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For the quantitative determination of creatine kinase activity in serum and plasma. Rx only.

Measurements of Creatine Kinase are used in the diagnosis and treatment of myocardial infaction and muscle disease, such as progressive Duchenne-type muscular dystrophy.

The Pointe Scientific Creatine Kinase (CK) Reagent Set consists of ready-to-use liguid reagents:

• . CK R1 (buffer) contains: Imidazole buffer (pH 6.7) 100.0 mmol/L; NADP 2.0 mmol/L: HK (Baker's yeast) 2.5 KU/L: Glucose 20.0 mmol/L: Magnesium Acetate 10.0 mmol/L; EDTA 2.0 mmol/L and N-acetylcysteine (NAC) 20.0 mmol/L.
• . CK R2 (enzyme reagent) contains: Imidazole buffer (pH 6.7) 100.0 mmol/L: ADP 2.0 mmol/L: AMP 5.0 mmol/L: Diadensosine pentaphosphate 10.0 mmol/L: Creatine phosphate 30.0 mmol/L; G6PDH (Baker's yeast) 1.5 KU/L and EDTA 2.0 mmol/L.

The kinetic procedure presented is a modification of Szasz of the Rosalki technique, which optimizes the reaction by reactivation of CK activity with N-actyl-L-cysteine (NAC).

Creatine Kinase specifically catalyzes the transphosphorylation of ADP to ATP. Through a series of coupled enzymatic reactions, NADPH is produced at a rate directly proportional to the CK activity. The method determines the NADPH absorbance increase per min at 340 nm.

The provided document describes the analytical performance studies for the Pointe Scientific Creatine Kinase (CK) Reagent Set, which supports its substantial equivalence to a predicate device.

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

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

The document doesn't explicitly state "acceptance criteria" in a separate table for each test. Instead, it presents the study results and implies that these results were considered acceptable for demonstrating substantial equivalence. For some tests, like Linearity, an acceptable deviation is stated.

However, based on the provided performance data, we can infer the acceptance criteria that the manufacturer likely aimed for to support their claims.

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

• Method Comparison (Serum):
  • Sample Size: 120 de-identified remnant serum samples. 4 samples were altered by mixing.
  • Data Provenance: Obtained from a commercial repository. Retrospective. Country of origin not specified, but likely within the US given the FDA submission.
• Method Comparison (Plasma):
  • Sample Size: 123 de-identified remnant plasma samples. 2 samples were altered by mixing.
  • Data Provenance: Obtained from a commercial repository. Retrospective. Country of origin not specified.
• Precision Studies:
  • Sample Size: 2 commercial quality controls, 3 serum pools, and 3 plasma pools. Each pool/control was tested in duplicate twice per day for 20 days (n=80 per sample type).
  • Data Provenance: Not explicitly stated, but common practice is for manufacturers to prepare pools or use commercially available controls.
• Linearity/Assay Range Study:
  • Sample Size: A set of 12 serum samples and 12 plasma samples (prepared by admixture of high-level and low-level pools).
  • Data Provenance: Not explicitly stated, likely prepared in-house or from common available resources.
• Detection Capability (LoB, LoD, LoQ):
  • LoB: Saline (1 sample * 20 repetitions * 3 days).
  • LoD: 20 low-level depleted serum samples and 20 depleted plasma samples.
  • LoQ: 5 low activity samples (each run in 8 duplicates over 5 days).
  • Data Provenance: Not explicitly stated, likely prepared in-house or from common available resources.
• Dilution Recovery Studies:
  • Sample Size: Three contrived high-level samples for both serum and plasma.
  • Data Provenance: Not explicitly stated, likely prepared in-house.
• Analytical Specificity (Endogenous Substances):
  • Sample Size: Not explicitly stated, but interference testing was conducted using "randomly selected serum and plasma samples ranging from 43 U/L to 268 U/L."
  • Data Provenance: Not explicitly stated.

