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The KaVo NOMAD Pro 2 Handheld X-ray System 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.

KaVo NOMAD Pro 2 Handheld X-ray System is a battery-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 KaVo NOMAD Pro 2 Handheld X-ray System 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 safequards are implemented. The device uses a rechargeable battery to allow for the use of the KaVo NOMAD Pro 2 Handheld X-ray System 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 KaVo NOMAD Pro 2 Handheld X-ray System is an X-ray device with a DC qenerator. The handheld device features a main unit (tube head), recharqeable battery (handset), charger, and charger AC/DC power supply. The power is supplied by a rechargeable Lithium Ion battery core pack built into a handset. 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, KaVo NOMAD Pro 2 Handheld Xray System uses a fixed tube voltage of 60kV and a fixed tube current of 2.5mA. 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 (60 kV) and current (2.5 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 KaVo NOMAD Pro 2 Handheld X-ray System is an extraoral source X-ray system. The document provided outlines the substantial equivalence to a predicate device, the NOMAD Pro X-ray System (K081664). This means that the device's performance is demonstrated by its adherence to recognized standards and by showing it functions comparably to an already approved device.

Here's the breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly demonstrated through compliance with various international standards and general performance characteristics that are "unchanged" or "same" as the predicate device, or show minor improvements. The table below highlights the key characteristics and indicates how performance is evaluated against the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product."

Therefore, there was no "test set" of patient data or clinical samples used for the approval of this device. The evaluation was entirely based on non-clinical engineering and bench testing, demonstrating compliance with various national and international standards applicable to medical electrical equipment and X-ray systems.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

As no clinical testing was performed, there were no clinical experts (like radiologists) involved in establishing ground truth for a test set. Evaluation was based on engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The approval is based on substantial equivalence to a predicate device and compliance with non-clinical performance and safety standards.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in a sense. The "performance" of the device was assessed in a "standalone" non-clinical manner, meaning its physical and electrical characteristics, and its compliance with safety and performance standards for X-ray devices, were tested independently of human operators or clinical outcomes. The device itself is an X-ray system, not an AI algorithm, so the concept of "algorithm only" or "human-in-the-loop" isn't directly applicable in the way it would be for AI software. Its functionality as an X-ray generator was validated through engineering tests.

7. The Type of Ground Truth Used

The "ground truth" for this device's approval is primarily established through compliance with recognized international and national standards for medical electrical equipment and diagnostic X-ray systems (e.g., IEC 60601 series, 21 CFR 1020.30, 1020.31), and by demonstrating substantial equivalence in technological characteristics and indications for use to a legally marketed predicate device. This involves engineering measurements and testing to ensure the device meets specified performance thresholds and safety requirements.

8. The Sample Size for the Training Set

Not applicable, as this is hardware (an X-ray system), not a software algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is hardware (an X-ray system), not a software algorithm that requires a training set.

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"AnyRay" is Portable X-Ray System intended to be used by trained dentists and technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

"AnyRay" is a wireless Portable X-Ray System that operates on DC22.5V supplied by a rechargeable Lithum-Polymer battery pack. The X-ray tubehead, X-ray controls and power source are ssembled into a single hand-held enclosure. The Package includes DC adaptor and Chair (Option) This equipment generates and controls X-ray in order to diagnose of tooth and jaw. It is composed of xray generator, controller, beam limiting device and chair (Option). Operating principle is that x-ay generated by high voltage electricity into x-ray tube, which (Openatifs primelpes in this x-ray images on receptor.

Here's a breakdown of the acceptance criteria and the study information based on the provided text for the "AnyRay" Portable X-Ray System:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provided does not specify explicit "acceptance criteria" in terms of performance metrics like accuracy, sensitivity, or specificity for the device itself in producing diagnostic images. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (NOMAD Dental X-Ray System, K051795) based on technical and safety specifications.

The table below summarizes the key features and performance parameters compared to the predicate device, which implicitly serve as the "acceptance criteria" for demonstrating equivalence in a 510(k) submission of this nature. The "Reported Device Performance" column directly reflects the information provided for the "AnyRay" device.

Study Proving Device Meets Acceptance Criteria:

The provided document describes a 510(k) premarket notification, which is a submission to the FDA to demonstrate substantial equivalence to an existing legally marketed device (the predicate device). It is not a clinical study in the traditional sense designed to prove superior performance or a specific diagnostic accuracy.

The "study" here is essentially the comparative analysis of the technical specifications and safety standards between the "AnyRay" device and its predicate, the NOMAD Dental X-Ray System (K051795). The conclusion states: "E-Woo Technology Co.,Ltd. concludes that the Portable X-Ray System "AnyRay" 's safety and effectiveness are substantially equivalent to predicate devices..." This conclusion is drawn from the detailed technical comparison presented in the table.

Here's an analysis of the requested information based on the 510(k) submission content:

2. Sample Size Used for the Test Set and the Data Provenance:

• Test Set: There is no "test set" in the context of image data for diagnostic performance evaluation mentioned in this document. The evaluation is based on a comparison of device specifications and adherence to recognized standards.
• Data Provenance: The data provenance is the device specifications provided by the manufacturer, E-Woo Technology Co., Ltd. for the "AnyRay" and specifications of the predicate device (NOMAD).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

• This information is not applicable to this type of 510(k) submission. There was no diagnostic image-based "ground truth" to be established for a test set by external experts.

4. Adjudication Method for the Test Set:

• This information is not applicable. There was no test set requiring expert adjudication.

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:

• No, an MRMC comparative effectiveness study was not done. This document pertains to an X-ray device (hardware) and its substantial equivalence in terms of technical specifications and safety, not an AI or software algorithm that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• No, a standalone algorithm performance study was not done. This document is for a physical X-ray device, not an algorithm.

7. The Type of Ground Truth Used:

• Not applicable in the context of diagnostic performance. The "ground truth" here is effectively the accepted technical specifications and safety compliance demonstrated by the predicate device and relevant industry standards (e.g., IEC, FDA regulations).

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set was Established:

• Not applicable. There is no "training set" for which ground truth would be established.

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