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Reagent: UniCel DxC SYNCHRON Systems HDL Cholesterol reagent (HDL), when used in conjunction with UniCel DxC 600/800 SYNCHRON System(s) and UniCel DxC SYNCHRON Systems HDL Calibrator, is intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.

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

Calibrator: The UniCel DxC SYNCHRON Systems HDL Calibrator is designed to provide suitable calibration levels for Beckman Coulter UniCel DxC 600/800 SYNCHRON Systems employing the quantitative UniCel DxC SYNCHRON Systems HDL Cholesterol reagent (HDL).

Not Found

This is a 510(k) premarket notification for in vitro diagnostic devices (UniCel DxC SYNCHRON Systems HDL Cholesterol Reagent and Calibrator), not an AI/ML medical device. Therefore, many of the requested criteria regarding AI model performance, ground truth, experts, and training/test sets are not applicable or typically documented in this type of submission.

However, I can extract and present information relevant to device performance and substantiation that is typically found in such a document for an IVD.

Here's an interpretation based on the provided text, acknowledging the limitations for an IVD device:

Device: UniCel DxC SYNCHRON Systems HDL Cholesterol Reagent (HDL) and UniCel DxC SYNCHRON Systems HDL Calibrator.
Intended Use: Quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.

1. Table of Acceptance Criteria and Reported Device Performance

For an IVD such as this, "acceptance criteria" and "device performance" typically refer to analytical performance characteristics demonstrated through validation studies (e.g., accuracy, precision, linearity, interference, method comparison). While the provided 510(k) summary (which is typically a brief overview) doesn't contain a detailed table of specific criteria and results, it implies that performance data was submitted and found acceptable for substantial equivalence to a predicate device.

To illustrate, here's a hypothetical table based on common IVD performance metrics that would be assessed for a device like this, as the actual data is not present in the provided snippet:

Note: The FDA's issuance of a determination of substantial equivalence (as stated in the letter) means that sufficient data was provided to demonstrate the device performs as intended and is as safe and effective as a legally marketed predicate device. This data would include studies addressing the above performance characteristics.

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

The provided text from the 510(k) notification does not specify the sample size for any test set or the provenance of the data. For IVD devices, clinical samples (serum/plasma), control materials, and calibrators are used in analytical validation studies. These studies are typically conducted by the manufacturer, often at multiple sites (laboratories), and typically use samples from diverse populations to ensure generalizability. The studies would be considered prospective in terms of data collection for the specific validation protocols.

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

This question is not applicable to an in vitro diagnostic reagent and calibrator like the one described. "Ground truth" in the context of an AI/ML medical device typically refers to expert annotations or conclusive diagnoses. For an IVD, the "ground truth" for evaluating performance would be established by:

• Reference Methods: Using a well-established, often CDC-certified or industry-standard reference method for HDL cholesterol measurement, which may itself involve highly skilled laboratory professionals.
• Certified Reference Materials: Using materials with established true values (e.g., NIST traceable materials).

The performance of the device is assessed against these established methods or materials, not against expert consensus on images or similar diagnostic interpretations.

4. Adjudication Method for the Test Set

This concept is not typically applicable to the validation of an IVD reagent and calibrator. Adjudication methods (like 2+1 or 3+1) are used in AI/ML performance studies where multiple human experts individually assess a case, and discrepancies are resolved. For an IVD, analytical results are quantitative and compared against established methods or values, not adjudicated expert opinions.

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 question is not applicable. MRMC studies are used to evaluate the diagnostic accuracy of imaging devices or AI algorithms (often with human readers). This device is a quantitative a chemical reagent and calibrator for an automated laboratory system, not an imaging device or an AI diagnostic tool that assists human readers in interpretation.

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

This question is not applicable. The device is a chemical reagent and calibrator system used on an automated analyzer (UniCel DxC 600/800 SYNCHRON System). Its performance is inherently "standalone" in the sense that the instrument processes the sample and yields a quantitative result without direct "human-in-the-loop" interpretation for each test result in the way an AI diagnostic tool might require. The "algorithm" here is the chemical reaction and photometric measurement, not a computational AI model.

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

For this IVD, the "ground truth" would be established by:

• Reference Measurement Procedures: Highly accurate and precise laboratory methods (e.g., CDC reference methods) for determining HDL cholesterol levels in samples.
• Certified Reference Materials: Materials with an accurately assigned value for HDL cholesterol.

Essentially, it's a comparison to established, highly accurate analytical methods rather than subjective expert consensus or pathology.

8. The sample size for the training set

This question is not applicable. This device is not an AI/ML model that requires a "training set" in the computational sense. The reagents are developed and optimized through chemical formulation and analytical studies, not statistical model training.

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

This question is not applicable, as there is no "training set" in the AI/ML context for this type of IVD device. The "ground truth" (reference values) established for validation studies (as in #7) would be used to assess the accuracy and performance of the finalized reagent and calibrator system.

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

Not Found

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

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

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

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

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

This information is not available in the provided document.

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

This information is not available in the provided document.

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

This information is not available in the provided document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

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

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

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

8. The sample size for the training set

This information is not available in the provided document.

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

This information is not available in the provided document.

