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CHOLESTEROL: Reagent kit intended for the quantitative determination of Cholesterol in human serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood, of lipid and lipoprotein metabolism disorders.

HDL-Cholesterol: Reagent kit intended for the quantitative determination of high-density lipoprotein in human serum. Measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases.

LDL-Cholesterol: Reagent kit intended for the quantitative determination of low-density lipoprotein in human serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

TRIGLYCERIDES: Reagent kit intended for the quantitative determination of triglycerides (neutral fat) in human serum. 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.

CHOLESTEROL: The Cholesterol Oxidase peroxidase (CHOD-PAP) enzymatic method is used. The cholesterol esterase enzyme catalyzes the hydrolysis of cholesterol and free fatty and free fatty acids. Free cholesterol, including that originally present in the sample, is then oxidized by the enzyme cholesterol oxidase (CHOD) to cholest-4-en-3-one, by using molecular oxygen as the electron acceptor and concurrently producing hydrogen peroxide (H2O2). The H2O2 produced is then used in a subsequent chromogenic oxidative coupling reaction, catalyzed by the enzyme peroxidase, in the presence of a redox indicator system, which leads to the formation of a colored compound, absorbing light at 550 nm. The increase in absorbance is directly proportional to the cholesterol concentration in the sample.

HDL-Cholesterol: The Accelerator Selective Detergent method is applied. The determination of HDL-Cholesterol is based on the following reactions: LDL, VLDL, and chylomicrons are neutralized by the combined action of the enzymes Cholesterol Oxidase, Peroxidase, accelerators and N,N-bis-(4-sulfobutyl)-m-toluidine-disodium (DSBmT). HDL remaining in the sample is disrupted by the action of a selective detergent and cholesterol is converted to △4 Cholestenone by the enzymatic action of Cholesterol Esterase and Cholesterol Oxidase, with the subsequent production of H2O2, which reacts with DSBmT and 4-aminoantipyrine in the presence of Peroxidase to a colored complex that absorbs light at 590 nm. The absorbance measured is proportional to the concentration of HDL-Cholesterol in the sample.

LDL-Cholesterol: The Selective Detergent method is applied. The method is in a two-reagent format and depends on the properties of a unique detergent. The first detergent solubilizes only the non-LDL lipoprotein particles. The cholesterol released is consumed by cholesterol esterase and cholesterol oxidase in a non-color forming reaction. The second detergent solubilizes the remaining LDL particles, and a chromogenic coupler allows for color formation. The enzyme reaction with LDL-Cholesterol in the presence of the coupler at 590 nm produces color that is proportional to the amount of LDL cholesterol present in the sample.

TRIGLYCERIDES: The enzymatic glycerol-3-phosphate-peroxidase (GPO-POD) method is used. The method enzymatically hydrolyzes by lipase to free fatty acids and glycerol is phosphorylated by adenosine triphosphate (ATP) with glycerokinase (GK) to produce glycerol-3-phosphate and adenosine diphosphate (ADP). Glycerol-3-phosphate-oxidase oxidizes glycerol-3-phosphate to dihydroxyacetone phosphate and H2O2. The catalytic action of peroxidase (POD) forms quinoneimine from H202, aminoantipyrine, and Dihydrate (N-Ethyl-N-(2hydroxy-3-sulfopropyl)-m-toluidine (TOOS). The absorption change at 550 nm is proportional to the triglycerides concentration in the sample.

Here's a breakdown of the acceptance criteria and the study information for the Medicon Hellas Cholesterol, HDL-Cholesterol, LDL-Cholesterol, and Triglycerides test systems, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by comparison to legally marketed predicate devices and alignment with clinical laboratory guidelines (CLSI). The document presents a clear comparison in the "Device Comparison Table" sections. For this summary, I'll focus on the key performance indicators for each analyte.

CHOLESTEROL

HDL-Cholesterol

LDL-Cholesterol

TRIGLYCERIDES

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

• Accuracy (Method Comparisons):

  • A minimum of 75 leftover specimens.
  • For the specific analytes:
    • CHOLESTEROL: 93 human serum samples
    • HDL-Cholesterol: 141 human serum samples
    • LDL-Cholesterol: 107 human serum samples
    • TRIGLYCERIDES: 163 human serum samples
  • Data Provenance: The document states "left-over specimens," implying retrospective use of clinical samples. The country of origin is not explicitly stated, but the company is Medicon Hellas, S.A. based in Greece, and testing was performed at the company premises.

• Precision/Reproducibility:

  • Three human serum pools for Cholesterol and Triglycerides.
  • Two pools for HDL-Cholesterol.
  • Four pools for LDL-Cholesterol.
  • Each sample was tested for 20 testing days, two different runs, and two replicate measurements per run (morning and afternoon run), for a total of 80 results per level concentration (e.g., for Cholesterol, 3 pools * 80 results/pool = 240 results).
  • Data Provenance: Human serum pools, likely prepared in-house or acquired for the study.

• Linearity:

  • 11 to 13 levels per analyte, prepared by dilution of a human serum pool.
  • Each level was tested in 4 replicates.
  • Data Provenance: Human serum pool.

• Analytical Specificity / Interference:

  • Serum pools at low and high levels of each analyte.
  • Each measurement of the blank and the sample containing the interferent was repeated at least 5 times.
  • Data Provenance: Serum pools.

• Detection Limit:

  • LoB: 5 blank serum samples measured in 4 replicates for 3 days (total of 60 measurements).
  • LoD: 5 low-level samples measured in 4 replicates for 3 days (total of 60 measurements).
  • LoQ: 10 samples that span the low end of linearity, measured 5 times each day for 3 days (total of 150 measurements).
  • Data Provenance: Serum samples.

• Stability and Calibration Frequency:

  • Two fresh serum pools and two serum-based commercial controls.
  • Measurements were repeated in triplicate at regular time points.
  • Data Provenance: Serum pools and commercial controls.

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

This information is not provided in the document. The ground truth for performance studies like those described (method comparison, precision, linearity, interference, detection limits) for in vitro diagnostic (IVD) devices like these typically involves established reference methods or highly accurate comparative analyzers, rather than expert human interpretation of results. The document states that the performance of the Medicon Hellas reagents was compared with "comparator methods" (Beckman Coulter reagents on AU400, Abbott Diagnostics reagents on Architect c8000), which serve as the reference for ground truth in these types of analytical performance studies. The qualifications of the operators performing these studies are not specified.

4. Adjudication method for the test set

This information is not applicable and therefore not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human interpretation of complex data (like medical images) is involved and a consensus is needed to establish ground truth. For quantitative chemical assays, the ground truth is established by the highly precise and accurate measurement of reference methods or predicate devices.

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 and therefore not provided. MRMC studies are specific to evaluating diagnostic devices where human readers interpret medical cases, often with and without AI assistance (e.g., radiology AI). The Medicon Hellas devices are in vitro diagnostic reagents for quantitative chemical measurements in serum, not image-based diagnostic tools that require human "readers" in the context of an MRMC study.

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

This concept is not applicable in the traditional sense for these in vitro diagnostic reagents. These devices are chemical assays that produce a quantitative numerical output (e.g., cholesterol level in mg/dL). There isn't an "algorithm" making a diagnostic interpretation independently in the way AI software would. The device is the standalone measurement system. Its performance is evaluated independently through analytical studies (precision, linearity, accuracy against reference methods, etc.). The results are then read and interpreted by a human clinician.

7. The type of ground truth used

The ground truth for the analytical performance studies (precision, linearity, interference, detection limits, and method comparison) was established against:

• Reference Methods/Predicate Devices: For method comparison, the device's performance was compared against established comparator methods (Beckman Coulter reagents on AU400 and Abbott Diagnostics reagents on ABBOTT Architect c8000). The document explicitly states these as the comparators.
• A Priori Values/Established Standards: For linearity, precision, and detection limits, the ground truth is based on the known concentrations of prepared samples (e.g., serially diluted pools, spiked samples, blank serum) and statistical analysis according to CLSI guidelines.
• Traceability to Reference Methods/Materials: For Cholesterol and Triglycerides, traceability is to Gas-chromatography-isotope dilution mass spectrometry (GC-IDMS). For HDL-Cholesterol and LDL-Cholesterol, traceability is to the Abell-Kendall (AK) reference method.

