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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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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.

Ask a specific question about this device

The CardioChek Home Test System (consisting of the CardioChek Home analyzer and CardioChek 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 Home 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 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 Home Test System consisting of the CardioChek Home analyzer and CardioChek 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 Home analyzer.

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 Home Test System (consisting of the CardioChek Home analyzer and CardioChek 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 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 PTS Panels Chol+HDL+Glu, Chol+HDL and Chol+Glu test strips and the CardioChek Home Chol+HDL+Glu, Chol+HDL and Chol+Glu test strips are used with the CardioChek Plus and CardioChek Home analyzers to measure total cholesterol, HDL cholesterol and glucose 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.

I am sorry, but the provided text does not contain the specific information required to answer your request.

The document is a 510(k) premarket notification letter from the FDA regarding the "Cardiochek Plus Test System" and "Cardiochek Home Test System". It describes the devices, their intended use, and states that they were found to be substantially equivalent to previously marketed predicate devices.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details on sample sizes, data provenance, or ground truth establishment for a specific study proving the device meets acceptance criteria.
• Information on expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.
• Sample size or ground truth details for a training set.

The document primarily focuses on the regulatory aspects of substantial equivalence based on modifications to existing devices, rather than presenting a detailed study report with performance metrics against acceptance criteria.

Ask a specific question about this device

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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The CardioChek Plus Test System is a small portable analyzer and test strip system 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. The tests strips are for the quantitative determination of glucose, total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides in venous whole blood from the fingertip. A Chol/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol and non-HDL cholesterol are calculated by the CardioChek Plus analyzer.

• 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.

• 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 includes the CardioChek Plus professional analyzer and analyte-specific test strips (PTS Panels eGLU test strips, PTS Panels Glucose test strips and PTS Panels Lipid Panel test strips). The CardioChek Plus Test System is modified in this submission by the addition of the CardioChek ChekMate strips. CardioChek ChekMate strips are dry strips that mimic the use of the PTS PANELS test strips to check the CardioChek analyzer system optics, calibration and result handling algorithms. ChekMate strips should not be used as a substitute for liquid quality control materials. There is no change to any of the test strips in any of the above named systems.

The provided text describes the CardioChek Plus Test System and its modification with the addition of CardioChek ChekMate strips. The 510(k) summary focuses on the performance characteristics of these new ChekMate strips, particularly their precision and stability.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical acceptance criteria in a dedicated table format. However, it reports on the precision of the CardioChek ChekMate strips.

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

• Sample Size for Test Set:
  • For the Intermediate Precision evaluation, three lots of ChekMate strips were evaluated. Two analyzers were used for each lot. The evaluation was performed over a 20-day period. (The exact number of individual samples/measurements is not specified beyond "three lots" and "two analyzers per lot").
  • For Value Assignment and Stability, the document states "Previously reported in K142302", implying these studies were conducted and reported in a prior submission, and details are not provided in this document.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be internal validation studies conducted by the manufacturer, Polymer Technology Systems, Inc., based in Indianapolis, IN, USA. The document does not specify if the data is retrospective or prospective, but clinical performance studies for IVD devices are typically prospective.

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 studies described are analytical performance studies (precision, stability) of a diagnostic device component rather than studies requiring expert interpretation of clinical data to establish ground truth.

4. Adjudication method for the test set:

This information is not applicable and not provided. The studies described are analytical performance studies focused on the device's technical specifications and do not involve clinical 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:

This is not applicable and not provided. The CardioChek Plus Test System is an in vitro diagnostic device for quantitative determination of analytes (glucose, cholesterol, etc.) from blood samples. It is not an AI-assisted diagnostic imaging or interpretation system that would involve human readers or MRMC studies.

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

This is not applicable and not provided in the context of an "algorithm only" performance for interpretive tasks. The "standalone" performance for this device refers to its analytical performance (e.g., precision, accuracy, linearity) in quantifying specific biomarkers, which is what the precision and stability studies address. It is an automated system providing quantitative results.

7. The type of ground truth used:

For the precision studies, the "ground truth" is typically established by the inherent statistical properties of repeated measurements, comparing individual readings to the mean of those readings to assess variability. For value assignment, the ground truth would typically be established against a reference method or certified reference material, although this detail is not provided in this document as it was "previously reported in K142302".

8. The sample size for the training set:

This information is not applicable and not provided. The CardioChek Plus Test System and ChekMate strips are not described as employing machine learning or AI algorithms that would require a distinct "training set" in the conventional sense. The "training" for such devices typically involves calibration curves and algorithms derived from analytical experiments, not a machine learning training dataset.

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

This information is not applicable and not provided for the same reasons as point 8.

