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For the quantitative in vitro determination of Triglycerides in serum. Triglyceride measurements are used in the diagnosis and treatment of diseases involving lipid metabolism and various endocrine disorders e.g Diabetes mellitus, nephrosis and liver obstruction

This in vitro diagnostic device is intended for prescription use only.

The Randox Triglycerides kit assay consists of ready to use reagent solutions.

Here's a breakdown of the acceptance criteria and the study information for the Triglycerides (TRIGS) device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of "acceptance criteria" for the entire device's performance followed by a direct comparison in a single table, but rather describes various performance characteristics and their findings. I will construct a table based on the individual performance criteria and the results presented.

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

• Precision/Reproducibility:
  • Test Set: Serum-based control material and unaltered human serum samples (some spiked or diluted). Specific numbers of individual patient samples beyond "Pool 1, Pool 2, Pool 3, Pool 4" are not given. For each sample type, 2 replicates per run were performed, twice daily for 20 non-consecutive days, using 2 reagent lots and 2 systems.
  • Data Provenance: Not explicitly stated, but implies laboratory testing with control materials and human serum samples. Given the manufacturer is based in the UK, it's likely the testing was done there, but this is not confirmed. It is a prospective study design for precision.
• Linearity:
  • Test Set: 11 levels prepared from low and high serum pools, each run in replicates of five.
  • Data Provenance: Not explicitly stated, but implies laboratory testing with serum pools. Prospective study design.
• Detection Limit:
  • Test Set: 240 determinations were made, including 4 low-level samples, to determine LoD, LoB, and LoQ.
  • Data Provenance: Not explicitly stated, implies laboratory testing. Prospective study design.
• Analytical Specificity (Interference):
  • Test Set: Spiked interferent samples with corresponding control solutions. Specific number of samples not provided. Triglycerides concentrations of 150 mg/dL and 496 mg/dL were examined.
  • Data Provenance: Not explicitly stated, implies laboratory testing. Prospective study design.
• Method Comparison:
  • Test Set: 109 serum patient samples spanning the range 14.2 to 986 mg/dl. Each tested in singlicate.
  • Data Provenance: Not explicitly stated (e.g., country of origin), but states "serum patient samples." Implies retrospective collection of samples or prospective collection for this study.

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

This device (Triglycerides assay) is an in-vitro diagnostic device for quantitative chemical analysis. The "ground truth" for these types of devices is established through analytical reference methods or highly characterized reference materials, not typically by expert consensus of human readers.

• No mention of human experts or their qualifications for establishing ground truth for the test set.

4. Adjudication Method for the Test Set

Not applicable for this type of quantitative analytical assay. Adjudication is typically used in image-based diagnostic studies involving human interpretation.

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

No, an MRMC comparative effectiveness study was not done. This type of study involves assessing the performance of human readers, sometimes with and without AI assistance, and is not relevant for a quantitative chemical assay.

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

Yes, the studies described (precision, linearity, detection limit, analytical specificity, method comparison) represent the standalone performance of the device/system (RX Daytona plus analyzer with Randox Triglycerides reagent) without human intervention in the analytical measurement process beyond sample loading and general operation.

7. The Type of Ground Truth Used

• Precision/Reproducibility, Linearity, Detection Limit, Analytical Specificity: The "ground truth" or reference for these studies refers to the true concentration of triglycerides in the samples (control materials, spiked samples, diluted samples) as determined by a highly accurate method or known values of reference materials.
• Method Comparison: The "ground truth" is the results obtained by a legally marketed predicate device (Randox Triglyceride Assay, K923508). For calibrators within the system, Randox Calibration Serum Level 3 is stated to be traceable to the Triglycerides reference method ID-GC/MS. This indicates a high-accuracy chemical method is the ultimate ground truth for calibration.

8. The Sample Size for the Training Set

This document describes a medical device (an in-vitro diagnostic reagent/system) for which "training sets" are not typically applicable in the same way as for AI/machine learning algorithms. The device's performance characteristics are inherent to its chemical formulation and the analytical instrument. There is no mention of a "training set" for an algorithm.

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

Not applicable, as there is no specific "training set" for an algorithm mentioned in the context of this device.

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The ADVIA® Chemistry Triglycerides 2 assay (TRIG 2) is intended for in vitro diagnostic use in the quantitative measurement triglycerides in human serum and plasma on the ADVIA® Chemistry systems. Measurements of triglycerides 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 Triglyceride 2 reagent is a ready-to-use liquid reagent packaged for use on the automated ADVIA 1800 Chemistry system. It is supplied as a 358 tests/wedge. 4 wedges/Kit with a 38 mL fill in a 40 mL wedge size.

Existing Siemens Set-Point Chemistry calibrator (classified under CFR 862.1150 - calibrator, multi-analyte mixture, product code JIX), cleared under 510k K030169, is used to calibrate the assay on the ADVIA Chemistry systems.

Here's a breakdown of the acceptance criteria and study information for the ADVIA® Chemistry Triglycerides 2 Reagents (TRIG 2) device, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the ADVIA® Chemistry Triglycerides 2 assay appear to be established by comparison with a predicate device and adherence to CLSI guidelines for various performance characteristics. Specific quantifiable acceptance criteria are often implied by "acceptable results" or meeting certain thresholds, but the document primarily reports the performance observed.

