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LOCI 8 CAL is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL) and estradiol (E2)methods on the Dimension Vista® Systems .

LOCI 8 CAL is a multi-analyte, liquid, frozen bovine serum albumin based product containing hormone, recombinant human prolactin, estradiol, buffers and preservatives.

The provided K101460 510(k) summary for the LOCI 8 Calibrator is for an in vitro diagnostic product (calibrator). The information requested regarding acceptance criteria and study details (like sample size for test sets, ground truth establishment, MRMC studies, standalone performance) is typically associated with studies evaluating the diagnostic performance of a medical device against a ground truth, often for imaging or patient-facing diagnostic tests.

A calibrator like the LOCI 8 CAL is not assessed in the same way as a diagnostic device. Its performance is primarily evaluated based on its ability to accurately calibrate an assay, ensuring the assay provides correct quantitative results for specific analytes (FSH, LH, Prolactin, Estradiol). The "acceptance criteria" for a calibrator would revolve around its manufacturing specifications, stability, and its impact on the accuracy and precision of the assays it calibrates.

Therefore, many of the requested categories are not applicable in the context of this 510(k) summary for a calibrator. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving diagnostic accuracy.

Here's a breakdown of the available information and why some categories are not applicable:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" and "reported device performance" in the typical sense of a diagnostic test's sensitivity, specificity, or accuracy. Instead, it describes the features and characteristics of the calibrator and compares them to predicate devices to demonstrate substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This 510(k) summary is for a calibrator. There is no "test set" of patient samples in the context of diagnostic performance evaluation. The data would pertain to internal validation studies of the calibrator manufacturing and its performance with the associated assay, not diagnostic accuracy on patient data.

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)

Not Applicable. Ground truth, in the sense of a clinical diagnosis, is not established for a calibrator. The "truth" for a calibrator is its assigned value, established through a rigorous process of traceability to international standards and reference methods (e.g., WHO standards for hormones, ID-GC/MS for Estradiol), performed by analytical chemists or metrology experts within the manufacturer's R&D.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods are used to resolve discrepancies in expert interpretations of diagnostic data, which is not relevant for a calibrator.

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. MRMC studies are for evaluating observer performance, particularly relevant for imaging devices or other diagnostic tests requiring human interpretation. This is a calibrator, with no human interpretation component in its function.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a calibrator, not an algorithm. Its "performance" is its ability to provide accurate and stable calibration points for an automated assay.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

As explained in point 3, the "ground truth" for a calibrator is its assigned value based on traceability to international reference standards and/or reference measurement procedures.

• FSH: WHO 1st IS for FSH 92/510
• LH: WHO 2nd IS for LH 80/552
• Prolactin: WHO 3rd IS for PRL 84/500
• Estradiol: Isotope Dilution gas chromatography mass spectroscopy (ID-GC/MS) reference measurement procedure.

8. The sample size for the training set

Not Applicable. This is a calibrator, not a machine learning model that requires a training set. The term "training set" is not relevant here.

9. How the ground truth for the training set was established

Not Applicable. See reasons for point 8.

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