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

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

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

Here's a breakdown of the acceptance criteria and study information for the Abaxis Piccolo HDL - Capillary Test System, based on the provided text:

Acceptance Criteria and Device Performance

The provided document doesn't explicitly state numerical "acceptance criteria" in a table format alongside the performance. Instead, it presents the results of various validation tests, implying that the device's performance within these studies was deemed acceptable for substantial equivalence. The predicate devices' specifications provide the implicit benchmarks for comparison.

Here's a table summarizing the reported device performance, with implicit acceptance criteria derived from the comparisons and intended use:

Study Details

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

• Linearity Study: The sample size for the linearity study is not explicitly stated in terms of number of unique patient samples, but the statistical results (Slope, Intercept, Correlation Coefficient) indicate multiple data points were analyzed across the dynamic range.
• Precision Study:
  • Sample Size: n = 160 (for both within-run and total precision for each serum level). This likely refers to 160 individual measurements for each of the two serum levels or 160 replicates of each serum level.
  • Data Provenance: Not explicitly stated, but the samples are referred to as "Serum 1" and "Serum 2," suggesting laboratory-prepared or pooled serum samples. No mention of country of origin or retrospective/prospective collection is provided for these particular samples.
• Method Comparison Study:
  • Sample Size: N = 559.
  • Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective. The samples are "analyzed by the Abaxis Piccolo HDL - Capillary Test System and the Roche HDL Test," suggesting human samples. The range of samples is 21 - 93 mg/dL for Piccolo and 23 - 92.5 mg/dL for Roche, indicating real-world patient samples covering a clinical range.

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

This device is an in-vitro diagnostic (IVD) chemistry analyzer for quantitative determination of HDL. For such devices, "ground truth" is typically established by:

• Reference laboratory methods,
• Predicate devices (clinically accepted and legally marketed), or
• NIST (National Institute of Standards and Technology) traceable standards.

In this case, the ground truth for the performance studies was established through comparison with a legally marketed predicate device (Roche HDL Test), which serves as the reference for method comparison. The precision and linearity studies use internal quality controls or characterized samples.

Therefore, the concept of "experts" establish ground truth in the same way as for imaging or clinical diagnosis is not directly applicable here. The "experts" would be the manufacturers and developers of the reference/predicate methods, and the laboratory professionals performing the analyses.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers interpret data, and there's a need to resolve discrepancies. Since this study concerns the performance of an automated IVD device comparing its results to a reference method (or itself for precision/linearity), no human adjudication method was employed or necessary. The quantitative results are compared statistically.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results (e.g., radiology AI). The Piccolo® HDL - Capillary Test System is an automated quantitative chemical analyzer, not a device requiring human interpretation in its output.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Yes, this was a standalone performance study in the context of an IVD device. The "algorithm" here is the device's integrated system of reagents, fluidic handling, and photometric detection, which automatically produces a quantitative HDL value. The performance metrics (linearity, precision, method comparison) evaluate the device's output without human intervention influencing the final analytical result. Human involvement is limited to sample collection, loading, and initiating the test.

7. Type of Ground Truth Used

• Linearity and Precision Studies: The ground truth for these studies relies on characterized samples or quality controls with known analyte concentrations. For linearity, serial dilutions of a high-concentration sample are used, with the expected values serving as the truth. For precision, control materials with specified concentrations are repeatedly measured.
• Method Comparison Study: The ground truth was established by comparison to a legally marketed predicate device: the Roche HDL Test (specifically, the "Roche HDL Test: Average of Duplicates"). The predicate device's results are considered the reference against which the new device's performance is measured.

8. Sample Size for the Training Set

No training set is explicitly mentioned or relevant in the context of this 510(k) submission. This device is a chemical analyzer based on established enzymatic calorimetric principles. It does not utilize machine learning or AI models that require a "training set" in the conventional sense. The "training" of the device involves its internal calibration (factory calibrated lot-specific data via bar code) and manufacturing processes to ensure it accurately measures the analyte.

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

As noted above, there is no "training set" in the AI/ML sense. The device's calibration and manufacturing are based on established chemical principles and metrology standards, ensuring the accuracy of its measurements across its assay range.

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The HDLC method is an in vitro diagnostic test for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension Vista® system. Measurements of HDL-C are used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.

