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The Creatine Kinase-MB assay is an in-vitro test for the quantitative determination of the catalytic activity of creatine kinase MB subunit (CK-MB) in human serum and plasma on Roche/Hitachi cobas c systems.

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 Creatine Kinase-MB assay is a two reagent assay for the quantitative determination of creatine kinase-MB (CK-MB) in human serum and plasma on automated clinical chemistry analyzers. The rate of the NADPH formation is directly proportional to the catalytic CK-MB activity. It is determined by measuring the increase in absorbance photometrically.

This document is a 510(k) summary for a medical device called "Creatine Kinase-MB" by Roche Diagnostics. It describes the device, its intended use, technological characteristics, and performance evaluation data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: This document is about a clinical chemistry assay (an in-vitro diagnostic test), not an AI/ML device. Therefore, many of the typical AI/ML study components (like multi-reader multi-case studies, expert adjudication, or separate training/test sets for AI models) are not applicable to this type of device. The "ground truth" here is the reference measurement method or the expected concentration of the analyte.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an in-vitro diagnostic test and not an AI/ML device, the acceptance criteria are not typically expressed as sensitivity/specificity in an MRMC study for diagnostic imaging. Instead, the acceptance criteria relate to analytical performance characteristics. The document presents the performance data against established analytical standards (CLSI guidelines) and comparisons to a predicate device.

Study Details:

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

• Precision (Repeatability & Intermediate Precision):
  • 5 human serum samples and 2 control samples.
  • Measurements: Two aliquots per run, two runs per day for ≥ 21 days on the same analyzer using 3 lots of reagent.
  • Data Provenance: Not explicitly stated (e.g., country of origin), but implies laboratory-based prospective testing as per CLSI guidelines.
• Analytical Sensitivity (LoB, LoD, LoQ):
  • LoB: One analyte-free sample. Measured with three lots, 10-fold determination in 6 runs, over 3 days (60 measurements per lot).
  • LoD: Five samples with low analyte concentration. Measured with three lots, twofold determination in 6 runs, over 3 days (60 measurements per lot).
  • LoQ: 5 human serum samples diluted to low levels. Tested in 5 replicates per sample on 5 days, one run per day.
  • Data Provenance: Implies laboratory-based prospective testing as per CLSI guidelines.
• Linearity:
  • One serum pool and one plasma pool, diluted to 16 (serum) and 18 (plasma) concentrations.
  • Measurements: Measured in triplicate.
  • Data Provenance: Implies laboratory-based prospective testing.
• Endogenous Interferences:
  • Pooled human serum samples spiked with varying levels of interferent.
  • Measurements: Tested in triplicate.
  • Data Provenance: Implies laboratory-based prospective testing.
• Exogenous Interferences (Drugs):
  • Two sample pools (low and high CKMB concentration).
  • Measurements: Aliquots spiked with drugs, determined in triplicate.
  • Data Provenance: Implies laboratory-based prospective testing.
• Method Comparison to Predicate:
  • 105 human serum samples (plus 4 spiked with CK MB rec human).
  • Data Provenance: Not explicitly stated origins of human serum samples, but implies prospective collection for this comparison.
• Matrix Comparison (Anticoagulants):
  • 31 Li Heparin tubes, 30 K2 EDTA tubes, 31 K3 EDTA tubes, and 31 Gel Separation tubes.
  • Data Provenance: Implies prospective collection of samples drawn into different tubes.

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

Not applicable. This is an analytical performance study for an in-vitro diagnostic assay. Ground truth is established by reference methods, known concentrations, or comparison to a predicate device, not by expert medical image interpretation.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or adjudication component in the analytical performance testing described for this device. Measurements are objective quantitative values.

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

Not applicable. This device is an in-vitro diagnostic test, not an AI-assisted diagnostic imaging tool or a device requiring human readers/interpreters in its primary use.

