(124 days)
The device is a digital X-ray system to generate X-ray images from the whole body including the skull, chest, abdomen, and extremities. The acquired images support medical professionals to make diagnostic and/or therapeutic decisions. Generic clinical benefits of radiographic examinations within the intended use are applicable for this device.
YSIO X.pree is not for mammography examinations.
The YSIO X.pree is a radiography X-ray system. It is designed as a modular system with components such as a ceiling suspension with X-ray tube, Bucky wall stand, Bucky table, X-ray generator, portable wireless and fixed integrated detectors that may be combined into different configurations to meet specific customer needs.
The provided document is a 510(k) summary for the Siemens YSIO X.pree X-ray system. It does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria for an AI/CAD-related product.
The document primarily focuses on establishing substantial equivalence to a predicate device (Ysio Max) based on technological characteristics, intended use, and compliance with general safety and performance standards for X-ray systems.
Specifically, the document states:
- "Al-based Auto Cropping" is a feature described as a "New Algorithm," but the comparison table explicitly states it "does not affect safety or effectiveness." This implies that its performance was not a critical factor in the substantial equivalence determination for this 510(k). The document does not provide any performance metrics or studies related to this AI feature.
- The comparison tables highlight changes in DQE and MTF for the "MAX mini" detector, noting "small changes...does not affect safety and effectiveness." These are technical specifications of the detector, not overall system performance against clinical or perceptual criteria.
Therefore, since the document does not seem to describe an AI/CAD device that requires specific clinical performance testing against established acceptance criteria, I cannot fulfill the request for a table of acceptance criteria and associated study details from the provided text.
The information requested, such as sample size, ground truth establishment, expert adjudication, MRMC studies, and standalone performance, is typically found in submissions for AI/CAD-assisted diagnostic devices where the AI's performance is central to the safety and effectiveness claim. This 510(k) notice is for a general radiographic X-ray system, where the primary focus is on the hardware and its general imaging capabilities.
§ 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.