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The GSP Neonatal Creatine Kinase-MM kit, is intended for the quantitative in vitro determination of creatine kinase MM-isoform (CK-MM) concentration in blood specimens dried on filter paper as an aid in screening newborns for Duchenne Muscular Dystrophy (DMD) using the GSP instrument.

The GSP Neonatal Creatine Kinase-MM assay is a solid phase, two-site fluoroimmunometric assay based on the direct sandwich technique and utilizes standard PerkinElmer DELFIA chemistry with the GSP instrument. The kit contains:

• . The CK-MM Calibrators (containing 0, 30, 120, 500, 2000 and 8000 ng/mL of creatine kinase) consisting of 7 cassettes each containing 1 set of dried blood spots.
• The CK-MM Controls (containing 130, 500 and 2000 ng/mL of creatine kinase) consisting of 5 cassettes each containing 2 set of dried blood spots.
• Anti-CK-MM-Eu Tracer ●
• CK-MM Assay Buffer ●
• Anti-CK-MM Microtitration strips ●
• Extra barcodes for the plates ●

Here's an analysis of the GSP Neonatal Creatine Kinase-MM kit's acceptance criteria and the study proving it meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" for the overall device performance in a summary table. Instead, it describes analytical performance studies (precision, linearity, detection limits, specificity) with implied acceptance based on CLSI guidelines. For clinical performance, the results are presented with different cut-off values, and the benefit-risk assessment provides the overall conclusion regarding the device's benefit.

However, we can infer some key performance metrics from the clinical study results and regulatory context. The primary clinical acceptance is tied to its ability to aid in screening for DMD.

Inferred Acceptance Criteria and Reported Device Performance:

• DMD Positive identified: 34 out of 34 (100%) |
  | (False Negative Rate) | As low as possible to prevent delayed diagnosis. (Labeling statement: future lots could range from 0% to 0.48% at 99.5th percentile, and 0% to 0.05% at 97.5th percentile) | Cut-off 1250 ng/mL: 0% (0 false negatives out of 34 confirmed DMD positive samples) |
  | (False Positive Rate) | Acceptable trade-off to enable screening benefits, considering the need for confirmatory testing. (Labeling statement: future lots could range from 0.4% to 0.7% at 99.5th percentile, and 2.0% to 3.7% at 97.5th percentile) | Cut-off 1250 ng/mL: 2.26% (Routine samples) (69 presumed negative / 3041 routine samples) |
  | | | Cut-off 2040 ng/mL: 0.53% (Routine samples) (16 presumed negative / 3041 routine samples) |
  | Analytical Performance | | |
  | Reportable Range | Sufficiently broad to cover clinically relevant CK-MM concentrations. (Implied by CLSI EP06 and subsequent claim) | 29.2-8000 ng/mL |
  | Limit of Blank (LoB) | Low enough to reliably distinguish between the absence and presence of analyte with a high degree of confidence. (Based on CLSI EP17-A2) | 0.7 ng/mL |
  | Limit of Detection (LoD) | Low enough to reliably detect the analyte above background noise. (Based on CLSI EP17-A2) | 2.2 ng/mL |
  | Limit of Quantitation (LoQ) | Low enough to quantify the analyte with acceptable precision and accuracy. (Based on CLSI EP17-A2 and (b)% CV acceptance limit) | 6.8 ng/mL |
  | Specificity (Absence of Interference) | Substances commonly found in neonatal blood or used in care should not significantly interfere with results within specified limits. (Limit for significant interference defined as (b)(4)%) | Most tested substances (bilirubin, triglycerides, albumin, acetaminophen, etc.) at high concentrations showed no significant interference. Chlorhexidine digluconate (0.04%) and low hematocrit (35-45% at 159 ng/mL CK-MM) showed interference. |
  | Cross-reactivity (CK-BB, CK-MB) | Clinically relevant levels of related enzymes (CK-BB, CK-MB) should not significantly cross-react to avoid false positives. (Limit for significant cross-reactivity defined as (b)(4)%) | Cross-reactivity results for CK-BB and CK-MB were provided in tables (values redacted). |
  | Stability of DBS Samples | CK-MM in DBS samples must maintain integrity over reasonable storage and shipping conditions for practical use. | - Stable for up to 200 days at +4°C (dry).
• Moderate loss (up to 27%) after 6 days at +4℃ (ambient).
• Stable for up to 25 days at -20℃ (ambient).
• Stable for up to 20 days at +21°C (dry).
• Unstable in humid conditions (+21℃ / +35℃,

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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:

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The Creatine Kinase-MB assay is an in-vitro test for the quantitative determination of the catalytic activity of creatine kinase MB subunit (CK-MB) in human serum and plasma on Roche/Hitachi cobas c systems.