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

This is fundamentally a "standalone" device in the sense that its performance is measured analytically on its own, producing a quantitative result. There is no "human-in-the-loop" performance as would be relevant for an AI-powered diagnostic imaging tool. The device provides a direct measurement.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance studies is based on:

• Reference Methods/Known Concentrations: For precision, linearity, and analytical sensitivity, samples with known or expected concentrations (e.g., controls, highly purified analytes, or diluted samples) are used.
• Comparison to a Legally Marketed Predicate Device: For method comparison, the results from the new device are compared to those obtained from the established predicate device, which serves as a de facto "truth" or reference standard for equivalence.
• CLSI Guidelines: The studies follow CLSI (Clinical and Laboratory Standards Institute) guidelines (e.g., EP5-A3, EP17-A2, EP6-A), which define how analytical performance characteristics should be determined using standard laboratory practices.

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 context of model development. The laboratory studies described are for system validation, not algorithm training.

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

Not applicable. As there is no "training set" for an AI/ML model, there is no ground truth established for such a set.

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ENVOY®500 CK REAGENT KIT is intended for the quantitative in vitro determination of creatine kinase (CK) in buman serum and plasma using the ENVOY 500 Chemistry System.

It is not intended for use in Point of Care settings.

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

ENVOY CK REAGENT KIT is available as kit only. It consists of a bi-reagent R1 and R2 whose composition,

for R1: 125 mmol/L Imidazole buffer, pH 6.10; 25 mmol/L D-Glucose; 25 mmol/L N-Acetyl-L-Cysteine; 12.5 mmol/L Magnesium acetate; 2.4 mmol/L NADP; 2.0 mmol/L EDTA; > 6800 U/L Hexokinase (microorganism);

This document describes the performance characteristics and acceptance criteria for the ENVOY 500 CK REAGENT KIT, an in vitro diagnostic device for the quantitative determination of creatine kinase (CK) in human serum and plasma.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Precision Test Set: 80 measurements for each of 3 levels of samples (Level 1, Level 2, Level 3). Each level was measured two times per run, for two runs per day, for twenty operating days, on two instruments.
• Linearity Test Set: 11 levels of patient pools (for serum).
• Detection Limit Test Set: 15 measurements of 4 samples for LoD; 15 measurements of 4 samples for LoQ.
• Interference Test Set: For each potential interferent, 2 serum sample pools (a low activity pool at 150 U/L and a high activity pool at 1200 U/L) were used. Aliquots of each pool were spiked with increasing interferent concentrations (e.g., 9 concentrations for triglycerides, 7 for unconjugated bilirubin, etc.). Each point was measured in triplicate per run.
• Method Comparison (Serum) Test Set: 100 serum patient samples.
• Method Comparison (Lithium Heparin Plasma) Test Set: 40 plasma specimens (in lithium heparin).
• On Board Stability Test Set: At least 3 levels of sample (high/medium/low) were tested in duplicate at Day 0, and 4 activity levels were analyzed in duplicate for at least 30 days.

Data Provenance: The document does not explicitly state the country of origin for the patient samples or if the data was retrospective or prospective. Given the submitter is ELITech Clinical Systems SAS, France, and the testing was conducted for regulatory submission in the US, it is plausible the studies were conducted in Europe or at contract research organizations. The nature of the studies (e.g., precision, linearity, interference, method comparison) generally involves prospective collection or commercially available control/patient samples for analytical validation.

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

This document describes the analytical performance of an in-vitro diagnostic reagent kit (ENVOY 500 CK REAGENT KIT). For such devices, "ground truth" generally refers to reference methods or measurements by highly calibrated instruments, not expert human interpretation. Therefore, the concept of "number of experts used to establish ground truth" and their qualifications is not applicable in this context. The ground truth for analytical studies is established by:

• Reference materials or calibrators traceable to international standards (e.g., IFCC method for CK).
• Predicate devices or established methods for method comparison studies.
• Precise gravimetric or volumetric preparations for linearity and spiking studies.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (e.g., 2+1, 3+1) is typically relevant for studies involving subjective human interpretation of diagnostic images or data, where discrepancies between readers need to be resolved to establish ground truth for algorithm training or testing.

