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System reagent for the quantitative determination of Cholinesterase activity (E.C. 3.1.1.8) in human serum and plasma on Beckman Coulter Synchron CX® Pro System(s), Synchron LX® Pro System(s) and UniCel® DxC 600/800 System(s).

Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

System reagent for the quantitative determination of Cholinesterase activity (E.C. 3.1.1.8) in human serum and plasma on Beckman Coulter Synchron CX® Pro System(s), Synchron LX® Pro System(s) and UniCel® DxC 600/800 System(s).

A cholinesterase test system is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

The method is based on the recommendations of the German Society for Clinical Chemisty (Deutsche Gesellschaft für Klinische Chemie, DGKCh).

Cholinesterase catalyses the hydrolysis of butyrytthiocholine to butyrate and thiocholine. Thiocholine reduces yellow hexacyanoferrate (III) to colorless hexacvanoferrate (II). The decrease in absorbance at 410 nm is directly proportional to the cholinesterase activity in the sample.

The provided document is a 510(k) summary for the SYNCHRON® Systems Cholinesterase (CHEX) Reagent, which is a device for measuring cholinesterase activity in human serum and plasma. This is an in vitro diagnostic device (IVD) and not an AI/ML powered medical device. Therefore, many of the requested categories for AI/ML device studies are not applicable.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The summary states that "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, linearity, and imprecision experiments." However, specific quantitative acceptance criteria or detailed performance metrics are not explicitly presented as a table in this summary. The summary highlights that key analytical characteristics are "same" as the predicate device (Olympus Cholinesterase (CHE) Assay).

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The experiments mentioned are "method comparison, stability, linearity, and imprecision experiments," which are typical for IVD devices, but the specifics are not provided in this summary.

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

This is not applicable as the device is an IVD for quantitative measurement of an enzyme. "Ground truth" in the context of expert consensus for image interpretation or diagnosis is not relevant here. The ground truth for such a device is typically established through reference methods or highly accurate analytical techniques, not expert review.

4. Adjudication Method for the Test Set

Not applicable for an IVD device measuring a quantitative biomarker.

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

Not applicable. This is an in vitro diagnostic reagent, not an AI/ML-powered device that assists human readers in interpreting medical cases.

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

Not applicable. This is an in vitro diagnostic reagent that produces a quantitative result. Its performance is evaluated through analytical studies, not typically against human interpretation.

7. The Type of Ground Truth Used

For an IVD device like this, the "ground truth" for evaluating its performance would typically involve:

• Reference methods: Using highly accurate and established analytical methods to determine the true concentration or activity of cholinesterase in samples.
• Known concentrations: Using samples with known, spiked concentrations of cholinesterase for linearity and accuracy studies.
• Comparative methods: Comparison against a legally marketed predicate device (as indicated by the "Comparison to Predicate(s)" section). The predicate device itself serves as a standard for comparison.

8. The Sample Size for the Training Set

Not applicable. This is an IVD device, not an AI/ML device that requires a training set. Its functionality is based on biochemical reactions.

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

Not applicable.

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The Dimension Vista™ Acetaminophen (ACTM) Flex® reagent cartridge is a device intended to measure acetaminophen, an analgesic and antipyretic (fever reducing) drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.

The Dimension Vista™ Amylase (AMY) Flex® reagent cartridge is a device intended to measure the activity of the enzyme amylase in serum, plasma and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

The Dimension Vista™ Creatine Kinase (CK) Flex® reagent cartridge is a device intended to measure the activity of the enzyme creatine kinase in serum and plasma. 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 Dimension Vista™ Cholesterol (CHOL) Flex® reagent cartridge is a device intended to measure cholesterol in serum and plasma. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

The Dimension Vista™ Gamma-glutamyl transferase (GGT) Flex® reagent cartridge is a device intended to measure gamma-glutamyl transferase in human serum and plasma. Gamma-glutamyl transferase measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.

The Dimension Vista™ Glucose (GLU) Flex® reagent cartridge is a device intended to measure glucose in human serum, plasma, urine and cerebrospinal fluid. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal and idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

The Dimension Vista™ High-Density Lipoprotein Cholesterol (HDLC) Flex® reagent cartridge is intended to measure high-density lipoprotein cholesterol in serum and plasma. Measurements of high-density lipoprotein cholesterol are used in the diagnosis of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The Dimension Vista™ Low-Density Lipoprotein Cholesterol (LDLC) Flex® reagent cartridge is intended to measure low-density lipoprotein cholesterol in serum and plasma. Measurements of low-density lipoprotein cholesterol are used in the diagnosis of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The Dimension Vista™ Lidocaine (LIDO) Flex® reagent cartridge is a device intended to measure lidocaine, an antiarrythmic and anticonvulsant drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of lidocaine overdose or in monitoring levels of lidocaine to ensure appropriate therapy.

