(15 days)
The SuniRay II Digital Radiography System is used to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.
The Suni SuniRay II Digital Radiography System ("System") will produce real time digital intra-oral images with a reduction in X-ray dosages as compared to film. The System accomplishes this by replacing X-ray film with an electronic sensor that captures the X-ray photons and converts the photons to an electronic signal which in turn is captured in a computer for viewing, manipulating, storing, and outputting (printing or Email).
The System consists of two sensor versions (designated as #1 & #2 sizes; equivalent to dental film sizes), an attached USB electronics box that controls the sensor and interfaces to the computer USB port. The System also includes software drivers that control the USB electronics box, and a Graphical User Interface (GUI) that allows the user access to the data and control functions of the System.
The GUI used with the device was designed by Apteryx, Inc. who holds 510(k) K983111 for their product. Apteryx is responsible for both product validation and GMP compliance. The SuniRay II System software utilizes the Windows XP environment.
The System sensors are in two formats. The #2 size is a larger sensor typical of the European format and the # 1 size is an intermediate size. The sensors consist of a CMOS type integrated circuit, and a high resolution scintillator screen that converts the photons from the X-rays into visible light, which is then acquired by the CMOS imaging integrated circuit. The sensors are encapsulated with a three-foot cable that is connected to the USB electronics box.
The USB electronics box plugs into a computer USB port via a supplied USB cable. The USB electronics box contains the support and control circuitry for the sensor and allows for data communications with the computer. The USB electronics box contains all necessary circuits for sensor data acquisition as well as memory for firmware control of the CMOS X-ray sensor and USB. The USB electronics box communicates with the computer under control of a specific device driver that is active with the GUI.
The System software functions on three levels: (1) The computer operating system (Microsoft Windows) controls the computer, user interface, and file structure; (2) Primary control of the sensor and bus functions is achieved by proprietary software and is either embedded firmware or in non user accessible drivers; and (3) A Graphical User Interface (GUI) allows the user to control the x-ray function, control of the sensor data acquisition, and image viewing, manipulation and output. Examples of the GUI include image capture, enhanced viewing features (zoom, pan, colorize, contrast/brightness, comparative analysis, etc) image organization, and storage.
This report does not contain the information required to fulfill your request. The document is a 510(k) summary for the SuniRay II Digital Radiography System, primarily focused on demonstrating substantial equivalence to a predicate device.
Specifically, it lacks the following crucial information:
- Acceptance criteria and reported device performance
- Details about any study conducted to prove the device meets acceptance criteria. This includes:
- Sample size used for the test set
- Data provenance
- Number of experts and their qualifications for ground truth establishment
- Adjudication method
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies
- Information about standalone performance studies
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document describes the device's function and components, its software, and its compliance with safety and electromagnetic compatibility standards (EN 60601). It also references Apteryx, Inc.'s 510(k) (K983111) for their GUI and states that Apteryx is responsible for product validation and GMP compliance. However, it does not provide details of any clinical or technical performance studies that would include acceptance criteria or specific performance metrics.
§ 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.