8. The sample size for the training set

This information is not applicable and therefore not provided. These are chemical reagent kits, not machine learning (AI/ML) models that require a "training set" in the computational sense. The development of such reagents involves chemical and enzymatic research and optimization, often tested with various batches and concentrations of samples during R&D. The studies described in this document are for validation and verification of the final device, not for "training" an algorithm.

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

As noted above, the concept of a "training set" with ground truth established in the AI/ML sense is not applicable to these chemical reagent devices. The "ground truth" for evaluating the analytical performance of the developed reagent kits is established through the reference methods and standardized protocols described in section 7.

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The Cholestech LDX™ System is a small, portable analyzer and test cassette system is for in vitro diagnostic use only and should not be used for testing in children under the age of 2 years. The Cholestech LDX™ System is comprised of the Cholestech LDX Analyzer and the following cassettes:

The Lipid Profile GLU cassette is for the quantitative determination of total cholesterol, HDL (high-density Ilpoprotein) cholesterol, triglycerides and glucose in whole blood. The TC/HDL (total cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are also reported.

The TC+HDL GLU cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, and glucose in whole blood.

The TC GLU cassette is for the quantitative determination of total cholesterol and glucose in whole blood.

The Lipid Profile cassette is for the quantitative determination of total cholesterol. HDL (high-density lipoprotein) cholesterol, and triglycerides in whole blood. The TC/HDL (total cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are also reported.

The TC+HDL cassette is for the quantitative determination of total cholesterol and HDL (high-density lipoprotein) cholesterol in whole blood.

The TC cassette is for the quantitative determination of total cholesterol in whole blood.

· Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

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

· Triglyceride measurements are used in the diagnosis and treatment with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

· Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The Cholestech LDX ™ system combines enzymatic methodology and solid-phase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube) or venipuncture. The sample is applied to the Cholestech LDX™ cassette®.

The cassette is then placed into the Cholestech LDX™ Analyzer where a unique system on the cassette separates the plasma from the blood cells. A portion of the plasma flows to the right side of the cassette and is transferred to both the total cholesterol and triglyceride reaction pads. Simultaneously, plasma flows to the left side of the cassette where the low- and very low-density lipoproteins (LDL and VLDL) are precipitated with dextran sulfate (50,000 MW) and magnesium acetate precipitating reagent.The filtrate, containing both glucose and HDL cholesterol, is transferred to both the glucose and HDL cholesterol reaction pads.

The Cholestech LDX ™ Analyzer measures total cholesterol and HDL cholesterol by an enzymatic method based on the method formulation of Allain et al, and Roeschlau. Cholesterol esterase hydrolyzes the cholesterol esters in the filtrate or plasma to free cholesterol and the corresponding fatty acid. Cholesterol oxidase, in the presence of oxygen, oxidizes free cholesterol to cholest-4-ene-3-one and hydrogen peroxide. In a reaction catalyzed by horseradish peroxidase, the peroxide reacts with 4-Aminoantipyrine and N-ethyl-N-sulfohydroxypropyl-m-toluidine, sodium sale (TOOS) to form a purple-colored quinoneimine dye proportional to the total cholesterol and HDL cholesterol concentrations of the sample.

The analyzer measures triglycerides by an enzymatic method based on the hydrolysis of triglycerides by lipase to glycerol and free fatty acids. Glycerol, in a reaction catalyzed by glycerol kinase, is converted to glycerol-3-phosphate. In a third reaction, glycerol-3phosphate is oxidized by glycerol phosphate oxidase to dihydroxyacetone phosphate and hydrogen peroxide. The color reaction utilizing horseradish peroxidase is the same as for the total cholesterol and HDL cholesterol. Estimated LDL cholesterol and non-HDL cholesterol and a TC/HDL ratio are calculated using the measured values for TC, HDL, and Triglycerides.

The analyzer measures glucose by an enzymatic method that uses glucose oxidase to catalyze the oxidation of glucose to gluconolactone and hydrogen peroxide. The color reaction utilizing horseradish peroxidase is the same as that for total cholesterol, HDL cholesterol and triglycerides. The resultant color in all the reactions is measured by reflectance photometry.

A brown (magnetic) stripe on each cassette contains the calibration information required for the Cholestech LDX ™ Analyzer to convert the reflectance reading (% R) to the total cholesterol, HDL cholesterol, triglycerides and glucose concentrations.

The provided text is a 510(k) summary for the Cholestech LDX™ System and primarily discusses device modifications and comparison to a predicate device. It certifies that verification studies were performed as required by risk analysis and all acceptance criteria were met. However, it does not provide the specific details of the acceptance criteria or the reported device performance for these studies. It also does not contain information about the sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established for test and training sets.

Therefore, based solely on the provided text, I cannot fulfill most of the requested information regarding the study that proves the device meets the acceptance criteria. The document states that such studies were done and met acceptance criteria, but omits the specifics.

Here's what can be inferred or stated from the provided text, and what is missing:

Table of Acceptance Criteria and Reported Device Performance

Information Not Available in the Text: The document explicitly states, "Verification studies were performed as required by risk analysis and all acceptance criteria were met." However, it does not list the specific acceptance criteria (e.g., specific accuracy thresholds, precision ranges, etc.) or the detailed reported device performance (e.g., actual measured accuracy, precision values, etc.) from these studies. The modification pertains to updating the performance claim related to conjugated and unconjugated Bilirubin interference. While it mentions that less than 10% interference was seen at specified levels for various substances, this is a general statement from the predicate device's limitations, not a specific acceptance criterion for the current modification or the exact performance data achieved.

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

Information Not Available in the Text: The document states that "verification studies" were performed, but it does not specify the sample size (e.g., number of patients, number of samples) used for any test set or the provenance of the data (e.g., country of origin, retrospective or prospective nature of the data collection).

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

Information Not Available in the Text: The document details changes to an in vitro diagnostic (IVD) device for measuring cholesterol, triglycerides, and glucose. For IVD devices, ground truth is typically established by reference laboratory methods, not by human experts interpreting images or clinical cases. Therefore, the concept of "experts" as in radiologists or pathologists establishing ground truth is not applicable here. Even if it were (e.g., for method comparison studies requiring expert clinical correlation), the document does not mention any role for experts in establishing ground truth.

4. Adjudication Method for the Test Set

Information Not Available in the Text: Since the ground truth for an IVD device is generally established using reference methods (as opposed to human interpretation needing adjudication), an adjudication method as typically used in AI studies of imaging (e.g., 2+1, 3+1) is not applicable or described in this 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

Information Not Applicable/Available in the Text: This is an in vitro diagnostic (IVD) device, not an AI-assisted diagnostic imaging device. Therefore, MRMC studies comparing human readers with and without AI assistance are not relevant to this type of device and are not mentioned in the documentation.

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

Information Not Applicable/Available in the Text: The Cholestech LDX™ System is a chemical analyzer, not an AI algorithm. Its performance is inherent to the device's enzymatic and solid-phase technology. The concept of "standalone algorithm performance" without human-in-the-loop is not directly applicable in the same way it would be for a software-as-a-medical-device (SaMD) that processes and interprets data for human review. The document describes the device's direct measurement capabilities.

7. The Type of Ground Truth Used

Inferred from Text: For an in vitro diagnostic device measuring analytes (cholesterol, HDL, triglycerides, glucose), the ground truth is typically established by reference laboratory methods (e.g., highly accurate and precise methods run on core laboratory instruments). While the document does not explicitly state "reference laboratory comparison" for ground truth, the context of an IVD device submission, especially one measuring these specific analytes, strongly implies this method.