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

This is a diagnostic reagent for quantitative determination of an analyte (Creatine Kinase), not an imaging or qualitative diagnostic device requiring expert interpretation of results to establish ground truth.

• Ground Truth for Method Comparison: The predicate device's results (Beckman Coulter Creatine Kinase (CK-Nac) on the Beckman Coulter Olympus AU400 Clinical Chemistry Analyzer) serve as the "reference" or "ground truth" for comparison. This is a common method for demonstrating substantial equivalence for in vitro diagnostic (IVD) devices. No human experts are used to establish ground truth in this context; rather, the established method of the predicate device is the reference.
• Ground Truth for other studies (Precision, Linearity, Detection, Dilution Recovery, Specificity): The "ground truth" is typically established by the analytical method itself, or by preparing samples with known concentrations/characteristics, without the need for human expert consensus.

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

No adjudication method is relevant or mentioned as this device measures an objective biochemical marker. The 'ground truth' is the quantitative measurement itself or the reference method's result.

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. This is not applicable. The device is a diagnostic reagent for quantitative measurement of creatine kinase, not an AI-powered diagnostic system for image interpretation or a device requiring human readers/scorers. Therefore, MRMC studies are not relevant.

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

The device is a reagent set used on an automated chemistry analyzer (Shenzhen Mindray BA-800M Chemistry Analyzer). The performance studies presented are for the "algorithm only" in the sense that they demonstrate the analytical performance of the reagent on the analyzer without human interpretation of the raw data to generate the numerical result. The "human-in-the-loop" would be a lab technician performing the test and reviewing the results, but the analytical performance itself is standalone.

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

• Method Comparison: The results obtained from the legally marketed predicate device (Beckman Coulter Creatine Kinase (CK-Nac) on the Beckman Coulter Olympus AU400 Clinical Chemistry Analyzer) served as the reference for comparison.
• Precision, Linearity, Detection, Dilution Recovery, Analytical Specificity: Ground truth is based on the inherent analytical properties of the method/reagent including samples with known concentrations (e.g., prepared standards, spiked samples, qualified controls, or established reference material). Linearity was assessed against expected values based on known admixtures. Detection limits were determined using statistical methods on low-level and blank samples.

8. The sample size for the training set:

There is no "training set" in the context of this 510(k) submission for a diagnostic reagent. This device is not an AI/machine learning algorithm that requires training data. The studies performed are analytical validation studies.

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

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

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For the in vitro quantitative measurement of creatine kinase activity in serum and plasma on the SK500 Clinical Chemistry System. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

The SEKURE Creatine Kinase Assay (CK Assay) is a spectrophotometric, coupled enzyme assay for the quantitative measurement of creatine kinase (CK) activity. The assay consists of two working reagents, a buffer solution (R1) and a substrate reagent (R2). The SEKURE CK Assay employs the reverse reaction of CK, to produce adenosine triphosphate (ATP). The reaction is coupled to hexokinase and G6PDH which consumes ATP to generate NADPH. The rate of NADPH formation is monitored at 340 nm and is directly proportional to CK activity. Testing is performed on the SK500 in conjunction with calibrator and controls which are provided separately.

The SK500 Analyzer is manufactured as Clinical Chemistry Analyzer Tokyo Boeki Medisys Inc. Biolis 50i Superior. "SK500" is the Sekisui Diagnostics labelled name for the Tokyo Boeki Medisys Inc. Biolis 50i Superior instrument.

This document describes the SEKURE Creatine Kinase Assay, an in vitro diagnostic device, and its performance study to demonstrate substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance

The device performance is evaluated against various analytical metrics. While explicit "acceptance criteria" for each study are not individually listed as pass/fail thresholds in a table, the document reports the results of these studies, implying that the observed performance met internal or regulatory expectations for demonstrating substantial equivalence. The predicate device's characteristics serve as an implicit benchmark for similarity.