Study Details

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

   • Precision: 80 replicates for each of the two serum controls and two serum pools. The data provenance is not explicitly stated (e.g., country of origin); however, the context of in vitro diagnostic testing in a 510(k) submission generally implies laboratory testing under controlled conditions, likely in the US by the manufacturer (Siemens Healthcare Diagnostics, Inc., Tarrytown, NY). The data is prospective as it was generated specifically for this submission.
   • Linearity: Not explicitly stated how many samples/replicates were used, but it involved mixing low and high serum pools to create 12 levels (9 intermediate, 3 low-end).
   • LoB, LoD: 320 determinations, comprising 160 blank and 160 low-level sample replicates.
   • Method Comparison (Serum): 101 serum samples.
   • Method Comparison (Plasma Matrices): 60 plasma samples (Lithium Heparin) and 60 plasma samples (Potassium EDTA).
   • Analytical Specificity: Not explicitly stated, but involved testing samples with varying concentrations of interferents and triglycerides.

2. 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):

   • For this type of in vitro diagnostic device (chemical assay), the "ground truth" is typically established by the reference method (the predicate device) or by known concentrations of analytes in calibrators and control materials, rather than by human expert consensus or pathology. No human experts are mentioned for establishing ground truth in this context.

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

   • Adjudication methods like "2+1" or "3+1" are characteristic of studies involving human interpretation (e.g., imaging studies). This information is not applicable to a chemical assay where results are quantifiable values based on instrument measurements.

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

   • No MRMC comparative effectiveness study was done. This type of study is not relevant for an automated chemical assay.

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

   • Yes, this is a standalone device in the sense that the assay itself generates the quantitative results without direct human intervention in the result determination. The performance characteristics described are "algorithm only" or "device only" performance. Humans operate the instrument and interpret results, but the measurement itself is automated.

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

   • The ground truth for performance evaluation (e.g., method comparison) is based on the predicate device (Dimension Clinical Chemistry Triglycerides FLEX reagent cartridge, K010871) and known concentrations for controls, calibrators, and linearity pools. For traceability, the assay is referenced to NIST SRM909c, a certified reference material.

7. The sample size for the training set:

   • This is a traditional IVD assay, not a machine learning or AI-based device. Therefore, there is no "training set" in the context of data used to train an algorithm. The development of the reagent and its parameters would have involved R&D studies, but these are not analogous to training data for AI.

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

   • Not applicable, as there is no training set for an AI/ML algorithm.

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For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS® Systems. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

Not Found

The provided document describes a 510(k) summary for a modified medical device, the "VITROS Chemistry Products TRIG Slides," and references a study conducted to demonstrate substantial equivalence to a predicate device. This is a Special 510(k) submission, indicating that the modifications did not alter the fundamental scientific technology or intended use, but rather involved changes to the product that necessitated new verification and validation. Therefore, the study described focuses on demonstrating that the modified device continues to meet established performance criteria.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it states that various performance characteristics were considered for potential hazards and that validation and verification testing were conducted and the modified device met the pre-determined acceptance criteria for all the performance testing.

The characteristics considered, implying where acceptance criteria would have been applied, are:

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

The document does not explicitly state the sample size used for the test set or the data provenance (country of origin of the data, retrospective or prospective). This information is typically detailed in the validation and verification reports, which are summarized in the 510(k) but not fully reproduced here.

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

This information is not provided. For this type of in vitro diagnostic device (IVD), ground truth is established through reference methods or comparative studies with an established predicate device, rather than expert interpretation of images or other subjective data. Therefore, "experts" in the context of establishing ground truth for a clinical diagnostic test would typically refer to laboratory professionals performing the reference measurements, for which specific qualifications might not be explicitly stated in the 510(k) summary itself.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation, such as image analysis, where multiple readers provide opinions that might need to be resolved. For an IVD device measuring a quantitative analyte like triglycerides, the "ground truth" is established by a reference method or predicate device, and differences are analyzed statistically, not through direct adjudication of expert opinions on the test results.

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

An MRMC comparative effectiveness study was not done. This is an In Vitro Diagnostic (IVD) device for measuring triglyceride concentration, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers and AI assistance.

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

This concept is not directly applicable to this device in the way it is typically understood for AI-based algorithms. The device itself performs the measurement (algorithmically via chemical reactions and spectrophotometry). The study implicitly evaluates the "standalone" performance of the modified VITROS Chemistry Products TRIG Slides by comparing its results to a predicate device and ensuring it meets established specifications (accuracy, precision, etc.). There is no "human-in-the-loop" component in the direct measurement process of this specific IVD device.

7. The Type of Ground Truth Used

For this IVD device, the "ground truth" would have been established by:

• Reference Methods: Highly accurate and precise laboratory methods for triglyceride measurement.
• Predicate Device Comparison: The performance of the modified device was compared to the legally marketed predicate device (VITROS Chemistry Products TRIG Slides cleared on August 3, 1981 (K812029)). This comparison ensures "substantial equivalence" to a device already deemed safe and effective.

The testing considered accuracy, precision, linearity, potential interferents, stability, limit of detection, and specimen type, all of which would be assessed against established scientific and clinical standards, and in comparison to the predicate.

