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The RADspeed PRO is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The RADspeed Pro enables radiographic or tomographic exposures of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. The RADspeed PRO uses portable or integrated flat panel detectors to generate diagnostic images by converting x-rays into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes. The Tomosynthesis option is intended to generate tomographic images of human anatomies. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals. The device is not intended for mammographic applications.

The RADspeed PRO is an X-ray radiography system that is mainly used for the radiography of various regions of the patient's body in a standing or recumbent position. The RADspeed PRO can be used in a wide range of applications from general radiography using X-ray film or Computed Radiography (CR) cassettes, to digital radiography. The RADspeed PRO consists of an X-ray high voltage generator, X-ray tube unit, X-ray tube support and collimator. The system can be configured with radiographic table, radiographic stand and digital radiography system as well. Optionally, the device is also used to perform tomosynthesis radiography by three different reconstruction modes. Filtered Back-Projection (FBP) mode is used to obtain a tomosynthesis image by performing back-projection after correcting the projection data. Shift Addition (SA) mode is used to obtain a tomosynthesis image at an arbitrary slice plane height by shifting each image according to projection angle of the tube based on the reconstruction height, and by applying image addition processing to them. Iteration (IR) mode is used to reduce metal artifact in tomosynthesis image. FBP mode is generally recommended for all body parts. In case an artifact is observed at joints and other similar places, SA mode may remedy this artifact. In case metal artifact is obviously displayed, IR mode is recommended to reduce metal artifact.

The provided document is a 510(k) premarket notification for the Shimadzu Corporation's RADspeed PRO, referencing K233722. It primarily focuses on demonstrating substantial equivalence to a predicate device (K152244) rather than presenting a performance study against specific acceptance criteria for a new clinical indication or AI algorithm.

The modifications to the RADspeed PRO are described as mainly cosmetic and updates to hardware components (larger displays, updated imaging panels that are themselves cleared 510k devices) and software infrastructure (programming language, operating system) without changes to the underlying software functionality or core technological features. The device does not appear to incorporate a new AI algorithm for diagnostic purposes that would require a study with clinical performance metrics like sensitivity, specificity, or reader improvement.

Therefore, the requested information regarding acceptance criteria and performance study results for an AI algorithm (including sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone performance) is not present in the provided text.

The document states:

• "The fundamental technological features are the same for the subject and the predicate systems. The modifications are mainly cosmetic in nature." (Page 4)
• "The software functionality remains unchanged." (Page 5, Page 6)
• "The imaging components were replaced by more recently cleared digital x-ray receptor panels made by FUJIFILM. ... All the imaging panels have 510(k) clearance... The integration software, although updated, has the identical functionality to the predicate." (Page 5)
• "The radiation safety aspects of the device have not changed. The device remains compliant with the FDA Radiation Safety Standards." (Page 9)
• "The non-clinical data supports the safety of the device and the hardware and software verification and validation demonstrate that new device should performs as intended in the specified use. Based on our risk analysis and bench testing, the differences do not affect its clinical safety or effectiveness." (Page 9)

The performance testing mentioned (Software Validation, EMC and Electrical Safety Testing) is related to regulatory compliance and safety for the modified device, not to the clinical performance of a new diagnostic algorithm.

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