(28 days)
CLINIQA Liquid QC Lipid Controls Levels 1 and 2 are intended for use as assayed quality control material for Apolipoprotein A-1, Apolipoprotein B, Cholesterol (total), High Density Lipoprotein, Low Density Lipoprotein and Triglyceride analysis.
CLINIQA LiniCAL Lipid Calibration Verifiers Levels A - E for Olympus AU Systems are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU Systems for Cholesterol (total), High Density Lipoprotein. Low Density Lipoprotein and Triglyceride at five useful concentrations.
CLINIQA QALIBRATE™ - Lipid Calibrator is intended for use in assay method calibration for clinical chemistry analyzers listed in the product insert.
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Here's an analysis of the provided text regarding the acceptance criteria and study for the CLINIQA® Liquid QC™ Lipid Controls, CLINIQA® LiniCAL® Lipid Calibration Verifiers, and CLINIQA® QALIBRATE™ - Lipid Calibrator.
It's important to note that the provided document is a 510(k) clearance letter from the FDA. This letter confirms that the devices are "substantially equivalent" to legally marketed predicate devices, meaning they have similar technology and intended use, and are deemed safe and effective. However, this document does not contain the detailed study report or specific acceptance criteria and performance data in the format typically used for AI/ML device evaluations. It primarily focuses on regulatory approval based on the substantial equivalence principle.
Therefore, much of the requested information (like specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, effect sizes, etc.) is not present in this regulatory letter.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not explicitly stated in the provided document. The 510(k) letter confirms that the devices are substantially equivalent to predicate devices, implying that their performance aligns with acceptable standards for their intended use. However, the specific quantitative acceptance criteria (e.g., precision, accuracy ranges) and the detailed study results meeting those criteria are not provided.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not available in the provided document. The 510(k) letter does not detail the specific studies (e.g., analytical performance studies) used to demonstrate substantial equivalence, nor does it specify the sample sizes or data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable/not available. These devices are "Calibrators" and "Quality Controls" for laboratory assays (Apolipoprotein A-1, Apolipoprotein B, Cholesterol, HDL, LDL, Triglyceride). The "ground truth" for such devices typically refers to their assigned values, which are established through rigorous analytical methods using reference materials and validated measurement procedures, not through expert consensus in the way a diagnostic imaging AI would. Therefore, the concept of "experts establishing ground truth" in this context is different and not described in the letter.
4. Adjudication Method for the Test Set:
This information is not applicable/not available for the reasons stated above in point 3.
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 applicable and not available. These devices are not AI/ML algorithms designed to assist human readers in interpreting medical images or data. They are in-vitro diagnostic products for calibrating and controlling laboratory assays. Therefore, MRMC studies and "human reader improvement with AI" are not relevant to these products.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done:
This information is not applicable and not available. These are not AI/ML algorithms, so the concept of standalone performance does not apply. Their performance is assessed through analytical validation studies (e.g., accuracy, precision, linearity) in a laboratory setting.
7. The Type of Ground Truth Used:
For these types of devices (calibrators and quality controls), the "ground truth" generally refers to:
- Assigned Values: The known, predetermined concentration or activity of the analytes within the calibrator or control solutions. These values are established by the manufacturer using highly accurate and precise reference methods, often traceable to international reference materials.
- Reference Methods: The established, gold-standard laboratory methods used to determine the assigned values of the control and calibrator materials.
The document does not detail how Cliniqa established these assigned values, but it's implicit that they followed standard practices for in vitro diagnostic product manufacturing and validation.
8. The Sample Size for the Training Set:
This information is not applicable/not available. These products are not AI/ML models that require "training sets." They are reagents with specific chemical compositions and assigned values.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/not available for the reasons stated in point 8.
Summary regarding the provided document:
The provided FDA 510(k) clearance letter serves as regulatory approval, indicating that the CLINIQA® Lipid products are substantially equivalent to existing marketed devices. It does not present a detailed study report with the specific performance acceptance criteria or study results that would typically be required for an AI/ML device. The nature of these devices (calibrators and quality controls) is fundamentally different from AI/ML diagnostic tools, hence many of the requested categories are not applicable.
To obtain the detailed performance data, one would typically need to refer to:
- The manufacturer's specific product inserts.
- Validation reports submitted to the FDA (which are not publicly detailed in the 510(k) summary letter).
- Peer-reviewed publications or internal validation studies conducted by the manufacturer.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.