(54 days)
syngo.CT Dental is post processing image analysis software for CT volume data sets that has been acquired continuously with computed tomography (CT) systems. The software provides the following digital image processing and visualization tools:
Basic reading tools: Multiplanar Reconstruction (MPR), Maximum Intensity Projection (MIP), Volume Rendering Technique (VRT), Minimal Intensity Projection (MinIP)
Basic geometric measurement tools: distance line, polyline, marker, arrow, angle
Basic HU measurement tools: Pixel lens, ROI Circle, ROI freehand, VOI sphere, VOI freehand Dedicated dental visualization tools: Dental panoramic views (curved MPRs) and dental paraxial views (cross-section MPRs) that are calculated based on a manually defined centerline.
A tool to manually outline the mandibular canal.
A tool that allows paraxial and panoramic result images to be saved as dental range series.
True Size (1:1) printing of panoramic and paraxial images to allow anatomy to be printed in its actual size on the film sheet.
The specific visualization of panoramic and paraxial views of the dental structures facilitates viewing, manual identification, and marking of dental pathologies and anatomy (for example, the position of the mandibular canal that needs to be preserved during dental interventions, such as dental (implant) surgery). Reporting and documentation of results is facilitated by the creation of ranges and snapshots, True Size (1:1) printing on DICOM printers, and by the use of a reporting tool.
syngo.CT Dental is post-processing image analysis software for computed tomography volume data sets that combines basic and advanced visualization that can be used in pre-surgical planning for dental operations, such as the planning of dental implant surgery. syngo.CT Dental contains image processing tools that allow for easy viewing and manual identification and marking of dental anatomy and pathologies by a physician.
The provided text describes the syngo.CT Dental software, a post-processing image analysis tool for CT scan data. It details the modifications made to a previously cleared predicate device and the testing performed to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list specific quantitative acceptance criteria for each feature (e.g., a specific percentage accuracy for a measurement tool). Instead, it states that "The test results show that all of the software specifications have met the acceptance criteria" and "The testing results support that all of the software specifications have met the acceptance criteria."
The reported device performance is described in terms of functionality and successful verification and validation:
| Feature/Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Software Specifications | All software specifications are met. | All test results met acceptance criteria. |
| Risk Mitigation | Identified hazards are controlled; risk analysis completed. | Risk analysis completed, risk control implemented; testing results support meeting acceptance criteria. |
| Verification & Validation | Device performs as intended; claims of substantial equivalence supported. | Performance tests conducted for functionality; all testing and documentation found acceptable to support claims of substantial equivalence. |
| Safety and Performance Standards | Conformance to listed standards (DICOM, IEC 62304, ISO 14971, IEC 60601-1-6, IEC 60601-1-4). | Siemens claims conformance to these five standards. |
| Cybersecurity | Prevention of unauthorized access, modifications, misuse, etc. | Siemens conforms to cybersecurity requirements by implementing a process for prevention. (Hospital's responsibility to comply with IEC 8001-1-2010). |
| Labeling | Contains instructions, cautions, and warnings for safe/effective use. | Device labeling contains necessary information for safe and effective use. |
| Electrical, Mechanical, Radiation Hazards | Hazards minimized. | Siemens adheres to recognized industry practice and standards for minimization. |
| Comparison to Predicate Device | Performance comparable to predicate device; no new safety risk. | syngo.CT Dental and predicate device have same intended use and operating principle; no significant changes in technological characteristics; non-clinical data supports safety and performs as intended, comparable to predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the sample size used for the test set. It mentions "Integration and functional tests were conducted" and "Performance tests were conducted," but provides no numbers of cases or datasets tested.
- Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method:
- Adjudication Method: Not specified. The document does not mention any form of adjudication for establishing ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document focuses on the software's functionality and safety modifications, comparing it to a predicate device rather than evaluating human reader performance with and without AI assistance.
6. Standalone Performance Study:
- Standalone Study: Yes, a standalone performance study was conducted. The "Nonclinical Testing" section states, "Nonclinical tests were conducted for syngo.CT Dental during product development. The modifications described in this premarket notification were supported with verification and validation testing." "Performance tests were conducted to test the functionality of the subject device, syngo.CT Dental." This indicates direct testing of the algorithm's performance.
7. Type of Ground Truth Used:
- Type of Ground Truth: The document does not explicitly state the type of ground truth used. Given that syngo.CT Dental is a post-processing image analysis software with tools for visualization, measurement, and identification, the ground truth would likely involve expert consensus or reference measurements based on the CT image data itself for features like mandibular canal outlining, measurement accuracy, and proper rendering of dental structures. Pathology or outcomes data are not indicated as the primary ground truth for this type of image analysis software.
8. Sample Size for the Training Set:
- Sample Size: Not specified. The document focuses on verification and validation testing of the product, not its development or training process.
9. How Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not specified. The document does not describe the training set or how its ground truth was established.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.