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CHOLESTEROL: Reagent kit intended for the quantitative determination of Cholesterol in human serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood, of lipid and lipoprotein metabolism disorders.

HDL-Cholesterol: Reagent kit intended for the quantitative determination of high-density lipoprotein in human serum. Measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases.

LDL-Cholesterol: Reagent kit intended for the quantitative determination of low-density lipoprotein in human serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

TRIGLYCERIDES: Reagent kit intended for the quantitative determination of triglycerides (neutral fat) in human serum. 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.

CHOLESTEROL: The Cholesterol Oxidase peroxidase (CHOD-PAP) enzymatic method is used. The cholesterol esterase enzyme catalyzes the hydrolysis of cholesterol and free fatty and free fatty acids. Free cholesterol, including that originally present in the sample, is then oxidized by the enzyme cholesterol oxidase (CHOD) to cholest-4-en-3-one, by using molecular oxygen as the electron acceptor and concurrently producing hydrogen peroxide (H2O2). The H2O2 produced is then used in a subsequent chromogenic oxidative coupling reaction, catalyzed by the enzyme peroxidase, in the presence of a redox indicator system, which leads to the formation of a colored compound, absorbing light at 550 nm. The increase in absorbance is directly proportional to the cholesterol concentration in the sample.

HDL-Cholesterol: The Accelerator Selective Detergent method is applied. The determination of HDL-Cholesterol is based on the following reactions: LDL, VLDL, and chylomicrons are neutralized by the combined action of the enzymes Cholesterol Oxidase, Peroxidase, accelerators and N,N-bis-(4-sulfobutyl)-m-toluidine-disodium (DSBmT). HDL remaining in the sample is disrupted by the action of a selective detergent and cholesterol is converted to △4 Cholestenone by the enzymatic action of Cholesterol Esterase and Cholesterol Oxidase, with the subsequent production of H2O2, which reacts with DSBmT and 4-aminoantipyrine in the presence of Peroxidase to a colored complex that absorbs light at 590 nm. The absorbance measured is proportional to the concentration of HDL-Cholesterol in the sample.

LDL-Cholesterol: The Selective Detergent method is applied. The method is in a two-reagent format and depends on the properties of a unique detergent. The first detergent solubilizes only the non-LDL lipoprotein particles. The cholesterol released is consumed by cholesterol esterase and cholesterol oxidase in a non-color forming reaction. The second detergent solubilizes the remaining LDL particles, and a chromogenic coupler allows for color formation. The enzyme reaction with LDL-Cholesterol in the presence of the coupler at 590 nm produces color that is proportional to the amount of LDL cholesterol present in the sample.

TRIGLYCERIDES: The enzymatic glycerol-3-phosphate-peroxidase (GPO-POD) method is used. The method enzymatically hydrolyzes by lipase to free fatty acids and glycerol is phosphorylated by adenosine triphosphate (ATP) with glycerokinase (GK) to produce glycerol-3-phosphate and adenosine diphosphate (ADP). Glycerol-3-phosphate-oxidase oxidizes glycerol-3-phosphate to dihydroxyacetone phosphate and H2O2. The catalytic action of peroxidase (POD) forms quinoneimine from H202, aminoantipyrine, and Dihydrate (N-Ethyl-N-(2hydroxy-3-sulfopropyl)-m-toluidine (TOOS). The absorption change at 550 nm is proportional to the triglycerides concentration in the sample.

Here's a breakdown of the acceptance criteria and the study information for the Medicon Hellas Cholesterol, HDL-Cholesterol, LDL-Cholesterol, and Triglycerides test systems, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by comparison to legally marketed predicate devices and alignment with clinical laboratory guidelines (CLSI). The document presents a clear comparison in the "Device Comparison Table" sections. For this summary, I'll focus on the key performance indicators for each analyte.

CHOLESTEROL

HDL-Cholesterol

LDL-Cholesterol

TRIGLYCERIDES

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

• Accuracy (Method Comparisons):

  • A minimum of 75 leftover specimens.
  • For the specific analytes:
    • CHOLESTEROL: 93 human serum samples
    • HDL-Cholesterol: 141 human serum samples
    • LDL-Cholesterol: 107 human serum samples
    • TRIGLYCERIDES: 163 human serum samples
  • Data Provenance: The document states "left-over specimens," implying retrospective use of clinical samples. The country of origin is not explicitly stated, but the company is Medicon Hellas, S.A. based in Greece, and testing was performed at the company premises.

• Precision/Reproducibility:

  • Three human serum pools for Cholesterol and Triglycerides.
  • Two pools for HDL-Cholesterol.
  • Four pools for LDL-Cholesterol.
  • Each sample was tested for 20 testing days, two different runs, and two replicate measurements per run (morning and afternoon run), for a total of 80 results per level concentration (e.g., for Cholesterol, 3 pools * 80 results/pool = 240 results).
  • Data Provenance: Human serum pools, likely prepared in-house or acquired for the study.

• Linearity:

  • 11 to 13 levels per analyte, prepared by dilution of a human serum pool.
  • Each level was tested in 4 replicates.
  • Data Provenance: Human serum pool.

• Analytical Specificity / Interference:

  • Serum pools at low and high levels of each analyte.
  • Each measurement of the blank and the sample containing the interferent was repeated at least 5 times.
  • Data Provenance: Serum pools.

• Detection Limit:

  • LoB: 5 blank serum samples measured in 4 replicates for 3 days (total of 60 measurements).
  • LoD: 5 low-level samples measured in 4 replicates for 3 days (total of 60 measurements).
  • LoQ: 10 samples that span the low end of linearity, measured 5 times each day for 3 days (total of 150 measurements).
  • Data Provenance: Serum samples.

• Stability and Calibration Frequency:

  • Two fresh serum pools and two serum-based commercial controls.
  • Measurements were repeated in triplicate at regular time points.
  • Data Provenance: Serum pools and commercial controls.

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

This information is not provided in the document. The ground truth for performance studies like those described (method comparison, precision, linearity, interference, detection limits) for in vitro diagnostic (IVD) devices like these typically involves established reference methods or highly accurate comparative analyzers, rather than expert human interpretation of results. The document states that the performance of the Medicon Hellas reagents was compared with "comparator methods" (Beckman Coulter reagents on AU400, Abbott Diagnostics reagents on Architect c8000), which serve as the reference for ground truth in these types of analytical performance studies. The qualifications of the operators performing these studies are not specified.

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 where human interpretation of complex data (like medical images) is involved and a consensus is needed to establish ground truth. For quantitative chemical assays, the ground truth is established by the highly precise and accurate measurement of reference methods or predicate devices.

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 and therefore not provided. MRMC studies are specific to evaluating diagnostic devices where human readers interpret medical cases, often with and without AI assistance (e.g., radiology AI). The Medicon Hellas devices are in vitro diagnostic reagents for quantitative chemical measurements in serum, not image-based diagnostic tools that require human "readers" in the context of an MRMC study.

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

This concept is not applicable in the traditional sense for these in vitro diagnostic reagents. These devices are chemical assays that produce a quantitative numerical output (e.g., cholesterol level in mg/dL). There isn't an "algorithm" making a diagnostic interpretation independently in the way AI software would. The device is the standalone measurement system. Its performance is evaluated independently through analytical studies (precision, linearity, accuracy against reference methods, etc.). The results are then read and interpreted by a human clinician.

