(255 days)
The device is indicated for use for applying ink to the skin to identify the margins for radiation therapy. The device is intended to be used in clinical settings by Radiotherapy professionals.
Comfort Marker 2.0 is an application system for placing reference marks on patients eligible for Radiotherapy treatments. The Comfort Marker 2.0 allows the user to place accurate tattoo markers (reference points) on patients enabling radio therapy. The device consists of a Control and Pen module which drives a Safety Needle. Different depth settings can be chosen to accommodate for different skin types. When the tattoo marking has been placed the Control Unit can be stored and charged in the Docking station.
Here's a breakdown of the acceptance criteria and study details for the Comfort Marker 2.0, as derived from the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (Comfort Marker 2.0) |
|---|---|---|
| Patient Comfort | Percentage of patients grading tattooing process as painless (compared to lancets). | 44.0% of patients graded the tattooing process as painless with Comfort Marker 2.0, compared to 16.0% with lancets (p = 0.008), indicating significantly less procedural pain. |
| Effectiveness (Visibility) | No fading of reference points, and a significantly higher proportion of radiotherapy professionals reporting good and excellent quality markings (compared to lancets). | No fading of reference points was recorded for Comfort Marker 2.0. Radiotherapy professionals reported a significantly higher proportion of good and excellent quality markings for Comfort Marker 2.0. The median score of good/excellent markings on the last evaluation compared to the first was significantly worse for lancets (67% vs. 89%; p = 0.003), but remained 100.0% for Comfort Marker 2.0 (p = 0.173), demonstrating consistent quality over time. |
| Radiotherapy Professional Satisfaction | Significantly higher radiotherapy professional reported tattooing processes evaluated as easy (compared to lancets). | 98.0% of radiotherapy professionals reported the tattooing process as easy with Comfort Marker 2.0, compared to 78.0% with lancets (p = 0.008), indicating higher ease of use. |
| Cosmesis (Aesthetic Appearance) | Significantly higher score on photographic assessment of reference points (compared to lancets), with a majority of patients in the Comfort Marker 2.0 group having a mean score of at least 4. | Comfort Marker 2.0 had a significantly higher score on photographic assessment (median score of 4.5) compared to lancets (median of 3.5) (**p |
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