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The ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration in serum and lithium heparin plasma using the ACE Axcel Clinical Chemistry System. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE HDL-C Reagent is intended for the quantitative determination of high density lipoprotein cholesterol (HDL-C) concentration in serum and lithium heparin plasma using the ACE Axcel Clinical Chemistry System. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE LDL-C Reagent is intended for the quantitative determination of low density lipoprotein cholesterol (LDL-C) concentration in serum and lithium heparin plasma using the ACE Axcel Clinical Chemistry System. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Triglycerides Reagent is intended for the quantitative determination of triglyceride concentration in serum and lithium heparin plasma using the ACE Axcel Clinical Chemistry System. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Cholesterol Reagent is composed of a single reagent bottle. The reagent contains 4-aminoantipyrine, p-hydroxybenzoic acid, cholesterol oxidase, cholesterol esterase and peroxidase.

The HDL-C Reagent assay utilizes two reagent bottles, the second containing a unique detergent. This detergent solubilizes only the HDL lipoprotein particles, thus releasing HDL cholesterol to react with the cholesterol esterase and cholesterol oxidase, in the presence of a chromogen to produce color. The detergent also inhibits the reaction of the cholesterol enzymes with LDL, VLDL and chylomicron lipoproteins by adsorbing to their surfaces. The amount of chromogen formed, determined by measuring the increase in absorbance bichromatically at 592/692 nm, is directly proportional to the HDL cholesterol concentration in the sample.

In the ACE LDL-C Reagent assay, detergent 1 solubilizes non-LDL lipoprotein particles (HDL, VLDL and chylomicrons) and releases cholesterol. The cholesterol is consumed by cholesterol esterase and cholesterol oxidase in a non-color forming reaction. In a second reaction, detergent 2 solublizes the remaining LDL particles and forms peroxide, via the enzymes cholesterol esterase and cholesterol oxidase. The peroxide, in the presence of peroxidase and two peroxidase substrates, 4-aminoantipyrine and DSBmT, results in a purple-red color. The amount of color formed, determined by measuring the increase in absorbance bichromatically at 544/692 nm, is directly proportional to the LDL cholesterol concentration in the sample.

In the ACE Triglycerides Reagent assay, triglycerides in serum are hydrolyzed by lipase to form glycerol and free fatty acids. In the presence of adenosine triphosphate (ATP) and glycerol kinase, the glycerol is converted to glycerol-1-phosphate and the ATP to adenosine diphosphate. Glycerol-1-phosphate is oxidized by glycerol phosphate oxidase to yield hydrogen peroxide. The hydrogen peroxide then acts to oxidatively couple p-chlorophenol and 4-aminoantipyrine in a reaction catalyzed by peroxidase, producing a red colored quinoneimine complex which absorbs strongly at 505 nm. The amount of chromogen formed, determined by measuring the increase in absorbance bichromatically at 505 nm/692 nm, is directly proportional to the triglycerides concentration in the sample.

The provided text describes a 510(k) submission for the ACE Axcel Clinical Chemistry System and its associated reagents for Cholesterol, HDL-C, LDL-C, and Triglycerides. The submission focuses on demonstrating substantial equivalence to a predicate device (K113262) by showing that the new device has "Same" intended use, instrument platform, basic principle, and reagent composition, with the only difference being the expanded sample type (serum and lithium heparin plasma for the candidate device vs. serum only for the predicate device).

The acceptance criteria are implicitly defined by the performance characteristics demonstrated in the study, which aim to show that the expanded sample type (lithium heparin plasma) does not negatively impact the accuracy and precision of the measurements compared to serum. The study largely relies on analytical performance data rather than clinical outcomes or expert consensus on interpretations.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the document; instead, the study intends to demonstrate comparable performance to the predicate device and acceptable analytical characteristics. The reported device performance for precision and matrix comparison is provided below, which implicitly became the "accepted" performance for the expanded sample type.

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

• Precision/Reproducibility Study (Test Set):
  • For each analyte (Cholesterol, HDL-C, LDL-C, Triglycerides), for both serum and plasma, 3 levels of samples were used.
  • Each level was tested with 2 replicates, twice a day, on 5 separate days, yielding a total of 20 replicates per level (3 levels * 2 sample types * 20 replicates/level = 120 total measurements per analyte category, e.g., Cholesterol on Serum).
  • Data Provenance: Not explicitly stated, but typically these studies are conducted in a laboratory setting, likely in the US (given the FDA submission). It is a prospective analytical study designed to evaluate device performance under controlled conditions.
• Matrix Comparison Study (Test Set):
  • Cholesterol: 54 paired serum and lithium heparin plasma specimens.
  • HDL-C: 53 paired serum and lithium heparin plasma specimens.
  • LDL-C: 54 paired serum and lithium heparin plasma specimens.
  • Triglycerides: 55 paired serum and lithium heparin plasma specimens.
  • These specimens covered the assay's dynamic range.
  • Data Provenance: Not explicitly stated, but likely from a clinical laboratory setting, potentially within the US. The samples are retrospective specimens collected for analytical comparison.

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

This type of submission for in vitro diagnostic reagents does not typically involve human experts establishing "ground truth" through interpretation. The "ground truth" for the test set is established by comparative measurements against a reference method or the predicate device, and by the inherent chemical/physical properties of the samples used in reproducibility studies. No information about experts or their qualifications is provided or relevant in this context.

4. Adjudication method for the test set

Not applicable. This is an analytical performance study for laboratory reagents, not a clinical study involving human interpretation that would require an adjudication method.

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 not an AI/imaging device, nor does it involve human readers or case interpretations. It is an in vitro diagnostic reagent.

