(272 days)
Planmeca Romexis is a medical imaging software intental and medical care as a tool for displaying and visualizing dental and medical 2D and 3D image files from imaging devices, such as projection radiography and CBCT. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, diagnose, review, store, print, and distribute images of both adult and pediatric patients.
Planmeca Romexis is also a preoperative software used for dental implant planning. Based on the plant position a model of a surgical guide for a guided implant surgery can be designed objects can be exported to manufacture a separate physical product.
Planmeca Romexis is also a preoperative software for simulating surgical treatment options.
Planmeca Romexis is also intended to be used for monitoring, storing and displaying mandibular jaw positions and movements relative to the maxilla.
Additionally, Planmeca Romexis includes monitoring features for Planmeca devices for maintenance purposes. The software is designed to work as a stand-alone or as an accessory to Planmeca dental unit products in standard PC.
The software is for use by authorized healthcare professionals. Use of the software for implant planning requires that the user has the necessary medical training in implantology and surgical dentistry. Use of the software for surgical treatment planning requires that the user has the necessary medical training in maxillofacial surgery.
Indications of the dental implants do not change with guided surgery compared to conventional surgery.
Planmeca Romexis is a modular imaging software for dental and medical use. It is divided into modules to provide user access to different workflow steps involving different diagnostic views of images. Patient management screen with search capabilities lets users to find patients and identify correct patient file before starting work with a patient. After creating or selecting patient, new images can be acquired using select Planmeca X-ray units.
Planmeca Romexis is capable of processing and displaying 2D images in different formats and 3D CBCT images in DICOM format. 3D CBCT images can be viewed in near real-time multi projection reconstruction (MPR) views. 2D and 3D image browsers are provided to allow user access to relevant images. Typical image enhancement filters and tools are available to assist the user in making diagnosis, but original exposure is always kept in the database for reference.
lmages can be exported to files or writable media, printed to paper or DICOM media or transferred securely to other users using Planmeca online services. Interfaces to select external software are provided to facilitate exchange of patient information and images or data between Software and 3rd party applications.
The provided text describes Planmeca Romexis, a medical imaging software. However, it does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.
Therefore, I cannot directly answer your request based on the provided text. The document lists the following:
- Indications for Use: The software's intended uses (displaying 2D/3D images, dental implant planning, surgical treatment simulation, jaw movement monitoring, device maintenance).
- Technological Characteristics Comparison: A table comparing features of Planmeca Romexis with predicate and reference devices, highlighting similarities in operating environment, functionalities, image files, and major features.
- Non-Clinical Test Results: A general statement about quality assurance measures applied during development (Risk Analysis, Requirements Reviews, Design Reviews, Performance testing, Safety testing, Final acceptance testing, Bench testing). It concludes that testing confirmed stability, operation as designed, hazard evaluation, and risk reduction. It also states that bench testing compared images rendered by Planmeca Romexis with predicate software and confirmed they are "equally effective in performing the essential functions and provide substantially equivalent clinical data."
Missing Information:
The document does not provide:
- A table of specific acceptance criteria and reported device performance against those criteria.
- Sample sizes for a test set, data provenance, or details about retrospective/prospective nature of a study.
- Number or qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- MRMC comparative effectiveness study details, including effect size.
- Details about a standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
In summary, while the document confirms non-clinical testing was performed to establish substantial equivalence, it does not detail the specific acceptance criteria or the study methodology (sample sizes, ground truth, expert involvement, etc.) that would prove the device quantitatively meets such criteria.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).