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The Eclipse MicroPen EVO 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 and older.

The Eclipse MicroPen EVO™ is a minimally invasive microneedling device that mechanically creates microscopic punctures in the epidermal and dermal layers of the skin by means of micro-needles in a reciprocating cartidge head. The MicroPen EVO is comprised of a reusable pen body, a sterile, single use microneedling cartridge, a rechargeable battery pack, a battery charger with power supply, and a disposible MicroSleeve sheath. The microneedling cartridge is attached to the pen body and activated with an On/Off button. The depth of needle penetration can be adjusted by the user depending on the skin being treated. Charging is accomplished by placing the MicroPen EVO pen body or the battery pack on the Charger base.

The provided text describes the acceptance criteria and performance of the Eclipse MicroPen EVO, a microneedling device. However, it does not contain information related to a study that involves human expert adjudication, multi-reader multi-case (MRMC) studies, or detailed information about training data for an AI model. The document focuses on bench testing and engineering verification for the device's physical and mechanical performance, and its biological compatibility.

Therefore, many of the requested sections (2-9) are not applicable or cannot be answered from the provided text, as they pertain to studies typically done for AI/ML-driven medical devices analyzing images or other complex data. The Eclipse MicroPen EVO is a mechanical device, and its evaluation is based on engineering and materials testing, not AI performance on clinical data or human reader assessments.

Here's a breakdown of what can be extracted about the acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the tests performed and the statements that the device "met the established criteria" or "passed." The reported performance is the outcome of these tests.

2. Sample size used for the test set and data provenance:

• Puncture Rate Testing: Not explicitly stated, just "All test articles" and "The MicroPen EVO handpieces with attached needling cartridges and battery pack."
• Needle Penetration Depth and Extension Accuracy: Not explicitly stated, just "All MicroPen EVO test articles."
• Needle Retention: n=35 needles from nine cartridges.
• Battery Life Testing: Thirty trials were completed.
• Use Life Testing: Not explicitly stated, just "test articles."
• Cartridge Reliability Testing: Nine test articles.
• Microbial Ingress Testing: Not explicitly stated, just "Fully assembled MicroPen EVO test units."
• Suction Testing: Not explicitly stated, just "all nine test cartridges."
• Cleaning and Disinfection: Not explicitly stated.
• Data Provenance: All testing appears to be internal company testing ("Eclipse conducted testing/trials"). The testing used synthetic skin (SynDaver SynTissue) to simulate worst-case human skin conditions and, for suction prevention, human forearms. This is retrospective in the sense that the data was collected for this submission, not a prospective clinical trial. The country of origin for the data is implied to be where Eclipse MedCorp LLC conducts its testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This device is evaluated through engineering and materials testing, not through expert assessment of clinical data or images.

4. Adjudication method for the test set:

• None. As above, this is laboratory/engineering testing with predefined objective pass/fail criteria.

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. This type of study is for AI-powered diagnostic/interpretive devices, not mechanical microneedling devices.

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

• Not applicable. There is no AI algorithm being evaluated for standalone performance.

7. The type of ground truth used:

• The "ground truth" for this device's performance is established through physical and mechanical measurements against defined engineering specifications and industry standards, and biological testing (biocompatibility, microbial ingress) against established limits. For example, RPMs are measured directly, needle depth is measured directly, and bacterial reduction is measured by CFU counts. For non-quantitative aspects like visual degradation, it's based on observable physical state.

8. The sample size for the training set:

• Not applicable. There is no AI model that requires a training set.

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

• Not applicable.

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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.

• 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.

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