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

This is an analytical device, and its performance is inherently standalone in terms of generating a quantitative result. The results are then interpreted by clinicians in the overall diagnostic process. The study evaluates the standalone performance of the reagents on the ACE Axcel Clinical Chemistry System.

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

The "ground truth" for this type of analytical validation is established by:

• Reference methods and/or the predicate device: For the matrix comparison, the serum measurements on the candidate device (which is substantially equivalent to the predicate) serve as the reference against plasma measurements. The predicate device's performance also implicitly serves as a benchmark for comparison.
• Known concentrations: For precision studies, samples are "clinically relevant decision levels" meaning they have known or well-characterized concentrations of the analytes. These concentrations are typically determined by highly accurate laboratory methods.

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device that requires a training set. The reagents are chemical formulations, and the system is an automated analyzer.

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

Not applicable, as there is no training set for this type of device.

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Eon Cholesterol Reagent is an in vitro diagnostic device intended for the quantitative determination of total cholesterol in human plasma and serum using the Eon 100 Clinical Chemistry Analyser. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Not Found

This is a 510(k) clearance letter for the Eon Cholesterol Reagent, an in vitro diagnostic device. This type of document typically provides regulatory approval based on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria as might be seen for novel or higher-risk devices, especially those involving AI/ML.

Therefore, the specific information requested in the prompt, especially regarding AI/ML aspects like training sets, expert adjudication, MRMC studies, and standalone performance, is not present in the provided document because it describes a chemical reagent, not an AI/ML device.

However, I can extract what is available about performance and acceptance criteria for this specific type of device.

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

For in vitro diagnostic reagents like the Eon Cholesterol Reagent, acceptance criteria typically involve demonstrating analytical performance characteristics (e.g., accuracy, precision, linearity) that are comparable to a legally marketed predicate device. The document states that the device is "substantially equivalent" to predicate devices, implying that its performance meets the regulatory expectations for such a comparison. However, the specific numerical acceptance criteria (e.g., ±X% accuracy, CV

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The ACE Axcel Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative determination of constituents in blood and other fluids.

The ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration in serum using the ACE Axcel Clinical Chemistry System. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE HDL-C Reagent is intended for the quantitative determination of high density lipoprotein cholesterol (HDL-C) concentration in serum using the ACE Axcel Clinical Chemistry System. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE LDL-C Reagent is intended for the quantitative determination of low density lipoprotein cholesterol (LDL-C) concentration in serum using the ACE Axcel Clinical Chemistry System. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Triglycerides Reagent is intended for the quantitative determination of triglyceride concentration in serum using the ACE Axcel Clinical Chemistry System. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Axcel Clinical Chemistry System consists of two major components, the chemistry instrument and an integrated Panel PC. The instrument accepts the physical patient samples, performs the appropriate optical or potentiometric measurements on those samples and communicates that data to an integral Panel PC. The Panel PC uses keyboard or touch screen input to manually enter a variety of data, control and accept data from the instrument, manage and maintain system information and generate reports relative to patient status and instrument performance. The Panel PC also allows remote download of patient requisitions and upload of patient results via a standard interface.

In the ACE Cholesterol Reagent assay, cholesterol esters in serum are completely hydrolyzed by cholesterol esterase to free cholesterol and free fatty acids. The cholesterol liberated by the esterase, plus any endogenous free cholesterol, are both oxidized by cholesterol oxidase to yield hydrogen peroxide. The hydrogen peroxide then acts to oxidatively couple p-hydroxybenzoic acid and 4-aminoantipyrine in a reaction catalyzed by peroxidase, producing a red colored quinoneimine complex which absorbs strongly at 505 nm. The amount of chromogen formed, determined by measuring the increase in absorbance, bichromatically at 505 nm/647 nm, is directly proportional to the cholesterol concentration in the sample.

The HDL-C Assay utilizes two reagents, the second containing a unique detergent. This detergent solubilizes only the HDL lipoprotein particles, thus releasing HDL cholesterol to react with the cholesterol esterase and cholesterol oxidase, in the presence of a chromogen to enzymes with LDL, VLDL and chylomicron lipoproteins by adsorbing to their surfaces. The amount of chromogen formed, determined by measuring the increase in absorbance bichromatically at 592/692 nm, is directly proportional to the HDL cholesterol concentration in the sample.

In the ACE LDL-C Reagent assay, detergent 1 solubilizes non-LDL lipoprotein particles (HDL, VLDL and chylomicrons) and releases cholesterol. The cholesterol is consumed by cholesterol esterase and cholesterol oxidase in a non-color forming reaction. In a second reaction, detergent 2 solublizes the remaining LDL particles and forms peroxide, via the enzymes cholesterol esterase and cholesterol oxidase. The peroxide, in the presence of peroxidase and two peroxidase sub- strates, 4-aminoantipyrine and DSBmT, results in a purple-red color. The amount of color formed, determined by measuring the increase in absorbance bichromatically at 544/692 nm, is directly proportional to the LDL cholesterol concentration in the sample.

