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510(k) Data Aggregation
(173 days)
The Silk'n HST is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV.
The Silk'n HST device is designed as a hand held device, which utilizes both RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (red and IR wavelengths, respectively) and a temperature stabilizer. The Silk'n HST device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The treatment surface is located at the applicator tip and comes in direct contact with the skin. The applicator is equipped with an ON/OFF switch that also selects the energy level as manifested using indicators panel. The adaptor connects the applicator to the electrical outlet using its plug and the applicator socket.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device Name: Silk'n HST
Intended Use: Over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV.
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criterion for effectiveness appears to be a statistically significant reduction of at least 1.0 score in the average score of the Fitzpatrick Wrinkle Severity Scale, according to at least 2 out of 3 blinded dermatologists, measured 3 months post-treatment end compared to baseline.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Effectiveness: | |
| Statistically significant reduction of at least 1.0 score in average Fitzpatrick Wrinkle Severity Scale score. | Achieved an average statistically significant reduction of 1.49 ± 0.51 Fitzpatrick scores (p<0.001). |
| Reduction determined by at least 2 out of 3 blinded dermatologists. | Downgrade of at least 1 score seen in: - Reviewer #1: 96.67% (29/30) - Reviewer #2: 90.0% (27/30) - Reviewer #3: 93.33% (28/30) - ≥2 agree: 100% (30/30) |
| Safety: | No unexpected adverse events detected. Treatment associated with no to merely mild pain. |
| Usability / User Satisfaction: | All 30 study participants were (very or somewhat) satisfied with the ease of learning to use the device. 86% (26/30) of patients were satisfied to very satisfied with overall device performance. 97% (29/30) indicated some improvement in wrinkle status. |
| Self-selection and Labeling Comprehension: | 100% success rate in self-selection study (25 subjects). 100% success rate in labeling comprehension test (20/20 patients found it easy to understand instructions). 100% of eligible subjects successfully performed device-related tasks with minimal assistance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Effectiveness Study (Test Set): 30 eligible adults (N=30, completer case analysis).
- Sample Size for Usability/Self-Selection Study (Test Set):
- Self-selection: 25 subjects.
- Usability/Labeling Comprehension: 20 subjects (from the 25, implying 5 were excluded due to contraindications).
- Data Provenance: The clinical study was conducted at a certified clinic in the US. The text does not explicitly state whether it was retrospective or prospective, but the description of the study design ("included 21 treatment sessions every other day, over a period of 6 weeks, and 2 maintenance treatments," "3 months following treatment end") strongly suggests a prospective study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: 3 blinded dermatologists.
- Qualifications of Experts: They are referred to as "blinded dermatologists," indicating a medical specialization relevant to skin conditions and aesthetic evaluation. No specific experience (e.g., years) is mentioned.
4. Adjudication Method for the Test Set
The effectiveness criterion explicitly states "according to at least 2 out of 3 blinded dermatologists." This indicates a 2/3 majority consensus adjudication method for determining success on the Fitzpatrick scale.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted. This study focused on the effectiveness of the device itself (AI is not mentioned here as assisting human readers, rather the device is the treatment).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is a physical, home-use treatment device (combining RF and LED energies) for wrinkles, not an AI algorithm. Therefore, the concept of a "standalone algorithm-only performance" does not apply in the context of this submission. The performance measured is that of the device's effect on patients.
7. The Type of Ground Truth Used
The ground truth for effectiveness was established by expert consensus (at least 2 out of 3 blinded dermatologists) using the Fitzpatrick Wrinkle Severity Scale. User satisfaction and usability were derived from subject questionnaires and observed task performance.
8. The Sample Size for the Training Set
The document does not mention any "training set" in the context of machine learning or AI models. This device is a physical energy-based device, not a software algorithm that requires a training set. The clinical study described served as the primary test set for the device's safety and effectiveness.
9. How the Ground Truth for the Training Set was Established
As there is no mention of an AI algorithm or a training set, this question is not applicable. The device's performance was evaluated through a clinical study where outcomes were assessed by blinded dermatologists and participant feedback.
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