(19 days)
The IDS-iSYS IGF-I Calibration Verifier is a device intended for verification of calibration of the IDS-iSYS IGF-I Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.
The IDS-iSYS IGF-I calibration verifer matrix is composed of a buffer solution containing bovine serum albumin with sodium azide as a preservative. The IGF-I peptide is added to this matrix and the resulting solution is lyophilised.
Here's a summary of the acceptance criteria and study details for the IDS-iSYS IGF-I Calibration Verifier, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the IDS-iSYS IGF-I Calibration Verifier are broadly defined by its intended use for calibration verification and its performance characteristics in value assignment and stability. While explicit numerical acceptance criteria for value assignment (e.g., a specific percentage deviation from the target) are not directly stated as pass/fail thresholds, the methodology for establishing the customer acceptance range is provided.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Intended Use | The device is intended for verification of calibration of the IDS-iSYS IGF-I assay. |
| Format | Lyophilized, same as predicate. |
| Unopened Stability | Store at 2-8°C until expiration date, same as predicate. |
| Analyte | IGF-I. (Difference from predicate, which uses hGH). |
| Levels | 4 levels. (Difference from predicate, which has 5 levels). |
| Matrix | Buffered protein. (Difference from predicate, which has human serum matrix). |
| Traceability | Traceable to the NIBSC code: 02/254 international standard. |
| Value Assignment | Mean value from valid runs (minimum 15 runs across at least 3 iSYS machines, with at least 3 runs per machine), with customer acceptance range based on 8% standard deviation from the mean. |
| Reconstituted Stability (on analyzer) | Up to 2.5 hours on the IDS-iSYS. (Difference from predicate, which has up to 5 hours). |
| Shelf-life Stability (unopened) | Initial shelf-life claim of 6 months at 2-8°C (supported by accelerated testing, real-time testing ongoing). |
| Reconstituted Stability (not on analyzer) | Not stored on board the analyzer. |
2. Sample Size Used for the Test Set and Data Provenance
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Test Set (Value Assignment):
- Minimum runs: At least 15 assay runs per lot.
- Minimum iSYS machines: At least 3 independent iSYS machines.
- Minimum runs per iSYS machine: At least 3 assay runs per iSYS machine.
- Samples/Controls per run: Tested in triplicate.
- Data Provenance: Not explicitly stated (e.g., country of origin). The submitter is based in the United Kingdom, suggesting the study may have been performed there, but this is not confirmed. The study appears to be prospective as it involves active performance evaluation for value assignment and stability testing.
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Test Set (Stability):
- The sample size for stability testing (accelerated and real-time) is not explicitly detailed beyond stating that such testing was performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This device is an in vitro diagnostic (IVD) calibration verifier. The "ground truth" for IVD calibrators/verifiers is typically established through a rigorous value assignment process, often involving reference methods or traceability to international standards, rather than expert human interpretation of results like in medical imaging.
- Number of Experts: Not applicable in the traditional sense for establishing ground truth for this type of device. The "ground truth" (assigned value) is derived from the robust statistical analysis of multiple assay runs performed on the IDS-iSYS system, traceable to an international standard.
- Qualifications of Experts: Not applicable. The process relies on standardized laboratory procedures and statistical methods.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "final result reported is the mean value of all valid runs." This is a statistical aggregation method, not an adjudication process involving human experts resolving discrepancies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results (e.g., radiologists reading images) and the AI aims to assist or replace them. The IDS-iSYS IGF-I Calibration Verifier is a passive control material used in an automated analyzer, not an AI-powered diagnostic tool for human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, in essence, the performance evaluation is standalone (algorithm/device only). The device itself (the calibration verifier material) is evaluated for its intrinsic characteristics (value assignment and stability) using the IDS-iSYS automated analyzer. There is no human-in-the-loop performance being evaluated in the same way an AI diagnostic algorithm would be. The device's performance is gauged through its interaction with the automated assay system, independent of human interpretation of a diagnostic outcome.
7. The Type of Ground Truth Used
- Traceability to an International Standard and Statistical Mean of Multiple Assay Runs: The "ground truth" for the assigned values of the calibration verifier is established through its traceability to the NIBSC code: 02/254 international standard and by taking the mean value of all valid runs performed across multiple iSYS machines and assay kits. This is further qualified by a calculated "customer acceptance range" based on an 8% standard deviation.
8. The Sample Size for the Training Set
- Not applicable / Not explicitly detailed. As a calibration verifier, this device typically does not involve a "training set" in the context of machine learning. Its values are assigned through a standardized laboratory process (analytical validation), not by training a model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As a calibration verifier, there isn't a "training set" for model development. Its reference values are established through the process described in point 7.
§ 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.