7. The type of ground truth used

The ground truth for the analytical performance studies (precision, linearity, interference, detection limits, and method comparison) was established against:

• Reference Methods/Predicate Devices: For method comparison, the device's performance was compared against established comparator methods (Beckman Coulter reagents on AU400 and Abbott Diagnostics reagents on ABBOTT Architect c8000). The document explicitly states these as the comparators.
• A Priori Values/Established Standards: For linearity, precision, and detection limits, the ground truth is based on the known concentrations of prepared samples (e.g., serially diluted pools, spiked samples, blank serum) and statistical analysis according to CLSI guidelines.
• Traceability to Reference Methods/Materials: For Cholesterol and Triglycerides, traceability is to Gas-chromatography-isotope dilution mass spectrometry (GC-IDMS). For HDL-Cholesterol and LDL-Cholesterol, traceability is to the Abell-Kendall (AK) reference method.

8. The sample size for the training set

This information is not applicable and therefore not provided. These are chemical reagent kits, not machine learning (AI/ML) models that require a "training set" in the computational sense. The development of such reagents involves chemical and enzymatic research and optimization, often tested with various batches and concentrations of samples during R&D. The studies described in this document are for validation and verification of the final device, not for "training" an algorithm.

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

As noted above, the concept of a "training set" with ground truth established in the AI/ML sense is not applicable to these chemical reagent devices. The "ground truth" for evaluating the analytical performance of the developed reagent kits is established through the reference methods and standardized protocols described in section 7.

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The Cholesterol2 assay is used for the quantitation of cholesterol in human serum or plasma on the ARCHITECT c System. The Cholesterol2 assay is to be used as an aid in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

The Cholesterol2 assay is an automated clinical chemistry assay for the quantitation of cholesterol in human serum or plasma on the ARCHITECT c System. Cholesterol esters are enzymatically hydrolyzed by cholesterol esterase to cholesterol and free fatty acids. Free cholesterol, including that originally present, is then oxidized by cholesterol oxidase to cholest-4-ene-3-one and hydrogen peroxide. The hydrogen peroxide oxidatively couples with N,N-Bis(4-sulfobutyl)-3-methylaniline (TODB) and 4-aminoantipyrine to form a chromophore (quinoneimine dye) which is quantitated at 604 nm.

The provided text describes the Abbott Cholesterol2 assay, an in vitro diagnostic device for quantifying cholesterol in human serum or plasma.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for each performance characteristic. Instead, it presents the results of various studies as proof of device performance. The table below summarizes the reported performance, which implicitly serves as the "met" criteria.

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

• Precision Study: 2 controls and 3 human serum panels were tested. Each sample was tested in duplicate, twice per day for 20 days. This means 80 measurements per sample (2 duplicates x 2 times/day x 20 days).
• Lower Limits of Measurement Study: n ≥ 60 replicates for LoB, LoD, and LoQ determinations. They used low-analyte level samples and zero-analyte samples.
• Linearity Study: The number of samples for the linearity study is not explicitly stated, but it covered the range of 5 to 748 mg/dL.
• Interference Studies: Each endogenous substance was tested at 2 analyte levels (approximately 150 mg/dL and 220 mg/dL). Exogenous substances were tested at various specified interferent levels. The number of samples for each interferent is not provided.
• Method Comparison Study: 138 serum samples were used.
• Tube Type Study: Samples were collected from a minimum of 40 donors.
• Dilution Verification: 8 human serum samples.

Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the context of medical device regulatory submission, these are typically prospective studies conducted in a controlled laboratory environment. The "human serum panels" and "human serum samples" imply human-derived biological samples.

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

This device is an in vitro diagnostic (IVD) chemistry assay. The concept of "experts establishing ground truth" as it applies to image interpretation or clinical diagnosis by medical professionals (like radiologists) does not directly apply here in the same way.

For IVDs like this, the "ground truth" or reference values are established through:

• Reference methods: The Cholesterol2 reagent is certified to be traceable to the National Reference System for cholesterol, against the Abell-Kendall reference method in a CDC-Certified Cholesterol Reference Method Laboratory Network (CRMLN). The Abell-Kendall method is considered the gold standard for cholesterol measurement.
• Analytically Validated Methods: For values outside the AMI but within the EMI, samples were "value assigned using the analytically validated method."
• Known concentrations: For studies like linearity, spiked samples with known concentrations are used.

Therefore, the "experts" are the methodologists and laboratory professionals overseeing and validating the reference methods and the analytical validation processes. No specific number or qualification of clinical experts (e.g., radiologists) is relevant for establishing the ground truth for a quantitative chemistry assay.

This is a standalone performance evaluation of the assay itself, demonstrating its analytical accuracy, precision, and robustness.

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

The concept of "adjudication" (e.g., 2+1, 3+1 where multiple human readers agree or have a tie-breaker by an expert) is not applicable to this type of quantitative diagnostic assay. The results are numerical values generated by the automated instrument and reagents. Deviations or discrepancies would be resolved through re-testing, quality control, or investigation into instrument or reagent issues, rather than human expert adjudication of a "diagnosis."

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

No, an MRMC comparative effectiveness study was not done. This is an in vitro diagnostic assay, not an AI-powered diagnostic imaging device or an AI assistant for human readers. Its output is a quantitative measurement of cholesterol, not an interpretation that requires human "reading" or decision support.

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

Yes, a standalone performance evaluation of the device (Cholesterol2 assay on the ARCHITECT c8000 System) was done. The studies described (reportable interval, precision, lower limits of measurement, linearity, interference, method comparison, tube type, dilution verification) all evaluate the analytical performance of the assay and instrument directly, without human interpretation as part of the primary outcome measure. The output is a numerical concentration of cholesterol.

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

The ground truth used for this quantitative assay primarily relies on:

• Reference Methods: Specifically, the Abell-Kendall reference method, which is considered the gold standard for cholesterol measurement and is used in CDC-Certified Cholesterol Reference Method Laboratory Networks (CRMLN). The device's traceability to this method is explicitly stated.
• Analytically Validated Methods: For verifying values in the extended measuring interval.
• Known Spiked Concentrations: For studies such as linearity and dilution verification, where samples are prepared with precisely known concentrations.

This is an analytical ground truth, not a clinical ground truth derived from pathology or patient outcomes.

8. The sample size for the training set

This document does not describe a typical "training set" in the context of machine learning or AI. This is a chemistry assay that uses reagents and enzymatic reactions, not an algorithm that is "trained" on data. Therefore, the concept of a training set as used in AI development is not applicable here. The assay's analytical characteristics are determined through standard laboratory validation studies.

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

As explained above, there is no "training set" in the AI sense for this device. The analytical accuracy and reliability are established through comparisons to certified reference methods and known standard concentrations, as described in point 7.

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Rx Only For in vitro diagnostic use only

The TRIG test within the VITROS XT Chemistry Products TRIG-CHOL Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS XT 7600 Integrated Systems. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver diseases involving lipid metabolism, or various endocrine disorders.

The CHOL test within the VITROS XT Chemistry Products TRIG-CHOL Slides quantitatively measure cholesterol (CHOL) concentration in serum and plasma using VITROS XT 7600 Integrated Systems. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases.

The new device, the VITROS XT Chemistry Products TRIG-CHOL Slide is a single device that contains both a TRIG test and a CHOL test multilayered, analytical elements coated on a polyester support separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur and test results are generated for each analyte independently of the other analyte.

