(89 days)
The EasyRA HDL Cholesterol reagent is intended for the quantitative determination of High Density Lipoprotein Cholesterol in human serum and plasma on the Medica EasyRA Chemistry Analyzer. The Medica EasyRA HDL-Cholesterol reagent can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. For in vitro diagnostic use only.
The EasyRA LDL Cholesterol reagent is intended for the quantitative determination of Low Density Lipoprotein Cholesterol in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. The LDL Cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. For in vitro diagnostic use only.
The EasyRA CHOL reagent is intended for the quantitative determination of total cholesterol in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Total cholesterol measurements are used to screen for elevated cholesterol as a risk factor in coronary artery disease. For in vitro diagnostic use only.
The EasyRA TRIG reagent is intended for the quantitative measurement of triglycerides in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism and various endocrine disorders. For in vitro diagnostic use only.
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The provided text is a 510(k) premarket notification letter from the FDA regarding in vitro diagnostic (IVD) reagents for cholesterol and triglyceride measurements. It is not about an AI-powered medical device or an imaging device, and therefore, many of the requested criteria (e.g., sample size for test set, number of experts, MRMC studies, ground truth establishment for AI models) are not applicable to this type of device.
This document confirms substantial equivalence of Medica Corporation's EasyRA reagents to legally marketed predicate devices, meaning their performance characteristics are considered similar enough for market entry without requiring a full Premarket Approval (PMA) application. The assessment for IVD reagents typically focuses on analytical performance characteristics like accuracy, precision, linearity, and interference, rather than diagnostic accuracy studies involving human readers or AI algorithms.
Here's an attempt to address the points based on the provided document, noting where information is not applicable:
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A table of acceptance criteria and the reported device performance
The document itself does not contain a table of acceptance criteria or reported device performance data. This information would typically be found in the manufacturer's 510(k) submission summary, which the FDA reviews. The letter only states that the FDA reviewed the submission and found the device substantially equivalent. For IVD reagents, acceptance criteria usually relate to analytical specifications (e.g., % bias vs. a reference method, coefficient of variation for precision). -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided FDA letter. This would be detailed in the manufacturer's submission.
- Data Provenance: Not specified in the provided FDA letter. For IVD reagents, samples typically refer to human serum or plasma specimens used to validate the reagent's performance.
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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)
Not Applicable. This is an in vitro diagnostic reagent. The "ground truth" for chemical measurements like cholesterol or triglycerides is typically established by using validated reference methods (e.g., CDC reference methods, certified reference materials) or by comparing to another FDA-cleared predicate device, not by expert human interpretation like in imaging. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. As explained above, this is an IVD reagent, not an imaging device requiring human adjudication of results. -
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
Not Applicable. No human readers or AI assistance are involved in the direct output of these IVD reagents. Their performance is measured analytically. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is not an AI algorithm. It's a chemical reagent for a lab analyzer. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for IVD reagents typically refers to:- Reference Methods: Highly accurate and precise laboratory methods (e.g., gas chromatography-mass spectrometry for some analytes, or established enzymatic methods traceable to reference standards).
- Certified Reference Materials (CRMs): Samples with known, certified concentrations of the analyte.
- Comparison to Predicate Devices: Performance is often compared to another legally marketed and validated device to demonstrate "substantial equivalence."
The specific method used is not detailed in this FDA letter.
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The sample size for the training set
Not Applicable. This is not an AI device that requires a "training set" in the machine learning sense. The "training" for a chemical reagent involves its formulation and validation, which doesn't use data sets in the same way. -
How the ground truth for the training set was established
Not Applicable. As above, no training set in the AI sense.
In summary, the provided document is a regulatory clearance letter for laboratory testing reagents, not for a medical device that utilizes artificial intelligence or requires human interpretation for its primary function. Therefore, the questions related to AI models, human expert review, and related study designs (like MRMC) are not relevant to this specific product.
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(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.