(55 days)
The IKOEngelo™ System is intended for use in tumor and normal tissue contour delineation to support the radiotherapy treatment planning process.
The IKOEngelo™ System is indicated for use by radiation oncologists, medical physicists, and medical dosimetrists for tumor and normal tissue contour delineation to support the radiotherapy treatment planning process. The resulting information may then be exported to a treatment planning system for dose calculation.
The IKOEngelo device is a software system that will assist radiation oncologists, with the assistance of physicists and dosimetrists, to more efficiently perform contour delineation of the tumor target and normal tissue on patient's CT images.
The sequence of events is illustrated in the following bullet items and diagram:
- Import patient's CT images. .
- Select the proper Expert Case (including the CT image data set and . contours) to match patient's CT.
- Automatically fuse the images to align patient's CT image data sets . with those of the Expert Case.
- Run deformable segmentation to auto-contour on the patient's CT . images.
- Review patient's contours and modify them if necessary. .
- Approval by qualified radiation oncologist. .
- Export patient's CT with its contours to the treatment planning system . used by the facility.
The provided text does not contain detailed information about specific acceptance criteria or the study that definitively proves the device meets such criteria. It primarily focuses on the device's description, intended use, and a comparison to a predicate device for 510(k) submission. Therefore, much of the requested information is not available in the provided document.
However, based on the information that is present, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or provide a table of reported device performance against those criteria. It offers a "Predicate Comparison Table" which outlines functional equivalence to the QwikSIM Virtual Simulation System (K013531). This comparison serves as the basis for demonstrating substantial equivalence for regulatory purposes, rather than a direct performance study against defined acceptance criteria.
Predicate Comparison Table (Indicating Functional Equivalence, not specific performance metrics against acceptance criteria):
| # | Feature | IMPAC Medical Systems, Inc. QwikSIM (K013531) | IKOEtech IKOEngelo ™ |
|---|---|---|---|
| 1 | Intended Use | QwikSIM is a radiation therapy virtual simulation system for patient image review, target and critical structure delineation, and geometric treatment planning. | The IKOEngelo ™ System is intended for use in tumor and normal tissue contour delineation to support the radiotherapy treatment planning process. |
| 2 | Image Study Import | Dicom3 | Dicom3 |
| 3 | Treatment Planning Connectivity | DICOM CT SCP and DICOM RT Structure Set SCP/SCU interface modalities. | DICOM CT SCP and DICOM RT Structure Set SCP/SCU interface modalities. |
| 4 | Flexible Image Display | Multiple-image views and allows side-by-side views for comparison, displaying the following perspectives: Slice View, Orthogonal Multi-Planar Reconstructed View, and Digital Scout View. | Multiple-image views and allows side-by-side views for comparison, displaying the following perspectives: Slice View, Orthogonal Multi-Planar Reconstructed View. |
| 5 | Image Viewing Tools | Tools for image review include zoom and pan tools for reviewing MPR/Slice planes, and tape measure and protractor controls. | Tools for image review include zoom and pan tools for reviewing MPR/Slice planes, slice indicators, tape measure, CT number displayer, and isocenter lines. |
| 6 | Contour Source | Anatomy Templates | Expert Case Library |
| 7 | Automatic Contouring | Based on pre-defined CT thresholds | Deformable registration and segmentation. |
| 8 | Contour Expansion | 2D inflation of anatomical objects with specified margins. | N/A |
| 9 | Image Fusion | N/A | Auto and manual fusion |
| 10 | Contours Review | Side-by-side only | Side-by-side with image linking to scroll through simultaneously. |
| 11 | Contour Modification Tools | Point-click draw contour tool. | Nudge contour, cut contour, draw contour and create new contour tools. |
2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The document describes a general comparison to a predicate device but does not detail a specific test set, its size, or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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:
This information is not provided in the document. The document describes the device as a software system to assist radiation oncologists, physicists, and dosimetrists, implying a human-in-the-loop scenario. However, no MRMC study or its results are mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The document states the device will assist radiation oncologists, with assistance of physicists and dosimetrists, to perform contour delineation. It also mentions "Review patient's contours and modify them if necessary" and "Approval by qualified radiation oncologist." This suggests the device is intended for use with human oversight and modification, not as a standalone, fully automated system without human-in-the-loop. Therefore, it is highly likely that a standalone performance study as an algorithm without human interaction was not the primary focus or reported.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided in the document. The "Expert Case Library" is mentioned as a "Contour Source," which implies pre-existing contours were used, likely established by experts, but the method for their establishment as "ground truth" for validation is not described.
8. The sample size for the training set:
This information is not provided in the document. The document mentions "Select the proper Expert Case (including the CT image data set and contours) to match patient's CT" and "Run deformable segmentation to auto-contour on the patient's CT images." This implies an underlying model that would have been trained, but no details of the training set size are given.
9. How the ground truth for the training set was established:
This information is not provided in the document. While "Expert Case Library" is identified as a contour source, the method of how those "Expert Cases" (and their contours) were established as ground truth for training (or for the general functioning of the system) is not detailed.
§ 892.5840 Radiation therapy simulation system.
(a)
Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II.