To perform the TRIG test, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. The Triton X-100 surfactant in the spreading layer aids in dissociating the triglycerides from lipoprotein complexes present in the sample. The triglyceride molecules are then hydrolyzed by lipase to yield glycerol and fatty acids. Glycerol diffuses to the reagent layer, where it is phosphorylated by glycerol kinase in the presence of adenosine triphosphate (ATP). In the presence of L-a-glycerolphosphate oxidase, L-α-glycerophosphate is then oxidized to dihydrox vacetone phosphate and hydrogen peroxide. The final reaction involves the oxidation of a leuco dye by hydrogen peroxide, catalyzed by peroxidase, to produce a dye. The density of the dye formed is proportional to the triglyceride concentration present in the sample and is measured by reflectance spectrophotometry.

To perform the CHOL test, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. The Triton X-100 (TX100) surfactant in the spreading layer aids in dissociating the cholesterol and cholesterol esters from lipoprotein complexes present in the sample. Hydrolysis of the cholesterol esters to cholesterol is catalyzed by cholesterol ester hydrolase. Free cholesterol is then oxidized in the presence of cholesterol oxidase to form cholestenone and hydrogen peroxide. Finally, hydrogen peroxide oxidizes a leuco dye in the presence of peroxidase to generate a colored dye. The density of dye formed is proportional to the cholesterol concentration present in the sample and is measured by reflectance spectrophotometry.

The provided text describes the analytical performance of the VITROS XT Chemistry Products TRIG-CHOL Slides, an in vitro diagnostic device for quantitatively measuring triglyceride (TRIG) and cholesterol (CHOL) concentrations in serum and plasma.

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

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

The document does not explicitly present a table of "acceptance criteria" but rather reports the analytical performance of the new device and shows its comparison to the predicate devices. The implicit acceptance criteria are that the new device performs at least as well as, and is substantially equivalent to, the predicate devices. The reported performance metrics are detailed in the tables for method comparison, precision, detection capability, and linearity.

TRIG Test

CHOL Test

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

• Method Comparison: 148 serum samples were used for both TRIG and CHOL tests.
• Precision: 80 observations (2 replicates per run, 2 runs per day over 20 days) for serum samples (patient pools and quality control materials).
• Detection Capability (LoQ): 180 determinations for both TRIG and CHOL.
• Linearity: Eighteen proportionally related admixtures of low and high test fluids, each tested in quadruplicate.

The data provenance is not explicitly stated in terms of country of origin or whether the samples were retrospective or prospective. It implies the use of patient samples, but specific details are absent.

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

This document describes the analytical performance of an in vitro diagnostic device, not a device that relies on expert human interpretation for its output (like an AI imaging device). Therefore, there is no mention of "experts used to establish the ground truth" in the way it would apply to a clinical imaging study or a study validating human performance. The "ground truth" for this type of device is established by its quantitative measurements against established analytical standards and reference methods/predicate devices.

4. Adjudication method for the test set

Not applicable. As noted above, this is an analytical performance study for an in vitro diagnostic device, not a human reader study 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 an analytical performance study of an in vitro diagnostic device, not an AI-assisted diagnostic tool that would involve human readers.

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

Yes, this entire study represents a "standalone" performance evaluation of the device (VITROS XT Chemistry Products TRIG-CHOL Slides on the VITROS XT 7600 Integrated System) without human intervention in the result generation. The device quantitatively measures the analytes.

7. The type of ground truth used

The ground truth for this in vitro diagnostic device is established through:

• Comparison to a legally marketed predicate device: The VITROS Chemistry Products TRIG Slides and VITROS Chemistry Products CHOL Slides. This implies that the predicate devices serve as the established reference standard for performance.
• Established analytical methods and materials: CLSI protocols (EP09c, EP05-A3, EP17-A2, EP06-A, EP07-03) are referenced, which dictate the methodology for evaluating analytical performance parameters.
• Quality Control Materials and reference pools: Used in precision and linearity studies.
• Clinically established guidelines: NCEP guidelines are referenced for expected values/classification of TRIG and CHOL, indicating alignment with clinical understanding of these analytes.

8. The sample size for the training set

This document describes pre-market validation studies for a diagnostic test kit and instrument system. It does not refer to a "training set" in the context of machine learning or AI. The development of such a device involves internal optimization and development work, but the data presented in this 510(k) summary are for the validation of the finalized product.

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

Not applicable, as this refers to a diagnostic test kit and instrument's analytical validation, not an AI or machine learning model that would involve a "training set" with ground truth established through expert annotation.

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The Extended Lipid Panel Assay is an in vitro diagnostic test for quantitative determination of Total Cholesterol, High Density Lipoprotein Cholesterol, and Triglycerides in human serum and Apolipoprotein B in human serum. Values for Total Cholesterol, High Density Lipoprotein Cholesterol, Triglycerides and Apolipoprotein B are calculated by the Vantera® Clinical Analyzer.

· Total Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood, lipid and lipoprotein metabolism disorders.

· High Density Lipoprotein Cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

· 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.

· Apolipoprotein B measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis.

The Extended Lipid Panel Assay involves the acquisition of a 400 MHz proton NMR spectrum of serum or plasma, passing the spectral information through a Partial Least Squares (PLS) regression model, and deriving analyte concentrations from the spectrum based on the trained PLS model. The proton NMR spectrum of serum and plasma is replete with information from the lipids packaged in lipoproteins. The spectrum consists of multiple proton signals emanating from the TG, cholesteryl esters and free cholesterol present in chylomicrons, VLDL, LDL and HDL, out of which the methylene and methyl proton signals are the most abundant. NMR spectra were recorded for several hundred to several thousand representative serum specimens for which the TG, TC, HDL-C and ApoB were chemically measured. Using a PLS regression routine, the spectral information in the combined methylene and methyl region (0.56 - 1.40 ppm) was trained against the chemical measurements where the information is connected through latent variables. Cross-validation was performed with PRESS statistics to optimize the regression model with an appropriate number of latent variables. Once trained with sufficient number of specimens, for any test specimen spectrum, the spectral information is then converted into lipid or ApoB concentrations through the optimum number of 24 to 27 latent variables for which the regression coefficients were known from the predictor matrix.

The Extended Lipid Panel Assay is an in vitro diagnostic test for the quantitative determination of Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein B (ApoB) in human serum and plasma. The device uses Nuclear Magnetic Resonance (NMR) technology to derive analyte concentrations.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are demonstrated through various analytical performance studies. The document does not explicitly state pre-defined acceptance criteria in a dedicated table with pass/fail results against specific thresholds for each performance metric, but rather presents the results of these studies. Based on the provided performance data, the implicit acceptance criteria would be for the device to show good analytical sensitivity, precision, linearity, and minimal interference, and to demonstrate substantial equivalence to predicate devices through method comparison studies.

Below is a table summarizing the reported device performance, which implicitly demonstrates it meets the necessary criteria for "substantial equivalence" based on the FDA's assessment in the 510(k) clearance.

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

• Analytical Sensitivity (LoQ): Not specified how "LoQ" was determined by sample size, but indicates "lowest concentration measurable with acceptable precision and accuracy."
• Assay Precision (Within-run and Within-laboratory): 20 replicates for within-run and 80 replicates (for n=80, it means 40 total runs over 20 days with 2 replicates per run on 1 instrument) for within-laboratory precision, using three patient serum pools (low, medium, high). The provenance is "patient serum pools."
• Reproducibility: Five levels of serum panels were tested for 5 days, 6 runs per day, 2 replicates per run at 3 sites. This results in 5 (levels) * 5 (days) * 6 (runs/day) * 2 (replicates/run) * 3 (sites) = 900 measurements per analyte. The provenance is from "serum panels," presumably patient-derived.
• Linearity: "Reference serum pools were prepared from patient specimens with low to high values" and "mean values from analysis of four replicates of each pool" were used. The exact number of 'pools' created for each analyte is not explicitly stated but implies multiple points across the range. The provenance is "patient specimens."
• Interfering Substances: "samples with spiked concentrations of interferent" were used. The number of samples is not specified, but it covered "Eight endogenous agents and thirty drugs."
• Method Comparison:
  • TC: n=281 pooled serum samples
  • TG: n=270 pooled serum samples
  • HDL-C: n=15575 (This number seems exceptionally high compared to other n values; it might be a typo or represent cumulative data points over various experiments) pooled serum samples
  • ApoB: n=266 pooled serum samples
    The data provenance for method comparison is "pooled serum samples across the reportable range" of the device. All studies appear to be retrospective using banked or prepared samples, as typical for analytical performance studies of this nature. The country of origin is not specified but is presumably the US given the FDA submission.

