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For the quantitative in vitro determination of LDL-cholesterol concentration in human plasma and serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis and various liver and renal diseases.

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

The LDL Cholesterol kit assay consists of ready to use reagent solutions. CATALOGUE NUMBER: CH8312

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

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

Acceptance Criteria and Reported Device Performance

Device Name: Direct LDL Cholesterol (LDL)

Study Details

1. Sample size used for the test set and the data provenance:
   • Precision (Analytical Performance): 80 determinations for each of 7 pools/QC levels (total of 560 determinations). The samples included control material and "unaltered human serum samples that were spiked with LDL cholesterol concentrations or diluted to achieve concentrations based on established ranges" (e.g.,

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The Randox Direct LDL/HDL Cholesterol Calibrator is intended for in vitro diagnostic use in the calibration of Randox HDL and LDL Cholesterol methods. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.

The Randox Direct LDL/HDL Cholesterol Calibrator is supplied in a kit containing 3x1mls vials. The calibrator contains the analytes LDL and HDL. The base matrix used for the manufacture of Randox Direct LDL/HDL Cholesterol Calibrator is Human Serum. The calibrator contains lipoproteins from the various lipoprotein classes including high density lipoproteins.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Randox Direct LDL/HDL Cholesterol Calibrator:

Acceptance Criteria and Device Performance Study for Randox Direct LDL/HDL Cholesterol Calibrator

Based on the provided K1221266 document, the device described is a calibrator, not a diagnostic device that measures patient samples directly. Therefore, the "acceptance criteria" and "device performance" are focused on its role as a calibration standard and its ability to maintain stability and assignable values. The document primarily describes the characteristics of the calibrator and how its values are assigned, rather than presenting a traditional clinical study with outcome-based performance metrics like sensitivity, specificity, or reader improvement.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the typical sense for a diagnostic device (e.g., meeting a certain accuracy threshold against a reference standard). Instead, the performance is demonstrated through its stability and the value assignment process, ensuring it reliably provides known concentrations of analytes for instrument calibration.

Acceptance Criteria (Implied from the document's content):

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

For a calibrator, a "test set" in the traditional sense of patient samples is not applicable. The "test set" for this device would refer to the samples used during the value assignment process.

• Sample Size: The document does not specify a distinct "sample size" of individual samples used to determine the values. Instead, it refers to "multiple analysers with reference to a master lot." This implies the calibrator was run numerous times on various instruments. The explicit number of replicates or individual calibrator vials tested for value assignment is not stated.
• Data Provenance: Not explicitly stated, but given Randox Laboratories is a UK-based company and the predicate device comparison table includes international analyzer brands, the testing likely occurred in a controlled laboratory setting (likely in the UK or a partner lab). The data is inherent to the manufacturing and quality control process of the calibrator itself, rather than external patient data. It is a prospective study in the sense that the testing was performed to assign values to the newly manufactured calibrator lots.

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

For a calibrator, the "ground truth" is established through a hierarchical metrological process, not typically by "experts" reviewing results in the way a radiologist reviews images.

• Number of Experts: Not applicable. The "ground truth" (assigned values) is traceable to established reference materials and methods, often from organizations like the CDC or a certified reference material producer. The document states values are established "with reference to a master lot," which would have its own established traceable values.
• Qualifications of Experts: Not specified or applicable in the context of expert review. The "experts" would be the metrologists and analytical chemists involved in establishing the master lot's values and performing the value assignment on specific instruments, ensuring adherence to rigorous analytical standards.

4. Adjudication Method for the Test Set

Not applicable. As discussed above, the "test set" refers to the value assignment process, which relies on analytical measurements and metrological traceability, not consensus-based adjudication.

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

No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. This is a calibrator, an in-vitro diagnostic reagent, so an MRMC study is not appropriate or presented.

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

This question is not applicable to a calibrator. A calibrator does not have an "algorithm" in the sense of an AI or software processing data. Its function is to provide known concentrations for instrument calibration. The "performance" is its ability to consistently deliver these known concentrations and be stable over time.

7. The Type of Ground Truth Used

The "ground truth" for the calibrator's values is established by metrological traceability to a master lot, which in turn is traceable to higher order reference materials and methods. The document explicitly mentions "The assigned values for the direct LDL/HDL Cholesterol Calibrator are established on multiple analysers with reference to a master lot." And the "Traceability" section identifies the specific human plasma products (Creative Labs) as the origin for the analytes.

8. The Sample Size for the Training Set

Not applicable. This device is a calibrator, not an algorithm that requires a "training set" of data.

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

Not applicable. No training set is used for this type of device.

