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In vitro diagnostic test for the quantitative determination of the HDL-cholesterol concentration in human serum and plasma on Roche/Hitachi cobas c systems.

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The HDL-Cholesterol Gen.4 is a homogeneous enzymatic colorimetric test. Non-HDL lipoproteins such as LDL, VLDL and chylomicrons are combined with polyanions and a detergent forming a water-soluble complex. In this complex the enzymatic reaction of CHER and CHOD towards non-HDL lipoproteins is blocked. Finally only HDL-particles can react with CHER and CHOD. The concentration of HDL-cholesterol is determined enzymatically by CHER and CHOD.

Here's a breakdown of the acceptance criteria and study details for the HDL-Cholesterol Gen.4 device, extracted from the provided document:

Device: HDL-Cholesterol Gen.4
Type: In vitro diagnostic test for the quantitative determination of HDL-cholesterol concentration in human serum and plasma on Roche/Hitachi cobas c systems.

Acceptance Criteria and Reported Device Performance

• PreciControl ClinChem Multi 1 (Mean 28.0 mg/dL): SD 0.20 mg/dL, CV 0.7%
• PreciControl ClinChem Multi 2 (Mean 68.1 mg/dL): SD 0.44 mg/dL, CV 0.6%
• Human Serum 1 (Mean 9.48 mg/dL): SD 0.17 mg/dL, CV 1.8%
• Human Serum 2 (Mean 40.5 mg/dL): SD 0.26 mg/dL, CV 0.7%
• Human Serum 3 (Mean 59.4 mg/dL): SD 0.32 mg/dL, CV 0.5%
• Human Serum 4 (Mean 79.4 mg/dL): SD 0.51 mg/dL, CV 0.6%
• Human Serum 5 (Mean 141 mg/dL): SD 0.83 mg/dL, CV 0.6%
  Intermediate Precision:
• PreciControl ClinChem Multi 1 (Mean 28.4 mg/dL): SD 0.30 mg/dL, CV 1.1%
• PreciControl ClinChem Multi 2 (Mean 66.4 mg/dL): SD 0.9 mg/dL, CV 1.4%
• Human Serum 1 (Mean 9.48 mg/dL): SD 0.20 mg/dL, CV 2.2%
• Human Serum 2 (Mean 40.7 mg/dL): SD 0.33 mg/dL, CV 0.8%
• Human Serum 3 (Mean 59.4 mg/dL): SD 0.40 mg/dL, CV 0.7%
• Human Serum 4 (Mean 79.4 mg/dL): SD 0.65 mg/dL, CV 0.8%
• Human Serum 5 (Mean 141 mg/dL): SD 1.07 mg/dL, CV 0.8% |
  | Analytical Sensitivity (LoB, LoD, LoQ) | LoB, LoD, and LoQ should be below the claimed measuring range. | LoB Observed: 0.00 mg/dL (Claim: 3.09 mg/dL)
  LoD Observed: 0.50 mg/dL (Claim: 3.09 mg/dL)
  LoQ Observed: 2.89 mg/dL (Claim: 3.09 mg/dL) |
  | Linearity/Assay Reportable Range | Measurements should be linear across the claimed measuring range (3.09 to 150 mg/dL), with good correlation and low deviation. | Serum: Slope 1.020, Intercept -0.399, Correlation Coefficient (r2) 0.9992, Repeatability 1.5%
  Plasma: Slope 1.022, Intercept -0.173, Correlation Coefficient (r2) 0.9929, Repeatability 0.8%
  Claimed Measuring Range: 3.09 to 150 mg/dL (for both serum and plasma).
  Nonlinearity did not deviate by more than 10%. |
  | Endogenous Interferences | No significant interference (bias >10%) from common interferents like hemolysis, lipemia, icterus, and triglycerides at specified levels. | Hemolysis: No Interference up to 1200 H index
  Lipemia: No Interference up to 2000 L index
  Unconjugated Bilirubin: No Interference up to 60 I index
  Conjugated Bilirubin: No Interference up to 60 I index
  Triglycerides: No Interference up to 1200 mg/dL |
  | Exogenous Interferences (Drugs) | No significant interference from a panel of common drugs at specified concentrations. | Results provided in Table 7 (specific details of "no interference" for each drug are implied by listing them in a "Test Concentrations Results" table within the interference section, assuming they met the 10% bias criterion for non-interference). |
  | Method Comparison to Predicate | Strong correlation with a legally marketed predicate device, with acceptable bias at medical decision points. | Regression Analysis (HDL-Cholesterol Gen.4 vs. Predicate): y = 0.956x - 0.949, r = 0.995
  Bias at medical decision points:
  -6.7 % at 40.2 mg/dL
  -6.0 % at 59.9 mg/dL |
  | Matrix Comparison | Acceptable correlation between serum and various plasma anticoagulant types. | Serum vs. Serum Gel Separation: y = 0.99x - 0.33, r = 0.999
  Serum vs. Li-heparin: y = 0.99x - 0.32, r = 1.000
  Serum vs. K2-EDTA: y = 0.98x - 0.70, r = 0.999
  Serum vs. K3-EDTA: y = 0.95x - 0.08, r = 0.999 |

Study Details

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

   • Precision (Repeatability & Intermediate Precision): 5 human serum pools and 2 control samples were used. Tested for 21 days with 4 replicates/day. Data provenance is not explicitly stated as country of origin, but implied to be from a laboratory setting (likely in the US or Germany, given Roche's locations). The nature of the study (analyzing human serum pools and controls) suggests prospective data collection for evaluating device performance.
   • Analytical Sensitivity (LoB, LoD, LoQ):
     • LoB: One analyte-free sample. Measured 10-fold in 6 runs over 3 days, per reagent lot (total 60 measurements per lot).
     • LoD: Five samples with low-analyte concentration. Measured two-fold in 6 runs over 3 days, per reagent lot (total 60 measurements per lot).
     • LoQ: A low-level sample set prepared by diluting 5 human serum samples. Tested in 5 replicates per sample on 5 days.
   • Linearity/Assay Reportable Range: Dilution series prepared using 1 serum pool and 1 plasma pool. The dilution series contained 11 concentrations for serum and 15 concentrations for plasma.
   • Endogenous Interferences: Two human serum pools spiked with HDL-Cholesterol and interfering substances.
   • Exogenous Interferences (Drugs): Two human serum sample pools.
   • Method Comparison to Predicate: 111 routine laboratory serum samples. Additionally, 4 samples spiked with high human serum HDL-Cholesterol and 1 sample diluted with 0.9% NaCl. Data provenance is not explicitly stated as country of origin, but implied to be from a laboratory setting. The use of "routine laboratory serum samples" suggests retrospective collection, though the spiking and dilution aspects are prospective for the study design.
   • Matrix Comparison: 38 paired samples (serum and plasma) from single donors.

