(53 days)
The Sentinel Plasmaproteins Cal 3x is a device intended for medical purpose for use in ceruloplasmin, kappa light chains and lambda light chains assay to establish points of reference that are used in the determination of values in the measurement of ceruloplasmin, kappa and lambda light chains in human serum and plasma.
Sentinel Plasmaproteins Cal 3x contains analytes (plasmaproteins) in human serum matrix. The analytes consist of ceruloplasmin, kappa light chains, and lambda light chains.
The provided text describes Sentinel Plasmaproteins Cal 3x, a calibrator for ceruloplasmin, kappa light chain, and lambda light chain assays. The device's performance is primarily assessed through its calibrator shelf-life stability.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Calibrator Shelf-life Stability (% Recovery) | 100 ± 10 % | Kappa light chains: 101.5% at 25 months; Lambda light chains: 99.2% at 25 months; Ceruloplasmin: 98.9% at 25 months. |
2. Sample size used for the test set and the data provenance:
- Sample size: One lot (lot P0387) of Plasmaproteins Cal 3x was used for the shelf-life stability study.
- Data provenance: Not explicitly stated, but it's a prospective study since it involves storing the calibrator and testing it at different time points to determine shelf-life. The country of origin is not specified for the data collection itself, but the submitter is from Milan, Italy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the study is for the stability of a calibrator, not a diagnostic device requiring expert interpretation for ground truth. The 'ground truth' here is the assigned value at manufacturing, which is determined by a value assignment process, not expert consensus.
4. Adjudication method for the test set:
This is not applicable as the study does not involve expert review or adjudication of results. The 'ground truth' is the initial assigned value, and results are compared against this instrumental determination.
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:
This is not applicable. The device is a calibrator, not an AI-powered diagnostic tool, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a calibrator, not an algorithm.
7. The type of ground truth used:
The ground truth for the stability study is the assigned value at manufacturing time. This value is established through a specific value assignment process (testing five replicates per three runs for each analyte, with the assigned value being the average of all replicates).
8. The sample size for the training set:
This is not applicable. The device is a calibrator, not a machine learning model, so there is no training set in the conventional sense.
9. How the ground truth for the training set was established:
This is not applicable, as there is no training set. The "ground truth" for the calibrator's value itself (the assigned value at manufacturing) is established by:
- Testing the new lot.
- Assessing five replicates per three runs for Kappa light chain, Lambda light chain, and Ceruloplasmin assays.
- Calculating the assigned value as the average of all replicates for each assay.
- Using quality control materials to verify assay performance and fresh reagents/new calibrations at each run.
§ 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.