(195 days)
The Quantimetrix Complete D® 25-OH Vitamin D Control is intended for the quality control of laboratory procedures used to quantitate Total 25-OH Vitamin D.
This quality control product is intended to allow an objective measurement of a laboratories performance (procedures and personnel techniques) in comparison to known values. Two clinically relevant levels of controls are available to compare observations with expected ranges therefore assuring consistent performance.
The provided text is a 510(k) summary for the Quantimetrix Complete D® 25-OH Vitamin D Control. This document is a premarket notification for an in vitro diagnostic (IVD) quality control device, not a medical device that diagnoses or treats patients. Therefore, the typical acceptance criteria and study design elements requested in the prompt, which are usually applicable to diagnostic or therapeutic AI/ML devices, do not directly apply here.
The "device" in this context is a quality control product designed to ensure the accuracy of laboratory procedures for quantifying Total 25-OH Vitamin D. Its performance is assessed in terms of its ability to provide known values for comparison, rather than its diagnostic accuracy or impact on human readers.
However, I will extract and present the relevant information from the document in the spirit of the request, mapping the concepts as best as possible.
1. A table of acceptance criteria and the reported device performance
For a quality control product, "acceptance criteria" generally refer to its stability, formulation characteristics, and its intended use aligning with its predicate. "Reported device performance" would relate to its composition and ability to serve its quality control purpose, rather than diagnostic accuracy metrics.
| Acceptance Criteria / Characteristic | Reported Device Performance (New Product: Complete D 25-OH Vitamin D Control) |
|---|---|
| Intended Use | Quality control of laboratory procedures used to quantitate Total 25-OH Vitamin D. |
| Analyte | 25-OH Vitamin D |
| Matrix | Vitamin D depleted human serum, reagent grade chemicals and preservatives. |
| Number of Levels | 2 |
| Volume | 3mLs. |
| Storage (unopened) | 24 months at 2 to 8° C |
| Form | Liquid |
| Similarity to Predicate | Employs a similar human serum matrix and constituent formulation, similar storage and stability requirements. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail specific "test set" sample sizes or data provenance in the context of clinical performance evaluation because this is a quality control device. The comparison provided is between the new product's characteristics and those of the predicate device. The information is descriptive of the product's formulation and specifications.
3. 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)
This concept is not applicable to a quality control product. The "ground truth" for a quality control material is its precisely manufactured, known concentration of the analyte (25-OH Vitamin D). This "truth" is established during the manufacturing process, not by expert interpretation in a clinical setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in clinical studies to resolve discrepancies in expert readings for diagnostic outcomes. For a quality control material, the "truth" is inherent in its formulation.
5. 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. MRMC studies are used to evaluate the impact of a diagnostic tool on human reader performance, typically for image-based diagnostics. This device is a quality control standard for laboratory assays, not a diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the performance of an algorithm without human intervention, again typically for diagnostic AI. The Quantimetrix Complete D® 25-OH Vitamin D Control is a physical quality control material, not an algorithm. Its "standalone" performance refers to its inherent properties and stability. The document focuses on characterizing these properties and comparing them to a predicate device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device is the known, precisely manufactured concentration of 25-OH Vitamin D within the control material. This is established through analytical chemistry and manufacturing processes, not clinical outcomes or expert consensus. It acts as a reference point for other laboratory assays.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set is involved for this type of 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.