(235 days)
The SkinPen® Precision system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and 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. 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. SkinPen® BioSheath: nonsterile, disposable cover for the microneedling pen handpiece to avoid contamination of the SkinPen® Precision.
Here's a breakdown of the acceptance criteria and study details for the SkinPen Precision System, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not explicitly state formal "acceptance criteria" with numerical thresholds for performance. Instead, it describes "effectiveness endpoints" and presents study results that demonstrate the device's ability to improve the appearance of wrinkles on the neck. The implicit acceptance criterion is a statistically significant and clinically meaningful improvement in wrinkle appearance and positive patient satisfaction, as evidenced by the measured outcomes.
| Metric / Endpoint | Acceptance Criteria (Implied) | Reported Device Performance (Neck Wrinkles) |
|---|---|---|
| Primary Effectiveness: G. Lemperle Wrinkle Scale (Photo Grading) | Statistically significant improvement in wrinkle severity from baseline at 3 months post-treatment. | Mean GLWS Score: Day 1: 3.31 (SD 0.74); 3 Months Post-Treatment: 2.45 (SD 0.93) |
| Change from Baseline: 16 out of 32 subjects (50%) showed ≥1 grade improvement at 3 months post-treatment. (This indicates a reduction in perceived wrinkle severity). | ||
| Secondary Effectiveness: Clinician's Global Aesthetic Improvement Assessment (CGAIS) | Clinically meaningful proportion of subjects showing "Improved," "Much Improved," or "Very Much Improved" ratings by clinicians. | At 3 months post-treatment: |
- 11.5% of subjects received a '2: much improved' grading.
- 31.5% of subjects received a '3: improved' grading.
- 57% received a '4: no change' grading. (Total of 43% showed improvement) |
| Secondary Effectiveness: Subject's Global Aesthetic Improvement Scale (SGAIS) | Clinically meaningful proportion of subjects reporting "Improved," "Much Improved," or "Very Much Improved" ratings. | At 3 months post-treatment: 22 out of 32 subjects (68.8%) reported some percentage of improvement in the appearance of their wrinkles.
(This suggests a high level of patient-perceived improvement). |
| Secondary Effectiveness: Patient Satisfaction Questionnaire - Question 1 (Improvement noticed) | High percentage of subjects reporting "Yes" to noticing improvement in fine lines and wrinkles. | 1-Month Post-Treatment: 93.8% (30 out of 32) reported "Yes".
3-Months Post-Treatment: 71.9% (23 out of 32) reported "Yes". (High initial and sustained patient perception of improvement). |
| Secondary Effectiveness: Patient Satisfaction Questionnaire - Question 2 (Satisfaction) | High percentage of subjects reporting "Favorable" satisfaction. | 1-Month Post-Treatment: 87.5% (28 out of 32) reported "Favorable".
3-Months Post-Treatment: 75.0% (24 out of 32) reported "Favorable". (High level of patient satisfaction). |
| Secondary Effectiveness: Patient Satisfaction Questionnaire - Question 3 (Recommendation) | High percentage of subjects reporting "Yes" to recommending the treatment. | 1-Month Post-Treatment: 80.6% (25 out of 31) reported "Yes".
3-Months Post-Treatment: 65.6% (21 out of 32) reported "Yes". (Strong willingness to recommend, though decreasing slightly over time). |
| Safety Endpoint (Adverse Events) | Absence of serious device-related adverse events. | No adverse events related to the SkinPen Precision treatment were observed on the face and neck during the study. (Common transient treatment responses like dryness, redness, burning, itching, peeling, tenderness were reported, lasting 1-7 days). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Study (Test Set): 35 subjects initially enrolled (2 male, 33 female). The detailed demographic table (Table 1) shows N=32 for the reported results, implying 32 subjects completed the study protocol in some capacity for the neck wrinkle indication.