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

   • For this type of in vitro diagnostic device (quantitative measurement of a biomarker), "ground truth" is typically established by reference methods or validated comparative methods, not by human expert consensus or clinical adjudication as would be seen in imaging diagnostics.
   • The predicate device (Ultra N-geneous HDL Cholesterol Reagent, K021316) serves as a comparative "ground truth" for the method comparison study. The precision, sensitivity, linearity, and interference studies establish the intrinsic performance properties of the device against predefined analytical standards (e.g., CLSI guidelines).
   • Therefore, the concept of "experts" as in "a radiologist with 10 years of experience" is not directly applicable here. The experts involved would be laboratory scientists, biochemists, and statisticians who designed and executed the studies according to CLSI guidelines and interpreted the analytical data.

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

   • Adjudication methods like 2+1 or 3+1 are typically used in clinical imaging studies where subjective interpretation is involved.
   • For this in vitro diagnostic device, measurements are quantitative, and "adjudication" is done through statistical analysis and adherence to predefined acceptance criteria based on established analytical guidelines (e.g., CLSI EP5-A3 for precision, CLSI EP17-A2 for detection limits, CLSI EP6-A for linearity). There is no "human adjudication" process for individual results as there would be for image interpretation.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices where human readers interpret medical images, and AI might assist or replace them. The HDL-Cholesterol Gen.4 is an in vitro diagnostic device that quantifies a substance in a laboratory sample; it does not involve human "readers" interpreting results in a subjective or visual manner that AI would enhance.

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

   • Yes, the performance evaluation reports are inherently demonstrating the "standalone" performance of the analytical algorithm/reagent system. The studies evaluate the device's ability to accurately and precisely measure HDL-cholesterol concentrations in samples, independent of further human interpretation beyond routine laboratory operation and quality control. The reported results (e.g., mean, SD, CV, regression equations) directly reflect the algorithm's performance.

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

   • Analytical Ground Truth: For the precision, sensitivity, linearity, and interference studies, the "ground truth" is based on the known concentrations of analytes in prepared samples (e.g., spiked samples, diluted samples, control materials) or the absence of analytes (blank samples), and performance is evaluated against established analytical standards and acceptable deviations.
   • Comparative Ground Truth: For the method comparison study, the predicate device (Ultra N-geneous HDL Cholesterol Reagent, K021316) served as the comparative "ground truth" or reference method for evaluating substantial equivalence. This is a common approach for 510(k) clearances.
   • No pathology or outcomes data was used for establishing the ground truth for device performance in this submission, as it's an analytical performance study for an IVD.

7. The sample size for the training set:

   • This document describes the pre-market notification (510(k)) studies for device validation, not the development or training of an AI algorithm. Therefore, there is no "training set" for an AI mentioned or implied in this submission. The device is a chemical reagent system, not an AI/ML independent medical device.

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

   • As noted above, no "training set" for an AI algorithm is described in this submission. The ground truth for the analytical studies described (e.g., precision, linearity) is based on the preparation of samples with known concentrations or comparative analysis against a validated predicate device, as per standard laboratory practice and CLSI guidelines.

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For the quantitative in vitro determination of HDL Cholesterol in serum and plasma. Such measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and renal diseases and for the assessment for the risk of developing cardiovascular disease.

This in vitro diagnostic device is intended for Rx Only.

The Direct HDL Cholesterol (HDL) kit assay consists of ready to use reagent solutions.

CATALOGUE NUMBER: CH8311

R1. Enzyme Reagent 1 4 x 20 ml
R2. Enzyme Reagent 2 4 x 9 ml

REAGENT COMPOSITION

R1. Enzyme Reagent 1 N,N-Bis(2-hydroxyethyl)- 2-aminoethanesulfonic acid N-(2-hydroxy-3-Sulfopropyl)- 3,5-dimethoxyaniline, sodium salt (HDAOS) Cholesterol Esterase [E.C.3.1.1.13. Microorganism] Cholesterol Oxidase [E.C.1.1.3.6. Streptomyces sp] Catalase [E.C.1.11.1.6. Microbial] Ascorbate oxidase [EC.1.10.3.3. Acremonium sp.] Initial Concentration of Solution 100 mM, pH 6.6 (+25 °C) 0.7 mM ≥800 U/L ≥500 U/L ≥300 KU/L ≥3000 U/L
R2. Enzyme Reagent 2 N,N-Bis(2-hydroxyethyl)- 2-aminoethanesulfonic acid 4-Aminoantipyrine Peroxidase [E.C.1.11.1.7, Horse Radish, +25°C] Sodium Azide Surfactants Initial Concentration of Solution 100 mM, pH 7.0 (+25 °C) 4.0 mM ≥3500 U/L 0.05 w/v % 1.4 % w/v %

This looks like a 510(k) summary for an in vitro diagnostic (IVD) device, specifically for a Direct HDL Cholesterol (HDL) test system. Since IVD devices, especially Class I, do not typically involve AI or machine learning components as described in the prompt's questions, many of the requested fields (such as "number of experts used to establish ground truth", "adjudication method", "MRMC study", "standalone performance", "training set size", and "how ground truth for training set was established") are not applicable.

