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Creatine Kinase is an in vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma on Roche/Hitachi cobas c systems. The determination of CK and CK isoenzyme activities is utilized in the diagnosis and monitoring of myocardial infarction and myopathies such as the progressive Duchenne muscular dystrophy.

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 assay is a two reagent assay for the quantitative determination of creatine kinase (CK) in human serum and plasma on automated clinical chemistry analyzers. Photometrically measured NAPDP formation is directly proportional to CK activity in a human sample.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Creatine Kinase Device Performance Study Summary

1. Acceptance Criteria and Reported Device Performance

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

• Detection Limits (LoB, LoD):
  • LoB: One analyte-free sample, measured with three lots, 10-fold determination in 6 runs (total 60 measurements per lot).
  • LoD: Five low-analyte concentration samples, measured with three lots, two-fold determination in 6 runs (total 60 measurements per lot).
• Limit of Quantitation (LoQ):
  • Five human serum samples, tested in 5 replicates per sample on 5 days.
• Precision (Repeatability & Intermediate):
  • Not explicitly stated as a single number, but experiments conducted with multiple human serum samples (5) and control materials (2), with two aliquots per run, two runs per day for ≥ 21 days on the same analyzer using 3 lots of reagent.
• Linearity (Serum & Plasma):
  • Two separate dilution series (serum and plasma), each with 14 concentrations, measured in triplicate.
• Matrix Comparison - Anticoagulants:
  • For each of the four tube types (Serum Gel Separation, Li-heparin, K2-EDTA, K3-EDTA), 30 tubes were filled completely. This implies 30 samples for each comparison.
• Interferences - H, L, I Indices:
  • Pooled human serum samples spiked with varying levels of interferent. The resulting sample series (10 dilution steps per sample) were tested in triplicate.
• Interferences - Drugs:
  • Two sample pools (low and high CK concentrations), divided into aliquots. Each spiked aliquot measured in triplicate.
• Method Comparison to Predicate:
  • 132 human serum samples (9 of which were spiked with human recombinant CK MB). Samples tested in singlicate.

Data Provenance: The document explicitly mentions "human serum samples" and "pooled human serum samples." The manufacturer is Roche Diagnostics Operations, located in Indianapolis, IN, USA. Based on the context of FDA submission for a device to be marketed in the USA, it is highly probable the data is retrospective and likely collected in a clinical laboratory setting (possibly in the USA or aligned with international standards like CLSI), but the specific country of origin for the patient samples is not stated.

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

N/A. This is a submission for an in vitro diagnostic device that quantitatively measures a biomarker (Creatine Kinase). The "ground truth" for the test set is established by the reference measurement procedure or the known concentration of the analyte in calibrators/controls, not by expert interpretation of images or clinical data. Therefore, human experts for ground truth adjudication are not applicable in this context.

4. Adjudication Method for the Test Set

N/A. See explanation above. The measurements are quantitative chemical analyses against instrument-derived values and established reference methods/materials, not subjective interpretations.

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

No. This is an in vitro diagnostic device for quantitative measurement of a biomarker in biological samples. MRMC studies are typically performed for imaging devices or other diagnostic tools where human interpretation plays a significant role, to evaluate how AI assistance impacts human reader performance. This is not applicable here.

6. Standalone (Algorithm Only) Performance Study

Yes, the entire submission is a standalone performance study of the Creatine Kinase assay on the Roche/Hitachi cobas c systems. The device itself is an "algorithm only" in the sense that it is an automated analytical system (reagent + instrument) that produces quantitative results without human intervention in the measurement process itself, beyond sample loading and system maintenance. The studies described (Detection Limits, Precision, Linearity, Interference, Method Comparison) directly assess the performance of this standalone analytical system.

7. Type of Ground Truth Used

The ground truth for the performance studies relies on:

• Reference Materials/Methods: For calibration and verification of accuracy, the method is stated to be traceable to IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) Method for Creatine Kinase.
• Known Concentrations: For studies like LoB, LoD, LoQ, linearity, and interference, samples are either analyte-free, spiked with known concentrations of analyte or interferents, or diluted from samples with established reference values. This essentially uses calibrated reference standards and materials as the ground truth.
• Predicate Device Measurements: For method comparison, the predicate device's results (COBAS INTEGRA Creatine Kinase cleared in K951595 on the COBAS INTEGRA analyzer) serve as a comparative ground truth to establish substantial equivalence.