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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.

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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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For the quantitative determination of Low-density lipoprotein cholesterol (LDL-C) in human serum or plasma. LDL Cholesterol is recognized as a useful tool in identifying patients who are at a higher risk for coronary heart diseas. High LDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.

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The provided FDA document is a 510(k) premarket notification for a "Direct LDL Cholesterol Reagent." This is an in vitro diagnostic device, not an AI/ML medical device. Therefore, the concepts of acceptance criteria met by an algorithm, training and test sets, expert ground truth, MRMC studies, or standalone performance do not apply in the context of this document.

The document states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This means its performance is considered comparable to existing, legally marketed devices.

The "Indications for Use" section specifies that the device is "For the quantitative determination of Low-density lipoprotein cholesterol (LDL-C) in human serum or plasma."

To adequately respond to your request for AI/ML device-specific information, I would need a document pertaining to an AI/ML medical device.

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Direct LDL Cholesterol LiquiColor® and Direct HDL/LDL Cholesterol Calibrator system is a testing device for the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in serum or plasma. LDL Cholesterol measurement aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders. For In Vitro Diagnostic Use Only.

The device is a system using the reagent and calibrator in combination to directly measure the LDL-Cholesterol. This is achieved by a homogenous method that directly measures serum LDL-Cholesterol levels without the need for any off-line pretreatment or centrifugation steps. It employs a two-reagent system. The first reagent (R1) contains a combination of detergent, organic and inorganic phosphoric acid compounds, which specifically binds HDL, VLDL and chylomicrons leaving the LDL particles exposed. The second reagent (R2) contains enzymes, which then react with the LDLcholesterol present in the sample.

The provided text describes the acceptance criteria and a study for the "Direct LDL-Cholesterol Liquid Color® and Direct HDL/LDL-Cholesterol Calibrator system" used for quantitative determination of LDL-C.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 62 patient samples.
• Data Provenance: The text does not specify the country of origin. It indicates "patient samples" without further details, so it's not possible to definitively classify it as retrospective or prospective based solely on the provided information.

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 text. The ground truth for the device's performance relies on comparison with a predicate device, not on expert consensus.

4. Adjudication Method for the Test Set

• This information is not applicable as the evaluation method was a method comparison study against a predicate device, not a human expert review process.

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

• No, an MRMC comparative effectiveness study was not done. The study was a method comparison of the new device against a predicate device.

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

• Yes, the performance data provided (method comparison, precision, linearity, sensitivity, interference) are for the device's standalone analytical performance. This device is a quantitative, in vitro diagnostic system, and its performance is evaluated based on its direct measurement capabilities, not with human interpretation as part of its core function.

7. The Type of Ground Truth Used

• The ground truth for the study was established by the measurements obtained from the legally marketed predicate device, "LDL Cholesterol Plus (K012287) calibrated with HDL/LDL Cholesterol Plus Calibrator (Roche)." This is a form of comparative reference standard.

8. The Sample Size for the Training Set

• This information is not applicable/not provided. The device is a reagent and calibrator system for direct measurement, not an AI or machine learning algorithm that requires a training set in the conventional sense. The performance data presented are for the analytical validation of the device itself.

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

• This information is not applicable/not provided for the same reasons as in point 8.

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The ATAC Direct LDL Reagent Kit, the ATAC Direct LDL Calibrator and the ATAC 8000 Random Access Chemistry System are intended for the quantitative determination of LDL-cholesterol in serum and plasma. LDL-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.

The ATAC Direct LDL Reagent determines LDL-cholesterol through a two step reaction, which specifically consumes non-LDL cholesterol in a series of reactions without producing color. In the second reaction step, the chromogen is added, and a second detergent solubilizes the LDL-cholesterol, allowing it to react with cholesterol oxidase, cholesterol esterase and peroxidase in the reagent to produce a color that is proportional to the amount of LDL-cholesterol in the sample.

Here's a breakdown of the acceptance criteria and the study details for the ATAC Direct LDL Reagent Kit, ATAC Direct LDL Calibrator, and ATAC 8000 Random Access Chemistry System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The SYNCHRON® Systems Direct LDL Cholesterol (LDLD) Reagent, when used in conjunction with the SYNCHRON® Systems LDLD Calibrator, is intended for the quantitative determination of low-density lipoprotein cholesterol (LDL cholesterol) in human serum or plasma on SYNCHRON Clinical Systems.

