(48 days)
The ACS:180 and ADVIA Centaur Insulin calibrators are used for calibrating the ACS:180 and ADVIA Centaur Insulin Immunoassays.
The ACS:180 and ADVIA Centaur Insulin are sandwich, chemiluminescence immunoassay for the quantitative determination of Insulin in human serum for use on the automated analyzer marketed by Bayer Corporation. The ACS:180 and ADVIA Centaur Insulin Immunoassays can be used to aid in the diagnosis and treatment of diabetes mellitus and hypoglycemia.
The ACS:180 and ADVIA Centaur Insulin Calibrator is a casein buffered solution containing potassium thiocyanate and sodium azide.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Bayer Diagnostics ACS:180 and ADVIA Centaur Insulin Calibrator:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in numerical thresholds, but rather implied by the objective of demonstrating "substantial equivalence" to the predicate device (TOSOH Corporation AIA-PACK IRI Calibrator Set) based on accuracy and precision for control samples. The performance of the new calibrator is compared to the predicate device, with "% Recovery vs TOSOH" serving as a key metric for accuracy.
| Metric | Acceptance Criteria (Implied for Substantial Equivalence) | ADVIA Centaur Performance | ACS:180 Performance |
|---|---|---|---|
| Accuracy (% Recovery vs TOSOH) | Recovery values close to 100% (indicating comparable mean values) | Level 1: 101.0% | |
| Level 2: 88.0% | |||
| Level 3: 100.5% | Level 1: 97.5% | ||
| Level 2: 89.9% | |||
| Level 3: 99.4% | |||
| Precision (Within Run %CV) | Comparable to or better than predicate device | Level 1: 2.9% | |
| Level 2: 2.8% | |||
| Level 3: 2.6% | Level 1: 4.8% | ||
| Level 2: 3.9% | |||
| Level 3: 3.1% | |||
| Precision (Total %CV) | Comparable to or better than predicate device | Level 1: 3.1% | |
| Level 2: 2.7% | |||
| Level 3: 3.3% | Level 1: 8.1% | ||
| Level 2: 7.6% | |||
| Level 3: 5.9% |
Note on Acceptance Criteria: The document does not specify exact thresholds (e.g., "within X% of the predicate device" or "CV must be less than Y%"). The FDA's substantial equivalence determination implies these values were deemed acceptable for the intended use in comparison to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document refers to "commercial control dose data" and lists "Level 1," "Level 2," and "Level 3" for both the predicate and the new devices. However, the specific number of individual samples or replicates used to generate the "Mean," "Within Run %CV," and "Total %CV" for each level is not specified.
- Data Provenance: The document does not explicitly state the country of origin for the data. The manufacturer is Bayer Diagnostics (US-based) and the predicate device manufacturer is TOSOH Corporation (Japan-based). It is implied the data was generated by Bayer Diagnostics. The study appears to be prospective in the sense that the data was generated specifically for this 510(k) submission to demonstrate equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. This study is about a calibrator for an immunoassay, which does not involve subjective interpretation or diagnosis by experts to establish a "ground truth" in the way a diagnostic imaging device might. The "ground truth" here is the established values of the control samples themselves and the performance metrics generated from repeated measurements.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers independently assess data and their discrepancies need to be resolved. This study focuses on objective quantitative measurements of a calibrator.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not provided. This is a study of an immunoassay calibrator, not an AI-powered diagnostic device, and thus does not involve human readers or AI assistance in this context.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. This is a calibrator, not an algorithm or AI device. The "standalone performance" is essentially the device performance as reported in the table.
7. The Type of Ground Truth Used
The "ground truth" for this study is derived from the known concentrations/values of the commercial control samples used. The performance metrics (mean, CV, recovery) are calculated relative to these known values or in comparison to a legally marketed predicate device's performance. The reference method for standardization is WHO 66/304.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This is a calibrator, not a machine learning or AI device that requires a "training set." The device is calibrated, and its performance is tested using control samples.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided for the reasons stated above (not an AI/ML device).
§ 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.