Search Results

The Cytrellis Dermal Micro-Coring System is indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV.

Device Description

The Cytrellis Dermal Micro-Coring System removes unwanted skin by rapidly excising full thickness micro-columns of the dermal and epidermal tissue via specially designed hollow coring needles. The needles are controlled to precise coring depths and positions by the device console and handpiece. The system provides a range of skin removal percentages (treatment densities) and needle depths settings to customize the user needs that is controlled by the LCD touch display on the console. The treatment is applied in 1cm2 areas of the skin at a time by the handpiece, which has a vacuum assisted disposable in order to help with alignment between treatment areas. The Cytrellis Dermal Micro-Coring System mechanically removes full thickness sections of skin without evidence of scarring or need for surgical procedure. As much as 7.9% of the surface area of the skin is removed in columns that are the size of the inner diameter of the needle which is too small to cause visible scarring. The holes quickly close because of the natural elastin of the skin as they start to heal. This wound response, combined with the mechanical removal of the skin's surface area, leads to a reduction in the appearance of wrinkles.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Cytrellis Dermal Micro-Coring System, based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Cytrellis Dermal Micro-Coring System are primarily focused on safety and effectiveness, demonstrated through non-clinical performance testing and a clinical study.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance/Result
Non-Clinical Performance Testing
Software	Documentation for moderate level of concern device in accordance with FDA Guidance.	Successfully submitted software documentation in accordance with FDA Guidance. (Page 6)
Electrical Safety	Meets relevant sections of IEC 60601-1.	Passed all relevant sections of IEC 60601-1. (Page 6)
Electromagnetic Interference (EMI)	Meets relevant sections (Radiated emissions, Conducted emissions, Harmonic emissions, Flicker emissions, Electrostatic discharge immunity test, radiated radio frequency immunity, Electrical fast transient/burst, lightning surge immunity, conducted RF immunity, electromagnetic field immunity, voltage dips and short interruptions, RFID compatibility, and power frequency magnetic field immunity test).	Successfully met all relevant sections to satisfy compliance. (Page 6)
Needle Characteristics	Identification of needle length, geometry, maximum penetration depth, and puncture rate.	Technical specifications and needle characteristics identified. (Page 7)
Accuracy of Needle Penetration Depth & Puncture Rate	Device performs as intended under anticipated conditions of use.	Accuracy of needle penetration depth and puncture rate tested in skin substrate model and measured using Keyence Laser System. (Page 7)
Safety Features (Cross-contamination, Fluid Ingress)	Device design prevents cross-contamination and fluid ingress (needle cartridge design, RFID, tortuous path).	Device design prevents cross-contamination and fluid ingress. Testing performed under worst-case scenarios. (Page 7)
Max Safe Needle Penetration Depth	Identification of max safe needle penetration depth for the device and labeled indications.	Maximum safe needle penetration depth identified in skin substrate model and measured using Keyence Laser System. (Page 7)
Sterility	Performance data demonstrates sterility of patient-contacting components according to ISO 11137-1:2006, ISO 11137-2:2013 and ISO/TS 13004:2013.	Performance data demonstrates sterility according to specified ISO standards. (Page 7)
Shelf Life	Performance data supports shelf life by demonstrating continued sterility, package integrity, and device functionality over intended shelf life according to ASTM F1980 -16, ISO 11607-1, ASTM F88-15, ASTM F1140 / F1140M-13, ASTM F2096-11, ASTM F1886 / F1886M-16.	Performance data supports shelf life according to specified ASTM and ISO standards. (Page 7)
Electrical Safety & EMC	Performance data demonstrates electrical safety and electromagnetic compatibility (EMC) of all electrical components according to IEC 60601-1:2012 3.1 edition and IEC 60601-1-2:2014.	Performance data demonstrates electrical safety and EMC according to specified IEC standards. (Page 7)
Software Verification, Validation, Hazard Analysis	Performed for all software components according to FDA Guidance.	Performed for all software components according to FDA Guidance. (Page 8)
Biocompatibility	Patient-contacting components demonstrated to be biocompatible (cytotoxicity, irritation, sensitization, acute systemic toxicity, material-mediated pyrogenicity, hemocompatibility per ISO 10993-1).	Demonstrated biocompatibility including evaluation of cytotoxicity, irritation, sensitization, acute systemic toxicity and material-mediated pyrogenicity and hemocompatibility per ISO 10993-1. (Page 8)
Cleaning & Disinfection Instructions	Validated for reusable components per AAMI TIR30:2011/(R)2016 and AAMI TIR12:2010.	Cleaning and disinfection validation performed for reusable components per AAMI TIR30:2011/(R)2016 and AAMI TIR12:2010. (Page 8)
Labeling (Device & Patient)	Includes required information on operation, technical parameters, reprocessing, disposal, shelf life, risks, benefits, and postoperative care.	Labeling includes all required information (as per sections 9 and 10 on page 8).
Clinical Study - Effectiveness
Reduction in Wrinkles	Mean change from baseline for the Lemperle Wrinkle Severity Scale (LWSS) is greater than 1.0.	Mean change from baseline for the LWSS was 1.3 [95% CI: 1.22, 1.42] when assessed at depth settings of up to 5mm. The lower limit of the 95% confidence interval is greater than 1.0, supporting the primary endpoint. When treatment was performed at up to 4mm, the LWSS change was 1.1. (Page 10)
Clinical Study - Safety
Adverse Events	No Serious Adverse Events; Anticipated Adverse Device Effects (ADEs) are mild to moderate and do not require intervention.	No Serious Adverse Events were reported. Nine (9) adverse events were reported in five (5) subjects, with four (4) considered ADEs (Black eye (bruising), cheek numbness, redness, track marks on cheek). All ADEs were classified as mild to moderate and did not require intervention, and were anticipated risks listed in labeling. (Page 10)