However, I can extract the relevant information regarding acceptance criteria and performance from the document.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Precision/Reproducibility:
  • Control material and human serum samples: 80 determinations per control level/serum pool (2 replicates/run x 2 runs/day x 20 days).
  • Provenance: "unaltered human serum samples" and "control material." The documentation does not specify the country of origin of the human serum samples. The study design (testing over 20 non-consecutive days) suggests it's a prospective study for data collection, but the samples themselves could be retrospective.
• Linearity/Reportable Range:
  • Samples: 11 levels, each run in replicates of five.
  • Provenance: Low and high serum pool samples. Not specified for country of origin or retrospective/prospective.
• Detection Limit:
  • Samples: 240 determinations (4 low-level samples) for LoD.
  • Provenance: Not specified for country of origin or retrospective/prospective.
• Analytical Specificity (Interference):
  • Samples: Spiked samples at 34.8 mg/dL and 70 mg/dL HDL Cholesterol concentrations. The number of individual samples is not explicitly stated.
  • Provenance: Not specified for country of origin or retrospective/prospective.
• Method Comparison:
  • Patient Samples: 103 serum patient samples.
  • Provenance: Not specified for country of origin or retrospective/prospective.
• Matrix Comparison:
  • Patient Samples: 45 matched patient sample pairs (serum and lithium heparin plasma).
  • Provenance: Not specified for country of origin or retrospective/prospective.

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

• Not applicable as this is an in vitro diagnostic (IVD) device for quantitative biochemical analysis, not an AI/image-based diagnostic device requiring expert interpretation for ground truth. Ground truth is typically established by reference methods or validated laboratory measurements.

4. Adjudication Method for the Test Set:

• Not applicable for this type of IVD device.

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

• Not applicable as this is an IVD device, not an AI-assisted diagnostic system involving human readers.

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

• This device is a standalone in the sense that its performance characteristics (precision, linearity, interference, method comparison) are evaluated for the device itself as an assay system. There is no "algorithm only" vs. "human-in-the-loop" distinction because it's a quantitative chemical assay.

7. The Type of Ground Truth Used:

• For precision, linearity, and detection limit: The "ground truth" is implied to be the actual concentration of HDL Cholesterol, which is determined by the preparation of controls, spiked samples, and dilutions, or by the inherent properties of the samples themselves, and measured by the device and predicate.
• For analytical specificity (interference): The ground truth is the presence/absence of interferents at specific concentrations and their impact on the HDL measurement.
• For method comparison: The "ground truth" for comparison is the measurement obtained from the predicate device (Randox Laboratories Ltd, Direct HDL Cholesterol reagent, K982341). This represents a legally marketed device against which equivalence is demonstrated.
• For matrix comparison: The ground truth for comparison is the measurement obtained from serum samples when comparing to plasma samples.

8. The Sample Size for the Training Set:

• Not applicable in the context of machine learning/AI where "training set" has a specific meaning. For an IVD, the development and optimization of the reagent formulation and assay parameters would be an analogous "training" phase, but it doesn't involve a distinct "training set" of patient data in the AI sense.

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

• Not applicable for the same reasons as above. The "ground truth" for developing the assay itself would be established through chemical principles, optimization experiments, and validation against known standards and reference materials.

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For the quantitative determination of high-density lipprotein cholesterol (HDL-C) in serum using the Carolina Liquid Chemistries CLC720® Clinical Chemistry Analyzer. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. For in vitro diagnostic use only.

Not Found

This document is a 510(k) clearance letter for the Carolina Liquid Chemistries HDL Cholesterol Reagent. It is not a study report demonstrating device performance against acceptance criteria. Therefore, most of the requested information cannot be extracted from this document.

However, I can provide what is explicitly stated in the document:

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

This document does not contain a table of acceptance criteria or reported device performance. It is a clearance letter, indicating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. Performance data would typically be found in the 510(k) submission itself, not the clearance letter.

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

This information is not available in the provided document.

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 information is not available in the provided document.

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

This information is not available in the provided document.

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 available in the provided document. The device is a "HDL Cholesterol Reagent" and a "Clinical Chemistry Analyzer," which suggests it's an in-vitro diagnostic test for quantitative determination of HDL-C, not an imaging device typically associated with human reader interpretation in the context of MRMC studies.

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

This information is not available in the provided document. Given the nature of the device (a reagent for an analyzer), its performance would inherently be "standalone" in the sense that the analyzer provides a quantitative result without human "interpretation" in the way an imaging algorithm might. However, this document does not detail performance studies.

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

This information is not available in the provided document. For a quantitative diagnostic test like this, ground truth would typically be established through a reference method or comparison to other established methods for HDL-C measurement.

8. The sample size for the training set

This information is not available in the provided document.

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

This information is not available in the provided document.

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For in vitro diagnostic use only. VITROS Chemistry Products dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS 250/350/950/5, I FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. High Density Lipoprotein (HDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with lower HDL cholesterol concentrations.

The VITROS dHDL assay is performed using the VITROS Chemistry Products dHDL Slide and the VITROS Chemistry Products Calibrator Kit 25 on the VITROS Chemistry Systems. The VITROS dHDL Slide is a multi-layered analytical element coated on a polyester support. The method is based on a non-HDL precipitation method followed by an enzymatic detection. All reactions necessary for a single quantitative measurement of HDLC take place within the multi-layered analytical element of a VITROS Chemistry Products dHDL Slide. A drop of sample fluid is metered onto the slide and a reaction occurs which ultimately generates a colored dye. The density of dye formed is proportional to the HDL Cholesterol concentration present in the sample and is measured by reflectance spectrophotometry.

The provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of clinical performance metrics like sensitivity, specificity, or reader studies for an AI device.

This document describes a Special 510(k) submission for a modification to an existing in vitro diagnostic (IVD) device, the VITROS Chemistry Products dHDL Slide, used to measure HDL cholesterol. The modification primarily involves a reduction in the physical size of the slide and consequently a reduction in the reagents per slide and the sample volume required per test, without changing the fundamental technology or intended use.

Therefore, the requested information elements related to AI device performance evaluation (e.g., sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device and submission.

The "study" conducted for this submission would have focused on demonstrating that despite the physical changes, the modified device performs equivalently to the predicate (unmodified) device in terms of analytical performance. This would typically involve analytical studies like method comparison, precision, linearity, and interference testing, not clinical performance studies as would be conducted for a new AI-powered diagnostic.

