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The Portable Dental X-Ray (Model: NP-350E) is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors.

Portable Dental X-ray (Model: NP-350E) is a super capacitor-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-rays images utilizing either film or digital imaging techniques. The Portable Dental X-ray Device is designed for use in a dental office. It can also be used in other similar environments (orthodontic office, general practitioner's office, hospital ward, etc.) where appropriate safeguards are implemented. The device uses a rechargeable super capacitor to allow for the use of the Portable Dental X-ray Device where transportation or use of other x-ray devices might be prohibitive due to the other device's size and/or lack of mobility.

The Portable Dental X-ray Device is an X-ray device with a DC generator. The handheld device features a main unit (tube head), charger AC/DC power supply. The power is supplied by a rechargeable super capacitor built into a device. This facilitates portability of the device. A beam-limiting cone is incorporated within the device. Internal and external shielding provide sufficient radiation protection to allow the clinician to remain in the operatory with the patient.

To make the system as simple as possible for the operator, Portable Dental X-ray Device uses a fixed tube voltage of 70kV and a fixed tube current of 3.5mA. The only operator-adjustable parameter is the exposure time. This adjustment can be quickly accomplished through the user-friendly control panel.

Control buttons, display, and a trigger provide the primary operator interface. Exposures settings can be selected and displayed. Voltage (70 kV) and current (3.5 mA) are fixed with the exposure time varying based on patient type, detector type, and anatomical feature. Exposures can be completed using the trigger. The device can be used with three detector types: film, digital imaging intraoral sensors, and phosphor plates.

The provided text describes a 510(k) premarket notification for a Portable Dental X-ray device (Model: NP-350E). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study with specific acceptance criteria related to diagnostic performance of an AI algorithm.

Therefore, the document does not contain the information requested regarding acceptance criteria for an AI device, a study proving it meets those criteria, sample sizes for test/training sets, expert qualifications, or details about MRMC studies or ground truth establishment for an AI-powered diagnostic device.

The study described in this document is a non-clinical test that assesses the device's adherence to various international safety and performance standards for X-ray equipment. It focuses on the physical and electrical characteristics of the X-ray system itself, not on the diagnostic accuracy of an AI algorithm.

Specifically, the "Non-Clinical Test Data" section lists several IEC standards the device was tested against (e.g., IEC 60601-1 for basic safety, IEC 60601-1-2 for electromagnetic compatibility, IEC 60601-1-3 for radiation protection, IEC 60601-2-65 for dental X-ray equipment). These are engineering and safety standards, not performance metrics for an AI's diagnostic capabilities.

The "Technological Characteristics" section provides a comparison table between the subject device, a predicate device (K173319 KaVo NOMAD Pro 2 Handheld X-ray System), and a reference device (K152859 Portable X-ray System). This comparison highlights physical dimensions, weight, source-to-skin distance, cone diameter, energy source, exposure time range, mA, kVp, and compliance with electrical safety, EMI, and performance standards. This further emphasizes that the evaluation is of the hardware's characteristics and safety, not AI performance.

In summary, none of the requested information regarding AI acceptance criteria, study design for AI evaluation, ground truth, or expert involvement for AI is present in this document. The document concerns the clearance of a traditional medical imaging device (a portable dental X-ray machine) based on its substantial equivalence to existing devices and compliance with relevant safety and performance standards for X-ray hardware.

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