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 assay is a two reagent assay for the quantitative determination of creatine kinase-MB (CK-MB) in human serum and plasma on automated clinical chemistry analyzers. The rate of the NADPH formation is directly proportional to the catalytic CK-MB activity. It is determined by measuring the increase in absorbance photometrically.

This document is a 510(k) summary for a medical device called "Creatine Kinase-MB" by Roche Diagnostics. It describes the device, its intended use, technological characteristics, and performance evaluation data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: This document is about a clinical chemistry assay (an in-vitro diagnostic test), not an AI/ML device. Therefore, many of the typical AI/ML study components (like multi-reader multi-case studies, expert adjudication, or separate training/test sets for AI models) are not applicable to this type of device. The "ground truth" here is the reference measurement method or the expected concentration of the analyte.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an in-vitro diagnostic test and not an AI/ML device, the acceptance criteria are not typically expressed as sensitivity/specificity in an MRMC study for diagnostic imaging. Instead, the acceptance criteria relate to analytical performance characteristics. The document presents the performance data against established analytical standards (CLSI guidelines) and comparisons to a predicate device.

Study Details:

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

• Precision (Repeatability & Intermediate Precision):
  • 5 human serum samples and 2 control samples.
  • Measurements: Two aliquots per run, two runs per day for ≥ 21 days on the same analyzer using 3 lots of reagent.
  • Data Provenance: Not explicitly stated (e.g., country of origin), but implies laboratory-based prospective testing as per CLSI guidelines.
• Analytical Sensitivity (LoB, LoD, LoQ):
  • LoB: One analyte-free sample. Measured with three lots, 10-fold determination in 6 runs, over 3 days (60 measurements per lot).
  • LoD: Five samples with low analyte concentration. Measured with three lots, twofold determination in 6 runs, over 3 days (60 measurements per lot).
  • LoQ: 5 human serum samples diluted to low levels. Tested in 5 replicates per sample on 5 days, one run per day.
  • Data Provenance: Implies laboratory-based prospective testing as per CLSI guidelines.
• Linearity:
  • One serum pool and one plasma pool, diluted to 16 (serum) and 18 (plasma) concentrations.
  • Measurements: Measured in triplicate.
  • Data Provenance: Implies laboratory-based prospective testing.
• Endogenous Interferences:
  • Pooled human serum samples spiked with varying levels of interferent.
  • Measurements: Tested in triplicate.
  • Data Provenance: Implies laboratory-based prospective testing.
• Exogenous Interferences (Drugs):
  • Two sample pools (low and high CKMB concentration).
  • Measurements: Aliquots spiked with drugs, determined in triplicate.
  • Data Provenance: Implies laboratory-based prospective testing.
• Method Comparison to Predicate:
  • 105 human serum samples (plus 4 spiked with CK MB rec human).
  • Data Provenance: Not explicitly stated origins of human serum samples, but implies prospective collection for this comparison.
• Matrix Comparison (Anticoagulants):
  • 31 Li Heparin tubes, 30 K2 EDTA tubes, 31 K3 EDTA tubes, and 31 Gel Separation tubes.
  • Data Provenance: Implies prospective collection of samples drawn into different tubes.

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

Not applicable. This is an analytical performance study for an in-vitro diagnostic assay. Ground truth is established by reference methods, known concentrations, or comparison to a predicate device, not by expert medical image interpretation.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or adjudication component in the analytical performance testing described for this device. Measurements are objective quantitative values.

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 device is an in-vitro diagnostic test, not an AI-assisted diagnostic imaging tool or a device requiring human readers/interpreters in its primary use.

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

This is fundamentally a "standalone" device in the sense that its performance is measured analytically on its own, producing a quantitative result. There is no "human-in-the-loop" performance as would be relevant for an AI-powered diagnostic imaging tool. The device provides a direct measurement.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance studies is based on:

• Reference Methods/Known Concentrations: For precision, linearity, and analytical sensitivity, samples with known or expected concentrations (e.g., controls, highly purified analytes, or diluted samples) are used.
• Comparison to a Legally Marketed Predicate Device: For method comparison, the results from the new device are compared to those obtained from the established predicate device, which serves as a de facto "truth" or reference standard for equivalence.
• CLSI Guidelines: The studies follow CLSI (Clinical and Laboratory Standards Institute) guidelines (e.g., EP5-A3, EP17-A2, EP6-A), which define how analytical performance characteristics should be determined using standard laboratory practices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set" in the context of model development. The laboratory studies described are for system validation, not algorithm training.

