Search Results

The Sensilight Pro device is an over-the-counter device intended for the removal of unwanted body and/or facial hair. Sensilight Pro is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured 6,9 and 12 months after the completion of treatment regimen.

The Sensilight Pro is an intense pulse light hair reduction device. Phototherapy (Lightbased) hair reduction is based on the theory of selective photothermolysis in which optical energy is used to disable hair re-growth. The Sensilight Pro is composed of a hand-held applicator and an external power supply/charger. The spot size (treatment area) in the Sensilight Pro is 4.5 cm² or 2 cm² (for large and precise treatment windows, respectively).

The device contains a lamp, a skin proximity and pigmentation sensor allowing application only on compatible skin tones and while in full contact with the treated area. If the Sensilight Pro is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the device will provide indications on the faulty conditions and will not trigger a pulse.

The Sensilight Pro device, intended for over-the-counter hair removal and permanent hair regrowth reduction, did not report specific acceptance criteria in the provided text. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through various tests and comparisons.

Here's an analysis of the provided information, structured to address your points:

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) were not explicitly defined in the provided text, they cannot be presented in a table. The performance evaluation primarily centered on safety, compliance with standards, and human factors validation.

However, we can infer some performance aspects from the human factors studies:

• IEC 60601-1:2012/EN 60601-1:2013 (Ed. 3.1) for basic safety and essential performance.
• IEC 60601-1-11:2015 (Ed. 2) for home healthcare environment.
• IEC 60601-2-57:2011 (Ed. 1) for non-laser light source equipment.
• FCC part 15, Subpart B, Class B.
• IEC 60601-1-2:2014 (Ed. 4) for electromagnetic compatibility.
• IEC 62471:2006 (Ed. 1) for photo-biological safety.
• IEC 62304:2006 for medical device software life cycle processes.
• ISO 10993-1:2009 for biological evaluation.
• ISO/IEC 14971:2007 (BS EN ISO 14971:2012) for risk management.
• CB IEC 62133:2012 and UN 38.3 for battery safety and transport. |

2. Sample Size Used for the Test Set and Data Provenance

• Labeling Comprehension/Self-Selection Study:
  • Sample Size: 25 participants (4 men, 21 women).
  • Data Provenance: Not explicitly stated, but based on the overall context of a submission to the US FDA, it would typically be conducted within the US or a region compliant with US regulatory requirements. The study appears to be prospective as participants were "enrolled" and received materials for evaluation.
• Usability/User Interface Study:
  • Sample Size: 25 participants initially ("all tasks were completed by 100% of the participants"), but the follow-up satisfaction questionnaire was filled by 18 of the 20 users. This suggests that the study may have involved 20 users for the primary usability tasks with 18 completing the satisfaction survey, or 25 for tasks and 18 for satisfaction. Clarification is needed, but 25 is the stated size for task completion.
  • Data Provenance: Not explicitly stated regarding country, but appears prospective as participants performed tasks with the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of experts being used to establish ground truth in the context of these human factors studies for the Sensilight Pro. The "ground truth" for these studies was the ability of the general public (participants) to comprehend labeling and successfully operate the device without assistance.

4. Adjudication Method for the Test Set

• Labeling Comprehension/Self-Selection Study: Answers were "further validated by the moderator." This implies a form of human review/adjudication. The text states "with correct answers: 'Yes' or 'No', explenation and further validation by the moderator."
• Usability/User Interface Study: The adjudication method for tasks was based on direct observation of task completion, with the "success rate (pass criteria) was 100% per each task scenario." No specific expert adjudication process beyond the moderator's observation is described.

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

No MRMC study was performed or reported. This device is an IPL hair removal device, not an AI-assisted diagnostic or interpretive system that would typically involve human "readers" or an MRMC study.

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

Not applicable in the AI sense. The Sensilight Pro is a medical device, not an AI algorithm. Its "standalone" performance is established through bench testing (safety, electrical, mechanical, photobiological, etc.) and compliance with various standards (listed in point 1). These tests ensure the device functions correctly and safely on its own.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For Human Factors Studies:
  • Labeling Comprehension: The "ground truth" was predefined correct answers to comprehension questions, potentially established by the device manufacturer's regulatory/clinical team.
  • Usability: The "ground truth" was verifiable task completion based on the device's design and instructions.
• For Clinical Efficacy (Hair Reduction): The document explicitly states: "No new clinical performance data is reported in this submission."
  Therefore, the ground truth for hair reduction efficacy for this submission was not directly established via new clinical studies. Instead, substantial equivalence to predicate devices (which presumably had established clinical efficacy) was argued based on similar technology and parameters. The stated definition of "permanent reduction in hair regrowth" (measured 6, 9, and 12 months after treatment) implies that outcomes data would be the typical ground truth for this claim, but this was not provided for the Sensilight Pro in this submission.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML product requiring a training set in the conventional sense. The "training" for the device's design and features would be through engineering development, safety testing, and compliance with standards.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there's no "training set" for this type of device. The design and safety features (like skin proximity and pigmentation sensors) were developed and validated through internal testing and compliance with recognized standards, which serve as the implicit "ground truth" for their proper functioning.

Ask a specific question about this device