Here's what can be extracted and inferred from the document regarding the device and its evaluation:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria (Inferred from a Special 510(k) for device modification): The primary acceptance criterion for this type of submission is demonstrating substantial equivalence to the predicate device. This means the modified device must perform comparably to the predicate device for its intended use, with no new questions of safety or effectiveness raised. Specifically, for an IVD, this generally means analytical performance (e.g., accuracy, precision, linearity, measuring range) should be equivalent. The document indicates that the concentration of ingredients per slide has changed, but the concentration of ingredients in the assay reaction remains the same, which is key to maintaining performance.
• Reported Device Performance: The document provides a summary stating: "The information presented in the premarket notification provides a reasonable assurance that the VITROS Chemistry Products dHDL Slides (modified) for use with human serum and plasma is substantially equivalent to the predicate (unmodified VITROS dHDL Slide) and is safe and effective for the stated intended use." This statement is the ultimate "reported performance" in the context of a 510(k) submission, confirming that the device meets the regulatory standard of substantial equivalence. Specific analytical performance metrics (e.g., bias, correlation coefficients between modified and predicate device results) are not detailed in this summary but would have been part of the full 510(k) submission to demonstrate equivalence.

2. Sample size used for the test set and the data provenance:
* Not applicable / Not explicitly stated in this summary. This document is a summary of a Special 510(k), which focuses on modifications to an existing device. The "test set" in this context refers to samples used for analytical verification and validation (e.g., method comparison, precision studies), not a clinical test set for AI performance. The details of these analytical studies (number of samples, study design) are not included in this summary document.
* Data Provenance: Not specified in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. This is an in vitro diagnostic device for quantitative measurement of HDL cholesterol. The "ground truth" for such a device is established by qualified laboratory methods (e.g., CDC reference methods, other validated clinical laboratory analyzers) or reference materials, not by human expert interpretation of images or other subjective data. Human experts are typically involved in interpreting the results in a clinical context, but not in establishing the "ground truth" for the device's measurement performance itself.

4. Adjudication method for the test set:
* Not applicable. See point 3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* Not applicable. This device is an automated in vitro diagnostic assay, not an AI-powered image analysis or diagnostic support system for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
* Not applicable. This is an automated laboratory test, not an AI algorithm. Its performance is inherently "standalone" in the sense that it provides a quantitative result without human subjective interpretation of an image or pattern.

7. The type of ground truth used:
* Inferred: For an IVD measuring HDL cholesterol, the ground truth for establishing analytical performance typically comes from:
* Reference methods: Comparability to established, validated reference methods (e.g., CDC-certified reference methods for lipid measurements).
* Certified reference materials: Materials with known, traceable concentrations of the analyte.
* Standard clinical laboratory analyzers: Comparison to existing, cleared devices in a method comparison study.

8. The sample size for the training set:
* Not applicable. This is not a machine learning or AI device that requires a "training set."

9. How the ground truth for the training set was established:
* Not applicable. This is not a machine learning or AI device.

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The NMR LipoProfile® test, when used with the NMR Profiler, 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. This test is performed and provided as a service by LipoScience Laboratory.

The NMR LipoProfile® test and NMR Profiler 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 ~0.8 ppm plasma NMR signal arises from the methyl group protons of the lipids carried in the LDL, HDL and VLDL subclasses of varying diameters. 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. LDL subclass particle concentrations, in units of nanomoles of particles per liter (nmol/L), are summed to give the reported total LDL particle concentration (LDL-P). By employing conversion factors assuming that the various lipoprotein subclass particles have cholesterol and triglyceride contents characteristic of normolipidemic individuals, HDL cholesterol and triglyceride concentrations are also derived.

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

Acceptance Criteria and Device Performance

The provided document focuses on analytical performance rather than clinical acceptance criteria. The acceptance criteria for the analytical evaluation (sensitivity, precision, linearity, and method comparison) are largely implied through the reported performance metrics and the use of CLSI guidelines. The document does not explicitly state pre-defined acceptance criteria values for bias or CVs in a standalone table, but rather presents the reported performance data.

Table 1: Acceptance Criteria and Reported Device Performance (Analytical)

Study Details

The provided text describes analytical performance studies designed to demonstrate substantial equivalence to a predicate device.

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

• Analytical Sensitivity (LOQ): "20 replicates of each were analyzed" for serially diluted serum specimens with low concentrations. The number of unique patient samples used for initial dilution is not specified.
• Assay Precision:
  • Within-run: 20 replicates of three patient serum pools.
  • Within-laboratory: 20 different runs over 20 days using three patient serum pools (n=80 for each pool across runs).
• Linearity: Four replicates of each of eleven (for LDL-P) or twelve (for TG and HDL-C) different samples derived from three serum pools.
• Method Comparison:
  • LDL-P: n=1555 serum samples
  • HDL-C: n=1599 serum samples
  • Triglycerides: n=1597 serum samples
• Interfering Substances: "Five endogenous agents and twenty two drugs were screened". No sample size for patient samples is given, but likely spiked samples.

Data Provenance: The document does not explicitly state the country of origin. The samples are described as "patient serum pools" and "serum samples," implying they are from human subjects, likely in a clinical laboratory setting. The terms "retrospective" or "prospective" are not used; these appear to be analytical validation studies on collected samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for these analytical studies is based on quantitative measurements (e.g., predicate device measurements for method comparison, or target values established through dilution for linearity and sensitivity). This is not an image-based or clinical diagnostic study requiring expert interpretation.

4. Adjudication method for the test set: Not applicable. These are quantitative analytical studies, not studies requiring expert adjudication of 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: Not applicable. This is an analytical device for quantifying lipoprotein particles, not an AI-assisted diagnostic imaging device with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the entire performance data section (Analytical Sensitivity, Assay Precision, Linearity, Interfering Substances, Method Comparison) represents standalone algorithm performance, as the device is an automated NMR spectrometer with deconvolution software. There is no human interpretation or intervention in the measurement process itself.

7. The type of ground truth used:

• Analytical Sensitivity (LOQ): Target values from serial dilution.
• Assay Precision: Mean values from repeated measurements of serum pools.
• Linearity: Expected target values derived from mixing and diluting serum pools.
• Method Comparison: Measurements from the legally marketed predicate device (NMR Profiler and NMR Lipoprofile Assay, K063841).
• Interfering Substances: Pre-established target concentrations of potential interferents.