8. The Sample Size for the Training Set

This information is not provided. For a traditional IVD device based on chemical reactions and spectrophotometry, there isn't a "training set" in the machine learning sense. The device's operational parameters (like calibration curves, reaction kinetics) are established through rigorous experimental design and optimization, not by "training" an algorithm on a 'training set' of patient data in the way a modern AI model would be.

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

As explained above, the concept of a "training set" and establishing ground truth for it, as typically applied to AI/ML devices, is not directly applicable here. The device's function is based on established biochemical principles and analytical chemistry, with its design and performance specifications developed through scientific experimentation and engineering.

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The Vantera® Clinical Analyzer is an automated laboratory test analyzer which measures the 400 MHz proton nuclear magnetic resonance (NMR) spectrum of clinical samples to produce signal amplitudes, converting these signal amplitudes to analyte concentration. The device includes a 400 MHz NMR spectrometer and software to analyze digitized spectral data. This instrumentation is intended to be used with NMR based assays to detect multiple analytes from clinical samples.

The NMR LipoProfile® test, when used with the Vantera® Clinical Analyzer, an automated NMR spectrometer, measures lipoprotein particles to quantify LDL particle number (LDL-P), HDL cholesterol (HDL-C), and triglycerides in human serum and plasma using nuclear magnetic resonance (NMR) spectroscopy. LDL-P and these NMR-derived concentrations of HDL-C and triglycerides are used in conjunction with other lipid measurements and clinical evaluation to aid in the management of lipoprotein disorders associated with cardiovascular disease.

The Vantera Clinical Analyzer is a clinical laboratory analyzer that employs nuclear magnetic resonance spectroscopic detection to quantify multiple analytes in biological fluid specimens, specifically blood plasma and serum. The Vantera Clinical Analyzer system design is divided into 3 major subassemblies: a sample handling assembly, an NMR subassembly, and an enclosure. The Vantera Clinical Analyzer control system is distributed across three separate computers: The Host (1U) controls user interface, data handling, results calculation, system startup and shutdown. The Process Control (4U) schedules and manages all activities required to process a sample, controls all hardware in the sample handling subsystem, and manages remote access to the system. The NMR Control Computer controls all magnet operations. Two of these computers are contained within the Sample Handling Subassembly (1U and 4U) and one in the NMR Subassembly (NMR Console).

The NMR LipoProfile test involves measurement of the 400 MHz proton NMR spectrum of a plasma/serum sample, deconvolution of the composite signal at approximately 0.8 ppm to produce signal amplitudes of the lipoprotein subclasses that contribute to the composite plasma/serum signal, and conversion of these subclass signal amplitudes to lipoprotein subclass concentrations.

The provided 510(k) summary focuses on the analytical performance of the Vantera® Clinical Analyzer and the NMR LipoProfile® test compared to predicate devices, establishing substantial equivalence rather than providing explicit acceptance criteria as would be typical for a novel device. The study described primarily demonstrates that the proposed device performs comparably to its predicate devices in terms of analytical accuracy and precision.

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

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

The document does not explicitly state acceptance criteria in a pass/fail format. Instead, it demonstrates performance by comparing the analytical results of the Vantera® Clinical Analyzer with the NMR LipoProfile® test to its predicate device (NMR Profiler for the assay) across various metrics. The unstated acceptance criteria for each analytical performance metric would be that the proposed device's performance must be comparable to or better than the predicate device's performance.

Study Proving Acceptance Criteria:

The study conducted was an analytical validation comparing the performance of the Vantera® Clinical Analyzer with the NMR LipoProfile® test to its predicate device (NMR Profiler for the assay) across various analytical parameters. The overall conclusion is that the new device is "as safe and effective as its predicate device."

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

• Test Sets (Analytical Studies):
  • Analytical Sensitivity (LoB, LoD, LoQ): Five serum pools for low concentrations tested in replicates of 4 for 3 days. Non-lipoprotein specimens analyzed 60 consecutive times for 3 days for LoB.
  • Assay Precision (Within-run & Within-Laboratory): 20 replicates of three patient serum pools in the same run and in 20 different runs over 20 days. Reproducibility study used 5 levels of serum panels tested for 5 days, 6 runs per day, 2 replicates per run at 3 sites (n=60 per panel per site, total N=177-180 across all sites for each panel).
  • Linearity: Three serum pools prepared from patient specimens mixed and diluted to produce eleven (for LDL-P) or twelve (for TG and HDL-C) different samples, with four replicates of each pool analyzed.
  • Method Comparison:
    • LDL-P: n=1483 serum samples.
    • HDL-C: n=1518 serum samples.
    • Triglycerides: n=1520 serum samples.
  • Interfering Substances: 7 endogenous agents and 23 drugs were screened.
  • Reference Range: Serum samples (n=452) from apparently healthy men (n=158) and women (n=294).
• Data Provenance: The document does not specify the country of origin. The studies were described as "analytical validations" and included testing using "patient specimens" and "serum pools." There is no explicit mention of the data being either retrospective or prospective, but the nature of the analytical studies suggests controlled laboratory environments rather than a large-scale clinical trial with patient follow-up. For the reference range, it states "serum samples... were analyzed from apparently healthy men and women," which implies a prospective collection for this specific purpose or a well-characterized existing cohort. The MESA (Multi-Ethnic Study of Atherosclerosis) is mentioned for the predicate device's reference range, suggesting a US context for that, but it's not explicitly stated for the proposed device's reference population.