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

This device is a clinical chemistry assay for quantifying specific analytes (TC, TG, HDL-C, ApoB) rather than an imaging or diagnostic AI device that interprets qualitative information and requires human expert consensus for ground truth.

• Ground Truth for Method Comparison: The "ground truth" for the method comparison studies was established by predicate clinical chemistry devices (biochemical assays like enzymatic colorimetric assay or nephelometric immunoassay). These are established methods that serve as the comparative standard. No human experts were involved in establishing the ground truth for the values themselves, as it's a quantitative measurement.
• Qualifications of Experts: Not applicable in the context of establishing ground truth for quantitative chemical measurements. However, the development, validation, and regulatory submission would have been overseen by qualified scientists and regulatory affairs professionals.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for qualitative or semi-quantitative diagnostic devices where human interpretation might differ, and an expert panel resolves discrepancies to establish ground truth. For quantitative clinical chemistry assays, the reference method (predicate device in this case) provides the "adjudicated" ground truth.

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. MRMC studies are designed for evaluating diagnostic devices that involve human interpretation of images or other qualitative data, often with AI assistance, to assess the impact of AI on reader performance. This device is a standalone clinical chemistry analyzer that provides quantitative measurements; it does not involve human "readers" or AI assistance in a diagnostic interpretation workflow.

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

Yes, this device is inherently a standalone algorithm. The Extended Lipid Panel Assay is described as utilizing "passing the spectral information through a Partial Least Squares (PLS) regression model, and deriving analyte concentrations from the spectrum based on the trained PLS model." This process is entirely automated and does not involve human intervention in the result generation once the sample is run on the Vantera® Clinical Analyzer. The performance studies (precision, linearity, method comparison) directly evaluate this standalone algorithmic performance.

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

The ground truth for evaluating the Extended Lipid Panel Assay was based on measurements obtained from legally marketed predicate clinical chemistry devices. These predicate devices are established methods for quantifying the specific lipid and lipoprotein analytes (TC, TG, HDL-C, ApoB).

8. The sample size for the training set

For the Partial Least Squares (PLS) regression model: "NMR spectra were recorded for several hundred to several thousand representative serum specimens for which the TG, TC, HDL-C and ApoB were chemically measured." The exact number is not precisely stated but indicates a substantial training dataset.

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

The ground truth for the training set was established by chemical measurements (presumably using standard, often wet-chemistry or enzymatic reference methods) for TG, TC, HDL-C, and ApoB on the "several hundred to several thousand representative serum specimens." These chemical measurements served as the target values for the PLS regression model to learn the relationship between the NMR spectra and the analyte concentrations.

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The Mission® Lipid Panel Monitoring System is intended for the quantitative determination of Total Cholesterol. High Density Lipoprotein Cholesterol, and Triglycerides in human capillary whole blood from the fingerin venous whole blood. The Mission® Lipid Panel Monitoring System consisting of the Mission® Lipid Panel Meter, Mission® Lipid Panel Test Cartridges, Mission® Cholesterol Optical Verifier, and Mission® Cholesterol Control Solution, and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto disabling lancing devices. This system is for in vitro diagnostic use only.

Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. HDL (High Density Lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism or various endocrine disorders.

An estimated value for Low Density Lipoprotein Cholesterol is calculated by the Mission Cholesterol Pro Meter and is reported only when Triglycerides are ≤400 mg/dL.

Not Found

The document provided (K180504) is a 510(k) premarket notification for the Mission Lipid Panel Monitoring System. Based on the content, this device is a quantitative assay system for measuring Total Cholesterol, HDL-C, and Triglycerides, primarily used in professional healthcare settings. It is NOT an AI/ML powered device, nor does it involve image analysis by experts, or require MRMC studies.

Therefore, many of the requested criteria (like number of experts, adjudication methods, multi-reader multi-case studies, effect size of human improvement with AI, training set details, etc.) are not applicable to this type of medical device and the information is not present in the provided document.

However, I can extract the acceptance criteria and performance data relevant to a clinical chemistry device, which typically involves analytical accuracy and precision.

Here's an attempt to answer the request based only on the provided document, acknowledging the limitations for an AI/ML context:

The Mission Lipid Panel Monitoring System is a quantitative in vitro diagnostic device. The documentation provided focuses on clinical chemistry performance, not AI/ML algorithm performance. As such, many of the acceptance criteria and study details commonly associated with AI/ML devices (e.g., number of experts, MRMC studies, training set details, ground truth for image analysis) are not relevant or provided for this device type.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K180504) is a 510(k) clearance letter and an Indications for Use statement. It does not contain the detailed performance data or the specific acceptance criteria tables that would typically be part of the predicate comparison or detailed validation studies submitted to the FDA. The letter only states that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

To illustrate what would typically be found for a quantitative diagnostic like this, and based on common regulatory expectations for lipid panels, performance would involve metrics like:

Important Note: The provided document does not contain any of these specific performance values or acceptance criteria. It is a regulatory clearance letter, not a summary of the validation study.

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

The document does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). Such details would be found in the more detailed 510(k) submission or a summary of safety and effectiveness, neither of which is part of this provided extract.

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

Not applicable. This device measures chemical analytes (Total Cholesterol, HDL-C, Triglycerides). The "ground truth" for such measurements is typically established by reference laboratory methods (e.g., enzymatic assays, gas chromatography-mass spectrometry (GC-MS), or high-performance liquid chromatography (HPLC)) traceable to international standards (e.g., CDC Lipid Standardization Program). It does not involve human expert interpretation of images or complex diagnostic reasoning.

4. Adjudication Method for the Test Set

Not applicable, as ground truth is established by objective laboratory methods, not expert consensus requiring adjudication.

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

Not applicable. MRMC studies are relevant for imaging devices where human readers interpret medical images. This device is a quantitative diagnostic instrument that measures chemical concentrations.

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

Not applicable. This device is an analytical instrument; its "performance" is its ability to accurately and precisely measure analytes. While there's an "algorithm" for calculating LDL-C (Friedewald formula), its performance is assessed through the accuracy of the underlying direct measurements (TC, HDL-C, TG) and comparison of the calculated LDL-C to a reference method, not typically in a "standalone algorithm" context as understood for image analysis AI.

7. The Type of Ground Truth Used

The ground truth for a device like the Mission Lipid Panel Monitoring System would be established by:

• Reference Laboratory Methods: Highly accurate and precise laboratory methods (e.g., those traceable to the CDC Lipid Standardization Program or other certified reference methods) for Total Cholesterol, HDL-C, and Triglycerides.
• Certified Reference Materials: Use of materials with known, established concentrations of the analytes.

8. The Sample Size for the Training Set

Not applicable in the context of AI/ML training. This device is likely based on established electrochemical or photometric principles, not on a machine learning model "trained" on a dataset of patient samples in the AI sense. Performance is validated through analytical studies on patient samples and quality control materials.

