(30 days)
3Shape Implant Studio is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in dental implantology and surgical dentistry. This software reads imaging information output from medical scanners such as CT and optical scanners. It allows pre-operative simulation of patient anatomy and dental implant placement.
Surgical guides and the planned implant position can be exported as 3D models and the guides can be manufactured using said 3D models when used as input to 3D manufacturing systems.
3Shape Implant Studio® is a stand-alone software device used to pre-operatively plan the placement of a dental implant based on the visualization of a patient's CT image, optionally aligned to an optical 3D surface scan. A virtual surgical quide can be designed and then exported to an external system for manufacturing.
The device has no patient contact being a software only device.
Here's an analysis of the provided text regarding the acceptance criteria and study for the 3Shape Implant Studio, structured as requested:
Acceptance Criteria and Device Performance Study for 3Shape Implant Studio (K202256)
Unfortunately, the provided text does not include a detailed table of acceptance criteria with reported device performance metrics. It mentions that "Each user need has its own validation acceptance criteria; each specification has its own verification acceptance criteria," and that "All test results have been reviewed and approved, showing 3Shape Implant Studio® to be substantially equivalent in safety and effectiveness to the primary predicate device." However, specific numerical targets or the device's performance against those targets are not present within this document.
Therefore, the following sections will address what information is available and highlight what is missing.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (as inferred) | Reported Device Performance (as inferred/stated) |
|---|---|---|
| Verification Testing | Each specification has its own verification acceptance criteria. | "All test results have been reviewed and approved, showing 3Shape Implant Studio® to be substantially equivalent in safety and effectiveness to the primary predicate device." Implied that all verification criteria were met. |
| Validation Testing | Each user need has its own validation acceptance criteria. Validation suite includes validation of implemented mitigations related to device hazards. | "All test results have been reviewed and approved, showing 3Shape Implant Studio® to be substantially equivalent in safety and effectiveness to the primary predicate device." Implied that all validation criteria were met and that identified risks were appropriately mitigated. Issues encountered during summative evaluation were reviewed and handled. |
| Bug Verification | Ensuring issue is not reproducible. | Implied that all identified bugs were successfully verified as not reproducible after fixes. |
| Substantial Equivalence | Comparison to predicate device (Straumann AG coDiagnostix, K130724) in terms of intended use, indications for use, scientific concept, features, technical data, and test results related to safety and effectiveness. | "3Shape Implant Studio® is found to be as safe and effective as the primary predicate device. Therefore, 3Shape Implant Studio® is found to be substantially equivalent with the primary predicate device." This suggests the device successfully met the criteria for substantial equivalence. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify the sample size used for either verification or validation testing.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only mentions that the software "reads imaging information output from medical scanners such as CT and optical scanners" and visualizes "an imported CT image from DICOM data."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- The document does not provide any information regarding the number of experts, their qualifications, or their role in establishing ground truth for the test set.
4. Adjudication Method for the Test Set
- The document does not provide any information regarding an adjudication method for the test set.
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
- The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study.
- The device is described as an "implant planning and surgery planning software tool" intended for use by "dental professionals." It is a tool for pre-operative simulation and planning, rather than an AI-driven diagnostic or interpretative tool that would typically involve human-in-the-loop performance studies as described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, the performance testing appears to be a standalone (algorithm only) assessment. The document states, "Software, hardware, and integration verification and validation testing was performed." The focus is on the software's functionality in terms of processing imaging data, enabling planning, and designing surgical guides, not on how human users perform with or without the software. The "summative evaluation" mentioned could potentially involve human interaction to assess usability but the performance itself is described as the software's inherent capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The document does not explicitly state the type of ground truth used. Given the nature of an implant planning software, the "ground truth" would likely relate to the accuracy of 3D reconstructions, measurements, planning parameters, and the fit/design of surgical guides. This would typically be established by expert dental professionals using established anatomical references, CAD/CAM standards, and potentially phantom models. However, this is inferred, not stated.
8. The sample size for the training set
- The document does not mention a training set. This is because the 3Shape Implant Studio is described as software that allows pre-operative simulation and evaluation based on imported scan data, and is used for designing surgical guides. It is not presented as a machine learning or AI algorithm that implicitly learns from a dataset (i.e., it doesn't appear to be a 'learning' algorithm in the sense that it requires a training set for model development). It is a CAD design and visualization tool.
9. How the ground truth for the training set was established
- As the document does not mention a training set (see point 8), there is no information on how its ground truth would have been 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).