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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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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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Teco Direct HDL/LDL Calibrator is used for the calibration of Teco Diagnostics' Direct HDL and Direct LDL Cholesterol Reagent Set in serum or plasma and with Teco Direct HDL Cholesterol Reagent for the quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum or plasma. HDL quantitative determination is used in identifying patients who are at a higher risk for coronary heart diseases. Low HDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.

Direct HDL Cholesterol Reagent and Direct HDL/LDL Calibrator

This document is a 510(k) premarket notification for a diagnostic reagent and calibrator (Direct HDL Cholesterol Reagent and Direct HDL/LDL Calibrator). As such, it is not a study document that details acceptance criteria and performance of a device in the way a clinical trial or AI/ML device study would.

Therefore, the requested information elements (1-9) which are typically associated with performance studies of medical devices, especially AI/ML-driven ones, cannot be extracted from this regulatory approval letter.

Instead, this document confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its approval. The "Indications for Use" section specifies the intended purpose of the device: "quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum or plasma." It also mentions that "Low HDL cholesterol levels are associated with an increased risk" for coronary heart diseases, and the reagent set is intended for "in vitro diagnostic use only."

To provide the kind of detail requested about acceptance criteria and study performance, one would need to refer to the original 510(k) submission document (K050623), which would contain the performance data and equivalence claims against the predicate device. This approval letter references that submission but does not contain the detailed study information itself.

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This in vitro method is intended to quantitatively measure HDL Cholesterol in human serum and plasma on the Bayer ADVIA® IMS systems. Measurements of HDL Cholesterol are used in assessing cardiovascular risk.

The Bayer ADV/A IMS Direct HDL Cholesterol (D-HDL) method is for in vitro diagnostic use to measure HDL Cholesterol in human serum and plasma. Such measurements are used in the risk assessment of cardiovascular diseases.

Not Found

Here's a breakdown of the acceptance criteria and study information for the Direct HDL Cholesterol Method for ADVIA® Modular System (IMS), based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical "acceptance criteria" values (e.g., "CV must be

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

The device is a system using the reagent and calibrator in combination to directly measure the HDL-Cholesterol. This is achieved by a homogenous method that directly measures serum HDL 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 LDL, VLDL and chylomicrons leaving the HDL particles exposed. The second reagent (R2) contains enzymes, which then react with the HDLcholesterol present in the sample.

Here's a breakdown of the acceptance criteria and study information for the Direct HDL-Cholesterol Liquid Color® and Direct HDL/LDL-Cholesterol Calibrator system, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state the numerical acceptance criteria for precision and interference. It only states that the results were "within acceptable range." For method comparison, the implied criterion is a strong correlation, which the reported 0.9987 satisfies. The regression equation also indicates minimal bias.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 50 patient samples were used for the correlation (method comparison) study.
• Data Provenance: The document does not specify the country of origin. It also does not explicitly state whether the data was retrospective or prospective, but the phrasing "using 50 patient samples" suggests it was likely prospective for the purpose of the study.

3. Number of Experts and Qualifications for Ground Truth

• This information is not provided in the document. The study relies on method comparison against a predicate device, not expert consensus for ground truth.

4. Adjudication Method for the Test Set

• This information is not applicable as the ground truth was established by comparison to a predicate device's measurements, not by human interpretation requiring adjudication.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This is an in-vitro diagnostic device for quantitative determination of a biomarker, not an imaging device requiring human reader interpretation. Therefore, the effect size of human reader improvement with or without AI assistance is not relevant or measured.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance study was done in the sense that the device's analytical performance (precision, linearity, sensitivity, interference) was evaluated independently. The method comparison study also assesses the device's performance against a reference method without human interpretation as part of the measurement process.

7. Type of Ground Truth Used

• The ground truth for the method comparison study was established by the measurements obtained from a legally marketed predicate device: HDL Cholesterol Plus (K000568) calibrated with HDL/LDL Cholesterol Plus Calibrator (Roche).
• For other analytical performance studies (precision, linearity, sensitivity, interference), the ground truth is typically derived from established laboratory protocols and reference materials but this is not explicitly detailed beyond stating the results were "within acceptable range."

8. Sample Size for the Training Set

• This information is not applicable or provided. This device is a chemical reagent system, not an AI/machine learning algorithm that requires a training set in the conventional sense. Its "training" would relate to its chemical formulation and optimization during development, not data-driven learning.

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

• This information is not applicable or provided for the reasons stated in point 8.

