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Dimension Vista® MMB Assay:
The MMB method is an in vitro diagnostic test for the quantitative measurement of mass creatine kinase MB isoenzyme in human serum and plasma on the Dimension Vista® System for confirmation of acute myocardial infarction.

Dimension Vista® 1500 System:
The Siemens Healthcare Diagnostics Dimension Vista® 1500 System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista® chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use.

Dimension Vista® MMB Assay:
The MMB method is a homogeneous sandwich chemiluminescent immunoassay based on LOCI® technology. LOC10 reagents include two synthetic bead reagents and a biotinylated antimass creatine kinase MB isoenzvme monoclonal antibody fragment. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitive dye. The second bead reagent (Chemibeads) is coated with a second anti-mass creatine kinase MB isoenzyme monoclonal antibody and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibody to form a beadmass creatine kinase MB isoenzyme-biotinylated antibody sandwich. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex by light at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of the mass creatine kinase MB isoenzyme concentration in the sample.

The Dimension Vista® 1500 System:
The Dimension Vista® 1500 System is a floor model, fully automated, microprocessor-controlled, integrated instrument system that uses prepackaged Flex reagent test cartridges to measure a variety of analytes in human body fluids. The system is a multi-functional analytical tool that processes chemical and immunochemical methodologies, utilizing photometric, turbidimetric, chemiluminescence, nephelometric, and integrated ion selective multisensor detection technologies for clinical use. The Dimension Vista® 1500 System can analyze up to 1500 tests/hour (typical, depending on the method mix) using a variety of analytical detection capabilities. Dimension Vista® 1500 System detection technologies are: Photometric, Turbidimetric, Chemiluminescent, Nephelometric, Multisensor, ion selective technology

The Siemens Healthcare Diagnostics Dimension Vista® MMB Assay is an in vitro diagnostic test for the quantitative measurement of mass creatine kinase MB isoenzyme in human serum and plasma for confirmation of acute myocardial infarction. The K143720 submission describes the modification of the Dimension Vista® 1500 System with a new photomultiplier tube (PMT) and its impact on the MMB assay.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a separate section with pass/fail thresholds. Instead, it presents performance characteristics (method comparison, precision, linearity, LoB, LoD, LoQ) for the modified system and implicitly assumes that these demonstrate substantial equivalence to the predicate device. For this response, I will interpret the performance data provided as the "reported device performance" and infer the implied "acceptance criteria" based on the comparison to the existing predicate and typical performance expectations for such devices.

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

• Test Set Sample Size: 111 native de-identified human serum and plasma samples were used for the method comparison study.
• Data Provenance: The samples were described as "native de-identified human serum and plasma samples," implying they were clinical samples. The country of origin is not explicitly stated, but given the manufacturer (Siemens Healthcare Diagnostics Inc. Newark, DE) and the submission to the FDA, it is likely the studies were conducted in the US or using samples relevant to the US market. The study is prospective in the sense that the samples were analyzed on both the predicate and modified devices specifically for this comparison study.

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

N/A - This device is an in vitro diagnostic assay that provides a quantitative measurement of an analyte (CK-MB). The "ground truth" for method comparison and performance evaluation is typically established by comparing the device's results to a legally marketed predicate device, a reference method, or by analyzing samples with known concentrations (e.g., in linearity or precision studies using controls or spiked samples). There are no human "experts" establishing a "ground truth" diagnosis for the purpose of validating the assay's analytical performance; rather, the predicate device serves as the comparator.

4. Adjudication Method for the Test Set

N/A - No human adjudication was performed or is relevant for this type of analytical performance study. The comparison is objective, based on quantitative measurements against a predicate device.

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 typically relevant for devices where human interpretation of images or other qualitative data is involved, and the AI's role is to assist human readers. The Dimension Vista® MMB Assay is an IVD device that provides quantitative measurements, not requiring interpretation by multiple readers in an MRMC setting for its analytical validation.

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

Yes, the studies presented are effectively "standalone" performance evaluations of the Dimension Vista® MMB Assay on the modified Dimension Vista® 1500 System. The device's performance (accuracy, precision, linearity, limits) is assessed purely analytically, without human intervention in the measurement process itself, beyond sample loading and general system operation. The comparison is between two automated systems (predicate vs. modified).

7. The Type of Ground Truth Used

The "ground truth" for the test set (111 samples) in the method comparison study was the measurements obtained from the predicate device (Dimension Vista® MMB assay on the Dimension Vista® 1500 Integrated System K051087). For precision, linearity, LoB, LoD, and LoQ studies, the ground truth was established by using characterized control materials, pooled plasma samples, or serially diluted samples with known theoretical concentrations.

8. The Sample Size for the Training Set

N/A - This device is not an AI/ML-driven algorithm that requires a "training set" in the conventional sense of machine learning. The system is based on chemiluminescent immunoassay technology and instrumental measurements, not a learned algorithm that processes data like images. Therefore, the concept of a "training set" for an algorithm is not applicable here.

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

N/A - As explained above, there is no "training set" for this type of IVD device.

