(10 days)
CLINIQA LiniCAL™ Chemistry 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 Albumin, Blood Urea Nitrogen, Calcium, Creatinine, Magnesium, Phosphorus, Total Protein, Triglycerides, Glucose, Iron, Sodium, Chloride, and Potassium at five useful concentrations.
assayed, liquid, quality control products
The provided text is a 510(k) clearance letter from the FDA for a device named "LiniCAL™ Chemistry Calibration Verifiers Levels A- E for Olympus AU Systems™". This letter is for a quality control material and not for a diagnostic device that processes patient data or uses AI. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and AI performance metrics is not applicable to this type of device.
Specifically:
- Acceptance Criteria and Reported Device Performance: The document does not describe specific numerical acceptance criteria or performance metrics for this quality control material. The FDA letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the primary criterion for 510(k) clearance for this type of device.
- Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone Performance: These concepts are relevant to studies evaluating the diagnostic accuracy of a medical device (e.g., an imaging AI product). A calibration verifier is used to check the performance of an analytical instrument (like the Olympus AU Systems™), not to diagnose patients. As such, these types of studies and associated metrics are not performed for this product.
- Training Set Information: Training sets, ground truth establishment for training, etc., are terms associated with machine learning or AI model development. This device is a chemical reagent, not an AI product.
Summary based on the document:
Since the device is a quality control material, the typical "acceptance criteria" and "study" as one might expect for a diagnostic or AI-powered device are not present in this regulatory filing. The FDA's acceptance is based on the determination that the device is "substantially equivalent" to legally marketed predicate devices.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Type | Reported Device Performance | Comments |
|---|---|---|
| Substantial Equivalence to Predicate Device | Determined to be substantially equivalent to legally marketed predicate devices. | This is the primary regulatory acceptance criterion for 510(k) clearance for this type of device. Specific performance characteristics are typically detailed in the 510(k) submission itself, but not summarized in the clearance letter as "acceptance criteria." |
Information Not Applicable or Not Found in the Provided Text:
- Sample size used for the test set and the data provenance: Not applicable for a quality control material.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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 (not an AI device).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (not an AI device).
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable (not an AI device).
- How the ground truth for the training set was established: Not applicable (not an AI device).
§ 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.