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The ATAC PAK Direct HDL Reagent Kit, the ATAC Direct HDL Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of HDL-cholesterol in serum and plasma. HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the risk of developing cardiovascular disease. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

The ATAC PAK Direct HDL Reagent determines HDL-cholesterol through the enzymatic action of cholesterol esterase and cholesterol oxidase on HDL-cholesterol while rendering other sources of cholesterol inactive. The resulting increase in absorbance at approximately 600 nm is proportional to the HDL-cholesterol concentration in the sample.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Linearity Study: n = 40 (for regression comparison of standard recoveries to standard factors, indicating the number of data points used to establish linearity). The provenance of these "standard factors" is not explicitly stated, but it implies a controlled laboratory setting.
• Precision (Replicate Assay): n = 66 (replicates for each of Serum 1, Serum 2, and Serum 3). The samples are described as "commercially available control serum and a serum pool," suggesting a controlled lab setting, likely in the US, but the country of origin is not explicitly stated. This was a retrospective analysis of method performance.
• Serum/Plasma Comparison: n = 156 ("mixed serum and plasma specimens, collected from adult patients"). The specific country of origin is not mentioned, but the overall context of the submission to the FDA in the US suggests a US-based study or data relevant to the US market. The phrasing "collected from adult patients" suggests a prospective or retrospectively collected clinical sample set.
• Detection Limit: 30 replicates of a diluted serum pool. Provenance is not specified, but likely a controlled lab setting.

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

This document describes a clinical chemistry device for quantitative determination, not an imaging or diagnostic interpretation device that typically relies on expert consensus for ground truth. Therefore, the concept of "experts" to establish ground truth in the traditional sense (e.g., radiologists interpreting images) does not apply here.

The "ground truth" for comparison is often established by a reference method or a competitive reagent. In this case, the Roche HDL-Cholesterol plus Reagent Kit is identified as the substantially equivalent predicate device, and the "Competitive Reagent" is used for comparison in the serum/plasma study. The qualifications of those who developed or validated the competitive reagent are not stated in this document.

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative measurement device, not one requiring diagnostic interpretation and adjudication of results by multiple experts. The "ground truth" for comparison is either a known value (for linearity standards), a reference method, or a competitive reagent.

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 cases (e.g., radiology images). This documentation describes the performance of a quantitative laboratory diagnostic system, not one involving human interpretation of cases.

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

Yes, this entire study describes the standalone performance of the ATAC PAK Direct HDL Reagent Kit and the ATAC Direct HDL Calibrator used on the ATAC 8000 Random Access Chemistry System. It reports the analytical performance characteristics of the device itself (linearity, precision, detection limit, correlation with a competitive method, and stability). There is no "human-in-the-loop" component in the direct measurement of HDL-cholesterol by this automated chemistry system.

7. The Type of Ground Truth Used

• Known Values/Standards: For the linearity study, "standard recoveries to standard factors" were compared, implying a ground truth established by known concentrations of HDL-cholesterol.
• Reference Method/Competitive Reagent: For the serum/plasma comparison, the "Competitive Reagent" (implicitly the Roche HDL-Cholesterol plus Reagent Kit or a similar validated method) served as the comparative standard.
• Analytical Determination: For precision and detection limit, the ground truth is based on statistical analysis of repeated measurements, effectively using the device's own measurements against each other to assess consistency.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. This is a traditional chemical assay, not an AI/ML-based device that typically requires distinct training and test sets. The studies described here are analytical validation studies for the device's performance.

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

Not applicable, as there is no mention of a "training set" in the context of an AI/ML model. The ground truth for the analytical validation studies was established as described in section 7.

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The ATAC Direct HDL Cholesterol Reagent Kit and the ATAC HDL-C Calibrator are intended for the quantitative determination of high density lipoprotein cholesterol in serum on the ATAC 6000 Chemistry Analyzer. HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders and various liver and renal diseases, and as a tool to assess the risk of developing and managing the progression of cardiovascular disease.

The ATAC Direct HDL Cholesterol Reagent determines HDL-cholesterol through the enzymatic action of cholesterol esterase, cholesterol oxidase and peroxidase after the selective removal non-HDL sources of cholesterol. The resulting increase in absorbance at 578 nm is proportional to the HDL cholesterol concentration in the sample.

Acceptance Criteria and Device Performance for ATAC Direct HDL Cholesterol Reagent Kit and ATAC HDL-C Calibrator

The ATAC Direct HDL Cholesterol Reagent Kit and ATAC HDL-C Calibrator are intended for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in serum on the ATAC 6000 Chemistry Analyzer. HDL-C results are used in the diagnosis and treatment of lipid disorders, atherosclerosis, and various liver and renal diseases, and as a tool to assess the risk of developing and managing the progression of cardiovascular disease.

