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The ActiMed ENA C-T™ Total Cholesterol Test is a non-instrumented, enzymatic assay intended for the in vitro quantitative determination of total cholesterol in fingerstick whole blood. It is indicated for physician directed use (PDU) by the patient for screening and monitoring cholesterol.

In a PDU monitoring application, the patient's physician (or other medical professional under the direction of a physician) initially trains the patient to use the test properly and provides information on the proper interpretation of results and limitations of the test. With the physician directed indication for use, patients on cholesterol lowering therapy can test their own total cholesterol at home and provide the results to their physician or other healthcare organization which works with the physician to maintain compliance on the therapy.

In a PDU screening application, a physician (or other medical professional under the direction of a physician) initially trains a group of individuals to use the test properly and provides information on the proper interpretation of results and limitations of the test. The physician directed use version of the ENA.C.T™ Total Cholesterol Test kits are then distributed to the group of individuals who can use the test at home and then communicate their results to the physician or healthcare organization.

The ActiMed ENA-C-T™ Total Cholesterol Test is a noninstrumented, enzymatic assay intended for the in vitro quantitative determination of total cholesterol in fingerstick whole blood. It is based on stable, dry chemistry reagents embedded in a flow device with a factory calibrated scale. The device provides a direct visual read-out of test results. It has built-in controls to indicate that a sufficient volume of whole blood has been added as sample, to verify that the reagents are functioning, and to confirm when the test has been completed. The test device is self-actuating, requiring neither timing nor handling between addition of the sample and reading the result.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: ACTIMED LABORATORIES, INC. ENA-C.T™ Total Cholesterol Test Physicians Directed Use

1. Table of Acceptance Criteria and Reported Device Performance:

• Ascorbic acid (up to 10 mg/dL)
• Uric acid (up to 11 mg/dL)
• Hemoglobin (up to 250 mg/dL)
• Triglycerides (up to 850 mg/dL)
• Bilirubin (up to 20 mg/dL) | No interference found in samples containing up to 10 mg/dL ascorbic acid, 11 mg/dL uric acid, 250 mg/dL of hemoglobin, 850 mg/dL of triglycerides, or 20 mg/dL bilirubin. (Note: Acetaminophen interferes at 1 mg/dL, and high concentrations of ascorbic acid also interfere, which were identified limitations not part of "acceptance" but noted characteristics) |
  | Precision (Reproducibility): | |
  | Comparable to predicate device; generally less than 6.9% CV for paired fingerstick whole blood samples. (Implied acceptance based on comparison to predicate and overall average achieved) | CVs were 5.2%, 6.7%, and 8.8% for Sites 1, 2, and 3 respectively, with an average CV for all sites of 6.9%. This demonstrates the device was reproducible in the hands of trained patients. |
  | Accuracy (Bias at key cholesterol levels):
• Bias not to exceed 3% at 200 mg/dL compared to CRMLN reference method
• Bias not to exceed 3% at 240 mg/dL compared to CRMLN reference method (Based on recommendation of the Laboratory Standardization Panel (LSP)) | Bias at 200 mg/dL was 2.86% (well within recommendation)
  Bias at 240 mg/dL was 2.69% (well within recommendation) |
  | Correlation to CRMLN method: Within 10% (Implied acceptance based on stated equivalence) | Least squares regression equation: y = 1.018x + 2.13, with a correlation coefficient of r = 0.917.
  Correlations between the ENA-C-T™ device (PDU) and the CRMLN Method were within 10%. |
  | Correlation to Predicate Device (ENA-C-T™ Total Cholesterol Test (POL)): Within 10% (Implied acceptance based on stated equivalence) | Least squares regression equation: y = 0.931x + 13.8, with a correlation coefficient of r = 0.899.
  Correlations between the ENA C T™ device (PDU) and the ENA C T™ device (POL) were within 10%. |
  | Substantial Equivalence to Predicate Device: | |
  | Intended use, design, materials, operational features, and performance comparable. | "Performance characteristics generated during analytical and clinical studies on the ENA-C-T™ Total Cholesterol Test (PDU) are comparable to those generated in the same study for the ENA-C T™ Total Cholesterol Test (POL)."
  "Thus, the ENA C T™ Total Cholesterol Test (PDU) is substantially equivalent to the ENA-C.T™ Total Cholesterol Test (POL) in terms of performance characteristics, as well as intended use, design, materials, and operational features." |

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

• Sample Size: 136 paired fingerstick whole blood and venous samples.
• Data Provenance: The studies were conducted at "three POL sites" (Physician Office Laboratory sites). While explicit country of origin is not stated, the submitter is in Burlington, NJ, USA, and the FDA approval is for the US market, strongly implying US-based data. The studies were prospective clinical studies to assess the performance of the ENA-C-T™ Total Cholesterol Test (PDU) in comparison to a reference method and the predicate device.

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

• The text does not explicitly state the number of experts. The ground truth was established by laboratory testing at a "Cholesterol Reference Method Network Laboratory (CRMLN)" using the "Abell-Kendall serum reference method or enzymatic method." This implies that the ground truth analysis was performed by trained laboratory technicians/scientists at a certified reference lab, adhering to established high-standard methodologies (CRMLN). No specific individual "experts" or their years of experience are mentioned, but the CRMLN designation assures high qualification.

4. Adjudication Method for the Test Set:

• The document describes a direct comparison between the ENA-C-T™ PDU device and the CRMLN reference method, and also between the PDU device and the POL predicate device. This is a direct comparison method rather than an adjudication method involving multiple human readers interpreting the same device results. For precision, differences between self-test/self-read and professional-test/professional-read devices were assessed, but this isn't an adjudication method in the typical sense for interpretative disagreements.

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

• No, an MRMC comparative effectiveness study was not done. The device provides a "direct visual read-out of test results" from a "factory-calibrated scale." The studies focused on the accuracy and precision of this visual read against laboratory reference methods and the predicate device, especially in the hands of trained patients. It was not a study comparing how human readers improve with AI assistance, as this is a non-instrumented, direct-read test, not an AI diagnostic tool.

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

• Yes, a standalone performance assessment was conducted (algorithm-like, without human interpretation for the ground truth). The "ENA-C-T™ Total Cholesterol Test" is described as a "noninstrumented, enzymatic assay" with a "factory calibrated scale" that provides a "direct visual read-out." While a human reads the result from the scale, the core performance characteristics (linearity, interference, precision, bias, and correlation to reference methods) were evaluated based on the chemical reaction and scale design itself. The "self test/self read" component of the precision study involved human users, but the key performance metrics are inherent to the device's chemical and physical properties.

7. The Type of Ground Truth Used:

• Expert Consensus / Reference Method: The primary ground truth for accuracy and bias was established by a Cholesterol Reference Method Network Laboratory (CRMLN) using the Abell-Kendall serum reference method or an equivalent enzymatic method on venous blood samples. This is considered a gold standard and a form of expert-validated reference data.

8. The Sample Size for the Training Set:

• The document does not explicitly state a separate "training set" sample size for the device's development. The "40 normal and abnormal clinical samples" mentioned in the linearity section might have been part of early development/calibration, but it's not designated as a distinct training set. This is typical for older, non-AI based medical devices where empirical testing and calibration against known standards form the development process, rather than a machine learning training paradigm.

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

• As a distinct training set (in the machine learning sense) is not mentioned, the method for establishing ground truth for a training set is not applicable here. However, the device's inherent "factory calibrated scale" would have relied on a process similar to how the ground truth was established for the test set – comparison to high-accuracy laboratory reference methods to ensure the scale accurately reflects cholesterol concentrations.

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