(131 days)
The IDS-iSYS CTX-1 (CrossLaps ®) Calibration Verifiers is a device intended for the verification of the IDS-iSYS CTX-I (CrossLaps ®) Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer
The IDS-iSYS CTX-I (CrossLaps®) Calibration Verifiers consists of one set of four vials, 2.5 mL each in liquid form, containing horse serum with
The document is a 510(k) Summary for the IDS-iSYS CTX-I (CrossLaps®) Calibration Verifiers, a device intended for the verification of calibration of the IDS-iSYS CTX-I (CrossLaps®) Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.
Here's an analysis of the provided information to answer your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for the device's performance in a table format. Instead, it defines the "Target Range" for each Calibration Verifier level, derived from the mean ± 2 standard deviations during value assignment. This target range implicitly serves as the acceptance criteria for individual measurements when verifying calibration.
| CVM | Target Mean (ng/mL) | Standard Deviation (SD) | Target Range (ng/mL) (Acceptance Criteria) | Reported Device Performance (Target Mean) |
|---|---|---|---|---|
| Cal. Ver. 0 | 0 (Undetectable) | NA | NA | 0 (Undetectable) |
| Cal. Ver. 1 | 0.14 | 0.009 | 0.12 - 0.16 | 0.14 |
| Cal. Ver. 2 | 2.8 | 0.168 | 2.4 - 3.2 | 2.8 |
| Cal. Ver. 3 | 6.1 | 0.366 | 5.6 - 6.6 | 6.1 |
Note: The "Reported Device Performance" here is the target mean derived during the value assignment process, which aligns with the center of the acceptance range. The study ensures that the device can consistently achieve these target means and fall within the defined ranges.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes the "value assignment" process, which functions as the primary method for establishing the performance characteristics and implicitly, the "test set" for the verifiers.
- Sample Size: "Each lot-specific value assignment was tested in five runs on at least three different IDS-iSYS analyzers in triplicate, for a total of 45 replicates." This refers to 45 individual measurements for each calibrator verifier (Cal. Ver. 0, 1, 2, 3).
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Given that Immunodiagnostic Systems Ltd is based in the United Kingdom, it's likely the studies were conducted there. The value assignment process described suggests a prospective study design for establishing lot-specific values.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this type of device. The device is a "Quality control material (assayed and unassayed)" for an in vitro diagnostic assay. Its "ground truth" (target values) is established through rigorous analytical testing and standardization against in-house reference standards, not by human expert interpretation of signals or images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As explained in point 3, the ground truth is established through analytical methods, not through expert adjudication.
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 study involving human readers or AI assistance. The device is a calibration verifier for an automated immunoassay.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the IDS-iSYS CTX-I assay on the IDS-iSYS Multi-Discipline Automated Analyzer when calibrated and verified using these verifiers. The "value assignment" study described is a standalone performance assessment of the verifiers themselves, demonstrating their ability to consistently produce expected concentration values within a statistically defined range. The objective of the verifiers is to ensure the assay's standalone performance is accurate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the calibrator verifiers is their assigned concentration values, which are established through:
- Standardization against in-house reference standards (CTX-I in horse serum).
- Derivation from the mean of multiple replicates across multiple runs and instruments. The target ranges (e.g., 0.12 - 0.16 ng/mL for Cal. Ver. 1) are determined statistically (mean ± 2SD).
8. The sample size for the training set
This concept is not directly applicable to a calibration verifier in the same way it would be for an AI algorithm. The "training" here refers to the process of standardizing the manufacturing of the verifiers and establishing their lot-specific values. The "value assignment" study (45 replicates per verifier level) serves to establish these "ground truth" values and ranges.
9. How the ground truth for the training set was established
For each lot, the "ground truth" (target mean values and ranges) was established through:
- Extensive testing: "Each lot-specific value assignment was tested in five runs on at least three different IDS-iSYS analyzers in triplicate," generating a substantial dataset for statistical analysis.
- Statistical analysis: The "assigned target value of each calibrator verifier was defined as the mean of all the runs for each calibrator verifier. The guideline target range is defined as the mean of all runs ± 2SD."
- Standardization: The IDS-iSYS CTX-I assay (for which these verifiers are used) is itself "standardized against in-house reference standards (CTX-I in horse serum)." This implies a chain of traceability to primary or secondary reference materials.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.