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510(k) Data Aggregation
(170 days)
The Cholestron™ Pro II Cholesterol Test (Cholestron) is a professional-use, point-ofcare in vitro diagnostic device for the measurement of total cholesterol in fingerstick whole blood samples. Total cholesterol measurements aid in the detection of persons who may be at risk for coronary heart disease, and aid in the management of patients undergoing therapy with lipid lowering drugs. The measurement range for the Cholestron is 150 - 300 mg/dL.
The Cholestron system consists of a photometer with a display assembly keypad, and single-use, disposable reagent strips. Fingerstick whole blood is applied directly to the device, and cholesterol results are available in approximately three minutes.
Here's an analysis of the acceptance criteria and study findings for the Lifestream Technologies, Inc. Cholesteron™ Pro II Cholesterol Test, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (NCEP Guidelines) | Reported Device Performance |
|---|---|---|
| Accuracy | Bias within 3% of reference method | All comparative biases were within 3% (e.g., Operator #1: 1.50% bias at 200 mg/dL, -1.25% at 240 mg/dL; Operator #2: 2.50% bias at 200 mg/dL, -0.42% at 240 mg/dL) |
| Precision (CV) | %CVs within 3% | Serum Precision: |
| - Low Control (184.4 mg/dL): Weekly %CV = 1.72% | ||
| - High Control (230.9 mg/dL): Weekly %CV = 2.91% | ||
| Whole Blood Precision: | ||
| - Low (179.4 mg/dL): %CV = 1.39% | ||
| - High (228.1 mg/dL): %CV = 2.38% |
2. Sample Size Used for the Test Set and Data Provenance
- Accuracy Studies: Two studies, each involving 62 subjects.
- Precision Studies (Serum): A two-level commercial control set was assayed 30 times for each level (6 times a day over 5 days).
- Precision Studies (Whole Blood): Two levels of venous heparinized whole blood were tested 30 times each.
- Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. Given the nature of a 510(k) submission for a new device, it is highly likely these were prospective studies conducted specifically for regulatory submission. The location of Lifestream Technologies Inc. (Post Falls, ID) suggests the studies were likely conducted in the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Accuracy Studies (Ground Truth): The reference method used was the Abell-Kendall (A-K) method for venous serum samples. This is a recognized laboratory reference method and does not rely on expert consensus for ground truth establishment.
- Precision Studies (Ground Truth): For serum, commercially prepared control samples with label-assigned mean values were used. For whole blood, "venous heparinized whole blood" samples were targeted at specific cholesterol concentrations. Again, these are analytical ground truths, not dependent on expert consensus.
4. Adjudication Method for the Test Set
- Adjudication methods (like 2+1, 3+1) are typically used when human interpretation of results is involved, often in imaging or diagnostic pathology.
- For the Cholesteron™ Pro II Cholesterol Test, which is an in vitro diagnostic device providing quantitative results, the "ground truth" for accuracy was established using a reference laboratory method (Abell-Kendall). Therefore, no adjudication method as typically understood in qualitative diagnostic studies was required or described. The device's results were compared directly to the quantitative output of the reference method.
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
- No MRMC comparative effectiveness study was done. This type of study is relevant for devices involving human interpretation (e.g., AI in radiology). The Cholesteron™ Pro II Cholesterol Test is an automated quantitative diagnostic device for measuring total cholesterol; therefore, MRMC studies are not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- The accuracy and precision studies evaluate the standalone performance of the Cholesteron™ Pro II Cholesterol Test device itself. While the device is "professional-use," meaning operated by trained personnel, the performance metrics (accuracy, precision compared to a reference method) are for the device's analytical capability, not for improved human interpretation with or without the device. The data provided in the "CHOLESTRON ACCURACY STATISTICS" table shows "Operator #1 vs A-K," "Operator #2 vs A-K," etc., indicating multiple operators used the device, but this is to demonstrate consistency across operators, not to measure human improvement with device assistance.
7. The Type of Ground Truth Used
- For accuracy: The ground truth was established by comparing the Cholestron device's results to a reference laboratory method: the Abell-Kendall (A-K) method using venous serum samples.
- For precision: The ground truth was established using commercial control samples with label-assigned values (for serum) and venous heparinized whole blood samples targeted at specific concentrations. These represent analytical ground truths.
8. The Sample Size for the Training Set
- The document does not provide information on a training set sample size. This is because the Cholesteron™ Pro II Cholesterol Test is not described as an AI/machine learning device that requires a distinct training and test set in the modern sense. It is a traditional in vitro diagnostic device based on enzymatic reactions and photometric measurement. Its development would involve calibration and optimization, but typically not a "training set" in the context of recent AI regulatory submissions.
9. How the Ground Truth for the Training Set Was Established
- As noted above, the concept of a "training set" and its associated ground truth as relevant for AI/ML devices is not applicable to this traditional in vitro diagnostic device. The device's calibration and optimization would have been based on established chemical and photometric principles, likely using reference materials and laboratory standards, rather than a "ground truth" derived from a separate training dataset.
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