8. The sample size for the training set: Not applicable. This is an analytical device validation, not a machine learning model that undergoes a distinct training phase in the context of this 510(k) submission. The underlying deconvolution software likely had development and calibration phases, but those are not described as a "training set" in this document.

9. How the ground truth for the training set was established: Not applicable, as no training set is explicitly described for this 510(k) submission.

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ELITech Clinical Systems CHOLESTEROL HDL SL 2G is intended for use with ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR and ELITech Clinical Systems ELITROL I and ELITROL II on ELITech Clinical Systems Selectra analyzers for the quantitative in vitro diagnostic determination of High Density Lipoprotein (HDL) Cholesterol in human serum and plasma. It is not intended for use in Point of Care settings. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR is a calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems CHOLESTEROL HDL SL 2G on the ELITech Clinical Systems Selectra analyzers.

ELITech Clinical Systems CHOLESTEROL LDL SL 2G is intended for use with ELITech Clinical Systems CHOLESTEROL LDL 2G CALIBRATOR and ELITech Clinical Systems ELITROL I and ELITROL II for the quantitative in vitro diagnostic determination of Low Density Lipoprotein (LDL) Cholesterol in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

ELITech Clinical Systems CHOLESTEROL LDL 2G CALIBRATOR is a calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems CHOLESTEROL LDL SL 2G on ELITech Clinical Systems Selectra Analyzers.

ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.

The device for this submission is available as kit only. It consists of 2 reagents, "R1" and "R2". Reagent R1 contains: Good's buffer, Cholesterol oxidase (CO bacterial), Peroxidase (horseradish), Ascorbate oxidase (bacterial), N,N-bis(4-sulphobutyl)-m-toluidine-disodium (DSBmT), Accelerator. Reagent R2 contains: Good's buffer, Cholesterol esterase (CHE bacterial), 4-Amino-Antipyrine (4-AA), detergent.

ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR is a lyophilized calibrator based on human serum containing lipoprotein from the various lipoprotein classes including high density lipoproteins and sodium azide as preservative. CHOLESTEROL HDL 2G CALIBRATOR 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.

The device for this submission is available as kit only. It consists of 2 reagents, "R1" and "R2". Reagent R1 contains: MES buffer, Detergent 1, Cholesterol esterase (CHE bacterial), Cholesterol oxidase (CO bacterial), Peroxidase (horseradish), 4-Amino-Antipyrine (4-AA), Ascorbate oxidase (vegetal). Reagent R2 contains: MES buffer, Detergent 2, N,N-bis(4-sulphobutyl)-m-toluidine-disodium (DSBmT).

ELITech Clinical Systems CHOLESTEROL LDL 2GCALIBRATOR is a lyophilized calibrator based on human serum containing lipoprotein from the various lipoprotein classes including low density lipoproteins and sodium azide as preservative. CHOLESTEROL LDL 2G CALIBRATOR is prepared from plasma donor units tested individually by FDA - approved methods and found to be negative for HbsAg, anti-HCV antibody and anti-HIV1&2 antibodies.

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 breakdown of the acceptance criteria and study information for the ELITech Clinical Systems CHOLESTEROL HDL SL 2G device, based on the provided text. Please note that the document is a 510(k) summary, which focuses on substantial equivalence to a predicate device rather than providing a detailed study protocol and raw data. Therefore, some information, especially regarding sample sizes for training sets or expert qualifications, may not be explicitly stated.

Device(s) being evaluated:

• ELITech Clinical Systems CHOLESTEROL HDL SL 2G (Reagent)
• ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR
• ELITech Clinical Systems ELITROL I and ELITROL II (Controls)

Predicate Devices:

• ABX PENTRA HDL Direct CP (K060854) for CHOLESTEROL HDL SL 2G
• Genzyme Ultra N-Geneous CHOLESTEROL HDL Calibrator for CHOLESTEROL HDL 2G CALIBRATOR
• Roche Diagnostics Precinorm U (K041227) and Roche Diagnostics Precipath U (K041227) for ELITROL I and ELITROL II

1. Table of Acceptance Criteria and Reported Device Performance

Device: ELITech Clinical Systems CHOLESTEROL HDL SL 2G (Reagent)

Device: ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR

Device: ELITech Clinical Systems ELITROL I and ELITROL II (Controls)

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

Given the nature of a 510(k) summary for an in vitro diagnostic (IVD) device, specific sample sizes for particular experiments (like method comparison, precision, or interference studies) are often summarized rather than detailed with exact numbers of individual patient samples.

• Test Set Sample Size: The document does not explicitly state the total number of samples used across all validation studies. However, for the method comparison for CHOLESTEROL HDL SL 2G, a range of "5 to 105 mg/dL" is mentioned for the ELITech device, implying that samples covering this range were used. Similar ranges are noted for the predicate.
• Data Provenance: Not explicitly stated. For IVDs, data typically comes from clinical laboratories. Without further information, it's difficult to determine the country of origin or if the data was retrospective or prospective.

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

This information is not applicable and not provided for this type of device (in vitro diagnostic reagent, calibrator, and controls). The "ground truth" for these devices is established by reference methods or comparison to a legally marketed predicate device, not by expert human interpretation like in imaging or pathology. The performance is assessed by quantitative analytical metrics (e.g., precision, linearity, method correlation).

4. Adjudication Method for the Test Set

This is not applicable for this type of device. Adjudication methods (like 2+1, 3+1) are typically used when there's subjective human interpretation involved (e.g., in diagnostic imaging or pathology assessments by multiple readers) to resolve disagreements and establish a consensual ground truth. This is not how the performance of an IVD reagent is evaluated.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for devices that involve human readers (e.g., radiologists, pathologists) interpreting images or data, and are designed to assess the impact of AI assistance on human diagnostic performance. This submission is for an IVD diagnostic reagent, calibrator, and controls, which are intended for automated analytical measurement and do not involve human interpretation in the same way.

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

The documented studies are essentially "standalone" in the context of the device's function: they assess the analytical performance of the reagent system (algorithm being the chemical reactions and measurement process) without human interpretive input affecting the core measurement. The performance data presented (precision, linearity, method comparison, interference) are all measures of the device's inherent analytical capability.

