subjects (180 normal, 185 suspected AMI). Data provenance similar to the precision study, from "individual hospital criteria." Normal subjects were consented, and waste samples were used for suspected AMI subjects. Samples were processed for rapid tests (RAMP and Triage) within one day, and heparin samples were frozen and sent to a reference lab for Dimension testing. This suggests a mixed prospective/retrospective approach.
   • Expected Values (Normal Range Study): 180 healthy individuals (84 males, 96 females). Data provenance is not specified beyond "normal population studied."

2. 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 device is an in vitro diagnostic (IVD) for measuring a biomarker (CK-MB). The ground truth for such devices is typically the quantitative value obtained from a reference method or predicate device, not expert interpretation of images or clinical diagnoses based on subjective input.
   • For the "Method Comparison Study," the Dimension® RxL Mass Creatine Kinase MB Isoenzyme Flex® assay was used as the reference method (predicate device) against which both RAMP CK-MB and Triage CK-MB were compared. The "ground truth" (or reference standard) in this context is the quantitative CK-MB concentration determined by the Dimension assay.
   • No human experts were used to establish the "ground truth" in the way one might for an imaging AI device; instead, an established laboratory method served as the reference. Clinical criteria for "suspected AMI" were mentioned as selection criteria for patients but not as the ground truth for an individual CK-MB value.

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

   • No adjudication method, as typically described for subjective assessments like clinical diagnoses or imaging interpretations, was mentioned. The comparison was statistical (correlation, slope, intercept) between quantitative measurements from different assays.
   • Outliers were removed from the dataset: "one outlier was removed from the population with suspect AMI" in the Precision Study, and "two outliers were removed from the suspect AMI samples from both the RAMP and Triage analyses" in the Method Comparison Study. This isn't an "adjudication" in the traditional sense but rather a data cleaning step.

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

   • No MRMC or human reader study was mentioned. This device is an in vitro diagnostic assay, not an AI for image interpretation or a decision support tool for human readers. Its performance is measured directly against predicate assays and analytical specifications.

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

   • Yes, the performance characteristics (precision, linearity, sensitivity, specificity, interference) and the method comparison studies represent the standalone performance of the RAMP CK-MB Assay and RAMP Reader system. It's essentially an "algorithm only" in the sense that the device outputs a quantitative value automatically, though it's an assay system rather than an AI algorithm as typically understood for imaging.

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

   • Analytical Performance (Precision, Linearity, etc.): Ground truth was established by controlled laboratory experiments using known concentrations of CK-MB and analysis of samples without known interferents.
   • Clinical Performance (Normal Range, Method Comparison): The "ground truth" or reference was the Dimension® RxL Mass Creatine Kinase MB Isoenzyme Flex® assay. For the normal range study, the normality of individuals was likely based on clinical screening (healthy individuals).

7. The sample size for the training set

   • The document does not explicitly describe a "training set" in the context of machine learning or AI. This is a traditional IVD device (immunochromatographic assay). The development of such an assay involves extensive laboratory work to optimize reagents, antibodies, and detection protocols. This optimization phase isn't typically referred to as "training" in the same way an AI model is trained.

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

   • As there's no explicitly defined "training set" for an AI model, this question is not directly applicable. The development process would have involved establishing the ground truth for various analytical parameters through experiments with known samples and concentrations, guiding the assay's design and calibration.

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The IMMULITE 2500 CK-MB is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.

The IMMULITE 2500 Myoglobin is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of myoglobin in serum and heparinized plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).

The IMMULITE 2500 STAT Troponin I is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).

IMMULITE 2500 CK-MB is a solid-phase, two-site IMMULITE chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.

IMMULITE 2500 Myoglobin is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.

IMMULITE 2500 STAT Troponin I is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.

Please note that the provided text describes an in vitro diagnostic (IVD) device, which measures biomarkers in patient samples. Such devices are evaluated based on analytical performance criteria (e.g., accuracy, precision, linearity, limits of detection) rather than clinical performance criteria like those for AI/ML-driven diagnostic aids. Therefore, many of the requested fields (multi-reader multi-case studies, expert adjudication, ground truth definition for training sets, effect size of human readers improving with AI) are not applicable to this type of device and will be marked as "N/A".

Here's an analysis of the provided text based on your request:

Device Name: IMMULITE® 2500 CK-MB, IMMULITE® 2500 Myoglobin, IMMULITE® 2500 STAT Troponin I

Device Type: In vitro diagnostic (IVD) chemiluminescent enzyme immunoassays for the quantitative measurement of cardiac biomarkers.

Intended Use:

• IMMULITE 2500 CK-MB: Quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.
• IMMULITE 2500 Myoglobin: Quantitative measurement of myoglobin in serum and heparinized plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
• IMMULITE 2500 STAT Troponin I: Quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).

