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Sebacia Microparticles are indicated for use as an accessory to 1064 nm lasers to facilitate photothermal heating of sebaceous glands for the treatment of mild to moderate inflammatory acne vulgaris.

Sebacia Microparticles are a non-sterile, single-use product that is topically applied to the face for the purpose of supporting and supplementing the performance of legally marketed 1064 nm medical lasers for dermatologic use. The liquid suspension contains microparticles comprised of a silica core wrapped in a gold shell and coated with polyethylene glycol. The Sebacia Microparticles are topically applied to the face followed by gentle agitation of the skin surface using a mechanical massager and irradiated with a commercially available 1064 nm laser that heats the microparticles resulting in localized selective photothermolysis.

Here's an analysis of the provided text regarding the acceptance criteria and the study for the Sebacia Microparticles device:

1. A table of acceptance criteria and the reported device performance

   The document does not explicitly state acceptance criteria for the device performance in a quantitative manner. Instead, the clinical study aims to demonstrate that using Sebacia Microparticles with a laser ("SM + Laser") provides equivalent or similar results to using the laser alone ("Laser Alone") but with fewer treatments and lower laser fluences.

   Therefore, the reported device performance is presented as a comparison between the "SM + Laser" group and the "Laser Alone" group.

   Performance Metric (Endpoint)	SM + Laser (n = 86)	Laser Alone (n = 82)
   PRIMARY ENDPOINT
   % reduction in ILC (Baseline to Week 12); mean	40.17	41.89
   % reduction in ILC (Baseline to Week 12); median	53.33	45.45
   SECONDARY ENDPOINTS
   % with ≥ 40% ILC reduction at Week 12	64.4	56.5
   % with IGA clear/almost clear at Week 12	30.1	31.9
   absolute reduction in ILC (Baseline to Wk 12); mean	8.4	8.5
   absolute reduction in ILC (Baseline to Wk 12); median	11.0	9.0
   TREATMENT PARAMETERS
   laser fluence (J/cm²); mean	29.44	48.93
   laser fluence (J/cm²); median	30.00	49.79
   number of treatment sessions (All Patients); mean	2.9	5.3
   number of treatment sessions (All Patients); median	3.0	6.0
   number of treatment sessions (Completers); mean	3.0	5.8
   number of treatment sessions (Completers); median	3.0	6.0

   Conclusion regarding acceptance: The study concluded that the "SM + Laser" group showed "equivalent reduction in mild to moderate inflammatory acne lesions when compared to the reduction in the Laser Alone Group" but with "fewer treatments and lower laser fluences." While subject satisfaction was higher in the SM + Laser group, the primary and secondary endpoints indicated similar clinical effectiveness.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   • Sample Size: A total of 168 subjects were enrolled in the clinical study.
     • SM + Laser group: n = 86
     • Laser Alone group: n = 82
   • Data Provenance: The study was a prospective, randomized, controlled, parallel group clinical study conducted in the U.S.

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)

   The document states "blinded assessment" for the clinical study. However, it does not specify the number of experts used or their qualifications for establishing the ground truth (e.g., assessing Inflammatory Lesion Count - ILC, or Investigator's Global Assessment - IGA).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

   The document does not provide details on any adjudication method used for the clinical assessments. It only mentions "blinded assessment."

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

   This study is not an MRMC comparative effectiveness study involving human readers and AI assistance. It's a clinical trial comparing a device (Sebacia Microparticles + laser) to a control (laser alone) in treating acne. Therefore, this question is not applicable.

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

   This device is a physical product (microparticles) used in conjunction with a laser, and its performance is evaluated in a human clinical trial, not as an standalone algorithm. Therefore, this question is not applicable.

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

   The ground truth was established through clinical assessments of acne severity. The primary endpoint was "percentage reduction in Inflammatory Lesion Count (ILC) from Baseline to Week 12." Secondary endpoints included the percentage of subjects with ≥ 40% ILC reduction and the percentage with Investigator's Global Assessment (IGA) of clear/almost clear. These are clinical outcome measures assessed by trained medical personnel.

8. The sample size for the training set

   The document describes a clinical study, not a machine learning model's development. Therefore, there is no "training set" in the context of this regulatory submission. Animal studies and non-clinical testing served as pre-clinical development/testing phases rather than a "training set" for an algorithm.

9. How the ground truth for the training set was established

   As there is no "training set" for an algorithm in this context, this question is not applicable. The "ground truth" for the main clinical study was established through blinded clinical assessment of acne lesion counts and global assessment, as described in point 7.

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