(266 days)
Planmeca Viso is a system intended to produce two-dimensional (2D) and three-dimensional (3D) digital X-ray images as well as three-dimensional (3D) optical images of the dento-maxillo-facial, cervical spine and ENT (Ear, Nose, and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
The Planmeca Viso -X-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) images of the maxillofacial and ENT anatomies. Two dimensional (2D) images are produced with tomosynthesis method (panoramic) imaging) as well as conventional 2D radiography (cephalometric imaging, 2D views). In CBCT a cylindrical volume of data is captured in one imaging procedure. The data consists of several hundred sample images which are taken from different directions to cover a certain pre-programmed target area. These samples are used for 3D reconstruction (using a dedicated 3D reconstruction hardware) that can be viewed in three dimensions using separate workstation and Planmeca Romexis software.
The provided text does not contain detailed acceptance criteria or a comprehensive study report for the Planmeca Viso device that would allow for a complete response to all aspects of your request. Specifically, the document focuses on demonstrating substantial equivalence to a predicate device through technical comparisons and general performance claims, rather than detailing specific quantitative acceptance criteria for image quality or clinical performance and exhaustive evidence proving they are met.
However, based on the information provided, here's a partial response:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Image Quality (General) | "suitable for the intended purpose and indications for use of the device" |
| Clinical Performance | "substantially equivalent to the evaluation performed on primary predicate device" |
| AI Denoising Feature (Endodontic Image Processing) | "produce diagnostic image quality in its intended application" |
| Electrical Safety | Complies with IEC 60601-1+A1:2012+A2:2020 |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2+A1:2020 |
| Basic Safety and Essential Performance of X-ray Equipment | Complies with IEC 60601-1-3+A1:2013+A2:2021 |
| Usability Engineering | Complies with IEC 60601-1-6+A1:2013+A2:2020 |
| Safety of Dental X-ray Equipment | Complies with IEC 60601-2-63+A1:2017+A2:2021 |
| Usability of Medical Devices | Complies with IEC 62366-1+A1:2020 |
| Medical Device Software Life Cycle Processes | Complies with IEC 62304+A1:2015 |
| Image Quality (Cone Beam CT - CBCT) | Similar diagnostic value to predicate device due to similar detector qualities and CT reconstruction algorithm. |
| Image Quality (Pan / ProCeph) | Similar diagnostic value to predicate device |
| Performance (Bench Testing - Sedentex & DIN 6868 Phantoms) | "performance of the device remains substantially similar to that of the primary predicate device" and "performs equally or better in all the testing scenarios." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For the AI Denoising feature evaluation, the study included eleven patients.
- Data Provenance: Not explicitly stated, but the submission is from a Finnish company (Planmeca Oy), suggesting the data could originate from Finland or other European countries. The study appears to be prospective for the AI denoising evaluation, as it explicitly describes "comparing images with no denoising and AI denoising" for 11 patients, implying new data collection. For the general clinical evaluation, it mentions evaluation of "human phantom images," which could be retrospective or simulated, but again, details are lacking.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Three dental professionals were involved in the evaluation of the AI Denoising feature.
- Qualifications of Experts: The specific qualifications (e.g., years of experience, subspecialty) of these dental professionals are not specified in the provided text.
4. Adjudication Method for the Test Set
- The adjudication method for the AI Denoising study is not explicitly stated. It mentions that a team of dental professionals "evaluated human phantom images" and that the AI denoising was "evaluated in a study performed by three dental professionals." It does not specify if they reached a consensus, if a majority vote was used, or if there was an independent adjudicator.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- A formal MRMC comparative effectiveness study comparing human readers with AI assistance vs. without AI assistance is not explicitly described in the provided text.
- The clinical evaluation mentions that the device's image quality was evaluated by "product relevant team of professionals who evaluated human phantom images," and this was "substantially equivalent to the evaluation performed on primary predicate device."
- The AI Denoising feature was evaluated by three dental professionals "by comparing images with no denoising and AI denoising," which is a comparative aspect. However, it doesn't quantify an "effect size of how much human readers improve with AI vs without AI assistance" in terms of diagnostic performance metrics. It only states the AI improved images to "produce diagnostic image quality."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- The AI Denoising feature was evaluated based on its "ability to produce diagnostic image quality in its intended application." While the evaluation involved human professionals comparing images, the goal was to assess the algorithm's output (denoised images). However, a purely standalone assessment without human input or comparison for decision-making is not explicitly detailed. The evaluation seems to be focused on the impact of the AI on image quality for human interpretation.
7. Type of Ground Truth Used
- For AI Denoising: The ground truth appears to be based on expert assessment/consensus (three dental professionals) regarding the "diagnostic image quality" of images with and without AI denoising.
- For General Image Quality: The clinical evaluation involved "human phantom images" assessed by "product relevant team of professionals," suggesting a form of expert assessment against an assumed standard of diagnostic suitability.
- For Bench Testing: The ground truth for bench testing (Sedentex and DIN 6868 Phantoms) would be the physical properties and known characteristics of the phantoms, with the device's performance measured against those.
8. Sample Size for the Training Set
- The sample size for the training set used for the AI Denoising feature (or any other AI component/algorithm) is not mentioned in the provided text.
9. How the Ground Truth for the Training Set Was Established
- How the ground truth for the training set (if any was used for AI model development) was established is not mentioned in the provided text.
§ 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.