In the ACE Triglycerides Reagent Assay, triglycerides in serum are hydrolyzed by lipase to form glycerol and free fatty acids. In the presence of adenosine triphosphate (ATP) and glycerol kinase, the glycerol is converted to glycerol-1-phosphate and the ATP to adenosine diphosphate. Glycerol-1-phosphate is oxidized by glycerol phosphate oxidase to yield hydrogen peroxide. The hydrogen peroxide then acts to oxidatively couple p-chlorophenol and 4-aminoantipyrine in a reaction catalyzed by peroxidase, producing a red colored quinoneimine complex which absorbs strongly at 505 nm. The amount of chromogen formed, determined by measuring the increase in absorbance bichromatically at 505 nm/692 nm, is directly proportional to the triglycerides concentration in the sample.

Here's an analysis of the acceptance criteria and study details for the Alfa Wassermann ACE Axcel Clinical Chemistry System and its associated reagents, based on the provided 510(k) summary:

Overview of Device and Study Purpose:

This submission describes the ACE Axcel Clinical Chemistry System and four associated reagents (ACE Cholesterol Reagent, ACE HDL-C Reagent, ACE LDL-C Reagent, ACE Triglycerides Reagent). The study's primary purpose is to demonstrate the substantial equivalence of the new ACE Axcel System and its reagents to predicate devices (Alfa Wassermann ACE plus ISE/Clinical Chemistry System and its reagents) by showing comparable performance in terms of precision, accuracy, and detection limits.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the typical expectations for clinical chemistry analyzers. The document focuses on demonstrating that the new system's performance is equivalent or better than the predicate.

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

• ACE Cholesterol Reagent (Accuracy): 110 samples.
• ACE HDL-C Reagent (Accuracy): 109 samples.
• ACE LDL-C Reagent (Accuracy): 108 samples.
• ACE Triglycerides Reagent (Accuracy): 111 samples.

The samples for the accuracy ("correlation") studies were assayed on both the new ACE Axcel System (y) and the predicate Alfa Wassermann ACE Clinical Chemistry System (x).

Data Provenance: The document does not explicitly state the country of origin. The studies were conducted at a main lab and three separate Physician Office Laboratory (POL) sites, suggesting real-world clinical samples. There is no indication of whether the data was retrospective or prospective, but given the nature of a comparability study for a new device, it is typically prospective, involving fresh samples run on both systems simultaneously.

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

This type of device (clinical chemistry analyzer) does not typically involve human experts establishing ground truth in the way radiological or pathological devices do. The "ground truth" for the test set is established by the predicate device (Alfa Wassermann ACE Clinical Chemistry System) itself, which is assumed to be accurate and clinically acceptable. The study's goal is to show agreement with this established method. Therefore, no external human experts are used for ground truth establishment for individual samples.

4. Adjudication Method for the Test Set

Not applicable. As explained above, this is a quantitative comparison study against a predicate device, not an interpretation-based study requiring expert adjudication of results. The predicate device's readings serve as the comparator.

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 for an automated clinical chemistry analyzer which provides quantitative measurements, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.

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

Yes, the studies presented are generally "standalone" in the sense that they evaluate the performance of the automated ACE Axcel Clinical Chemistry System (device and reagents) directly. The system provides quantitative results, and the performance metrics (precision, accuracy, detection limit) are intrinsic to the device's operation. There isn't a human-in-the-loop component being evaluated for diagnostic decision-making, rather the system is automated to provide a numerical result.

7. The Type of Ground Truth Used

The ground truth used for accuracy (correlation) studies is the measurement obtained from the predicate device, the Alfa Wassermann ACE Clinical Chemistry System. This is a common approach for demonstrating substantial equivalence for clinical chemistry analyzers, where the new device's performance is compared against another legally marketed device's performance.

8. The Sample Size for the Training Set

Not applicable. This document describes the validation of a clinical chemistry system and its reagents, not an AI/ML algorithm that typically requires a separate training set. The "training" for such systems would involve chemical formulation and instrument calibration, not data-driven machine learning.

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 calibration of the instrument and formulation of reagents are based on established chemical and engineering principles rather than data-driven ground truth for machine learning.

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ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

ACE HDL-C Reagent is intended for the homogeneous, quantitative determination of HDL cholesterol (HDL-C) in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

ACE LDL-C Reagent is intended for the quantitative determination of low density lipoprotein cholesterol (LDL-C) in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

ACE Triglycerides Reagent is intended for the quantitative determination of triglycerides in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

In the ACE Cholesterol Reagent assay, cholesterol esters in serum or heparin plasma are completely hydrolyzed by cholesterol esterase to free cholesterol and free fatty acids. The cholesterol liberated by the esterase, plus any endogenous free cholesterol, are both oxidized by cholesterol oxidase to yield hydrogen peroxide. The hydrogen peroxide then acts to oxidatively couple p-hydroxybenzoic acid and 4-aminoantipyrine in a reaction catalyzed by peroxidase, producing a red colored quinoneimine complex which absorbs strongly at 505 nm. The amount of chromogen formed, determined by measuring the increase in absorbance, bichromatically at 505 nm/647 nm, is directly proportional to the cholesterol concentration in the sample.

The HDL-C Assay utilizes two reagents, the second containing a unique detergent. This detergent solubilizes only the HDL lipoprotein particles, thus releasing HDL cholesterol to react with the cholesterol esterase and cholesterol oxidase, in the presence of a chromogen to produce color. The detergent also inhibits the reaction of the cholesterol enzymes with LDL, VLDL and chylomicron lipoproteins by adsorbing to their surfaces. The amount of chromogen formed, determined by measuring the increase in absorbance bichromatically at 592/692 nm, is directly proportional to the HDL cholesterol concentration in the sample.