For the analytical performance studies described for the ENVOY 500 CK Reagent Kit, no such adjudication method was used or is applicable. The measurements are quantitative and objective, following established laboratory protocols and guidelines (e.g., CLSI protocols). Discrepancies would be resolved through re-testing, investigation of instrument or reagent issues, or statistical analysis (e.g., outliers).

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 document describes an in-vitro diagnostic reagent kit, not an AI-based diagnostic device intended for human reader assistance. Therefore, no MRMC comparative effectiveness study involving human readers or AI assistance was performed.

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

This document describes the performance of an in-vitro diagnostic reagent kit that functions on a chemistry analyzer (Envoy 500 Chemistry System). The device itself is the reagent kit, which works in conjunction with the instrument to provide quantitative results. It is not an algorithm or AI-based device. The performance described is inherently "standalone" in the sense that it measures the analytical capability of the reagent-instrument system to quantify CK levels without human intervention in the measurement process itself, beyond sample loading and system operation. No human-in-the-loop performance is relevant for the analytical measurement part of the device's function.

7. The Type of Ground Truth Used

The ground truth for the various analytical performance characteristics was established using:

• Reference Methods/Standards: For traceability, the calibration factor for the ENVOY 500 CK Reagent Kit has traceability to the IFCC method (International Federation of Clinical Chemistry and Laboratory Medicine) recommendations for CK activity determination.
• Predicate Device Comparison: For method comparison, the predicate device (ELITech Clinical Systems CK NAC SL on Selectra ProM analyzer) served as the reference for comparison using patient samples.
• Prepared Samples/Known Concentrations:
  • For linearity, patient pools were prepared by spiking a serum pool and dilution to obtain 11 levels with equidistant activities (known relative concentrations).
  • For detection and quantification limits, samples were prepared by diluting patient samples to obtain specific activities (e.g., approximately 3.5 U/L for LoD, 5 U/L for LoQ).
  • For interference, serum sample pools were spiked with increasing concentrations of known interferents against control samples.
• Statistical Analysis: Precision studies rely on repeated measurements to quantify variability, with "ground truth" derived from the calculated mean and statistical metrics.

In summary, the ground truth is primarily based on reference methods (IFCC), comparison to a legally marketed predicate device, and precisely prepared samples with known (or highly characterized) concentrations/activities.

8. The Sample Size for the Training Set

Not applicable. This device is an in-vitro diagnostic reagent kit, not a machine learning or artificial intelligence-based device that requires a "training set" in the conventional sense. The "training" of such a system involves chemical formulation, optimization of reaction conditions, and calibration procedures using calibrators or reference materials.

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

Not applicable. As stated above, this device does not utilize a "training set" in the context of machine learning. The "ground truth" for developing and optimizing the reagent kit and its associated methods would involve:

• Chemical principles and stoichiometry: The understanding of the enzyme kinetics and chemical reactions being measured (e.g., the IFCC recommended method for CK).
• Reference materials and calibrators: Used to ensure accuracy and traceability of the quantitative measurements.
• Experimental optimization: Through iterative testing and modification of reagent concentrations, pH, and reaction conditions to achieve optimal performance characteristics (sensitivity, specificity, stability, etc.).

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ELITech Clinical Systems CK NAC SL is intended for the quantitative in vitro determination of creatine kinase (CK) in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Creatine phosphokinase and its isoenzymes measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.

ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametric control sera for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.

CK NAC SL is available as kit only. It consists of 2 reagents R1 & reagent R2: Reagent R1 contains: Imidazole buffer (pH 6.10), D-Glucose, N-Acetyl-L-Cysteine, Magnesium acetate, NADP, EDTA, Hexokinase (microorganisms), sodium azide. Reagent R2 contains: Creatine phosphate, ADP, AMP, Diadenosine pentaphosphate, Glucose-6-phosphate Dehydrogenase (G-6-PDH) (micro-organisms), sodium azide.

