(21 days)
The MYO Calibrator is intended to be used to calibrate the MYO Method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.
MYO Calibrator is a five level liquid bovine serum albumin-based product with target concentrations of 0, 35, 100, 500, and 1060 ng/ml. Level 1 contains no detectable myoglobin. Levels 2 through 5 contain human heart myoglobin. The kit consists of ten vials; two at each level
This document describes the Dade Behring Dimension® RxL Myoglobin (MYO) Calibrator, a secondary calibrator intended for use with the Dimension® RxL clinical chemistry system.
Based on the provided text, the device is a calibrator, not a diagnostic device that generates performance metrics like sensitivity, specificity, or AUC. Calibrators are used to establish a reference point for an assay, ensuring accurate quantitative measurements. Therefore, the concept of "acceptance criteria" and "device performance" in the typical sense (e.g., detecting a disease) does not directly apply here. Instead, the "study" demonstrating its effectiveness would likely involve showing that the calibrator functions correctly to enable accurate calibration of the Myoglobin (MYO) Method.
Given that this is a 510(k) submission primarily for demonstrating substantial equivalence to a predicate device, the "study" would focus on comparing the characteristics and performance of the new calibrator to an already legally marketed one.
Here's an attempt to answer your questions based on the available information, with caveats due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
Since this is a calibrator, "acceptance criteria" likely relate to its composition, stability, and its ability to properly calibrate the associated assay, leading to accurate Myoglobin measurements. The provided document doesn't explicitly state quantitative acceptance criteria or detailed performance metrics from a specific study on the calibrator itself beyond the comparison to the predicate.
| Acceptance Criteria (Implied for a Calibrator) | Reported Device Performance (from comparison to predicate) |
|---|---|
| Fulfills intended use as a calibrator | Calibrator |
| Contains human heart myoglobin as analyte | Human heart myoglobin |
| Matrix is bovine serum albumin | Bovine serum albumin |
| Form is liquid | Liquid |
| Target concentrations for calibration are appropriate | 0, 35, 100, 500, 1060 ng/mL |
| Number of levels is suitable for calibration | Five |
| Substantially equivalent to predicate device | Found "substantially equivalent" |
Note: The "reported device performance" here is largely based on direct comparison of characteristics to the predicate device, not on extensive performance data for the calibrator itself. The "substantial equivalence" determination by the FDA implies that the new calibrator is expected to perform comparably to the predicate in its intended function.
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 describe a "test set" in the traditional sense of evaluating a diagnostic algorithm. The comparison is primarily between the characteristics of the new calibrator and the predicate calibrator. There is no mention of sample size, data provenance, or retrospective/prospective nature for evaluating the calibrator's performance beyond its intrinsic properties.
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)
Not applicable. This device is a calibrator, not a diagnostic tool requiring expert interpretation of results to establish ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" or adjudication process described for this calibrator.
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. This is a calibrator, not an AI-assisted diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical calibrator, not an algorithm, so "standalone performance" of an algorithm is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a calibrator, the "ground truth" would be the known, verified concentrations of myoglobin within each calibrator level. The text states:
- "Level 1 contains no detectable myoglobin."
- "Levels 2 through 5 contain human heart myoglobin."
- "Target Concentrations: 0, 35, 100, 500, 1060 ng/mL."
This indicates that these concentrations are designed and verified by the manufacturer, rather than being derived from external expert consensus, pathology, or outcomes data in the context of diagnostic evaluation.
8. The sample size for the training set
Not applicable. This is a calibrator, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable for the same reason as above. The "ground truth" for the calibrator levels themselves would be established through precise manufacturing processes and analytical verification of the myoglobin concentrations within each vial.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.