The Dimension Vista™ Magnesium (MG) Flex® reagent cartridge is intended for the measurement of magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

The Dimension Vista™ Pseudocholinesterase (PCHE) Flex® reagent cartridge is a device intended to measure pseudocholinesterase activity in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

The Dimension Vista™ Phosphorus (PHOS) Flex® reagent cartridge is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

The Dimension Vista™ Procainamide (PROC) Flex® reagent cartridge is a device intended to measure procainamide in serum and plasma. Measurements obtained may be used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to ensure appropriate therapy.

The Dimension Vista™ Salicylate (SAL) Flex® reagent cartridge is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human serum. Measurements obtained by this device are used in the diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.

The Dimension Vista™ Thyroxine (T4) Flex® reagent cartridge is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

The Dimension Vista™ Tobramycin (TOBR) Flex® reagent cartridge is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in palsma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.

The Dimension Vista™ Triglyceride (TRIG) Flex® reagent cartridge is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

The Dimension Vista™ Uric Acid (URCA) Flex® reagent cartridge is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

The Dimension Vista™ Valproic Acid (VALP) Flex® reagent cartridge is a device intended to measure valproic acid, an anti-convulsant drug in serum and plasma. Measurements obtained may be used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy.

The Dimension Vista™ Vancomycin (VANC) Flex® reagent cartridge is a device intended to measure vancomycin, an antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Vade 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 (K 051087). 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 packaging modification, does not affect the intended use of the devices, nor does it alter the fundamental scientific technology of the devices.

Here's a breakdown of the acceptance criteria and study information for the Dade Behring Dimension Vista™ Flex® reagent cartridges, based on the provided 510(k) summary:

This device submission is a Special 510(k) for a packaging modification, meaning the core technology and reagents are the same as previously cleared devices. Therefore, the primary goal of the study is to demonstrate substantially equivalent performance after the packaging change, rather than to establish initial performance claims for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria or specific performance metrics (e.g., accuracy, precision values) for each analyte. Instead, it relies on a comparative equivalency approach to a predicate device.

The overarching acceptance criterion is "substantially equivalent performance" to the predicate Dimension® Flex® reagent cartridges.

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

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

• Sample Size for Test Set: This information is not explicitly stated in the provided summary. The summary refers to a "protocol included in this submission," which would contain these details.
• Data Provenance: This information is not explicitly stated in the provided summary.
• Retrospective or Prospective: This information is not explicitly stated. However, given the nature of in-vitro diagnostic testing for performance comparison, it would typically involve prospective testing on patient samples or spiked samples.

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

This is an in-vitro diagnostic device for quantitative measurement of analytes in human samples (serum, plasma, urine, CSF). The ground truth for such devices is established by:

• Reference Methods: Highly accurate and precise laboratory methods, often gold standards like GC-MS, HPLC, or other well-validated enzymatic or spectrophotometric methods.
• Certified Reference Materials (CRMs): Samples with known, certified concentrations of the analytes.

Therefore, the concept of "experts" in the clinical imaging or diagnostic interpretation sense (e.g., radiologists) is not applicable here. The ground truth is laboratory-based and instrumental.

4. Adjudication Method for the Test Set

Not applicable for this type of in-vitro diagnostic device. Ground truth is established by reference methods or certified materials, not by expert consensus or adjudication.

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

• No, an MRMC comparative effectiveness study was not done.
• This device is an in-vitro diagnostic reagent cartridge, not an AI-powered diagnostic imaging tool or a system designed for human interpretation with or without AI assistance. The performance is measured instrumentally.

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

• Yes, the performance evaluated is inherently "standalone" in the context of an automated analytical instrument. The Flex® reagent cartridges are designed to be used on the Dimension Vista™ Integrated system, a "fully automated, microprocessor-controlled, integrated instrument system." The performance of the reagent (device) is measured by its output on this automated system.
• There is no "human-in-the-loop" decision-making component for the measurement process itself, although clinical interpretation of the results by a healthcare professional is expected.

7. The Type of Ground Truth Used

The ground truth for this type of in-vitro diagnostic device would typically involve:

• Reference Method Assays: Using established, highly accurate, and precise laboratory methods (e.g., a recognized primary reference measurement procedure or a well-characterized predicate device itself) to determine the true concentration of the analytes in the test samples.
• Certified Reference Materials: Commercial or internal standards with known, traceable concentrations of the analytes.
• Sample Matrix: Patient samples (serum, plasma, urine, CSF) with concentrations spanning the analytical range.