In the ACE LDL-C Reagent assay, detergent 1 solubilizes non-LDL lipoprotein particles (HDL, VLDL and chylomicrons) and releases cholesterol. The cholesterol is consumed by cholesterol esterase and cholesterol oxidase in a non-color forming reaction. In a second reaction, detergent 2 solublizes the remaining LDL particles and forms peroxide, via the enzymes cholesterol esterase and cholesterol oxidase. The peroxide, in the presence of peroxidase and two peroxidase substrates, 4-aminoantipyrine and DSBmT, results in a purple-red color. The amount of color formed, determined by measuring the increase in absorbance bichromatically at 544/692 nm, is directly proportional to the LDL cholesterol concentration in the sample.

In the ACE Triglycerides Reagent assay, triglycerides in serum or heparin plasma are hydrolyzed by lipase to form glycerol and free fatty acids. In the presence of adenosine triphosphate (ATP) and glycerol kinase, the glycerol is converted to glycerol-1-phosphate and the ATP to adenosine diphosphate. Glycerol-1-phosphate is oxidized by glycerol phosphate oxidase to yield hydrogen peroxide. The hydrogen peroxide then acts to oxidatively couple p-chlorophenol and 4-aminoantipyrine in a reaction catalyzed by peroxidase, producing a red colored quinoneimine complex which absorbs strongly at 505 nm. The amount of chromogen formed, determined by measuring the increase in absorbance bichromatically at 505 nm/692 nm, is directly proportional to the triglycerides concentration in the sample.

Here's a breakdown of the acceptance criteria and study details for the Alfa Wassermann ACE Cholesterol Reagent, ACE HDL-C Reagent, ACE LDL-C Reagent, and ACE Triglycerides Reagent, based on the provided 510(k) summary:

The studies presented are "matrix comparison data" studies, aiming to demonstrate substantial equivalence between using serum and lithium heparin plasma samples with the new ACE reagents on the ACE and ACE Alera Clinical Chemistry Systems. The performance is assessed by comparing quantitative measurements from paired serum/plasma samples.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on demonstrating strong correlation and agreement between serum and plasma measurements, specifically looking for regression equations close to y=x (slope near 1, intercept near 0) and high correlation coefficients. The provided confidence intervals for slope and intercept also serve as an implicit measure of acceptance.

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

• ACE Cholesterol Reagent (ACE Clinical Chemistry System): 102 paired samples (serum and lithium heparin plasma). 5 samples spiked.
• ACE Cholesterol Reagent (ACE Alera Clinical Chemistry System): 100 paired samples (serum and lithium heparin plasma). 6 samples spiked.
• ACE HDL-C Reagent (ACE Clinical Chemistry System): 101 paired samples (serum and lithium heparin plasma).
• ACE HDL-C Reagent (ACE Alera Clinical Chemistry System): 100 paired samples (serum and lithium heparin plasma).
• ACE LDL-C Reagent (ACE Clinical Chemistry System): 99 paired samples (serum and lithium heparin plasma). 4 samples spiked.
• ACE LDL-C Reagent (ACE Alera Clinical Chemistry System): 99 paired samples (serum and lithium heparin plasma). 4 samples spiked.
• ACE Triglycerides Reagent (ACE Clinical Chemistry System): 101 paired samples (serum and lithium heparin plasma). 5 samples spiked.
• ACE Triglycerides Reagent (ACE Alera Clinical Chemistry System): 101 paired samples (serum and lithium heparin plasma). 5 samples spiked.

Data Provenance: The data provenance is described as "paired samples drawn from the same patients." There is no explicit mention of the country of origin of the data, but the context of an FDA 510(k) submission for commercialization in the USA suggests it would likely be from a US-based or internationally recognized clinical setting. The studies are prospective in nature, as they involve drawing paired samples for direct comparison. Spiking of some samples was done to extend the measurement range.

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

This type of study does not involve "experts" establishing a ground truth in the traditional sense of medical image interpretation or clinical diagnosis. Instead, the ground truth for each measurement type (Cholesterol, HDL-C, LDL-C, Triglycerides) is the quantitative value obtained from the serum sample, which serves as the established reference matrix. The performance of the devices is then compared against this reference when using plasma samples. Therefore, no external experts were used for this purpose; the "ground truth" is the instrumental measurement itself.

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative laboratory test performance study, not an expert-driven adjudication of medical findings. The comparison is statistical (Deming regression) between instrument measurements from two different sample matrices (serum vs. plasma).

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 evaluating the performance of in-vitro diagnostic reagents and systems, not an AI-assisted diagnostic device involving human readers.

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

This study evaluates the standalone performance of the reagent and instrument system when used with different biological matrices (serum vs. plasma). There is no "human-in-the-loop" component in the interpretation of the numerical results beyond standard laboratory quality control and reporting procedures. The results provided are direct numerical outputs from the analytical instruments.

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

The "ground truth" used in these studies is the quantitative measurement of the analytes (Cholesterol, HDL-C, LDL-C, Triglycerides) obtained from serum samples using the same ACE and ACE Alera Clinical Chemistry Systems. Serum is generally considered the standard matrix for these assays. The purpose of the study is to demonstrate that lithium heparin plasma samples yield comparable results to serum samples.

8. The sample size for the training set

Not applicable. This is a performance validation study for a medical device (reagents and instrument system), not a machine learning model that requires a distinct training set. The "training" in this context would refer to the development and optimization of the reagents and assay protocols, which typically occurs during the R&D phase and doesn't involve a formal "training set" as understood in AI/ML.

