(22 days)
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.
| Acceptance Criterion (Implied by Substantial Equivalence) | Reported Device Performance / Justification |
|---|---|
| Similar Intended Use | "The intended use and indications for use of this modified device as described in its labeling have not changed from its predicate device." (AXIOM Aristos FX K013826) |
| Similar Technological Characteristics (X-ray System) | "Many of the components (Generator, X-ray tube, Imaging system, Collimator, FD detector) used in the AXIOM Aristos FX Plus are either commercially available with current Siemens AXIOM Aristos FX system or include minor modifications to existing components." |
| Similar Technological Characteristics (Wireless Remote Control) | "The Wireless Remote Control is substantially equivalent to the wireless footswitch for AXIOM Artis system" (AXIOM Artis with Wireless Footswitch K052202). Uses RF technology, short-range, low-power radio communication. |
| Safety and Effectiveness | "Instructions for use are included within the device labeling... Several safety features including visual and audible warnings are incorporated into the system design. In addition, the AXIOM Aristos FX Plus System is continually monitored, and if an error occurs an error message will be displayed." "To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing." |
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).
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.