8. The Sample Size for the Training Set

Information Not Applicable/Available in the Text: This is a chemical analyzer, not a machine learning or AI-based device that requires a "training set" in the computational sense. The device's operation is based on established enzymatic and chemical reactions, not on data-driven learning. Therefore, there is no "training set" in the context of AI/ML.

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

Information Not Applicable/Available in the Text: As noted above, there is no "training set" for this type of IVD device in the context of AI/ML. The device's calibration and performance are based on chemical principles and validation studies, not on learning from a training dataset.

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The CardioChek Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels Chol+Glu test strips) is for the quantitative determination of total cholesterol and glucose in venous whole blood and capillary whole blood from the fingertip and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. This system is for in vitro diagnostic use only.
· Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
· Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The CardioChek Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels Chol+HDL test strips) is for the quantitative determination of total cholesterol and HDL (high density lipoprotein) cholesterol in venous whole blood and capillary whole blood from the fingertip and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. This system is for in vitro diagnostic use only.
· Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
· HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
A Chol/HDL ratio is calculated by the CardioChek Plus analyzer.

The CardioChek Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels Chol+HDL+Glu test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and glucose in venous whole blood and capillary whole blood from the fingertip and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. This system is for in vitro diagnostic use only.
· Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
· HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
· Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
A Chol/HDL ratio is calculated by the CardioChek Plus analyzer.

The CardioChek Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels Lipid Panel test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides in venous whole blood and capillary whole blood from the fingertip and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. This system is for in vitro diagnostic use only.
· Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
· HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
· Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellius, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders.
A Chol/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek Plus Analyzer.

The CardioChek Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels eGlu test strips) is for the quantitative determination of glucose in venous whole blood from the fingertip and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. This system is for in vitro diagnostic use only.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The CardioChek Plus Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus Home Chol+Glu test strips) is for the quantitative determination of total cholesterol and glucose in capillary whole blood from the fingertip and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only.
· Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
· Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The CardioChek Plus Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus Home Chol+HDL test strips) is for the quantitative determination of total cholesterol and HDL (high density lipoprotein) cholesterol in capillary whole blood from the fingertip and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only.
· Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
· HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
A Chol/HDL ratio is calculated by the CardioChek Plus Home analyzer

The CardioChek Plus Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus Home Chol+HDL+Glu test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and glucose in capillary whole blood from the fingertip and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only.
· Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
· HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
· Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
A Chol/HDL ratio is calculated by the CardioChek Plus Home analyzer.

The CardioChek Plus Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus Home Lipid Panel test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides in capillary whole blood from the fingertip and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only.
· Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
· HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
· Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellius, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders.
A Chol/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek Plus Home Analyzer.

The CardioChek Plus Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus Home eGlu test strips) is for the quantitative determination of glucose in capillary whole blood from the fingertip and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The CardioChek Plus and CardioChek Plus Home analyzers are professional (Rx) use (CardioChek Plus) and home use/OTC (CardioChek Plus Home) in vitro diagnostic systems to measure various analytes in capillary fingerstick whole blood for both home and professional use and in venous whole blood for professional use only for glucose, cholesterol, HDL cholesterol, and triglycerides. The system includes a small analyzer and test strips. The analyzers utilize PTS Diagnostics brands of dry strip chemistry test strips. The test strips are single-use and utilize one of two types of technologies: reflectance photometry and amperometric/electrochemical technology. The test strips are used with the CardioChek Plus and CardioChek Plus Home analyzers to measure total cholesterol, HDL cholesterol, triglycerides, and glucose in whole blood. The test strips utilize enzymatic methods on dry colorimetric test strips that are read by reflectance photometry or amperometric/electrochemical test strips that measure the current produced when blood is applied to the test strip. These test strips are for in vitro diagnostic use only. The analyzer has software that converts the reflectance or current produced into an analyte concentration by comparing the reading to a lot-specific calibration curve that is programmed into a EEPROM MEMo chip that is inserted into the analyzer. Each vial of test strips includes a lot-specific MEMo chip, thus eliminating any need for the user to calibrate the system. The analyzer is powered by 4 AA alkaline batteries.

The supplied document is a 510(k) premarket notification for a modification to an existing device, the CardioChek Plus Test System and CardioChek Plus Home Test System. This notification focuses on a design change to the battery compartment of the analyzer case to prevent overheating due to incorrect battery insertion. Therefore, the information provided primarily addresses the modification and its impact, rather than a comprehensive study on the overall device performance against acceptance criteria for its intended use (measurement of cholesterol, HDL, triglycerides, and glucose).

Here's an analysis based on the provided text:

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

The document does not provide a table of acceptance criteria for the analytical performance of the CardioChek Plus Test System (e.g., accuracy, precision for cholesterol, glucose, etc.) nor does it report the device performance against such criteria. This is because the submission is for a modification to an already cleared device, K140068, which likely established those initial performance criteria. The current submission's "testing" section is solely focused on the battery compartment modification.

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

The document does not specify a distinct "test set sample size" for the battery compartment modification study in terms of number of devices or number of tests. It broadly states "Testing of the modified battery compartment of the case showed that the new design prevented the negative terminal...". The nature of this testing would likely involve physical examination and insertion attempts, rather than a large-scale clinical study.

Data Provenance: Not specified, but implied to be from the manufacturer's internal testing.

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

This information is not applicable to the type of modification described. Ground truth in this context would likely be engineering verification that the physical design change addresses the identified safety issue. No external experts or their qualifications are mentioned for this specific modification testing.

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

Not applicable. This type of engineering verification for a physical modification does not typically involve adjudication methods like those used in clinical or image-based studies.

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. The device is a diagnostic test system for quantitative determination of analytes, not an AI-assisted diagnostic imaging or interpretation tool.

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

Not applicable. The device is a physical diagnostic system, not an algorithm.

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

For the battery compartment modification, the "ground truth" would be the successful physical prevention of contact between the incorrectly inserted negative battery terminal and the positive terminal of the case, and the absence of battery overheating, verified through engineering tests. This is a technical, hardware-level verification, not based on clinical "expert consensus, pathology, or outcomes data."

For the original performance of the analytes (cholesterol, glucose, etc.), the ground truth would likely have been established during the clearance of the predicate device (K140068) using reference methods or clinical laboratory analyzers. However, this document does not detail those studies.

8. The sample size for the training set

Not applicable. This is a hardware modification for an existing device, not an AI or algorithm-based device that would require a training set.

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

Not applicable, as no training set is relevant to this submission.

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Rx Only For in vitro diagnostic use only

The TRIG test within the VITROS XT Chemistry Products TRIG-CHOL Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS XT 7600 Integrated Systems. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver diseases involving lipid metabolism, or various endocrine disorders.

The CHOL test within the VITROS XT Chemistry Products TRIG-CHOL Slides quantitatively measure cholesterol (CHOL) concentration in serum and plasma using VITROS XT 7600 Integrated Systems. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases.

The new device, the VITROS XT Chemistry Products TRIG-CHOL Slide is a single device that contains both a TRIG test and a CHOL test multilayered, analytical elements coated on a polyester support separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur and test results are generated for each analyte independently of the other analyte.

To perform the TRIG test, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. The Triton X-100 surfactant in the spreading layer aids in dissociating the triglycerides from lipoprotein complexes present in the sample. The triglyceride molecules are then hydrolyzed by lipase to yield glycerol and fatty acids. Glycerol diffuses to the reagent layer, where it is phosphorylated by glycerol kinase in the presence of adenosine triphosphate (ATP). In the presence of L-a-glycerolphosphate oxidase, L-α-glycerophosphate is then oxidized to dihydrox vacetone phosphate and hydrogen peroxide. The final reaction involves the oxidation of a leuco dye by hydrogen peroxide, catalyzed by peroxidase, to produce a dye. The density of the dye formed is proportional to the triglyceride concentration present in the sample and is measured by reflectance spectrophotometry.