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The EasyRA Creatine Kinase-MB (CK-MB) Reagent is intended for the quantitative determination of CK-MB activity in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurements of CK-MB activity are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. For in vitro diagnostic use only. For prescription use only.

Medica's EasyRA C-Reactive Protein (CRP) Reagent is intended for use in the quantitative in-vitro diagnostic determination of C-reactive protein in human serum or plasma using the EasyRA clinical chemistry analyzer. Measurements of C-reactive protein aids in evaluation of the amount of injury to body tissues. For in-vitro diagnostic use only. For prescription use only.

The EasyCAL C-Reactive Protein (CRP) Calibrator Kit is used for calibrating the CRP assay on the EasyRA clinical chemistry analyzer when used in conjunction with EasyRA CRP Reagent. The CRP calibrators are used to establish points of reference that are used in the determination of values in the measurement of CRP in human serum and plasma. For in-vitro diagnostic use only. For prescription use only.

The EasyQC C-Reactive Protein (CRP) Quality Control Materials are intended for use as quality control material for the CRP turbidimetric assay, using the EasyRA CRP Reagent and calibrator kit on the EasyRA clinical chemistry analyzer. For in-vitro diagnostic use only. For prescription use only.

Not Found

This document is a letter from the FDA regarding the 510(k) premarket notification for several diagnostic reagents and related calibrator/control materials. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval and indications for use, not performance studies.

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Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma. Measurements of the MB isoenzyme of creatinine kinase are used as an aid in the diagnosis of myocardial infarction.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the indicated Elecsys and cobas e immunoassay analyzers.

The CK-MB STAT (one-step incubation) Assay is a sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection.
Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve (5-point-calibration) provided with the reagent bar code.
The CK-MB STAT (one-step incubation) application is identical to the CK-MB STAT (two-step incubation) assay, the only difference being for the CK-MB STAT (one-step incubation) application, the sample, reagent 1, reagent 2 and microparticles are added at one time.

This document describes the acceptance criteria and study results for the Elecsys CK-MB STAT Immunoassay, a device used for the quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma, as an aid in diagnosing myocardial infarction.

This submission is a Special 510(k), indicating a modification to an existing device, the Elecsys CK-MB STAT (two-step incubation) Assay (K132571). The key difference in the modified device is the change to a one-step incubation protocol and its evaluation on the cobas e 601 Immunoassay Analyzer, compared to the predicate's two-step protocol on the cobas e 411.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to the predicate device by comparing various performance characteristics. The "Acceptance Criteria" for the modified device are generally considered to be equivalent to or better than the performance of the predicate device, or within acceptable clinical laboratory standards.

Study Proving Device Meets Acceptance Criteria:

The study conducted is a method comparison study to demonstrate that the modified Elecsys CK-MB STAT (one-step incubation) Assay on the cobas e 601 Immunoassay Analyzer performs substantially equivalently to the legally marketed predicate device, the Elecsys CK-MB STAT (two-step incubation) Assay on the cobas e 411.

Key Information about the Studies:

1. Sample Size used for the Test Set and Data Provenance:

   • Plasma Type Comparison: For each plasma type (Na Heparin, Li Heparin, K2-EDTA, K3-EDTA), "at least 30" or specific numbers rounded to 34 or 35 samples were used (e.g., 30 for Na Heparin, 35 for Li Heparin, 34 for K2-EDTA, 35 for K3-EDTA).
   • Linearity: 3 series of serum samples were used, with ranges from 0.13 to 563 ng/mL.
   • Precision: Not explicitly stated, but CLSI EP5-A2 guidelines typically involve multiple replicates (e.g., 2 runs per day for 20 days) for multiple samples (e.g., controls and patient samples at different concentrations). The performance values provided (e.g., %CV) are derived from such a study.
   • Interference (Common Pharmaceuticals and Special Drugs): Not explicitly stated, but "11 numerical values" were tested for general interferents, and "18 commonly used pharmaceuticals" and "33 special drugs" were tested.
   • Clinical/Reference Range: 523 female subjects and 568 male subjects ("apparently heart healthy") were used to establish the 99th percentile for the predicate device.
   • Method Comparison: A sample size of n = 115 was used, with CK-MB concentrations ranging from 1.47 ng/mL to 269 ng/mL.
   • Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given that Rochester Diagnostics GmbH (Germany) is the submitter, it is likely that parts of the data originated from Europe, but this is not confirmed. The clinical study for reference ranges specifies "Subjects represented 'apparently heart healthy' population," which implies prospective selection, but the details are scarce.

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

   • For the analytical performance studies (precision, linearity, interference, analytical sensitivity, specificity), the "ground truth" is typically established by the reference methods/standards used for spiking, dilution, or comparison, rather than expert consensus on individual cases. For example, linearity samples are generated by diluting a high-concentration sample with a low-concentration matrix, and the expected values are the "ground truth."
   • For the clinical reference range, the "apparently heart healthy" population was selected based on "exclusion of subjects with known poor cardiac health or known peripheral vascular disease." This implies clinical assessment, but the number and qualifications of experts involved in this selection are not specified.
   • For the method comparison, the "ground truth" implicitly relies on the predicate device's established performance. No external experts are mentioned for establishing ground truth for the test set.