Study Details for Clinical Evidence

Here are the details regarding the clinical study that proves the device meets the acceptance criteria for effectiveness and safety:

2. Sample Size and Data Provenance

Sample Size for Test Set: Fifty-one (51) subjects completed the study.
Data Provenance:
- Country of Origin: United States (multicenter study conducted at four (4) sites).
- Retrospective or Prospective: Prospective (subjects were treated over a period, and assessments were made at defined intervals post-treatment).

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Three (3) independent evaluators.
Qualifications of Experts: The document states they were "blinded independent evaluators." While specific qualifications like "radiologist with 10 years of experience" are not provided, the context implies they are medical professionals qualified to assess wrinkle severity using the Lemperle Wrinkle Severity Scale (LWSS).

4. Adjudication Method for the Test Set

The document implies that the assessment was performed by three independent evaluators, suggesting that their individual assessments contributed to the outcome. It does not explicitly state a specific adjudication method like "2+1" or "3+1" (e.g., if discrepancies were resolved by a tie-breaker or consensus). It reports a "mean change" based on their assessments, indicating all three evaluators' input was considered.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done comparing human readers with AI vs. without AI assistance.
- The study involved human evaluators assessing photographs to determine wrinkle improvement, but this was a measurement of the direct effect of the device on patients, not a study of AI assistance for human readers. The device itself is a physical microneedling system, not an AI diagnostic or assistance tool.

6. Standalone (Algorithm Only) Performance

No standalone (algorithm-only) performance was done.
- As noted above, the Cytrellis Dermal Micro-Coring System is a physical medical device, not an AI algorithm. Its performance is measured by its direct effect on patients.

7. Type of Ground Truth Used

Expert Consensus / Physician Reported Outcomes using a validated scale.
- The primary effectiveness endpoint was measured by improvement in wrinkles using the Lemperle Wrinkle Severity Scale (LWSS), assessed by three blinded independent evaluators from professional clinical portrait photographs.
- Safety ground truth was based on reported adverse events, classified by physicians as part of the clinical study.

8. Sample Size for the Training Set

Not applicable / Not explicitly stated.
- This device is a physical medical device. The concept of a "training set" is typically associated with machine learning or AI models, which is not what this device is. The "training" for this device would refer to the development and engineering processes, which don't have a distinct "training set" like an AI model.

9. How the Ground Truth for the Training Set Was Established

Not applicable.
- As explained above, there isn't a "ground truth for a training set" in the context of this physical device. The device's design and development would rely on engineering principles, preclinical testing (as outlined in section 1), and clinical studies for validation.

Ask a Question

Ask a specific question about this device

Page 1 of 1