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

The document does not describe the use of human experts to establish "ground truth" for the test set in the context of interpretation or diagnosis. This device is an automated laboratory analyzer for quantifying analytes. The "ground truth" for its analytical performance studies (e.g., precision, linearity, method comparison) is established by comparing its measurements to a reference method or known concentrations, or by assessing consistency internally.

4. Adjudication method for the test set

Not applicable. There was no clinical study involving human interpretation or diagnosis that would require an adjudication method. The testing involved direct analytical measurements.

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

Not applicable. This is an in-vitro diagnostic (IVD) device for quantifying analytes (LDL-P, HDL-C, Triglycerides), not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.

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

Yes, the primary performance studies presented are "standalone" in the sense that they assess the device's analytical performance (algorithm + instrument) in quantifying the specified analytes without human-in-the-loop performance for diagnosis or interpretation. The device's output is explicit numerical analyte concentrations.

7. The type of ground truth used

The ground truth used for verifying the analytical performance of the device was:

• Reference Methods/Known Concentrations: For analytical sensitivity (LoB, LoD, LoQ), linearity, and precision, the "ground truth" was established through precisely prepared serum pools and non-lipoprotein specimens with known or target concentrations, or through statistical determination methods (e.g., EP17-A).
• Comparison to Predicate Device: For method comparison studies, the "ground truth" or reference was the measurements obtained from the legally marketed predicate device (NMR Profiler) using patient samples. The goal was to show high correlation and similar results between the two devices.
• CLSI Guidelines: Standardized guidelines (e.g., EP5-A2, EP6-A, EP7-A2, EP9-A2, EP17-A) from the Clinical and Laboratory Standards Institute (CLSI) were referenced for establishing protocols for these analytical validations.

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of machine learning or AI models. This device is an automated NMR spectrometer that measures signals and converts them to concentrations based on specified deconvolution analysis models. The development of these deconvolution models would have involved a form of "training" or optimization, but the document does not detail the dataset size or methodology used for this prior model development. The document focuses on the analytical validation of the manufactured device.

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

As there is no explicit mention of a "training set" in the conventional AI/ML sense, this question cannot be directly answered from the provided text. However, the assay description mentions:
"The NMR signals from the various lipoprotein subclasses have unique and distinctive frequencies and lineshapes, each of which is accounted for in the deconvolution analysis model. Each subclass signal amplitude is proportional to the number of subclass particles emitting the signal, which enables subclass particle concentrations to be calculated from the subclass signal amplitudes derived from the spectral deconvolution analysis."
This suggests that the deconvolution analysis model was developed using a "ground truth" based on the established biophysical properties of lipoprotein subclasses and their NMR spectral characteristics. This likely involved:

• Carefully characterized lipoprotein samples with known subclass concentrations.
• Expert knowledge of NMR spectroscopy and signal processing.
• Calibration against established reference methods for lipoprotein analysis.

The document does not provide details on the specific data sets or expert consensus used for the initial development and establishment of this deconvolution model.

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ELITech Clinical Systems TRIGLYCERIDES SL is intended for the quantitative in vitro diagnostic determination of triglycerides in human serum and plasma on ELITech Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

ELITech Clinical Systems CHOLESTEROL SL is intended for the quantitative in vitro diagnostic determination of cholesterol in human serum and plasma on ELITech Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the ELITech Vital Scientific Selectra/Flexor Analyzers.

ELITech Clinical Systems ELITROL I & ELITROL II are multiparametric control sera for use in quality control of ELITech Clinical Systems methods on ELITech Vital Scientific Selectra/Flexor Analyzers.

The device for this submission is available as kit only. It consists of 1 reagent, "R". Reagent R contains: Pipes buffer, p-chlorophenol, ATP, Amino-4-antipyrine (4-AAP), Lipoprotein lipase (bacterial), Glycerol kinase (bacterial), Glycerol-3-phosphate oxidase (microorganisms), Peroxidase (horseradish), Potassium ferrocyanide, Magnesium (Mg2+) and Sodium azide.

The device for this submission is available as kit only. It consists of 1 reagent, "R". Reagent R contains: Pipes buffer, 4-Aminoantipyrine (4-AAP), Cholesterol esterase (CHE bacterial), Cholesterol oxidase (CHO microorganisms), Peroxidase (POD horseradish), Sodium cholate, Phenol and Sodium azide.

ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

Here's a summary of the acceptance criteria and the studies for the ELITech Clinical Systems TRIGLYCERIDES SL reagent, ELITech Clinical Systems CHOLESTEROL SL reagent, ELICAL 2 calibrator, and ELITROL I/ELITROL II controls, based on the provided documents.

ELITech Clinical Systems TRIGLYCERIDES SL Reagent

1. Table of Acceptance Criteria and Reported Device Performance

For TRIGLYCERIDES SL, the acceptance criteria are not explicitly stated as distinct numerical targets; instead, the performance is demonstrated through comparison with a predicate device. The implied acceptance is that the device performs comparably to the predicate or within clinically acceptable ranges for the specified parameters.

