(103 days)
The Eclipse MicroPen® EVO 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 Eclipse MicroPen EVO™ is a minimally invasive microneedling device that mechanically creates microscopic punctures in the epidermal layers of the skin by means of micro-needles in a reciprocating cartridge head. The MicroPen EVO is comprised of a reusable pen body, a sterile, single use microneedlingcartridge, a rechargeable battery pack, and a battery charger with power supply. The microneedling cartridge is attached to the pen body and activated with an On/Off button. The depth of needle penetrationcan be adjusted by the user depending on the condition of the skin being treated. Charging is accomplished by placing the MicroPen EVO battery pack on the Charger base.
The information provided focuses on the substantial equivalence of the Eclipse MicroPen EVO to a predicate device, rather than a clinical study evaluating its performance against specific acceptance criteria. Therefore, several of the requested categories, such as "Effect size of how much human readers improve with AI vs without AI assistance" or "Sample size for the training set," are not applicable.
However, based on the provided text, I can infer information relevant to other categories.
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state acceptance criteria in a quantitative format for clinical efficacy. Instead, it relies on demonstrating equivalence to a predicate device which is already cleared for similar indications. The "Performance Data" section lists various engineering and biocompatibility tests whose successful completion serves as an "acceptance criteria" for safety and performance characteristics, but not for clinical appearance improvement.
| Acceptance Criterion Type (Implied) | Reported Device Performance Statement |
|---|---|
| Puncture rate, needle penetration depth & accuracy, needle retention, battery life, cartridge reliability, suction prevention | Device was subjected to performance testing and adheres to special controls and standards. (No specific quantitative results provided in the summary). |
| Fluid ingress testing for cross-contamination prevention | Device was subjected to performance testing and adheres to special controls and standards. (No specific quantitative results provided in the summary). |
| Cleaning and disinfection validation for reusable components | Device was subjected to performance testing and adheres to special controls and standards. (No specific quantitative results provided in the summary). |
| Biocompatibility | "The results of these tests demonstrated the device to be biocompatible with no evidence of material mediated pyrogenicity." (Tests included: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity) |
| Sterilization, Shelf Life/Package Integrity | Device was subjected to performance testing and adheres to standards (e.g., Ethylene oxide sterilization per ISO 11135-2014, ASTM-F1980, ASTM-F1886-2016, ASTM-F1929-2015, ASTM-F88, ANSI/AAMI/ISO 11607-1). (No specific quantitative results or acceptance criteria values are provided). |
| Electrical Safety and Electromagnetic Compatibility | Device was subjected to performance testing and adheres to standards (IEC- 60601-1:2005 + A1: 2012, EN/IEC 60601-1-2: 2015 /IEC 60601-1-2:2014). (No specific quantitative results or acceptance criteria values are provided). |
| Clinical Efficacy (Improvement in appearance of wrinkles of the neck / facial acne scars) | The device is substantially equivalent to the predicate device (SkinPen Precision System, K202243) which has established efficacy for these indications. The document does not provide independent clinical trial data for the MicroPen EVO. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not applicable for clinical testing of the Eclipse MicroPen EVO as no independent clinical efficacy study is described. The various engineering, biocompatibility, and sterility tests would have used different sample sizes relevant to their respective testing methodologies, but these are not specified in the document.
- Data provenance: Not applicable in terms of clinical trials for the Eclipse MicroPen EVO, as its efficacy is based on substantial equivalence to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no described clinical study involves establishing ground truth through expert review for the Eclipse MicroPen EVO. The "ground truth" for its efficacy is essentially derived from the predicate device's established performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no described clinical study involves expert adjudication for the Eclipse MicroPen EVO.
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:
Not applicable. This device is a microneedling device, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a microneedling device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the safety and performance aspects (biocompatibility, electrical safety, etc.), the ground truth is established by conformity to recognized international and national standards (e.g., ISO, ASTM, IEC).
For the clinical efficacy (improvement in appearance of wrinkles and acne scars), the "ground truth" is indirect, established by substantial equivalence to a legally marketed predicate device (SkinPen Precision System, K202243) that has already demonstrated such efficacy.
8. The sample size for the training set:
Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/machine learning device.
§ 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.