(362 days)
The Renuvion® Dermal System is an electrosurgical device for dermatological procedures for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II or III. The treatment is achieved through controlled heating of the outer layers of the skin so that part or all of the epidermis becomes non-viable and there is controlled thermal modification to the underlying dermis.
The Renuvion® Dermal Handpiece is only compatible with Apyx Medical Electrosurgical Generators.
The Renuvion® Dermal Handpiece is a sterile single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible Apyx Helium Plasma Generator (APYX-200P, APYX-RS3 - cleared under 510(k) K170188 & K192867) for the delivery of radiofrequency energy and/or helium plasma for the delivery of helium plasma for the noninvasive treatment of facial wrinkles and rhytides, in patients with Fitzpatrick skin types I, II or III.
The Renuvion Dermal handpiece is part of the Renuvion System composed of the compatible Apyx generator, Foot switch, helium source, and patient grounding pad.
The tip of the Renuvion® Dermal Handpiece is used to deliver thermal energy to tissue through a precise helium plasma beam. The device connects to the electrosurgical generator which is also connected to a helium gas tank and regulator. The device requires the use of a grounding pad plugged into the generator to complete the circuit. The device is offered only in one size, 44mm, catalog number APYX-044-DERM. The handpiece is activated by pressing the activation button on the handpiece or by pressing the purple foot pedal on the foot control accessory. The device is rated at 4.0kVpeak.
The provided text describes the acceptance criteria and the study that proves the Renuvion® Dermal Handpiece meets the criteria, as part of a 510(k) premarket notification.
1. Table of Acceptance Criteria and Reported Device Performance
The document describes both bench testing and human clinical trial results.
Bench Testing Acceptance Criteria & Results:
| Test | Objective | Acceptance Criteria Met (Result) |
|---|---|---|
| Mechanical Verification & Functionality | Verify Mechanical functionality of the Renuvion® Dermal Handpiece and associated accessories, Renuvion® Dermal Spacers. | Mechanical functionality requirements met |
| System Compatibility Testing | Verify the device, when connected to the generators (with all the components and accessories working together as a system), are working as intended and are compatible with all system components. | System compatibility requirements met |
| Thermal Tissue Effect | Compare the tissue thermal effects of the subject device (Renuvion® Dermal Handpiece) with the reference device (Renuvion®/J-Plasma Precise Open Handpiece) using 4 different tissue types. | Thermal tissue effect requirements met |
| Inspectional Verification | Document parameters that can be verified through inspection for the Renuvion® Dermal Handpiece. | Inspectional requirements met |
| Packaging Validation | Evaluate simulated (and/or real-time) aging and associated package integrity and shelf-life claims. Assess the potential for damage to the device (e.g., drop tests of the instrument in its packaging). | Packaging requirements met |
Human Clinical Trial Acceptance Criteria & Results:
| Endpoint | Acceptance Criteria (Objective) | Reported Device Performance (Result) |
|---|---|---|
| Primary Effectiveness Endpoint | Proportion of subjects with at least one-point improvement from Baseline in Fitzpatrick Wrinkle and Elastosis Scale (FWS) at 90-days post-procedure as determined by 2 out of 3 blinded Independent Photographic Reviewers (IPR) assessment of photographs. | - 92.7% (51/55) of subjects scored at least a one-point improvement on the FWS at 90 days. |
- 25.5% scored at least a two-point improvement.
- 5.5% scored at least a three-point improvement.
The primary effectiveness endpoint was achieved. The effectiveness outcomes were described as "as good or better" than the predicate device. |
| Primary Safety Endpoint | Evaluation of adverse events up to the 3-month visit following the procedure. | - No serious adverse events (SAEs) related to the study device or procedure were reported. - Adverse events (AEs) were in line with expectations for dermatological wrinkle reduction procedures involving controlled heat to the epidermis.
- Common AEs: edema, erythema, and post-inflammatory hyperpigmentation.
- The rate of AEs was consistent with the expected range for the predicate device, as reported in literature. |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Bench Testing: Not explicitly stated as a numerical sample size but "all acceptance criteria were met" for the various tests.
- Pre-clinical Animal Studies: Not specified, but conducted on "live porcine skin tissue."
- Human Clinical Trial: 55 study subjects.
- Data Provenance:
- Bench Testing: Likely conducted in a lab environment by the manufacturer.
- Pre-clinical Animal Studies: Conducted in a lab environment.
- Human Clinical Trial: Prospective, multicenter, single-arm clinical study evaluating the use of the Renuvion® Dermal System. Conducted at 3 investigational centers in the United States. The study was an evaluator-blinded prospective study.
3. Number of Experts and Qualifications for Ground Truth
- Human Clinical Trial: Ground truth for the primary effectiveness endpoint (FWS improvement) was established by 3 blinded Independent Photographic Reviewers (IPR). Their specific qualifications (e.g., radiologist, years of experience) are not explicitly stated in the provided text. However, their role as "Independent Photographic Reviewers" suggests expertise in evaluating aesthetic outcomes from medical photographs.
4. Adjudication Method for the Test Set
- Human Clinical Trial Adjudication: For the primary effectiveness endpoint, an improvement was determined when 2 out of 3 blinded Independent Photographic Reviewers (IPR) agreed. This is a form of consensus-based adjudication, specifically a "majority rule" (2/3).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- A formal MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted, as this device is an energy-based surgical device, not an AI diagnostic tool.
- The clinical study did compare the device's safety and effectiveness profile (AEs, improvement rates) to the predicate device's data from existing literature. This is a comparison of device performance, not a human reader study.
6. Standalone Performance (Algorithm Only)
- This device is an electrosurgical system, not an algorithm. Therefore, a standalone (algorithm-only) performance evaluation does not apply in this context. The performance evaluated was that of the physical device and its interaction with tissue.
7. Type of Ground Truth Used
- Bench Testing: Engineering specifications, functional requirements, and established physical/electrical properties served as ground truth.
- Pre-clinical Animal Studies: Ground truth for thermal damage zone (coagulation necrosis) was established by histology under magnification on porcine skin tissue.
- Human Clinical Trial:
- Effectiveness: Ground truth for wrinkle and rhytide improvement was based on a consensus of 3 blinded Independent Photographic Reviewers using the Fitzpatrick Wrinkle and Elastosis Scale (FWS) applied to photographs.
- Safety: Ground truth for adverse events was based on clinical observation and reporting by investigators and subjects during the study.
8. Sample Size for the Training Set
- The provided document describes a premarket notification (510(k)) for a medical device that involves physical interaction with tissue, not an AI/Machine Learning device that requires a "training set" in the computational sense. Therefore, "training set" sample size is not applicable to this type of device submission. The clinical study of 55 subjects serves as the clinical validation dataset.
9. How Ground Truth for Training Set was Established
- As noted above, the concept of a "training set" in the context of an AI/ML algorithm does not apply to this device. The clinical study served as a validation study for the device's performance in humans. The ground truth for this clinical validation was established as described in section 7.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.