Dimension Vista® HDCL Flex® reagent cartridge is a pre-packaged in-vitro diagnostic test method (assay) that is specifically designed to be used on the Dimension Vista® Integrated system, a floor model, fully automated microprocessor-controlled, integrated instrument system. The reagents contained in the Dimension Vista® Flex® reagent cartridges are the same as those manufactured for the Dimension® clinical chemistry analyzers. The packaging modification does not affect the fundamental scientific technology of the device. The HDLC assay measures serum HDL cholesterol levels directly without the need for sample pretreatment or separation steps, using a two reagent format. In the first reaction, lipoproteins are precipitated with dextran sulfate in the presence of magnesium sulfate. These complexes are resistant to the polyethylene glycol (PEG)-modified cholesterol esterase (CE) and cholesterol oxidase (CO) that react with HDL cholesterol. In the second reaction, in the presence of oxygen, the HDL cholesterol is oxidized to A-4-cholestenone and hydrogen peroxide. The generated hydrogen peroxide then reacts with 4-aminoantipyrine (4-AAP) and N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxyaniline (HSDA) in the presence of peroxidase. The resulting quinoneimine dye is measured using a bichromatic (600/700 nm) technique. The color intensity of the dye is directly proportional to the serum HDL-C concentration.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical targets in a formal table outside of the comparison, but it implies that the performance of the new device (Dimension Vista® HDLC Flex® reagent cartridge - K3408A) must be "substantially equivalent" to the predicate device (Dimension® AHDL Flex® reagent cartridge - K073072). The comparison table below highlights key identical features and performance aspects. The "Conclusion" section explicitly states that "Comparative testing also demonstrates substantially equivalent performance."

Table of Acceptance Criteria (Implied Equivalence) and Reported Device Performance:

Note on Differences (Not Acceptance Criteria but Design Changes):

• Reagents Cartridge: Predicate uses 6-well plastic Flex® cartridges; New device uses 12-well plastic Flex® cartridges.
• Total Tests per Cartridge: Predicate provides 30 tests; New device provides 120 tests.
• Sample Size: Predicate uses 3 µL; New device uses 1.3 µL.

Study Information:

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence rather than a detailed clinical trial report. As such, specific study details are limited.

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

   • The document states "Comparative testing also demonstrates substantially equivalent performance." However, it does not explicitly state the sample size used for this comparative testing or the data provenance (e.g., country of origin, retrospective/prospective).
   • Given the nature of an in-vitro diagnostic device for cholesterol measurement, it would typically involve human serum/plasma samples, but the specifics are not provided.

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

   • Not applicable/Not mentioned. For this type of in-vitro diagnostic device, ground truth is typically established through a reference method or comparison to a predicate device's established performance, rather than expert interpretation of results. The device and its predicate were "Evaluated by and met the certification criteria of the Cholesterol Reference Method Laboratory Network (CRMLN)," which implies adherence to a highly standardized and validated reference method for ground truth.

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

   • Not applicable/Not mentioned. Adjudication methods are typically used in imaging or clinical interpretation studies where there is subjective assessment. This is an IVD device measuring a quantitative analyte.

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:

   • Not applicable. This is an in-vitro diagnostic device for quantitative measurement of High-Density Lipoprotein Cholesterol (HDL-C), not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.

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

   • Yes, implicitly. The device itself is an automated assay system (Dimension Vista® Integrated system) designed for quantitative measurement. Its performance, as demonstrated by "comparative testing," refers to the algorithm's ability to accurately measure HDL-C concentrations on the new system compared to the predicate, in a standalone fashion without human intervention in the measurement process itself. Human involvement would be in operating the instrument and interpreting the numerical results, not in the direct measurement by the device.

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

   • The ground truth is established through adherence to the Cholesterol Reference Method Laboratory Network (CRMLN) certification criteria. This indicates that the device's measurements are traceable to a highly accurate and standardized reference method for cholesterol, which serves as the "gold standard" for quantitative cholesterol measurement.

7. The sample size for the training set:

   • Not applicable/Not mentioned. This device is not an AI/machine learning device that requires a separate "training set" in the conventional sense. It's a new formulation/packaging of an existing chemical reagent for a known analytical method. The development would involve analytical validation rather than machine learning training.

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

   • Not applicable. As noted above, there's no "training set" in the context of machine learning. The analytical performance (accuracy, precision) is validated against established reference methods (CRMLN).

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The AHDL method is an in vitro diagnostic test for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension® clinical chemistry system. Measurements of HDL-C are used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.

