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For in vitro diagnostic use with the CARESIDE Analyzer™ to measure CK-MB from whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with myopathic disorders including myocardial infarction, myocarditis, Duchenne's muscular dystrophy, polymyosititis, and rhabdomyolysis.

CARESIDE™ CKMB cartridges are used with the CARESIDE, Inc. CARESIDE Analyzer™ to measure CK-MB activity in whole blood, serum or plasma specimens. The CARESIDE™ CKMB cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of serum or plasma to a dry film to initiate the measurement of CK-MB activity. The film cartridge (patent pending) contains all reagents necessary to measure CK-MB activity.

Each CARESIDE™ CKMB cartridge consists of a CK-MB-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the specimen into the cartridge Sample Well, closes the lid and inserts the cartridge into the CARESIDE Analyzer™.

Once loaded, the CARESIDE Analyzer™ scans the cartridge barcode, brings the cartridge and the contained specimen to 37℃, and spins the cartridge to move the sample from the Sample Well into the cartridge channels and chambers. 8.5 uL of sample remains in the metering passage. Any excess sample flows into an overflow well.

The sample is automatically dispensed onto the multi-laver reagent film. The spreading layer distributes the specimen uniformly. In this layer CK-M activity is inhibited by the anti-CK-M subunit antibody contained in the layer. The CK-B subunit is not inhibited by the antibody but rather is activated by N-acetylcysteine. The CK-B activity is stoichometrically related to the CK-MB activty. The CK-B catalyzes the reaction of creatine phosphate with ADP, producing creatine and ATP. ATP reacts with endogenous glucose in a hexokinase-catalyzed reaction to produce glucose-6-phosphate and ADP. G-6-P is then oxidized by glucose-6-phosphate dehydrogenase producing nicotinamide adenine dinucleotide (NADH). NADH reduces nitrotetrazolium blue in a diaphorase catalyzed reaction, producing a diformazan dye. The rate of change of the color intensity of the resulting reddish dye, as measured by the amount of reflected light at 570 nanometers, directly relates to the specimen CK-MB activity.

As the cartridges spin, a photodiode measures reflectance of light emitted by a wavelength-specific light emitting diode (LED) over a fixed time period. The analyzer uses the reflectance measurements and the lot-specific standard curve to calculate CK-MB activity.

Here's a summary of the acceptance criteria and study information for the CARESIDE™ CKMB device, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

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

   • Test Set Sample Size: Not explicitly stated in the provided text. The "Method comparison" section mentions "CARESIDE™ = 1.00 (Paragon) - 8.9 U/L, r = 0.98," which implies a comparison study was performed, but the number of samples used for this correlation is not provided.
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts: Not applicable. This device is an in vitro diagnostic (IVD) for quantitative measurement of a biomarker, not an interpretative AI device requiring expert adjudication of images or signals. The "ground truth" for its performance is typically established by comparison to reference methods or validated laboratory measurements.

3. Adjudication Method for the Test Set: Not applicable for this type of IVD device.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done: No, this is not an MRMC study. MRMC studies are typically for medical image analysis or diagnostic interpretation by human readers, often comparing performance with and without AI assistance. This device is a quantitative diagnostic test.

5. If a Standalone Performance Study Was Done: Yes, a standalone performance study was conducted. The "Comparative Performance Characteristics" section directly reports the CARESIDE™ CKMB's performance metrics (detection limit, reportable range, accuracy, precision, linearity, interference) independently, and then compares them against the predicate device where possible. The method comparison with "Paragon" also represents a standalone assessment against an established method.

6. The Type of Ground Truth Used:

   • For Method Comparison: The device's results were compared against an unstated "Paragon" method (likely an established laboratory reference method).
   • For Reference Method: The text states the reference method for % CKMB was "Electrophoresis for % CKMB in combination with kinetic spectrophotometric determination of total CK." This is what would be considered the "ground truth" or gold standard for validating the CK-MB measurements.

7. The Sample Size for the Training Set: Not applicable. This device is an in vitro diagnostic assay, not an AI/ML model that requires a "training set" in the conventional sense. Its "training" is inherent in its chemical design and calibration process.

8. How the Ground Truth for the Training Set Was Established: Not applicable. As an IVD assay, its accuracy relies on the validated chemical reactions and calibration materials rather than a "training set" with established ground truth labels. Calibration information is "bar-coded on each cartridge" and can change with each lot, indicating internal validation processes.

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For in vitro diagnostic use with the CARESIDE Analyzer™ to quantitatively measure CK from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of patients with myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

CARESIDE™ CK cartridges are used with the CARESIDE, Inc. CARESIDE Analyzer™ to measure CK activity in whole blood, serum or plasma specimens. The CARESIDE™ CK cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of serum or plasma to a dry film to initiate the measurement of CK activity. The film cartidge (patent pending) contains all reagents necessary to measure CK activity.

Here is a summary of the acceptance criteria and the study details for the CARESIDE™ CK device, based on the provided text:

Acceptance Criteria and Device Performance

Note: The provided document does not explicitly state pre-defined "acceptance criteria" against which these performance metrics were tested, but rather reports the device's performance. The conclusion states that the data demonstrates the device "performs as well as or better than the legally marketed predicate device," implying these results met the necessary thresholds for substantial equivalence to the predicate (Vitros CK DT Slides). The predicate device's specific values for Accuracy, Linearity, and Reference Method are not provided for direct comparison, but the detection limit and reportable range are identical.

Study Details

1. Sample sizes used for the test set and the data provenance:

   • The document does not specify the sample size used for the test set (e.g., for accuracy, precision, linearity, or interference studies).
   • The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.

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

   • The document does not mention the use of experts or their qualifications for establishing ground truth in the context of the device's performance evaluation. The reference method used for comparison is a "Kinetic determination with enzymatically coupled spectrophotometric detection of creatine." This suggests a laboratory-based method of higher accuracy was used as the ground truth.

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

   • No adjudication method is described. The performance is reported against a "Reference Method."

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

   • This is a diagnostic device for measuring Creatine Kinase (CK) activity, not an AI-assisted imaging or diagnostic tool that involves "human readers." Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance in that context is not applicable and was not performed.

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

   • Yes, the performance characteristics (detection limit, reportable range, accuracy, precision, linearity, interference) are reported for the CARESIDE™ CK device as a standalone analytical instrument. This device is an in vitro diagnostic test system; its performance metrics describe the algorithm/device's ability to measure CK activity independently.

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

   • The ground truth for accuracy and method comparison was established using a "Reference Method: Kinetic determination with enzymatically coupled spectrophotometric detection of creatine." This is a laboratory-based analytical method considered highly accurate for CK measurement.

7. The sample size for the training set:

   • The document does not mention a "training set" in the context of device development. This device is a chemical assay system, not a machine learning model that typically requires a separate training set. Its calibration is mentioned as "bar-coded on each cartridge" and "may change with each lot," indicating a manufacturer-defined calibration rather than a trained algorithm.

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

   • As no "training set" is described for this type of device, this question is not applicable. The device relies on a pre-defined chemical reaction and established spectrophotometric principles for its measurement and calibration.

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