ELITech Clinical Systems ELICAL2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to the antibodies to HCV and HIV according to FDA-approved methods.

ELITROL I and ELITROL II are two level quality control products consisting of a lyophilized human serum containing constituents at desired levels. ELITROL I and ELITROL II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods.

Here's an analysis of the provided text regarding the ELITech Clinical Systems CK NAC SL device, focusing on acceptance criteria and supporting studies:

Preface: This document primarily details the analytical performance of the ELITech Clinical Systems CK NAC SL reagent, calibrator (ELICAL 2), and controls (ELITROL I and ELITROL II). It is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than defining novel clinical acceptance criteria. The "acceptance criteria" in this context refer to the performance metrics that the device achieved and that were deemed acceptable for substantial equivalence. There are no explicit "acceptance criteria" presented as threshold values that needed to be met; rather, the successful demonstration of performance comparable to the predicate device and established guidelines served as the de facto acceptance.

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned above, explicit numerical acceptance criteria were not predefined in the document. Instead, the reported performance metrics were presented and implicitly accepted if they demonstrated substantial equivalence and adherence to CLSI guidelines. The table below summarizes the key performance characteristics reported for the ELITech Clinical Systems CK NAC SL, its calibrator, and controls.

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

• Precision Study:

  • Sample Size: For each of the 3 levels of samples, 'n' = 80 measurements were performed (presumably 2 runs/day x 2 measures/run x 20 days).
  • Data Provenance: Not explicitly stated, but typically these studies use commercially available control materials or pooled patient samples. Given the context of IVD submissions, these would be laboratory-generated data, likely in a controlled environment. The country of origin is not specified, but the submitter is ELITech Clinical Systems SEPPIM S.A.S in France, so the studies were likely conducted within their facilities or partner labs. Retrospective or prospective is not specified, but it would be prospective data collection for the study.

• Linearity/Assay Reportable Range:

  • Sample Size: Not explicitly stated how many samples were used, but it involved multiple dilutions across the claimed range.
  • Data Provenance: Not specified, but laboratory-generated.

• Detection Limit:

  • Sample Size: 15 measurements of 4 samples (total 60 measurements) with low analyte concentrations.
  • Data Provenance: Not specified, but laboratory-generated.

• Interference Study:

  • Sample Size: Not explicitly stated how many samples were initially spiked with interferents, but the results describe "concentrations up to..." of various interferents.
  • Data Provenance: Not specified, but laboratory-generated using spiked samples.

• Method Comparison Study:

  • Sample Size: 100 patient serum samples.
  • Data Provenance: "100 serum patient samples." The country of origin is not specified. This is prospective data collected for the study.

• Matrix Comparison Study:

  • Sample Size: 40 paired serum and lithium heparin plasma samples.
  • Data Provenance: Patient samples. Country of origin not specified. This is prospective data collected for the study.

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

For this type of in vitro diagnostic device (IVD) for quantitative measurement of creatine kinase (CK), the "ground truth" for the test set is established by:

• Reference Methods: The values of calibrators and control materials are traceable to the IFCC method (Schumann, 2002), which is a widely accepted international reference method for enzymes. This method itself (and its development) would involve expert consensus and established protocols.
• Predicate Device Measurements: In the method comparison study, the predicate device (Roche Diagnostics CKL on a cobas c111 analyzer) essentially serves as the "ground truth" or reference for comparison, reflecting its established accuracy and validation.
• Internal Validation: The value assignment for Elitrol I and II and Elical 2 involves testing against predetermined values on multiple instruments and calculation of median/mean values. This process is overseen by qualified laboratory personnel, but not typically "experts" in the sense of clinicians establishing a diagnosis.