8. Sample Size for the Training Set

N/A. This is not a machine learning or AI-based diagnostic device in the modern sense that requires a "training set" of data to learn from. It is a traditional in vitro diagnostic assay based on a defined enzymatic chemical reaction and photometric measurement. The development of such assays involves extensive research and development to optimize reagents and instrument parameters, but not in the framework of a "training set" as understood in AI/ML.

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

N/A. As explained above, there is no "training set" in the context of an AI/ML device for this product. The development of the assay involves chemical and enzymatic principles, optimized through laboratory experimentation and knowledge of biochemistry, rather than learning from a dataset via a specified ground truth.

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The CKMB UDR assay is an in vitro diagnostic test used for the kinetic quantitative determination on Unicel DxC 600 System of the CK-MB isoenzyme activity of creatine kinase in serum and Liheparin plasma by inhibition method. The assay is intended for professional use only. Creatine Kinase (CK) catalyses the reversible phosphorylation of creatine by ATP. CK is a dimer composed of two subunits which form three active isoenzymes: BB (CK-1), MB (CK-2), MM (CK-3). CK-BB isoenzyme only rarely appears in serum.

Elevated CK values are due to muscular damages and associated pathologies. CK determination, usually performed with CK2 (also called CK-MB), is used for the diagnosis and follow-up of AMI (acute myocardial infarction) and some muscular diseases.

Anti CK-M mouse monoclonal antibodies in the reagent 1 inhibit the CK-M subunit in the sample without affecting the CK-B subunits. The CK-B activity is determined by the CK-NAC method and corresponds to half the CK-MB activity.

The provided text describes the performance characteristics of the CKMB UDR Assay, focusing on its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and study details:

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

Study Proving Acceptance Criteria (Type of Study):

The study described is a comparative performance study to demonstrate substantial equivalence to a predicate device (Roche CK-MB assay K003158). This is primarily an analytical validation study.

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

• Test Set Sample Size: 306 human sera samples (for method comparison).
• Data Provenance: The text does not specify the country of origin. It implicitly describes a prospective study in the sense that samples were tested with both the new device and the predicate for comparison. However, the exact collection method (e.g., whether samples were collected specifically for this study or were existing banked samples) is not explicitly stated. It is referred to as "human sera samples," suggesting clinical samples.

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)

This is not applicable to this type of analytical device validation. The "ground truth" for an assay like CKMB is established by the reference method (in this case, the predicate device) and the intrinsic chemical/biological properties being measured, not by expert consensus on interpretations.

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

Not applicable. This is not a study involving human interpretation or adjudication of results. The comparison is quantitative between two analytical instruments.

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

Not applicable. This is an in vitro diagnostic assay, not an imaging device or AI-assisted diagnostic tool that involves human readers.

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

Yes, the studies described are standalone (algorithm/assay only) performance assessments. The device measures CK-MB activity directly, and its performance is evaluated based on its analytical characteristics (correlation, precision, range) against a predicate device, without human intervention in the result determination.

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

The "ground truth" in this context is the results obtained from the legally marketed predicate device (Roche CK-MB assay K003158). The study aimed to demonstrate that the new device's measurements are substantially equivalent to those of the predicate device. For the imprecision and AMR studies, the ground truth is implicitly the inherent biological measurement of the samples at various concentrations using the new device.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-driven device that requires a training set in that sense. It is a chemical assay.

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

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

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The S-Test Creatine Kinase Reagent is intended for the quantitative determination of Creatine Kinase activity in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of creatine phosphokinase activity are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Creatine Kinase (CK) reagent cartridge, used with the S40 Clinical Analyzer, is intended for quantitative in vitro diagnostic determination of CK activity in serum or heparin plasma based on a photometric test measuring the formation of NADPH, which absorbs strongly at 340 nm.

1. Table of Acceptance Criteria and Reported Device Performance

• Within-run CV: 1.4% to 2.0% (at three CK levels)
• Total CV: 5.1% to 6.1%

Field (3 POL sites, 5 days):

• Within-run CVs: 0.5% to 3.7%
• Total CVs: 0.8% to 3.7% |
  | Accuracy | High correlation with a comparative method (high correlation coefficient, slope near 1, intercept near 0, low standard error). | Correlation Study (95 samples, CK: 32-1181 U/L):
• Correlation coefficient (r): 0.998
• Standard error estimate: 14.5
• Confidence interval slope: 1.027 to 1.053
• Confidence interval intercept: -12.5 to -5.2

Patient Correlation Studies (3 POL sites):

• Correlation coefficients (r): 1.00
• Standard error estimates: 5.0 to 8.5
• Confidence interval slopes: 1.006 to 1.059
• Confidence interval intercepts: -10.8 to -3.5 |
  | Sensitivity | Ability to detect low levels of CK activity. | The detection limit was 24 U/L. |