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The CardioChek Home Test System is a small portable analyzer and test strip system for self-testing by lay users. It is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only. The tests strips are for the quantitative determination of glucose, total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides in capillary whole blood from the fingertip. A Chol/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol and non-HDL cholesterol are calculated by the CardioChek Plus analyzer.

• Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess ● cholesterol in the blood 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.
• 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 is a small portable analyzer and test strip system 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. The tests strips 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. A Chol/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol and non-HDL cholesterol are calculated by the CardioChek Plus analyzer.

• Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood 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.
• 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 professional test system consists of the CardioChek Plus professional analyzer and analyte specific test strips and is intended for professional use. The CardioChek Plus professional analyzer is an in vitro diagnostic device consisting of both a reflectance photometer and amperometer. This device measures various analytes in blood once the blood is applied to dry phase test strips that are specifically designed for reflectance or amperometric (electrochemical) analysis.

The CardioChek Home test system consists of the CardioChek Home analyzer and analyte specific test strips. The CardioChek Home analyzer is an in vitro diagnostic device consisting of both a reflectance photometer and amperometer. This device measures various analytes in blood once the blood is applied to dry phase test strips that are specifically designed for reflectance or amperometric (electrochemical) analysis.

The CardioChek Plus professional and CardioChek Home test systems are a modification of the original device (cleared as BioScanner Plus, K014099) to include the following modifications:

• · Wireless communications capability (professional system)
• · Software solutions capability
• · Printer connectivity capability
• · MEMo chip appearance
• · Battery type
• · Multiple language software capability
• · Wired PC Communication
• · Analyzer dimensions

The provided text is a 510(k) summary for the CardioChek Plus and CardioChek Home Test Systems. It describes the devices, their intended use, and states their substantial equivalence to a predicate device (BioScanner Plus System, K014099). However, it does not contain specific acceptance criteria, study data, or details about patient sample sizes, training sets, or ground truth establishment methods.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) study results.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document primarily focuses on the device modifications and
the argument for substantial equivalence based on similarities and minor
differences from the predicate device (BioScanner Plus System K014099).
It states that "The CardioChek Plus and CardioChek Home test systems are as safe and effective and perform as well as our predicate device, the BioScanner Plus."
However, it does not provide the detailed study results that would
substantiate this claim in terms of specific performance metrics or
acceptance criteria.

Key information present in the document:

• Device Names: CardioChek Plus Test System, CardioChek Home Test System
• Intended Use: Quantitative determination of glucose, total cholesterol, HDL, and triglycerides in capillary whole blood (CardioChek Home) and venous/capillary whole blood (CardioChek Plus).
• Predicate Device: BioScanner Plus System (K014099)
• Modifications: Wireless communications, software solutions, printer connectivity, MEMo chip appearance, battery type, multi-language software, wired PC communication, analyzer dimensions. These are cosmetic, connectivity, and usability changes, not fundamental changes to the core measurement technology.
• Conclusion: The new devices are "as safe and effective and perform as well as our predicate device, the BioScanner Plus." This conclusion implies that the performance of the predicate device serves as the implicit "acceptance criteria" and that the modifications did not degrade this performance.

To answer your questions thoroughly, detailed study reports (e.g., analytical and clinical validation studies) would be required, which are not included in this 510(k) summary document.

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The BioScanner Plus Glucose Test Systems are intended for the quantitative determination of glucose in human whole blood for use by healthcare professionals in both physicians' office and convalescent care facility bedside testing. 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 Chol+Glu Test Panel system is intended to measure cholesterol and glucose in whole blood on a BioScamer Plus (CardioChek brand) analyzer. The test strips are intended to be used by healthcare professionals to measure blood cholesterol and glucose. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Glucose measurements are used in the management of carbohydrate metabolism disorders.

The Lipid Panel Test system is intended to measure cholesterol and triglycerides in whole blood on a BioScanner Plus (CardioChek brand) analyzer. The test strips are intended to be used by healthcare professionals to measure three blood analytes: cholesterol and triglycerides. 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. 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.

The PTS PANELS HDL Cholesterol Test system is intended to measure high density lipoprotein cholesterol in whole blood. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases.

The PTS PANELS CHOL+HDL Panel Test system is intended to be used by medical professionals to measure cholesterol and high density lipoprotein cholesterol in whole blood. 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.

The PTS PANELS CHOL+HDL+GLU Panel Test system is intended to be used by medical professionals to measure cholesterol, high density lipoprotein cholesterol and glucose in whole blood. 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. Glucose measurements are used by individuals with diabetes to measure glucose in fingerstick whole blood at home for the management of carbohydrate metabolism disorders.

The PTS PANELS Metabolic Chemistry Panel Test system is intended to be used by medical professionals to measure glucose, high density lipoprotein cholesterol and triglycerides in fingerstick whole blood. Glucose measurements are used in the management of carbohydrate metabolism disorders. 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. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver diseases involving lipid metabolism or various endocrine disorders.

