Search Results

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 version 2.0 device is a software system upgraded from version 1.0. This submitted new version has better contour modification tool, faster image files loading and display, and a new function for image fusion. For the same purpose of version 1.0, this software 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 provided document is a 510(k) summary for the IKOEngelo™ Software Version 2.0. It describes the device's intended use and technological characteristics, and importantly, highlights the verification and validation aspects. However, it does not contain a detailed study proving the device meets explicit acceptance criteria in the format requested.

The document states that "The validation test results have demonstrated that the contour modification tools were improved with efficiency and versatility, the image file loading and display were faster and the new image fusion functions were similar to the predicate device." This is a general statement about meeting validation goals rather than specific acceptance criteria with quantitative performance metrics.

Therefore, many of the requested fields cannot be filled directly from the provided text.

Here is an attempt to structure the available information, with clear indications where information is not present in the document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified.
• Data Provenance (country of origin, retrospective/prospective): Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not specified.

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

• MRMC Study: Not specified or implied. The device is a software system to assist radiation oncologists, physicists, and dosimetrists, but no comparative effectiveness study with human readers (with vs. without AI assistance) is mentioned.
• Effect Size: Not applicable, as no MRMC study is detailed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Standalone Performance: Not explicitly stated as a standalone evaluation. The validation statement indicates "The validation test results have demonstrated that...", suggesting an evaluation of the software's functionality, but it's unclear if this was algorithm-only or if it involved human interaction/evaluation of the output. The device's intended use is to "assist" human experts, implying it's not a standalone diagnostic tool.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: Not specified. The document mentions "contour delineation of the tumor target and normal tissue on patient's CT images" as the core function, but how the "truth" for these contours was established for validation is not described.

8. The sample size for the training set

• Sample Size: Not specified. (The document describes validation, not specifically training of a machine learning model, though the term "improved" tools could imply some form of iterative development and testing).

9. How the ground truth for the training set was established

• Ground Truth Establishment: Not specified. (As above, training set details are not provided).

Ask a specific question about this device