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510(k) Data Aggregation
(604 days)
BELLUS MEDICAL, LLC.
SkinPen® Precision System is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years or older.
The SkinPen® Precision System consists of a microneedling pen handpiece (SkinPen Precision) and a sterile needle cartridge (SkinPen Precision Cartridge). The accessories are a charging base and a BioSheath. A SkinPen Precision System treatment kit is provided separately and contains the following:
- SkinPen Precision Cartridge: sterile, disposable needle cartridge. Not to be . resterilized or reused.
- . SkinPen BioSheath: nonsterile, disposable cover for the microneedling pen handpiece to avoid contamination of the SkinPen Precision
- . Lift HG: hydrogel wound dressing (without drugs and/or biologics) to protect against abrasion and friction during the microneedling procedure. May be applied to prevent skin from drying out post procedure
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
SkinPen Precision System: Acceptance Criteria and Performance Study
The SkinPen Precision System is a microneedling device intended to improve the appearance of facial acne scars in adults aged 22 years or older. The regulatory information outlines various non-clinical and clinical studies conducted to ensure its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" for clinical effectiveness in a singular table, but rather presents performance goals through the clinical study outcomes. The regulatory framework defines special controls that serve as acceptance criteria for safety and performance aspects.
Here's an interpretation combining the clinical effectiveness results and the special controls as acceptance criteria:
| Acceptance Criterion (Based on Special Controls & Clinical Outcomes) | Reported Device Performance (Summary from Study) |
|---|---|
| Clinical Effectiveness: 1-grade reduction in Acne Scar Assessment Scale at 6 months post-treatment compared to baseline | 35% (7/20) of subjects showed a 1-grade reduction. An additional 20% (4/20) showed an improvement greater than 0 but less than 1, totaling 55% of subjects showing improvement. Mean score improved from 2.80 (mild) to 2.35 (mild). |
| Clinical Effectiveness: Patient-reported improvement in scar appearance (Self-assessed Scar Improvement Scale) | 85% (17/20) subjects reported some improvement at 1-month post-treatment; 90% (18/20) subjects reported some improvement at 6-months post-treatment. Mean score of 1.70 (1-25% improvement) at 6-months. |
| Clinical Effectiveness: Patient-reported overall aesthetic improvement (Subject Global Aesthetic Improvement Scale) | 80% (16/20) subjects reported "much improved" or "improved" at 1-month post-treatment; 90% (18/20) subjects reported "very much improved," "much improved," or "improved" at 6-months post-treatment. Mean score of 2.50 (improved) at 6-months. |
| Clinical Effectiveness: Patient satisfaction and willingness to recommend | 90% (18/20) subjects noticed improvement in acne scars at 6-months. 90% (18/20) would recommend to friends and family at 6-months. |
| Safety: No serious adverse events related to the device. Common treatment responses resolve within days. | No serious adverse events reported. One mild, possibly related AE (skin striae) resolved. Common treatment responses (dryness, rough skin, tightness, redness, itching, peeling, discomfort, tenderness, burning) were reported but all resolved within 1-6 days. |
| Biocompatibility: Patient-contacting components are biocompatible. | Testing provided on needle cartridge and SkinFuse Lift HG, including evaluation of cytotoxicity, irritation, and sensitization. |
| Sterility: Patient-contacting components (needle cartridge) are sterile and maintain sterility over shelf life. | Cartridge sterilized using EO (SAL 10-6). Shelf-life evaluated for accelerated aging equivalent to (b)(4) |
| . Met acceptance criteria for peel strength, dye penetration, and burst testing. Functional testing demonstrated maintenance of performance. | |
| Cross-Contamination Prevention: Effective barrier to test soil; validated cleaning/disinfection instructions for reusable components; fluid ingress protection. | BioSheath maintained effective barrier (no test organisms recovered from handpiece). Cleaning and disinfection instructions validated (results support acceptability). Fluid ingress testing showed no organisms detected beyond cartridge barrier. Lock-out feature prevents re-use of cartridge. |
| Electrical Safety & EMC: Complies with relevant standards. | Passed all relevant portions of IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 62366 testing. |
| Software: Verification, validation, and hazard analysis performed for all software components. | Adequate documentation provided for moderate LOC software. V&V activities described and met pass/fail criteria. Hazard analysis performed and addressed. |
| Bench Performance: Accurate needle penetration depth, puncture rate, reliable motor speed, needle durability, retraction, and suction prevention. | Puncture rate within tolerance (7000 RPM ± 10%). Minimal needle deformation observed. Needles fully retracted in "home" position. Needle extension within ± 0.35 mm of target at 2.5 mm depth (up to 2.75 mm). All 11 depth settings (0-2.5 mm) within +0 mm/-0.25 mm of selected depth. No visible signs of suction. Needles withstood >110-gram force. Device use-life reliability of ≥ 2000 hours. Needle cartridge reliability demonstrated under worst-case use. |
| Labeling: Comprehensive information provided (operation, technical parameters, reprocessing, disposal, shelf life, risks, benefits, post-operative care). | Labeling includes user manual, IFU, box labeling, and patient labeling with described content. Contains precaution for depths >1.5 mm and recommended procedure depths. |
Note: This table synthesizes information. The original document does not explicitly present clinical "acceptance criteria" but rather states the results and concludes that the probable benefits outweigh the probable risks.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Clinical Study (Effectiveness): 20 subjects treated with the SkinPen Precision System.
- Clinical Study (Safety - includes prototype): 41 subjects (20 SkinPen Precision, 21 prototype device).
- Data Provenance: The general location of the clinical study is not explicitly stated as a country but it was a "single center" study. The method was prospective (clinical study conducted to evaluate safety and effectiveness).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: 2 blinded evaluators.
- Qualifications of Experts: Board Certified Dermatologists. Specific experience (e.g., 10 years) is not provided.
4. Adjudication Method for the Test Set
The document states, "2 blinded evaluators would evaluate images after completion of the clinical study." It does not specify an adjudication method like 2+1 or 3+1 if their ratings differed. It implies both evaluators independently graded the images.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus those without AI assistance was not done. This study focused on the device's effectiveness on subjects, with expert graders evaluating subject images, not evaluating AI performance or AI-assisted human performance.
6. Standalone (Algorithm Only) Performance Study
This device is a physical microneedling system, not an AI algorithm. Therefore, no standalone (algorithm only) performance study was conducted. The performance studies were for the physical device itself.
7. Type of Ground Truth Used (for Clinical Effectiveness)
The ground truth for clinical effectiveness was established by expert consensus (two blinded dermatologists) grading digital images of facial acne scars using the "Acne Scar Assessment Scale" and the "Clinician's Global Aesthetic Improvement Assessment (CGAIS)". The Acne Scar Assessment Scale was also stated to be a "validated scale." Patient-reported outcomes (Self-assessed Scar Improvement Scale, Subject Global Aesthetic Improvement Scale, Patient Satisfaction Questionnaire) were also collected as secondary endpoints.
8. Sample Size for the Training Set
This report does not describe a machine learning algorithm that requires a "training set." The clinical study data was used to demonstrate the device's performance, not to train an AI model.
9. How the Ground Truth for the Training Set Was Established
As noted above, there was no training set in the context of an AI/ML algorithm. The clinical data was used for direct evaluation of the device.
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