Here's a table summarizing the reported device performance, with implied acceptance based on the submission being cleared:

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

• Precision:

  • Sample Size: 80 replicates per sample type (Serum Control 1, Serum Control 2, Serum High Pool, Plasma Low Pool, Plasma Med Pool, Plasma High Pool) for each of two reagent lots. Total of 480 measurements per lot.
  • Data Provenance: Not explicitly stated, but typical for in vitro diagnostic device studies would be laboratory-generated or purchased control materials and pooled human specimens. The study was conducted in-house by SEKISUI DIAGNOSTICS P.E.I. INC.
  • Retrospective/Prospective: Analytical studies like precision are typically prospective, performed under controlled laboratory conditions.

• Analytical Sensitivity (LoB, LoD):

  • Sample Size: 60 measurements for each level (low level samples, saline blanks, dilutions of pooled serum/plasma) for each reagent lot and matrix type.
  • Data Provenance: Not explicitly stated, but likely laboratory-generated materials.
  • Retrospective/Prospective: Prospective laboratory study.

• Limit of Quantitation (LoQ):

  • Sample Size: 40 replicates (8 linear serum samples, 8 linear plasma samples assayed in 5 runs over 3 days) for each reagent lot and matrix type.
  • Data Provenance: Not explicitly stated, but likely laboratory-generated materials.
  • Retrospective/Prospective: Prospective laboratory study.

• Linearity/Assay Reportable Range:

  • Sample Size:
    • Serum: 8 dilutions of pooled serum, tested in quadruplicate on two lots.
    • Plasma: 10 dilutions and admixtures of pooled plasma, tested in quadruplicate on two lots.
  • Data Provenance: Pooled serum and plasma likely from human donors, obtained through commercial biospecimen providers or internal collection (with ethics approval).
  • Retrospective/Prospective: Prospective laboratory study.

• Analytical Specificity (Interference):

  • Sample Size: Minimum of seven interferent concentrations in replicates of five on each of two reagent lots.
  • Data Provenance: Laboratory spiked samples using serum.
  • Retrospective/Prospective: Prospective laboratory study.

• Method Comparison with Predicate Device:

  • Sample Size: 112 serum specimens, tested in duplicate.
  • Data Provenance: Human serum specimens, source not further specified (e.g., country of origin).
  • Retrospective/Prospective: Likely prospective collection or use of banked retrospective samples under controlled laboratory conditions.

• Matrix Comparison (Serum vs. Lithium Heparin Plasma):

  • Sample Size: 75 matched serum and lithium heparin plasma specimens, assayed in duplicate.
  • Data Provenance: Matched human serum and plasma specimens, source not further specified.
  • Retrospective/Prospective: Likely prospective collection or use of banked retrospective samples under controlled laboratory conditions.

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

This type of in vitro diagnostic device (IVDD) for Creatine Kinase measurement, which measures a biochemical analyte, does not typically rely on "experts" in the same way an imaging AI device would. The "ground truth" for these studies is established through:

• Reference Methods: For value assignment (e.g., DC-Cal Multi-Analyte Calibrator traceable to an IFCC reference method).
• Highly Characterized Materials: Pooled serum/plasma, control materials with known target values.
• Statistical Analysis: CLSI guidelines (e.g., EP05-A3, EP17-A2, EP06-A, EP07-A2, EP09-A3) provide the statistical framework for defining performance metrics like precision, linearity, and limits of detection/quantitation.
• Comparison to Predicate: The predicate device's established performance serves as a comparative benchmark.

Therefore, there were no specific "experts" (like radiologists interpreting images) establishing ground truth for individual test cases in the context of this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth for this IVDD study is based on quantitative measurements against reference methods, characterized materials, and statistical analysis, not on subjective interpretations requiring adjudication by multiple readers or experts.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are primarily relevant for imaging devices or AI tools where human interpretation of medical images is involved, and the AI's impact on reader performance is being evaluated. This 510(k) is for an in vitro diagnostic assay, which directly measures an analyte concentration.

