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The device is a diagnostic X-ray system which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors. Its use is intended for both adults and pediatric subjects.

Intended as extraoral x-ray source to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians.

The Ray98(P) by Ningbo Runyes Medical Instrument Co., Ltd., is a portable x-ray device. The technology of this device was originally developed in Korea more than a decade ago and global production is still concentrated in that country.

The subject device is designed for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure by exposing an x-ray image receptor to ionizing radiation. The x-ray source, a tube, is located inside the portable device. All three conventional types of intraoral receptors can be used with this device-analog x-ray film, digital phosphorous plates, and digital x-ray sensors.

This device is used in general dentistry and is supplied with an internal timer to control the duration of the x-ray source to the patient. The portable x-ray device is a choice model to assist doctors with special need patients, nursing home patients in the office that cannot be easily moved, as well as other special situations. The choice of an x-ray generator is a matter of functional utility in the dental operatory and personal preference by the medical professional.

This document describes the 510(k) premarket notification for the Portable X-ray System Model Ray98(P). However, the information provided does not contain details about a study evaluating the device's performance against specific acceptance criteria for an AI/CAD system, nor does it detail a multi-reader multi-case (MRMC) comparative effectiveness study.

The document primarily focuses on establishing substantial equivalence to a predicate device (MobileX Portable X-ray System, K180561) based on similar indications for use, intended use, technological characteristics, and conformity to relevant safety and performance standards for X-ray systems.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication methods, or MRMC study details because this information is not present in the provided text.

The document states that:

• Non-Clinical Performance Data was collected for electrical safety and EMC, software validation, usability, clinical evaluation, and risk assessment.
• All tests were performed in accordance with IEC and ISO standards.
• Conformity with all standards was determined by the device manufacturer, Ningbo Runyes Ltd., Korea.
• Electrical tests were performed by KCTL, Inc. Laboratories, Inc., Korea.
• The Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" applies to this device, and details are provided within the Software Validation Report (which is not included here).

Based on the provided text, the device is a portable X-ray system, not an AI/CAD system, and the clearance is for the hardware device itself, not for an AI algorithm's diagnostic performance. Hence, the request for details on AI-specific performance criteria, MRMC studies, ground truth establishment for AI models, etc., is not applicable to the content of this document.

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