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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

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: 100 patients (50 assigned to the Comfort Marker 2.0 arm, 50 assigned to the lancet arm).
   • Data Provenance: Prospective, randomized, multi-arm, double-blind study with a concurrent active control. The study was performed in Portugal between October 2021 and January 2022. The document notes that the majority of the population in Europe and specifically Portugal where the study was performed is of Caucasian/Mediterranean ethnicity.

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

   • Effectiveness (Reference Points Visibility): Radiotherapy professionals assessed tattoo quality, but the exact number of professionals or their specific qualifications (e.g., years of experience) is not explicitly stated.
   • Cosmesis (Aesthetic Appearance): 20 observers (both physicians and radiotherapy professionals) performed the photographic assessment. Their specific qualifications (e.g., years of experience) are not explicitly stated.

3. Adjudication method for the test set:

   • The document implies individual assessments by radiotherapy professionals for effectiveness and by 20 observers for cosmesis. There is no mention of a formal adjudication method (like 2+1 or 3+1 consensus) for these assessments.

4. 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 was not an MRMC study utilizing AI. It was a comparative clinical trial between a new device (Comfort Marker 2.0) and a traditional method (lancets) for applying radiation therapy markings. Human readers (radiotherapy professionals, physicians) were the evaluators of the aesthetic and quality outcomes, not "improving with AI vs. without AI assistance."

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

   • No, this device is not an AI algorithm. It is a physical medical device (a radiation therapy marking device). The study assessed its performance in a clinical setting with human operators, not a standalone algorithm.

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

   • Patient Comfort: Patient-reported experience (pain level graded by patients).
   • Effectiveness (Visibility): Assessments by radiotherapy professionals based on visual inspection.
   • Radiotherapy Professional Satisfaction: Professional-reported experience (ease of tattooing process).
   • Cosmesis: Blinded photographic assessment by a panel of physicians and radiotherapy professionals.
   • Safety: Observational data (recorded sharp injuries).

7. The sample size for the training set:

   • Not applicable. This device is a physical marking tool, not an AI/ML algorithm that requires a training set of data.

8. How the ground truth for the training set was established:

   • Not applicable, as it's not an AI/ML algorithm.

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