(18 days)
The Ferritin Calibrator is intended to be used to calibrate the ferritin (FERR) method on the Dimension® RxL clinical chemistry system.
The Ferritin Calibrator is a liquid bovine albumin-based product. The Level 1 calibrator contains no detectable ferritin. Levels 2 through 5 contain human liver ferritin. The kit consists of ten vials; two at each of five levels.
Based on the provided text, the device is a medical calibrator, not an AI or imaging device, so many of the requested fields (like sample size for test/training sets, expert ground truth, MRMC studies) are not applicable or not found in the document. The document focuses on regulatory approval based on substantial equivalence to a predicate device.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics (like sensitivity, specificity, accuracy) for a diagnostic device. Instead, the "acceptance criteria" appear to be met by demonstrating substantial equivalence to an existing predicate device. The performance is assessed by comparing key attributes.
| Criteria (Comparison to Predicate Device) | Predicate Device (Cleared Ferritin Calibrator) | Modified Ferritin Calibrator (Reported Performance) |
|---|---|---|
| Intended Use | Calibrator | Calibrator |
| Analytes | ferritin | ferritin |
| Matrix | bovine albumin base | bovine albumin base |
| Form | lyophilized | liquid |
| Volume | 2.0 mL per vial, reconstituted | 1.0 mL per vial |
| Levels | 5 levels | 5 levels |
| Reference Standard | WHO standard, 2nd IS | WHO standard, 3rd IS |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable/Not provided. This is a calibrator, not a diagnostic device evaluated with patient samples. The "test" here is a comparison of product attributes against a predicate.
- Data Provenance: Not applicable/Not provided in the context of patient data. The comparison is based on the characteristics of the calibrator itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth for patient data is not relevant for a calibrator. The "truth" in this context is the stated characteristics of the calibrator and its preparation against a WHO standard.
4. Adjudication method for the test set
- Not applicable. There is no subjective interpretation or adjudication process described as this is a product comparison, not a diagnostic performance study.
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 device is a calibrator for a clinical chemistry system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a calibrator, not an algorithm.
7. The type of ground truth used
- For the calibrator values themselves: WHO standard (2nd IS for predicate, 3rd IS for modified device). This refers to the internationally recognized standard for ferritin. The base matrix is bovine albumin, and the ferritin is from human liver.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for this type of 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.