To perform the CHOL test, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. The Triton X-100 (TX100) surfactant in the spreading layer aids in dissociating the cholesterol and cholesterol esters from lipoprotein complexes present in the sample. Hydrolysis of the cholesterol esters to cholesterol is catalyzed by cholesterol ester hydrolase. Free cholesterol is then oxidized in the presence of cholesterol oxidase to form cholestenone and hydrogen peroxide. Finally, hydrogen peroxide oxidizes a leuco dye in the presence of peroxidase to generate a colored dye. The density of dye formed is proportional to the cholesterol concentration present in the sample and is measured by reflectance spectrophotometry.

The provided text describes the analytical performance of the VITROS XT Chemistry Products TRIG-CHOL Slides, an in vitro diagnostic device for quantitatively measuring triglyceride (TRIG) and cholesterol (CHOL) concentrations in serum and plasma.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly present a table of "acceptance criteria" but rather reports the analytical performance of the new device and shows its comparison to the predicate devices. The implicit acceptance criteria are that the new device performs at least as well as, and is substantially equivalent to, the predicate devices. The reported performance metrics are detailed in the tables for method comparison, precision, detection capability, and linearity.

TRIG Test

CHOL Test

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

• Method Comparison: 148 serum samples were used for both TRIG and CHOL tests.
• Precision: 80 observations (2 replicates per run, 2 runs per day over 20 days) for serum samples (patient pools and quality control materials).
• Detection Capability (LoQ): 180 determinations for both TRIG and CHOL.
• Linearity: Eighteen proportionally related admixtures of low and high test fluids, each tested in quadruplicate.

The data provenance is not explicitly stated in terms of country of origin or whether the samples were retrospective or prospective. It implies the use of patient samples, but specific details are absent.

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

This document describes the analytical performance of an in vitro diagnostic device, not a device that relies on expert human interpretation for its output (like an AI imaging device). Therefore, there is no mention of "experts used to establish the ground truth" in the way it would apply to a clinical imaging study or a study validating human performance. The "ground truth" for this type of device is established by its quantitative measurements against established analytical standards and reference methods/predicate devices.

4. Adjudication method for the test set

Not applicable. As noted above, this is an analytical performance study for an in vitro diagnostic device, not a human reader study requiring adjudication.

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

Not applicable. This is an analytical performance study of an in vitro diagnostic device, not an AI-assisted diagnostic tool that would involve human readers.

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

Yes, this entire study represents a "standalone" performance evaluation of the device (VITROS XT Chemistry Products TRIG-CHOL Slides on the VITROS XT 7600 Integrated System) without human intervention in the result generation. The device quantitatively measures the analytes.

7. The type of ground truth used

The ground truth for this in vitro diagnostic device is established through:

• Comparison to a legally marketed predicate device: The VITROS Chemistry Products TRIG Slides and VITROS Chemistry Products CHOL Slides. This implies that the predicate devices serve as the established reference standard for performance.
• Established analytical methods and materials: CLSI protocols (EP09c, EP05-A3, EP17-A2, EP06-A, EP07-03) are referenced, which dictate the methodology for evaluating analytical performance parameters.
• Quality Control Materials and reference pools: Used in precision and linearity studies.
• Clinically established guidelines: NCEP guidelines are referenced for expected values/classification of TRIG and CHOL, indicating alignment with clinical understanding of these analytes.

8. The sample size for the training set

This document describes pre-market validation studies for a diagnostic test kit and instrument system. It does not refer to a "training set" in the context of machine learning or AI. The development of such a device involves internal optimization and development work, but the data presented in this 510(k) summary are for the validation of the finalized product.

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

Not applicable, as this refers to a diagnostic test kit and instrument's analytical validation, not an AI or machine learning model that would involve a "training set" with ground truth established through expert annotation.

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The PTS Professional Chemistry Kit is a medical device convenience kit that quantitatively measures the percent of glycated hemoglobin (%Alc), total cholesterol, high density lipoprotein (HDL), triglycerides, and glucose in capillary (fingerstick) or venous whole blood.

· Cholesterol measurements are used in the diagnosis and treatments of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

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

· Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellius, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders.

· Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

• The HbA1C test provides quantitative measurement of the percent of glycated hemoglobin levels. The test is for professional use to monitor glycemic control in people with diabetes.

The PTS Professional Chemistry Kit combines devices that are already cleared and packages them together for the convenience of the user.

There are two CardioChek® Analyzers: the CardioChek® PA Analyzer and the CardioChek® Plus Analyzer. These analyzers are part of portable test systems. The CardioChek® PA test system and the CardioChek® Plus test system consist of their respective analyzer and PTS Panels® Test Strips with a lotspecific MEMo® Chip.

The CardioChek® PA and Plus test systems are for the quantitative determination of glucose, total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides in venous whole blood and capillary whole blood from the fingertip and are intended for multiple patient uses in professional healthcare settings. These systems are for in vitro diagnostic use only.

The PTS Panels® Test Strips consist of varying amounts of test strips packed into a vial and a lot-specific MEMo® Chip. PTS Panels® Test Strips include reflectance and electrochemical test strips. The reflectance assays include quantitative determination of glucose, total cholesterol. HDL (high density lipoprotein) cholesterol and triglycerides. The electrochemical assay is for glucose measurement. The reflectance test strips are available with one, two, and three assays and come in various combinations of assays. The included PTS Panels® Test Strips include: PTS Panels® Lipid Panel Test Strips, PTS Panels® Chol+HDL+Glu Test Strips, PTS Panels® Chol+HDL Test Strips, PTS Panels® Chol+Clu Test Strips, PTS Panels® eGlu Test Strips, PTS Panel® Glucose Test Strips, and CardioChek Plus Smart Bundle™ Pack. The PTS Panels® Test Strips are single-use.

PTS Panels® Controls contain chemicals that react with test strips to produce color or an electrical current depending on the test strips used. Controls should be run to verify the test system performance, when results are questionable, to comply with a facility's quality control requirements, or as required by local accrediting and regulatory bodies. They contain two vials of control solution that have two levels of each analyte. Controls included in this kit are the PTS Panels® HDL Cholesterol Controls and PTS Panels® Multi-Chemistry Controls.

The PTS Collect™ Capillary Tubes are a glass and plastic tube capable of dispensing an exact volume of blood from the capillary tube to a test strip. The tubes are available with volumes of 15, 20, 30, and 40 uL.

The A1CNow + test provides quantitative measurement of glycated hemoglobin (%A1C) levels in capillary (fingerstick) or venous whole blood samples. A1CNow®+ consists of three components: a semi-disposable plastic-encased device (the analyzer), a plastic cartridge enclosing dry reagent strips, and a shaker kit. The units of the analyzer are pre-programmed on the analyzer and are available in either percentage of glycated hemoglobin (%A1C) or millimoles per mole (mmol/mol). The analyzers are lot specific and intended to be discarded once the provided cartridges are consumed.

The Unistik® 3 Pre-set Single Use Safety Lancets are sterile, single-use, auto-disabling lancets to perform finger sticks to obtain capillary blood.

The PTS Connect™ Dock and PTS Connect® ProLink are included to transfer data from the CardioChek® Plus Analyzer, CardioChek® PA Analyzer, and the A1CNow®+ to computer systems. The CardioChek® Printer interfaces with the CardioChek® Plus and CardioChek® PA Analyzer to print results onto paper and self-adhesive labels.

The PTS Professional Chemistry Kit contents are customizable according to user needs. Individual kits may not contain all the devices described in this submission.

The provided text describes the 510(k) premarket notification for the "PTS Professional Chemistry Kit." However, it does not contain a study demonstrating the device meets specific acceptance criteria in the format requested.

Instead, the document states that the "PTS Professional Chemistry Kit" is a convenience kit combining previously cleared devices. Therefore, the performance criteria and studies for each individual component refer to their original 510(k) clearances.

