(27 days)
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.
| Characteristic | Predicate Device (NOMAD Pro X-ray System - K081664) | KaVo NOMAD Pro 2 Handheld X-ray System (New Device) | Acceptance Criteria/Performance Proved By |
|---|---|---|---|
| Indications for Use | Same | Same | Direct comparison (substantial equivalence) |
| Mechanical Size (Body) | 11"L x 10"H x 5.5"W | 11"L x 10.5"H x 5.5"W | Direct comparison (minor change) |
| Weight | 5.5 lbs. | 6.0 lbs. | Direct comparison (minor change) |
| Source to skin distance | 21 cm | Not specified (implied same as predicate) | Direct comparison |
| Cone diameter | 6 cm | Not specified (implied same as predicate) | Direct comparison |
| User Interface | Same, plus several user-selectable preset times. | Same, plus several user-selectable preset times. | Direct comparison (unchanged functionality) |
| Backscatter radiation protection | 6.75" dia. Pb-filled acrylic plastic scatter shield | Not specified (implied same as predicate) | Direct comparison |
| Exposure switch | Trigger located on handset | Trigger located on handset | Direct comparison |
| Tubehead mounting | Handheld | Handheld | Direct comparison |
| Energy Source (Battery) | Rechargeable 22.2 V DC Li-polymer battery core pack (1.25 A-hr capacity) | Rechargeable 21.6 V DC Li-ion battery core pack (1.7 A-hr capacity) | Direct comparison and compliance with IEC 62133 |
| Recharge capability | 60% remaining capacity after 400 cycles | 70% remaining capacity after 300 cycles | Direct comparison (minor change with improved capacity) |
| Exposure Time | 0.02 - 1.0 seconds in 0.01 increments | Not specified (implied same as predicate) | Direct comparison |
| Timer Accuracy | Same | Same | Direct comparison |
| mA | 2.5 mA fixed | 2.5 mA fixed | Direct comparison |
| kVp | 60 kVp fixed | 60 kVp fixed | Direct comparison |
| Waveform | Constant Potential (DC) | Constant Potential (DC) | Direct comparison |
| Electrical Safety Standards | IEC60601-1, UL60601-1, EN60601-1 | AAMI ES60601-1:2005/(R)2012 And A1:2012 | Compliance with updated standard |
| EMI Standards | IEC60601-1-2 Ed. 2 | IEC60601-1-2 Ed. 4 | Compliance with updated standard |
| X-RAY Performance Standard | 21 CFR 1020.30, 1020.31; IEC60601-1-3; IEC60601-2-7 | 21 CFR 1020.30, 1020.31; IEC60601-1-3; IEC60601-2-65 | Compliance with updated standard |
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.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.