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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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