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The Lifestream Cholesterol Monitor is an over-the-counter 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 provide information for individuals who are attempting to lower their levels through diet and exercise, or who are under a physician's care with lipid lowering drugs.

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This FDA 510(k) clearance letter for the Lifestream PLUS Cholesterol Monitor provides very limited information regarding the performance study and acceptance criteria. It primarily focuses on the regulatory aspects of device clearance. However, based on the provided text, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter does not include a table of acceptance criteria or reported device performance metrics for the Lifestream PLUS Cholesterol Monitor. It merely states that the device is "substantially equivalent" to legally marketed predicate devices. To determine acceptance criteria for a cholesterol monitor, one would typically look for:

• Accuracy/Bias: How close are the device's readings to a reference method (e.g., laboratory wet chemistry)?
• Precision/Reproducibility: How consistent are the device's readings when measured repeatedly on the same sample?
• Linearity/Measuring Range: Does the device accurately measure across a defined range of cholesterol concentrations?
• Interference: What substances (e.g., triglycerides, bilirubin) might affect the accuracy of the readings?
• User Performance Metrics: For an over-the-counter device, ease of use and accuracy when used by laypersons are important.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

The document does not provide any information about the number or qualifications of experts used to establish ground truth. For a cholesterol monitor, the ground truth would typically be established by a reference laboratory using an established, highly accurate method.

4. Adjudication Method

The document does not mention any adjudication method for the test set.

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

Given this is an in-vitro diagnostic device (cholesterol monitor) and not an imaging or diagnostic interpretation aid for human readers, a MRMC comparative effectiveness study is not applicable or mentioned.

6. Standalone Performance Study

While the letter implies a performance evaluation was done to prove substantial equivalence, it does not explicitly describe a standalone (algorithm only) performance study in terms of specific metrics like sensitivity, specificity, or accuracy. It only states that the device measures total cholesterol in fingerstick whole blood samples. For such a device, the "standalone performance" is essentially the accuracy and precision of the meter itself when performing the biochemical assay.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. However, for a cholesterol monitor, the ground truth would almost certainly be established using a laboratory reference method (e.g., enzymatic colorimetric assays performed on venous plasma by a certified clinical laboratory). This is considered the gold standard for cholesterol measurements.

8. Sample Size for the Training Set

The document does not provide any information about the sample size used for the training set. For a simple in-vitro diagnostic device like a cholesterol monitor, "training sets" in the typical AI sense are less common. Device calibration and internal validation would be performed using a variety of known concentration samples.

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

The document does not specify how the ground truth for any training set was established. As mentioned in point 7, it would likely involve a laboratory reference method to establish known cholesterol concentrations.

In summary, the provided FDA 510(k) clearance letter primarily focuses on the administrative and regulatory aspects of device clearance through the "substantial equivalence" pathway. It does not contain the detailed technical performance study information typically found in clinical study reports or scientific publications. To obtain such information, one would need to refer to the actual 510(k) submission documentation if it were publicly accessible, or scientific literature published by the manufacturer.

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