1. Table of Acceptance Criteria and Reported Device Performance

• Serum 1 (mean 35.4 mg/dL): 1SD = 0.84, %CV = 2.4%
• Serum 2 (mean 45.1 mg/dL): 1SD = 0.89, %CV = 2.0%
  Total:
• Serum 1 (mean 32.7 mg/dL): 1SD = 2.47, %CV = 7.6%
• Serum 2 (mean 45.1 mg/dL): 1SD = 3.30, %CV = 7.3% |
  | Method Comparison | Strong correlation with an accepted clinical method. | y = - 2.4 mg/dL + 1.077x (where y = ATAC 6000 results, x = accepted clinical method). Correlation coefficient (r) = 0.962. |
  | Detection Limit | Claimed detection limit of 2 mg/dL should be met or exceeded by observed detection limit. | Observed detection limit = 1.3 mg/dL. This is below the claimed limit of 2 mg/dL, indicating the device meets the criterion. |

2. Sample Sizes and Data Provenance

• Test Set (Method Comparison): 131 serum specimens.
  • Data Provenance: The specimens were collected from adult patients. The country of origin is not explicitly stated, but the submission is from Elan Diagnostics in Brea, California, USA, suggesting the data is likely from the USA. The study design appears to be prospective due to the nature of comparing a new device against an existing method using collected specimens, though the exact timing of collection relative to the study is not specified in detail.
• Test Set (Linearity): 8 linearity standards.
• Test Set (Precision - Within Run): 22 replicates for each of 2 control sera.
• Test Set (Precision - Total): 40 replicates for each of 2 control sera.
• Test Set (Detection Limit): 22 replicates of a diluted HDL-C control.

3. Number of Experts and Qualifications for Ground Truth

Not applicable for this type of in vitro diagnostic device study. The ground truth for chemical analytes like HDL-C is established through reference methods or precisely prepared standards, not typically through human expert consensus in the same way an imaging or clinical diagnostic algorithm would be.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth for these studies relies on analytical measurements rather than expert human interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging or interpretation tasks where human readers' performance is being evaluated and potentially enhanced by AI. This submission is for an in vitro diagnostic reagent kit.

6. Standalone Performance Study

Yes, the studies described represent the standalone performance of the ATAC Direct HDL Cholesterol Reagent Kit and ATAC HDL-C Calibrator when used on the ATAC 6000 Chemistry Analyzer. The reported linearity, precision, and detection limit are intrinsic performance characteristics of the assay and the analyzer system. The method comparison study also evaluates the algorithm (reagent kit + analyzer) performance against an established clinical method.

7. Type of Ground Truth Used

• Linearity: Based on "standard values" of linearity standards, which are known, precise concentrations.
• Precision: Based on the measured values of "commercially available control sera" at different concentration levels, where the 'true' value is often derived from extensive inter-laboratory studies or established reference values.
• Method Comparison: The "accepted clinical method" serves as the reference or 'gold standard' for comparison.
• Detection Limit: Derived from repetitive assay of a "diluted HDL-C control" with a known low concentration.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" in the context of an algorithm or machine learning model. This is an in vitro diagnostic (IVD) reagent kit, where the "training" is more akin to assay development and optimization rather than machine learning. The studies described are performance studies demonstrating the final product's characteristics.

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

As noted above, a distinct "training set" with ground truth in the conventional machine learning sense is not applicable here. The development and optimization of the reagent kit would involve formulating the reagent to achieve specific chemical reactions and analytical performance characteristics, which is guided by established chemical principles and perhaps empirical testing against known standards and samples, rather than a formal machine learning training process with a labeled dataset.

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The ATAC-PAK Direct HDL Cholesterol Reagent Kit, the ATAC HDL-C Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of high density in serum. HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders, atherosclerosis and various liver and renal diseases, and as a tool to assess the risk of developing and managing the progression of cardiovascular disease. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

The ATAC-PAK Direct HDL Cholesterol Reagent Kit, the ATAC HDL-C Calibrator and the ATAC 8000 Random Access Chemistry System are used as a system for the quantitative analysis of high density lipoprotein cholesterol (HDL-C) in serum. HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders and various liver and renal diseases, and as a tool to assess the risk of developing and managing the progression of cardiovascular disease. The ATAC-PAK Direct HDL Cholesterol Reagent determines HDL-cholesterol through the enzymatic action of cholesterol esterase, cholesterol oxidase and peroxidase after the selective removal non-HDL sources of cholesterol. The resulting increase in absorbance at 578 nm is proportional to the HDL cholesterol concentration in the sample.

Here's a breakdown of the acceptance criteria and study information for the ATAC-PAK Direct HDL Cholesterol Reagent Kit, ATAC HDL-C Calibrator, and ATAC 8000 Random Access Chemistry System:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Linearity/Recovery: Regression statistics were based on standard recoveries ranging from 0.6 to 155.5 mg/dL. The number of unique standards is not explicitly stated, but di = 8 is mentioned, which often refers to the degrees of freedom in a regression, suggesting at least 9 data points.
• Precision:
  • Serum control 1: n = 40 (replicates)
  • Serum control 2: n = 40 (replicates)
• Method Comparison: One hundred and thirty-eight (n = 138) serum specimens.
• Detection Limit: 22 replicates were used for the within-run precision study to calculate the observed detection limit.
• Reagent and Calibration Stability: Not explicitly stated, but involved assays of "serum controls over the claimed periods."