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

Not applicable. As there is no "training set" for an AI/ML model, there is no ground truth established for such a set.

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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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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 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 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 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)

{
"1. A table of acceptance criteria and the reported device performance": null,
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": null,
"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)": null,
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": null,
"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": null,
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": null,
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": null,
"8. The sample size for the training set": null,
"9. How the ground truth for the training set was established": null
}

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The CK CAL is an in vitro diagnostic product for the calibration of Creatine Kinase (CK) method on the Dimension Vista™ System.

CK CAL is frozen, liquid, bovine serum albumin based product containing creatine kinase from porcine heart. The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B. The volume per vial is 1.0 mL.

This document describes the 510(k) submission for the Dimension Vista™ System Creatine Kinase Calibrator (CK CAL - KC340). As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional clinical study with acceptance criteria often seen for diagnostic algorithms.

However, we can extract details about the performance characteristics and the internal studies conducted to ensure the calibrator meets its intended purpose.

1. Table of Acceptance Criteria and Reported Device Performance

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

Since this is a calibrator, the "test set" in the context of diagnostic algorithms doesn't directly apply. However, we can analyze the data used for performance characterization.

• Stability Studies:
  • Shelf-life stability: "Recovery versus time is monitored and percent change over time is determined..." The exact number of samples or data points is not specified, but it's an ongoing monitoring process.
  • Open vial stability: Vials are opened/punctured on day zero and tested on days 1, 8, 15, 22, and 32. The number of vials tested on these specific days is not explicitly stated.
• Value Assignment:
  • Master Pool: N = 45 replicates (measurements) on multiple instruments.
  • Commercial Calibrator Lot: N = 45 total replicates (measurements) on multiple instruments.

Data Provenance: The document does not explicitly state the country of origin for the data. However, as Dade Behring Inc. is based in Newark, DE (USA), it is highly likely the studies were conducted within the US. The studies are prospective in the sense that they are specifically designed experiments to characterize the calibrator's performance.

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

This information is not applicable to a calibrator product. The "ground truth" for a calibrator is its assigned value, which is established through a rigorous, metrologically sound process rather than expert-derived diagnoses.

4. Adjudication Method

Not applicable to a calibrator product. Adjudication is typically used in clinical studies where expert consensus is needed to establish a definitive diagnosis or outcome.

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

Not applicable. This is not a diagnostic device that requires human interpretation, nor is it an AI-assisted diagnostic tool.

6. Standalone Performance Study

Yes, the performance characteristics described are for the standalone calibrator device. The stability, traceability, and value assignment studies are all evaluations of the calibrator itself, independent of human intervention other than the procedures for testing it. For example, the stability studies determine how the calibrator's values change over time under various storage conditions.

7. Type of Ground Truth Used

The "ground truth" for the calibrator's assigned values is based on:

• Gravimetric addition: For preparing the Master Pool and stock solutions, quantities of creatine kinase are gravimetrically added to the base material to achieve target concentrations. This provides an initial "true" concentration based on precise measurement of mass.
• Comparison to previously approved Master Pool lot: The new Master Pool is verified against an existing, approved Master Pool, establishing a reference point.
• Dimension® clinical chemistry system values: The assigned values are traceable to the Dimension® clinical chemistry system, implying that the system itself, when properly calibrated, serves as the reference measurement.

Essentially, the ground truth is established through a hierarchical metrological traceability chain, starting with fundamental physical measurements (gravimetric) and then validated against established reference materials and methods within the manufacturer's system.

8. Sample Size for the Training Set

Not applicable. This is a calibrator, not a 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 for a calibrator.

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The Nano-Check ™AMI 3 IN 1 Test is a rapid immunoassay for the qualitative determination of Cardiac Troponin I (cTnl), Creatine Kinase MB (CK-MB), and Myoglobin in human serum and plasma specimens at cutoff concentrations of 0.5 ng/ml, 5.0 ng/ml, and 80 ng/ml, respectively, as an aid in the diagnosis of Acute Myocardial Infarction (AMI).

The Nano-Check™ AMI 3 IN 1 Test is a qualitative assay, which can not monitor the rise and fall of cTnl, CK-MB, and Myoglobin in single testing. Single testing is not recommended for AMI monitoring. Test results should be interpreted by the physician in conjunction with other laboratory test results and patient clinical findings.

The Nano-Check ™ AMI 3 IN 1 Test is a one-step lateral flow immunochromatography assay for the qualitative determination of three cardiac markers simultaneously in serum and heparin plasma.