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

• Sample Size:
  • Precision:
    • In-house: Not explicitly stated, but "three CK levels for 22 days" implies a substantial number of replicates per level.
    • Field: Not explicitly stated, but "three separate Physician Office Laboratory (POL) sites and in-house over five days" implies multiple replicates per site and day.
  • Accuracy (Correlation Study): 95 samples with CK values ranging from 32 to 1181 U/L.
  • Accuracy (Patient Correlation Studies): Not explicitly stated, but performed at "three separate POL sites."
  • Sensitivity: Not explicitly stated, but the "detection limit" is a single value derived from testing.
• Data Provenance: The document does not explicitly state the country of origin. The test for precision was conducted both in-house and at three Physician Office Laboratory (POL) sites. The accuracy studies were also conducted in a similar fashion. It is implied to be a prospective study as this is performance data reported for submission.

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

This type of device (Clinical Analyzer for Creatine Kinase) does not typically involve human experts establishing a "ground truth" for the test set in the same way an imaging or diagnostic AI device does. The ground truth for such devices is established by a "comparative method" (a reference laboratory method or an established, legally marketed device against which the new device's performance is measured).

Therefore:

• Number of Experts: Not applicable in the context of typical AI device ground truth.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Not applicable. For a clinical analyzer, the "ground truth" is determined by a comparative laboratory method, not by human expert adjudication of individual case results.

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 imaging or diagnostic AI devices where human readers interpret results, and the AI might assist in that interpretation. The S-Test CK is a clinical analyzer for quantitative determination of an analyte, not an AI-assisted diagnostic tool that humans interpret visually.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, the studies described are standalone performance evaluations of the S-Test CK reagent and S40 Clinical Analyzer system. The device itself performs the quantitative measurement of CK activity. There is no human interpretation "in the loop" that would alter the device's numerical output for the specified performance metrics.

7. Type of Ground Truth Used

The ground truth for the accuracy studies was established by a comparative method. This refers to an established, presumably FDA-cleared or gold-standard laboratory assay for creatine kinase. The document states: "assayed on the S40 Clinical Analyzer using S-Test CK (y) and a comparative method (x)."

8. Sample Size for the Training Set

The document does not provide information about a "training set" in the context of machine learning. This device is a traditional in-vitro diagnostic (IVD) measurement system, not a machine learning or AI-based device that requires a separate training set for algorithm development. The "training" for such devices typically refers to the development and optimization of the chemical reagents and instrument calibration, which is not usually reported with specific sample sizes in this manner.

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

Not applicable. As explained in point 8, this is not an AI/ML device requiring a training set with established ground truth. The "ground truth" related to the performance of the system would be established through internal R&D and validation processes using reference materials and comparative methods, but this is part of the product development rather than a labeled "training set" for an algorithm.

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The Dimension Vista™ Creatine Kinase MB Isoenzyme (CKMB) Flex® reagent cartridge is a device intended to measurement the activity of the creatine kinase MB isoenzyme in plasma and serum. Measurements with isoenzyme are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

The HAIC assay used on the Dimension Vista™ integrated system is an in-vitro diagnostic assay for the quantitative determination of percent hemoglobin A1c(HbA1c) in anticoagulated whole blood. Measurements of percent hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.