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

Not applicable, as there is no training set in the context of machine learning. The reagents are developed to specifically measure the target analytes based on well-established biochemical principles (enzymatic reactions). The "ground truth" for the development of such assays would involve chemical standards, certified reference materials, and comparison to established reference methods, but this is part of the assay development, not a "training set" for the reported performance studies.

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

Medica's HDL cholesterol reagent consists of two parts R1 and R2. The first step involves the removal of other non-HDL lipoproteins via selective reaction with reagent R1. In the second step, the selective detergent in R2 solubilizes the HDL cholesterol specifically, which then reacts with a chromagen to develop a color that can be read optically at 600nm. The intensity of the color is proportional to the concentration of HDL cholesterol in the sample.

Here's an analysis of the acceptance criteria and study details for the Medica Corporation EasyRA HDL Cholesterol Reagent, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (a reagent for an in-vitro diagnostic test), acceptance criteria are typically related to analytical performance characteristics. The document doesn't explicitly state "acceptance criteria" as a pass/fail threshold, but rather reports the performance demonstrated, implying that these levels met regulatory expectations for substantial equivalence.

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

• Linearity: Not explicitly stated beyond "commercial linearity standards." These are typically synthetic or pooled human samples.
• Within-Run Precision: Five replicates of two levels of commercial serum-based QC material tested each day for five days. This is a total of 5 replicates * 2 levels * 5 days = 50 measurements per analyzer, across three analyzers. So, 150 data points in total for each QC level across the three analyzers. The samples were "commercial serum-based Quality control material". The provenance is not specified (e.g., country of origin, retrospective/prospective), but given they are commercial QC materials, they would likely be manufactured under controlled conditions.
• Total Precision: Two levels of commercial serum-based QC material tested in duplicate twice daily for 20 days. This is a total of 2 replicates * 2 times/day * 20 days = 80 measurements per analyzer, across three analyzers. So, 240 data points in total for each QC level across the three analyzers. The samples were "commercial serum-based Quality control material." Provenance not specified.
• Method Comparison: "At least 40 samples" were tested. The provenance is not specified, but these would typically be human serum samples, likely collected prospectively or retrospectively from a local population at the time of the study.
• Sample Carryover: "Eleven samples" (L, M, H range) were analyzed. Provenance not specified.
• Sensitivity: "20 replicates of reagent grade water." Provenance is irrelevant as it's a non-biological sample.
• Interference Testing: Not specified, but involved specific concentrations of hemoglobin, bilirubin, and intralipid, likely spiked into a normal serum matrix.

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

This type of device (a diagnostic reagent for a chemistry analyzer) does not typically rely on human expert interpretation for "ground truth" in the same way an imaging or pathology device would. The "ground truth" for the test set is established by:

• Reference Methods/Materials: For linearity, it's NIST-traceable commercial linearity standards.
• Predicate Device: For method comparison, the "ground truth" is established by the measurements from the legally marketed predicate device (Genzyme HDL Cholesterol Reagent on a Cobas-Mira analyzer).
• Known Concentrations: For precision, it's known concentrations in commercial quality control materials.
• Spiked Samples: For interference, it's known concentrations of interferents added to serum.

Therefore, the concept of "number of experts" and "qualifications of those experts" for establishing ground truth is not applicable in this context. The accuracy of the "ground truth" relies on the validated performance of the reference methods, predicate device, and QC materials used.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessments. Since this is an analytical performance study of an in-vitro diagnostic reagent, such adjudication methods are not applicable. The measurements are quantitative and objectively determined by the analyzer.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are relevant for devices where human readers or interpreters interact with the device's output (e.g., interpreting medical images with or without AI assistance). This device is a reagent for an automated chemistry analyzer, producing quantitative numerical results, not requiring human interpretation as part of the primary diagnostic step.

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

Yes, the studies described are essentially standalone performance studies of the reagent on the EasyRA analyzer. The performance metrics (linearity, precision, method comparison, sensitivity, interference) evaluate the reagent and analyzer system's ability to accurately and precisely measure HDL cholesterol without human intervention affecting the measurement itself. The "algorithm" here is the chemical reaction and photometric measurement process implemented by the reagent and analyzer.

7. Type of Ground Truth Used

• NIST-traceable commercial linearity standards: For linearity.
• Commercial serum-based Quality control material with known target values: For precision.
• Measurements from a legally marketed predicate device (Genzyme HDL Cholesterol Reagent on Cobas-Mira): For method comparison.
• Reagent grade water: For sensitivity.
• Serum samples spiked with known concentrations of interferents: For interference testing.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of device development. For an IVD reagent, method development involves extensive experimentation and optimization, but it's not typically quantified as a "training set" in the same way a machine learning algorithm would have one. The performance studies described are validation studies, not training studies.

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

As no explicit "training set" is described for this type of IVD reagent, this question is not fully applicable. The development process would involve establishing "ground truth" through various analytical chemistry principles, using reference materials, and comparing results to established methods to optimize the reagent's formulation and reaction conditions.

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EasyRA Calcium Reagent is intended for the quantitative determination of total calcium concentration in serum using the Medica EasyRA Chemistry Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). For in-vitro diagnostic use only. For Professional use only.