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

Not applicable. As noted above, this is not an AI/ML device that requires a "training set" in that context. Its analytical method is based on established chemical principles. Validation is done against reference methods and materials, as described in point 7.

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The Mission® Cholesterol Monitoring System is intended for the quantitative determination of Total Cholesterol. High Density Lipoprotein Cholesterol, and Triglycerides in human capillary whole blood from the fingertip. The Mission Cholesterol Monitoring System is a portable system consisting of the Mission Cholesterol Mission Cholesterol Test Cartridges, Mission Cholesterol Optical Verifier and Mission Cholesterol Control Solution, and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only.

Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

HDL (High Density Lipoprotein Cholesterol) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Trighcerides measurements are used in the diagnosis and treatment with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism or various endocrine disorders.

Use this product at the frequency your doctor recommends for testing Total Cholesterol, and Triglycerides.

An estimated value for Low Density Lipoprotein Cholesterol is calculated by the Mission Cholesterol Meter and is reported only when Triglycerides are <400 mg/dL.

The Mission® Cholesterol Pro Monitoring System is intended for the quantitative determination of Total Cholesterol. High Density Lipoprotein Cholesterol, and Triglycerides in human capillary whole blood from the fingertip and lithium heparin venous whole blood. The Mission Cholesterol Pro Monitoring System is a portable system consisting of the Mission Cholesterol Pro Meter, Mission Cholesterol Pro Test Cartridges, Mission Cholesterol Optical Verifier, and Mission Cholesterol Control Solution, and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. This system is for in vitro diagnostic use only.

Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

HDL (High Density Lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Triglycerides measurements are used in the diagnosis and treatments with diabetes mellitus. nephrosis, liver obstruction, and other diseases involving lipid metabolism or various endocrine disorders.

An estimated value for Low Density Lipoprotein Cholesterol is calculated by the Mission Cholesterol Meter and is reported only when Triglycerides are <400 mg/dL.

Over the Counter (home use): The Mission Cholesterol Monitoring System is a portable system consisting of the Mission Cholesterol Meter, Mission Cholesterol Test Cartridges, Mission Cholesterol Optical Verifier and Mission Cholesterol Control Solution and is intended to be used by a single person and should not be shared.
The Mission Cholesterol Monitoring System is designed for the quantitative measurement of Total Cholesterol (CHOL), High Density Lipoprotein Cholesterol (HDL) and Triglycerides (TRIG) in capillary whole blood from the fingertip. The Mission Cholesterol Meter is an in vitro diagnostic device consisting of a reflectance photometer that analyzes the intensity and color of light reflected from the reagent area of the test cartridge. This device measures analytes in blood once the blood is applied to dry phase test cartridges that are specifically designed for reflectance analysis.

Professional: The Mission Cholesterol Pro Monitoring System is a portable system consisting of the Mission Cholesterol Pro Meter. Mission Cholesterol Pro Test Cartridges. Mission Cholesterol Pro Optical Verifier and Mission Cholesterol Pro Control Solution and is intended for professional use in healthcare settings for multiple patient uses.
The Mission Cholesterol Pro Monitoring System is designed for the quantitative measurement of Total Cholesterol (CHOL), High Density Lipoprotein Cholesterol (HDL) and Triglycerides (TRIG) in capillary and venous human whole blood. The Mission Cholesterol Pro Meter is an in vitro diagnostic device consisting of a reflectance photometer that analyzes the intensity and color of light reflected from the reagent area of the test cartridge. This device measures analytes in blood once the blood is applied to dry phase test cartridges that are specifically designed for reflectance analysis.

Test Cartridge:
The Mission Cholesterol (Home use) Test Cartridge is a 3 in 1 Lipid Panel test device used to measure concentration of CHOL, HDL and TRIG in capillary whole blood from the fingertip. A code Chip automatically calibrates the meter with the code number of the cartridges when inserted into the meter.

The Mission Cholesterol Pro (Professional) Test Cartridge is a 3 in 1 Lipid Panel test device used to measure concentration of CHOL, HDL and TRIG in capillary and venous human whole blood. A code Chip automatically calibrates the meter with the code number of the cartridges when inserted into the meter.

Control Solution:
Both the Mission® Cholesterol (home use) Monitoring System's and the Mission® Cholesterol Pro Monitoring System's Control Solutions are used to estimate precision of meter readings for determination of total cholesterol (CHOL), high density lipoprotein cholesterol (HDL) and triglycerides (TRIG).

Optical verifier:
Both the Mission® Cholesterol (home use) Monitoring System's and the Mission® Cholesterol Pro Monitoring System's Optical Verifiers are used to verify that the meter functions properly by checking that the meter can detect a pre-calibrated value.

Here's a summary of the acceptance criteria and study findings for the Mission Cholesterol Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state formal "acceptance criteria" values in a table. However, the linearity, precision, and bias data are direct measures of performance against presumed internal or regulatory benchmarks for acceptable accuracy and precision in cholesterol measurement devices. We will infer the reported device performance from the study results presented.

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

• Sample Size: A total of 369 patients were recruited for the clinical study.
• Data Provenance: The study was conducted at three point-of-care (POC) sites located in different geographical locations. It is a prospective clinical study as patients were recruited and tested specifically for this study. The country of origin is not explicitly stated, but given the FDA submission, it can be inferred to be compliant with US regulatory standards, likely involving data collected within the US or under equivalent standards.

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

The document does not explicitly state the number of experts. However, it mentions:

• "For professional use, patient blood was collected from fingertip and venous blood draws. Capillary blood samples from fingertip were tested at clinical sites by professionals. Venous blood samples were tested at a laboratory using an FDA cleared method."
• "The plasma concentration was confirmed by the reference method."

This implies that trained "professionals" (likely medical technicians or laboratory personnel) performed the official comparative testing, and an FDA-cleared reference method was used to establish the ground truth. No specific number or qualification (e.g., "radiologist with 10 years of experience") for these "professionals" is given beyond their professional role in clinical sites or laboratories.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1). The ground truth was established by comparing the device's results to an "FDA cleared method" and a "reference method" in laboratory settings. This suggests direct quantitative comparison rather than a consensus-based adjudication process typical for qualitative or image-based diagnostics.

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 explicitly mentioned or performed in the context of improving human reader performance with AI assistance. This study focuses on the device's standalone analytical performance compared to a reference method, and also includes layperson use, not assisted reading by human experts.

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

Yes, a standalone performance study was done for the device. The entire clinical study, comparing the Mission Cholesterol Monitoring System's measurements against a reference method, evaluates the algorithm's performance. Both professional operators and laypersons used the device independently to obtain results, which were then compared to the established ground truth.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established by comparing the device's results to an FDA cleared method and a reference method (for plasma concentration).

8. The Sample Size for the Training Set

The document does not provide information regarding a separate training set or its sample size. The studies described are for the validation of an already developed device.

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

As no training set is described, there's no information on how its ground truth would have been established. The provided document focuses on the validation of the device through performance and clinical studies.

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The CardioChek Home Test System (consisting of the CardioChek Home analyzer and CardioChek Home Lipid Panel test strips) is for the quantitative determination of total cholesterol. HDL (high density lipoprotein) cholesterol and triglycerides in capillary whole blood from the fingertip and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only.

• o Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
• HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes ● mellitus), atherosclerosis, and various liver and renal diseases.
• 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.
  A Chol/HDL ration and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek Home Analyzer.

