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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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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 professional use in settings such as clinical laboratories and physician office laboratories (POLs) to screen for elevated cholesterol as a risk factor in coronary heart disease (CHD).

The ENA-C-T™ Total Cholesterol Test 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.

The ENA.C.T™ Total Cholesterol Test starts when a sufficient amount of whole blood has been introduced into the sample well. A self-actuating siphon, in turn, transfers the blood to an absorbent pad located immediately below the "START" window. The blood saturated pad shows through the clear window as a red indicator, signaling that enough sample has been added and that the analytical process has been initiated. The absorbent pad and a second filter separate red cells from plasma. The plasma subsequently flows into an enzyme pad containing cholesterol esterase and cholesterol oxidase which completely convert cholesterol and cholesterol esters into cholestenone and hydrogen peroxide. A flow delay pad restricts passage of the plasma to permit completion of the enzymatic reactions. Subsequently, the plasma flows into the measurement zone which acts as a capillary. In this zone, colorless dyes and the enzyme peroxidase are immobilized on a thin fabric layer. The hydrogen peroxide converted from cholesterol in the plasma converts the colorless dye layer into a blue color bar, the length of which is proportional to the amount of hydrogen peroxide, and in turn, cholesterol in the sample. The bar extends until a precise amount of plasma has completely filled the measurement zone and "END/QA" draw zone. This draw zone turns green at the end of the procedure when the cholesterol converting enzymes dissolved in the plasma react with control cholesterol contained in the draw zone. The appearance of a green color signals that the test is complete and that reagents were active. The total cholesterol concentration is directly read from the factory calibrated scale on the device. The entire process typically requires 12 to 15 minutes. The color bar formed is stable and may be read at any time within 48 hours.

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

ENA·C·T™ Total Cholesterol Test: Acceptance Criteria and Study Details

The provided text details the 510(k) summary for the ENA·C·T™ Total Cholesterol Test, comparing it to the predicate device, the ChemTrak, Inc. AccuMeter® Cholesterol Test (K905405). The primary goal is to demonstrate substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a dedicated section with specific numerical thresholds. Instead, the document discusses performance in relation to the predicate device and national recommendations (NRS/CHOL, LSP). I've inferred the "acceptance criteria" based on these comparisons and stated recommendations.

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ENA C T™ Assayed Total Cholesterol Controls are intended for exclusive use with the ENA-C.T™ Total Cholesterol Test to monitor the performance of the test at the medical decision points in the determination of elevated cholesterol. The ENA-C-T™ Total Cholesterol Test is an instrumentfree enzymatic assay for the quantitative determination of cholesterol in fingerstick whole blood for use by physicians to screen for elevated cholesterol as a risk factor in coronary heart disease (CHD).

The ENA·C·T™ Assayed Total Cholesterol Controls are ready to use polymer solutions containing cholesterol from non-human (bovine) plasma. There are two levels of control included with each set: Level I is approximately 200 mg/dL and Level II is approximately 240 mg/dL. Assay range values for the ENA·C·T™ Assayed Total Cholesterol Controls are determined by testing the materials on multi-lot ENA·C·T™ Total Cholesterol devices which have been calibrated to produce results correlating to the Abell-Kendall reference method and are thus, traceable to the National Reference System for Cholesterol (NRS/CHOL). The controls are intended for exclusive use with the ENA·C·T™ Total Cholesterol Test.

The controls are used to ensure proper performance of the ENA·C·T™ Total Cholesterol Test and are tested in the same manner as a patient sample. Sufficient volume of the control is added to the ENA C TM Total Cholesterol Test device in the sample well. A self-actuating siphon, in turn, transfers the control to an absorbent pad located immediately below the "START" window. The control-saturated pad shows through the clear window as a yellow indicator, signaling that enough volume has been added and that the analytical process has been initiated. The control solution subsequently flows into an enzyme pad containing cholesterol esterase and cholesterol oxidase which completely convert cholesterol and cholesterol esters into cholestenone and hydrogen peroxide. A flow delay pad restricts passage of the control solution to permit completion of the enzymatic reactions. Subsequently, the control solution flows into the measurement zone where colorless dyes and the enzyme peroxidase are immobilized on a thin fabric layer.

