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Elecsys ACTH Assay: Immunoassay for the in vitro quantitative determination of adrenocorticotropic hormone (ACTH) in human EDTA plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E 170 (Elecsys module) immunoassay analyzers. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushings syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.

Elecsys ACTH CalSet is used for calibrating the quantitative Elecsys ACTH assay on the Elecsys immunoassay analyzers.

Elecsys ACTH CalCheck: For use in the verification of the calibration established by the Elecsys ACTH reagent on Elecsys 1010/2010 and MODULAR E170 immunoassay analyzers.

Elecsys PreciControl ACTH is used for quality control of the Elecsys ACTH immunoassay on the Elecsys immunoassay analyzers.

(1) The Elecsys ACTH Assay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code.
(2) The Elecsys ACTH CalSet is a lyophilized product consisting of equine serum with added ACTH in two concentration range. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
(3) The Elecsys ACTH CalCheck is a lyophilized product consisting of buffered equine serum with added ACTH. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
(4) The Elecsys PreciControl ACTH is a lyophilized product consisting of equine serum with added ACTH in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
Note: The reagent, calibrator, calibration verification material and the quality control are all packaged separately.

This document describes the Elecsys ACTH Immunoassay, CalSet, CalCheck, and PreciControl ACTH. The study focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria with acceptance criteria and a study to prove it.

However, based on the provided text, we can extract the reported performance of the device and compare it to the predicate device, which implicitly serves as a benchmark for "acceptance." The document doesn't explicitly state "acceptance criteria" as pass/fail thresholds for the Elecsys ACTH system, but rather presents its performance characteristics and compares them to legally marketed predicate devices to establish substantial equivalence.

Here's an attempt to structure the information in the requested format, acknowledging the limitations of the provided text which is a 510(k) summary focused on substantial equivalence rather than a detailed performance study report:

1. Table of Acceptance Criteria and Reported Device Performance

Since no explicit "acceptance criteria" are given for the Elecsys ACTH Immunoassay, the table below presents its reported performance characteristics and compares them to the predicate Immulite ACTH assay, as demonstrating comparable performance to a legally marketed device is the basis for 510(k) clearance. The implied "acceptance criteria" for a 510(k) submission is that the new device performs acceptably and substantially equivalently to the predicate.

Study Proving Device Meets Acceptance Criteria (as per 510(k) Summary):

The document provided is a 510(k) Summary, which aims to demonstrate "substantial equivalence" of the new device (Elecsys ACTH Test System) to legally marketed predicate devices. The "study" referenced within this context is a series of performance evaluations and comparisons described in the "Substantial equivalence" sections. The Elecsys ACTH Immunoassay's performance characteristics (measuring range, precision, sensitivity, method comparison, specificity, and interferences) were measured and compared to the predicate Immulite ACTH assay (K960066) or other relevant predicate devices for the CalSet, CalCheck, and PreciControl components.

The data presented shows that the Elecsys ACTH Immunoassay generally meets or exceeds the performance of the predicate device, particularly in terms of measuring range, precision, and analytical sensitivity. The method comparison also indicates a strong correlation with a commercially available ACTH test.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Method Comparison (Test Set): n=180 samples were used for the method comparison study (Elecsys ACTH (y) vs. a commercially available ACTH test (x)).
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given it's a 510(k) submission for a global company (Roche Diagnostics), it is likely to include data from various testing sites, potentially international, and both prospective and retrospective samples may have been used. However, this information is not detailed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts & Qualifications: This is not applicable in the context of an immunoassay performance study. The "ground truth" for the test set (patient samples) would be the actual ACTH concentration as determined by a reference method or a legally marketed comparative device, not by expert interpretation. The commercially available ACTH test (x) used for method comparison serves as the reference for comparative accuracy.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. For quantitative immunoassays, the "ground truth" is typically established by quantitative measurement on a reference or predicate device, not by expert adjudication of subjective results.

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

• This is not applicable. The device described is a fully automated immunoassay system for quantitative determination of ACTH levels. It does not involve human readers interpreting images or data where AI assistance would improve their performance. It's an in-vitro diagnostic (IVD) device, not an AI software diagnostic aid for human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• The Elecsys ACTH Immunoassay is a standalone automated assay. Its performance characteristics (precision, analytical sensitivity, measuring range, specificity) are evaluated as the algorithm/system only, without human intervention in the result generation. Human involvement is limited to sample loading, system maintenance, and result review.

7. The Type of Ground Truth Used

• The "ground truth" for evaluating the Elecsys ACTH Immunoassay's performance (specifically for method comparison) was established by comparison to a commercially available ACTH test. This implies using an already established and validated quantitative method. For other performance aspects like precision and analytical sensitivity, the ground truth is inherent in the known concentrations of spiked samples or statistically derived from repeated measurements.

8. The Sample Size for the Training Set

• The document does not specify a separate "training set" for the assay. For immunoassays, the "training" typically refers to the development and optimization process, where various formulations and parameters are tested. The "calibration" of the device uses reference materials (CalSet) with known concentrations to establish a standard curve. The document mentions a master curve provided with the reagent bar code, which is essentially pre-determined calibration data based on extensive prior testing during development and manufacturing.

9. How the Ground Truth for the Training Set Was Established

• As a traditional immunoassay, there isn't a "training set" in the sense of machine learning algorithms.
  • Calibration: The "ground truth" for calibrators (Elecsys ACTH CalSet) is established by spiking known concentrations of ACTH into the matrix and gravimetric standardization with synthetic ACTH produced at Roche.
  • Control Materials: Similarly, for control materials (Elecsys PreciControl ACTH), known concentrations of ACTH are spiked into the matrix.
  • The "master curve" used by the instrument is derived from extensive testing of reference materials with confirmed ACTH concentrations during the assay development process.

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