Search Results

AxSYM B12 is a microparticle enzyme intrinsic factor assay for the quantitative determination of vitamin B12 in human serum or plasma.

AxSYM B12 is a microparticle enzyme intrinsic factor assay for the quantitative determination of vitamin B12 in human serum or plasma. AxSYM B12 is calibrated with Abbott B12 calibrators. Abbott B12 controls are assayed for the verification of the accuracy and precision of the Abbott AxSYM System.

Here's an analysis of the provided 510(k) summary for the Abbott AxSYM® B12, structured according to your request:

Device: Abbott AxSYM® B12, a microparticle enzyme intrinsic factor assay for the quantitative determination of vitamin B12 in human serum or plasma.

Predicate Device: Abbott IMx® B12 assay.

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: 337 specimens.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It simply states "using 337 specimens." Given the context of a 510(k) summary, these would typically be clinical samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the 510(k) summary. For in-vitro diagnostic (IVD) devices like this, the "ground truth" for individual samples is typically established by their actual B12 concentration, as measured by a gold standard method or the predicate device itself, rather than by human expert interpretation in the way it applies to imaging or diagnostic interpretation tasks. The comparison here is between two quantitative assays.

4. Adjudication Method for the Test Set

This concept of "adjudication" (e.g., 2+1, 3+1) is typically associated with studies where human readers are interpreting images or clinical data, and their interpretations are reconciled to establish ground truth or resolve discrepancies. For a quantitative IVD device like this, which measures a biomarker concentration, adjudication methods are not applicable. The comparison is between the numerical output of two different assays.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading medical images). The Abbott AxSYM® B12 is an automated quantitative assay, not an AI-assisted diagnostic tool that requires human interpretation in the workflow described.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Yes, the study described is inherent to a standalone performance evaluation of the AxSYM B12 assay. The data presented compares the AxSYM B12's quantitative output directly against the predicate IMx B12's quantitative output. There is no mention of human interaction or interpretation affecting the reported B12 values from either system during the comparison. It is essentially an "algorithm-only" (or "assay-only") comparison.

7. The Type of Ground Truth Used

The "ground truth" in this context is implicitly the measurement provided by the predicate device, the Abbott IMx® B12 assay. The study's primary goal is to demonstrate that the AxSYM B12 results are substantially equivalent to the established IMx B12 results for the same samples. While "true" B12 levels could ultimately be determined by a reference method (e.g., mass spectrometry), for 510(k) substantial equivalence, the predicate's performance often serves as the de facto "ground truth" for comparison.

8. The Sample Size for the Training Set

This information is not provided. The 510(k) summary describes a validation study comparing the new device against a predicate. It does not mention a "training set" in the context of machine learning. For IVD assays, development involves method optimization, reagent formulation, and analytical validation. There isn't typically a distinct "training set" in the same way as for AI/ML algorithms that learn from data.

9. How the Ground Truth for the Training Set Was Established

As noted above, the concept of a "training set" with associated "ground truth establishment" is not applicable or described in this 510(k) summary for an IVD assay. Assay development and calibration are distinct processes. The AxSYM B12 is "calibrated with Abbott B12 calibrators," which implies using known concentrations to establish its standard curve.

Ask a specific question about this device