Number of Experts: Not applicable in the traditional sense of medical experts reviewing individual cases. The ground truth relies on established analytical methods and comparisons to a legally marketed predicate device.
Qualifications of Experts: Not applicable for establishing ground truth of individual cases. The reference methods (e.g., IFCC) are developed and maintained by international bodies comprising experts in clinical chemistry and enzymology.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies where a human expert consensus is required for complex qualitative or semi-quantitative assessments (e.g., image interpretation, pathology review).

For this quantitative diagnostic device performing biochemical measurements, such adjudication methods are not applicable. The "adjudication" is inherent in the analytical methods themselves:

• Agreement with Reference Method: Traceability to the IFCC method provides the "gold standard."
• Agreement with Predicate Device: The method comparison study assesses device performance against a legally marketed, previously cleared device.
• Statistical Analysis: Performance is assessed using statistical methods (e.g., regression analysis, CV%) rather than expert consensus on individual data points.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement

No, an MRMC comparative effectiveness study was not done.

MRMC studies are typically performed for devices that involve human interpretation, such as diagnostic imaging systems where multiple readers evaluate cases with and without AI assistance to measure improvements in diagnostic accuracy, efficiency, or confidence.

This submission is for a fully automated in vitro diagnostic reagent and associated calibrators/controls, where the analysis is performed by an instrument (ELITech Clinical Systems Selectra analyzers). There is no "human reader" component in the analytical process that the device assists, therefore, an MRMC study and related effect sizes are not relevant here.

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

The entire performance evaluation described for the ELITech Clinical Systems CK NAC SL device (precision, linearity, detection limits, interference, method comparison, matrix comparison) represents standalone performance.

The device is an "algorithm only" (or rather, a reagent-based chemistry system) that provides quantitative results. There is no human intervention in the generation of the CK concentration value itself beyond the initial sample loading and instrument setup. The performance studies detailed in the submission are precisely evaluating this standalone analytical performance.

7. The Type of Ground Truth Used

The ground truth used for the performance studies is multi-faceted:

• Reference Method Traceability: For calibrators and controls, the values are traceable to the IFCC method (Schumann, 2002), which is an international reference method for creatine kinase. This is a highly robust and standardized form of ground truth based on rigorously defined analytical procedures.
• Predicate Device Values: For the method comparison study, the measurements obtained from the legally marketed Roche Diagnostics CKL reagent on a cobas c111 analyzer served as the comparative ground truth. This is a common approach in 510(k) submissions to demonstrate substantial equivalence.
• Spiked Samples/Known Concentrations: For studies like linearity, detection limits, and interference, samples prepared with known concentrations of the analyte or interferents are used.

8. The Sample Size for the Training Set

The document describes performance studies, which are analogous to validation or test sets. It does not provide information on a "training set".

This type of device (a chemical reagent kit for measuring biomarkers) typically does not involve machine learning algorithms that require a distinct training set in the way AI/ML software devices do. Its analytical characteristics are determined by the chemical principles of the assay and optimization through traditional laboratory methods, not by training on a large dataset of results.

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

As noted in section 8, there is no explicit "training set" reported for this device in the context of an AI/ML algorithm. Therefore, the question of how ground truth for a training set was established is not applicable.

Any internal development and optimization of the reagent formulation or instrument parameters would be based on established chemical principles, analytical testing, and potentially iterative refinement to meet desired performance benchmarks, rather than training on a separate labeled dataset.

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The "Wiener lab. CK-MB DS UV unitest" test system is a quantitative in vitro diagnostic device intended to measure the activity of the MB isoenzyme of creatine phosphokinase in plasma and serum. 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.

Not Found

I am sorry, but the provided text does not contain the detailed study information, acceptance criteria, or device performance metrics needed to answer your request. The document is a 510(k) clearance letter from the FDA for a device called "Weiner lab. CK-MB DS UV unitest," which is a creatine phosphokinase/creatine kinase or isoenzymes test system.

While it mentions the device's intended use and substantial equivalence to a predicate device, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about specific studies, such as sample sizes, data provenance, ground truth establishment, or expert qualifications.
• Information regarding MRMC comparative effectiveness studies or standalone algorithm performance.

