(90 days)
VALIDATE® D-Dimer Calibration Verification / Linearity Test Kit solutions are assayed quality control materials intended for in vitro diagnostic use in the quantitative determination verification verification and verification of reportable range for the following analyte: D-Dimer in a clinical laboratory personnel. The product is intended for use with quantitative assays on the indicated analyzers specified in the labeling.
Each VALIDATE® D-Dimer Calibration Verification / Linearity Test Kit contains one analyte set of D-Dimer in a human plasma base matrix. The kit includes a set containing five liquid levels, 3.0 mL each. The set is provided to establish the relationship between theoretical and actual performance of the included analyte D-Dimer. Material of human origin used in the manufacture of this test kit was tested at the donor level using FDA approved methods and was found to be non-reactive for HBsAG and to antibodies to HCV and HIV-1/2.
The provided text describes a 510(k) premarket notification for an in vitro diagnostic device, the VALIDATE® D-Dimer Calibration Verification / Linearity Test Kit. This document does not pertain to an AI/ML medical device, but rather to a quality control material used for calibrating laboratory instruments.
Therefore, many of the requested criteria for describing an AI/ML device's acceptance criteria and study proving its performance (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this document.
However, I can extract information related to the device's performance validation as presented in the document:
Acceptance Criteria and Device Performance (for a Calibration Verification/Linearity Test Kit - Not an AI/ML Device)
1. Table of Acceptance Criteria and Reported Device Performance
The document describes performance in terms of precision/reproducibility and linearity, rather than typical AI metrics like sensitivity, specificity, or AUC. The "acceptance criteria" are implied by the statements that "All levels of the VALIDATE® D-Dimer kit met the CV% acceptance criteria on the Siemens CS-2500 instrument system." and that linearity testing was carried out. Specific numerical acceptance criteria for CV% are not explicitly stated in the provided text.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | All levels to meet pre-defined CV% acceptance criteria. | All levels of the VALIDATE® D-Dimer kit met the CV% acceptance criteria on the Siemens CS-2500 instrument system. |
| Linearity | The kit must demonstrate a linear relationship between levels for calibration verification and reportable range verification. | Linearity testing was carried out, and a linear relationship is stated to exist between each level. The product design relies on "equal deltas" as outlined in CLSI EP6-A. |
| Stability | Product must maintain performance within acceptance criteria over time and freeze-thaw cycles. | Shelf Life Claim: 9 months stability. All product levels tested within acceptance criteria limits after 6 freeze-thaw vial events. |
2. Sample Size Used for the Test Set and Data Provenance
-
Precision/Reproducibility Study:
- Sample Size (Replicates): 80 replicates per kit level for precision study; 75 replicates per kit level for reproducibility study.
- Data Provenance: Not explicitly stated (e.g., country of origin), but implied to be from internal lab testing ("on the Siemens Sysmex CS-2500 instrument system" at "multi-site" for reproducibility). The studies are prospective in nature, as they involve active testing of the device.
-
Linearity Study:
- Sample Size: Not explicitly stated in terms of number of runs or replicates, beyond "Linearity testing was carried out."
- Data Provenance: Internal lab testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This is a quality control material for an in vitro diagnostic test, not an AI/ML device that requires human expert annotation for ground truth. The "ground truth" (or target values) for this device is based on its intended concentration levels (Levels 1 through 5) and the expected linear relationship between them.
4. Adjudication Method for the Test Set
- Not applicable. No human interpretation or qualitative assessment requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This type of study is relevant for AI/ML devices that assist human readers in image interpretation or similar tasks. This device is a quantitative control material.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical kit used to verify instrument performance, not a standalone algorithm. Its "performance" is its ability to reproducibly produce expected values and demonstrate linearity when run on an instrument.
7. The Type of Ground Truth Used
- Internal Reference Standard / Expected Values: The "ground truth" for this device revolves around the predetermined concentrations of D-Dimer in each level (1-5) and their designed linear relationship.
- Level 1 and 5 are prepared independently with D-Dimer added to a human plasma base.
- Levels 2, 3, and 4 are subsequently prepared from Levels 1 and 5 by equal part dilutions following CLSI EP6-A guidelines.
- "Typical recovery values" are established by testing 30 replicates of Levels 1 and 5.
- The device is traceable to the instrument's (Siemens Sysmex CS-2500) calibrator curve (Innovance® reagent calibrator).
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML model that undergoes "training" in the computational sense. Its formulation and design are based on established laboratory quality control guidelines (e.g., CLSI EP6-A).
9. How the Ground Truth for the Training Set was Established
- Not applicable. See point 8. The "ground truth" for the development of the kit (i.e., establishing the target values and linearity across levels) is described by:
- Independent preparation of Levels 1 and 5.
- Subsequent preparation of Levels 2, 3, and 4 via equal part dilutions from Levels 1 and 5.
- Determination of "typical value ranges" and "typical recovery values" for Levels 1 and 5 through 30 replicates of testing.
- Adherence to CLSI EP6-A guidelines for linearity.
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.