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

Yes, the studies presented are all "standalone" in the sense that they evaluate the performance of the SEKURE Creatine Kinase Assay and the SK500 analyzer system based on their analytical capabilities to directly measure CK activity. There is no "human-in-the-loop" component in the direct measurement process or the evaluation of its analytical performance. The device provides a quantitative result without human interpretive input for the measurement itself.

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

The ground truth used here is primarily analytical ground truth based on:

• Reference Methods: Specifically, the CK activity value assignment for DC-Cal is traceable to an IFCC reference method.
• Characterized Materials: Pooled serum and plasma with known or expected CK activity levels derived from rigorous analytical testing.
• Statistical Models: Ground truth for linearity (theoretical values) and detection limits (through statistical calculation as per CLSI guidelines).
• Comparison to a Legally Marketed Predicate Device: The predicate device's performance (Creatine Kinase-SL Assay on a Hitachi 717 Analyzer) serves as a comparative ground truth for demonstrating substantial equivalence.

8. The sample size for the training set

This submission pertains to the performance validation of a diagnostic assay (reagents and analyzer), not a machine learning or AI algorithm in the traditional sense that requires distinct "training sets" and "test sets" for model development and validation. Therefore, there is no explicit separate "training set" described for an AI model.

The "training" of such a system involves the development and optimization of the assay chemistry and instrument parameters. The data presented here are part of the verification and validation (V&V) studies conducted on the final product to demonstrate its performance characteristics and substantial equivalence, akin to a "test set" for a traditional product.

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

As there isn't a "training set" in the context of an AI algorithm, the concept of establishing ground truth for it doesn't apply directly here. The development of the assay involves standard analytical chemistry principles, optimization of reagent concentrations, reaction conditions, and instrument calibration, with performance iteratively assessed against established analytical standards and clinical relevance. This is an engineering and chemistry development process rather than an AI model training process that relies on labeled datasets.

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ADVIA Chemistry® Creatine Kinase (CK_L) Assay:

The ADVIA Chemistry® Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy.

ADVIA Chemistry® Enzyme 3 Calibrator:

ADVIA Chemistry® Enzyme 3 Calibrator is intended for in vitro diagnostic use in the calibration of the ADVIA Chemistry Creatine Kinase (CK L) assay on the ADVIA Chemistry systems.

ADVIA Chemistry Creatine Kinase (CK L) assay is a ready-to-use liquid reagent packaged for use on the automated ADVIA Chemistry systems. Creatine Kinase reacts with creatine phosphate and ADP to form adenosine triphosphate (ATP), which is coupled to the hexokinase-G6PD reaction, generating NADPH. The concentration of NADPH is measured by the increase in absorbance at 340/596 nm.

ADVIA Chemistry ENZ 3 CAL:

ENZ 3 CAL is a liquid frozen human serum albumin based product containing creatine kinase MM from human heart. Enzyme 3 Calibrator kit consists of six vials of the same calibrator which is ready for use (no preparation is required).

The provided document is a 510(k) Premarket Notification for an in vitro diagnostic device, the ADVIA Chemistry® Creatine Kinase (CK L) Assay and ADVIA Chemistry® Enzyme 3 Calibrator. It describes the device's technical specifications, intended use, and performance characteristics to demonstrate substantial equivalence to a legally marketed predicate device.

However, the request asks for information relevant to the development and validation of an AI/ML-driven medical device, which typically involves acceptance criteria for model performance (e.g., accuracy, sensitivity, specificity), study design for clinical validation (e.g., test set sample size, ground truth establishment by experts, MRMC studies), and training set details.

The provided document describes the analytical validation of a chemical assay, which measures the concentration of a substance (Creatine Kinase) in human samples. Its performance is evaluated through parameters like method comparison, precision, linearity, detection capability, and interference testing. These are fundamentally different from the performance metrics and study designs used for AI/ML devices, which often involve image analysis, pattern recognition, and diagnostic classification.