The AHDL assay measures HDL cholesterol levels directly without the need for sample pretreatment or specialized centrification steps, using a two reagent format. In the first reaction, chylpmicrons, VLDL and LDL form water soluble complexes with dextran sulfate in the presence of magnesium sulfate. These complexes are resistant to the polyethylene glycol (PEG)-modified cholesteril esterse and cholesterol oxidase that react with HDL cholesterol. In the presence of oxygen, the HDL cholesterol is oxidized to 24-cholestenone and hydrogen peroxide. The generated hydrogen peroxide then reacts with 4-aminoantipyrine and sodium N-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxyaniline (HSDA) in the presence of peroxidase to form a colored dye that is measured using a bichromatic (600/700 nm) endpoint technique. The color intensity of the dye is directly proportional to the serum HDL-C concentration.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Dade Behring Dimension® AHDL Method:

This document is a 510(k) summary for a new version of an in vitro diagnostic (IVD) device, specifically a reagent cartridge for measuring HDL cholesterol. The study presented here is a method comparison study to demonstrate that the new device (DF48B) is substantially equivalent to a previously cleared predicate device (DF48A).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a traditional table format with pass/fail thresholds. Instead, it demonstrates substantial equivalence through a direct comparison with a predicate device and reports statistical measures of agreement.

Note: The "acceptance criteria" are implied by the goal of demonstrating substantial equivalence to the predicate device. The reported performance metrics (slope, intercept, correlation coefficient) are used to support this claim, showing "good analytical and clinical agreement."

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

• Sample Size for Test Set: 130 human serum samples.
• Data Provenance: The data provenance is not explicitly stated regarding country of origin. It is a retrospective study using human serum samples. The statement "using Leftover Human Specimens that are Not Individually Identifiable" from the cited FDA guidance document suggests these samples were collected previously and then used for this study.

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

This type of study (method comparison for an in vitro diagnostic device) does not typically involve "experts" establishing a ground truth in the way one might for an imaging or clinical diagnosis device.
Instead, the "ground truth" for this study is implicitly the measurement obtained by the predicate device (Dimension® AHDL method, DF48A), as the goal is to show agreement of the new device (DF48B) with the established predicate. There are no external experts adjudicating the results of the predicate device.

4. Adjudication Method for the Test Set

No adjudication method is described, as it is not applicable to this type of chemical assay comparison study. The comparison is between two quantitative measurement methods.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (e.g., imaging devices) where human readers interpret results, and the AI's impact on human performance is assessed. This document describes a chemical assay, so human reader involvement in the measurement itself (beyond operating the instrument) is not a relevant factor.

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

Yes, a standalone performance study was inherently done. This is a standalone performance study of the device (reagent cartridge on a clinical chemistry system). The algorithm in this context refers to the chemical reaction and measurement method rather than a software algorithm making diagnostic decisions. The "performance" being evaluated is the analytical agreement of the new reagent cartridge with the predicate reagent cartridge in measuring HDL-C.

7. Type of Ground Truth Used

The "ground truth" used for this method comparison study is the quantitative measurement of HDL-C obtained from the predicate device (Dimension® AHDL method, DF48A) for the same 130 human serum samples. The study aims to demonstrate that the new device's readings are in close agreement with the predicate's readings. It is not pathology, outcomes data, or expert consensus in the typical sense.

8. Sample Size for the Training Set

The document does not mention a training set. This is expected for an in vitro diagnostic (IVD) reagent cartridge. Unlike machine learning algorithms that require training data, these chemical assays are developed and validated based on their chemical properties and analytical performance without a "training" phase on patient data.

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

As there is no mention of a training set, the establishment of ground truth for a training set is not applicable.

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The AHDL method for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure high density lipoprotein cholesterol (HDL-C) in human serum and plasma. HDL-C measurements are used as an aid in the diagnosis of lipid disorders.

The Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48A) is an in vitro diagnostic device that consists of prepackaged reagents in a plastic cartridge (Flex®) for use on the Dade Behring Dimension® clinical chemistry system.

This document describes a 510(k) premarket notification for a revised in vitro diagnostic device, the Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48A). The purpose of the submission is to demonstrate substantial equivalence to a predicate device, the Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48).

Here's an analysis of the provided information, framed by your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (in vitro diagnostic for quantitative measurement), acceptance criteria are typically related to the correlation and agreement with a predicate device. The performance is demonstrated through a split-sample comparison study.

Note: The document explicitly states "Comments on Substantial Equivalence" and presents these statistical parameters. While explicit 'acceptance criteria' values (e.g., "correlation coefficient > 0.98") are not formally listed, these statistical measures infer the criteria for demonstrating substantial equivalence.