- Data Provenance: The study was a "single center study" (location not explicitly stated, but typically US-based for FDA submissions). It was a prospective clinical study conducted to specifically evaluate the device for the new indication (wrinkles on the neck).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Two separate independent blinded Board Certified Physicians.
- Qualifications of Experts: Board Certified Physicians. (No specific years of experience are mentioned).
4. Adjudication Method for the Test Set
- The document states that the G. Lemperle Wrinkle Scale and Clinician's Global Aesthetic Improvement Assessment were "graded by two blinded graders." It does not specify an adjudication method such as 2+1, 3+1, or any other consensus mechanism if the two graders disagreed. It only reports the results based on these two independent blinded assessments.
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, an MRMC comparative effectiveness study was not done. This study evaluates the direct clinical effectiveness of a physical microneedling device for aesthetic improvement, not an AI-assisted diagnostic or interpretative tool for human readers. Therefore, the concept of human reader improvement with/without AI assistance is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, this is not an algorithm. The SkinPen Precision System is a physical microneedling device. The study evaluates the device's direct effect on patients, interpreted by human clinicians for efficacy and safety.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for evaluating the device's effectiveness was primarily based on:
- Expert Assessment: Graded by two independent, blinded Board Certified Physicians using standardized aesthetic scales (G. Lemperle Wrinkle Scale, Clinician's Global Aesthetic Improvement Assessment) based on digital images. This leans towards expert consensus if their results were combined or averaged, though the method isn't detailed.
- Patient-Reported Outcomes/Subjective Assessment: Subject Global Aesthetic Improvement Scale and Patient Satisfaction Questionnaires provided outcomes data directly from the subjects.
- Safety Data: Monitoring of adverse events and subject safety diaries also contributed to the overall outcomes data.
8. The Sample Size for the Training Set
- This clinical study was conducted to support the safety and effectiveness of the SkinPen Precision System for the treatment of wrinkles on the neck. This appears to be a pivotal clinical trial for the new indication, meaning it serves as the primary evidence for this specific claim, not a "training set" for an algorithm. There is no mention of a separate training set for an algorithm as the device itself is not an algorithm.
- The document mentions a previous clinical study for acne scars (DEN160029) but does not provide details about its sample size in this submission.
9. How the Ground Truth for the Training Set Was Established
- As this is not an AI/algorithm-driven device with a training set, the concept of establishing ground truth for a training set does not apply. The "ground truth" for establishing the device's efficacy and safety for its intended use was derived directly from the prospective clinical study as outlined in section 7.
§ 878.4430 Microneedling device for aesthetic use.
(a)
Identification. A microneedling device for aesthetic use is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use. This classification does not include devices intended for transdermal delivery of topical products such as cosmetics, drugs, or biologics.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical specifications and needle characteristics must be identified, including needle length, geometry, maximum penetration depth, and puncture rate.
(2) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Accuracy of needle penetration depth and puncture rate;
(ii) Safety features built into the device to protect against cross-contamination, including fluid ingress protection; and
(iii) Identification of the maximum safe needle penetration depth for the device for the labeled indications for use.
(3) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life.
(5) Performance data must demonstrate the electrical safety and electromagnetic compatibility (EMC) of all electrical components of the device.
(6) Software verification, validation, and hazard analysis must be performed for all software components of the device.
(7) The patient-contacting components of the device must be demonstrated to be biocompatible.
(8) Performance data must validate the cleaning and disinfection instructions for reusable components of the device.
(9) Labeling must include the following:
(i) Information on how to operate the device and its components and the typical course of treatment;
(ii) A summary of the device technical parameters, including needle length, needle geometry, maximum penetration depth, and puncture rate;
(iii) Validated methods and instructions for reprocessing of any reusable components;
(iv) Disposal instructions; and
(v) A shelf life.
(10) Patient labeling must be provided and must include:
(i) Information on how the device operates and the typical course of treatment;
(ii) The probable risks and benefits associated with use of the device; and
(iii) Postoperative care instructions.