(246 days)
WillCeph is intended for use by specialized dental practices for capturing, storing and presenting patient images and radiographs and to aid in cephalometric analysis, orthodontic treatment planning and case follow-up. Results produced by the software tools are to be interpreted by trained and licensed dental practitioners.
WillCeph is a software device for Cephalometric Analysis & Maxillo-facial Surgical Simulation, Consulting, Diagnosis, Surgical Planning, Analysis, Growth Forecast. It includes features for patient data management, various gallery formats, image fusion and comparing, cephalogram and tracing on digitized X-ray film, treatment simulation (VTO / STO), chart and analysis, superimposition, photo-film image fusion, growth forecast, and PACS integration (Option). It can be used as a client or standalone software on Microsoft Windows 7 or higher.
The provided document, a 510(k) premarket notification for the "WillCeph" device, contains a limited amount of information regarding acceptance criteria and study details. It explicitly states that "No clinical studies were considered necessary and performed." This means there is no study described in this document that proves the device meets specific acceptance criteria through clinical performance.
However, the document does refer to "Non-Clinical Test Summary" and states that "WillCeph ... was designed and developed according to a software development process and was verified and validated." While it doesn't provide specific numerical acceptance criteria or detailed performance reports, it implies that the device was tested against design specifications.
Based on the available information, here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
As no clinical study was performed, there are no specific performance metrics reported for device clinical performance. The "acceptance criteria" here would be related to software verification and validation, but the document does not detail these criteria or their fulfillment numerically. The comparison table focuses on technological characteristics and intended use, demonstrating substantial equivalence to a predicate device, rather than explicit performance against predefined criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software designed and developed according to a software development process | "WillCeph was designed and developed according to a software development process" |
| Software verified and validated | "was verified and validated" |
| Substantial equivalence to predicate device in intended use and technological characteristics | Demonstrated through comparison table (see below for details) |
Summary of Technological Characteristics (extracted from the comparison table, serving as a basis for substantial equivalence, not performance):
| Feature | Proposed Device (WillCeph) | Predicate Device (ORTOMED - K131348) |
|---|---|---|
| Intended Use | Specialized dental practices for capturing, storing, and presenting patient images and radiographs, aiding in cephalometric analysis, orthodontic and orthognathic treatment planning, and case follow-up. Results interpreted by trained and licensed dental practitioners. | Same as Proposed Device |
| Type of Use | Prescription Use | Prescription Use |
| Modality Support | X-ray | X-ray |
| Component | Client or Standalone software | Client or Standalone software |
| Operating System | Windows 7 or higher | Windows 2000/XP, Vista and Windows 7 |
| User Interface | Mouse, Keyboard | Mouse, Keyboard |
| Image Communication Standard | DICOM | DICOM |
| Patient Data Management | Patient module for registration and file management; Image module for image management. | GESDEN module for patient registration and file management; GESIMAG module for image management. |
| Patient Database Engine | My SQL / Microsoft® SQL© | Microsoft® SQL© |
| Image Measurement | Yes (linear, distance, angle) | Yes (linear, distance, angle) |
| Matching / Adjustment of Photograph to X-ray | Yes | Yes |
| Cephalometric Analyses | User-configured analysis; Lateral, Frontal, Models Analyses; Photo studies of soft tissues. | User-configured analysis; Lateral, Frontal, Models Discrepancy Studies; Photo studies of soft tissue. |
| Treatment Planning, Simulation, and Follow-up | Orthodontic treatment (translate, tip, rotate incisors, reposition molars, rotate mandible); Growth Forecast; Growth simulation on traced x-ray; Superimpose growth tracings; VTO – Visual Treatment Objective; STO – Surgical Treatment Objective (orthognathic surgery); Warping and Morphing. | Orthodontic treatment (translate, tip, rotate incisors, reposition molars, auto-rotate mandible); Arch length discrepancy worksheet; CO/CR Conversion Growth Forecast (Ricketts algorithm); Growth simulation on traced x-ray; Superimpose growth tracings; VTO – Visual Treatment Objective; SVTO – Surgical Visual Treatment Objective (orthognathic surgery); Warping and Morphing. |
2. Sample Size Used for the Test Set and Data Provenance
Since "No clinical studies were considered necessary and performed," there is no test set in the traditional sense for clinical performance evaluation. The "test set" would implicitly refer to data used for software verification and validation, but details on sample size, country of origin, or retrospective/prospective nature are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given the absence of clinical studies, there is no mention of experts or ground truth establishment for a clinical test set. The document focuses on regulatory compliance through substantial equivalence.
4. Adjudication Method for the Test Set
As no clinical test set is described, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed or described. The document does not discuss human reader performance with or without AI assistance.
6. Standalone Performance
The product, WillCeph, is a standalone software that aids in cephalometric analysis. However, its effectiveness is assessed through substantial equivalence to a predicate device, not through a standalone clinical performance study. The statement "Results produced by the software tools are to be interpreted by trained and licensed dental practitioners" indicates human-in-the-loop, but the core functionality is algorithm-only. The document does not provide standalone performance metrics for the algorithm.
7. Type of Ground Truth Used
As no clinical study was performed, there is no explicit mention of ground truth types (e.g., expert consensus, pathology, outcomes data) for clinical performance evaluation. The "ground truth" for software verification and validation would likely be defined by internal software requirements and specifications.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. This suggests the device's functionality is based on established algorithms and calculations for cephalometric analysis, rather than a machine learning model trained on a large dataset for image interpretation.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, there is no information on how ground truth for a training set was established.
In summary: The WillCeph device received 510(k) clearance based on demonstrating substantial equivalence to a legally marketed predicate device (ORTOMED - K131348). This means the FDA determined that the device is as safe and effective as the predicate device, primarily through a comparison of their intended use and technological characteristics, and through non-clinical software verification and validation activities (which are not detailed in terms of their criteria or results). No clinical studies or performance data against specific numerical acceptance criteria were deemed necessary or provided in this submission for device clearance.
§ 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).