3. Adjudication Method for the Test Set:

   • Not applicable as this is an in-vitro diagnostic device for quantitative measurement, and the studies described are analytical performance evaluations and method comparisons against a predicate device. There is no mention of subjective interpretation of results requiring adjudication.

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

   • No, an MRMC comparative effectiveness study was not done. This type of study typically applies to imaging or diagnostic devices where human reader interpretation is a key component, often comparing AI-assisted reading to unassisted reading. The Elecsys CK-MB STAT Immunoassay is an in-vitro diagnostic test that provides a quantitative numerical result, not an image or complex data requiring human interpretation in the same way.

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

   • Yes, this is effectively a standalone performance study of the modified assay. The device itself (the immunoassay and the analyzer) is an automated system. The studies evaluate the analytical performance of this automated system directly (e.g., precision, linearity, analytical sensitivity, specificity, interference) and compare its output to the predicate device. There is no human-in-the-loop component in the direct measurement and reporting of CK-MB values by the device itself that would require a separate "human-in-the-loop" study.

6. Type of Ground Truth Used:

   • The ground truth for the performance studies is rooted in established laboratory standards, reference materials, and comparative methods.
     • Linearity: Gravimetric dilutions of known concentration samples.
     • Analytical Sensitivity: Statistical treatment of blank and low-concentration samples (CLSI EP17-A standard).
     • Analytical Specificity: Spiking samples with known concentrations of interfering substances (e.g., CK-MM, CK-BB, bilirubin, drugs) and measuring recovery.
     • Method Comparison: The established values measured by the predicate device (Elecsys CK-MB STAT two-step on cobas e 411) serve as the comparative standard.
     • Clinical Reference Range: Derived from measurements in a population of "apparently heart healthy" individuals, based on clinical exclusion criteria.

7. Sample Size for the Training Set:

   • This document describes a premarket notification (510(k)) for a modified immunoassay device, not a machine learning or AI algorithm in the traditional sense that requires a "training set." The development of such an assay involves extensive R&D, reagent formulation, and optimization which can be considered "training," but it doesn't involve a distinct "training set" of patient data in the same way an AI algorithm for image recognition would have. The performance studies detailed are for validation/testing of the developed assay.

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

   • As noted above, the concept of a "training set" and associated "ground truth establishment" is not directly applicable in the context of this traditional immunoassay device's submission. The "training" for such a device is the iterative process of optimizing reagent concentrations, incubation times, antibody pairs, and detection methods during its analytical development, often guided by known chemical principles and calibrated against reference standards. The studies presented here are to validate the final optimized product.

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Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma. Measurements of the MB isoenzyme of creatinine kinase are used as an aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the indicated Elecsys and cobas e immunoassay analyzers.

The CK-MB STAT Assay and the CK-MB Assay are two-step sandwich immunoassays with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve (5-point-calibration) provided with the reagent bar code. The CK-MB STAT application is identical to the CK-MB assay, with the only difference being the length of incubation (9 minutes vs. 18 minutes).

This document describes the 510(k) Summary for the Elecsys CK-MB STAT and Elecsys CK-MB Immunoassays (4th Generation reagent). The purpose of the submission is to market a new reagent developed by Roche Diagnostics, claiming substantial equivalence to the previous 3rd Generation CK-MB STAT assay (K022654). The new reagent is intended for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma, used as an aid in diagnosing myocardial infarction on Elecsys and cobas e immunoassay analyzers.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the performance characteristics of the predicate device and the goals for the new 4th Generation assay. The study demonstrated the performance of the new device (referred to as "4th Generation CK-MB STAT Assay (modified)" or "4th Generation CK-MB 18-Minute assay (modified)") against these implied benchmarks and established its own performance characteristics.

Here's a table summarizing the performance characteristics for both the predicate (3rd Generation Elecsys CK-MB STAT Assay) and the 4th Generation CK-MB STAT Assay (the primary focus of the comparison):

Study Proving Acceptance Criteria:

The studies presented in the 510(k) summary are direct comparisons demonstrating that the new 4th Generation Elecsys CK-MB STAT and Elecsys CK-MB Immunoassays meet performance criteria for substantial equivalence to the predicate device (Elecsys 3rd Generation CK-MB STAT Assay, K022654) and also illustrate the performance characteristics of the new assays themselves.