The summary states "Comparative testing... demonstrates substantially equivalent performance." This strongly implies that the new device's measurements were compared against the measurements obtained by the predicate device on the same samples, which serves as the "reference" or "ground truth" for the equivalence claim.

8. The Sample Size for the Training Set

This device is a reagent cartridge for an in-vitro diagnostic test, not a machine learning or AI algorithm in the contemporary sense that requires a "training set" to learn. The reagents and their chemical reactions are based on established scientific principles.

Therefore, the concept of a "training set" as understood in machine learning is not applicable to this device.

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

As noted above, the concept of a "training set" is not applicable to this device. The ground truth for the performance evaluation (test set) would be established by reference methods or comparison to the predicate device, as described in point 7.

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The Cholinesterase Gen.2 Test System is an in vitro test for the quantitative determination of the catalytic activity of cholinesterase (EC 3.1.1.8; acylcholine acylhydrolase) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders.

The Cholinesterase Gen.2 Test System is an in vitro test for the quantitative determination of the catalytic activity of cholinesterase in serum and plasma. The test is based on the butyrylthiocholine method. Cholinesterase catalyzes the hydrolysis of butyrylthiocholine to thiocoline and butyrate. Thiocholine reduces the yellow substrate hexacyanoferrate III to the almost colorless hexacyanoferrate II. The decrease in color is measured spectrophotometrically. The calibrator is the Calibrator for automated systems (C.f.a.s; and the recommended control materials are Precinorm U or Precinorm U Plus; and Precipath U or Precipath U plus.

The provided text describes the Cholinesterase Gen.2 test system, a device for in vitro quantitative determination of cholinesterase catalytic activity. The submission compares this new device to a predicate device (Cholinesterase Test System, K951595) to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than explicit "acceptance criteria" against pre-defined performance goals for a new medical device. However, performance characteristics are presented, which implicitly serve as the basis for demonstrating equivalence.

Study Proving Device Meets Acceptance Criteria:

The "study" refers to the entire submission and the performance data presented within it, which are used to show the new device is substantially equivalent to the predicate. The "Method comparison" section specifically details a direct comparison study.

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

The sample size for the method comparison (test set) is not explicitly stated. The provenance of the data (country of origin, retrospective/prospective) is also not specified.

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

This information is not applicable and not provided. The study compares the performance of two in vitro diagnostic devices measuring an analyte, not an interpretation of images or clinical diagnoses by human experts.

4. Adjudication method for the test set

This information is not applicable and not provided. The study involves quantitative measurements by automated systems, not subjective assessments requiring 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 information is not applicable. This is an in vitro diagnostic device for quantitative measurement, not an AI-assisted diagnostic imaging device or an interpretation task by human readers.

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

The context is an in vitro diagnostic test system, which inherently operates as a standalone algorithm/system to produce a quantitative result. The results are then used by a human clinician for diagnosis and treatment. The performance metrics reported (precision, measuring range, detection limit, method comparison) represent the standalone performance of the Cholinesterase Gen.2 Test System.

7. The type of ground truth used

The "ground truth" for this type of quantitative diagnostic device is established by comparison to a reference method or a legally marketed predicate device, and through fundamental analytical validation methods.

• For Method Comparison: The predicate device ("Integra cholinesterase (granulate)") serves as the comparative standard.
• For Traceability/Standardization: The device is "Standardized against a reference method using a manual application of the butyrylthiocholine/hexacyanoferrate (III) method on a photometer and the published molar absorptivity of hexacyanoferrate (III)." This manual reference method acts as a form of ground truth for calibration and accuracy.

8. The sample size for the training set

This information is not provided. For this type of IVD, a "training set" in the machine learning sense is not typically applicable. Development involves optimizing reagents and analytical conditions, and validation involves characterizing performance.

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

This information is not applicable as there is no mention of a "training set" in the context of an AI/ML algorithm. The "standardization" and "traceability" sections describe how the device's measurements are referenced to established analytical methodologies.

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The Sentinel Cholinesterase Liquid assay is used to measure cholinesterase in human specimens. There are two principal type of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is note present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition and disorders. For In Vitro diagnostics use only. CFR 862.3240

Sentinel Cholinesterase Liquid is an in vitro diagnostic assay for the quantitative determination of cholinesterase in serum and plasma.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text.

