(13 days)
Qualicheck5+ is a liquid, four ampoule quality control system, for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood gases, Co-oximetry, Electrolytes, Glucose and Lactate.
Qualicheck5+ is a four level quality control system consisting of part numbers S7730, S7740, S7750 and S7760. Each level consists of 30 ampoules per box.
The provided text is a 510(k) summary for the Qualicheck™5+ quality control system. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through testing of a new algorithm or system. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, sample sizes, ground truth, expert involvement, or comparative effectiveness studies, as this information is not present in the provided document.
Here's why and what information is available:
The document explicitly states:
- "Qualicheck5 + is technologically similar to Multicheck. DEVICE:"
- "EQUIVALENCE: Qualicheck5+ is substantially equivalent in features and characteristics to the current Multicheck (K961355) marketed by Radiometer America Inc. The major difference is the addition of the chloride (cCL) analyte."
This indicates that the submission is primarily focused on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing a detailed performance study with specific acceptance criteria as you would see for a novel algorithmic device.
The FDA's response confirms they reviewed the 510(k) notification and determined the device is "substantially equivalent." This determination is typically based on comparing the new device's design, materials, and intended use to a predicate device, and often includes bench testing to ensure the new device performs as expected, but the details of such testing (e.g., specific acceptance criteria, sample sizes, ground truth) are usually not included in this type of summary document.
In summary, the provided text does not contain the information required to complete your request for acceptance criteria and a study proving those criteria are met for an AI/algorithmic 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.