Therefore, the provided text does not contain the information requested regarding acceptance criteria related to AI/ML device performance, expert adjudication, MRMC studies, or training set details typical of AI/ML model development.

I cannot create the table or answer the specific questions about an AI/ML device's acceptance criteria and study data based on the provided document. The document describes a traditional in-vitro diagnostic assay rather than an AI/ML-driven device.

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Randox Liquid CK-MB: The Randox Liquid CK-MB test system is a device intended for the quantitative in vitro determination of CK-MB concentration in serum and plasma. Measurements of CK-MB are used in the diagnosis and treatment of myocardial infarction (MI). This product is suitable for use on the RX series instruments including the RX Daytona and the RX Imola.
Randox CK-MB Calibrator: The Randox CK-MB calibrator is an in vitro diagnostic product intended for use in the calibration of Randox CK-MB methods.
The Randox Liquid CK-MB test system for the RX Imola is a prescription use device intended to be used in clinical laboratories only.

Liquid CK-MB is supplied in a kit containing:

• 4 x 20.0 mL CK-MB Buffer
• 4 x 6.0 mL CK-MB Substrate.
  The CK-MB calibrator is lyophilised, single analyte, human serum based product. The kit contains ten vials (single level) with 1.0 mL per vial. Double de-ionised water is required for reconstitution.

Here's a summary of the acceptance criteria and the study details for the Randox Liquid CK-MB and Randox CK-MB Calibrator, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document outlines performance characteristics rather than explicit "acceptance criteria" in a pass/fail table. However, implied acceptance is demonstrated by the reported empirical results.

Note: Intralipid interfered, and the recommendation is to use clear, non-lipemic serum and plasma.

2. Sample Size and Data Provenance for Test Set

• Precision/Reproducibility:
  • Human Serum Samples (Spiked): 5 levels (10U/L, 50U/L, 250U/L, 450U/L, and 1100U/L).
  • Calibrator and Control Material: 1 level each.
  • Testing Protocol: 20 or 21 non-consecutive days, twice per day, 2 replicates per run. This totals 80-84 measurements per sample type.
  • Data Provenance: Not explicitly stated, but "unaltered human serum samples" and "control material" are mentioned. The origin (country, retrospective/prospective) is not provided.
• Linearity/Assay Reportable Range:
  • Samples prepared at 11 levels.
  • Data Provenance: Not explicitly stated.
• Detection Limit:
  • 300 determinations with 1 blank and 4 low-level samples for LoD.
  • Data Provenance: Not explicitly stated.
• Analytical Specificity:
  • Two serum pools (20U/L and 415U/L) spiked with various interferents.
  • Data Provenance: Not explicitly stated.
• Method Comparison:
  • RX Daytona: 90 serum samples (6 spiked)
  • RX Imola: 93 serum samples (4 spiked)
  • Data Provenance: "Patient samples," but no country of origin or retrospective/prospective information is given.
• Matrix Comparison:
  • RX Daytona (Lithium Heparin): Minimum of 72 matched patient sample pairs.
  • RX Daytona (Potassium EDTA): Minimum of 71 matched patient sample pairs.
  • RX Imola (Lithium Heparin): Minimum of 71 matched patient sample pairs.
  • RX Imola (Potassium EDTA): Minimum of 71 matched patient sample pairs.
  • Data Provenance: "Patient samples," but no country of origin or retrospective/prospective information is given.
• Expected Values/Reference Range:
  • 40 normal donors (16 Male, 24 Female; age 17-69).
  • Data Provenance: "human serum from 40 normal donors." No country of origin or retrospective/prospective information is given.

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

There is no mention of experts being used to establish ground truth for the test set. The performance is based on analytical measurements and comparisons to a predicate device, which is typical for in vitro diagnostic (IVD) device submissions of this nature.