The above named test systems are for in vitro diagnostic use with the prescription use BioScanner Plus (CardioChek PA) reflectance photometer.

The above named test systems are modified in this submission by the addition of a CardioChek ChekMate strip for use only with the prescription use analyzer. CardioChek ChekMate strips are dry strips that mimic the use of the PTS PANELS test strips to check the CardioChek analyzer system optics, calibration and result handling algorithms. ChekMate strips should not be used as a substitute for liquid quality control materials. There is no change to any of the test strips in any of the above named systems.

The provided document describes the BioScanner Plus Glucose Test System and related PTS PANELS test systems. The primary focus of the performance characteristics section is on the CardioChek ChekMate strips, which are a modification to the system. While the document mentions several test systems and their intended uses (glucose, cholesterol, triglycerides, HDL cholesterol), the performance data specifically addresses the ChekMate strips, which are used to check the analyzer's optics, calibration, and result handling. The information regarding the various analyte test systems largely defers to previously cleared strips and an unmodified analyzer, indicating their performance was established in prior submissions.

Here's a breakdown of the acceptance criteria and study information for the CardioChek ChekMate Strips:

Table of Acceptance Criteria and Reported Device Performance (for CardioChek ChekMate Strips)

Study Details for CardioChek ChekMate Strips:

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

   • Value Assignment Test Set: 45 strips evaluated on a single CardioChek PA meter, and then "Every ChekMate strip" (up to 400 pieces per lot) was measured on a different CardioChek PA meter.
   • Real-time Stability Test Set: Four (4) lots of ChekMate strips.
   • Re-use Stability Test Set: Individual ChekMate strips were tested for 1,253 uses across 13 CardioChek PA analyzers.
   • Data Provenance: Not explicitly stated, but typically such studies are conducted by the manufacturer (Polymer Technology Systems, Inc.) in the USA. The document does not specify if the data is retrospective or prospective, but stability studies are inherently prospective.

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

   • This device (CardioChek ChekMate strips) is a quality control/verification strip, not a diagnostic device that requires expert interpretation for ground truth. The "ground truth" for the ChekMate strips is based on instrument readings (% R values) against predefined acceptable ranges and stability curves. Therefore, no human experts were involved in establishing the ground truth for these strips.

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

   • Not applicable. The evaluation criteria for the ChekMate strips are objective, numerical measurements of % R values and their adherence to predefined ranges and stability criteria. There is no need for expert adjudication.

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

   • No. This is an in vitro diagnostic device for quantitative measurements of analytes or, in the case of ChekMate strips, for verification of an instrument. It is not an AI-assisted diagnostic tool that would involve human readers or an MRMC study.

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

   • The ChekMate strips themselves do not operate as an algorithm in isolation. They are physical strips used with an analyzer. The document describes the performance of the strips in verifying the analyzer's functions (optics, calibration, result handling algorithms). The analyzer itself (CardioChek PA) operates in a "standalone" fashion to generate a result from the strip, but the performance evaluation here is focused on the strips and their ability to consistently produce expected values within the analyzer. The algorithms referred to are integral to the analyzer's function, not a separate AI system.

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

   • For the ChekMate strips, the ground truth is established through internal scientific and engineering processes, likely involving highly calibrated reference instruments and defined chemical/optical properties. The "acceptable ranges" and "baseline results" are the ground truth for testing these verification strips.

7. The sample size for the training set:

   • Not applicable. This document describes the performance of an in vitro diagnostic device (and its quality control strips). It does not involve machine learning or AI models that require a separate "training set."

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

   • Not applicable, as there is no "training set" in the context of this device's performance evaluation.

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PTS PANELS CHOL+HDL Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure cholesterol and high density lipoprotein 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. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various liver and renal diseases.

Dry chemistry test strip for use with PTS reflectance photometer. One test strip containing two tests.

This document is a 510(k) summary for the PTS Panels CHOL+HDL Panel Test Strips. It focuses on the device modification and its substantial equivalence to previously cleared predicate devices. The provided text is a regulatory submission, not a detailed scientific study report. Therefore, much of the requested information regarding a "study that proves the device meets the acceptance criteria" in terms of rigorous clinical trial design (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance) is not present in the provided text.

Here's an analysis of the information that can be extracted, and where limitations exist:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the format of specific thresholds for accuracy, precision, or other performance metrics. Instead, it aims to demonstrate substantial equivalence to predicate devices. The "reported device performance" is essentially the claim that the new device performs "the same" as the predicate device regarding its intended use and chemical methods.