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not explicitly state the sample size used for the test set for precision and method comparison studies.
• Data Provenance: Not specified in the provided text. It is a submission by SEPPIM S.A.S. from FRANCE, suggesting data could be of French origin or from other regions. Studies are generally retrospective as they are performance evaluations of an existing reagent formulation.

3. Number of Experts and Qualifications

This information is not applicable. The studies are laboratory-based analytical performance evaluations of a diagnostic reagent, not interpretations by medical experts.

4. Adjudication Method

This information is not applicable for this type of analytical performance study.

5. MRMC Comparative Effectiveness Study

• This information is not applicable. This is an analytical performance study of a diagnostic reagent, not a study evaluating human reader performance with or without AI assistance.

6. Standalone Performance Study

• Yes, the performance data presented (measuring range, precision, method comparison, limitations) are for the standalone performance of the ELITech Clinical Systems TRIGLYCERIDES SL reagent on the ELITech Vital Scientific Selectra/Flexor analyzers.

7. Type of Ground Truth Used

• For precision and linearity, the "ground truth" refers to laboratory controls and reference materials with known concentrations, or samples run repeatedly to establish variability.
• For method comparison, the "ground truth" is established by comparing the device's results to those obtained using the legally marketed predicate device (ABX PENTRA TRIGLYCERIDES CP). The predicate device's results serve as the reference for comparison.

8. Sample Size for Training Set

• This information is not applicable. This is a chemical reagent, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set was Established

• This information is not applicable.

ELITech Clinical Systems CHOLESTEROL SL Reagent

1. Table of Acceptance Criteria and Reported Device Performance

For CHOLESTEROL SL, similar to TRIGLYCERIDES SL, acceptance is implied by comparison to the predicate device and being within clinically acceptable ranges.

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not explicitly state the sample size used for the test set for precision and method comparison studies.
• Data Provenance: Not specified in the provided text. It is a submission by SEPPIM S.A.S. from FRANCE, suggesting data could be of French origin or from other regions. Studies are generally retrospective as they are performance evaluations of an existing reagent formulation.

3. Number of Experts and Qualifications

This information is not applicable. The studies are laboratory-based analytical performance evaluations of a diagnostic reagent, not interpretations by medical experts.

4. Adjudication Method

This information is not applicable for this type of analytical performance study.

5. MRMC Comparative Effectiveness Study

• This information is not applicable. This is an analytical performance study of a diagnostic reagent, not a study evaluating human reader performance with or without AI assistance.

6. Standalone Performance Study

• Yes, the performance data presented (measuring range, precision, method comparison, limitations) are for the standalone performance of the ELITech Clinical Systems CHOLESTEROL SL reagent on the ELITech Vital Scientific Selectra/Flexor analyzers.

7. Type of Ground Truth Used

• For precision and linearity, the "ground truth" refers to laboratory controls and reference materials with known concentrations, or samples run repeatedly to establish variability.
• For method comparison, the "ground truth" is established by comparing the device's results to those obtained using the legally marketed predicate device (ABX PENTRA CHOLESTEROL CP). The predicate device's results serve as the reference for comparison.

8. Sample Size for Training Set

• This information is not applicable. This is a chemical reagent, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set was Established

• This information is not applicable.

ELITech Clinical Systems ELICAL 2 Calibrator

1. Table of Acceptance Criteria and Reported Device Performance

For ELICAL 2, the primary acceptance criteria revolve around format, stability, and handling being comparable to the predicate, and traceability being established.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not specified for stability studies.
• Data Provenance: Not specified. From SEPPIM S.A.S. (FRANCE). Studies are for characterization of the calibrator's properties.

3. Number of Experts and Qualifications

Not applicable.

4. Adjudication Method

Not applicable.

5. MRMC Comparative Effectiveness Study

• Not applicable.

6. Standalone Performance Study

• Yes, the stability and handling characteristics are for the standalone performance of the ELICAL 2 calibrator.

7. Type of Ground Truth Used

• For stability, the "ground truth" involves testing the calibrator's analyte concentrations over time under specified storage conditions and comparing them against initial established values or specified ranges. For traceability, it refers to documentation linking the analyte values to international reference methods or materials.

8. Sample Size for Training Set

• Not applicable.

9. How Ground Truth for Training Set was Established

• Not applicable.

ELITech Clinical Systems ELITROL I and ELITROL II Controls

1. Table of Acceptance Criteria and Reported Device Performance

For ELITROL I and ELITROL II, the acceptance criteria focus on comparable format, levels, handling, and stability to the predicate.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not specified for stability studies.
• Data Provenance: Not specified. From SEPPIM S.A.S. (FRANCE). Studies are for characterization of the control materials' properties.

3. Number of Experts and Qualifications

Not applicable.

4. Adjudication Method

Not applicable.

5. MRMC Comparative Effectiveness Study

• Not applicable.

6. Standalone Performance Study

• Yes, the stability and handling characteristics are for the standalone performance of the ELITROL I and ELITROL II controls.

7. Type of Ground Truth Used

• For stability, the "ground truth" involves testing the control's analyte concentrations over time under specified storage conditions and comparing them against initial established values or specified ranges. The control materials are "assayed," meaning their analyte concentrations are determined using reference methods or established analytical procedures.

8. Sample Size for Training Set

• Not applicable.

9. How Ground Truth for Training Set was Established

• Not applicable.

