(87 days)
The QuickRay DSX 730 sensor device and related components is used to provide instant images of x-rayed human oral tissue and teeth without the use of conventional film.
The QuickRay DSX 730 sensor device and related components. This is acheived by using the conventional x-ray tube, but by placing an electronic sensor, instead of film, inside the patients mouth. The sensor, and by means of the imaging acquisition software provide automatically captures the images into a computer for viewing, storage and printing. Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zooming, pseudo coloration, image inversion, histograms, etc.
The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for the QuickRay DSX 730 device. This device is a digital X-ray sensor for capturing images of human oral tissue and teeth, replacing conventional film.
Unfortunately, neither of these documents contains information regarding acceptance criteria or a study proving the device meets acceptance criteria. The letter only confirms that the device is substantially equivalent to a legally marketed predicate device, indicating it has met regulatory requirements for market clearance, not necessarily performance-based acceptance criteria from a specific study.
Therefore, I am unable to provide the requested information based on the input text. The documents do not contain:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Information about a standalone (algorithm only) performance study.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 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.