(244 days)
CephSimulation is a software application intended for storing and visualization of patient images and assisting in case diagnosis and surgical treatment planning. Results of the software are to be interpreted by trained and licensed dental and medical practitioners. It is intended for use by dentist, medical surgeons, and other qualified individuals using a standard PC. This device is not indicated for mammography use.
CephSimulation is an interactive imaging software device. It is used for the visualization of patient image files from scanning devices such as CT scanners, and for assisting in case diagnosis and review, treatment planning and simulation for orthodontic and craniofacial applications. Doctors, dental clinicians, medical surgeons and other qualified individuals can render, review and process the images, perform measurement, analysis and surgery simulation. The software runs with standard PC hardware and visualizes imaging data on standard computer screen. CephSimulation is designed as a plug-in component for InVivoDental software. It is seamlessly integrated into InVivoDental for extended capabilities. The key functionality includes image visualization, cephalometric tracing and measurements and 3D surgery simulation.
The CephSimulation device is a software application intended for storing and visualizing patient images, assisting in case diagnosis, and surgical treatment planning.
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly present a table of acceptance criteria with specific quantitative thresholds. Instead, it describes a general approach to performance validation. However, based on the narrative, the implicit acceptance criterion is that the software is "as effective as its predicate in its ability to perform essential functions."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software is stable and operates as designed. | Confirmed by performance testing, usability testing, and final acceptance testing. |
| Software has been evaluated for hazards and risk is reduced to acceptable levels. | Confirmed by risk analysis and traceability analysis. |
| CephSimulation is as effective as its predicate in its ability to perform essential functions. | Confirmed by bench testing against predicate software, evaluated by an expert radiologist. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the exact sample size (number of cases or images) used for bench testing. It only mentions "evaluation of major function outputs from CephSimulation and predicate software."
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "an expert" (singular) was used.
- Qualifications of Experts: The expert was "in the field of radiology." No further details on years of experience or sub-specialization are provided.
4. Adjudication method for the test set:
The document does not describe a formal adjudication method (like 2+1 or 3+1). It states that the bench testing result "was evaluated by an expert in the field of radiology," implying a single-expert assessment rather than a consensus-based adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, a multi-reader multi-case (MRMC) comparative effectiveness study, evaluating human reader improvement with vs. without AI assistance, was not conducted or reported in the provided document. The testing focused on the standalone performance of the CephSimulation software compared to a predicate.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance assessment was done. The "bench testing of the software with predicate software" compared the outputs of CephSimulation directly against those of the predicate software, essentially evaluating the algorithm's performance without the user interface being the primary focus of comparison. The expert reviewer evaluated "major function outputs from CephSimulation and predicate software."
7. The type of ground truth used:
The ground truth for the bench testing was the "major function outputs" of the predicate software. This implies that the predicate's performance or outputs were considered the reference truth for comparison, rather than an independent expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
The document does not provide any information regarding the sample size used for the training set, as it describes validation testing (benchmarking) rather than development or training details.
9. How the ground truth for the training set was established:
Since no information on a training set is provided, there is no mention of how its ground truth was established.
§ 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).