(187 days)
Planmeca Romexis is a medical imaging software intended for use in dental 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 application used for dental implant planning. Based on the planned implant position a model of a surgical guide for a guided implant surgery can be designed data can be exported to manufacture a separate physical product.
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 a 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.
Indications of the dental implants do not change with guided surgery compared to conventional surgery.
Planmeca Romexis is also intended to be used for monitoring, storing and displaying mandibular jaw positions and movements relative to the maxilla.
This device is not indicated for mammography use.
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.
Images 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 does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria. The document is a 510(k) summary for a medical imaging software (Planmeca Romexis) and focuses on demonstrating substantial equivalence to a predicate device.
Therefore, I cannot provide the requested table and detailed study information.
Here's what the document does provide in relation to non-clinical testing:
- Non-Clinical Test Results:
- Quality Assurance Measures Applied: Risk Analysis, Requirements Reviews, Design Reviews, Performance testing (Verification), Safety testing (Verification), Final acceptance testing (Validation), Bench testing to compare with predicate software.
- Confirmation: "Testing confirmed that Planmeca Romexis is stable and operating as designed. Testing also confirmed that Planmeca Romexis has been evaluated for hazards and that the risk has been reduced to acceptable levels."
- Bench-testing with Predicate Software: "The non-clinical bench-testing of Planmeca Romexis with predicate software version was performed by comparison of images rendered by Planmeca Romexis and the predicate software version. The results confirm that the software applications are equally effective in performing the essential functions and provide substantially equivalent clinical data."
This information indicates that general software development and testing practices were followed, and a comparison was made to a predicate device, but it does not specify:
- Acceptance criteria (e.g., specific metrics like accuracy, sensitivity, specificity, or error rates).
- Reported device performance against any specific criteria.
- Sample size for any test sets.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts or their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study details or effect size.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document concludes that the device is "substantially equivalent in technology, functionality, and indicated use to the currently marketed predicate device" based on "intended use, product, performance, and testing information provided in this notification," but it does not elaborate on the specific performance data that led to this conclusion.
§ 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).