• No number of experts mentioned.
• No qualifications mentioned.

4. Adjudication Method for the Test Set

Not applicable. The study involves quantitative analytical measurements and comparisons rather than subjective assessments requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating a diagnostic image interpretation aid rather than an in vitro diagnostic reagent.

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

Yes, the studies presented are all standalone performance evaluations of the analytical device (reagent used on the RX Daytona and RX Imola instruments). There is no human-in-the-loop component described for these performance characteristics.

7. The Type of Ground Truth Used

The "ground truth" for this in vitro diagnostic device is primarily established by:

• Measured concentrations: For precision, linearity, detection limits, and analytical specificity, the "truth" is the actual or expected concentration of CK-MB in the prepared samples or controls.
• Predicate device measurements: For method comparison, the "ground truth" or reference is the results obtained from the legally marketed predicate device (Roche CK-MB Kit on Hitachi 717).
• Statistical analysis: For characteristics like precision, correlation coefficients serve as measures of agreement and performance.
• Clinical consensus/literature: For expected values/reference range, the results are compared against an established range (<25 U/L) from cited literature.

8. The Sample Size for the Training Set

No explicit "training set" is mentioned for this device performance evaluation. IVD performance studies typically focus on validation of a pre-defined method rather than training an algorithm.

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

Not applicable, as no training set is mentioned in the provided text.

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Vital Diagnostics CPK Reagent is a device intended for the in vitro quantitative determination of creatine phosphokinase activity in human serum or 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.

Vital Diagnostics CPK Reagent

The provided text is a 510(k) clearance letter for a medical device called "Vital Diagnostics CPK Reagent". It primarily focuses on the regulatory approval of the device and its indications for use. The document does not contain information about the acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation reports or performance studies.

Therefore, I cannot populate the requested information. The document is strictly a regulatory approval letter.

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The creatine kinase MB (MBI) method is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB isoenzyme activity in human serum and plasma on the Dimension Vista® clinical chemistry system. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

The CKI method is an in vitro diagnostic test for the quantitative measurement of creatine kinase in human serum and plasma on the Dimension Vista® chemistry system. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Dimension Vista® (CKI) Flex® Reagent Cartridge (K2038): In a coupled enzyme reaction, the creatine kinase in patient samples catalyzes the transphosphorylation of phosphate from creatine phosphate to adenosine-diphosphate (ADP) producing adenosine-triphosphate (ATP). Hexokinase (HK) phosphorylates glucose from the ATP to phosphorylate glucose. The resulting glucose-6-phosphate is oxidized by glucose-6-phosphate dehydrogenase (G-6-PDH) with the simultaneous reduction of nicotinamide adenine dinucleotide phosphate (NADP). The rate of formation of NADPH is directly proportional to the CK activity in the sample and is measured bichromatically at 340 and 540 nm.

Dimension Vista® (MBI) Flex® Reagent Cartridge (K2032): The activity of the CK-MM isoenzyme is inhibited by an antibody specific for the CK-M subunit. The activity of the B subunit of creatine kinase MB isoenzyme is not inhibited, and it is on this basis that CK-MB can be measured. In an enzyme coupled reaction, creatine kinase in patient samples catalyzes the transphosphorylation of creatine phosphate to adenosine-diphosphate (ADP), producing adenosine-triphosphate (ATP). Hexokinase (HK) uses the ATP to phosphorylate glucose. The resulting glucose-6-phosphate is oxidized by glucose-6-phosphate dehydrogenase (G-6-PDH) with the simultaneous reduction of nicotinamide adenine dinucleotide phosphate (NADP) to NADPH. The rate of formation of NADPH is measured bichromatically at 340, 540 nm and is directly proportional to CK-B activity in the sample.

This document describes the 510(k) summary for the Dimension Vista® Creatine Kinase Flex® and Creatine Kinase MB Flex® Reagent Cartridges (K2038 and K2032, respectively).

