(48 days)
The ACS:180 and ADVIA Centaur C-peptide calibrators are used for calibrating the ACS:180 and ADVIA Centaur C-peptide Immunoassays.
The ACS:180 and ADVIA Centaur C-peptide are sandwich, chemiluminescence immunoassay for the quantitative determination of C-peptide in human serum for use on the automated analyzer marketed by Bayer Corporation. The ACS:180 and ADVIA Centaur C-peptide Immunoassays can be used to aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
The ACS:180 and ADVIA Centaur C-peptide Calibrator is a citric acid buffered saline with casein and preservatives (micro-protect).
The provided text describes the acceptance criteria and study proving the device meets those criteria. Here's a breakdown by the requested points:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical targets for the ACS:180 and ADVIA Centaur C-peptide Calibrator. However, it indicates that substantial equivalence to the predicate device (TOSOH Corporation AIA-PACK C-Peptide Calibrator Set) is based on the comparison of control accuracy and precision. The table below presents the reported performance values that were used for this comparison.
| System | Performance Metric | Predicate Device (AIA TOSOH) | Test Device (ACS:180) | Test Device (ADVIA Centaur) |
|---|---|---|---|---|
| Accuracy | % Recovery vs TOSOH | N/A | Level 1: 95.3% | Level 1: 83.6% |
| Level 2: 99.8% | Level 2: 93.3% | |||
| Level 3: NA | Level 3: NA | |||
| Precision | Within Run %CV (Level 1) | 2.8% | 4.3% | 3.7% |
| Within Run %CV (Level 2) | 2.0% | 3.2% | 4.0% | |
| Within Run %CV (Level 3) | N/A | 3.6% | 4.1% | |
| Total %CV (Level 1) | 5.7% | 9.8% | 6.1% | |
| Total %CV (Level 2) | 5.8% | 6.1% | 5.1% | |
| Total %CV (Level 3) | N/A | 7.6% | 6.2% |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "The commercial control dose data represented in this document was generated using the calibrators for each respective C-peptide immunoassay."
- Sample Size for Test Set: Not explicitly stated. The data is presented for "Level 1," "Level 2," and "Level 3" control samples for each system, but the number of runs or individual samples contributing to the mean, within-run %CV, and total %CV is not specified.
- Data Provenance: Not specified regarding country of origin or whether it was retrospective or prospective. It is implied to be internal testing by Bayer Diagnostics as part of the 510(k) submission.
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 study involves a calibrator for an immunoassay, not a diagnostic imaging device that typically requires expert interpretation for ground truth. Therefore, the concept of "experts" establishing ground truth in this context is not applicable. The reference method for standardization is stated as WHO 84/510, which implies an established international standard for C-peptide quantification.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations (e.g., medical image reading). This is a quantitative measurement, and therefore, an adjudication method in that sense is not applicable. The ground truth for the assay values is established by the WHO 84/510 standard.
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
No, an MRMC comparative effectiveness study was not done. This study is for a medical device calibrator, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a calibrator for an immunoassay, a chemical analysis and not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of an algorithm is not applicable. The device's performance is measured directly through its ability to calibrate the immunoassay accurately and precisely.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for standardization of the C-peptide calibrator is the WHO 84/510 reference method. This is an internationally recognized standard for C-peptide quantification, ensuring consistency across different assays.
8. The sample size for the training set
This is a calibrator device, not a machine learning algorithm. Therefore, there is no "training set" in the conventional sense. The device is manufactured according to established chemical and analytical principles.
9. How the ground truth for the training set was established
As there is no training set for an algorithm, this question is not applicable. The performance is assessed against the predicate device and the WHO 84/510 standard.
§ 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.