The letter is primarily a regulatory communication indicating that the device has met the requirements for market clearance, not a technical report detailing performance study results.

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Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase (CK-MB) in human serum and plasma.

A creatine phosphokinase / creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine kinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy

The Elecsys® CK-MB test principle is based on a two-step sandwich with Streptavidin microparticles and electrochemiluminescence detection.

Total duration of the assay: 9 minutes
1st incubation: 15 µl of sample, a biotinylated monoclonal CK-MB-specific antibody and a monoclonal CK-MB-specific antibody labeled with a ruthenium complex react to form a sandwich complex
2nd incubation: after the addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin.
• The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier.
• Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.

The provided document is a 510(k) summary for the "Elecsys® CK-MB" device, a creatine kinase MB isoenzyme immunoassay. It compares this new device to a predicate device, the "Abbott IMx CK-MB".

This document does not describe acceptance criteria for a study or a study proving the device meets acceptance criteria in the typical format of a clinical trial for an AI/algorithm-based diagnostic device. Instead, it presents performance characteristics of the Elecsys® CK-MB device as part of establishing substantial equivalence to a predicate device for regulatory approval.

Therefore, many of the requested fields are not applicable or cannot be extracted directly from this type of regulatory submission. The information provided is primarily about the analytical performance of the immunoassay.

Here's an attempt to answer the questions based on the available information:

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

The document does not explicitly state "acceptance criteria" in the sense of predefined thresholds for performance that the device must meet to be deemed acceptable. Instead, it presents various performance characteristics and then compares them to the predicate device or a reference method. The goal of this 510(k) summary is to demonstrate that the new device is "substantially equivalent" to the predicate, implying that its performance is comparable and safe/effective.

However, we can infer some implicit performance "targets" or comparisons from the data presented, especially regarding precision and analytical range. The "reported device performance" is directly stated in the table.

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

• Precision:
  • For Elecsys® CK-MB: N = 60 for each of 5 sample types (HS1, HS2, HS3, CCI, CCII).
  • For Abbott IMx CK-MB (predicate): N = 48 for each of 3 sample types (1, 2, 3).
• Method Comparison: N = 95 for comparison against Abbott IMx CK-MB.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This is common for analytical performance studies in 510(k) summaries unless there are specific clinical studies involved.

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

Not applicable. This device is an immunoassay for quantitative determination of a biomarker. The "ground truth" for its performance is established by reference methods or comparison to a predicate device, not by human expert consensus or adjudication in the way an imaging diagnostic device might. The "truth" is the actual concentration of CK-MB as measured by a gold standard or accepted method.

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

Not applicable, for the same reasons as in 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 in-vitro diagnostic (IVD) immunoassay, not an AI-assisted diagnostic tool that involves human readers interpreting results.

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

This is a standalone analytical device. Its performance characteristics (precision, sensitivity, assay range, method comparison, interfering substances, specificity) are inherently "standalone" in this context. It performs the measurement and outputs a quantitative result without human-in-the-loop performance assessment in the way an AI algorithm might be evaluated.

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

The "ground truth" in these analytical studies is typically:

• Reference measurements: For method comparison, the predicate device (Abbott IMx CK-MB) or other established methods (e.g., Hybritech Tandem®-E CK-MB) serve as the reference.
• Known concentrations: For studies like precision, sensitivity, and specificity, samples with known concentrations of the analyte (CK-MB) or interfering substances are used.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a "training set" in the conventional sense. The device's calibration curve is generated via a 2-point calibration and a master curve provided via the reagent bar code, which is an intrinsic part of the manufacturing and operational setup, not a data-driven training process.

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

Not applicable, as there is no "training set" in the machine learning context. For the instrument's internal calibration, the "ground truth" is established by carefully prepared standards with known concentrations, following established analytical chemistry and manufacturing protocols.

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