The AMPH Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of amphetamines in human urine using a cutoff of either 300, 500, or 1000 ng/mL. Measurements obtained with the AMPH method are used in the diagnosis and treatment of amphetamines use or overdose. The AMPH method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The BARB Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of barbiturates in human urine. Measurements obtained with the BARB method are used in the diagnosis and treatment of barbiturates use or overdose. The BARB method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The BENZ Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of benzodiazepines in human urine. Measurements obtained with the BENZ method are used in the diagnosis and treatment of benzodiazepines use or overdose. The BENZ method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The COC Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of benzoylecgonine (cocaine metabolite) in human urine using a cutoff of 150 or 300 ng/mL. Measurements obtained with the COC method are used in the diagnosis and treatment of cocaine use or overdose. The COC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The EXTC Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of methylenedioxymethamine (MDMA), and closely related drugs in human urine using a cutoff of either 300 or 500 ng/mL. Measurements obtained with the EXTC method are used in the diagnosis and treatment of ecstasy use or overdose. The EXTC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The METH Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of methadone in human urine. Measurements obtained with the METH method are used to detect methadone use or overdose and to determine compliance with methadone maintenance treatment. The METH method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The OPI Flex® reagent cartridge (300 ng/mL cutoff) used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semi-quantitative determination of opiates in human urine. Measurements obtained with the OPI method are used in the diagnosis and treatment of opiates use or overdose. The OPI method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The PCP Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of phencyclidine in human urine. Measurements obtained with the PCP method are used in the diagnosis and treatment of phencyclidine use or overdose. The PCP method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The THC Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of cannabinoids in human urine. Measurements obtained with the THC method are used in the diagnosis and treatment of cannabinoids use or overdose. The THC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Dade Behring Dimension Vista™ Flex® reagent cartridges and the HA1C kit are prepackaged Dade Behring products that are specifically designed to be used on the Dade Behring Dimension Vista™ integrated system, a floor model, fully automated, microprocessor-controlled, integrated instrument system. The Dimension Vista™ system was previously cleared with seven associated test methods (K051087). This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic devices that have been cleared under the 510(k) process for use on Dimension® clinical chemistry systems. The packaging change is to allow use on the Dimension Vista™ system. The reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The calibrator included in the Dimension Vista™ HAIC kit is the same product (unchanged) as that used in the Dimension® HA1C Kit. The packaging modification, does not affect the intended use of the devices. nor does it alter the fundamental scientific technology of the devices.

Please find the requested information regarding the acceptance criteria and study details below.

1. Table of Acceptance Criteria and the Reported Device Performance

The provided document describes a 510(k) submission for new reagent cartridges and a kit for the Dimension Vista™ system, which are essentially packaging modifications of existing, previously cleared devices for use on a new analyzer system. The core scientific technology and reagents remain the same.

The document mainly focuses on demonstrating substantial equivalence to predicate devices rather than establishing new performance criteria. Therefore, the "acceptance criteria" are implied to be performance comparable to the predicate devices, and the "reported device performance" is framed in terms of achieving this equivalence.

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 substantially equivalent performance." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for these comparative tests.

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. As this is an in-vitro diagnostic device for quantitative and qualitative measurements, the "ground truth" would likely be established through reference methods (e.g., GC/MS for drug screens, or an established method for CKMB and HbA1c) rather than expert consensus on images or clinical cases.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided in the document. Given the nature of these in-vitro diagnostic tests, adjudication methods like 2+1 or 3+1, which are common in image interpretation or clinical expert review, are not applicable. Instead, the performance would be compared against a reference method or predicate device.

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

No MRMC comparative effectiveness study was done, nor is it applicable to this submission. The device involves in-vitro diagnostic reagent cartridges for automated analyzer systems, not an AI-assisted interpretation or diagnostic tool for human readers.

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

Yes, this describes a standalone performance evaluation in the context of an in-vitro diagnostic device. The Dimension Vista™ system is described as a "floor model, fully automated, microprocessor-controlled, integrated instrument system." The reagents are designed for use on this automated system. The comparative testing would confirm the analytical performance of the reagents on the new system, without human interpretation of the raw data beyond standard laboratory procedures.

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

For the drug screens (Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Ecstasy, Methadone, Opiates, Phencyclidine, Cannabinoids), the "Indications For Use" sections explicitly state: "A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method." This indicates that GC/MS is the ground truth or gold standard against which the screening tests are compared.

For Creatine Kinase MB Isoenzyme (CKMB) and Hemoglobin A1c (HA1C), while not explicitly stated as GC/MS, the "ground truth" would be established by comparison to accepted reference methods or the performance of the predicate devices themselves, as the submission aims to demonstrate substantial equivalence to these existing methods.

8. The Sample Size for the Training Set

The document is a 510(k) submission for modifications to existing products for use on a new instrument system. It focuses on comparative testing to establish substantial equivalence. It does not describe a "training set" in the context of machine learning or algorithm development. The reagents and their fundamental scientific technology are stated to be unchanged from previously cleared devices.

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

As noted in point 8, there is no mention of a "training set" in the context of algorithm development or machine learning in this document. The device's underlying technology is based on established biochemical assays, not a learnable algorithm requiring a training set.

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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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IMMULITE CK-MB is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) antigen in heparinized plasma or serum. It is intended strictly for in vitro use as an aid in patient and the assessment of prognosis of myocardial infarction.

IMMULITE® CK-MB is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE® Automated Analyzer.

IMMULITE® CK-MB is a chemiluminescent enzyme-labeled immunometric assay, based on ligand-labeled monoclonal antibody and separation by anti-ligand-coated solid phase.