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

• Method Comparison (4th Gen STAT vs. Predicate): n = 165 serum samples.
• Method Comparison (4th Gen STAT vs. 4th Gen 18-Minute): n = 115 serum samples.
• Precision Testing (4th Gen STAT & 4th Gen 18-Minute): Performed using human serum samples and PreciControl Cardiac II over 21 days, according to CLSI EP5-A2. The number of samples for precision is not explicitly stated as 'n=' for unique patients but rather implied through the CLSI methodology.
• Analytical Sensitivity (LoB, LoD, LoQ): Determined in accordance with CLSI EP17-A requirements, involving n ≥ 60 measurements of analyte-free samples.
• Matrix Comparison (Plasma vs. Serum): 35 tubes collected per anticoagulant (Na-heparin, Li-heparin, K2-EDTA, K3-EDTA).
• Clinical Study/Reference Range Study: N = 760 women, 628 men for 3rd Gen (predicate). For 4th Gen, N=523 female, 568 male for all subjects, and N=120 female, 102 male for subjects with no self-reported risk factors. Subjects were "apparently heart healthy" with exclusion of known poor cardiac health.
• Data Provenance: The document does not explicitly state the country of origin for the patient samples. The studies were conducted internally by Roche Diagnostics. The nature of the studies (method comparisons, precision, analytical sensitivity, matrix comparisons) suggests these were primarily prospective laboratory studies designed to characterize the device's performance, rather than retrospective analysis of existing clinical data. The Clinical Study/Reference Range Study would typically involve prospective collection and analysis of de-identified healthy donor samples.

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

This submission concerns an in vitro diagnostic (IVD) immunoassay, not an imaging device or AI algorithm that requires human experts for ground truth establishment in the same way. The "ground truth" for this device is established through:

• Reference Methods: Comparison against a legally marketed predicate device (Elecsys 3rd Generation CK-MB STAT Assay) and comparison between the two new assays (STAT and 18-minute versions). The predicate device itself was cleared based on its own performance relative to established methods.
• Industry Standards: Adherence to CLSI (Clinical and Laboratory Standards Institute) guidelines (EP5-A2 for precision, EP17-A for analytical sensitivity, EP6-A for linearity). These guidelines define rigorous statistical and experimental approaches for evaluating assay performance.

Therefore, the "ground truth" is not established by a panel of human experts reviewing individual cases but by the analytical characteristics of the device when measured against well-defined reference standards and methods in laboratory settings, overseen by qualified laboratory scientists and statisticians.

4. Adjudication Method for the Test Set:

Not applicable in the context of an IVD immunoassay. Adjudication methods like 2+1 or 3+1 are typically used in clinical imaging studies where multiple human readers interpret results, and a consensus or tie-breaking mechanism is needed to establish ground truth for a dataset. For this immunoassay, performance is evaluated against quantitative measurements from other assays or statistical targets derived from CLSI guidelines.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, particularly in diagnostic imaging. The Elecsys CK-MB STAT and Elecsys CK-MB Immunoassays are standalone laboratory diagnostic devices that provide quantitative measurements, not AI tools designed to assist human readers.

6. Standalone Performance Study (Algorithm Only):

Yes, the studies presented are essentially standalone performance studies of the reagent (the "algorithm" in a broad sense for an IVD). The various performance characteristics (measuring range, precision, analytical sensitivity, analytical specificity, hook effect, interference, and method comparisons) directly represent the performance of the immunoassay system (reagent + instrument) without human-in-the-loop assistance in interpreting the final quantitative result. The device provides a numerical value (ng/mL) directly.

7. Type of Ground Truth Used:

The ground truth for evaluating this immunoassay is primarily based on:

• Reference Measurement (Predicate Device): The performance of the new 4th Generation assay is compared against the established performance of the legally marketed 3rd Generation predicate device.
• Analytical Standards: Performance metrics like precision, analytical sensitivity (LoB, LoD, LoQ), and linearity are established using statistical methods defined by CLSI guidelines (e.g., EP5-A2, EP17-A, EP6-A). This involves using control materials and samples with known or precisely characterized analyte concentrations.
• Biological Samples: Human serum and plasma samples are used to assess performance characteristics, including method comparisons and matrix effects. The "true" value for these clinical samples is often assigned by the reference method or by a highly characterized comparative method.
• Traceability: The CK-MB STAT assay is traceable to the Abbott IMx CK-MB assay and linearized using human recombinant CK-MB from Seradyn, indicating an effort to link its measurements to recognized standards.

8. Sample Size for the Training Set:

The document does not specify a distinct "training set" sample size in the context of machine learning or AI. For IVD reagents, the development process involves extensive internal testing and optimization (which can be considered analogous to "training" and "validation" phases in AI development, but with biochemical and analytical methodology), but these details are typically not provided as specific "training set sizes" in 510(k) summaries. The data presented are performance validation data.

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

As above, the concept of a "training set" and its "ground truth" doesn't directly apply in the machine learning sense here. For reagent development and optimization, the "ground truth" during development would be established through a combination of:

• Known concentration standards and calibrators: Used to ensure the assay accurately measures CK-MB levels.
• Reference methods: Comparing experimental formulations against existing, well-characterized CK-MB assays.
• Clinical samples: Testing various formulations with a wide range of human serum and plasma samples, with consensus values likely derived from established methods or expert laboratories.
• Biochemical principles: Ensuring the immunoassay's capture and detection mechanisms accurately target the MB isoenzyme of creatine kinase.

The summary details the methods for determining analytical performance characteristics, indicating a rigorous scientific approach to developing and validating the device.

