(84 days)
The LIPL Calibrator is an in vitro diagnostic product to be used to calibrate the Lipase (LIPL) method for the Dimension® clinical chemistry systems.
The LIPL calibrator is a liquid bovine serum albumin-based product. The level 1 calibrator contains no detectable lipase. Levels 2 and 3 contain porcine pancreas lipase. The kit consists of six vials, two vials of Calibrator Level 1, two vials of Calibrator Level 2, and two vials of Calibrator Level 3 which are ready for use (no preparation is required). The volume per vial is 1.0 mL.
The provided text describes a 510(k) premarket notification for a medical device, specifically the Dimension® Clinical Chemistry System Lipase Calibrator (LIPL CAL - DC56). This device is a calibrator material used to calibrate the Lipase (LIPL) method for Dimension® clinical chemistry systems.
It is important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive performance studies with acceptance criteria in the same way one might assess the accuracy of a diagnostic test. For a calibrator, the primary performance characteristic is its traceability to reference materials and the consistency of its assigned values.
Here's an analysis of the provided information concerning acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
For calibrators, explicit "acceptance criteria" in terms of clinical sensitivity/specificity or other diagnostic performance metrics are not typically provided. Instead, the focus is on traceability and value assignment consistency.
| Acceptance Criteria (Implied for a Calibrator) | Reported Device Performance |
|---|---|
| Traceability to Master Pool Values | The assigned values of the Dimension® LIPL Calibrator are traceable to Master Pool values, assigned on the Dimension® clinical chemistry system. |
| Consistent Value Assignment of Master Pool Level 1 | Master Pool level 1 of BSA base is assigned a value of 0 U/L. |
| Consistent Value Assignment of Master Pool Levels 2 & 3 | LIPL Master Pool bottle values levels 2 and 3 are assigned on multiple instruments calibrated with LIPL Anchor Pool. |
| Traceability of Anchor Pool | The LIPL Anchor Pool values are assigned using an external reference system (PBS/Precical®). |
| Control Against Previous Lots | A previous Master Pool lot is used as a control. |
| Verification of Calibrator Concentration | Calibrators are prepared gravimetrically from porcine lipase. The concentration of each level is verified against Master Pool values. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly define a "test set" in the traditional sense for evaluating diagnostic performance. The evaluation described relates to the traceability and value assignment process of the calibrator.
- Sample Size: The master pool levels 2 and 3 are assigned on "multiple instruments." The number of instruments is not specified. Calibrator concentrations are verified against Master Pool values, which implies testing a certain number of calibrator vials, but the exact number isn't given.
- Data Provenance: The data comes from internal testing and validation by Siemens Healthcare Diagnostics Inc. No country of origin for patients or samples is relevant as this is a calibrator, not a patient-facing diagnostic. The studies are by nature prospective in the sense of manufacturing and validating new lots of calibrator.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable in the context of this calibrator validation. The "ground truth" for calibrators is established through a hierarchical traceability chain to reference materials and methods, not expert consensus on patient data.
- Qualifications of Experts: Not applicable. The process relies on laboratory procedures, validated analytical methods, and qualified personnel following good manufacturing and laboratory practices, rather than expert interpretation of a test set.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" of patient samples requiring expert adjudication. The process involves analytical measurements and comparison to established reference values and internal controls.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a calibrator, not a diagnostic device that requires human interpretation. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The performance described is inherent to the calibrator material and its assigned values, which are determined through analytical procedures, not human-in-the-loop interpretation. The "algorithm" here is the analytical method used to assign the calibrator values and the instrument's subsequent calibration function.
7. The Type of Ground Truth Used
The "ground truth" for the calibrator is established through:
- Reference Materials/Methods: The LIPL Anchor Pool values are assigned using an external reference system (PBS/Precical®).
- Gravimetric Preparation: Calibrators are prepared gravimetrically from porcine lipase, providing a known starting concentration.
- Hierarchical Traceability: The process involves tracing values from a Master Pool, which is itself traceable to an Anchor Pool, and ultimately to an external reference system.
8. The Sample Size for the Training Set
Not applicable. As a calibrator, this device does not involve machine learning or AI that would require a "training set." Its values are determined through analytical and manufacturing processes.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is involved.
§ 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.