Data Provenance:
The data provenance is not explicitly stated in terms of country of origin. The specimens for method comparison were "collected from adult patients," suggesting the data is retrospective as samples would have been collected prior to the study.

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

Not applicable for this type of device. This device is an in-vitro diagnostic (IVD) quantitative assay, where the "ground truth" is typically established by comparing its results to a validated reference method or known concentrations of analytes (standards/calibrators). There are no human "experts" establishing qualitative ground truth for diagnostic images or interpretations.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this device is a quantitative assay, not one requiring expert adjudication of results.

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

No. This is a standalone in-vitro diagnostic device, not an imaging device or medical AI intended for human reader assistance.

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

Yes, the studies presented are all standalone performance evaluations of the ATAC-PAK Direct HDL Cholesterol Reagent Kit and ATAC HDL-C Calibrator when used on the ATAC 8000 Random Access Chemistry System. The device performs the quantitative analysis automatically.

7. The Type of Ground Truth Used

• Linearity/Recovery: Known concentrations of linearity standards.
• Precision: Commercially available control sera with established target values.
• Method Comparison: Results from an "accepted clinical method" as the reference for comparison. While not explicitly defined, an "accepted clinical method" implies a well-established and validated laboratory method for HDL-C measurement.
• Detection Limit: A diluted HDL-C control and the statistical calculation based on its variability.
• Stability: Serum controls with known properties over time.

8. The Sample Size for the Training Set

Not applicable. This device is a chemical reagent kit and an associated analyzer, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" for such a system would involve method development and optimization by the manufacturer to achieve the stated performance specifications.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The "ground truth" for the development of the reagent and system would have been established through extensive chemical and analytical testing against reference materials and methods during its design and optimization phases.

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The K-ASSAY Direct HDL-Cholesterol reagent is intended for the quantitative in vitro determination of HDL-cholesterol in serum or plasma which is used in the diagnosis and treatment of lipid disorders.

The K-ASSAY Direct HDL-Cholesterol calibrator is intended to be used for the calibration of the K-ASSAY Direct HDL-Cholesterol assay.

K-Assay Direct HDL-Cholesterol Reagent K-Assay Direct HDL-Cholesterol Calibrator

This document is a 510(k) clearance letter from the FDA for a medical device called the "K-Assay Direct HDL-Cholesterol Reagent and Calibrator". This type of document does not contain the detailed information about acceptance criteria or specific study results that you are requesting.

Here's why and what information is typically missing:

Why this document doesn't have the requested information:

• 510(k) Clearance: A 510(k) clearance primarily focuses on demonstrating "substantial equivalence" to a predicate device already on the market. It's not a pre-market approval (PMA) and doesn't require the same depth of clinical study data to be submitted or publicly summarized in the clearance letter itself.
• Regulatory Focus: The letter confirms that the device can be marketed because it meets the regulatory requirements for substantial equivalence. It refers to the "indications for use" but doesn't detail the specific performance studies that underpinned those claims.
• Proprietary Information: Detailed study results, acceptance criteria, and ground truth methodologies are often considered proprietary by the manufacturer and are submitted to the FDA confidentially. They are rarely fully disclosed in the public 510(k) clearance letter.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document only states the device's intended use for quantitative determination of HDL-cholesterol. It does not provide performance metrics like accuracy, precision, sensitivity, specificity, or the acceptance criteria for these.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable for an in vitro diagnostic reagent like this. MRMC studies are typically for imaging devices where human interpretation is involved.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable for an in vitro diagnostic reagent. Its performance is inherent to the chemical assay itself.
7. The type of ground truth used: Not mentioned. For a diagnostic assay, the "ground truth" would likely be established by a reference method for HDL-cholesterol.
8. The sample size for the training set: Not mentioned. In the context of an in vitro diagnostic reagent, there isn't typically a "training set" in the same way an AI algorithm has one. Performance is established through validation studies.
9. How the ground truth for the training set was established: Not mentioned.

In summary, the provided FDA 510(k) clearance letter confirms the regulatory status of the device but does not contain the detailed technical and scientific performance data or study design information you are looking for. To find such information, one would typically need to consult the device's Instructions For Use (IFU), peer-reviewed publications by the manufacturer, or the more detailed (and often redacted) 510(k) summary filed with the FDA, if available, though even that rarely contains all the detail requested.

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