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System reagent for the quantitative determination of Triglyceride concentrations in human serum and plasma on OLYMPUS analyzers. Measurements of triglyceride are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various enocrine disorders, and in the assessment of risk factors for atherosclerosis and coronary artery disease.

This Olympus Triglyceride procedure is based on a series of coupled enzymatic reactions. The triglycerides in the sample are hydrolyzed by a combination of microbial lipases to give glycerol and fatty acids. The glycerol is phosphorylated by adenosine triphosphate (ATP) in the presence of glycerol kinase (GK) to produce glycerol-3-phosphate. The glycerol-3-phosphate is oxidized by molecular oxygen in the presence of GPO (glycerol phosphate oxidase) to produce hydrogen peroxide (H2O2) and dihydroxyacetone phosphate. The formed H2O2 reacts with 4-aminophenazone and N,N-bis(4-sulfobutyl)-3,5-dimethylaniline, disodium salt (MADB) in the presence of peroxidase (POD) to produce a chromophore, which is read at 660/800nm. The increase in absorbance at 660/800 nm is proportional to the triglyceride content of the sample.

Here's a summary of the acceptance criteria and study information for the Olympus Triglyceride Test System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the comparison to a predicate device, showing "similarities" and specific performance characteristics. The specific thresholds for acceptable performance are not explicitly stated as strict "acceptance criteria" but rather as "Performance Characteristics" which are compared to the predicate device.

Study Details:

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

  • The document mentions "samples" for precision and method comparison studies but does not specify the exact number of samples (sample size) used for the test sets. For precision, multiple "samples" (likely control or pooled patient samples) were tested across different Olympus analyzer models. For method comparison, it implies a set of samples were run on both the new and predicate devices, yielding the Intercept, Slope, and R values.
  • Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the studies were retrospective or prospective.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

  • This is a diagnostic reagent for quantitative measurement of triglyceride concentrations, not an imaging device requiring expert interpretation. Therefore, the concept of "experts establishing ground truth" in the interpretive sense does not directly apply. The "ground truth" for such devices is established through reference methods or highly characterized control materials. The document states traceability to College of American Pathology (CAP) Serum Lipid (RM016) #2, which serves as the reference for accuracy.

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

  • Not applicable as this is a quantitative chemical assay, not an interpretive device 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

  • Not applicable. This is a chemical diagnostic reagent device, not an AI or imaging device involving human readers.

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

  • Yes, the performance data presented (precision, assay range, method comparison, interfering substances) represents the standalone performance of the Olympus Triglyceride Reagent when run on Olympus analyzers. There is no human-in-the-loop component for the direct measurement of triglycerides by this device.

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

  • The ground truth for accuracy and calibration is based on traceability to College of American Pathology (CAP) Serum Lipid (RM016) #2. This implies that the device's measurements are referenced against established standards or values obtained from a highly reliable and recognized reference material.

• 8. The sample size for the training set

  • Not applicable. This is a chemical reagent, not a machine learning or AI device that typically requires a "training set." The development would involve chemical optimization and formulation, followed by validation studies.

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

  • Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this type of device. The development and validation relied on established chemical principles and reference materials (like CAP standards).

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The Dimension® RxL Max™ with StreamLAB® Analytical Workeell and Sample Transfer Module is a discrete photometric chemistry analyzer for clinical use intended to duplicate analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes.

The modified device includes the connection of a StreamLAB® Analytical Workcell and Sample Transfer Module. These are used to prepare specimens from the human body for testing on the Dimension® RxL Max™ system.

This submission (K043546) is a Special 510(k) for a device modification; therefore, the provided document does not contain an acceptance criteria table or a detailed study report with performance metrics. The submission focuses on demonstrating substantial equivalence to a predicate device after a modification, rather than proving performance against specific acceptance criteria for a novel device.

The modification involves connecting a StreamLAB® Analytical Workcell and Sample Transfer Module to the existing Dimension® RxL Max™ Clinical Chemistry System. The core functionality and assay performance are stated to be "the same" as the predicate device.

However, based on the provided text, here's what can be extracted or inferred about the device and the nature of this submission:

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

This information is not provided in the given text. As a Special 510(k) for a device modification, the manufacturer primarily asserts that the modified device has "the same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device." Therefore, explicit acceptance criteria and corresponding reported device performance for the modified components are not detailed, as the focus is on maintaining equivalence to the existing, cleared predicate.

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

This information is not provided in the given text.

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 given text.

4. Adjudication method for the test set

This information is not provided in the given text.

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

An MRMC study is not applicable to this device. This is a clinical chemistry analyzer, not a device requiring human reader interpretation of images or other subjective data.

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

This is a standalone clinical chemistry analyzer. The device itself performs the analysis; human interpretation is involved in reviewing the results it produces. However, the document does not describe "standalone performance" in the context of comparing an algorithm to human performance, as it's an automated analytical system.

7. The type of ground truth used

This information is not explicitly stated. For clinical chemistry analyzers, ground truth would typically be established through reference methods (e.g., gold standard laboratory tests) for accuracy and precision studies, but such studies are not described for this specific modification. The submission implies that the "assay performance characteristics" are the same as the predicate, which would have had its performance validated against appropriate ground truth.

8. The sample size for the training set

This information is not provided in the given text. Given that this is a modification to an existing device, it's unlikely that a new "training set" for an algorithm, as understood in AI/ML, would be applicable or explicitly mentioned in such a submission.

