(40 days)
The HELIODENT Plus is an extraoral X-Ray source System intended to be used for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
The HELIODENT Plus is an extraoral source dental X-ray system intended for intraoral imaging. X-rays are produced using a multi-pulse generator with a selectable tube voltage of 60 and 70 kV and a tube current of 7 mA. A microprocessar-controlled timer allows for consistent and accurate exposure control, and an adjustable arm allows for easy positioning. The system can be used either with conventional film or a digital imaging system. Basic settings of exposure times are programmed and may be selected by buttons.
This 510(k) summary for the Sirona Dental Systems HELIODENT Plus does not contain the type of acceptance criteria and study information requested.
The document is a submission to the FDA for market clearance, asserting substantial equivalence to predicate devices (Sirona HELIODENT DS and Progeny Preva Dental X-Ray System). This type of submission primarily focuses on comparing the new device's intended use, construction, and technical features to existing legally marketed devices.
Therefore, I cannot provide the requested information from the given text.
Here's a breakdown of why and what information is missing:
- Table of acceptance criteria and reported device performance: This document explicitly states that the HELIODENT Plus is "substantially equivalent" to predicate devices based on "intended use, construction, and technical features," and that "technical specifications... are the same or very similar." It does not present specific acceptance criteria (e.g., image quality metrics, diagnostic accuracy targets) or corresponding performance results for the HELIODENT Plus. Instead, it relies on the previously established performance of the predicate devices.
- Sample size, data provenance, number of experts, qualifications, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and ground truth establishment for the training set: None of these details are included in the provided 510(k) summary. A substantial equivalence submission for an X-ray system typically focuses on engineering specifications, safety, and performance as demonstrated by meeting recognized standards, rather than extensive clinical efficacy studies comparing diagnostic outcomes, especially if the technology is well-established. For instance, the safety and effectiveness of dental X-ray systems are generally accepted, and the submission aims to show that the new device meets these conventional expectations through technical comparability.
§ 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.