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System reagent for the quantitative determination of Creatine Kinase-MB isoenzyme in human serum and plasma on Olympus analyzers.
Measurements of Creatine Kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

In this Olympus procedure: The R1 reagent antibody binds to the M subunit of CK in the serum sample. The B subunit of the enzyme acts on the substrate present in the R2 reagent. CK reversibly catalyzes the transfer of a phosphate group from creatine phosphate to ADP to give creatine and ATP. The ATP is used to produce glucose-6-phosphate and ADP, catalyzed by hexokinase (HK) which requires magnesium ions for maximum activity. The glucose-6-phosphate is oxidized by the action of the enzyme G6P-DH with simultaneous reduction of the coenzyme NADP to give NADPH and 6-phosphogluconate. The rate of increase of absorbance at 340/660 nm due to the formation of NADPH is directly proportional to the activity of CK-MB in the sample.

Here's an analysis of the provided text regarding the Olympus CK-MB Reagent (OSR6x155), focusing on the acceptance criteria and the study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document compares the new Olympus CK-MB (OSR6x155) reagent with a predicate device (Olympus CK-MB OSR6x53). While explicit "acceptance criteria" for performance are not directly stated in the format of a threshold to be met, the comparison with the predicate device implies that performance similar to or better than the predicate is the acceptance standard.

Summary of Acceptance Criteria and Performance:

• Precision: For AU400/400e, the new device shows higher CV% values (less precise) than the predicate for all samples. For AU600/640/640e and AU2700/5400, the new device generally shows lower (better) CV% values than the predicate. Without explicit thresholds, it's hard to say if the higher CVs on AU400/400e meet acceptance, but the improvements on other instruments are positive.
• Assay Range: The new device matches the predicate's assay range.
• Sensitivity: The new device shows a larger change in absorbance per U/L, suggesting potentially better sensitivity than the predicate.
• Method Comparison: The R2 value of 1.000 for the new device is excellent, indicating strong linearity and agreement with the predicate. The slope and intercept are also very close, demonstrating substantial equivalence in performance. The range is comparable although slightly different.
• Interfering Substances: The performance varies. For bilirubin, the new device sometimes shows a higher percentage interference but often allows for higher concentrations of bilirubin (e.g., 40 mg/dL vs 24 mg/dL on AU2700/5400). For lipemia, the new device generally shows a higher percentage of interference but also allows for much higher concentrations of intralipid (e.g., 900 mg/dL vs 200 mg/dL on AU600/640/640e). These differences would need to be evaluated against specific clinical requirements for acceptable interference.

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

The document provides specific data points for precision (using 3 samples per instrument type, but the number of replicates for each sample is not specified). For method comparison, a range of 12-1860 U/L is given, implying a comparison against samples across this range, but the exact number of individual samples is not stated.

Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. Given that it's a submission by "Olympus Life and Material Science Europa GmbH" from Ireland, it's likely the testing was conducted in Europe. The context suggests a prospective laboratory study to generate performance data for the new reagent.

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

This section is not applicable to this type of device. This document describes an in vitro diagnostic (IVD) reagent for quantitative determination of a biomarker (CK-MB). The "ground truth" or reference method for such devices is typically an established laboratory method (e.g., the predicate device or a recognized standard method like the IFCC or Szasz method mentioned). The accuracy is determined by analytical performance against these methods or known concentrations, not by expert consensus on visual assessment or clinical interpretation.

4. Adjudication Method for the Test Set

This section is not applicable to this type of device. Adjudication refers to processes like multiple reviewers resolving discrepancies, which is common in image interpretation or clinical decision-making. For an IVD reagent, performance is objectively measured against analytical standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This section is not applicable to this type of device. MRMC studies are typically for medical imaging or interpretation devices where human readers are involved. This device is an automated laboratory reagent.

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

This is essentially what the performance data presented represents. The "device" (reagent) is used on automated Olympus analyzers to produce quantitative results. The performance characteristics (precision, sensitivity, method comparison, interference) are measurements of the reagent's analytical performance on these instruments, without human interpretation influencing the numerical result.

7. The Type of Ground Truth Used

The ground truth for evaluating the Olympus CK-MB Reagent (OSR6x155) is based on:

• Comparison to a legally marketed predicate device: Olympus OSR6X53 CK-MB method (K971817). The performance of the new reagent is directly compared side-by-side with this predicate.
• Theoretical extinction coefficients: The calibration of the new device is based on the theoretical extinction coefficient for NADPH, while the predicate used NADP. This indicates a reliance on established chemical principles for quantification.
• Modification of established methods: The new procedure is described as a "modification of the IFCC method," which is a widely recognized standard for CK measurements. The predicate was a modification of the Szasz method, another established method. This implies that the 'ground truth' is tied to these established analytical methodologies.

8. The Sample Size for the Training Set

The document does not provide information about a "training set." For an IVD reagent, development typically involves optimizing the chemical formulation and reaction conditions. While there's an R&D phase where different formulations are tested, there isn't a "training set" in the sense of machine learning algorithms. The performance characteristics presented are from verification and validation testing, not a dataset used to "train" the reagent.

