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AXIOM Aristos FX Plus 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 AXIOM Aristos FX Plus allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying 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 AXIOM Aristos FX Plus is designed as a set of two ceiling mounted telescoping arms. One arm is supporting the x-ray tube with the collimator; the other arm is supporting the FD (Flat panel detector) with new detector housing and two hand grips. Different table tops, including a painted one for children are available. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions.

A Wireless Remote Control using RF technology has been designed to allow the clincian to remotely operate the system movements from virtually anywhere in the room through a short-range, low-power radio communication link between a hand held transmitter and the receiver. Additional hardware (independent of microcontroller) and Siemens own communication protocol layers will provide a safety-oriented signal transmission.

The provided text is a 510(k) premarket notification for the Siemens AXIOM Aristos FX Plus X-ray system and its Wireless Remote Control. This documentation aims to demonstrate substantial equivalence to previously cleared devices, rather than presenting a de novo study with explicit acceptance criteria and performance data for a new, innovative device feature.

Therefore, much of the requested information about acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, and comparative effectiveness studies is not present in the provided text. The document focuses on demonstrating that the new device is substantially equivalent to existing, cleared predicate devices.

However, I will extract and infer what information is available based on the document's nature.

Description of Acceptance Criteria and Device Performance Study for Siemens AXIOM Aristos FX Plus

The Siemens AXIOM Aristos FX Plus is a dedicated X-ray system. The 510(k) submission primarily focuses on demonstrating that this device, and specifically its new Wireless Remote Control feature, is substantially equivalent to previously cleared predicate devices. Therefore, the "acceptance criteria" discussed here are implicitly related to regulatory substantial equivalence rather than performance metrics from a de novo clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a substantial equivalence submission, explicit quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy) from a de novo study are not provided. Instead, the "acceptance criteria" are implied by the process of demonstrating that the modified device's features and performance do not raise new questions of safety and effectiveness compared to its predicates.

2. Sample size used for the test set and the data provenance

The document does not describe a clinical "test set" in the context of a performance study with a specific sample size. The demonstration of substantial equivalence relies on comparison to predicate devices and adherence to established safety standards, not on a new clinical trial with a defined test set of patients or images.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical test set requiring expert ground truth establishment is described in this 510(k) submission.

4. Adjudication method for the test set

Not applicable. No clinical test set is 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 an X-ray system and a remote control, not an AI-powered diagnostic tool. No MRMC study is mentioned.

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

Not applicable. This is not an AI algorithm submission. The device is an X-ray system.

7. The type of ground truth used

Not applicable. No clinical ground truth data from specific patient cases are presented in this regulatory document. The "ground truth" for this submission revolves around demonstrating that the device and its modifications meet engineering standards and operate safely and effectively in comparison to previously cleared devices.

8. The sample size for the training set

Not applicable. This submission describes an X-ray imaging system, not a machine learning algorithm requiring a "training set."

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

Not applicable. (See #8).

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