(266 days)
OTOPLAN is intended to be used by otologists and neurotologists as a software interface allowing the display, segmentation, and transfer of medical image data from medical CT, MR, and XA imaging systems to investigate anatomy relevant for the preoperative planning and postoperative assessment of otological and neurotological procedures (e.g., cochlear implantation).
OTOPLAN is a Software as a medical Device (SaMD) which consolidates a DICOM viewer, ruler function, and calculator function into one software platform. The user can
- import DICOM-conform medical images, fuse supported images and view these images.
- navigate through the images and segment ENT relevant structures (semi-automatic/automatic), which can be highlighted in the 2D images and 3D view.
- use a virtual ruler to geometrically measure distances and a calculator to apply established formulae to estimate cochlear length and frequency.
- create a virtual trajectory, which can be displayed in the 2D images and 3D view.
- identify electrode array contacts, lead, and housing of a cochlear implant to assess electrode insertion and position.
- input audiogram-related data that were generated during audiological testing with a standard audiometer and visualize them in OTOPLAN.
OTOPLAN allows the visualization of third-party information, that is, cochlear implant electrodes, implant housings and audio processors.
The information provided by OTOPLAN is solely assistive and for the benefit of the user. All tasks performed with OTOPLAN require user interaction; OTOPLAN does not alter data sets but constitutes a software platform to perform tasks that are otherwise performed manually. Therefore, the user is required to have clinical experience and judgment.
The provided document describes the acceptance criteria and the study that proves the device (OTOPLAN version 3.1) meets these criteria for several new functionalities.
Here's the breakdown:
Acceptance Criteria and Device Performance Study for OTOPLAN v3.1
1. Table of Acceptance Criteria and Reported Device Performance
The document describes performance tests for several new automatic functions introduced in OTOPLAN v3.1. These are broadly categorized into Temporal Bone, Skin, and Inner Ear segmentation and thickness mapping, and CT-CT and CT-MR Image Fusion.
Table: Acceptance Criteria and Reported Device Performance
| Functionality Tested | Acceptance Criteria | Reported Device Performance | Pass/Fail |
|---|---|---|---|
| Temporal Bone Thickness Mapping | Mean Absolute Difference (MAD) ≤ 0.6 mm, 95% Confidence Interval (CI) upper limit ≤ 0.8 mm | MAD: 0.17–0.20 mm, CI: 0.19–0.22 | Pass |
| Temporal Bone 3D Reconstruction | Mean DICE coefficient ≥ 0.85, 95% CI lower limit ≥ 0.85 | DICE coefficient (R1): 0.88 [CI: 0.87–0.89] | |
| DICE coefficient (R2): 0.86 [CI: 0.85–0.87] | |||
| DICE coefficient (R3): 0.89 [CI: 0.88–0.90] | Pass | ||
| Skin Thickness Mapping | Mean Absolute Difference (MAD) ≤ 0.6 mm, 95% Confidence Interval (CI) upper limit ≤ 0.8 mm | MAD: 0.21–0.23 mm, CI: 0.23–0.26 | Pass |
| Skin 3D Reconstruction | Mean DICE coefficient ≥ 0.68, 95% CI lower limit ≥ 0.68 | DICE coefficient (R1): 0.89 [CI: 0.88–0.90] | |
| DICE coefficient (R2): 0.87 [CI: 0.86–0.88] | |||
| DICE coefficient (R3): 0.86 [CI: 0.84–0.88] | Pass | ||
| Scala Tympany 3D Reconstruction | Mean DICE coefficient ≥ 0.65, 95% CI lower limit ≥ 0.65 | DICE coefficient: 0.76 [CI: 0.75–0.77] | Pass |
| Inner Ear (Cochlea, Semi-circular canals, internal auditory canal) 3D Reconstruction (CT) | Mean DICE coefficient ≥ 0.80, 95% CI lower limit ≥ 0.80 | DICE coefficient (R1): 0.82 [CI: 0.81–0.83] | |
| DICE coefficient (R2): 0.84 [CI: 0.83–0.85] | |||
| DICE coefficient (R3): 0.85 [CI: 0.84–0.86] | Pass | ||
| Inner Ear (Cochlea, Semi-circular canals, internal auditory canal) 3D Reconstruction (MR) | Mean DICE coefficient ≥ 0.80, 95% CI lower limit ≥ 0.80 | DICE coefficient (R1): 0.81 [CI: 0.80–0.82] | |
| DICE coefficient (R2): 0.83 [CI: 0.82–0.84] | |||
| DICE coefficient (R3): 0.84 [CI: 0.83–0.85] | Pass | ||
| Cochlear Parameters (CT) | Mean absolute error (MAE) CDLoc measurement ≤ 1.5 mm | MAE (±SD) for CDLoc: | |
| R1: 0.59 ± 0.37 mm | |||
| R2: 0.64 ± 0.44 mm | |||
| R3: 0.62 ± 0.39 mm | Pass | ||
| Cochlear Parameters (MR) | Mean absolute error (MAE) CDLoc measurement ≤ 1.5 mm | MAE (±SD) for CDLoc: | |
| R1: 0.56 ± 0.42 mm | |||
| R2: 0.70 ± 0.39 mm | |||
| R3: 0.64 ± 0.43 mm | Pass | ||
| Image Fusion (CT-CT) - Semitones | Maximum mean absolute semitone error per electrode contact |
§ 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).