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

As there is no "training set" for this type of device in the context of machine learning, this question is not applicable. The "ground truth" for the development of such reagents would involve rigorous chemical and analytical testing against known standards and established reference methods to ensure accurate and reliable measurements.

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The SPIFE CK Kit is used in the identification and quantitation of serum creatine kinase isoenzymes. This test is especially useful in detecting acute myocardial infarction (AMI) when used in conjunction with LD isoenzyme studies.

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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study proving the device meets those criteria.

The document is a 510(k) clearance letter from the FDA for the "SPIFE CK Kit". It states that the device is substantially equivalent to a legally marketed predicate device for the identification and quantitation of serum creatine kinase isoenzymes, particularly useful in detecting acute myocardial infarction. However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Information on experts, adjudication methods, or ground truth establishment for a test set.
4. Details of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes.
5. Information about a standalone algorithm performance study.
6. Details on the type of ground truth used.
7. Sample size for a training set or how its ground truth was established.

This document is a regulatory approval, not a scientific study report.

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Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma. 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 ELECSYS® CK-MB STAT and Elecsys® CK-MB Assays are a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection.

Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve provided with the reagent bar code.

The Elecsys® CK-MB application is identical to the Elecsys® CK-MB STAT assay, the only difference being the length of incubation (18 minutes vs. 9 minutes).

The provided 510(k) summary (K022654) describes the Elecsys® CK-MB STAT and Elecsys® CK-MB Assays, which are in vitro quantitative immunoassays for the MB isoenzyme of creatine kinase. This document focuses on demonstrating substantial equivalence to a predicate device, not on establishing specific acceptance criteria and proving the device meets them through a formal clinical study with ground truth and expert adjudication.

However, based on the information provided, we can extract details about the performance characteristics of the modified devices and how they compare to the original device (which serves as a benchmark for what might be considered "acceptance" for the predicate).

Here’s a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this 510(k) is implicitly derived from the performance of the legally marketed predicate device (the "original device") and the demonstration that the modified devices ("CK-MB STAT (modified device)" and "CK-MB (modified device)") maintain comparable or improved performance characteristics. Since this is an immunoassay and not a diagnostic imaging AI, many of the typical AI-specific criteria (like specificity, sensitivity, ROC AUC) are not directly discussed in the provided text. Instead, the focus is on analytical characteristics.

Note: The "acceptance criteria" here are inferred from the need to demonstrate substantial equivalence. The modified devices either retain the same characteristics as the predicate or show improvements (e.g., standardization method, more detailed expected values).

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

The document does not explicitly state the sample size for any test set or the data provenance (country of origin, retrospective/prospective). The data presented for "Expected values" (median, 97.5th, and 99th percentiles) would have been derived from a study on healthy individuals, but the details of this study are not provided in this summary.

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

This 510(k) pertains to an in vitro diagnostic immunoassay, not a device relying on human interpretation (like radiology images) or clinical expert consensus for its "ground truth" establishment in the way an AI diagnostic tool would. Therefore, this information is not applicable and not provided in the summary. The "ground truth" for an immunoassay largely relies on biochemical reference methods or validated standards.

4. Adjudication method for the test set

As above, this information is not applicable and not provided for this type of in vitro diagnostic device. Adjudication methods like 2+1 or 3+1 are used for expert consensus on image interpretations or clinical diagnoses, which is not the nature of this submission.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic imaging or interpretation tools, not for an automated quantitative immunoassay like the Elecsys® CK-MB. There is no human-in-the-loop component for interpretation in the conventional sense that would necessitate such a study.

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

Yes, in a sense, the performance described here is standalone performance of the assay itself. The Elecsys® CK-MB assays are automated quantitative immunoassays performed on specific analyzers (Roche Elecsys® 1010 / 2010 and Modular Analytics E170). The results are generated by the algorithm/system, and there is no subsequent human interpretation step that would modify the numerical output of the assay. The measured concentrations are the direct output.

7. The type of ground truth used

The ground truth implicitly used for the standardization of the modified devices is the AACC CK-MB reference material (human recombinant CK-MB). This indicates reliance on a well-defined and recognized reference standard for calibration, which serves as the "ground truth" for accurate measurement.

8. The sample size for the training set

The document does not provide information on the sample size for any "training set." This is because the device as described is an immunoassay, not a machine learning or AI model in the modern sense that requires a "training set." The assay relies on established biochemical reactions, calibrated against reference materials, and characterized through analytical validation.

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

Not applicable, as there is no "training set" in the context of an AI/ML model for this immunoassay. The calibration and standardization are established using the AACC CK-MB reference material, which serves as the reference standard for analytical accuracy.

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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 1ª incubation: 15 ul of sample, a biotinylated monoclonal CK-MB-specific antibody and a monoclonal CK-MB-specific antibody labeled with a ruthenium 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.