The test is a single-use, visually read, cassette device in a plastic housing. Membrane strip inside the plastic housing contains immobilized molecules at three test lines and one control line; CK-MB antibody, Myoglobin antibody, streptavidine and goat anti-mouse antibody. Dye pad at the end of the membrane strip contains biotinylated cTnl antibody and gold colloidal particles coupled with CK-MM, cTnl and Myoqlobin antibodies. Cutoff level of each marker is 0.5 ng/ml, 5 ng/ml and 80 ng/ml for cTnl. CK-MB and Myoglobin respectively.

Device is sealed in pouch with desiccant and provided with instructions for use and disposable sample dropper.

The provided document is a 510(k) summary for the Nano-Check™ AMI 3 IN 1 Test, which is a qualitative immunochromatography assay for cardiac markers. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results with specific acceptance criteria and performance metrics typically found in a clinical trial report for AI/CADe devices.

Therefore, much of the requested information (like specific acceptance criteria values, sample sizes for test sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance with metrics like sensitivity/specificity/AUC, detailed ground truth establishment for training, and training set size) is not present in this document. This submission primarily relies on "analytical performance" and "method comparison" studies, not complex clinical effectiveness studies with human readers or large-scale AI validation.

Here's a summary of what can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" as clear numerical thresholds for performance metrics. Instead, it refers to "overall performance and characteristics" and "analytical performance" being addressed to support substantial equivalence. The "performance" is demonstrated by addressing analytical characteristics and comparing them to a predicate device.

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

• Sample Size: Not specified in the provided summary. The document mentions "Method Comparison with Predicate Device" and "Analytical Performance" studies, but does not provide the number of samples used in these non-clinical tests.
• Data Provenance: Not specified. Given it's a 510(k) for an IVD, these stability and analytical studies are typically conducted at the manufacturer's site or contracted labs. Country of origin for data is not mentioned.
• Retrospective/Prospective: Not specified, but analytical and method comparison studies are often conducted using banked samples (retrospective) or spiked samples.

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

• Not Applicable. This device is a diagnostic assay (an IVD) run on a sample (serum/plasma), not an imaging AI device that relies on expert interpretation for ground truth. The "ground truth" for such assays is established through reference methods (e.g., highly accurate laboratory analyzers) and spiked samples with known concentrations. The summary does not involve human readers interpreting images.

4. Adjudication Method for the Test Set:

• Not Applicable. See point 3. This is an in-vitro diagnostic device, not an AI/CADe system requiring human adjudication of interpretations.

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

• No. An MRMC study is not mentioned or implied because this is an in-vitro diagnostic test. These studies are relevant for imaging devices where human readers interpret medical images with and without AI assistance.

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

• Yes, implicitly. The entire device is the "algorithm only" in the context of its function as an IVD. It's a qualitative test that produces a visual result (red bands) indicating the presence or absence of cardiac markers above a cutoff. Its performance is evaluated through analytical studies (precision, accuracy relative to reference, detection limit, specificity, etc.) which collectively represent its standalone performance characteristics. However, detailed results of these studies (e.g., sensitivity, specificity derived from analytical studies) are not provided in this summary.

7. The Type of Ground Truth Used:

• For analytical performance studies (Detection Limit, Analytical Specificity, Assay Cut-off), the ground truth would typically be established using:
  • Known concentrations: Samples (serum/plasma) spiked with known, precise concentrations of cTnl, CK-MB, and Myoglobin.
  • Reference methods: Comparison against established, high-accuracy laboratory reference assays for these cardiac markers.
  • Clinical correlation: While not a direct "ground truth" for the device's output, the overall utility is "as an aid in the diagnosis of Acute Myocardial Infarction (AMI)," implying that the presence of these markers above the cutoff correlates with AMI, which would be pathology-confirmed or clinically adjudicated. However, the study supporting this 510(k) focused on analytical performance and comparison to a predicate, not clinical outcomes directly.

8. The Sample Size for the Training Set:

• Not Applicable/Not Specified. This device is a lateral-flow immunochromatographic assay, not a machine learning or AI model that requires a distinct "training set" in the conventional sense. Its "training" is inherent in the chemical and manufacturing process design to ensure appropriate binding and visual signaling at the defined cutoffs.

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

• Not Applicable/No training set in the conventional sense. As explained in point 8, this device doesn't have a "training set" like an AI algorithm. The assay's "truth" (i.e., its ability to correctly identify positive/negative samples) is built into its biochemical design and validated through analytical studies, as outlined in section 7a.

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