(15 days)
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
The provided text describes the regulatory submission for calibration and control devices (ELITech Clinical Systems ELICAL 2, ELITROL I, and ELITROL II) for use with Lipase testing on ELITech Clinical Systems Selectra Analyzers. The focus of the submission is to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating the device's performance in diagnosing patients.
Therefore, many of the requested points, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types related to diagnostic performance of an AI model, are not applicable to this type of device submission.
The "study" referenced in this document is a value assignment and verification process for the calibrator and control materials, not a clinical trial of a diagnostic device.
Here's the information that can be extracted from the provided text, adapted to the context of a calibrator and control material:
1. Table of Acceptance Criteria and Reported Device Performance (for Lipase value assignment):
| Acceptance Criteria (for Lipase Value Assignment) | Reported Device Performance (for Lipase Value Assignment) |
|---|---|
| Calibration factor of control lots systems must be within an acceptance range. | The document states this criterion was met. |
| Value obtained for lipase must be ±9% of the target value. | The document states this criterion was met. |
2. Sample size used for the test set and the data provenance:
- Test Set (for ELICAL 2 Lipase Value Assignment): "The test system" was calibrated using "a previously qualified lot of ELICAL 2 and two different approved lot of lipase reagents." The amount of lipase in the "new lot of ELICAL 2" was then measured. The exact number of measurements or samples within this process is not specified, but it involves a comparison against two different approved lots of lipase reagents.
- Test Set (for ELITROL I and ELITROL II Lipase Value Assignment): "The test system" was calibrated using "a previously qualified lot of ELICAL 2 with two different approved lots of lipase test reagents" and then measuring the amount of lipase in the "new lots of ELITROL I and ELITROL II." The exact number of measurements or samples within this process is not specified but involves a comparison against two different approved lots of lipase test reagents.
- Data Provenance: The data is generated internally by ELITech Clinical Systems as part of their manufacturing and quality control process for calibrators and control materials. No country of origin for the "data" as clinical patient data is provided, as it's a lab-based calibration process. This is a prospective process for each new manufacturing lot.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. The "ground truth" here is the established value of lipase in the calibrator/control material, which is determined through internal procedures and traceability to a titrimetric manual method, not through consensus of human experts interpreting diagnostic results.
4. Adjudication method for the test set:
- Not Applicable. As the "ground truth" is a measured value against a target, there is no expert adjudication involved in the typical sense of interpreting clinical data. The process involves meeting predefined numerical acceptance criteria.
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 not a diagnostic AI device; it's a calibrator/control material. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device. Its purpose is to ensure the accuracy of laboratory measurements by providing known reference points (calibrators) and quality control materials.
7. The type of ground truth used:
- For ELICAL 2 and ELITROL I/II: The "ground truth" for the lipase values is established through a process traceable to a titrimetric manual method. This serves as the reference standard against which the device's assigned values are verified. The ultimate "ground truth" is therefore a chemical/analytical reference standard.
8. The sample size for the training set:
- Not Applicable. This is not a machine learning or AI device that requires a training set. The "training" of the device is its manufacturing and formulation.
9. How the ground truth for the training set was established:
- Not Applicable. No training set is used. The inherent "ground truth" for the calibrator and control materials is their chemical composition and the established lipase activity, which is then verified against a titrimetric manual method.
§ 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.