(29 days)
For in vitro diagnostic use in the control of ADVIA Chemistry systems for certain chemistry methods.
The Bayer Special Chemistry Controls are two separate levels of quality control material prepared from human serum with nonserum constituents added. All the analytes currently in the control material are: Acid Phosphatase Lactate Pancreatic Amylase Lipase Cholinesterase The intention of this submission is to add the assigned values to the labeling claims for: Cholinesterase
This document is a 510(k) premarket notification for a quality control material and does not describe a study with acceptance criteria and device performance in the way typically associated with AI/ML medical devices.
Instead, it's a submission for an in vitro diagnostic device (IVD), specifically a quality control material called "Special Chemistry Control." The "performance" being described is the control's suitability for monitoring precision and accuracy of certain chemistry test procedures. The primary focus of this submission is to add assigned values for a new analyte (Cholinesterase) to the labeling claims of an existing, already cleared device.
Therefore, most of the questions you've asked about acceptance criteria, study design, sample sizes, ground truth, experts, and MRMC studies for AI/ML devices are not applicable to this type of submission.
Here's an attempt to answer the relevant parts based on the provided text, and explain why other parts are not applicable:
-
A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria and reported device performance in the context of diagnostic accuracy (e.g., sensitivity, specificity for a disease). The "device performance" in this context refers to its ability to serve as an accurate control for an analyzer.
The key "performance" aspect mentioned is the addition of assigned values for Cholinesterase to the labeling claims. This implies that the manufacturer performed internal validation to establish these assigned values, ensuring they are appropriate for controlling an ADVIA Chemistry analyzer. However, the specific acceptance criteria (e.g., within X% of a reference method, or within a certain coefficient of variation) and the results of that validation are not detailed in this summary. The FDA's acceptance is based on the substantial equivalence to a predicate device and the suitability of the control material, including its analytically derived assigned values.
Not Available in the document: Specific quantitative acceptance criteria or detailed performance data for the Cholinesterase assay within the control. The approval is based on the premise that the product is a control material and the method for determining its assigned values is sound, and it's substantially equivalent to a previously cleared control.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable / Not Available: This document does not describe a clinical study with a "test set" of patient data. The "testing" done would have been laboratory-based analytical validation to determine the assigned values for Cholinesterase within the control material. Details on the number of runs, replicates, or lots used to establish these values are not provided in this summary. The data provenance would be from Bayer's internal laboratories or a contract manufacturer (Randox Laboratories in the UK).
-
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)
Not Applicable / Not Available: "Ground truth" in the diagnostic sense is not being established here. The "ground truth" for a quality control material is its analytically determined concentration for a given analyte. This is typically established through rigorous laboratory methods, often using reference methods or multiple assays, not by expert consensus in the clinical sense.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable: This is irrelevant for a quality control material submission.
-
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: This submission is for a quality control material, not an AI-powered diagnostic device. No MRMC study was performed.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable: This is not an algorithm or AI device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for a quality control material is its analytically determined concentration/activity for each analyte. This is established by the manufacturer using validated laboratory methods, often involving comparison to reference materials or methods, and robust statistical analysis of multiple measurements. This is not expert consensus, pathology, or outcomes data.
-
The sample size for the training set
Not Applicable / Not Available: There is no "training set" in the context of machine learning. If we interpret "training set" very broadly as the data used to establish the assigned values for the control, the specific sample sizes (e.g., number of replicates, number of lots) for this analytical validation are not provided in this document.
-
How the ground truth for the training set was established
Not Applicable / Not Available: The "ground truth" (assigned values) for the Cholinesterase in the control material would have been established through a manufacturing process's analytical validation. This involves:
- Careful formulation of the control material.
- Multiple analyses of the control material using highly precise and accurate methods (often the same ADVIA Chemistry analyzers or reference methods).
- Statistical determination of the mean or target value and its acceptable range.
- This is an internal process by the manufacturer based on analytical chemistry principles, not clinical expert review.
§ 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.