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

This information is not provided in the given text.

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The Vitalab Triglycerides Reagent, the Vitalab Calibrator and the Vitalab Selectra Analyzer are intended for use as a system for the quantitative determination of triglycerides in serum and plasma. Triglycerides results may be used for the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver diseases involving lipid metabolism, various endocrine disorders, or for assessing of the risk of developing cardiovascular diseases.

The Vitalab Triglycerides Reagent, the Vitalab Calibrator and the Vitalab Selectra Analyzer are used as a system for the quantitative analysis of triglycerides in serum and plasma. The Vitalab Triglycerides Reagent determines triglycerides using the lipase/GPO enzymatic assay procedure coupled to a Trinder indicator reaction. The resulting increase in absorbance at 505 nm is proportional to the triglycerides concentration of the sample.

This response is based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

(Note: The "Acceptance Criteria (Implied)" column contains interpretations of what would generally be considered acceptable performance for such a device in comparison to a predicate, as explicit criteria are not always stated but inferred from the study design and conclusion of substantial equivalence.)

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

• Linearity/Recovery: n = 44 (This sample size likely refers to dilution factors or individual measurements across the range). Provenance: Not explicitly stated, but likely laboratory-prepared standards or spiked samples.
• Precision:
  • Serum 1: 60 replicates
  • Serum 2: 60 replicates
  • Serum 3: 60 replicates
    Provenance: Commercially available control serum.
• Method Comparison:
  • Serum samples: 59 specimens
  • Heparinized plasma samples: 60 specimens
    Provenance: Collected from adult patients. Country of origin not specified, but the submission is to the FDA, implying studies likely conducted in the US or internationally to US standards. Retrospective or prospective design is not explicitly stated, but the description "were collected from adult patients and were assayed for triglycerides" often implies a prospective or at least recently collected set of samples for the purpose of the study.
• Minimum Detection Limit: 30 replicate measurements of normal saline. Provenance: Laboratory materials.
• Onboard Reagent Stability & Calibration Stability: Not explicitly stated beyond "serum controls."
• Reconstituted Calibrator Stability: Not explicitly stated beyond "calibrators of increasing ages."

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

• This device is a quantitative clinical chemistry assay. The "ground truth" for such assays is typically established by reference methods or comparison to a legally marketed predicate device, rather than expert consensus on individual cases.
• In this case, the "ground truth" for the method comparison study was the results from "another commercially available method," which served as the reference standard for comparison. The predicate device, the Beckman Trighycerides Reagent Kit and Synchron Multi-Calibrator, also serves as a benchmark for substantial equivalence.
• Therefore, traditional "experts" like radiologists establishing ground truth for images are not applicable here. The "expertise" lies in the validated performance of the reference method and the established accuracy of commercially available control sera.

4. Adjudication Method for the Test Set:

• Not applicable. This is a quantitative chemical assay, not a subjective interpretation task that would typically involve adjudication by multiple experts. The comparison is statistical (Deming regression) between the new device and a reference method.

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

• Not applicable. This is a standalone in-vitro diagnostic (IVD) device for quantitative measurement of triglycerides, not an AI-assisted diagnostic tool that involves human readers interpreting results. Therefore, no MRMC study with human readers was conducted, and the concept of "improvement with AI vs without AI" does not apply.

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

• Yes, this entire submission describes standalone performance studies for the Vitalab Triglycerides Reagent and Calibrator on the Vitalab Selectra Analyzer. The performance metrics (linearity, precision, method comparison, detection limit, stability) are all intrinsic to the device system itself, operating without direct human interpretive input influencing the quantitative result. The device outputs a numerical value for triglyceride concentration.

7. The Type of Ground Truth Used:

• Reference Method Comparison: For the method comparison studies, the "ground truth" was established by analyzing patient samples with "another commercially available method" (presumably a validated and accepted diagnostic method for triglycerides).
• Known Concentrations/Standards: For linearity and detection limit, the ground truth was based on known concentrations of standards or normal saline (effectively 0 mg/dL).
• Certified Control Sera: For precision and stability studies, commercially available control serum with established target values was used.

8. The Sample Size for the Training Set:

• This submission describes performance validation studies for an IVD reagent and calibrator. It does not mention any "training set" in the context of machine learning or AI algorithms. The assay procedure is based on a well-established lipase/GPO enzymatic reaction coupled to a Trinder indicator, not a statistical model that requires a training set.

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

• Not applicable, as there is no mention of a training set for an AI/machine learning algorithm.

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The CARESIDE Triglyceride cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE Analyzer to quantitatively measure the concentration of triglycerides in anti-coagulated whole blood, plasma or serum. This product is indicated for use in the diagnosis and treatment of patients with primary or secondary hyperlipidemias. Hyperlipidemias may result from liver obstruction, diseases involving lipid metabolism, or various endocrine disorders. Triglyceride results are used together by the CARESIDE Analyzer with total cholesterol and HDL-cholesterol results to calculate LDL-cholesterol levels.

