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A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.

The Abbott AxSYM System is a fully automated immunoassay analyzer designed to perform Microparticle Enzyme Immunoassay (MEIA), Fluorescence Polarization Immunoassay (FPIA), Radiative Energy Attenuation (REA), and Ion Capture (IC) Immunoassay Technologies. The unique features of the AxSYM System allow it to perform random access, continuous access, and STAT processing of both large and small molecular weight analytes.

The provided text is a 510(k) summary for the Abbott AxSYM® System, seeking substantial equivalence to the Abbott AxSYM II System. The study described focuses on demonstrating this equivalence rather than establishing acceptance criteria for a new device's performance against a predefined clinical metric. Therefore, some of the requested information, such as "acceptance criteria and reported device performance" as typically reported for a clinical performance study, "number of experts," "adjudication method," "MRMC study," "training set size and ground truth establishment," and direct "sample size for the test set," are not explicitly detailed in the provided document in the way they would be for a clinical validation of a diagnostic device.

However, based on the information available, here's a breakdown of what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are based on a comparison to a predicate device (Abbott AxSYM II System). The performance metric used for comparison is the correlation coefficient between the two systems.

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

• Sample Size: The document states "patient samples" were used, but the specific number of samples is not provided.
• Data Provenance: The country of origin is not specified. The study is inherently retrospective in the sense that it compares a new system to an existing one using collected data, but the collection of the "patient samples" themselves could have been prospective relative to the study. The document doesn't specify if these were newly collected or existing archived samples.

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

This section is not applicable in the traditional sense for this type of substantial equivalence study. The "ground truth" here is the performance of the predicate device (Abbott AxSYM II System). The study aims to show that the new device's results correlate highly with the predicate device's results. There's no mention of human experts establishing a separate ground truth.

4. Adjudication Method for the Test Set

This is not applicable as there was no expert review or adjudication of results for this type of comparison study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The Abbott AxSYM System is an automated immunoassay analyzer, not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, an MRMC study and effects on human reader performance are irrelevant to this device.

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

Yes, this was effectively a standalone performance evaluation. The study compared the results generated by the Abbott AxSYM System (the "algorithm/device") directly with the results generated by the Abbott AxSYM II System (the "predicate device"). There is no human intervention in the analytical output that is being compared.

7. The Type of Ground Truth Used

The "ground truth" in this context is the performance against the predicate device (Abbott AxSYM II System). The study's objective was to demonstrate that the new AxSYM System's measurements of various analytes using MEIA, FPIA, Ion Capture, and REA technologies correlated extremely well (0.98-0.99) with those obtained from the established AxSYM II System. This is a comparison for substantial equivalence, not a validation against a definitive clinical outcome or pathology.

8. The Sample Size for the Training Set

This information is not provided and is likely not relevant in the context of this 510(k) submission. The AxSYM System is an analytical instrument, not an algorithm that undergoes a "training" phase with a dataset in the machine learning sense. The "training" would be more akin to instrument calibration and assay development, which are internal processes not detailed here.

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

This is not applicable for the reasons stated in point 8.

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