The available information is as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria for the kit itself. Instead, it refers to the performance established for its individual components in their respective prior 510(k) clearances. The "Similarities" table indicates the analytes measured and the intended use are the same as the predicate devices.

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

This information is not provided in the given document for the "PTS Professional Chemistry Kit." It would be found within the detailed clinical and non-clinical testing reports for the individual predicate devices (K140068, K090413, K151545, K162282, K071507, K041750, K014099).

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 provided in the given document. It is relevant for image-based diagnostic AI, not typically for chemical test kits like this. The ground truth for chemical analytes is established through laboratory reference methods.

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

This information is not applicable and not provided in the given document. Adjudication methods are typically used in clinical studies involving interpretation of results, often for imaging or subjective assessments, not for quantitative chemical measurements.

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 and not provided in the given document. MRMC studies are relevant for human-in-the-loop AI systems that assist human readers in interpreting complex data (e.g., radiology images). This device is a quantitative chemical test kit.

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

The device measures chemical analytes directly. The performance described (precision, linearity, limit of detection, analytical specificity, method comparison) for the predicate devices would inherently be "standalone" performance for the instrument measuring the analytes. The "PTS Professional Chemistry Kit" itself is a collection of these standalone devices.

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

For chemical measurement devices, the ground truth is typically established using reference laboratory methods (e.g., standardized assays on high-precision lab equipment). The document mentions "method comparison" studies, implying comparison against such reference methods.

8. The sample size for the training set:

This information is not provided in the given document. For traditional chemical test kits, a "training set" in the machine learning sense is not typically used. Instead, methods are developed and validated through extensive analytical testing and calibration curves.

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

As mentioned, a "training set" as understood in AI/ML is not directly applicable here. For the development and validation of these chemical assays, the "ground truth" (i.e., true concentration values) would be established using reference laboratory methods for calibrating the devices and evaluating their accuracy against known standards.

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The Extended Lipid Panel Assay is an in vitro diagnostic test for quantitative determination of Total Cholesterol, High Density Lipoprotein Cholesterol, and Triglycerides in human serum and Apolipoprotein B in human serum. Values for Total Cholesterol, High Density Lipoprotein Cholesterol, Triglycerides and Apolipoprotein B are calculated by the Vantera® Clinical Analyzer.

· Total Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood, lipid and lipoprotein metabolism disorders.

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

· 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.

· Apolipoprotein B measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis.

The Extended Lipid Panel Assay involves the acquisition of a 400 MHz proton NMR spectrum of serum or plasma, passing the spectral information through a Partial Least Squares (PLS) regression model, and deriving analyte concentrations from the spectrum based on the trained PLS model. The proton NMR spectrum of serum and plasma is replete with information from the lipids packaged in lipoproteins. The spectrum consists of multiple proton signals emanating from the TG, cholesteryl esters and free cholesterol present in chylomicrons, VLDL, LDL and HDL, out of which the methylene and methyl proton signals are the most abundant. NMR spectra were recorded for several hundred to several thousand representative serum specimens for which the TG, TC, HDL-C and ApoB were chemically measured. Using a PLS regression routine, the spectral information in the combined methylene and methyl region (0.56 - 1.40 ppm) was trained against the chemical measurements where the information is connected through latent variables. Cross-validation was performed with PRESS statistics to optimize the regression model with an appropriate number of latent variables. Once trained with sufficient number of specimens, for any test specimen spectrum, the spectral information is then converted into lipid or ApoB concentrations through the optimum number of 24 to 27 latent variables for which the regression coefficients were known from the predictor matrix.

The Extended Lipid Panel Assay is an in vitro diagnostic test for the quantitative determination of Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein B (ApoB) in human serum and plasma. The device uses Nuclear Magnetic Resonance (NMR) technology to derive analyte concentrations.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are demonstrated through various analytical performance studies. The document does not explicitly state pre-defined acceptance criteria in a dedicated table with pass/fail results against specific thresholds for each performance metric, but rather presents the results of these studies. Based on the provided performance data, the implicit acceptance criteria would be for the device to show good analytical sensitivity, precision, linearity, and minimal interference, and to demonstrate substantial equivalence to predicate devices through method comparison studies.

Below is a table summarizing the reported device performance, which implicitly demonstrates it meets the necessary criteria for "substantial equivalence" based on the FDA's assessment in the 510(k) clearance.

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

• Analytical Sensitivity (LoQ): Not specified how "LoQ" was determined by sample size, but indicates "lowest concentration measurable with acceptable precision and accuracy."
• Assay Precision (Within-run and Within-laboratory): 20 replicates for within-run and 80 replicates (for n=80, it means 40 total runs over 20 days with 2 replicates per run on 1 instrument) for within-laboratory precision, using three patient serum pools (low, medium, high). The provenance is "patient serum pools."
• Reproducibility: Five levels of serum panels were tested for 5 days, 6 runs per day, 2 replicates per run at 3 sites. This results in 5 (levels) * 5 (days) * 6 (runs/day) * 2 (replicates/run) * 3 (sites) = 900 measurements per analyte. The provenance is from "serum panels," presumably patient-derived.
• Linearity: "Reference serum pools were prepared from patient specimens with low to high values" and "mean values from analysis of four replicates of each pool" were used. The exact number of 'pools' created for each analyte is not explicitly stated but implies multiple points across the range. The provenance is "patient specimens."
• Interfering Substances: "samples with spiked concentrations of interferent" were used. The number of samples is not specified, but it covered "Eight endogenous agents and thirty drugs."
• Method Comparison:
  • TC: n=281 pooled serum samples
  • TG: n=270 pooled serum samples
  • HDL-C: n=15575 (This number seems exceptionally high compared to other n values; it might be a typo or represent cumulative data points over various experiments) pooled serum samples
  • ApoB: n=266 pooled serum samples
    The data provenance for method comparison is "pooled serum samples across the reportable range" of the device. All studies appear to be retrospective using banked or prepared samples, as typical for analytical performance studies of this nature. The country of origin is not specified but is presumably the US given the FDA submission.

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

This device is a clinical chemistry assay for quantifying specific analytes (TC, TG, HDL-C, ApoB) rather than an imaging or diagnostic AI device that interprets qualitative information and requires human expert consensus for ground truth.

• Ground Truth for Method Comparison: The "ground truth" for the method comparison studies was established by predicate clinical chemistry devices (biochemical assays like enzymatic colorimetric assay or nephelometric immunoassay). These are established methods that serve as the comparative standard. No human experts were involved in establishing the ground truth for the values themselves, as it's a quantitative measurement.
• Qualifications of Experts: Not applicable in the context of establishing ground truth for quantitative chemical measurements. However, the development, validation, and regulatory submission would have been overseen by qualified scientists and regulatory affairs professionals.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for qualitative or semi-quantitative diagnostic devices where human interpretation might differ, and an expert panel resolves discrepancies to establish ground truth. For quantitative clinical chemistry assays, the reference method (predicate device in this case) provides the "adjudicated" ground truth.

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. MRMC studies are designed for evaluating diagnostic devices that involve human interpretation of images or other qualitative data, often with AI assistance, to assess the impact of AI on reader performance. This device is a standalone clinical chemistry analyzer that provides quantitative measurements; it does not involve human "readers" or AI assistance in a diagnostic interpretation workflow.

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

Yes, this device is inherently a standalone algorithm. The Extended Lipid Panel Assay is described as utilizing "passing the spectral information through a Partial Least Squares (PLS) regression model, and deriving analyte concentrations from the spectrum based on the trained PLS model." This process is entirely automated and does not involve human intervention in the result generation once the sample is run on the Vantera® Clinical Analyzer. The performance studies (precision, linearity, method comparison) directly evaluate this standalone algorithmic performance.

