(16 days)
The Access Inhibin A calibrators are intended to calibrate the Access Inhibin A assay for the quantitative determination of dimeric Inhibin A levels in human serum and plasma using the Access Immunoassay Systems.
The Access Inhibin A QC is intended for monitoring system performance of the Access Inhibin A assay.
The Access Inhibin A Calibrators & Controls are designed for use with the Access Inhibin A Reagent for generation of the Inhibin A assay calibration curve on Beckman Coulter's Access immunoassay Systems. The Access Inhibin A Calibrator kit contains 7 X 2.5 mL bottles, one for each of seven calibrator levels. The Access Inhibin A Control kit contains 3 X 2.5 mL bottles, one for each of three control levels. The Access Immunoassay Systems utilize a competitive binding immunoenzymatic method for quantitative analyte measurement.
The provided K070144 510(k) summary for the Access Inhibin A Calibrators & Controls indicates that the device met its acceptance criteria through performance characteristics testing, demonstrating substantial equivalence to the predicate device. However, the specific acceptance criteria and detailed performance results that would allow for a table comparing expected vs. reported performance are not explicitly defined in the provided document. The 510(k) summary generally states that the device "meet product claims and specifications" and "supports a finding of substantial equivalence."
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the specific quantitative acceptance criteria (e.g., precision limits, linearity ranges, recovery percentages) and the detailed results demonstrating performance against these criteria are not provided in the submitted document. The 510(k) summary only offers a high-level statement that the device met its performance characteristics and claims.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific criteria for calibration, control range, precision, stability, etc., are not detailed in the provided document. | The document states, "Based on the results of the performance characteristics testing, these calibrator materials meet product claims and specifications." and "Performance data from validation testing supports a finding of substantial equivalence to the Diagnostic Systems Laboratories (DSL) ACTIVE® Inhibin A ELISA Calibrators and Controls already in commercial distribution." No specific numerical performance metrics are given. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The document states that "Performance data from validation testing" was conducted, but it does not elaborate on the details of this testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that this is an in vitro diagnostic (IVD) device (calibrators and controls), the "ground truth" is typically established through analytical methods, reference materials, and comparison to a predicate device, rather than expert interpretation of images or clinical data. Therefore, the concept of "experts" establishing a ground truth for a test set in the way it might be for an AI diagnostic device is not applicable here. The ground truth for the calibrators and controls would be based on their assigned values and their performance in an assay, which is analytically determined.
4. Adjudication Method for the Test Set
As this is an IVD device, adjudication methods (like 2+1, 3+1) used for human interpretation of clinical cases are not applicable. Device performance is assessed through analytical testing and comparison to reference standards or predicate devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this type of IVD device (calibrators and controls). MRMC studies are typically performed for diagnostic imaging or AI devices where human readers interpret results, and the study aims to assess the impact of AI on reader performance. This device does not involve human interpretation of cases in that manner.
6. Standalone Performance Study
Yes, implicit in the submission is that a standalone (algorithm only without human-in-the-loop performance) was done. The "performance characteristics testing" mentioned in the summary refers to analytical studies evaluating the calibrators and controls themselves, independent of human interpretation or assistance. These studies would assess aspects like:
- Calibration curve generation: How well the calibrators establish the assay's dose-response curve.
- Control material accuracy and precision: How accurately and consistently the controls measure expected values.
- Stability: The shelf-life and in-use stability of the calibrators and controls.
- Matrix effects: Performance in different sample matrices.
- Method comparison: Comparison of the Access Inhibin A assay (using these calibrators/controls) to the predicate device's assay.
The document states, "The Access Inhibin A Calibrators have been demonstrated to be equivalent to the predicate product. Based on the results of the performance characteristics testing, these calibrator materials meet product claims and specifications." This confirms standalone testing was performed.
7. Type of Ground Truth Used
The ground truth for an IVD calibrator and control kit is based on analytical characterization and alignment to reference standards. Specifically, the document states: "Both are aligned to WHO international standard 91/624." This indicates that the values assigned to the calibrators and controls are traceable to an internationally recognized standard. The performance testing would then verify that the device accurately reflects these ground truth values.
8. Sample Size for the Training Set
The concept of a "training set" in the context of machine learning (AI) is not applicable to this traditional IVD device. Calibrators and controls are manufactured to specific specifications and then analytically validated. There is no algorithm "trained" in the sense of AI.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the AI sense, this question is not applicable. The values for the calibrators and controls are established during their manufacturing process, quality control, and by alignment to recognized reference standards, not through an AI training process.
§ 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.