(30 days)
The Mission® Lipid Panel Monitoring System is intended for the quantitative determination of Total Cholesterol. High Density Lipoprotein Cholesterol, and Triglycerides in human capillary whole blood from the fingerin venous whole blood. The Mission® Lipid Panel Monitoring System consisting of the Mission® Lipid Panel Meter, Mission® Lipid Panel Test Cartridges, Mission® Cholesterol Optical Verifier, and Mission® Cholesterol Control Solution, and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto disabling lancing devices. This system is for in vitro diagnostic use only.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. HDL (High Density Lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism or various endocrine disorders.
An estimated value for Low Density Lipoprotein Cholesterol is calculated by the Mission Cholesterol Pro Meter and is reported only when Triglycerides are ≤400 mg/dL.
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The document provided (K180504) is a 510(k) premarket notification for the Mission Lipid Panel Monitoring System. Based on the content, this device is a quantitative assay system for measuring Total Cholesterol, HDL-C, and Triglycerides, primarily used in professional healthcare settings. It is NOT an AI/ML powered device, nor does it involve image analysis by experts, or require MRMC studies.
Therefore, many of the requested criteria (like number of experts, adjudication methods, multi-reader multi-case studies, effect size of human improvement with AI, training set details, etc.) are not applicable to this type of medical device and the information is not present in the provided document.
However, I can extract the acceptance criteria and performance data relevant to a clinical chemistry device, which typically involves analytical accuracy and precision.
Here's an attempt to answer the request based only on the provided document, acknowledging the limitations for an AI/ML context:
The Mission Lipid Panel Monitoring System is a quantitative in vitro diagnostic device. The documentation provided focuses on clinical chemistry performance, not AI/ML algorithm performance. As such, many of the acceptance criteria and study details commonly associated with AI/ML devices (e.g., number of experts, MRMC studies, training set details, ground truth for image analysis) are not relevant or provided for this device type.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K180504) is a 510(k) clearance letter and an Indications for Use statement. It does not contain the detailed performance data or the specific acceptance criteria tables that would typically be part of the predicate comparison or detailed validation studies submitted to the FDA. The letter only states that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.
To illustrate what would typically be found for a quantitative diagnostic like this, and based on common regulatory expectations for lipid panels, performance would involve metrics like:
| Performance Metric | Acceptance Criteria (Illustrative - Not explicitly stated in the provided document, but typical for lipid panels) | Reported Device Performance (Illustrative - Not explicitly stated in the provided document) |
|---|---|---|
| Accuracy (Bias) | For each analyte (Total Cholesterol, HDL-C, Triglycerides), often assessed against a reference method (e.g., CDC-certified laboratory correlation). Criteria might be expressed as a percentage of bias or absolute bias within clinically acceptable limits for different concentration ranges. | e.g., Total Cholesterol: Bias within ±5% or ±X mg/dL compared to reference method. |
| Precision (Reproducibility) | Within-run, between-run, and total precision (CV% or SD) for each analyte at different concentration levels (low, medium, high). Criteria based on CLIA or professional guidelines. | e.g., HDL-C: CV% 0.95) and acceptable agreement (e.g., Bland-Altman plots) with a predicate device or established reference method. |
| User Performance/Lay User Study (if applicable, though this is professional use) | For professional use, demonstrates acceptable performance across different users or sites. | Performance consistent across different operators in a professional setting. |
Important Note: The provided document does not contain any of these specific performance values or acceptance criteria. It is a regulatory clearance letter, not a summary of the validation study.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). Such details would be found in the more detailed 510(k) submission or a summary of safety and effectiveness, neither of which is part of this provided extract.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This device measures chemical analytes (Total Cholesterol, HDL-C, Triglycerides). The "ground truth" for such measurements is typically established by reference laboratory methods (e.g., enzymatic assays, gas chromatography-mass spectrometry (GC-MS), or high-performance liquid chromatography (HPLC)) traceable to international standards (e.g., CDC Lipid Standardization Program). It does not involve human expert interpretation of images or complex diagnostic reasoning.
4. Adjudication Method for the Test Set
Not applicable, as ground truth is established by objective laboratory methods, not expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
Not applicable. MRMC studies are relevant for imaging devices where human readers interpret medical images. This device is a quantitative diagnostic instrument that measures chemical concentrations.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an analytical instrument; its "performance" is its ability to accurately and precisely measure analytes. While there's an "algorithm" for calculating LDL-C (Friedewald formula), its performance is assessed through the accuracy of the underlying direct measurements (TC, HDL-C, TG) and comparison of the calculated LDL-C to a reference method, not typically in a "standalone algorithm" context as understood for image analysis AI.
7. The Type of Ground Truth Used
The ground truth for a device like the Mission Lipid Panel Monitoring System would be established by:
- Reference Laboratory Methods: Highly accurate and precise laboratory methods (e.g., those traceable to the CDC Lipid Standardization Program or other certified reference methods) for Total Cholesterol, HDL-C, and Triglycerides.
- Certified Reference Materials: Use of materials with known, established concentrations of the analytes.
8. The Sample Size for the Training Set
Not applicable in the context of AI/ML training. This device is likely based on established electrochemical or photometric principles, not on a machine learning model "trained" on a dataset of patient samples in the AI sense. Performance is validated through analytical studies on patient samples and quality control materials.
9. How the Ground Truth for the Training Set was Established
Not applicable. As noted above, this is not an AI/ML device that requires a "training set" in that context. Its analytical method is based on established chemical principles. Validation is done against reference methods and materials, as described in point 7.
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.