Note: The provided text describes a submission for a chemical assay (Cholinesterase Liquid), not an AI-powered device or an image-based diagnostic. Therefore, many of the requested criteria related to AI, ground truth, expert review, MRMC studies, and training/test sets are not applicable to this type of submission and are not mentioned in the documentation. The description focuses on demonstrating substantial equivalence of a modified in-vitro diagnostic assay to a previously cleared one.

Acceptance Criteria and Device Performance

The acceptance criteria for this device revolve around demonstrating substantial equivalence to a predicate device for its intended use and performance characteristics, specifically after adapting it to new analyzer systems.

Due to the nature of this submission (modification of an IVD assay to run on different analyzers), the acceptance criteria are implicitly met when the comparative performance studies show acceptable correlation.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The study was a comparative performance study aimed at demonstrating the substantial equivalence of the modified Sentinel Cholinesterase Liquid assay when run on the Abbott AEROSET® and ARCHITECT® c8000® Analyzers, compared to the previously cleared Sentinel Cholinesterase Liquid Model Number 17.019A and 17.606 assay on Hitachi 717.

2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample size used for the comparative performance studies (method comparison studies). It states "comparative performance studies were conducted" but does not detail the number of samples or patients included. The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications:
This is not applicable as the device is an in-vitro diagnostic assay for quantitative determination of cholinesterase, not an AI or image-based diagnostic requiring expert interpretation for ground truth. The "ground truth" for method comparison in an IVD context is typically the results obtained from a reference method or a legally marketed predicate device.

4. Adjudication Method:
This is not applicable for the reasons stated above. There is no expert adjudication process described for the performance of a quantitative chemical assay.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No. This is definitively not applicable as this device is a laboratory assay, not an AI or imaging device involving human readers.

6. If a standalone (algorithm only without human-in-the loop performance) was done:
The device itself is standalone in the sense that it is a quantitative assay performed by an analyzer. Its performance is evaluated intrinsically through comparison to a predicate, not in interaction with a human "in the loop" in a diagnostic workflow like an AI algorithm might be. So, yes, the performance assessed is of the assay independent of immediate human interpretative input in a diagnostic decision-making context.

7. The Type of Ground Truth Used:
For the comparative performance studies, the "ground truth" was established by the results obtained from the legally marketed predicate device, Sentinel Cholinesterase Liquid Model Number 17.019A and 17.606 assay on Hitachi 717, and also by the AEROSET system's results being used as a comparator for the ARCHITECT c8000 system. This is a common approach for demonstrating substantial equivalence of IVD modifications.

8. The Sample Size for the Training Set:
Not applicable. This device is a chemical assay, not a machine learning algorithm that requires a "training set." The development of the assay itself would have involved method optimization and validation, but not in the context of a "training set" for an AI model.

9. How the Ground Truth for the Training Set Was Established:
Not applicable. See point 8.

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Reagent for the determination of cholinesterase concentrations in human serum and plasma using the Olympus family of clinical chemistry analyzers.

Measurement of serum cholinesterase has been used to assess liver function and to investigate the variants of cholinesterase enzyme. It is also useful in predicting susceptibility to prolonged apnea after the administration of succinylcholine and in monitoring excessive exposure to organophosphorus insecticides.

Not Found

Please provide the full study report or 510(k) submission for the Olympus Cholinesterase Reagent (K030045).

The provided text is an FDA clearance letter and an "Indications for Use Statement." These documents confirm that the device has been cleared for market and state its intended use, but they do not contain the detailed study information or acceptance criteria needed to answer your questions.

Specifically, the clearance letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the device's performance was compared to a predicate device, but the details of that comparison, including acceptance criteria and the study design, are not present in these documents.

To answer your questions accurately, I would need a document like the "510(k) Premarket Notification" itself, or a detailed study report that describes the validation studies performed for the Olympus Cholinesterase Reagent.

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The WIENER LAB. Colinesterasa AA test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens, on both manual and automated systems. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

Kinetic Method. The principle is based on the following reaction system: Cholinesterase Butyrylthiocholine + H2O -> Thiocholine + Butyrate Thiocholine + DTNB -> 2-Nitro-5-Mercapto-benzoate The cholinesterase activity is determined by measuring the rate of absorbance change at 405 nm. DTNB: 5,5'-Dithiobis-2-Nitrobenzoic Acid. ChE: serum or plasma cholinesterase.