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

The ground truth for evaluating the Extended Lipid Panel Assay was based on measurements obtained from legally marketed predicate clinical chemistry devices. These predicate devices are established methods for quantifying the specific lipid and lipoprotein analytes (TC, TG, HDL-C, ApoB).

8. The sample size for the training set

For the Partial Least Squares (PLS) regression model: "NMR spectra were recorded for several hundred to several thousand representative serum specimens for which the TG, TC, HDL-C and ApoB were chemically measured." The exact number is not precisely stated but indicates a substantial training dataset.

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

The ground truth for the training set was established by chemical measurements (presumably using standard, often wet-chemistry or enzymatic reference methods) for TG, TC, HDL-C, and ApoB on the "several hundred to several thousand representative serum specimens." These chemical measurements served as the target values for the PLS regression model to learn the relationship between the NMR spectra and the analyte concentrations.

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SD LipidoCare BT Home System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertip. SD LipidoCare BT Home System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use).

The glucose testing system is for use by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare BT Home System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, and triglycerides.

SD LipidoCare BT Home Blood Glucose Test Strips are for use with SD LipidoCare BT Home Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by a single person and should not be shared. SD LipidoCare BT Home Lipid Profile Test Strips are intended for use with the SD LipidoCare BT Home Analyzer to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by a single person and should not be shared.

SD LipidoCare BT Professional System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertip. SD LipidoCare BT Professional System is intended to be used by lay-users and medical professionals. It is intended to be used by a single person and should not be shared. It is intended for testing outside the body (in vitro diagnostic use).

The glucose testing system is for people with diabetes as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare BT Professional System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, and triglycerides.

SD LipidoCare BT Professional Blood Glucose Test Strips are for use with SD LipidoCare BT Professional Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by lay users and medical professionals. SD LipidoCare BT Profile Test Strips are intended for use with the SD LipidoCare BT Professional Analyzer to be used to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by lay users and medical professionals.

SD LipidoCare Home System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertip. SD LipidoCare Home System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use).

The glucose testing system is for use by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare Home System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, and triglycerides.

SD LipidoCare Home Blood Glucose Test Strips are for use with SD LipidoCare Home Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by a single person and should not be shared. SD LipidoCare Home Lipid Profile Test Strips are intended for use with the SD LipidoCare Home Analyzer to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by a single person and should not be shared.

SD LipidoCare Professional System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertip. SD LipidoCare Professional System is intended to be used by lay-users and medical professionals. It is intended to be used by a single person and should not be shared. It is intended for testing outside the body (in vitro diagnostic use).

The glucose testing system is for people with diabetes as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare Professional System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatments with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, and triglycerides.

SD LipidoCare Professional Blood Glucose Test Strips are for use with SD LipidoCare Professional Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, or upper arm by lay users and medical professional Lipid Profile Test Strips are intended for use with the SD LipidoCare Professional Analyzer to be used to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by lay users and medical professionals.

SD LipidoCare (BT) Professional/Home Analyzer can measure TC, TG, HDL, and Glucose, and it also can calculate LDL and non-HDL using the blood sample from the human with the SD LipidoCare (BT) Profiessional/Home Lipid Profile and SD LipidoCare (BT) Professional/Home Glucose test strips. This system is portable using batteries for power source and can store up to 500 test results in the memory. Users can search the stored results and can review the average results for 7, 15 and 30 day glucose test results. The average calculation function is for glucose test results only. This system can set the beep, date, time, unit, auto printing, simplex/duplex printing, hypo warning for glucose, alarms and Bluetooth. The analyzer offers 2 models: one with Bluetooth function for printing the test results and transferring data to a PC via Bluetooth technology and the other without it. The analyzer without the Bluetooth unit can still print the test results and transfer the data to a PC using a cable.

The system includes Lipid Profile Test Strip which is based on a reflectance photometry, and Glucose Test Strip which is based on glucose oxidase biosensor.

There are also lipid check strips and glucose check the internal malfunction (or problem) of the analyzer prior to testing.

The code chip is for the analyzer to read the lot-specific characteristics of the test strips currently in use. The SD Ezi Tube+ is used to apply blood sample for lipid profile testing.

Here's a breakdown of the acceptance criteria and the study information for the SD LipidoCare systems, based on the provided document:

The document combines information for four devices: SD LipidoCare Home System, SD LipidoCare Professional System, SD LipidoCare BT Home System, and SD LipidoCare BT Professional System. All four systems are intended for the quantitative measurement of glucose, total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood. The "BT" versions add Bluetooth functionality.

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed clinical study report with explicit acceptance criteria for each performance metric. Therefore, some information, particularly around specific acceptance criteria values and the detailed methodology of how "ground truth" was established, is inferred or generalized from the context of substantial equivalence testing for IVD devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for the subject devices (SD LipidoCare systems). Instead, it relies on demonstrating substantial equivalence to predicate devices. However, it does list the test ranges for both the predicate and new devices, which can be seen as the operational range where performance is expected to be acceptable. Performance is generally presented as "substantially equivalent" rather than with specific quantifiable metrics against a pre-defined criterion table.

Inferred Performance and Comparison:

Acceptance Criteria Implication: For many IVD devices, acceptance criteria often relate to accuracy (bias, precision), linearity, interference, and user performance. The document states that "We performed various clinical and bench tests and the test results supported that despite these differences the [subject device is] substantially equivalent to the predicate devices." This implies that the performance of the new devices, within their specified (and sometimes wider) ranges, met the accepted performance characteristics typically associated with the predicate devices, thereby not raising questions of safety and effectiveness.

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

The document does not specify the sample size used for the "clinical and bench tests" that demonstrated substantial equivalence.

Data Provenance: The manufacturer is SD Biosensor, Inc. from the Republic of Korea. The document does not explicitly state whether the data was retrospective or prospective, but clinical and bench testing for 510(k) submissions are typically prospective studies designed to evaluate the new device's performance.

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

The document does not specify the number or qualifications of experts used to establish ground truth. For in vitro diagnostic (IVD) devices measuring biomarkers, ground truth is typically established using established laboratory reference methods performed by qualified laboratory personnel, rather than expert consensus on image interpretation.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method. For quantitative measurements by IVD devices, adjudication (like 2+1 or 3+1 for imaging studies) is generally not applicable in the same way. The comparison is usually made directly against a reference 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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where AI assists human readers. The SD LipidoCare systems are in vitro diagnostic devices for quantitative measurement of blood analytes.

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

The device itself is a standalone measurement system (analyzer and test strips). Its performance is inherently "standalone" in the sense that it provides a quantitative result without direct human interpretation of complex visual data or complex human-AI interaction. The "clinical and bench tests" would have evaluated this standalone performance.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For IVD devices measuring analytes like glucose, total cholesterol, triglycerides, and HDL cholesterol, the ground truth is typically established using reference laboratory methods (e.g., enzymatic colorimetric methods on a chemistry analyzer) operated by trained laboratory professionals. These methods are considered the gold standard for accurate quantitative measurements for these specific analytes in blood. The document implies this approach through its discussion of "Substantial Equivalence," which generally means the device's results correlate sufficiently with established laboratory methods.

8. The Sample Size for the Training Set

The document does not specify the sample size for a "training set." These devices typically do not involve AI algorithms that require explicit "training sets" in the conventional machine learning sense. Their performance is based on the chemical and enzymatic reactions within the test strips and the photometric/biosensor reading technology, which are validated through analytical and clinical studies.

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

As noted above, a "training set" in the machine learning sense is not applicable here. The device's underlying principles (e.g., enzymatic reactions for glucose, photometric reading for lipids) are based on established scientific methods. Any calibration or internal adjustments made during manufacturing (which would be analogous to "training" in a very broad sense) would be done against reference standards, with the "ground truth" being the known concentrations of those reference standards.