The EasyRA Cholesterol Reagent is intended for the quantitative determination of cholesterol in human serum on the Medica EasyRA Chemistry analyzer to screen for elevated cholesterol as a risk factor in coronary artery disease.

For in-vitro diagnostic use only. For Professional Use Only.

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Here's a summary of the acceptance criteria and study information for the EasyRA Calcium Reagent and EasyRA Cholesterol Reagent, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Linearity: The number of unique samples is not specified, but the study used "NIST-traceable commercial linearity standards." The data provenance (country, retrospective/prospective) is not explicitly stated.
• Within Run Precision: Twenty replicates of three levels of commercial human-based QC material were tested. The provenance of the QC material is not specified, but it's "commercial human-based."
• Total Imprecision: Duplicate measurements of each of three levels of QC material were tested twice a day for 20 days. This means 3 levels * 2 replicates/day * 20 days = 120 measurements per reagent. The provenance of the QC material is not specified.
• Method Comparison: At least 40 samples for each analyte were tested. The data provenance is not specified.
• Sample Carryover: 11 samples (L, M, H) in a predefined sequence, tested twice in a single day. The data provenance is not specified.
• Interference Testing: The number of samples for each interfering substance is not explicitly stated, but it involved testing Hemoglobin, Bilirubin, Lipemia (Intralipid), Glucose, and Ascorbic Acid up to specified concentrations. The data provenance is not specified.

In general, the data provenance (country of origin, retrospective/prospective) for these studies is not explicitly mentioned in the provided text.

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

This information is not applicable to this type of device and study. The device is an in-vitro diagnostic reagent for quantitative measurement of analytes (Calcium and Cholesterol) in serum. The "ground truth" is established by reference methods, certified materials (like NIST-traceable standards), or comparison to a legally marketed predicate device, rather than human expert consensus on interpretations of images or complex clinical scenarios.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are focused on analytical performance of a quantitative reagent, not on classifying or interpreting results where human adjudication would be necessary.

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. This is an in-vitro diagnostic reagent, not an AI-assisted diagnostic imaging or interpretation device.

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

This concept is not applicable to a chemical reagent. The device itself is the reagent used in an automated analyzer. The "standalone" performance refers to the analytical performance of the reagent on the EasyRA Chemistry Analyzer, which is precisely what the performance data describes (linearity, precision, interference, carryover). There is no "human-in-the-loop" aspect to the measurement itself; human operators are involved in running the analyzer and interpreting the quantitative results in a clinical context.

7. The Type of Ground Truth Used

• Linearity: NIST-traceable commercial linearity standards.
• Precision (Within Run & Total): Commercial human-based QC material with known (or established) values.
• Method Comparison: Analytical results obtained from the predicate device (Roche COBAS MIRA analyzer), which serves as the comparative "truth" for substantial equivalence.
• Interference Testing: Known concentrations of interfering substances added to samples to assess their impact on the measurement.

8. The Sample Size for the Training Set

This information is not applicable. This device is a chemical reagent and does not use machine learning or AI that requires a "training set" in the conventional sense. Its performance specifications are determined through analytical validation studies as detailed.

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

This information is not applicable as there is no "training set" for this type of device.

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The Diazyme LDL-Cholesterol Assay is intended for the in vitro quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. Elevated LDL cholesterol is the primary target of cholesterol-lowering therapy.

The assay is based on a modified polyvinyl sulfonic acid (PVS) and polyethylene-glycol methyl ether (PEGME) coupled classic precipitation method with the improvements in using optimized quantities of PVS/PEGME and selected detergents. LDL, VLDL. and chylomicron (CM) react with PVS and PEGME and the reaction results in inaccessibility of LDL, VLDL and CM by cholesterol oxidase (CHOD) and cholesterol esterase (CHER), whereas HDL reacts with the enzymes. Addition of R2 containing a specific detergent releases LDL from the PVS/PEGME complex. The released LDL reacts with the enzymes to produce H2O2 which is quantified by the Trinder reaction.

Here's an analysis of the acceptance criteria and study details for the Diazyme LDL-Cholesterol Reagent, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" as distinct, quantifiable thresholds that the device must meet on its own for approval. Instead, the performance of the Diazyme LDL-Cholesterol Reagent is presented and compared primarily to a legally marketed predicate device (Genzyme N-Geneous LDL Cholesterol Reagent, K971573) to demonstrate substantial equivalence. The implication is that performance comparable to the predicate (and within generally accepted clinical laboratory standards for such assays) constitutes the acceptance.

Therefore, the table below reflects the reported performance of the Diazyme device and, for comparison, the predicate device as presented in the submission. The "acceptance criteria" are inferred as comparable performance to the predicate and generally good laboratory practice for quantitative assays.

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

• Sample Size: The document repeatedly mentions "samples tested with Diazyme LDL-Cholesterol Reagent showed good correlation with Genzyme N-geneous LDL Cholesterol Reagent (K971573) with correlation coefficients of 0.996 for serum samples" and refers to "clinical patient samples." However, the exact number of samples used for the method comparison (test set) is not explicitly stated in the provided text.
• Data Provenance: The text does not specify the country of origin of the data. It is implied that the data is retrospective, as it involves "samples tested" and a comparison was made using these samples. The term "clinical patient samples" also suggests that these were real-world samples collected from patients.