Here's an analysis of the provided text to extract the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document establishes substantial equivalence by comparing the performance characteristics of the new Dimension Vista® cartridges with their predicate devices, Dimension® CKI (DF38) and MBI (DF32) Flex® Reagent Cartridges (K081731). The acceptance criteria are implicitly defined by the performance of the predicate device, and the new devices are deemed to "demonstrate substantial equivalent performance."

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

The document states, "Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance." However, it does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective).

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

This information is not provided in the document. For in vitro diagnostic tests like these, "ground truth" is typically established by reference methods or validated laboratory results, not by human expert interpretation of images or other subjective data.

4. Adjudication method for the test set:

This information is not applicable as the "test set" in this context refers to clinical samples analyzed by the device, not data requiring expert adjudication.

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

This is not applicable as the device is a reagent cartridge for an in vitro diagnostic assay, not an AI-powered diagnostic imaging tool that would involve human readers.

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

The device is inherently a "standalone" system in the sense that it performs the measurement algorithmically without a human actively interpreting its real-time output for a diagnostic decision in the same way an AI for image analysis would. The device generates quantitative results, which are then used by clinicians for diagnosis and treatment. Therefore, the performance presented is standalone performance of the reagent cartridges on the Dimension Vista® system.

7. The type of ground truth used:

The "ground truth" for evaluating these reagent cartridges would typically be established by:

• Reference methods: Highly accurate and precise laboratory methods for measuring Creatine Kinase (CK) and Creatine Kinase MB (CK-MB).
• Validated laboratory results: Measurements obtained using existing, cleared devices that are considered reliable standards.

The document implicitly refers to this by stating "comparative testing" with the predicate devices, meaning the predicate device results served as the reference for determining substantial equivalence.

8. The sample size for the training set:

This information is not provided in the document. For in vitro diagnostic reagents, there isn't a "training set" in the machine learning sense. The "development" or "optimization" phase would involve testing various formulations and conditions, but this is not typically referred to as a "training set" with explicit sample sizes in the regulatory submission summary for such devices.

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

This information is not provided and is generally not applicable in the context of traditional in vitro diagnostic reagent development in the same way it would be for an AI algorithm. The "ground truth" would be established by the rigorous chemical and enzymatic principles underlying the assay and validated against known standards and reference materials during the development and manufacturing process.

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The CKI method is an in vitro diagnostic test for the quantitative measurement of creatine kinase in human serum and plasma on the Dimension® clinical chemistry system. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

The creatine kinase MB (MBI) method is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB isoenzyme activity in human serum and plasma on the Dimension® clinical chemistry system. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

The CKI/MBI CAL is an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension® clinical chemistry system.

Dimension® (CKI) Flex® Reagent Cartridge (DF38): In a coupled enzyme reaction, the creatine kinase in patient samples catalyzes the transphosphorylation of phosphate from creatine phosphate to adenosine diphosphate (ADP) producing adenosine-triphosphate (ATP). Hexokinase (HK) phosphorylates glucose from the ATP to phosphorylate glucose. The resulting qlucose-6-phosphate is oxidized by qlucose-6-phosphate dehydrogenase (G-6-PDH) with the simultaneous reduction of nicotinamide adenine dinucleotide phosphate (NADP). The rate of formation of NADPH is directly proportional to the CK activity in the sample and is measured bichromatically at 340 and 540 nm.

Dimension® (MBI) Flex® Reagent Cartridge (DF32): The activity of the CK-MM isoenzyme is inhibited by an antibody specific for the CK-M subunit. The activity of the B subunit of creatine kinase MB isoenzyme is not inhibited, and it is on this basis that CK-MB can be measured. In an enzyme coupled reaction, creatine kinase in patient samples catalyzes the transphosphorylation of creatine phosphate to adenosine-diphosphate (ADP), producing adenosine-triphosphate (ATP). Hexokinase (HK) uses the ATP to phosphorylate glucose_The resulting glucose-6-phosphate is oxidized by glucose-6phosphate dehydrogenase (G-6-PDH) with the simultaneous reduction of nicotinamide adenine dinucleotide phosphate (NADP) to NADPH. The rate of formation of NADPH is measured bichromatically at 340, 540 nm and is directly proportional to CK-B activity in the sample.