Here's a breakdown of the acceptance criteria and study information for the "Wiener lab. Colinesterasa AA" device, based on the provided text:

Device: Wiener lab. Colinesterasa AA (Cholinesterase test system)
Predicate Device: SIGMA DIAGNOSTICS Cholinesterase (BTC) (Cat. 421-10)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as separate targets, but rather are implied by direct comparison to the predicate device. The study's goal was to demonstrate "substantial equivalence" to the predicate, meaning the performance of the Wiener lab. Colinesterasa AA device should be comparable to or better than the SIGMA DIAGNOSTICS Cholinesterase (BTC) system.

Note on Acceptance Criteria: The document explicitly states the objective is to demonstrate "substantial equivalence" to the predicate device. Therefore, the "acceptance criteria" are implied to be achieving comparable or improved performance across the listed metrics. The reported device performance generally demonstrates better performance (e.g., higher linearity, lower CVs for precision) than the predicate device, which supports the claim of substantial equivalence.

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

The document does not explicitly state the sample size for the test set used to generate the reported performance data (linearity, precision, expected values).

The data provenance is not explicitly stated. However, given that "Wiener Laboratorios S.A.I.C." is located in Rosario, Argentina, it is reasonable to infer that the studies were likely conducted in Argentina or involved samples from that region. The study type (retrospective or prospective) is not mentioned.

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

This information is not applicable to this type of in vitro diagnostic device for chemical analysis. Ground truth for enzyme activity measurements is established through the analytical performance of the device (e.g., linearity, precision, accuracy against known standards or validated methods), not through expert consensus on qualitative interpretation. The "ground truth" here is the actual cholinesterase activity in the samples, measured by the device and compared for consistency and accuracy.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used for qualitative or interpretive assessments (e.g., diagnostic imaging, pathology slides) where there might be inter-reader variability. This is not applicable to the quantitative measurement of an enzyme activity by an in vitro diagnostic device.

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. The device is an in vitro diagnostic for quantitative chemical analysis, not an AI-powered diagnostic imaging or qualitative assessment tool that involves human readers or AI assistance.

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

This is not applicable in the context of an "algorithm only" device as typically understood for AI or image analysis. The "Wiener lab. Colinesterasa AA" system is a chemical reagent-based assay. Its performance is inherent to the chemical reactions and subsequent spectrophotometric measurement, whether operated manually or on an automated system. Its operation is analogous to a standalone diagnostic test in that the result is directly generated by the system, requiring human intervention primarily for sample handling, instrument setup, and interpretation of the numerical result against reference ranges.

7. The Type of Ground Truth Used

The ground truth used for performance validation (linearity, precision, expected values) would typically be:

• For Linearity: Known concentrations of cholinesterase, or samples whose concentrations have been established by a gold-standard reference method.
• For Precision: Repeated measurements on control materials or patient samples where consistent readings are expected.
• For Expected Values: Data collected from a statistically significant healthy population (reference ranges) as well as patient populations with known cholinesterase inhibition disorders. The provided "Expected values" table serves as a reference range established through clinical studies.

8. The Sample Size for the Training Set

This is not applicable as the device is a chemical reagent-based analytical system, not a machine learning model that requires a "training set" in the conventional sense. The "training" for such a system involves formulation optimization and calibration, which doesn't typically involve a "training set" of patient data as understood in AI/ML.

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

This is not applicable for the reasons stated in point 8.

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The ADVIA 1650 Cholinesterase in vitro diagnostic procedure is intended to measure cholinesterase in human I he ADVANT 1050 Onlinesser any and 650 system. Such measurement is used in the diagnosis and treatment Scruit and pashia on the Dayer AD Previous liver diseases such as cirrhosis and acute and chronic hepatitis.

The Cholinesterase in vitro diagnostic procedure is intended to measure cholinesterase enzyme activity in human serum, plasma (lithium heparin) on the Bayer ADVIA® 1650 Such measurement is used in the diagnosis and treatment of organophosphorus System. poisoning and certain liver diseases such as cirrhosis, acute and chronic hepatitis.

Here's an analysis of the provided text, focusing on the acceptance criteria and study details for the Bayer ADVIA® 1650 System's Cholinesterase method:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for each metric. Instead, the demonstration of "substantial equivalence" to the predicate device (Kodak Vitros 250/ Cholinesterase) implies that the performance of the new device (ADVIA 1650 Cholinesterase) should be comparable to or better than the predicate. For imprecision, the ADVIA 1650 clearly shows lower CVs, indicating better precision than the predicate. For correlation and interference, the results are presented as positive data points supporting equivalence.

