(21 days)
Planmeca Promax, panoramic x-ray imaging system with Cephalostat, is an extraoral source x-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device can be equipped with accessories to fulfil the different diagnostic needs. In digital configuration the images are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer.
Planmeca Promax is a conventional panoramic x-ray system utilizing either films and intensifying screens or digital imaging. The product can be equipped with a cephalostat. The product modification includes a new DEC (Dynamic Exposure Control) system, which is designed to be used in digital imaging, in both panoramic and cephalostat modes, and replaces the old AEC system used.
The provided text is a 510(k) Summary for the Planmeca Promax with DEC (Dynamic Exposure Control), a panoramic x-ray system with a cephalostat, dated May 27, 2005. This summary focuses on establishing substantial equivalence to previously cleared devices rather than presenting a detailed study with specific acceptance criteria and performance metrics for the new DEC system.
Therefore, the document does not contain the information requested in points 1-9 regarding specific acceptance criteria, a study proving the device meets those criteria, sample sizes, expert qualifications, ground truth methods, or comparative effectiveness.
The document primarily states:
- Substantial Equivalence: The manufacturer considers the product modification, including the new DEC system, to be substantially equivalent in design and function to the Planmeca Promax (#K011619) and PM 2002 Proline with AEC (#K000163).
- Safety and Effectiveness: It claims that "Planmeca Promax with DEC is as safe and effective as the predicate devices."
Without a separate study report detailing performance metrics for the DEC system, it's impossible to fill out the requested table and answer the specific questions about acceptance criteria and study results. This 510(k) summary is a regulatory filing asserting equivalence based on modification, not a performance study report.
§ 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.