This document is a 510(k) summary for a medical device and does not contain studies proving the device meets acceptance criteria. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, rather than providing detailed studies against pre-defined acceptance criteria in the way a pharmaceutical trial or a software validation study might.

Therefore, most of the requested information regarding study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from the provided text.

However, I can provide the limited information that is present regarding the device and its intended use.

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

The document does not explicitly state acceptance criteria or report performance against such criteria. It states that the device is "substantially equivalent" to a predicate device, meaning its performance is considered comparable, not necessarily meeting specific numerical thresholds outlined in this submission.

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

Not provided in the document.

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, as this is a laboratory immunoassay device, not an imaging or diagnostic device relying on expert interpretation for ground truth in the traditional sense. Ground truth for an immunoassay typically refers to accurate measurements by a reference method or known concentrations of analytes. However, this information is not provided.

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

Not applicable/not provided.

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 automated immunoassay device, not an AI-powered diagnostic tool requiring human interpretation comparison.

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

The device itself is a standalone immunoassay system. The document describes its mechanism as an automated process: "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." This implies a standalone algorithm's performance in generating quantitative results. However, there's no mention of a separate "standalone study" with specific performance metrics (e.g., sensitivity, specificity, accuracy) detailed in this summary.

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

Not explicitly stated. For an immunoassay, ground truth would typically be established by highly accurate reference methods or known concentrations of the analyte (CK-MB).

8. The sample size for the training set

Not provided. The document describes the assay principle and its components but does not detail internal validation or development datasets.

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

Not provided.

Summary of available information:

• Device Name: Elecsys® CK-MB STAT Assay
• Intended Use: Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase (CK-MB) in human serum and plasma. Used in the diagnosis and treatment of myocardial infarction and muscle diseases.
• Predicate Device: Boehringer Mannheim Elecsys CK-MB STAT (K961501) (first generation).
• Key Modification: Addition of an anti-BB antibody to Reagent 1.
• Claimed Equivalence: Substantially equivalent to the predicate device.
• Assay Principle: Two-step sandwich with Streptavidin microparticles and electrochemiluminescence detection.
• Assay Duration: 9 minutes (rapid STAT assay).

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The MMB Method for the Dimension® RxL Clinical Chemistry System with the heterogeneous immunoassay module is used to quantitatively measure CKMB in human serum and plasma.

The MMB Method for the Dimension® RxL Clinical Chemistry System is a one-step enzyme immunoassay based on the "sandwich" princible. Sample is incubated with chromium dioxide particles, coated with monoclonal anitbodies specific for the CKB subunit, and conjugate reagent (Bgalactosidase labeled monoclonal antibodies specific for CKMB isoenzyme). A particle-CKMB -coniugate sandwich forms during the incubation period. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound ß-galactosidase is combined with a chromogenic substrate chlorophen! red-ß-d-galactopyranoside (CPRG). Hydrolysis of CPRG releases a chromophore (CPR). The color change at 577 nm is directly proportional to the concentration of CKMB in the original sample.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, 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: 137 clinical patient samples
• Data Provenance: The text states "clinical patient samples," implying human origin. It does not provide information about the country of origin or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This information is not provided in the text. The study compares the performance of the new device against a predicate device, which itself is an established method. The "ground truth" here is essentially the results generated by the predicate device.

4. Adjudication Method for the Test Set

• None. The comparison is a direct split-sample analysis between the new device and the predicate device. There is no mention of independent expert adjudication of results from either method.

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

• No. This was not an MRMC study. The comparison was between two analytical methods, not involving human readers interpreting results in a diagnostic setting.

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

• Yes, effectively. The study assesses the performance of the "MMB Method for the Dimension® RxL Clinical Chemistry System" as a standalone analytical device, comparing its output directly to an established predicate device. There is no human intervention mentioned in the measurement process itself that would alter the device's inherent performance.

7. The Type of Ground Truth Used

• Predicate Device Results: The "ground truth" for the comparison is established by the results obtained from the Abbott IMx® Stat CK-MB assay, which is the predicate device. The new device's performance is gauged by its concordance with this established method.

8. The Sample Size for the Training Set

• This information is not provided in the text. The document describes a validation study for the device, not the development or training of the assay itself.

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

• This information is not provided in the text, as no details about a training set are given.

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This in vitro diagnostic procedure is a solid- phase enzyme immunoassay intended for the quantitative determination of CK-MB in human serum or plasma on the Technicon Immuno 1 system. When used in combination with other clinical data such as presenting symptoms and EKG values, measurement of CK-MB aids in the diagnosis of acute myocardial infarction.