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

• Imprecision: Not explicitly stated as "test set," but the data suggests it's from a study.
  • Three levels were tested for the ADVIA 1650 Cholinesterase. The sample size for each level to calculate the CV is not specified (e.g., number of replicates).
  • Two levels were reported for the Kodak Vitros 250 Cholinesterase. The sample size for each level to calculate the CV is not specified.
• Correlation:
  • Serum: N = 58
  • Plasma vs Serum: N = 40
• Interfering Substances: Not explicitly stated as "test set," but for each interfering substance, "control" and "test sample" values are provided, implying at least two measurements for each. The overall number of samples (e.g., healthy or spiked) for this study is not detailed.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given it's an in vitro diagnostic device for human serum/plasma, the samples would be human biological specimens. The study was conducted by Bayer Diagnostics, a multinational company.

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

This information is not provided in the document. For in vitro diagnostic tests like Cholinesterase, the "ground truth" is typically established by the reference method or comparison method itself, rather than expert interpretation of results. The Cholinesterase activity is a measurable analyte, and the focus is on the accuracy, precision, and correlation of the new device's measurement against a validated comparator, not subjective expert assessment.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective interpretation of medical images or clinical outcomes where there might be disagreement among reviewers, requiring a consensus or tie-breaker. For an in vitro diagnostic test measuring a specific analyte concentration, the "ground truth" or reference is the quantitative value from a comparison system.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for imaging devices or diagnostics that depend on human interpretation, where the goal is to assess how a device (often AI-assisted) impacts the diagnostic performance of multiple readers across various cases. The Cholinesterase assay is a quantitative laboratory test, not an imaging or interpretive diagnostic.

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

Yes, this entire study represents a standalone (algorithm only) performance assessment. The ADVIA 1650 Cholinesterase system is an automated in vitro diagnostic device. The performance metrics (imprecision, correlation, interference, analytical range) presented are the direct output and performance characteristics of the instrument and its associated reagents, without human interpretive involvement in the measurement itself. The "algorithm" here refers to the chemical reactions and photometric measurements performed by the ADVIA 1650 system.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation was the comparison to a legally marketed predicate device/method: the Kodak Vitros 250/ Cholinesterase.

• For correlation studies, the measurements obtained from the Kodak Vitros 250 were effectively treated as the reference or "ground truth" against which the ADVIA 1650 results were compared.
• For imprecision, the inherent variability of the predicate served as a benchmark for what's acceptable.
• For interference, the "control" sample (without interferent) served as the baseline to assess the effect of the interfering substance.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" for the ADVIA 1650 Cholinesterase method. This is understandable because the device is a chemical assay system, not an AI/ML algorithm that typically requires a distinct training phase on data.

If there were any internal development or optimization studies done during the method's development by Bayer, those would have used various samples, but they are not detailed in this 510(k) summary, which focuses on validation data against a predicate.

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

Since a "training set" in the context of AI/ML is not discussed, the method for establishing "ground truth" for a training set is not applicable and not provided. The development of the Cholinesterase reagent and instrument parameters would be based on established biochemical principles and extensive internal R&D, rather than a data-driven training process with externally established ground truth labels common in AI/ML.

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The ILab 600 is an automated, random access clinical chemistry analyzer which uses analytical techniques (photometry and potentiometry) for the in vitro quantitation of analytes found in physiological fluids such as serum, plasma, urine and cerebrospinal fluid. The results of the measurements are used as medical diagnostic tools.

The ILab 600 is an automated, random access clinical chemistry analyzer which uses analytical techniques (photometry and potentiometry) for the in virro quantitation of analytes found in physiological fluids such as serum, plasma, urine and cerebrospinal fluid. The results of the measurements are used as medical diagnostic tools.

The ILab 600 Clinical Chemistry System is an automated, random access clinical chemistry analyzer that quantifies analytes in physiological fluids using photometry and potentiometry. The device was found substantially equivalent to the ILab 900/1800 Clinical Chemistry System (K932467, K943595) and IL Test assays (K943366, K952646, K943367, K952647).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ILab 600 are implicit in its claim of substantial equivalence to the predicate device, the ILab 900. This means the performance of the ILab 600 must be "statistically similar" to that of the ILab 900 across various analytes and sample types (serum, urine, cerebrospinal fluid).

The reported device performance is demonstrated through method comparison studies and precision studies.

