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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 Olympus Creatine Kinase MB reagent is for the quantitative determination of Creatine Kinase-MB isoenzyme in human serum on Olympus analyzers.

Not Found

This document is a 510(k) clearance letter from the FDA for the Olympus CK-MB Reagent, not a study report or a detailed technical specification. Therefore, it does not contain the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.

The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices for the indicated use, which is the quantitative determination of Creatine Kinase-MB isoenzyme in human serum on Olympus analyzers.

Therefore, I cannot provide the requested information from the given input.

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