7. The Type of Ground Truth Used

The "ground truth" for an IVD reagent and its associated calibrators/controls is established by:

• Comparison to a Legally Marketed Predicate Device: The primary method for proving substantial equivalence in a 510(k) submission. Performance characteristics of the new device are compared directly against those of the predicate device (ABX PENTRA HDL Direct CP, Genzyme Ultra N-Geneous CHOLESTEROL HDL Calibrator, Roche Diagnostics Precinorm U / Precipath U).
• Established Analytical Methods: For parameters like linearity, precision, and limit of detection, the "ground truth" is based on recognized statistical and analytical chemistry principles and established reference measurement procedures, where applicable, to demonstrate the device's inherent analytical accuracy and reliability.
• Reference Materials: For calibrators, the assigned values are based on established reference methods and reference materials.

8. The Sample Size for the Training Set

Not applicable/Not provided. This submission is for an IVD reagent and associated components, not an AI/ML model that typically requires a discrete training set. The "development" or "training" of such a chemical reagent involves formulation, optimization, and characterization through various analytical experiments rather than data-driven machine learning.

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

Not applicable. As mentioned above, there isn't a "training set" in the context of an AI/ML model for this type of IVD device. The development process relies on chemical principles, enzymatic reactions, and analytical validation against international standards or established methods.

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The EasyRA HDL Cholesterol reagent is intended for the quantitative determination of High Density Lipoprotein Cholesterol in human serum and plasma on the Medica EasyRA Chemistry Analyzer. The Medica EasyRA HDL-Cholesterol reagent can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. For in vitro diagnostic use only.

The EasyRA LDL Cholesterol reagent is intended for the quantitative determination of Low Density Lipoprotein Cholesterol in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. The LDL Cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. For in vitro diagnostic use only.

The EasyRA CHOL reagent is intended for the quantitative determination of total cholesterol in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Total cholesterol measurements are used to screen for elevated cholesterol as a risk factor in coronary artery disease. For in vitro diagnostic use only.

The EasyRA TRIG reagent is intended for the quantitative measurement of triglycerides in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism and various endocrine disorders. For in vitro diagnostic use only.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding in vitro diagnostic (IVD) reagents for cholesterol and triglyceride measurements. It is not about an AI-powered medical device or an imaging device, and therefore, many of the requested criteria (e.g., sample size for test set, number of experts, MRMC studies, ground truth establishment for AI models) are not applicable to this type of device.

This document confirms substantial equivalence of Medica Corporation's EasyRA reagents to legally marketed predicate devices, meaning their performance characteristics are considered similar enough for market entry without requiring a full Premarket Approval (PMA) application. The assessment for IVD reagents typically focuses on analytical performance characteristics like accuracy, precision, linearity, and interference, rather than diagnostic accuracy studies involving human readers or AI algorithms.

Here's an attempt to address the points based on the provided document, noting where information is not applicable:

1. A table of acceptance criteria and the reported device performance
   The document itself does not contain a table of acceptance criteria or reported device performance data. This information would typically be found in the manufacturer's 510(k) submission summary, which the FDA reviews. The letter only states that the FDA reviewed the submission and found the device substantially equivalent. For IVD reagents, acceptance criteria usually relate to analytical specifications (e.g., % bias vs. a reference method, coefficient of variation for precision).

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

   • Sample Size: Not specified in the provided FDA letter. This would be detailed in the manufacturer's submission.
   • Data Provenance: Not specified in the provided FDA letter. For IVD reagents, samples typically refer to human serum or plasma specimens used to validate the reagent's performance.

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)
   Not Applicable. This is an in vitro diagnostic reagent. The "ground truth" for chemical measurements like cholesterol or triglycerides is typically established by using validated reference methods (e.g., CDC reference methods, certified reference materials) or by comparing to another FDA-cleared predicate device, not by expert human interpretation like in imaging.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   Not Applicable. As explained above, this is an IVD reagent, not an imaging device requiring human adjudication of 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
   Not Applicable. No human readers or AI assistance are involved in the direct output of these IVD reagents. Their performance is measured analytically.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   Not Applicable. This is not an AI algorithm. It's a chemical reagent for a lab analyzer.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   The "ground truth" for IVD reagents typically refers to:

   • Reference Methods: Highly accurate and precise laboratory methods (e.g., gas chromatography-mass spectrometry for some analytes, or established enzymatic methods traceable to reference standards).
   • Certified Reference Materials (CRMs): Samples with known, certified concentrations of the analyte.
   • Comparison to Predicate Devices: Performance is often compared to another legally marketed and validated device to demonstrate "substantial equivalence."
     The specific method used is not detailed in this FDA letter.

8. The sample size for the training set
   Not Applicable. This is not an AI device that requires a "training set" in the machine learning sense. The "training" for a chemical reagent involves its formulation and validation, which doesn't use data sets in the same way.

9. How the ground truth for the training set was established
   Not Applicable. As above, no training set in the AI sense.

In summary, the provided document is a regulatory clearance letter for laboratory testing reagents, not for a medical device that utilizes artificial intelligence or requires human interpretation for its primary function. Therefore, the questions related to AI models, human expert review, and related study designs (like MRMC) are not relevant to this specific product.

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The Poly-Chem 90 Direct HDL-Cholesterol test system is an in vitro diagnostic procedure intended to measure high density lipoproteins quantitatively in human serum on the Poly-Chem 90 analyzer. HDL Cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various other liver and renal diseases, and for the assessment for the risk of developing cardiovascular disease.

The Poly-Chem 90 Direct LDL-Cholesterol test system is an in vitro diagnostic procedure intended to measure low density lipoprotens quantitatively in human serum on the Poly-Chem 90 analyzer. LDL Cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various other liver and renal diseases, and for the assessment for the risk of developing cardiovascular disease.

The Poly-Chem 90 Cholesterol test system is an in vitro diagnostic procedure intended to measure cholesterol quantitatively in human serum on the Poly-Chem 90 analyzer. Cholesterol measurements are used in the diagnosis and treatment of lipid disorders, lipoprotein metabolism disorders and atherosclerosis.

The Poly-Chem 90 Triglycerides test system is an in vitro diagnostic procedure intended to measure triglyceride quantitatively in human serum on the Poly-Chem 90 analyzer. Triglycerides measurements are used in the diagnosis and treatment of disease involving lipid metabolism and various endocrine disorders e.g. diabetes mellitus, nephrosis and liver obstruction.