2. Sample Size for the Test Set and Data Provenance

Note: The country of origin for the data is not specified in the provided text.

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

This information is not applicable and not provided in the document.

• For in vitro diagnostic devices measuring a quantitative analyte like HDL Cholesterol, the "ground truth" for method comparison is typically the result obtained from a legally marketed and accepted predicate device or a reference method, not an expert panel.
• The study compares the new device (DF48A) to an existing, legally marketed predicate device (DF48). The predicate device's results are considered the benchmark for comparison, not a consensus of human experts.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. As explained above, this study is a quantitative method comparison, not one that requires adjudication by experts.

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

This information is not applicable and not provided in the document.

• MRMC studies are typically performed for diagnostic imaging devices where human readers interpret images, sometimes with AI assistance.
• This device is an automated in vitro diagnostic test for a chemical analyte (HDL-C) and does not involve human interpretation of cases or a "human-in-the-loop" application in the way an imaging device would.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, this study represents a standalone performance evaluation of the device.

• The device is an "Automated HDL Cholesterol (AHDL) Flex® reagent cartridge." It is designed to quantitatively measure HDL-C in human serum and plasma directly.
• The comparison study evaluates the performance of this automated system directly against the predicate automated system, without any human interpretation or intervention in the measurement process itself.

7. Type of Ground Truth Used

The "ground truth" (or reference standard) for this study is the results obtained from the predicate device, the "Current" Dimension® Automated HDL Cholesterol Flex® reagent cartridge (DF48). This is a common approach for demonstrating substantial equivalence of a new in vitro diagnostic device to an already cleared one.

8. Sample Size for the Training Set

This information is not provided and likely not applicable in the context of this device.

• The Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge is an in vitro diagnostic device composed of prepackaged reagents that use an "Enzymatic Colormetric Bichromatic Endpoint" detection method. These methods are based on established chemical reactions and principles.
• There's no indication that this device uses machine learning or AI models that would require a "training set" in the conventional sense (e.g., for pattern recognition or classification). The development would involve chemical optimization and calibration, not machine learning model training.

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

This information is not applicable as there is no indication of a "training set" in the context of machine learning for this device.

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Intended for the In Vitro, quantitative determination of LDL Cholesterol in human serum on automated chemistry analyzers.

LDL Cholesterol measurements are used in the diagnosis and treatment of disorders involving high LDL Cholesterol, which is associated with an increased risk of coronary heart disease and coronary artery disease.

Not Found

This document is a 510(k) clearance letter for an in vitro diagnostic (IVD) device, specifically an "LDL Cholesterol (Automated) Reagent." The letter indicates that the device has been found substantially equivalent to a predicate device. However, it does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a summary of safety and effectiveness.

Here's a breakdown based on the provided text, highlighting what's not present:

Missing Information: The core request for acceptance criteria and a study demonstrating performance is not addressed in this regulatory clearance letter. This type of letter acknowledges substantial equivalence but does not delve into the specifics of performance studies.

Despite the limitations, I will attempt to answer each point, noting when the information is unavailable in the provided text.

Acceptance Criteria and Device Performance Study Information

This 510(k) clearance letter does not provide the acceptance criteria or detailed results of a performance study for the LDL Cholesterol (Automated) Reagent. The letter is a regulatory document indicating substantial equivalence to a legally marketed predicate device, rather than a technical report on the device's performance characteristics.

Therefore, the following table and subsequent sections will largely indicate "Not provided in the text" for the requested details.

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

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

• Sample Size: Not provided in the text.
• Data Provenance: Not provided in the text (e.g., country of origin, retrospective/prospective).

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

• Not applicable/Not provided in the text. For IVD devices like a cholesterol reagent, ground truth is typically established by reference methods or validated laboratory measurements, not by expert interpretation in the same way as imaging or pathological diagnosis.

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

• Not applicable/Not provided in the text. Adjudication methods are typically used in studies involving human interpretation (e.g., imaging, clinical diagnoses) rather than quantitative laboratory assays.

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 reagent for quantitative determination of LDL Cholesterol, not an AI-assisted diagnostic imaging or interpretative tool that would involve human "readers."

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

• The device described, "LDL Cholesterol (Automated) Reagent," is inherently a standalone (algorithm/reagent only) system for quantitative measurement. The concept of "human-in-the-loop" assistance, as typically applied to AI, does not directly apply here. The performance of the reagent is evaluated on its ability to accurately measure LDL cholesterol without human interpretation affecting the result generation itself. However, the specific study details confirming this standalone performance are not provided.