Method Comparison Studies (ILab 600 vs. ILab 900):

Precision Studies (ILab 600):

• Serum Samples: Two levels of serum samples (three for Cholesterol) were tested in triplicate twice a day for 10 days (n=60 total). The Total %CV for most analytes was generally low, indicating good precision. For example:
  • Albumin: Level 1 (1.79%), Level 2 (1.08%)
  • ALT/GPT: Level 1 (1.26%), Level 2 (0.99%)
  • Cholesterol: Level 1 (2.11%), Level 2 (1.35%), Level 3 (1.37%)
  • ISE Sodium: Level 1 (0.94%), Level 2 (0.67%)
• Urine Samples: Two levels of urine samples were tested in triplicate twice a day for 10 days (n=60 total). Similar to serum, Total %CV remained low:
  • Amylase: Level 1 (2.56%), Level 2 (2.02%)
  • Creatinine: Level 1 (2.11%), Level 2 (1.73%)
  • ISE Sodium: Level 1 (1.13%), Level 2 (0.65%)
• Cerebrospinal Fluid Samples: Two levels of CSF samples were tested using IL Test Glucose Oxidase in triplicate twice a day for 5 days (n=30 total).
  • Glucose Oxidase: Level 1 (1.49%), Level 2 (0.98%)

The studies conclude that the ILab 600 and ILab 900 are "statistically similar" for the tests evaluated. The precision studies demonstrate acceptable levels of reproducibility based on the reported Coefficient of Variation (%CV) values for within-run, among-run, among-day, and total precision. No specific numerical thresholds for acceptance criteria were explicitly stated, but the robust statistical similarity and low %CV values imply the device meets the necessary performance standards for clinical use.

2. Sample Sizes and Data Provenance

• Test Set (Method Comparison):

  • Serum Samples: Sample sizes ranged from a minimum of 64 (Lipase) to a maximum of 137 (Glucose Oxidase).
  • Urine Samples: Sample sizes ranged from 49 (ISE Potassium and Sodium) to 95 (Glucose Hexokinase).
  • Cerebrospinal Fluid Samples: Sample size was 20 (Glucose Oxidase).
  • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

• Test Set (Precision Studies):

  • Serum Samples: n=60 for most analytes (triplicate measurements, twice a day, for 10 days). Cholesterol used n=60 across three levels.
  • Urine Samples: n=60 for all analytes (triplicate measurements, twice a day, for 10 days).
  • Cerebrospinal Fluid Samples: n=30 for Glucose Oxidase (triplicate measurements, twice a day, for 5 days).
  • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

The document pertains to the performance characteristics of a clinical chemistry analyzer, which measures quantitative values of analytes. The "ground truth" in this context refers to the actual concentration of the analytes in the samples. Clinical chemistry analyzer performance is typically evaluated by comparing results to a reference method (in this case, the predicate device ILab 900) or by using certified reference materials with known concentrations. Therefore, expert interpretation or consensus, as might be used in image-based diagnostic AI, is not applicable here. No mention of human experts defining "ground truth" is provided or expected.

4. Adjudication Method

Not applicable. As described in point 3, this is a quantitative measurement device, not an interpretation task requiring adjudication of expert opinions.

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

Not applicable. The device is a clinical chemistry analyzer, not an AI system assisting human readers in diagnostic interpretation. The study evaluates the analyzer's performance directly against a predicate device and for precision, not the human reader's effectiveness with or without AI.

6. Standalone Performance Study

Yes, standalone performance was done.

• Method Comparison Studies: The performance of the ILab 600 was compared directly to that of the ILab 900 (predicate device). This is a standalone comparison of the new device against an established one.
• Precision Studies: The precision of the ILab 600 was evaluated independently, measuring its reproducibility across different runs and days. This is also a standalone performance evaluation of the device itself.

7. Type of Ground Truth Used

The ground truth used for these studies is the quantitative analytical result obtained from the predicate device (ILab 900) for method comparison studies, and the inherent, measured concentration within the biological samples for precision studies. This is a form of reference method comparison or analytical accuracy assessment, rather than pathology, expert consensus, or outcomes data, which are typically associated with qualitative or interpretative diagnostics. For precision, the ground truth is implicitly the true, stable concentration in the control/patient samples being repeatedly measured.

8. Sample Size for the Training Set

Not applicable. The ILab 600 is a clinical chemistry analyzer, which operates based on established chemical and photometric/potentiometric principles and internal calibration curves. It is not an AI/ML device that requires a "training set" in the sense of supervised learning. Its analytical methods are pre-programmed and validated, not learned from data in the way a machine learning algorithm would be.

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

Not applicable, as there is no "training set" for this type of device. The device's operational parameters and calibration are established through engineering design and standard laboratory calibration procedures, not through a data-driven training process.

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The SYNCHRON Systems Alkaline Phosphatase (ALP) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of alkaline phosphatase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) or the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).

The SYNCHRON Systems Cholinesterase (CHE) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of pseudo-cholinesterase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).

The SYNCHRON Systems ~- Glutamyl Transferase (GGT) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of yglutamyl transferase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).

