(30 days)
EasyGuide is intended for pre-treatment software planning for the placement of dental implants using a CT scan which has been input into the EasyGuide treatment planning software.
Not Found
This FDA 510(k) clearance letter for the "EasyGuide" device, a software for pre-treatment planning of dental implants based on CT scans, does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them.
The letter is a notification of substantial equivalence to a predicate device, which means the FDA has determined it is as safe and effective as a legally marketed device. It does not typically include the in-depth technical performance characteristics or detailed study results that would satisfy your request for acceptance criteria and supporting study data.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance: This information is completely absent.
- Sample size used for the test set and data provenance: No details on testing, sample sizes, or data origin are provided.
- Number of experts used to establish ground truth and their qualifications: This is not mentioned.
- Adjudication method for the test set: No information on this.
- MRMC comparative effectiveness study details: This type of study is not mentioned or summarized.
- Standalone (algorithm only) performance study details: Not present.
- Type of ground truth used: Not specified.
- Sample size for the training set: Not applicable, as this document is not about algorithm training or validation in that context.
- How ground truth for the training set was established: Not applicable.
The letter focuses on the regulatory aspects of 510(k) clearance, such as product code, regulation number, substantial equivalence determination, and general controls. It refers to the "Indications for Use" for the device on the enclosed page, which is a high-level description of its intended use, but not performance specifications.
To obtain the information you're looking for, you would generally need to consult the actual 510(k) submission document itself, which contains the detailed testing and validation data provided by the manufacturer to the FDA. This summary letter does not include that level of detail.
§ 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).