CARESIDE Trighceride cartridges are used with the CARESIDE Analyzer to measure triglyceride concentration in anti-coagulated whole blood, plasma or serum specimens. The CARESIDE Triglyceride cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of triglyceride concentration. The patented film cartridge contains all reagents necessary to measure triglyceride concentration. Each CARESIDE Triglyceride cartridge consists of a triglyceride-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the anticoagulated whole blood, serum, or plasma specimen into the cartridge Sample Well, closes the lid and inserts the cartridge into the CARESIDE Analyzer. Once loaded, the CARESIDE Analyzer scans the cartridge barcode, brings the cartridge and the contained specimen to 37℃, and spins the cartridge to move the sample from the sample deposition well into the cartridge channels and chambers. As the cartridge continues to spin, the blood cells are separated from the plasma/serum and the cells accumulate in the separation well. Approximately 8.5 microliters of plasma (or serum, as applicable) remain in the metering passage. Any excess sample flows into an overflow well. The plasma (or serum, as applicable) is automatically dispensed onto the multi-layer The triglyceride-containing specimen is distributed uniformly by the reagent film. spreading layer. The sample then passes through a reflection layer and into the reaction layer. Finally, the reaction mixture is pulled through the reaction layer by a suction layer where the NTB chromogen is converted into a purple formazan dye. As the cartridge spins, a photodiode measures film reflectance of light emitted from a wavelength-specific light emitting diode (LED) at a lixed time. The instrument uses the reflectance measurements and the lot-specific standard curve to calculate triglyceride concentration.

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

CARESIDE Triglyceride Premarket Notification (K020488)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by comparing the CARESIDE Triglyceride device's performance characteristics against its predicate device (Vitros TRIG DT Slides) and general analytical standards. The document doesn't explicitly state "acceptance criteria" as a separate section, but rather presents performance characteristics of both devices side-by-side. The key areas of comparison are:

Study Proving Device Meets Acceptance Criteria:

The document describes a comparative performance characteristics study, though the details are somewhat summarized rather than a full protocol.

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

• Sample Size: Not explicitly stated for each characteristic. For "Precision," a single sample concentration (146 mg/dL) is mentioned as tested. For "Method Comparison," the slope and intercept are provided, indicating a regression analysis was performed on a set of samples, but the number of samples is not stated. Similarly, for "Interference" and "Specimen Types & Anticoagulants," various conditions were tested, but specific sample numbers (n) are not given.
• Data Provenance: Not explicitly stated. Given that it's a premarket notification for a US market, it's highly likely the data was generated in a lab environment (prospective testing) but the country of origin of the samples themselves is not specified.

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

• Not Applicable. This is an in vitro diagnostic device for measuring a biochemical analyte (triglycerides). The "ground truth" for the test set would be established by a well-characterized reference measurement method (e.g., an assay on a high-precision clinical chemistry analyzer like the BM/Hitachi 902, or a gas chromatography-mass spectrometry method if available at the time for direct comparison). It does not involve human expert interpretation of images or clinical cases.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is a quantitative chemical assay, there is no human adjudication process involved in establishing the "ground truth" or comparing results. The comparisons are statistical and analytical.

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

• No. An MRMC study is relevant for diagnostic imaging or interpretation tasks where human readers make subjective assessments (e.g., radiologists reading scans). This device is an automated in vitro diagnostic assay, so MRMC studies are not applicable.

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

• Yes. The entire performance characteristic section (Section IV.C. "Comparative Performance Characteristics") is effectively a standalone performance evaluation of the CARESIDE Triglyceride system (cartridge + Analyzer). The device is designed to be an automated measurement device, and the reported accuracy, precision, linearity, and method comparison data reflect its standalone performance. The document highlights features like "accurate pipetting not required" and "reagent pre-warming not required," which further emphasize its automated, standalone nature.

7. The Type of Ground Truth Used:

• For Method Comparison, the ground truth was established by another well-accepted clinical chemistry analyzer, specifically the "BM/Hitachi 902." The comparison yielded the equation: CARESIDE = 0.98 (BM/Hitachi 902) + 2.92 mg/dL. This indicates the BM/Hitachi 902 served as the reference or comparative "ground truth" for evaluating the CARESIDE device's quantitative accuracy.
• For Accuracy (Recovery), the ground truth would be the known concentration of triglycerides in spiked samples or certified reference materials, where the device's measured value is compared to the expected true value.
• For Precision, the ground truth is the statistical property of repeatability and reproducibility, typically assessed by running samples multiple times to determine the variability (CV%).
• For Linearity, the ground truth is derived from preparing samples with known serially diluted or mixed concentrations and ensuring the device's readings are proportional to these known values.

8. The Sample Size for the Training Set:

• Not applicable / Not explicitly stated for this type of device. Clinical chemistry devices like this typically undergo extensive analytical validation (accuracy, precision, linearity, interference) using characterized samples. While there's an internal "lot-specific standard curve" mentioned for calibration, this isn't a "training set" in the machine learning sense. The device's underlying chemistry and optical detection principles are well-established. The development process would involve optimizing reagents and calibration, but the specific term "training set" with a defined sample size as used in AI/ML is not relevant here.

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

• Not applicable for a "training set" in the AI/ML sense. For the calibration curves that the instrument uses, "ground truth" is established through carefully characterized calibrator materials with known triglyceride concentrations, measured by highly accurate reference methods. The device then generates a standard curve based on these calibrators to convert raw reflectance data into triglyceride concentrations.

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