(38 days)
CLINIQA LiniCAL™ Esoterics 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 Ammonia, Ethanol, Microalbumin, Salicylate, and Urinary/CSF Protein at five useful concentrations.
assayed, liquid, quality control products
The provided document is a 510(k) clearance letter from the FDA for a Class I medical device, LiniCAL™ Esoterics Calibration Verifiers. This type of device is a quality control material used to evaluate the performance of diagnostic systems (in this case, Olympus AU Systems™ for specific analytes).
For Class I devices like this, the regulatory burden is significantly lower than for Class II or Class III devices, particularly those involving AI or complex diagnostic algorithms. The clearance is based on "substantial equivalence" to a legally marketed predicate device, not on extensive clinical studies proving device efficacy or meeting detailed performance criteria like those found for AI/ML-driven diagnostics.
Therefore, the information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is generally not applicable or not provided in this type of FDA clearance document for a Class I quality control material.
Here's why and what can be inferred:
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Acceptance Criteria and Reported Device Performance:
- Not Applicable in this context. For a quality control material, "performance" would typically refer to its stability, accuracy of its assigned values, and its ability to challenge the assay system across a range of concentrations. The FDA clearance letter itself does not detail specific acceptance criteria for these aspects or present performance data from a pivotal study. Such information would be contained in the 510(k) submission itself, but it's not publicly available in this letter.
- The "performance" implied here is that the device "may be used to evaluate the performance of the Olympus AU Systems™ for Ammonia, Ethanol, Microalbumin, Salicylate, and Urinary/CSF Protein at five useful concentrations." This statement describes its intended function, not quantitative performance metrics.
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Sample Size used for the test set and the data provenance:
- Not provided in this document. For a quality control material, testing would involve manufacturing batches, stability studies, and verification of assigned values using reference methods or predicate devices. This is not a "test set" in the sense of patient data for an AI algorithm.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for a quality control material is established through rigorous analytical chemistry techniques, using reference methods, and often by comparing with established calibrators/controls, not by expert consensus on patient data.
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Adjudication method for the test set:
- Not applicable. Adjudication is relevant for subjective interpretation tasks, particularly in image analysis or pathology. This is an objective chemical control.
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If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No, not done. MRMC studies are specific to diagnostic devices (often imaging) where human readers interpret cases. This is a quality control material for an analytical instrument.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a reagent used by an analytical instrument. It is not an algorithm, nor does it operate "standalone" in the way an AI diagnostic would.
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The type of ground truth used:
- Inferred: For a quality control material, the "ground truth" for its assigned values would be established through certified reference materials, traceable analytical methods, and comparisons to established, analytically validated predicate controls/calibrators. It is not pathology, expert consensus, or outcomes data in the usual sense.
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The sample size for the training set:
- Not applicable. There is no "training set" for a quality control material in the same way there is for an AI/ML algorithm.
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How the ground truth for the training set was established:
- Not applicable. As above, no training set.
In summary: The provided document is an FDA 510(k) clearance for a Class I "Quality Control Material (Assayed and Unassayed)." This type of device does not involve artificial intelligence, machine learning, or complex diagnostic interpretations by human readers, and therefore, the structured questions about acceptance criteria, study methodologies, ground truth establishment, and expert involvement are not pertinent to this device or documented in this type of regulatory letter. The clearance is based on showing substantial equivalence to a predicate device, implying its analytical performance is comparable and safe for its intended use.
§ 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.