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The Mission® Cholesterol Monitoring System is intended for the quantitative determination of Total Cholesterol. High Density Lipoprotein Cholesterol, and Triglycerides in human capillary whole blood from the fingertip. The Mission Cholesterol Monitoring System is a portable system consisting of the Mission Cholesterol Mission Cholesterol Test Cartridges, Mission Cholesterol Optical Verifier and Mission Cholesterol Control Solution, and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only.

Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

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

Trighcerides measurements are used in the diagnosis and treatment with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism or various endocrine disorders.

Use this product at the frequency your doctor recommends for testing Total Cholesterol, and Triglycerides.

An estimated value for Low Density Lipoprotein Cholesterol is calculated by the Mission Cholesterol Meter and is reported only when Triglycerides are <400 mg/dL.

The Mission® Cholesterol Pro Monitoring System is intended for the quantitative determination of Total Cholesterol. High Density Lipoprotein Cholesterol, and Triglycerides in human capillary whole blood from the fingertip and lithium heparin venous whole blood. The Mission Cholesterol Pro Monitoring System is a portable system consisting of the Mission Cholesterol Pro Meter, Mission Cholesterol Pro Test Cartridges, Mission Cholesterol Optical Verifier, and Mission Cholesterol Control Solution, and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. This system is for in vitro diagnostic use only.

Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

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

Triglycerides measurements are used in the diagnosis and treatments with diabetes mellitus. nephrosis, liver obstruction, and other diseases involving lipid metabolism or various endocrine disorders.

An estimated value for Low Density Lipoprotein Cholesterol is calculated by the Mission Cholesterol Meter and is reported only when Triglycerides are <400 mg/dL.

Over the Counter (home use): The Mission Cholesterol Monitoring System is a portable system consisting of the Mission Cholesterol Meter, Mission Cholesterol Test Cartridges, Mission Cholesterol Optical Verifier and Mission Cholesterol Control Solution and is intended to be used by a single person and should not be shared.
The Mission Cholesterol Monitoring System is designed for the quantitative measurement of Total Cholesterol (CHOL), High Density Lipoprotein Cholesterol (HDL) and Triglycerides (TRIG) in capillary whole blood from the fingertip. The Mission Cholesterol Meter is an in vitro diagnostic device consisting of a reflectance photometer that analyzes the intensity and color of light reflected from the reagent area of the test cartridge. This device measures analytes in blood once the blood is applied to dry phase test cartridges that are specifically designed for reflectance analysis.

Professional: The Mission Cholesterol Pro Monitoring System is a portable system consisting of the Mission Cholesterol Pro Meter. Mission Cholesterol Pro Test Cartridges. Mission Cholesterol Pro Optical Verifier and Mission Cholesterol Pro Control Solution and is intended for professional use in healthcare settings for multiple patient uses.
The Mission Cholesterol Pro Monitoring System is designed for the quantitative measurement of Total Cholesterol (CHOL), High Density Lipoprotein Cholesterol (HDL) and Triglycerides (TRIG) in capillary and venous human whole blood. The Mission Cholesterol Pro Meter is an in vitro diagnostic device consisting of a reflectance photometer that analyzes the intensity and color of light reflected from the reagent area of the test cartridge. This device measures analytes in blood once the blood is applied to dry phase test cartridges that are specifically designed for reflectance analysis.

Test Cartridge:
The Mission Cholesterol (Home use) Test Cartridge is a 3 in 1 Lipid Panel test device used to measure concentration of CHOL, HDL and TRIG in capillary whole blood from the fingertip. A code Chip automatically calibrates the meter with the code number of the cartridges when inserted into the meter.

The Mission Cholesterol Pro (Professional) Test Cartridge is a 3 in 1 Lipid Panel test device used to measure concentration of CHOL, HDL and TRIG in capillary and venous human whole blood. A code Chip automatically calibrates the meter with the code number of the cartridges when inserted into the meter.

Control Solution:
Both the Mission® Cholesterol (home use) Monitoring System's and the Mission® Cholesterol Pro Monitoring System's Control Solutions are used to estimate precision of meter readings for determination of total cholesterol (CHOL), high density lipoprotein cholesterol (HDL) and triglycerides (TRIG).

Optical verifier:
Both the Mission® Cholesterol (home use) Monitoring System's and the Mission® Cholesterol Pro Monitoring System's Optical Verifiers are used to verify that the meter functions properly by checking that the meter can detect a pre-calibrated value.

Here's a summary of the acceptance criteria and study findings for the Mission Cholesterol Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state formal "acceptance criteria" values in a table. However, the linearity, precision, and bias data are direct measures of performance against presumed internal or regulatory benchmarks for acceptable accuracy and precision in cholesterol measurement devices. We will infer the reported device performance from the study results presented.

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

• Sample Size: A total of 369 patients were recruited for the clinical study.
• Data Provenance: The study was conducted at three point-of-care (POC) sites located in different geographical locations. It is a prospective clinical study as patients were recruited and tested specifically for this study. The country of origin is not explicitly stated, but given the FDA submission, it can be inferred to be compliant with US regulatory standards, likely involving data collected within the US or under equivalent standards.

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

The document does not explicitly state the number of experts. However, it mentions:

• "For professional use, patient blood was collected from fingertip and venous blood draws. Capillary blood samples from fingertip were tested at clinical sites by professionals. Venous blood samples were tested at a laboratory using an FDA cleared method."
• "The plasma concentration was confirmed by the reference method."

This implies that trained "professionals" (likely medical technicians or laboratory personnel) performed the official comparative testing, and an FDA-cleared reference method was used to establish the ground truth. No specific number or qualification (e.g., "radiologist with 10 years of experience") for these "professionals" is given beyond their professional role in clinical sites or laboratories.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1). The ground truth was established by comparing the device's results to an "FDA cleared method" and a "reference method" in laboratory settings. This suggests direct quantitative comparison rather than a consensus-based adjudication process typical for qualitative or image-based diagnostics.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed in the context of improving human reader performance with AI assistance. This study focuses on the device's standalone analytical performance compared to a reference method, and also includes layperson use, not assisted reading by human experts.

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

Yes, a standalone performance study was done for the device. The entire clinical study, comparing the Mission Cholesterol Monitoring System's measurements against a reference method, evaluates the algorithm's performance. Both professional operators and laypersons used the device independently to obtain results, which were then compared to the established ground truth.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established by comparing the device's results to an FDA cleared method and a reference method (for plasma concentration).

8. The Sample Size for the Training Set

The document does not provide information regarding a separate training set or its sample size. The studies described are for the validation of an already developed device.

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

As no training set is described, there's no information on how its ground truth would have been established. The provided document focuses on the validation of the device through performance and clinical studies.

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The CardioChek Home Test System (consisting of the CardioChek Home analyzer and CardioChek Home Lipid Panel test strips) is for the quantitative determination of total cholesterol. HDL (high density lipoprotein) cholesterol and triglycerides in capillary whole blood from the fingertip and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only.

• o Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
• HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes ● mellitus), atherosclerosis, and various liver and renal diseases.
• Triglycerides 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.
  A Chol/HDL ration and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek Home Analyzer.

The CardioChek Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels Lipid Panel test strips) is for the quantitative determination of total cholesterol. HDL (high density lipoprotein) cholesterol and triglycerides in venous whole blood and capillary whole blood from the fingertip and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. This system is for in vitro diagnostic use only.

• o Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
• HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes ● mellitus), atherosclerosis, and various liver and renal diseases.
• Triglycerides 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.
  A Chol/HDL ration and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek Plus Analyzer.

The CardioChek PA Test System (consisting of the CardioChek PA analyzer and PTS Panels Lipid Panel test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides in venous whole blood and capillary whole blood from the fingertip and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. This system is for in vitro diagnostic use only.

• Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol . in the blood and lipid and lipoprotein metabolism disorders.
• HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
• Triglycerides 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.
  A Chol/HDL ration and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA Analyzer.