The hydrogen peroxide generated from the cholesterol in the control solution converts the colorless dyes into a blue color bar, the length of which is proportional to the amount of hydrogen peroxide, and in turn, cholesterol in the control. The bar grows until a precise amount of solution has completely filled the measurement zone and "End/Q. A." draw zone. This draw zone turns green at the end of the procedure when the cholesterol converting enzymes dissolved in the solution react with control cholesterol contained in the draw zone. The appearance of a green color signals that the test is complete and that reagents were active. The total cholesterol concentration is directly read from the factory calibrated scale on the device. Results outside the linear measurement range of the ENA·C·T™ Total Cholesterol Test cannot be reported since the printed scale on the device only covers the range between 120 and 360 mg/dL. The color formed is stable and may be read at any time within 48 hours.

Acceptance Criteria and Device Performance Study for ENA·C·T™ Assayed Total Cholesterol Controls

This document describes the acceptance criteria and the study that demonstrates the performance of the ENA·C·T™ Assayed Total Cholesterol Controls, based on the provided 510(k) summary.

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for the control materials themselves. Instead, the performance is described in terms of their intended use with the ENA·C·T™ Total Cholesterol Test, which is calibrated to the Abell-Kendall reference method and traceable to the National Reference System for Cholesterol (NRS/CHOL).

The key performance described relates to the determination of assay range values for the controls and their ability to monitor the performance of the ENA·C·T™ Total Cholesterol Test.

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

The provided 510(k) summary does not explicitly state the sample size used for determining the assay range values of the ENA·C·T™ Assayed Total Cholesterol Controls. It mentions "multi-lot ENA·C·T™ Total Cholesterol devices," implying multiple devices from different manufacturing lots were used.

The data provenance is not specified regarding country of origin. The study appears to be prospective in nature, involving active testing of the control materials with the ENA·C·T™ Total Cholesterol Test devices to establish their expected performance.

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

The concept of "experts" as in "radiologist with 10 years of experience" is not applicable here. The ground truth for the control materials is derived from their chemical composition and their interaction with the immunoassay system (ENA·C·T™ Total Cholesterol Test). The "ground truth" for cholesterol values is traceable to the Abell-Kendall reference method and the National Reference System for Cholesterol (NRS/CHOL). This is a highly standardized and globally recognized reference method for cholesterol determination, established by expert consensus in clinical chemistry over many years.

4. Adjudication Method

The concept of an "adjudication method" (e.g., 2+1, 3+1) is not applicable in this context. Adjudication methods are typically used in studies involving human interpretation of data where consensus among multiple reviewers is needed to establish ground truth (e.g., pathology slide review, image interpretation). Here, the "ground truth" for control values is based on a definitive chemical reference method (Abell-Kendall) and the performance characteristics of the diagnostic test itself.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as this device is a quality control material and not an interpretive or diagnostic device requiring human reader input or comparison of reader performance. The purpose of the controls is to monitor the performance of an instrument-free enzymatic assay, not to assist human readers in making diagnoses.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The performance described here is inherently "standalone" in the sense that the control material is assayed by the ENA·C·T™ Total Cholesterol Test without human intervention during the analytical process itself. The product is not an algorithm or AI; it is a chemical control material. The "algorithm" is the enzymatic reaction and colorimetric measurement built into the test device. The controls are designed to assess the functionality of this built-in assay process.

7. Type of Ground Truth Used for the Test Set

The ground truth for the control materials' expected cholesterol values is established through two primary mechanisms:

• Reference Method Traceability: The ENA·C·T™ Total Cholesterol Test devices, with which the controls are used, are calibrated to produce results correlating to the Abell-Kendall reference method and are thus, traceable to the National Reference System for Cholesterol (NRS/CHOL).
• Intended Performance: The physical properties and chemical composition of the control materials (polymer solutions containing bovine plasma cholesterol) define their inherent cholesterol levels, which are then verified against the calibrated test system.

8. Sample Size for the Training Set

The concept of a "training set" in the context of machine learning or AI is not applicable to this device. This is a chemical control material, not a software algorithm that is "trained" on data.

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

As noted above, the concept of a "training set" and associated "ground truth" establishment is not applicable to this quality control material.

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