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MPRS is a dedicated x-ray system with a flat panel detector, which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions. The intended use and indications for use of this modified device as described in its labeling have not changed from its predicate device.

The MPRS Multipurpose Radiography System is designed as a set of two ceiling mounted telescoping arms. One arm is supplying the x-ray tube with the collimator, the other arm is supplying the FD (Flat panel detector), which replaces the conventional film/cassette system. A modified patient table is provided, which is based on the Siemens Koordinat M Radiographic X-ray table. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions.

The provided text is a 510(k) summary for the Siemens AXIOM Aristos FX (Multipurpose Radiography System) and does not contain the detailed information necessary to fully address all parts of your request regarding acceptance criteria and a study proving device performance.

This document focuses on establishing substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria for a new or significantly modified feature.

However, based on the input, I can extract the following:

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

The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in the way you've requested (e.g., sensitivity, specificity, accuracy against a numerical target). The primary "acceptance" criteria for this 510(k) submission are based on substantial equivalence to predicate devices. The claim is that:

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

This information is not provided in the given text. The submission relies on demonstrating substantial equivalence, not on a new clinical performance study with a test set of 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)

This information is not provided as there is no mention of a specific test set of images requiring expert ground truth establishment for performance evaluation.

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

This information is not provided for the same reason as point 3.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor is there any mention of Artificial Intelligence (AI) in this 2001 document. The device is a conventional x-ray system.

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

This is not applicable as the device is an imaging system, not an algorithm.

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

This information is not provided as there is no specific performance study described that would require ground truth. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

This information is not provided. The document describes a medical device (an X-ray system), not an AI algorithm that would typically use a training set.

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

This information is not provided for the same reason as point 8.

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