The CardioChek Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels Lipid Panel test strips) is for the quantitative determination of total cholesterol. HDL (high density lipoprotein) cholesterol and triglycerides in venous whole blood and capillary whole blood from the fingertip and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. This system is for in vitro diagnostic use only.

• o Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
• HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes ● mellitus), atherosclerosis, and various liver and renal diseases.
• 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.
  A Chol/HDL ration and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek Plus Analyzer.

The CardioChek PA Test System (consisting of the CardioChek PA analyzer and PTS Panels Lipid Panel test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides in venous whole blood and capillary whole blood from the fingertip and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. This system is for in vitro diagnostic use only.

• Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol . in the blood and lipid and lipoprotein metabolism disorders.
• HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
• 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.
  A Chol/HDL ration and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA Analyzer.

The CardioChek PA Home Test System (consisting of the CardioChek PA Home analyzer and CardioChek Home Livid Panel test strips) is for the quantitative determination of total cholesterol. HDL (high density lipoprotein) cholesterol and triglycerides in capillary whole blood from the fingertip and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only.

• Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol o in the blood and lipid and lipoprotein metabolism disorders.
• HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
• 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.
  A Chol/HDL ration and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA Home Analyzer.

The PTS Panels Lipid Panel test strips and the CardioChek Home Lipid Panel test strips are used with the CardioChek Plus, CardioChek PA, CardioChek Home and CardioChek PA Home analyzers to measure total cholesterol and triglycerides in whole blood. The test strips utilize enzymatic methods on a dry strip that is read by reflectance photometry. These test strips are for in vitro diagnostic use only.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the CardioChek Test Systems (CardioChek Plus, CardioChek Home, CardioChek PA, CardioChek PA Home) involve demonstrating accuracy and precision for HDL cholesterol measurements within a modified dynamic range of 20-120 mg/dL. The reported performance is based on comparison to a reference laboratory method (Roche Cobas Integra 400 plus) and precision studies.

2. Sample Size and Data Provenance for the Test Set

• Accuracy Test Set:
  • Sample Size: 80 samples for each analyzer type (CardioChek Plus Home, CardioChek Plus, CardioChek PA, CardioChek PA Home).
  • Data Provenance: Not explicitly stated, but based on the nature of medical device studies for FDA submission, it would typically be prospective data collected for the purpose of the study. The country of origin is not specified, but the submission is to the U.S. FDA.
• Precision Test Set:
  • Sample Size: 80 observations for Level 1 and Level 2 for all analyzers, and 80 observations (CardioChek PA/PA Home) or 78 observations (CardioChek Plus/Home) for Level 3. These observations were obtained by "three operators tested three levels of whole blood samples on five analyzers... over three time periods."
  • Data Provenance: Not explicitly stated, but likely prospective data collected in a controlled laboratory setting.

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

• This relates to a diagnostic device for quantitative measurement, not an AI classification system requiring expert interpretation for ground truth.
• For Accuracy: The ground truth for HDL cholesterol measurements was established using a Roche Cobas Integra 400 plus HDL Cholesterol instrument, which is a recognized reference method in clinical chemistry. This is a laboratory analyzer, not an expert panel.
• For Precision: The "ground truth" is the mean value obtained from repeated measurements of the same whole blood samples.

4. Adjudication Method for the Test Set

• Not applicable as this is a quantitative measurement device study, not an AI diagnostic study requiring human expert adjudication of interpretations. The "ground truth" is derived from a reference laboratory instrument.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this is a study for a quantitative measurement device (lipid panel test system), not an AI algorithm intended for interpretation by human readers. The context is not one of human-in-the-loop performance improvement with AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Yes, the accuracy and precision studies performed can be considered standalone performance of the device (analyzer with test strips), as it evaluates the device's ability to accurately and precisely measure HDL cholesterol compared to a reference method, without human interpretation as part of the primary output.

7. Type of Ground Truth Used

• Accuracy: The ground truth for the accuracy study was established using a reference laboratory instrument (Roche Cobas Integra 400 plus HDL Cholesterol). This is considered a highly reliable, objective, and standardized method for clinical chemistry analytes.
• Precision: The ground truth for precision is the central tendency (mean) of repeated measurements of controlled samples.

8. Sample Size for the Training Set

• This document describes performance testing for a medical device (CardioChek Test System) that determines quantitative values using enzymatic methods on dry strips read by reflectance photometry. It is a traditional in vitro diagnostic device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense for model development. The device's calibration parameters are programmed into a lot-specific memory chip. Therefore, there is no "training set" in the context of machine learning model development. The calibration and manufacturing processes would involve internal quality control and standardization.

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

• As there is no "training set" for an AI/machine learning model, this question is not applicable. The device's operational parameters and calibration are established through manufacturing processes and validated through studies like those described (accuracy and precision).

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For the quantitative in vitro determination of Cholesterol in serum and plasma. Cholesterol measurements are used in the diagnosis and treatments of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders.

The Cholesterol kit assay consists of ready to use reagent solutions.

CATALOGUE NUMBER: CH8310

R1. Reagent 4 x 20 ml

REAGENT COMPOSITION

Contents: R1. Reagent 4-Aminoantipyrine, Phenol, Peroxidase (E.C.1.11.1.7, Horse Radish, +25°C), Cholesterol esterase (E.C.3.1.1.13. Pseudomonas, +37°C), Cholesterol oxidase (E.C.1.1.3.6. Nocardia, +37°C), Sodium Azide

Concentrations in the Test: 0.25 mmol/l, 6.00 mmol/l, >=0.50 U/ml, >= 0.20 U/ml, >=0.10 U/ml, 0.09%

MATERIALS REQUIRED BUT NOT PROVIDED: Randox Assayed Multisera Level 2 (Cat. No. HN 1530) and Level 3 (Cat. No. HE 1532); 510(k) # K942458, Randox Calibration Serum Level 3 (Cat. No. CAL 2351); 510(k) # K053153, RX series Saline (Cat. No. SA 8396)

Here's a breakdown of the acceptance criteria and study information for the Randox Laboratories Ltd. Cholesterol device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for all tests in a single table, but rather presents the performance results of various analytical studies that demonstrate the device's capability. I've compiled the relevant performance data from the document into a table, noting the implicit acceptance measures (e.g., meeting CLSI guidelines, certain correlation coefficients, or imprecision percentages).

2. Sample Sizes and Data Provenance for the Test Set

• Precision/Reproducibility:
  • Controls: Not explicitly stated as "sample size" but data is reported for commercial control materials (717UE, 724UE, 952UN).
  • Patient Samples: 4 concentrations of unaltered human serum samples (3 diluted, 1 spiked for Linearity Pool, 1 Sensitivity Pool). Each sample run in 2 replicates per run, twice per day for 20 non-consecutive days, using 2 reagent lots on 2 RX Daytona plus systems.
  • Data Provenance: "unaltered human serum samples" implies human origin, likely retrospective for spiking/dilution. No country of origin is specified.
• Linearity/Assay Reportable Range:
  • Sample Size: 11 levels of samples covering the measuring range. Each level run in 5 replicates.
  • Data Provenance: "linearity samples" were prepared. Implies in-vitro prepared samples to cover the range, likely based on human serum/plasma.
• Detection Limit (LoD), Limit of Blank (LoB), Limit of Quantitation (LoQ):
  • Sample Size: LoD was based on 240 determinations with 4 low-level samples.
  • Data Provenance: Not specified, but generally prepared samples for low-level determination.
• Analytical Specificity (Interference):
  • Sample Size: Not explicitly stated for the number of interferent samples, but tested at Cholesterol concentrations of 150 mg/dl and 250 mg/dl for each interferent.
  • Data Provenance: Prepared samples spiked with interferents.
• Method Comparison with Predicate Device:
  • Sample Size: 107 serum patient samples.
  • Data Provenance: "serum patient samples" spanning 25 to 599 mg/dl. Retrospective. No country of origin specified.
• Matrix Comparison:
  • Sample Size (Lithium Heparin): Minimum of 54 matched patient sample pairs (serum vs. lithium heparin plasma).
  • Sample Size (Potassium 2 EDTA): Minimum of 50 matched patient sample pairs (serum vs. potassium 2 EDTA plasma).
  • Data Provenance: "Patient samples were drawn in matched pairs". Retrospective from human subjects. No country of origin specified.

