(32 days)
VALIDATE® SP1 Calibration Verification Test Set solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration and verification of reportable range in automated, semi-automated and manual chemistry systems for the following analytes: Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Complement C3 (C3), Complement C4 (C4), c1-Antitrypsin (AAT), and Transferrin (TRF).
VALIDATE® SP1 Calibration Verification Test Sets are human serum calibration verification / linearity materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. Each test set consists of one bottle each of five (5) levels. Each bottle of Levels 1 through 5 contains 1.0 milliliter. There exists a linear relationship between Levels 1 through 5.
The provided text is a 510(k) summary for a medical device called "VALIDATE® SP1 Calibration Verification Test Set". This document primarily focuses on demonstrating substantial equivalence to a predicate device and receiving FDA clearance. It does not contain details about specific acceptance criteria for a device's performance, nor does it describe a study proving the device meets such criteria in the way a typical clinical or technical performance study would for a diagnostic or AI-powered device.
Therefore, I cannot extract the information required in your request about acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. The submission is for a quality control material which functions differently from devices that diagnose or interpret medical information.
Here's why the input does not contain the requested information:
- Type of Device: The device is a "Multi-Analyte Controls, All Kinds (Assayed and Unassayed)," specifically a "Calibration Verification Test Set." This type of device is used to check the accuracy and linearity of other diagnostic instruments, not to perform a diagnostic test itself.
- Nature of 510(k) Summary: A 510(k) summary for this kind of device typically focuses on demonstrating that the new device is "substantially equivalent" to an already legally marketed predicate device. This often involves showing similar materials, intended use, and performance characteristics (like stability), without necessarily having a formal "acceptance criteria table" and a study demonstrating meeting those criteria in the context of clinical accuracy or an AI model's performance.
- Missing Details: There is no mention of "test sets" in the context of patient data, "experts" to establish ground truth from medical images/data, "adjudication," "MRMC studies," or "standalone performance" of an algorithm. These concepts are relevant for diagnostic devices that process and interpret patient data, especially AI/ML-enabled ones.
In summary, the provided document does not contain the information you requested because it describes a quality control material, not a diagnostic device that would typically have the kind of performance study you're asking about.
§ 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.