CKI/MBI Calibrator (DC32): CKI/MBI CAL is a liquid, multi-analyte, human serum albumin based product containing creatine kinase (human source) and creatine kinase MB (porcine source). The kit consists of four vials per level (2 and3) with 2.0 mL per vial. Level 1 calibrator for CKI/MBI is not included in the CKI/MBI CAL carton. Purified Water Diluent or reagent grade water is required for use as Calibrator Level 1. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dimension® Creatine Kinase MB Flex® Reagent Cartridge (DF32) and CKI/MBI Calibrator (DC32):

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list "acceptance criteria" with numerical targets for performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices. The performance is implied by the comparison tables, showing that the new devices perform comparably to the predicates in terms of intended use, technology, measuring range, and analytical sensitivity.

Without explicit acceptance criteria, we can infer the reported device performance from the comparison to the predicate devices.

For CKI (DF38):

For CKI/MBI Calibrator (DC32):

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

The summary states: "Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance."

• Sample Size: The document does not specify the sample size used for the comparative testing (test set patients or samples).
• Data Provenance: The document does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the samples). It only mentions "human serum and plasma" as sample types.

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

This information is not applicable as the devices are in vitro diagnostic reagents and calibrators designed for quantitative laboratory measurement, not for interpretation by human experts. The "ground truth" in this context would be the measured values from the predicate devices or reference methods. The performance is assessed by analytical comparison, not expert consensus on diagnoses.

4. Adjudication Method for the Test Set

This is not applicable to this type of in vitro diagnostic device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human readers interpret medical images or conduct clinical assessments, and disagreements need resolution. For laboratory assays, performance is assessed through statistical methods comparing results to a reference.

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 submission concerns in vitro diagnostic reagents and calibrators, not an AI-assisted diagnostic tool that would involve human readers interpreting results. Therefore, an MRMC study and AI-assisted performance improvement are not relevant to this submission.

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

This is not applicable. The device is an in vitro diagnostic reagent system that functions on a clinical chemistry analyzer. It is an algorithm-driven system in the sense that the analyzer's software processes the photometric measurements, but it's not a standalone "algorithm" in the context of AI or image interpretation. Its performance is its standalone performance on the Dimension® system, generating quantitative results. The comparison is made against existing predicate assays.

7. The Type of Ground Truth Used

The "ground truth" for proving substantial equivalence in this context is the results obtained from the legally marketed predicate devices (Roche CK-NAC Reagent, Roche CK-MB Reagent, and their respective calibrators). The comparative testing would involve analyzing samples with both the new device and the predicate to show similar results.

8. The Sample Size for the Training Set

This information is not applicable in the context of this submission. "Training set" typically refers to data used to train a machine learning model. These are chemical reagents and calibrators, whose performance is based on established biochemical reactions, not on data-driven machine learning models. Performance is validated through analytical studies, not an AI training process.

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

This information is not applicable for the same reasons as point 8.

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The Teco Diagnostics Creatine Kinase liquid reagent is intended for in vitro diagnostic test for the quantitative determination of creatine kinase activity in human serum. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Creatine Kinase Liquid Reagent (Kinetic Method)

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"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": null,
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Cardiac Markers reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure cardiac marker analytes.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

ABX PENTRA Myoglobin CP (Reagent for Myoglobin)

ABX PENTRA Myoglobin Cal (Calibrator)

ABX PENTRA Multical (Calibrator)

ABX PENTRA CK Control (Control)

ABX PENTRA Immuno II Control L/H (Control)

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

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

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

8. The Sample Size for the Training Set

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

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

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

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