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

This device is an in vitro diagnostic (IVD) for quantitative measurement of cholesterol. The "ground truth" for such devices is established by precise laboratory reference methods or established commercially available controls and calibrators with known values.

• No "experts" in the sense of radiologists or pathologists establishing ground truth as would be the case for imaging devices.
• Ground truth is established by:
  • Reference materials (e.g., NIST 1952a for the calibrators, mentioned under traceability).
  • Established analytical methods used by the predicate device and in clinical laboratories.
  • CLSI guidelines for experimental design and data analysis.

4. Adjudication Method for the Test Set

Not applicable for this type of quantitative IVD device. Adjudication methods (like 2+1, 3+1) are typically used for qualitative or semi-quantitative assessments, especially in imaging or pathology, where human expert discrepancy resolution is needed. For quantitative chemical measurements, the ground truth is often numerical and objectively determined.

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

No. This is an in vitro diagnostic device for chemical analysis of cholesterol, not an imaging or qualitative assessment device involving human readers. Therefore, an MRMC study is not relevant.

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

Yes, the entire performance evaluation presented is a standalone study of the device (Cholesterol assay on the RX Daytona plus system). The device performs the analytical measurement autonomously once the sample is loaded. The studies demonstrate the analytical performance of the device itself.

7. Type of Ground Truth Used

The ground truth for the performance studies is multi-faceted:

• Reference Materials: Randox Calibration Serum Level 3 is traceable to Cholesterol reference material NIST 1952a. This is a primary ground truth for calibration and accuracy.
• Predicate Device: For method comparison studies, the predicate device (Randox Cholesterol reagent, K923504) serves as a comparative ground truth, aiming to demonstrate substantial equivalence rather than absolute biological truth.
• CLSI Guidelines: The studies adhere to CLSI (Clinical and Laboratory Standards Institute) guidelines (EP5-A2 for precision, EP6-A for linearity, EP17-A2 for detection limits, EP9-A2 for method comparison), which represent an industry-accepted "ground truth" for how these analytical performance characteristics should be determined and evaluated.
• Prepared Samples: For linearity, sensitivity, detection limits, and interference, samples were prepared to known concentrations or spiked with known substances to create specific "ground truth" scenarios.

8. Sample Size for the Training Set

There is no mention of a "training set" in the context of machine learning or AI, as this device is a traditional in vitro diagnostic reagent system, not an AI/ML-based device.

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

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

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The Afinion™ Lipid Panel is an in vitro diagnostic test for quantitative determination of total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig) in serum. Values for low-density lipoprotein (LDL) cholesterol, non-HDL cholesterol and Chol/HDL ratio are calculated by the Afinion™ AS100 Analyzer. Chol, HDL cholesterol, Trig, and calculated LDL cholesterol, non-HDL cholesterol and Chol/HDL ratio) are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Afinion™ Lipid Panel Control has been designed for use with the Afinion™ AS100 Analyzer and Afinion™ Lipid Panel. Afinion™ Lipid Panel Control is intended for use as assayed control material for total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig). The controls should be used to confirm that the Afinion™ AS100 Analyzer System is working properly and provides reliable results.

For use in clinical laboratories and point of care laboratory settings.

For prescription use only.

Afinion™ Lipid Panel is a fully automated assay for quantitative determination of Chol. HDL and Trig in serum. LDL, non- HDL and Chol/HDL are calculated by the Afinion™ AS100 Analyzer.

The Afinion™ Lipid Panel Test Cartridge contains all reagents necessary for determination of Chol, HDL and Trig in serum. The sampling device integrated in the test cartridge is filled with sample material. The test cartridge is then placed in the Afinion™ AS100 Analyzer. The analyzer inspects the sampling device, and the sample is then diluted.

Total Cholesterol (Chol) is measured by an enzymatic colorimetric method.
Triglycerides (Trig) are measured by an enzymatic colorimetric method.
HDL cholesterol is measured by an enzymatic colorimetric method with direct determination of HDL by initial antibody blocking of apolipoprotein B (apo-B).
LDL cholesterol is calculated by use of the Friedwald formula: LDL (mg/dL) = Chol - HDL - Trig/5.
non-HDL cholesterol is calculated as total cholesterol minus HDL: non-HDL = Chol - HDL.
Chol/HDL ratio is calculated as Total Cholesterol/ HDL Cholesterol.

Acceptance Criteria and Device Performance for Afinion™ Lipid Panel

This document outlines the acceptance criteria and the study that demonstrates the Afinion™ Lipid Panel's performance, as derived from the provided 510(k) summary (K132031).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria values for bias, precision (repeatability and within-device), or linearity. Instead, it presents the results of these studies and implies that these results were considered acceptable for demonstrating substantial equivalence to predicate devices. The reported device performance based on acceptable outcomes from comparison studies is presented below.

Interference: No significant interference (<10%) was observed from 26 common substances at specified concentrations. Limitations were noted for Calcium dobesilate, Methyldopa, Acetylcysteine, and Levodopa at certain levels.

Reporting Ranges (supported by linearity and LoQ studies):

Accuracy (Method Comparison with Predicate Devices):

Bias at Medical Decision Levels (Implied Acceptance: Low Bias):

Precision (Repeatability and Within-device %CV - Implied Acceptance: Low %CV):

Precision results are presented for control samples at two levels and one serum sample across three sites. The Coefficients of Variation (CV%) are generally low, indicating good precision. For example:

• Total Cholesterol: Repeatability CVs range from 1.7% to 3.5%, Within-device CVs range from 2.3% to 3.9%.
• HDL Cholesterol: Repeatability CVs range from 2.1% to 3.9%, Within-device CVs range from 2.6% to 4.9%.
• Triglycerides: Repeatability CVs range from 1.8% to 4.4%, Within-device CVs range from 2.2% to 4.9%.

2. Sample Sizes and Data Provenance

• Linearity Testing:

  • Test Set Sample Size: 11 concentration levels for each analyte, produced by intermixing one low and one high serum sample. Each level was measured in 4-6 replicates.
  • Data Provenance: Not explicitly stated, but the studies were performed by the manufacturer, Axis-Shield PoC AS (located in Oslo, Norway). The samples were described as "serum samples." It's retrospective in the sense that it's test data generated for regulatory submission, but the samples themselves could have been collected prospectively or retrospectively.

• Limits of Quantitation (LoQ) Testing:

  • Test Set Sample Size: 5 samples with concentrations near 0 mg/dL (LoB samples) and 5 low concentration samples (LoD samples). Each sample was measured in a total of 60 replicates (likely 12 replicates per sample, using 3 analyzers and 2 test cartridge lots).
  • Data Provenance: Not explicitly stated, but performed by the manufacturer. "Serum" is the sample type.