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

• Not explicitly stated in the provided text. For an LDL Cholesterol assay, the ground truth would typically be established by a recognized reference method (e.g., CDC reference method for cholesterol, ultracentrifugation, or isotope dilution-mass spectrometry) or by a highly validated predicate device.

8. The sample size for the training set

• Not applicable/Not provided in the text. This is a chemical reagent, not a machine learning algorithm that requires a "training set" in the conventional sense. Performance is evaluated through analytical and clinical validation studies using patient samples.

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

• Not applicable/Not provided in the text, as this is not an AI/ML device with a "training set."

Summary of Document Content:

The provided document is an FDA 510(k) clearance letter for the JAL Diagnostics, Inc. LDL Cholesterol (Automated) Reagent. Key information from the letter includes:

• Device Name: LDL Cholesterol (Automated) Reagent
• Indications for Use: Intended for the In Vitro, quantitative determination of LDL Cholesterol in human serum on automated chemistry analyzers. Used in the diagnosis and treatment of disorders involving high LDL Cholesterol, associated with increased risk of coronary heart disease.
• Regulatory Status: Class I device, Product Code: MRR; JHM; JIX; JJY. Found substantially equivalent to a legally marketed predicate device.
• Clearance Date: September 30, 2002.

Conclusion:

This 510(k) clearance letter confirms that the FDA found the device "substantially equivalent" to existing predicate devices, allowing it to be marketed. However, it does not include the detailed technical data, performance acceptance criteria, or specific study results that would typically be contained within a device's 510(k) submission summary or a separate performance study report. This kind of detail is usually found in the original 510(k) submission, which is not provided here.

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The AHDL method for the Dimension® clinical chemistry system is a device used to quantitatively measure High Density Lipoprotein Cholesterol in human serum or plasma. AHDL measurements are used as an aid in the diagnosis and treatment of lipid disorders.

The AHDL method for the Dimension® clinical chemistry system is a homogeneous method for direct measurement of high density lipoprotein (HDL) cholesterol levels without the need for off-line pretreatment or centrifugation steps. The method is in a two-reagent format and depends on the properties of a unique detergent, which solubilizes only the HDL particles, thus releasing HDL cholesterol to react with cholesterol esterase to produce color. In addition to selectively disrupting the HDL particles, this detergent also inhibits the reaction of the cholesterol enzymes with LDL, VLDL and chylomicrons by adsorbing to their surfaces. A polyanion is contained in the first reagent to assist with complexing LDL, VLDL and chylomicrons, further enhancing the selectivity of the detergent and enzymes for HDL cholesterol.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the new device. Instead, it demonstrates substantial equivalence to a predicate device. The performance is assessed through a split-sample comparison, with the implicit criterion being a strong correlation and acceptable agreement between the new device and the predicate.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 272 clinical patient samples.
• Data Provenance: The document does not specify the country of origin. It states "clinical patient samples," implying they were collected from patients. It's a retrospective comparison against existing samples analyzed by the predicate device.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This study does not involve expert readers establishing ground truth for images or interpretations. It's a quantitative measurement device comparison where the predicate device's results serve as the comparison baseline.

4. Adjudication Method for the Test Set

Not applicable. There's no adjudication needed as it's a direct comparison of quantitative measurements from two analytical methods on the same samples.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human interpretation is involved. The Dimension® AHDL is an automated quantitative measurement device.

6. Standalone Performance Study

Yes, a standalone performance study of the new device relative to the predicate device was conducted. The "split-sample comparison" essentially serves as the standalone performance assessment of the new device's quantitative output. While it's compared to another device, the core functionality of the AHDL system is evaluated on its own merits for linearity, correlation, and agreement within the context of substantial equivalence.

7. Type of Ground Truth Used

The "ground truth" for the comparison was the results obtained from the predicate device (Dimension® HDL Assay). The study aimed to demonstrate that the new device's measurements were substantially equivalent to those of a previously approved method. While the predicate device's results are not considered absolute "ground truth" in the pathological sense, they serve as the acceptable reference standard for this type of equivalence claim.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This is a chemical assay, and its development would involve method optimization and validation rather than a training set for an algorithm.

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

Not applicable, as there is no mention of a training set or AI algorithm in this context. The method's performance characteristics (e.g., reagent formulation, reaction kinetics) would be established through laboratory experiments and verification against known standards and other established methods.

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