(56 days)
The Access Estradiol Calibrators are intended to calibrate the Access Estradiol assay for the quantitative determination of estradiol levels in human serum and plasma using the Access Immunoassay Systems.
The Access Estradiol Calibrators are liquid calibrators to be used with the Access Estradiol assay to generate the estradiol calibration curve on the Access Immunoassay Systems. The Access Estradiol Calibrator kit contains six vials, one for each calibrator level. The Access Immunoassay Systems utilize a competitive binding immunoenzymatic assay for the quantitative measurement of estradiol.
The provided documentation describes a 510(k) premarket notification for a modification to an existing device, the Access® Estradiol Calibrators. The modification is a restandardization of the calibrators' traceability. The document focuses on demonstrating substantial equivalence to the predicate device, not on directly proving new acceptance criteria for a novel device or AI algorithm. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC studies, training set details) are not applicable or not provided in this type of submission.
Here's an analysis based on the available information:
1. Table of acceptance criteria and the reported device performance
The document doesn't explicitly state numerical "acceptance criteria" in the typical sense for an AI/diagnostic algorithm (e.g., sensitivity, specificity thresholds). Instead, the performance demonstrated is that the restandardized calibrators are "substantially equivalent" to the predicate device. This is a regulatory finding rather than a specific performance metric.
| Aspect of Performance | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | No change from predicate device | "No Change" in intended use. |
| Calibrator Levels | New, specified approximate levels (traceable to ID-GC/MS) | Estradiol at approximate levels of 106, 570, 1800, 3100, and 4800 pg/mL, liquid. |
| Traceability | Traceable to ID-GC/MS reference method (change from predicate) | "Traceable to ID-GC/MS (isotope dilution-gas chromatography/mass spectrometry) reference method." |
| Fundamental Technology | No alteration from predicate device | "does not... alter the fundamental scientific technology." |
| Safety and Efficacy | No impact on safety and efficacy compared to predicate device | "does not... affect the safety and efficacy of the device." "Performance data generated from validation testing demonstrates that the restandardized Access Estradiol Calibrators on the Access Immunoassay Systems is substantially equivalent to the currently commercialized Access Estradiol Calibrators." |
2. Sample sized used for the test set and the data provenance
The document states "Performance data generated from validation testing," but does not specify the sample size used for this testing or the data provenance. This type of detail is typically found in the full submission, not the 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable to this type of device (calibrators) or submission. The "ground truth" here refers to the reference method (ID-GC/MS) for estradiol levels, which is a chemical method, not an interpretation by human experts.
4. Adjudication method for the test set
Not applicable. This concept pertains to resolving discrepancies in human interpretation, which is not relevant for the chemical calibration process described.
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 submission is for a medical device (calibrators) that is part of an immunoassay system, not an AI algorithm for image interpretation or diagnosis that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no standalone algorithm being evaluated in this submission. The device is a calibrator for an immunoassay system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the calibrator values is established through ID-GC/MS (isotope dilution-gas chromatography/mass spectrometry) reference method. This is a highly accurate and precise analytical chemistry method.
8. The sample size for the training set
Not applicable. Calibrators are developed and manufactured according to specific chemical and analytical processes to meet target concentrations. There is no "training set" in the context of machine learning for this type of device.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set. The values for the calibrators are established by rigorous analytical methods (ID-GC/MS) to ensure their accuracy and traceability.
§ 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.