Not Found

This document is a 510(k) premarket notification from the FDA for an in vitro diagnostic device (IVD) called "Poly-Chem 90 Direct HDL-Cholesterol, Direct LDL-Cholesterol, Cholesterol and Triglycerides tests."

It is important to note that a 510(k) notification primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves performance data, but it does not usually include the level of detail regarding acceptance criteria, study design, and ground truth establishment that would be found in a full efficacy study for a novel device or a clinical trial for an AI/ML-based device.

The document does not contain the detailed study information required to fully answer the request, particularly regarding acceptance criteria and the specifics of a study proving the device meets them in the context of an AI/ML device. The device described here is a chemical assay kit, not an AI/ML-based diagnostic.

Therefore, many of the requested fields cannot be populated from the provided text.

Here's an attempt to answer based on the available information, with clear indications of what is not present:

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

This information is not present in the provided document. The 510(k) summary (which is not provided here, only the decision letter and indications for use) would typically contain performance characteristics like precision, accuracy, linearity, and interference studies compared to a predicate device. Acceptance criteria for these metrics would have been established by the manufacturer and accepted by the FDA for the substantial equivalence determination.

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

This information is not present in the provided document. For an IVD, the sample size would typically refer to the number of patient samples tested. The provenance and study type are also not mentioned.

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 information is not applicable/relevant for this type of chemical IVD and is not present in the document. Ground truth for chemical assays like cholesterol levels is established through reference methods (e.g., gas chromatography-mass spectrometry, ultracentrifugation) or comparison to well-established, previously validated commercial assays, not typically by expert adjudication of images or clinical cases.

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

This information is not applicable/relevant for this type of chemical IVD and is not present in the document. Adjudication methods like 2+1 are used for interpreting qualitative or subjective data, often in imaging or pathology.

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/relevant for this type of chemical IVD and is not present in the document. MRMC studies are used for evaluating diagnostic performance of systems involving human interpretation, often with AI assistance, which is not the case here.

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

This information is not applicable/relevant for this type of chemical IVD and is not present in the document. This concept applies to AI/ML algorithms, not to a chemical assay. The Poly-Chem 90 operates as a standalone analyzer for measuring these analytes.

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

For this type of chemical IVD, the ground truth would typically be established through:

• Reference methods: Highly accurate and precise laboratory methods (e.g., GC-MS for cholesterol, ultracentrifugation for lipoproteins) used to assign true values to samples.
• Comparison to a legally marketed predicate device: The submitted 510(k) is based on demonstrating substantial equivalence to existing devices. Therefore, the predicate device's performance would serve as a de facto "ground truth" for comparison, provided the predicate itself was rigorously validated.

The specific ground truth method used is not detailed in this document.

8. The sample size for the training set

This information is not applicable/relevant as this is not an AI/ML device with a training set in the typical sense. For a chemical IVD, "training" might refer to calibration procedures, which involve a very small set of known standards. This information is not present in the document.

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

This information is not applicable/relevant for the reasons stated above (not an AI/ML device). If considering "training" as calibration, the "ground truth" for calibration samples would be established by preparing precise concentrations of the analyte using primary reference materials. This information is not present in the document.

Summary of what the document DOES tell us:

The document is an FDA 510(k) clearance letter for the "Poly-Chem 90 Direct HDL-Cholesterol, Direct LDL-Cholesterol, Cholesterol and Triglycerides tests." This device is an in vitro diagnostic procedure intended to quantitatively measure these lipids in human serum on the Poly-Chem 90 analyzer.

• Indications for Use: The document clearly outlines the specific medical conditions for which each test's results are used (e.g., diagnosis and treatment of lipid disorders, assessment of cardiovascular disease risk).
• Regulatory Classification: Class I, falling under specific regulations for lipoprotein test systems.
• Device Type: This is a chemical assay kit designed to measure specific biomolecules in a laboratory setting, not an AI/ML-based diagnostic.

Therefore, the detailed questions about AI-specific study methodologies (MRMC, standalone AI performance, expert adjudication, training/test sets for algorithms, etc.) are fundamentally misaligned with the nature of the device described in the provided text.

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HDLX reagent, when used in conjunction with SYNCHRON LX® System(s), UniCel® DxC 800 System(s) and Genzyme Liquid N-geneous® HDL Cholesterol Calibrator is intended for quantitative determination of HDL Cholesterol in the high density lipoprotein fraction of human serum or plasma.

HDL cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.

HDLX reagent, when used in conjunction with SYNCHRON LX® System(s), UniCel® DxC 800 System(s) and Genzyme Liquid N-geneous® HDL Cholesterol Calibrator is intended for quantitative determination of HDL Cholesterol in the high density lipoprotein fraction of human serum or plasma.

HDL cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.

This direct HDL Cholesterol method is a homogeneous assay without the need for any offline pretreatment or centrifugation steps. The method depends on a unique detergent which solubilizes only the HDL lipoprotein particles and releases HDL cholesterol to react with cholesterol esterase and cholesterol oxidase in the presence of chromogens, to produce a color product. The same detergent also inhibits the reaction of the cholesterol enzymes with LDL, VLDL, and chylomicrons lipoproteins by adsorbing to their surfaces. A polyanion contained in the reagent enhances the selectivity for HDL cholesterol assay by complexing LDL, VLDL, and chylomicrons lipoproteins.

HDLX reagent is used to measure the cholesterol concentration by a timed-endpoint method. The SYNCHRON® System(s) automatically proportions the appropriate HDL cholesterol sample and reagent volumes into a cuvette. The ratio used is one part sample to 93 parts reagent. The System monitors the change in absorbance at 560 nanometers. This change in absorbance is directly proportional to the concentration of cholesterol in the sample and is used by the System to calculate and express the HDL-cholesterol concentration.