1. Table of Acceptance Criteria and the Reported Device Performance

The provided 510(k) summary documents typically focus on demonstrating substantial equivalence to a predicate device based on similar intended use and technological characteristics, and often summarize the analytical performance data without listing specific pre-defined acceptance criteria values alongside achieved performance. The document states that "The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence." This implies that the presented data met the FDA's requirements for substantial equivalence, which would include acceptable analytical performance.

However, specific quantitative acceptance criteria (e.g., "bias must be less than X%", "CV must be less than Y%") are not explicitly stated in this summary document. The document refers to the data being sufficient for FDA clearance rather than providing a detailed breakdown of acceptance criteria and performance against those criteria.

Note: For IVD devices, acceptance criteria typically include parameters like:

• Precision/Reproducibility: Within-run, between-run, total precision (e.g., %CV at various concentrations).
• Accuracy/Method Comparison: Correlation and agreement with a reference method or predicate device (e.g., Deming regression analysis, absolute bias).
• Linearity/Analytical Measurement Range: The range over which results are proportional to the analyte concentration.
• Limit of Detection (LoD) / Limit of Quantitation (LoQ): The lowest concentration that can be reliably detected/quantified.
• Interferences: Effects of common interfering substances (hemolysis, lipemia, icterus, etc.).
• Specificity: Cross-reactivity with structurally similar compounds.
• Stability: Reagent and calibration stability.

Since these specific quantitative criteria and results are not detailed in the provided text, a comprehensive table cannot be generated. The document only confirms that "The data presented [...] is the data that the Food and Drug Administration used in granting DPC substantial equivalence."

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

The document does not explicitly state the sample sizes used for the analytical performance studies (test sets) or the provenance (country of origin, retrospective/prospective nature) of the samples. For IVD devices, samples are typically patient samples (serum, plasma) collected under defined protocols to assess analytical performance.

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

N/A. For IVD assays measuring biomarkers, "ground truth" is typically established by reference methods, comparison to predicate devices, or clinical diagnosis. The analytical performance studies do not involve experts establishing a "ground truth" in the way a radiological image interpretation study would.

4. Adjudication method for the test set

N/A. Adjudication methods (like 2+1 or 3+1) are common in image interpretation studies or clinical trials where expert consensus is needed to define a ground truth from subjective assessments. This is not applicable to quantitative biomarker measurements in IVD 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

N/A. This is an IVD device measuring biomarkers, not an AI-driven image analysis tool or decision support system that would involve human "readers" or AI assistance.

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

Yes, in a sense, the device operates in a standalone manner as an automated immunoassay system. The analytical performance studies evaluate the device's ability to accurately and precisely measure the target biomarkers in biological samples without direct human-in-the-loop interpretational performance being part of the primary evaluation. The "performance" here refers to the analytical performance of the assay itself.

7. The type of ground truth used

For these IVD products, the "ground truth" for evaluating analytical performance is typically:

• Reference methods: Highly accurate and precise laboratory methods.
• Predicate device comparison: Measurement of the same samples on a legally marketed, substantially equivalent predicate device.
• Assigned values: For quality control materials or calibrators, values might be assigned through rigorous consensus or characterization methods.
• Clinical diagnosis: While not directly establishing "ground truth" for the biomarker level itself, samples may be derived from patients with confirmed clinical diagnoses (e.g., AMI positive, non-AMI negative) to assess clinical performance characteristics (e.g., diagnostic sensitivity and specificity), though this specific detail is not provided in the summary.

The document implicitly suggests that the ground truth was established through comparison with the predicate devices (IMMULITE/IMMULITE 1000 Turbo CK-MB, IMMULITE/IMMULITE 1000 Turbo Myoglobin, IMMULITE/IMMULITE 1000 Turbo Troponin I), common practice for demonstrating substantial equivalence.

8. The sample size for the training set

N/A. This is an immunoassay kit, not an AI/ML device that requires a training set in the computational sense. The "training" of such a system involves the development and optimization of the chemical reagents and assay protocols.

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

N/A. As above, the concept of a "training set" and establishing ground truth for it is not applicable to a traditional immunoassay. Assay development involves optimizing reagents and parameters to achieve desired analytical performance characteristics.

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The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum and plasma using the Access Immunoassay Systems. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction.

The Access CK-MB reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, and Synchron LXi 725) comprise the Access Immunoassay Systems for the quantitative determination of CK-MB in human serum and plasma.

This document describes the analytical studies performed for the Beckman Coulter Access CK-MB assay. The studies focus on demonstrating the performance of the device rather than comparing it to human readers or establishing ground truth from expert consensus or pathology, as typically seen in AI-based diagnostic device submissions.

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

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for each metric. Instead, it presents the results of analytical studies to demonstrate the device's performance characteristics. This is common for in-vitro diagnostic devices where the "acceptance" is often implied by meeting established scientific and regulatory standards for assay performance.

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