The SYNCHRON Systems Lactate Dehydrogenase (L.D) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of lactate dehydrogenase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).

The SYNCHRON Enzyme Validator Set, in conjunction with specified enzyme assays on Beckman SYNCHRON Systems, is intended to provide points of reference in the measurement of selected human enzymes. Use of this product will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).

The SYNCHRON Systems ALP. CHE, GGT, and LD Reagents are intended for use on Beckman's SYNCHRON Clinical Systems. These reagents may be used in conjunction with the SYNCHRON Enzyme Validator for assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) or the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).

The provided document describes the SYNCHRON Systems Enzyme Reagents (ALP, CHE, GGT, LD) and the SYNCHRON Enzyme Validator Set, intended for quantitative determination of enzyme activity in human serum or plasma. It focuses on demonstrating substantial equivalence to predicate devices already on the market.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format with specific thresholds for performance. Instead, it demonstrates performance through method comparison and imprecision studies, aiming to show equivalence to existing methods (predicate devices and IFCC/DGKCh recommended methods).

The "acceptance criteria" can be inferred from the goal of demonstrating substantial equivalence, meaning the performance should be comparable to the predicate devices and recognized clinical chemistry methods.

It's important to note that the document does not explicitly define acceptable ranges for slope, intercept, or correlation coefficient, nor for imprecision. The reported values are presented as evidence of performance.

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

• Test Set Sample Sizes (Method Comparison):
  • SYNCHRON LX System Calibrated (DGKCh) ALP Reagent: n = 67
  • SYNCHRON LX System Calibrated (IFCC) ALP Reagent: n = 79
  • SYNCHRON LX System Calibrated CHE Reagent: n = 72
  • SYNCHRON LX System Calibrated GGT Reagent: n = 79
  • SYNCHRON LX System Calibrated LD Reagent: n = 70
• Test Set Sample Sizes (Imprecision): For each reagent (ALP, CHE, GGT, LD) and each level (1-3, or 1-2 for LD), "N" is consistently 80 for both within-run and total imprecision measurements.
• Data Provenance: The document does not explicitly state the country of origin of the data. Given Beckman Instruments, Inc. is located in Brea, California, USA, and the submission is to the FDA, it is highly probable the data was generated in the USA. The study design appears to be prospective for the performance testing of the new reagents and validator set, as it involves generating new data for method comparison and imprecision.

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

This information is not applicable to this type of device. The ground truth for quantitative enzyme assays is established through established analytical methods and reference materials, not through expert human interpretation or consensus. The comparison is made against existing, validated laboratory methods (predicate devices and IFCC/DGKCh recommended methods).

4. Adjudication Method for the Test Set:

This information is not applicable to this type of device. Adjudication typically refers to resolving discrepancies between human readers or between an AI and human readers, which is not relevant for quantitative chemical assays.

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 information is not applicable to this device. An MRMC study is relevant for diagnostic imaging or similar interpretation tasks involving human readers, not for automated quantitative enzyme reagent systems. There is no "human reader" involved in the direct output of these reagents, nor is an AI component being evaluated in conjunction with human interpretation.

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

The studies presented (method comparison and imprecision) inherently represent standalone performance of the reagent system on the SYNCHRON Clinical Systems. The results generated are direct measurements by the automated system—there is no human-in-the-loop component for result generation, only for operating the instrument and interpreting the final quantitative values.

7. The Type of Ground Truth Used:

The "ground truth" for the test set is established by:

• Comparison to predicate devices: The uncalibrated SYNCHRON Systems Enzyme Reagents, which are already marketed and accepted.
• Compatibility with methods recommended by the International Federation of Clinical Chemistry (IFCC) or the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh): These are internationally recognized standard methods for clinical enzyme determination. The new device, when used with the Enzyme Validator, aims to produce results compatible with these reference methods.

In essence, the ground truth is based on established and recognized analytical methods and their results.

8. The Sample Size for the Training Set:

The document does not report a "training set" sample size. This is a 510(k) submission for in-vitro diagnostic (IVD) reagents, which at the time (1997) did not typically involve "training sets" in the context of machine learning or AI models. The development and validation of such reagents rely on analytical studies to establish performance characteristics rather than training data for an algorithm.

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

As there is no "training set" in the context of AI/ML, this question is not applicable. The methods for developing and validating these reagents would have involved extensive R&D, formulation optimization, and initial analytical testing to ensure chemical stability, reactivity, and specificity, leading to the performance demonstrated in the summary. The "ground truth" for method development would be based on fundamental principles of analytical chemistry and biochemistry.

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