{
  "1_table_of_acceptance_criteria_and_reported_device_performance": {
    "Method Comparison Study (vs. Olympus HDLX Assay)": {
      "Platform": [
        "UniCel DxC 800",
        "LX20"
      ],
      "Acceptance Criteria (implicit based on R value)": [
        "High correlation (R near 1)"
      ],
      "Reported Device Performance": [
        "R = 0.991",
        "R = 0.984"
      ]
    },
    "Precision Study (Within-Run Imprecision)": {
      "Platform and Sample": [
        "UniCel DxC 800 - SYN 1",
        "UniCel DxC 800 - SYN 2",
        "UniCel DxC 800 - SYN 3",
        "UniCel DxC 800 - Vigil Lipid 1",
        "UniCel DxC 800 - Vigil Lipid 2",
        "UniCel DxC 800 - Vigil Lipid 4",
        "LX20 - SYN 1",
        "LX20 - SYN 2",
        "LX20 - SYN 3",
        "LX20 - Vigil Lipid 1",
        "LX20 - Vigil Lipid 2",
        "LX20 - Vigil Lipid 4"
      ],
      "Acceptance Criteria (implicit based on %C.V.)": [
        "Low imprecision (low %C.V.)"
      ],
      "Reported Device Performance (%C.V.)": [
        "1.66",
        "0.85",
        "0.82",
        "1.83",
        "1.13",
        "0.85",
        "1.05",
        "0.77",
        "0.87",
        "1.64",
        "1.33",
        "1.39"
      ]
    }
  },
  "2_sample_size_and_data_provenance": {
    "Method Comparison Study": {
      "Sample Size (Test Set)": "100 samples for each platform (UniCel DxC 800 and LX20)",
      "Data Provenance": "Not specified (retrospective or prospective, country of origin not mentioned in the provided text)."
    },
    "Precision Study (Within-Run Imprecision)": {
      "Sample Size (Test Set)": "20 replicates for each of 6 samples on each platform (UniCel DxC 800 and LX20), totaling 240 measurements (20 * 6 * 2).",
      "Data Provenance": "Not specified (retrospective or prospective, country of origin not mentioned in the provided text)."
    }
  },
  "3_number_of_experts_and_qualifications_for_ground_truth": "Not applicable. This device is a diagnostic reagent for quantitative determination, not an imaging or diagnostic interpretation device requiring expert ground truth for classification.",
  "4_adjudication_method": "Not applicable. This device is a diagnostic reagent for quantitative determination, not an imaging or diagnostic interpretation device requiring adjudication.",
  "5_mrmc_comparative_effectiveness_study": "No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This is a diagnostic reagent, not an AI-assisted interpretation device for human readers.",
  "6_standalone_performance_done": "Yes, standalone performance was done for both method comparison and precision studies. The studies compare the device's performance against a predicate device and evaluate its consistency.",
  "7_type_of_ground_truth_used": {
    "Method Comparison Study": "The 'ground truth' was established by the predicate method, the Olympus HDLX Assay ([K040692](https://510k.innolitics.com/search/K040692)). The study aims to demonstrate substantial equivalence to this legally marketed device.",
    "Precision Study": "The 'ground truth' is the quantitative measurement itself, assessed for its consistency and reliability (imprecision). There isn't an external 'ground truth' in the same sense as a diagnostic gold standard; rather, it measures the inherent reproducibility of the device."
  },
  "8_sample_size_for_training_set": "Not applicable/Not specified. This document describes a medical device (a diagnostic reagent) and its validation, not an AI model requiring a training set in the conventional sense.",
  "9_how_ground_truth_for_training_set_was_established": "Not applicable. This document describes a medical device (a diagnostic reagent) and its validation, not an AI model requiring a training set in the conventional sense."
}

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The APOLOWAKO T-CHO is for the quantitative determination on the APOLOWAKO analyzer of total cholesterol in whole blood. The APOLOWAKO HDL-C is for the quantitative determination on the APOLOWAKO analyzer of HDL cholesterol in whole blood. The APOLOWAKO TG is for the quantitative determination on the APOLOWAKO analyzer of triglycerides in whole blood. In conjunction with the above values, the APOLOWAKO analyzer also calculates LDL cholesterol for triglyceride values up to 400 mg/dL and T-CHO/HDL-C ratio.

APOLOWAKO Analyzer is a discrete photometric chemistry analyzer for clinical use in both central laboratories and in point of care sites. The device is intended to duplicate manual analytical procedures by automatically performing various steps such as pipetting, mixing and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes of clinical interest in whole blood samples.

The measurements of total cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol (by calculation for triglyceride values up to 400 mg/dL) when used in conjunction with other biochemical markers and coronary risk factors, is useful in the prediction of CHD/CVD risk and the assessment of CHD/CVD severity.

The APOLOWAKO analyzer is a fully-integrated POC test system that can perform up to six analytical tests per individual sample. The analyzer automatically separates plasma from whole blood for testing. Once the plasma has been separated, it is transferred to a cell on a measurement disk where the chemical reactions take place. The analyzer uses liquid reagents which are packaged into kits. Each kit contains 2 reagent units. Each unit is composed of two enzyme color reagents and a lyophilized calibrator. All of the reagents have a reagent information tag applied to the back of each bottle which controls the reagent parameters and conditions such as, calibration, reagent quantity, shelf-life, and lot number. The instrument contains an automated liquid dispenser, temperature controlled reagent carrousel, analysis compartment, and sample holder. The instrument is designed to automatically and constantly monitor the reagents, dispensing system, measurement disk, and measurement process to ensure that no erroneous results are shown. The APOLOWAKO's lipid panel will include, total cholesterol, HDL cholesterol, LDL cholesterol (by calculation), and triglycerides in tubed venous whole blood. The test system is designed for professional use and consists of a small table top instrument (31 cm wide x 47.5 cm high x 56 cm deep, weight: 25 kg).

The provided text describes the Wako Diagnostics APOLOWAKO Lipid Panel and Analyzer, a point-of-care test system designed for the quantitative determination of total cholesterol, HDL cholesterol, and triglycerides in whole blood, with calculated LDL cholesterol. The device aims for substantial equivalence to the CHOLESTECH LDX system.

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

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

The document doesn't explicitly state "acceptance criteria" in a separate section. Instead, the performance characteristics (imprecision, linearity, interference) of the APOLOWAKO system are compared against or shown to be superior to those of the predicate device (Cholestech LDX) and demonstrate acceptable analytical performance. The substantial equivalence conclusion is based on comparable or better performance characteristics.

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