The patient sample, a ligand-labeled anti-CK-MB monoclonal antibody and an alkaline phosphatase-labeled anti-CK-BB polyclonal antibody are simultaneously introduced into the Test Unit containing immobilized anti-ligand, and incubated for approximately 30 minutes at 37°C with intermittent agitation. During this time, CK-MB in the sample forms an antibody sandwich complex which, in turn, binds to anti-ligand on the solid phase. Unbound conjugate is removed by a centrifugal wash: substrate is then added and the Test Unit is incubated for a further 10 minutes.

The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus also the photon output, as measured by the luminometer - is proportional to the concentration of CK-MB in the sample.

Here's a breakdown of the acceptance criteria and study information for the IMMULITE® CK-MB device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria in terms of a specific accuracy, sensitivity, or specificity threshold. Instead, the performance is demonstrated through a method comparison study. The implicit acceptance criterion is "substantial equivalence" to the predicate device, Roche® Isomune® -CK. This is demonstrated by the linear regression analysis results.

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set: Forty-three (43) patient samples.
• Data Provenance: Not explicitly stated (e.g., country of origin). The samples are referred to as "patient samples," implying they were obtained clinically.
• Retrospective or Prospective: Not explicitly stated, but the description "patient samples" (past tense) and the comparison to an already marketed device suggest a retrospective analysis of collected clinical samples.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. This diagnostic device determines a quantitative analyte concentration. The "ground truth" for the test set is established by the predicate device, the Roche® Isomune® -CK.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As noted above, the "ground truth" for the comparison is the measurement obtained from the predicate device, not human expert consensus.

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

• MRMC Study: No, an MRMC study was not done. This is a quantitative in vitro diagnostic device, not an imaging or qualitative diagnostic device that would typically involve human readers interpreting results.

6. Standalone Performance Study

• Standalone Study: Yes, a standalone performance study was implicitly done to characterize the device's measurements relative to a known standard (the predicate device). The stated "performance equivalence" and "method comparison" sections detail this. The IMMULITE® CK-MB's measurements are compared directly to those of the predicate device at various concentrations.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the comparative study was the results obtained from the predicate device, Roche® Isomune® -CK. This is a common approach for demonstrating substantial equivalence for new diagnostic assays.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not specified in the provided text. The document describes a comparison study for performance evaluation, not a description of the device's internal algorithm development or training.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not specified. This information would typically be part of a detailed assay development report, which is not included in this 510(k) summary. Given it's an immunometric assay, the "training" (calibration) would typically involve known standards with defined CK-MB concentrations.

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The intended use of ACS CKMB II is for the quantitative determination of CK-MB (CK-2) in serum or plasma using the Ciba Corning Automated Chemiluminescence Systems.

The Ciba Corning ACS CKMB II assay is a two-site chemilumometric (sandwhich) assay. which uses constant amounts of two antibodies. The first antibody or Lite Reagent is a monoclonal mouse anti-CK-MB antibody labeled with acridinium ester. The second antibody or solid phase is a monoclonal mouse anti-CK-BB antibody covalently coupled to paramagnetic particles. A direct relationship exists between the CK-MB in a sample and the relative light units (RLUs) detected by the ACS:180 systems. The assay is unaffected by increased levels of other CK isoenzymes.

The provided text describes a medical device, the "ACS CKMB II Immunoassay," and its performance but does not include information relevant to AI/ML device studies as outlined in your request.

Specifically, the document focuses on an immunoassay for detecting CK-MB, which is a laboratory test. The "performance data" section details traditional analytical performance characteristics of such an assay (Sensitivity, Accuracy using a correlation with a reference method, and Precision).

Therefore, I cannot extract the following information because it is not present in the provided text:

• A table of acceptance criteria and the reported device performance (in the context of AI/ML performance metrics like sensitivity, specificity, AUC, etc.): The document lists traditional analytical performance metrics.
• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): While a sample size of 1744 is mentioned for the accuracy study, details on data provenance are absent.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an immunoassay.
• Adjudication method: Not applicable for an immunoassay.
• 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 an immunoassay, not an imaging AI device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is an immunoassay, not an AI algorithm.
• The type of ground truth used (expert concensus, pathology, outcomes data, etc): The ground truth for this immunoassay is likely the result from the "FEIA reference method."
• The sample size for the training set: Not applicable for an immunoassay, which does not typically involve machine learning training sets in this context.
• How the ground truth for the training set was established: Not applicable for an immunoassay.

In summary, the provided document describes a traditional in-vitro diagnostic device (an immunoassay) and its analytical performance, not an AI/ML powered device. Therefore, none of the requested AI/ML specific criteria can be extracted from this text.

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