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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.

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.

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