• Analytical Specificity (Interference) Testing:

  • Test Set Sample Size: "Samples covering two medical decision concentrations of each lipid analyte" were measured.
  • Data Provenance: Not explicitly stated, but performed by the manufacturer.

• Accuracy (Method Comparison) Testing:

  • Test Set Sample Size:
    • Cholesterol: 348 samples
    • Triglycerides: 246 samples
    • HDL: 251 samples
  • Data Provenance: The study was "performed at four point-of-care sites." No specific country of origin is mentioned, but the manufacturer is based in Norway. The samples were "serum." The nature of sample collection (retrospective or prospective) is not specified.

• Precision Testing:

  • Test Set Sample Size: Two control samples and one serum sample were tested. For each sample, 80 replicates were performed at each of the three point-of-care sites (2 replicates per run, 2 runs per day for 20 days).
  • Data Provenance: "Performed at three point-of-care sites." The origin of the control and serum samples is not detailed, but the study was conducted by the manufacturer.

3. Number of Experts and Qualifications for Ground Truth

This device is an in vitro diagnostic (IVD) for quantitative determination of analytes in serum. The ground truth for such devices is established by reference methods or highly accurate laboratory methods, not by expert interpretation of images or clinical assessments.

• Traceability:
  • Cholesterol (Chol) and HDL are traceable to the National Reference System for Cholesterol (NRS/CHOL).
  • Triglycerides (Trig) are traceable to a Centers for Disease Control and Prevention (CDC) reference method.
  • The device is CRMLN certified for Total Cholesterol and HDL Cholesterol, indicating its accuracy against reference measurement procedures.

Therefore, "experts" in the traditional sense (e.g., radiologists) are not used to establish ground truth for this type of device. The ground truth is established by recognized reference standards and methods in clinical chemistry.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessments (e.g., image reading). This is a quantitative diagnostic device, and the ground truth is established by objective, highly accurate reference methods or laboratory instruments. Therefore, no "adjudication method" in this context is applicable or described.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that assist human readers in interpreting complex data (e.g., medical images). The Afinion™ Lipid Panel is a standalone quantitative measurement device, not an AI-assisted human reading system.

6. Standalone Performance Done

Yes, a standalone performance study was done. The studies detailed (linearity, limits of quantitation, analytical specificity, accuracy/method comparison, and precision) all represent the performance of the Afinion™ Lipid Panel device (algorithm only, without human-in-the-loop performance) in measuring lipid levels in serum samples.

7. Type of Ground Truth Used

The ground truth used is based on:

• Reference Methods: Specifically, the National Reference System for Cholesterol (NRS/CHOL) for Total Cholesterol and HDL Cholesterol, and a CDC reference method for Triglycerides.
• Comparison to Predicate Devices/Automated Laboratory Methods (CM): For accuracy evaluation, the Afinion™ Lipid Panel's results were compared against an "automated laboratory method (CM)" for Chol, Trig, and HDL, which are themselves established and validated lab instruments.

8. Sample Size for the Training Set

This document describes a 510(k) submission for an in vitro diagnostic device that measures specific analytes. It is highly unlikely that this device uses machine learning or AI models that require a "training set" in the conventional sense (i.e., iterative learning from labeled data). The device's operation is based on established enzymatic colorimetric methods and pre-programmed algorithms. Therefore, a "training set" size is not applicable or stated in this context.

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

As stated in point 8, a "training set" as understood in machine learning is not applicable to this type of IVD device. The methods for establishing the device's accuracy and performance are described under "Traceability" and "Accuracy" (method comparison with reference and predicate methods).

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The Piccolo Total Cholesterol - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of total cholesterol in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location.

Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein disorders.

The Piccolo® Lipid Panel - Capillary Reagent Disc (which contains the Piccolo® Total Cholesterol - Capillary Test System) is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer.

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

Device: Piccolo® Total Cholesterol - Capillary Test System

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implicitly defines successful performance by demonstrating strong correlation, linearity, and acceptable precision in comparison to the predicate device and established reference methods. Explicit numerical acceptance criteria (e.g., "R² must be >0.98") are not stated in this summary, but the reported results clearly meet the standards for substantial equivalence.

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

• Linearity Test: Samples across the measuring range were used. The specific number of distinct samples isn't given, but testing was done on 20 Piccolo analyzers. The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective), but it would typically be prospective for device validation.
• Precision Test:
  • Serum Samples for Within-Run and Total Precision: 160 measurements for each serum level (Serum 1 & Serum 2).
  • Whole Blood Precision: 5 fresh whole blood samples were tested 7 times each on 4 analyzers over 3 hours. This means a total of 5 * 7 = 35 measurements per analyzer, and 35 * 4 = 140 measurements in total for whole blood precision (though the table states 28 for each sample). The document also states "a total of 20 analyzers were used" for this specific test, which introduces some ambiguity on the total number of data points if each sample was run on all 20 analyzers.
  • The data provenance is not explicitly stated.
• Method Comparison Test:
  • Site 1: 216 samples
  • Site 2: 210 samples
  • Site 3: 213 samples
  • Combined Data: 639 samples
  • The data provenance (e.g., country of origin, retrospective or prospective) for these clinical samples is not explicitly mentioned in the provided text. Based on the context of a 510(k) submission, these would typically be prospectively collected samples from a clinical laboratory or point-of-care setting.

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

The ground truth for the device's performance (specifically for method comparison) was established by comparison to the Roche Cholesterol Test on the Cobas 6000 Analyzer.

For accuracy, the device was certified by the CRMLN (Cholesterol Reference Method Laboratory Network). This implies adherence to established reference methods and standards, which are overseen by expert bodies but doesn't involve individual experts establishing ground truth for each test case in the same way as, for example, image interpretation. The "experts" are essentially the established reference methods and organizations that define accurate cholesterol measurement.

4. Adjudication Method for the Test Set

Not applicable. This device is an in-vitro diagnostic (IVD) quantitative test system, not an interpretive device like an AI-powered diagnostic imaging tool that would require human expert adjudication of results. The "ground truth" is analytical (e.g., reference assay results, certified reference materials).

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 design is typically used for interpretive diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance to measure the AI's impact on human performance. This device is an automated quantitative test system.

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

Yes, the studies presented (Linearity, Precision, Method Comparison) represent the standalone performance of the Piccolo® Total Cholesterol - Capillary Test System as an algorithm/device-only system. Its output is a quantitative value, not an interpretation requiring human input for its direct result.

7. The Type of Ground Truth Used

• For Linearity, Precision, and Method Comparison: The ground truth was established by comparison to:
  • Reference materials or samples of known concentration (for linearity, precision).
  • A legally marketed predicate device: The Roche Cholesterol Test on the Cobas 6000 Analyzer (for method comparison).
• For Accuracy: The ground truth was established by "completing the certification process of the CRMLN" (Cholesterol Reference Method Laboratory Network). CRMLN certification signifies that the method is traceable to the Centers for Disease Control and Prevention (CDC) reference method for cholesterol.

8. The Sample Size for the Training Set

The provided document describes validation studies (linearity, precision, method comparison) for a predicate-based 510(k) submission for an IVD device. It does not mention any "training set" in the context of machine learning. The device is a chemical analyzer using enzymatic endpoint reactions, not an AI/ML algorithm that requires a training set in the typical sense.

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

As this is not an AI/ML device, the concept of a "training set" and its associated ground truth establishment is not applicable as described in the document. The device's operational parameters (e.g., reagent formulations, reaction conditions, calibration) would be developed and optimized through standard analytical chemistry and engineering practices, not machine learning training. Calibration is done via a barcode with factory-calibrated lot-specific data.

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