Search Results
Found 1 results
510(k) Data Aggregation
(324 days)
SNA-001 Silver Photoparticle Topical Gel is indicated for use as an accessory to 810 mm diode laser for temporary removal of light-colored hair in patients with skin types I, II and III. Light-colored hair types include blonde, light red, light brown, gray and white.
SNA-001 Silver Photoparticle Topical Gel (SNA-001) is used as an accessory to 810 nm diode dermatologic lasers for the removal of unwanted body hair. SNA-001 consists of near-infrared lightabsorbing silver particles suspended in a topical gel that mediates selective photothermolysis of the hair follicle when illuminated by a specific wavelength of laser light (810 nm). The photoparticles are nanoscale silver plates coated with silica and tuned to a wavelength of 810 nm corresponding to commonly used dermatologic lasers. These photoparticles function as highly efficient chromophores for the absorption of laser light. When exposed to laser light of the appropriate wavelength, the photoparticles rapidly heat to temperatures capable of facilitating targeted damage to the hair follicle . SNA-001 is dark blue/black in color, is for single use only, and is provided non-sterile in 1cc polypropylene syringe dispensers.
This document describes the SNA-001 Silver Photoparticle Topical Gel, an accessory to 810 nm diode lasers for temporary removal of light-colored hair. However, it does not include detailed acceptance criteria or a study that uses an AI device, as per the typical context of your questions. The clinical study described evaluates the performance of the SNA-001 gel itself, not an AI-powered device.
Therefore, I cannot directly answer your questions as they pertain to AI device acceptance criteria and studies.
However, based on the provided text, I can infer the effectiveness criterion used in the clinical study for the SNA-001 Silver Photoparticle Topical Gel.
Inferred Effectiveness Criterion and Reported Performance for SNA-001 Gel:
The primary effectiveness measure was the "mean percentage change in hair count from baseline to 3 months post-treatment." The study established a "prespecified non-inferiority criterion for the percentage change in hair count" with SNA-001 + laser compared to Vehicle + laser.
Here's the information extracted and formatted as closely as possible to your request, but focused on the SNA-001 gel's effectiveness, not an AI device.
Acceptance Criteria and Study for SNA-001 Silver Photoparticle Topical Gel
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criteria | Reported Device Performance (SNA-001 + Laser) |
|---|---|---|
| Effectiveness | Non-inferiority of SNA-001 + laser compared to Vehicle + laser based on the mean percentage change in hair count from baseline to 3 months post-treatment (specific non-inferiority margin not explicitly stated, but success implies it was met). | The primary effectiveness analysis demonstrated non-inferiority of SNA-001 + laser to Vehicle + laser for the percentage change in hair count from baseline to 3 months post-treatment (using Multiple Imputation for the Intent-To-Treat Population). |
| Additionally, a statistically significant greater proportion of subjects achieving 50% or greater hair reduction in the SNA-001 + laser group compared to the Vehicle + laser group. | 17.4% subjects in SNA-001 + laser group achieved >=50% hair reduction vs. 8.7% in Vehicle + laser group (p = 0.046). | |
| Safety | Treatment to be safe and well tolerated, with adverse events similar to those observed with dermatologic lasers and resolved without sequelae. No serious and/or unanticipated adverse events related to study treatment. | Most reported adverse events were local dermatologic reactions of mild to moderate intensity (erythema, blistering, scabbing, bruising, rash, pigmentation changes), similar to those routinely observed with dermatologic lasers, and resolved without sequelae by 3 months post-treatment. No serious/unanticipated adverse events. |
Performance Summary Table (from document for effectiveness):
| Analysis Population (Data) | SNA-001 + Laser (mean % change) | Vehicle + Laser (mean % change) |
|---|---|---|
| ITT (Observed) | -17.5 | -1.1 |
| ITT (MI)* | -16.5 | -3.6 |
| PP (Observed) | -25.4 | -19.7 |
| PP (MI) | -24.6 | -13.9 |
| *The analysis of the difference between treatments demonstrated non-inferiority of SNA-001 + laser to Vehicle + laser. |
Regarding the Absence of AI-Specific Information:
Since the provided document describes a medical device (SNA-001 Silver Photoparticle Topical Gel) and its clinical study, not an AI-powered device, the following specific points from your request cannot be addressed as they are not applicable or mentioned:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test set sample size: Not explicitly defined in terms of AI test set. However, for the clinical study of the gel: A total of 77 subjects were included in the Safety Population. 65 were included in the Intent to Treat (ITT) Population and 49 in the Per Protocol (PP) population.
- Data provenance: The study was a "multicenter, randomized, within-subject controlled clinical study with blinded assessment... conducted in the U.S." This indicates a prospective study.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as this is not an AI study. Assessment was "blinded assessment" likely by clinical staff, but specific qualifications and number of experts for ground truth are not detailed.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as this is not an AI study.
- 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
- Not applicable as this is not an AI study and does not involve "human readers" in the context of an AI-assisted diagnostic task.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is a device (topical gel) used in conjunction with a laser, not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the effectiveness measure: "mean percentage in hair count from baseline to 3 months post-treatment." This is a quantitative, objective measurement.
- For safety: Observation and reporting of adverse events.
- 8. The sample size for the training set
- Not applicable as this is not an AI study.
- 9. How the ground truth for the training set was established
- Not applicable as this is not an AI study.
Ask a specific question about this device
Page 1 of 1