The SYNCHRON System Direct LDL Cholesterol (LDLD) Reagent is designed for optimal performance on the SYNCHRON CX (CX4/4CE/4J/4PRO, CX5/5CE/5Δ/5PRO, CX7/7RTS/7/7/7PRO, CX9ALX/9PRO) and LX (LX20/PRO) Systems. The assay is intended for use in the quantitative determination of low-density lipoprotein cholesterol concentration in human serum or plasma. The reagent kit contains two 100-test cartridges and is packaged with the single-level calibrator.

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Acceptance Criteria": null,
    "Reported Device Performance": {
      "Method Comparison Study Results (SYNCHRON LX Systems vs. Genzyme N-Geneous on Hitachi 911)": {
        "Range of LDL cholesterol analyzed": "52 to 192 mg/dL",
        "Equation": {
          "SYNCHRON = ": "1.200 * N-Geneous"
        }
      },
      "Estimated SYNCHRON LX LDLD Assay Imprecision": {
        "Within-Run Imprecision": {
          "Level 1 (Mean 49.9 mg/dL)": {
            "S.D. (mg/dL)": "2.2",
            "%C.V.": "nil"
          },
          "Level 2 (Mean 211.9 mg/dL)": {
            "S.D. (mg/dL)": "2.9",
            "%C.V.": "1.4"
          },
          "Level 3 (Mean 410.4 mg/dL)": {
            "S.D. (mg/dL)": "5.0",
            "%C.V.": "1.2"
          }
        },
        "Total Imprecision": {
          "Level 1 (Mean 49.9 mg/dL)": {
            "S.D. (mg/dL)": "1.4",
            "%C.V.": "2.9"
          },
          "Level 2 (Mean 211.9 mg/dL)": {
            "S.D. (mg/dL)": "3.8",
            "%C.V.": "1.8"
          },
          "Level 3 (Mean 410.4 mg/dL)": {
            "S.D. (mg/dL)": "6.7",
            "%C.V.": "1.6"
          }
        }
      }
    }
  },
  "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 (for Imprecision Study)": "80 samples per level (Levels 1, 2, and 3)",
    "Data Provenance": "Not specified (neither country of origin nor retrospective/prospective is mentioned in the provided text)."
  },
  "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. The study involves a chemical assay for LDL cholesterol measurement, not expert-based interpretation.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. The study involves a chemical assay, and adjudication methods are typically used for qualitative or imaging-based assessments.",
  "5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": "Not applicable. This is a study of a diagnostic reagent, not an AI-assisted interpretation by human readers.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Yes, this study represents a standalone performance evaluation of the SYNCHRON® Systems Direct LDL Cholesterol Reagent.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The ground truth for the method comparison was implicitly the results obtained from the Genzyme N-Geneous LDL Cholesterol Reagent on the Hitachi 911 clinical analyzer, which is itself a predicate device for quantitative determination of LDL cholesterol. For imprecision, the ground truth is the statistical variation around the measured mean values.",
  "8. The sample size for the training set": "Not applicable. This is a reagent assay, not a machine learning model, so there isn't a 'training set' in the conventional sense. The development of the reagent would involve its own pre-clinical testing and optimization.",
  "9. How the ground truth for the training set was established": "Not applicable. See point 8."
}

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For use in clinical laboratories and physicians' office laboratories for quantitative determination of low density lipoprotein (LDL) cholesterol in human serum as a risk factor in coronary artery disease.

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This is an FDA Premarket Notification (510(k)) for the RDI Direct LDL Reagent (also referred to as RDI Direct LDL Cholesterol Test). This document confirms substantial equivalence to a predicate device and permits marketing. It does not contain information about acceptance criteria or specific study results that prove the device meets such criteria because 510(k) submissions typically rely on comparison to existing predicate devices rather than novel performance studies outlining acceptance criteria for a new type of device.

Therefore, most of the requested information cannot be found in the provided text.

Here's a breakdown of what can and cannot be answered based on the input:

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

• Cannot be answered from the provided text. The document is an FDA letter granting substantial equivalence, not a performance study report.

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

• Cannot be answered from the provided text. The document does not describe a clinical study.

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)

• Cannot be answered from the provided text. The document does not describe a clinical study.

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

• Cannot be answered from the provided text. The document does not describe a clinical study.

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

• Cannot be answered from the provided text. This device is a reagent for measuring LDL cholesterol, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study is not applicable.

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

• Cannot be answered from the provided text. This device is a reagent, not an algorithm. Performance of the reagent itself would typically be evaluated without human-in-the-loop unless it's an interpretation step, but the document doesn't provide such details.

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

• Cannot be answered from the provided text. The document does not describe a clinical study. For a diagnostic reagent, ground truth would typically be established by a reference method for the analyte being measured.