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

This information is not provided in the document. For an in vitro diagnostic reagent like this, the "ground truth" for the test set is established by testing the same samples using a well-established, often reference, method or a legally marketed predicate device. The expertise lies in the laboratory performing the tests and ensuring proper execution, not typically in a panel of experts reviewing the results in the same way as, for example, image-based diagnostics.

In this case, the predicate device (Genzyme N-geneous LDL Cholesterol Reagent) serves as the comparator or "reference" for demonstrating substantial equivalence. The ground truth for the predicate device itself is stated to be traceable to the CDC HDL reference method, which is a highly standardized and rigorous method.

4. Adjudication Method for the Test Set

This is not applicable in the context of this type of quantitative diagnostic assay. Adjudication methods (like 2+1 or 3+1) are typically used in studies involving subjective interpretation, such as image analysis where multiple readers might disagree, and a consensus needs to be formed for the ground truth. Here, the "truth" is a quantitative value obtained from a chemical reaction. The comparison is statistical, between two quantitative results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, especially in imaging, where human readers interpret results with and without AI assistance. The Diazyme LDL-Cholesterol Reagent is a laboratory reagent for quantitative chemical analysis, not an AI-assisted diagnostic tool that aids human readers.

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

The entire performance evaluation described for the Diazyme LDL-Cholesterol Reagent is a standalone (algorithm/reagent only) performance. The device is a reagent system that produces a quantitative result. There is no "human-in-the-loop" in the interpretation of the final quantitative value (though humans operate the instruments and handle the samples). The accuracy and precision data presented are reflective of the reagent's performance on its own.

7. The Type of Ground Truth Used

The ground truth used for comparison (and thus, implicitly, for evaluating the Diazyme device) is derived from the results obtained from a legally marketed predicate device (Genzyme N-geneous LDL Cholesterol Reagent, K971573). The submission states: "Genzyme N-geneous LDL Cholesterol Reagent (K971573) was selected for comparing serum samples with to the results generated by Diazyme LDL-Cholesterol Reagent." The predicate device itself traces its calibrator to the NIST SRM 1915b and its method to the CDC HDL reference method, indicating a robust underlying ground truth reference.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided in the document. The Diazyme LDL-Cholesterol Reagent is a chemical reagent assay, not an AI/machine learning model that requires a "training set." Its operating parameters (e.g., reagent concentrations, reaction times) would be optimized during its development process, but this is a different concept from training an algorithm.

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

This information is not applicable as there is no "training set" in the context of this chemical reagent device.

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The Diazyme HDL-Cholesterol reagent is intended for the in vitro quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. Low HDL cholesterol is related to the high risk of coronary heart disease.

The assay is based on a modified polyvinyl sulfonic acid (PVS) and polyethylene-glycol-methyl ether (PEGME) coupled classic precipitation method with the improvements in using optimized quantities of PVS/PEGME and selected detergents. LDL, VLDL, and chylomicron (CM) react with PVS and PEGME and the reaction results in inaccessibility of LDL, VLDL and CM by cholesterol oxidase (CHOD) and cholesterol esterase (CHER). The enzymes selectively react with HDL to produce H2O2 which is detected through a Trinder reaction.

Here's a breakdown of the acceptance criteria and study information for the Diazyme HDL-Cholesterol Reagent, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than explicit pre-defined acceptance criteria in the form of thresholds. Instead, the "acceptance criteria" are implied by showing comparable performance to the predicate device.

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

• Sample Size for Test Set: The document mentions "samples tested with Diazyme HDL-Cholesterol Reagent showed good correlation with Genzyme Ultra N-geneous HDL Cholesterol Reagent (K021316) with correlation coefficients of 0.985 for serum samples." However, the exact number of samples used in the method comparison study (test set) is not specified.
• Data Provenance: The text refers to "clinical patient samples." It does not explicitly state the country of origin or whether the data was retrospective or prospective.

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

• Not Applicable. For this in vitro diagnostic device, "ground truth" is established by comparison to a legally marketed predicate device, not through expert consensus on medical images or clinical outcomes. The predicate device itself serves as the benchmark.

4. Adjudication Method for the Test Set

• Not Applicable. Since ground truth is established by a predicate device's measurement, there is no expert adjudication process in this context. The comparison is a direct quantitative correlation between the results of the new device and the predicate device.

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

• Not Applicable. This is an in vitro diagnostic reagent, not an AI-powered diagnostic imaging device. Therefore, MRMC studies and human reader improvement with AI assistance are not relevant.

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

• Yes, a standalone performance was done for the device itself. The performance characteristics (linearity, precision, accuracy, interference) are all intrinsic to the reagent's analytical capability, independent of a human "in the loop" for interpretation. The comparison is between the new reagent's measurements and those of the predicate reagent.

7. The Type of Ground Truth Used

• Predicate Device Measurement: The "ground truth" for evaluating the Diazyme HDL-Cholesterol Reagent is the results obtained from the Genzyme Ultra N-geneous HDL Cholesterol Reagent (K021316), which is a legally marketed predicate device. This is a form of comparison to a reference method, where the reference is an established and approved device. The predicate device itself measures the outcome (HDL-C concentration).

8. The Sample Size for the Training Set

• Not Applicable / Not Specified. This is a chemical reagent, not a machine learning algorithm that requires a "training set" in the conventional sense. The development of the reagent involves chemical formulation and optimization, not data training.

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

• Not Applicable. As explained above, there is no "training set" for this type of device. The development and validation process focuses on analytical performance characteristics and comparison to an established reference (the predicate device).

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