The assay is an enzyme label sandwich assay using two monoclonal antibodies. A CK-MB specific antibody is labelled with fluorescein and the Fab' fragment of an antibody specific for the B subunit is labelled with alkaline phosphatase( ALP) The solid phase consists of a suspension of magnetizable particles coated with antibody to fluorescein ( IMP reagent). Sample or calibrator. R1 reagent containing fluorescein - antibody conjugate, R2 reagent containing ALP-antibody conjugate and IMP reagent are mixed and incubated at 37°C. In the presence of CK-MB a fluorescein-conjugate: CK-MB: ALP-conjugate complex is formed and captured by the anti fluorescein antibodies on the magnetic particles. The particles are washed and pNPP (paranitrophenyl phosphate) substrate is added. The ALP in the antibody conjugate reacts with the pNPP to form para-nitrophenoxide and phosphate. Increasing absorbance due to the formation of paranitrophenoxide is monitored at 405 nm and 450 nm. The dose response curve is directly proportional to the concentration of CK-MB in the sample. A quadratic fit through zero is used to construct the dose response curve.

The assay has a range of 0 to 300 ng/ml and calibrators are provided with values of 0, 5, 10, 30, 100 and 300 ng/ml.

All the results reported herein were obtained by using a quadratic fit through zero algorithm to construct the standard curve.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Immuno 1 CK-MB method:

Understanding the Context:

This document describes the performance of the Immuno 1 CK-MB method, an in vitro diagnostic procedure for measuring CK-MB in human serum or plasma. The primary focus of the provided sections is to demonstrate the comparability and stability of results when using plasma samples as opposed to serum, and to establish storage guidelines.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state formal "acceptance criteria" in a tabulated format with pass/fail thresholds. Instead, it presents performance data (regression analysis, imprecision, and storage stability) and implicitly suggests that the observed performance validates the use of plasma samples under specified conditions.

Based on the provided data and the intent to show plasma is comparable and stable, here's a table reflecting implied acceptance or expected performance:

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

• Comparability Study (Plasma vs. Serum):
  • Sample Size:
    • Site 1: 45 samples
    • Site 2: 60 samples
    • Site 3: 55 samples
    • Total: 160 samples
  • Data Provenance: Retrospective and prospective. "Specimens submitted for CK-MB analysis from patients with suspected acute myocardial infarction" (implying clinical samples). "Only specimens from patients who had both serum and lithium heparin plasma samples drawn at the same time were used." The study was conducted at "three independent sites." The country of origin is not specified, but the context generally suggests a developed country (e.g., US or Europe) where such diagnostics are common.
• Imprecision Study (Plasma):
  • Sample Size: 10 volunteer blood donations, from which plasma was spiked and aliquoted. Each aliquot was tested in three replicates. So, 10 samples, with 3 replicates per measurement point.
  • Data Provenance: Prospective (samples from volunteers specifically for the study). Country of origin not specified.
• Stability Study (Plasma):
  • Sample Size: 10 volunteer blood donations (same as imprecision study).
  • Data Provenance: Prospective (samples from volunteers specifically for the study). Country of origin not specified.

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

This type of information is not applicable to this study. The "ground truth" here is the actual concentration of CK-MB in a sample, a quantitative value determined by the Immuno 1 system itself (or implied by its calibration). This is a measurement performance study, not an diagnostic interpretation study by human experts. The comparison baseline for plasma is serum results on the same device.

4. Adjudication Method for the Test Set

This is not applicable. There is no "adjudication" in the sense of resolving discrepancies between human readers or between an AI and human readers. The study involves comparing quantitative measurements from a diagnostic device.

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

This is not applicable. This is an in vitro diagnostic device performance study, not an AI-assisted diagnostic study involving human readers.

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

Yes, the studies described are standalone performance studies of the Immuno 1 CK-MB method. The method itself is an automated laboratory assay (solid-phase enzyme immunoassay). The algorithm used is to "construct the dose response curve" (a quadratic fit through zero) and process results directly from the instrument's optical readings. There is no human interpretation or intervention in the measurement of CK-MB concentration by the algorithm/device. The "performance" being evaluated is the accuracy, precision, and stability of this automated measurement.

7. The Type of Ground Truth Used

The ground truth used in these studies is the quantitative CK-MB concentration as measured by the Immuno 1 system.

• For the comparability study, the "ground truth" for plasma is effectively established by the corresponding serum samples run on the same system, assuming serum is the validated or reference matrix. The regression analysis aims to show that plasma measurements are equivalent to serum measurements.
• For the imprecision and stability studies, the "ground truth" is the established concentration of the spiked CK-MB in the plasma samples, and the consistency of the device's readings against this established value over time and repeated measurements.

8. The Sample Size for the Training Set

• Training Set for the assay's dose response curve: This is built into the assay's calibration process. Calibrators are provided with values of 0, 5, 10, 30, 100, and 300 ng/mL. So, there are 6 calibration points that form the basis for the quadratic fit.
• No other "training set" in the context of machine learning (AI model training) is mentioned or relevant here, as this is a traditional immunoassay.

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

The "ground truth" for the calibrators (the training set for the dose-response curve) is established through:

• Known concentrations: The calibrators are prepared with specific, pre-defined concentrations of CK-MB (0, 5, 10, 30, 100, and 300 ng/mL). These concentrations would be meticulously prepared and verified using highly accurate reference methods or gravimetric techniques by the manufacturer (Bayer Corp.).
• These known concentrations are then used to build the standard curve, allowing the system to convert absorbance measurements into quantitative CK-MB concentrations.

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