The key acceptance criterion implied by a 510(k) submission is that the modified device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and as effective. This is achieved by demonstrating that the modified device has the same intended use, technology, storage, specimen type, chemistry methods, and calibration curve as the predicate, with minor differences that do not raise new questions of safety or effectiveness.

The document highlights the following similarities and differences:

Conclusion regarding performance: The document implicitly argues that because the core technology, chemistry, and intended use are the same, the performance is also "the same" or substantially equivalent. The only reported performance difference is the time to obtain results (2 minutes for the new device vs. 1 minute per test for the old, but the new device combines both tests into one strip).

Study Information (Not Present in Detail)

The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence, not typically a detailed report of a new clinical study with specific acceptance criteria and performance data. Therefore, the following information is not available in the provided document:

1. Sample size used for the test set and the data provenance: Not mentioned. The 510(k) summary typically references studies conducted, but the details of those studies (like sample size or data origin) are usually found in the full 510(k) submission, not the summary.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a test strip for chemical analysis, not an AI-assisted diagnostic imaging device that involves human readers.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an algorithm. This is a chemical test strip. Its "standalone" performance would be its analytical accuracy and precision, which are typically evaluated against a reference method. While such studies would have been performed for the original predicate devices and likely for the modified device to show equivalence, the details are not in this summary.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned explicitly. For chemical assays like this, the "ground truth" (or reference method) is typically a highly accurate laboratory method (e.g., a standardized enzymatic reference method run on a clinical chemistry analyzer).
7. The sample size for the training set: Not applicable for this type of device. There isn't an "algorithm" being trained in the conventional sense of machine learning. The "calibration curve" resides on an EEPROM chip, which is pre-programmed based on manufacturing data and chemical principles, not a "training set" of patient data.
8. How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary, the provided text is a regulatory submission demonstrating substantial equivalence for a modified medical device (test strips for cholesterol and HDL). It does not contain the detailed study results and specific acceptance criteria that would typically be found in a clinical performance study report for an AI-enabled device or a novel diagnostic. The "acceptance criteria" here are met by demonstrating that the new device is fundamentally the same as its cleared predecessors.

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PTS PANELS CHOL+HDL+GLU Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure cholesterol, high density lipoprotein cholesterol and glucose 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. 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 by individuals with diabetes to measure glucose in fingerstick whole blood at home for the management of carbohydrate metabolism disorders.

Dry chemistry test strip for use with PTS reflectance photometer. Single test strip with three tests.

The provided text describes a 510(k) submission for the PTS PANELS CHOL+HDL+GLU Panel Test Strips, which are intended to measure cholesterol, HDL cholesterol, and glucose in whole blood. However, the document does not contain the acceptance criteria or a study that specifically proves the device meets those criteria.

The document primarily focuses on:

• 510(k) Summary: Basic regulatory information, applicant details, device classification, intended use, and reason for submission (device modification).
• Predicate Device Information: Comparison of the modified device with its predicate devices, highlighting similarities in intended use, technology, storage, specimen type, chemistry method, and calibration. The key difference noted is that the modified device combines three tests into a single strip with a slightly longer overall result time (about two minutes for all three tests, compared to about one minute for each of three separate tests in the predicate).
• FDA Premarket Notification Letter: Official communication from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.
• Indications for Use: Detailed statement of how the device is intended to be used.

Based on the provided text, I cannot complete the requested information regarding acceptance criteria and the study that proves the device meets them, as this information is not present. The document states that the device is a modification of an existing device and that the FDA has determined it is substantially equivalent to legally marketed predicate devices. This suggests that the performance requirements might be similar to those of the predicate devices, but the specific acceptance criteria and the study design to demonstrate meeting them are not detailed here.

To answer your questions, I would need a different document, likely a "Performance Characteristics" or "Method Comparison Study" section, which is typically included in a 510(k) submission but is absent from the provided excerpt.

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PTS PANELS Metabolic Chemistry Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure glucose, high density lipoprotein cholesterol and triglycerides in fingerstick whole blood. Glucose measurements are used in the management of carbohydrate metabolism disorders. 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 (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.

Dry chemistry test strip for use with PTS reflectance photometer. Single test strip with three tests.

The provided text does not contain detailed acceptance criteria or a study that explicitly demonstrates the device meets such criteria. It primarily focuses on the 510(k) summary for a modified medical device, comparing it to predicate devices. The document states "Similarities Between Predicate and Modified Device" and "Differences Between Predicate and Modified Device," but these refer to the device's characteristics and intended use, not performance metrics against acceptance criteria.

The submission is for a device modification, and the FDA has determined it to be "substantially equivalent" to legally marketed predicate devices, which implies that its performance is considered acceptable based on the already approved predicates. However, the specific performance data or acceptance criteria used for this determination are not detailed in the provided sections.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement as this information is not present in the provided text.

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