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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.

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).

Ask a specific question about this device

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.

Ask a specific question about this device

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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