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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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INTENDED USE
The Lifestream Cholesterol Monitor is a professional-use, point-of-care in vitro diagnostic device for the measurement of total cholesterol in fingerstick whole blood samples, used with the Privalink Software accessory to provide personalized health related information
INDICATIONS FOR USE
Total cholesterol measurements aid in the detection of persons who may be at risk for coronary heart disease, and with personalized health related information, aid in the management of patients undergoing therapy with lipid lowering drugs.
The measurement range for the Cholestron is 150 - 300 mg/dL.
Prescription Use

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This document is a 510(k) clearance letter from the FDA for a software accessory to a cholesterol monitor, not a study report or clinical trial. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, and ground truth establishment is not present in the provided text.

However, based on the information that is present, here's what can be inferred or explicitly stated:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria or reported device performance for the Privalink Software Accessory itself. The 510(k) process is primarily about demonstrating substantial equivalence to a predicate device, not necessarily proving new performance against specific criteria.

The only performance-related information mentioned is the measurement range for the Lifestream Cholesterol Monitor: 150 - 300 mg/dL. This is a functional specification of the main device, not the software accessory, and it's presented as an operational range rather than a performance target met through a study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The letter focuses on the regulatory clearance based on substantial equivalence, not on the details of a specific performance study for the software accessory.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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 information is not provided in the document. The Privalink Software Accessory is described as providing "personalized health related information," which suggests it might assist in interpretation, but there's no mention of a comparative effectiveness study involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided in the document. Given its role as an "accessory" to a cholesterol monitor for personalized health information, it's unlikely to have been evaluated as a standalone diagnostic algorithm in the same way an AI-powered image analysis tool might be.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document.

9. How the ground truth for the training set was established

This information is not provided in the document.

Summary based on available information:

The provided document is a regulatory clearance letter, not a detailed study report. It confirms the FDA's finding of "substantial equivalence" for the Privalink Software Accessory to a legally marketed predicate device. This implies that the performance for the purpose of regulatory clearance was demonstrated through comparison to an existing device rather than through a de novo clinical study with specific acceptance criteria and detailed performance metrics as would be expected for a novel diagnostic algorithm.

The only quantitative information related to performance is the measurement range of the Lifestream Cholesterol Monitor from 150 - 300 mg/dL, which is the device the software accessory works with. Details about the software accessory's specific performance (e.g., accuracy of personalized health information, impact on user interpretation) are not included in this letter.

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