The CardioChek PA Home Test System (consisting of the CardioChek PA Home analyzer and CardioChek Home Livid Panel test strips) is for the quantitative determination of total cholesterol. HDL (high density lipoprotein) cholesterol and triglycerides in capillary whole blood from the fingertip and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only.

• Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol o in the blood and lipid and lipoprotein metabolism disorders.
• HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
• Triglycerides 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.
  A Chol/HDL ration and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA Home Analyzer.

The PTS Panels Lipid Panel test strips and the CardioChek Home Lipid Panel test strips are used with the CardioChek Plus, CardioChek PA, CardioChek Home and CardioChek PA Home analyzers to measure total cholesterol and triglycerides in whole blood. The test strips utilize enzymatic methods on a dry strip that is read by reflectance photometry. These test strips are for in vitro diagnostic use only.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the CardioChek Test Systems (CardioChek Plus, CardioChek Home, CardioChek PA, CardioChek PA Home) involve demonstrating accuracy and precision for HDL cholesterol measurements within a modified dynamic range of 20-120 mg/dL. The reported performance is based on comparison to a reference laboratory method (Roche Cobas Integra 400 plus) and precision studies.

2. Sample Size and Data Provenance for the Test Set

• Accuracy Test Set:
  • Sample Size: 80 samples for each analyzer type (CardioChek Plus Home, CardioChek Plus, CardioChek PA, CardioChek PA Home).
  • Data Provenance: Not explicitly stated, but based on the nature of medical device studies for FDA submission, it would typically be prospective data collected for the purpose of the study. The country of origin is not specified, but the submission is to the U.S. FDA.
• Precision Test Set:
  • Sample Size: 80 observations for Level 1 and Level 2 for all analyzers, and 80 observations (CardioChek PA/PA Home) or 78 observations (CardioChek Plus/Home) for Level 3. These observations were obtained by "three operators tested three levels of whole blood samples on five analyzers... over three time periods."
  • Data Provenance: Not explicitly stated, but likely prospective data collected in a controlled laboratory setting.

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

• This relates to a diagnostic device for quantitative measurement, not an AI classification system requiring expert interpretation for ground truth.
• For Accuracy: The ground truth for HDL cholesterol measurements was established using a Roche Cobas Integra 400 plus HDL Cholesterol instrument, which is a recognized reference method in clinical chemistry. This is a laboratory analyzer, not an expert panel.
• For Precision: The "ground truth" is the mean value obtained from repeated measurements of the same whole blood samples.

4. Adjudication Method for the Test Set

• Not applicable as this is a quantitative measurement device study, not an AI diagnostic study requiring human expert adjudication of interpretations. The "ground truth" is derived from a reference laboratory instrument.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this is a study for a quantitative measurement device (lipid panel test system), not an AI algorithm intended for interpretation by human readers. The context is not one of human-in-the-loop performance improvement with AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Yes, the accuracy and precision studies performed can be considered standalone performance of the device (analyzer with test strips), as it evaluates the device's ability to accurately and precisely measure HDL cholesterol compared to a reference method, without human interpretation as part of the primary output.

7. Type of Ground Truth Used

• Accuracy: The ground truth for the accuracy study was established using a reference laboratory instrument (Roche Cobas Integra 400 plus HDL Cholesterol). This is considered a highly reliable, objective, and standardized method for clinical chemistry analytes.
• Precision: The ground truth for precision is the central tendency (mean) of repeated measurements of controlled samples.

8. Sample Size for the Training Set

• This document describes performance testing for a medical device (CardioChek Test System) that determines quantitative values using enzymatic methods on dry strips read by reflectance photometry. It is a traditional in vitro diagnostic device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense for model development. The device's calibration parameters are programmed into a lot-specific memory chip. Therefore, there is no "training set" in the context of machine learning model development. The calibration and manufacturing processes would involve internal quality control and standardization.

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

• As there is no "training set" for an AI/machine learning model, this question is not applicable. The device's operational parameters and calibration are established through manufacturing processes and validated through studies like those described (accuracy and precision).

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For the quantitative in vitro determination of Triglycerides in serum. Triglyceride measurements are used in the diagnosis and treatment of diseases involving lipid metabolism and various endocrine disorders e.g Diabetes mellitus, nephrosis and liver obstruction

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

The Randox Triglycerides kit assay consists of ready to use reagent solutions.

Here's a breakdown of the acceptance criteria and the study information for the Triglycerides (TRIGS) device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of "acceptance criteria" for the entire device's performance followed by a direct comparison in a single table, but rather describes various performance characteristics and their findings. I will construct a table based on the individual performance criteria and the results presented.

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

• Precision/Reproducibility:
  • Test Set: Serum-based control material and unaltered human serum samples (some spiked or diluted). Specific numbers of individual patient samples beyond "Pool 1, Pool 2, Pool 3, Pool 4" are not given. For each sample type, 2 replicates per run were performed, twice daily for 20 non-consecutive days, using 2 reagent lots and 2 systems.
  • Data Provenance: Not explicitly stated, but implies laboratory testing with control materials and human serum samples. Given the manufacturer is based in the UK, it's likely the testing was done there, but this is not confirmed. It is a prospective study design for precision.
• Linearity:
  • Test Set: 11 levels prepared from low and high serum pools, each run in replicates of five.
  • Data Provenance: Not explicitly stated, but implies laboratory testing with serum pools. Prospective study design.
• Detection Limit:
  • Test Set: 240 determinations were made, including 4 low-level samples, to determine LoD, LoB, and LoQ.
  • Data Provenance: Not explicitly stated, implies laboratory testing. Prospective study design.
• Analytical Specificity (Interference):
  • Test Set: Spiked interferent samples with corresponding control solutions. Specific number of samples not provided. Triglycerides concentrations of 150 mg/dL and 496 mg/dL were examined.
  • Data Provenance: Not explicitly stated, implies laboratory testing. Prospective study design.
• Method Comparison:
  • Test Set: 109 serum patient samples spanning the range 14.2 to 986 mg/dl. Each tested in singlicate.
  • Data Provenance: Not explicitly stated (e.g., country of origin), but states "serum patient samples." Implies retrospective collection of samples or prospective collection for this study.

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

This device (Triglycerides assay) is an in-vitro diagnostic device for quantitative chemical analysis. The "ground truth" for these types of devices is established through analytical reference methods or highly characterized reference materials, not typically by expert consensus of human readers.

• No mention of human experts or their qualifications for establishing ground truth for the test set.

4. Adjudication Method for the Test Set

Not applicable for this type of quantitative analytical assay. Adjudication is typically used in image-based diagnostic studies involving human interpretation.

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 involves assessing the performance of human readers, sometimes with and without AI assistance, and is not relevant for a quantitative chemical assay.

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

Yes, the studies described (precision, linearity, detection limit, analytical specificity, method comparison) represent the standalone performance of the device/system (RX Daytona plus analyzer with Randox Triglycerides reagent) without human intervention in the analytical measurement process beyond sample loading and general operation.

7. The Type of Ground Truth Used

• Precision/Reproducibility, Linearity, Detection Limit, Analytical Specificity: The "ground truth" or reference for these studies refers to the true concentration of triglycerides in the samples (control materials, spiked samples, diluted samples) as determined by a highly accurate method or known values of reference materials.
• Method Comparison: The "ground truth" is the results obtained by a legally marketed predicate device (Randox Triglyceride Assay, K923508). For calibrators within the system, Randox Calibration Serum Level 3 is stated to be traceable to the Triglycerides reference method ID-GC/MS. This indicates a high-accuracy chemical method is the ultimate ground truth for calibration.

8. The Sample Size for the Training Set

This document describes a medical device (an in-vitro diagnostic reagent/system) for which "training sets" are not typically applicable in the same way as for AI/machine learning algorithms. The device's performance characteristics are inherent to its chemical formulation and the analytical instrument. There is no mention of a "training set" for an algorithm.

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

Not applicable, as there is no specific "training set" for an algorithm mentioned in the context of this device.

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