8. The sample size for the training set

• Cannot be answered from the provided text. The document does not describe a clinical study or an algorithm requiring a training set.

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

• Cannot be answered from the provided text. The document does not describe a clinical study or an algorithm requiring a training set.

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LDL-cholesterol test system is a device to measure LDL-cholesterol in serum. LDL-Cholesterol measurements are used in diagnosis and treatment of disorders of excess cholesterol in the blood and lipid and lipoprotein metabolisms disorders.

The Wako Direct LDL-C test is an in vitro diagnostic assay for the quantitative determination of low density lipoprotein cholesterol in serum.

Here's an analysis of the provided text to extract the requested information about the Wako Direct LDL-C test:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to a predicate device and a reference method. The key performance metrics are correlation coefficients and regression equations.

• Serum samples: Correlation coefficient = 0.986; Regression equation (y = Wako Direct LDL-C, x = Predicate) = 1.018x + 0.135
• Plasma samples: Correlation coefficient = 0.988; Regression equation (y = Wako Direct LDL-C, x = Predicate) = 0.98x + 4.18 |
  | Performance against reference method ("beta quantification" involving ultracentrifugation) |
• Serum samples: Correlation coefficient = 0.983; Regression equation (y = Wako Direct LDL-C, x = Reference) = 0.97x + 5.12 |
  | Precision | "Precision studies indicate acceptable values can be obtained on a day to day basis." (No specific quantitative criteria or results provided beyond this statement). |
  | Minimum detectable level | 1 mg/dL |

2. Sample Sizes and Data Provenance

The document does not explicitly state the sample sizes used for the comparison studies (test set). It mentions "serum and plasma samples" for predicate comparison and "serum samples" for reference method comparison, but no specific number of samples.

The data provenance (country of origin, retrospective/prospective) is also not mentioned.

3. Number of Experts and Qualifications for Ground Truth Establishment

This information is not provided. The study relies on comparisons to a predicate device and a "reference method" (beta quantification), which are themselves laboratory procedures, not expert visual assessments.

4. Adjudication Method for the Test Set

Not applicable. This is a laboratory assay, not a study involving human interpretation that would require adjudication.

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

No, an MRMC study was not done. This type of study is typically for evaluating devices that assist human readers in interpreting images or other data, which is not the function of this direct LDL-C measurement assay.

6. Standalone (Algorithm Only) Performance

Yes, the studies described are standalone performance studies. The Wako Direct LDL-C test is an automated in vitro diagnostic assay that directly measures LDL-C in a sample. Its performance is evaluated independently against a predicate device and a reference method. There is no human-in-the-loop component for the measurement itself.

7. Type of Ground Truth Used

The ground truth for the comparison studies was:

• Predicate Device Performance: The results obtained from the "Equal LDL Direct Liquid Select Cholesterol reagent."
• Reference Method Performance: The results obtained from the "beta quantification" method, which involves ultracentrifugation. This is generally considered the gold standard laboratory method for LDL-C.

8. Sample Size for the Training Set

The document does not mention a separate "training set" or "training data." This device is a biochemical assay, not a machine learning algorithm that typically requires a distinct training phase. The development of the assay itself would have involved extensive R&D and optimization, but those details are not part of this 510(k) summary.

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

As there's no explicitly mentioned "training set" in the context of a machine learning algorithm, this question is not directly applicable. If one considers the development and optimization of the assay, the "ground truth" during that phase would have involved established chemical and biochemical principles, validation against known standards, and potentially experiments comparing early versions of the assay to existing methods (like the Friedwald formula or beta quantification). However, the document does not detail this developmental process.

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The Randox Laboratories Limited Direct LDL Cholesterol Test Kit is an in vitro diagnostic reagent for use in the quantitative determination of LDL Cholesterol in serum and plasma. The method, an elimination enzymatic assay, does not require any sample preparation.

Accurate measurement of LDL Cholesterol is of vital importance in therapies that focus on lipid reduction to prevent atherosclerosis or reduce its progress.

Suitably qualified laboratory personnel under appropriate laboratory conditions must use this Test Kit.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a Direct LDL Cholesterol Test Kit. This document approves the marketing of the device based on its substantial equivalence to a legally marketed predicate device.

However, the document does not contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets them. It primarily focuses on the regulatory approval process and the administrative aspects of getting the device to market.

The information requested in your prompt (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is typically found in the device's 510(k) submission itself, specifically in sections detailing the performance studies. These sections are usually much more extensive than the approval letter provided here.

Therefore, I cannot provide the requested information based on the given document.

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